Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris
Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288
Pinskaya, Yuliya B; Hsieh, Tsung-Ju; Roberts, W Eugene; Hartsfield, James K
To supplement the American Board of Orthodontics (ABO) objective grading system (OGS) for posttreatment dental casts and panoramic radiographs, a comprehensive clinical assessment (CCA) method was developed to assess facial form, dental esthetics, vertical dimension, arch form, periodontium preservation, root resorption, and treatment efficiency. The sum of the CCA and the ABO OGS scores was defined as the clinical outcome. To determine a 3-year baseline for treatment outcomes in a graduate orthodontic program, the posttreatment records of 521 consecutive patients were evaluated. The mean ABO OGS score for the entire sample was 34.4 points: 32.4, 33.1, and 37.8 points for 1998, 1999, and 2000, respectively. The mean CCA score for the entire sample was 4.67 points: 2.96, 5.13, and 6.15 points for 1998, 1999, and 2000, respectively. Corresponding ABO OGS and CCA scores showed a progressive decrease in the quality of finished cases that was associated with a treatment time increase from 28.9 to 39.3 months. Overall, longer active treatment times resulted in a diminished clinical outcome, primarily due to "patient burn-out." Scoring of all finished cases is an effective means for determining clinical outcomes. However, the data suggest that, in initiating a clinical grading program, it is important to establish a multiyear baseline. Patients who are progressing well in treatment tend to be finished by the time the current class graduates, and the problem patients are transferred. Because long treatment times are associated with diminished clinical outcomes, it is often in the best interest of the uncooperative patient to terminate treatment rather than extend active mechanics in an attempt to achieve a better result.
De Salvo, Simona; Bramanti, Placido; Marino, Silvia
Summary The neurophysiological approach to patients with disorders of consciousness allows recording of both central and peripheral nervous system electrical activities and provides a functional assessment. Data obtained using this approach can supplement information from clinical neurological examination, but also from the use of morphological neuroimaging techniques: computed tomography and magnetic resonance imaging. Neurophysiological techniques, such as electroencephalography (EEG), evoked potentials, transcranial magnetic stimulation, and EEG in association with functional magnetic resonance imaging, allow monitoring of clinical conditions and can help in the formulation of a prognosis. The aim of this review is to describe the main neurophysiological techniques used in disorders of consciousness to evaluate residual cerebral function, to provide information on the neuronal dysfunction for outcome evaluation, and to differentiate clinically between the vegetative and minimally conscious states. PMID:23402676
Rogers, Katherine D; Young, Alys; Lovell, Karina; Evans, Chris
This article discusses translation issues arising during the production of a British Sign Language (BSL) version of the psychological outcome measure "Clinical Outcomes in Routine Evaluation-Outcome Measure" (CORE-OM). The process included forward translation, meeting with a team of translators, producing a second draft of the BSL version and back translating into English. Further modifications were made to the BSL version before piloting it with d/Deaf populations. Details of the translation process are addressed, including (a) the implications of translating between modalities (written text to visual language); (b) clarity of frequency anchors: analog versus digital encoding; (c) pronouns and the direction of signing; and (iv) the influence of the on-screen format. The discussion of item-specific issues encountered when producing a BSL version of the CORE-OM includes the expression of precise emotional states in a language that uses visual modifiers, problems associated with iconic signs, and the influence of Deaf world knowledge when interpreting specific statements. Finally, it addresses the extent to which lessons learned through this translation process are generalizable to other signed languages and spoken language translations of standardized instruments. Despite the challenges, a BSL version of the CORE-OM has been produced and found to be reliable.
Friedberg, Mark Kevin; Roche, Susan Lucy; Balasingam, Mervin; Stephenson, Elizabeth; Slorach, Cameron; Fackoury, Cheryl; Kantor, Paul Fraser
We studied mechanical dyssynchrony and its association with clinical status in children with idiopathic dilated cardiomyopathy (IDC). The SD of QRS to peak systolic velocity interval by tissue Doppler was measured in 12 left ventricular segments, as a dyssynchrony index (DI), in each child with IDC during a 12-month period. Results were compared with a control cohort. We used the adult-defined DI cutpoint of 32.6 ms to define patients with IDC as "dyssynchronous" or "synchronous" and compared clinical status and outcomes (transplantation listing/death) between these groups. Patients with IDC (n = 23) and controls (n = 14) had similar age, gender, and QRS duration. Patients with IDC had a higher DI than controls (44.8 +/- 23.7 vs 19.9 +/- 8 ms, p <0.0001). A DI >32.6 ms defined mechanical dyssynchrony in 65% of patients with IDC. Dyssynchronous and synchronous patients had similar QRS durations. Age at diagnosis, at dyssynchrony evaluation, and duration of clinical illness were similar in the 2 groups. New York Heart Association score was better in dyssynchronous than in synchronous patients (2 vs 3.1, p <0.05). Number of synchronous and dyssynchronous patients reaching the end point of death or transplantation was similar, although synchronous patients had poorer actuarial survival from the time of diagnosis (hazard ratio 3.25, p = .04). In conclusion, left ventricular mechanical dyssynchrony is prevalent in pediatric IDC. QRS duration alone is inadequate to define dyssynchrony in pediatric IDC, whereas the adult-derived DI of >32.6 ms seems applicable to the pediatric population. In this cohort, the presence of mechanical dyssynchrony was not associated with more severe clinical status or adverse outcomes.
Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack
Assessed the viability of the Comprehensive Clinical Performance Grid for Student Evaluation, introduced at The New England College of Optometry in 1996 in clinical student assessment. Analyzed faculty and student feedback and consistency with previous evaluations, between evaluators, and between clinical sites and tracts. Found satisfaction with…
Souza, José Celso Rodriques de; Bento, Ricardo Ferreira; Pereira, Larissa Vilela; Ikari, Liliane; Souza, Stephanie Rugeri; Della Torre, Ana Adelina Giantomasi; Fonseca, Anna Carolina de Oliveira
Introduction Otosclerosis is a primary disease of the temporal bone that leads to stapes ankylosis. Hearing loss is the main symptom. Treatment includes surgery, medical treatment, and sound amplification therapy alone or in combination. Objective To evaluate the functional outcomes of patients with clinical diagnosis of otosclerosis undergoing primary stapes surgery in a teaching institution. Method Retrospective descriptive study. Results A total of 210 ears of 163 patients underwent stapes surgery. Of the 163 patients, 116 (71.2%) underwent unilateral surgery and 47 (28.8%) underwent bilateral surgery. Six of the 210 operated ears had obliterative otosclerosis. The average preoperative and postoperative air–bone gap was 32.06 and 4.39 dB, respectively. The mean preoperative and postoperative bone conduction threshold was 23.17 and 19.82 dB, respectively. A total of 184 (87.6%) ears had a residual air–bone gap <10 dB, and 196 (93.3%) had a residual air–bone gap ≤15 dB. Two patients (0.95%) had severe sensorineural hearing loss. Conclusion Stapes surgery showed excellent functional hearing outcomes in this study. This surgery may be performed in educational institutions with the supervision of experienced surgeons. PMID:26722344
Gajjar, Devarshi U.; Pal, Anuradha K.; Ghodadra, Bharat K.; Vasavada, Abhay R.
Purpose. Fusarium, Aspergillus, and Dematiaceous are the most common fungal species causing keratitis in tropical countries. Herein we report a prospective study on fungal keratitis caused by these three fungal species. Methodology. A prospective investigation was undertaken to evaluate eyes with presumed fungal keratitis. All the fungal isolates (n = 73) obtained from keratitis infections were identified using morphological and microscopic characters. Molecular identification using sequencing of the ITS region and antifungal susceptibility tests using microdilution method were done. The final clinical outcome was evaluated in terms of the time taken for resolution of keratitis and the final visual outcome. The results were analyzed after segregating the cases into three groups, namely, Fusarium, Aspergillus, and Dematiaceous keratitis. Results. Diagnosis of fungal keratitis was established in 73 (35.9%) cases out of 208 cases. The spectra of fungi isolated were Fusarium spp. (26.6%), Aspergillus spp. (21.6%), and Dematiaceous fungi (11.6%). The sequence of the ITS region could identify the Fusarium and Aspergillus species at the species complex level, and the Dematiaceous isolates were accurately identified. Using antifungal agents such as fluconazole, natamycin, amphotericin B, and itraconazole, the minimum inhibitory concentrations (MICs) for Fusarium spp. were >32 μg/mL, 4–8 μg/mL, 0.5–1 μg/mL, and >32 μg/mL, respectively. Antifungal susceptibility data showed that Curvularia spp. was highly resistant to all the antifungal agents. Overall, natamycin and amphotericin B were found to be the most effective antifungal agents. The comparative clinical outcomes in all cases showed that the healing response in terms of visual acuity of the Dematiaceous group was significantly good when compared with the Fusarium and Aspergillus groups (P < 0.05). The time required for healing in the Fusarium group was statistically significantly less when compared with
Klapow, J C; Slater, M A; Patterson, T L; Doctor, J N; Atkinson, J H; Garfin, S R
Individuals with persisting pain often present a constellation of symptoms that includes pain, health-related impairment and dysphoric mood. It is now widely accepted that comprehensive assessment must address each of these dimensions. Despite recognition of the value of multidimensional assessment, no empirical efforts have validated the construct of a multidimensional clinical outcome presentation based on the dimensions of pain, impairment and dysphoric mood. We employed cluster analytic procedures on standard measures of pain, impairment and depression in chronic low back pain (CLBP) patients (n = 96) attending a general orthopedic clinic in order to empirically characterize multidimensional clinical outcomes. Results indicated that 3 groups could be identified reliably: (1) 'Chronic Pain Syndrome' (n = 25; high levels of pain, impairment and depression), (2) 'Positive Adaptation to Pain' (n = 24; high levels of pain with low levels of impairment and depression) and (3) 'Good Pain Control' (n = 47; low levels of pain, impairment and depression). The reliability of this cluster solution was supported by several tests of internal consistency. Discriminability of the clusters was examined across both the outcome measures themselves and several additional independent variables. The cluster solution was then cross-validated in an independent sample of pain clinic CLBP patients (n = 180) to test its generalizability. Finally the stability of the cluster dimensions over time was tested by re-assessing 36 CLBP patients 6 months after they initially were characterized into 1 of the 3 outcome groups on the same measures. MANOVA results indicated that the outcome groups were differentiated statistically across assessments. The multiple outcome measures did not change significantly across time, nor did the outcome groups change differentially across time on these measures. We conclude that the outcome dimensions of pain, impairment and depression are relatively stable
Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie
Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully
Ibekwe, Perpetus Chudi; Onu, Fidelis Agwu; Onwe, Ogah Emeka; Ezeonu, Thecla Chinonyelum; Omeje, Innocent
Introduction Fetal distress has been shown to contribute to the increasing caesarean section rate. There has been controversy on the usefulness of clinical diagnosis of fetal distress using only the intermittent counting of the fetal heart rate and/or passage of meconium-stained liquor. Aim To evaluate the clinical diagnosis of fetal distress and the perinatal outcome. Materials and Methods This was a retrospective study in which the case records of the patients, who were diagnosed of fetal distress at Federal Teaching Hospital, Abakaliki, Nigeria, from January 1, 2008 to December 31, 2014, were collated. The statistical analysis was done using the Statistical Package for Social Sciences version 17 software (SPSS Inc., Chicago IL, USA). Results Out of the 15,640 deliveries carried out within the study period, 3,761 (24.05%) deliveries were through caesarean section. A total of 326 (8.9%) of the 3,761 caesarean sections were due to fetal distress within the study period. More so, a total of 227 (70.9%) babies were born with ≥ 7 Apgar score at the 1st minute of delivery. The perinatal mortality rate was 31.25 per 1000 deliveries. Though birth asphyxia was recorded more on babies of mothers that had fresh meconium-stained liquor and whose decision-intervention interval was more than 30 minutes when compared with those without any of the two conditions, there was no statistical significant difference between them. Conclusion The clinical diagnosis of fetal distress is accurate in 29.1% of the cases. However, it has led to an unnecessary caesarean section in the remaining 70.9% of the parturients. In order to reduce this high trend of unnecessary caesarean sections due to clinical diagnosis of fetal distress in this environment, antepartum fetal assessment with non-stress test or biophysical profile and intrapartum use of continuous electronic fetal monitoring should be used to confirm or refute the fetal distress before any surgical intervention. Fetal blood sampling
Nemeth, Nicole M; Kratz, Gail E; Bates, Rebecca; Scherpelz, Judy A; Bowen, Richard A; Komar, Nicholas
West Nile virus (WNV) infection and associated disease and mortality have been documented in numerous North American raptor species. Information regarding clinical presentations and long-term outcomes of WNV-infected raptors is important in the clinic for the diagnosis, treatment, and assessment of prognosis, as well as for understanding potential population level effects on raptor species. Raptors of 22 species admitted to a rehabilitation clinic were tested, from 2002 to 2005, for previous and acute WNV infection, while comparing clinical syndromes, trauma, and rehabilitation outcomes. Forty-two percent of admitted raptors (132/314) had been infected with WNV, and these presented with a WNV-attributed clinical disease rate of 67.4% (89/132). West Nile virus-infected raptors were less likely to be released (79/132 [59.8%]) than negative raptors (138/182 [75.8%]) and more likely to die or be euthanized (47/132 [35.6%] for WNV-infected vs. 32/182 [17.6%] for WNV-negative). However, WNV-infected raptors with neurologic disease were no less likely to be released (29/53 [54.7%]) than those without neurologic disease (50/79 [63.3%]). Clinical WNV-associated syndromes varied among species. Great horned owls (Bubo virginianus) were more likely to have neurologic signs, whereas American kestrels (Falco sparverius) and Swainson's hawks (Buteo swainsonii) were less likely to have neurologic signs. These results suggest that free-ranging raptors are frequently infected with WNV and that clinical syndromes differ among species. WNV has potentially devastating effects on raptors; however, rehabilitation of WNV-infected raptors can lead to positive outcomes, even for those having had severe neurologic disease.
Patty, Willard W.
This 1949 paper considers the evaluation of health education outcomes. It describes the nature of health education, discusses whether it is possible to measure all health education outcomes, then examines how to evaluate student health habits and skills, health attitudes, and health knowledge. It concludes that it is important to evaluate health…
Ingram, Megan; Choi, Yun Hee; Chiu, Chung-Yi; Haggard, Rob; Dougall, Angela Liegey; Buschang, Peter; Gatchel, Robert J.
Temporomandibular joint and muscle disorder (TMJMD) is one of the most prevalent types of musculoskeletal disorders. The major goal of the study was to more objectively quantify clinically meaningful relief for TMJMD treatment outcomes by using the new metric of minimal clinically important difference (MCID). Pre- to post-treatment changes on a number of self-report measures were evaluated in a cohort of 101 acute TMJMD patients. An anchor-based MCID approach was employed, with an objective chewing performance measure serving as the clinical outcome of interest. Using a Receiver Operating Curve analysis, it was found that the Physical Component Scale (PCS) of the SF-36 was the most robust self-report measure to use as the MCID in a TMJMD patient population. PMID:22919263
Cézar, Rodrigo S; Cerqueira, Bruno A V; da Paz, Silvana de Souza; Barbosa, Cynara G; de Moura Neto, José P; Barreto, José H de S; Goncalves, Marilda de S
The aim of this study is to investigate the clinical, hematological, and immunophenotypic characteristics of Brazilian children with B-cell acute lymphoblastic leukemia (B-ALL) to identify prognostic biomarkers of the disease. Thirty-three children newly diagnosed with B-ALL were followed between March 2004 and December 2009. Information about the demographic profile, diagnosis, immunophenotype, clinical manifestations, and disease outcome were gathered from the patients' medical records. Of the 33 patients with B-ALL, 18 were male and 15 female. Eighteen patients were classified as high risk; 13 as low risk, and 2 as true low risk. The frequencies of cluster of differentiation (CD)10, CD19, and CD20 antigens were 69.7%, 81.8%, and 18.2%, respectively. Six patients (18.2%) had aberrant expression of myeloid antigens. At diagnosis, patients immunopositive for CD20 had elevated white blood cell counts (P = 0.018) and lower platelet counts (P = 0.017). The 6-year overall survival was 67.5%± 3.47%. Our results demonstrate the distinct immunophenotypic and prognostic characteristics of patients with B-ALL, which can be related to the Brazilian racial admixture. Consequently, these results will most likely aid in the selection of additional prognostic markers and their use in monitoring the clinical manifestations and treatment response among B-ALL patients.
Murray, Aja L; McKenzie, Karen; Murray, Kara R; Richelieu, Marc
Mokken scaling is increasingly being applied to assessing the extent to which clinical scales possess clinically useful properties, especially invariant item ordering (IIO). These scales are often used to track progress in symptoms over time to evaluate the success of an intervention. Such interventions are designed to affect psychopathological trait levels overall but may in some cases act disproportionately on some symptoms over others. As a result, there is no guarantee that the item orderings of a clinical scale will be preserved between the point at which individuals begin treatment and the point at which they can be considered recovered. In these situations, many of the potential benefits of IIO are undermined because an IIO identified at either time point will not be informative about changes in symptoms over time. In this study, we aimed to assess the extent to which the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) retained the same item orderings in a sample of individuals when initially presenting for counseling treatment and when discharged. From the 34 items of the CORE-OM we found a subset of 10 items exhibiting monotonicity, invariant item ordering, and highly similar item orderings when measured at both time points.
Harris, Wayne B
The bulk of the literature on kidney cancer in African Americans comes from population-based studies of incidence and survival over varying periods of time using databases from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI). The purpose of this review is to summarize the literature on racial disparities in clinical outcome in patients with renal cell carcinoma (RCC) with the objective of identifying any biomarkers that might point to a biological explanation for these differences. Special attention is given to biomarkers of systemic inflammation and their potential utility for kinetic risk assessment. In addition, arguments are presented as to why the study of ethnic and racial disparities is a promising strategy for accelerating the pace of biomarker development for all patients with RCC.
Mohammed, Noor; Subramanian, Venkataraman
Ulcerative colitis (UC) is a chronic inflammatory bowel condition characterised by a relapsing and remitting course. Symptom control has been the traditional mainstay of medical treatment. It is well known that histological inflammatory activity persists despite adequate symptom control and absence of endoscopic inflammation. Current evidence suggests that presence of histological inflammation poses a greater risk of disease relapse and subsequent colorectal cancer risk. New endoscopic technologies hold promise for developing endoscopic markers of mucosal inflammation. Achieving endoscopic and histological remission appears be the future aim of medical treatments for UC. This review article aims to evaluate the use of endoscopy as a tool in assessment of mucosal inflammation UC and its correlation with disease outcomes. PMID:27895420
Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike
Clinical scores and motion-capturing gait analysis are today's gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients' actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee.
Esterly, John S.; Wagner, Jamie; McLaughlin, Milena M.; Postelnick, Michael J.; Qi, Chao
Predictive modeling suggests that actual carbapenem MIC results are more predictive of clinical patient outcomes than categorical classification of the MIC as susceptible, intermediate, or resistant. Some have speculated that current CLSI guidelines' suggested thresholds are too high and that clinical success is more likely if the MIC value is ≤1 mg/liter for certain organisms. Patients treated with carbapenems and with positive blood cultures for Pseudomonas aeruginosa, Acinetobacter baumannii, or extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria were considered for evaluation in this clinical retrospective cohort study. Relevant patient demographics and microbiologic variables were collected, including carbapenem MIC. The primary objective was to define a risk-adjusted all-cause hospital mortality breakpoint for carbapenem MICs. Secondarily, we sought to determine if a similar breakpoint existed for indirect outcomes (e.g., time to mortality and length of stay [LOS] postinfection for survivors). Seventy-one patients met the criteria for study inclusion. Overall, 52 patients survived, and 19 died. Classification and regression tree (CART) analysis determined a split of organism MIC between 2 and 4 mg/liter and predicted differences in mortality (16.1% versus 76.9%; P < 0.01). Logistic regression controlling for confounders identified each imipenem MIC doubling dilution as increasing the probability of death 2-fold (adjusted odds ratio [aOR] 2.0; 95% confidence interval [CI], 1.3 to 3.2). Secondary outcomes were similar between groups. This study revealed that patients with organisms that had a MIC of ≥4 mg/liter had worse outcomes than patients whose isolates had a MIC of ≤2 mg/liter, even after adjustment for confounding variables. We recommend additional clinical studies to better understand the susceptibility breakpoint for carbapenems. PMID:22777044
Takamori, Shinkichi; Akamine, Takaki; Toyokawa, Gouji; Morodomi, Yosuke; Okamoto, Tatsuro; Maehara, Yoshihiko
Background: Analog chest drainage systems (ACS) are generally used to monitor postoperative alveolar air leakage (PAL) after lung resection. An electronic digital chest drainage system (DCS) has recently been developed that reportedly has several advantages over the traditional ACS. Here, we report a single institution’s experience of PAL management with the DCS. We also sought to establish whether DCS had superior clinical benefits and outcomes compared with ACS. Methods: We enrolled 112 consecutive patients who underwent lung resection and were subsequently managed with DCS. We compared PAL rate, duration of chest drainage, and the incidence of complications with a group of 121 consecutive patients previously managed with ACS after lung resection, using propensity score matching. Results: Mean maximum and minimum PAL rates during DCS chest drainage were 48.9 ml/min (range: 2.0–868.6 ml/min) and 0.1 ml/min (0.0–1.2 ml/min), respectively. Mean PAL rate at DCS removal was 1.3 ml/min (0.0–10.0 ml/min). After propensity score matching, mean duration of chest drainage was significantly shorter with DCS than ACS (2.7 days, range: 1–9 days, compared with 3.7 days, range: 1–21 days, respectively; P = 0.031). Conclusions: Managing PAL with DCS after pulmonary resection appears to reduce the duration of chest drainage. PMID:27885215
Pransky, G; Benjamin, K; Himmelstein, J; Mundt, K; Morgan, W; Feuerstein, M; Koyamatsu, K; Hill-Fotouhi, C
The purpose of this study was to describe the demographic, vocational, medical, workplace, and psychosocial characteristics of patients treated for work-related upper-extremity disorders, to document treatment patterns in a community-practice setting, and to determine which of these factors predicts subsequent employment and functional status outcomes. A questionnaire was administered by mail or telephone to 112 patients seen at the University of Massachusetts Occupational Upper Extremities Disorders Clinic and included measures of disease-specific functional status, pain, reactions to pain, employer-employee relations, and number and type of interventions used to treat the disorder. Results were compared with baseline data obtained, on average, 16 months prior to follow-up. Of the original cohort (n = 124), 112 participated in the prospective study. Although most patients reported improvement in pain severity, fear of pain, life situation, and functional status, there was little change in employment status. Patients' self-reported intentions of return to work at baseline did not predict work status at follow-up. In general, those who were employed at baseline remained employed, had a greater reduction in symptom severity over time, and were significantly more likely to report improvement in their problem than those who were unemployed. The efficacy of various interventions was examined by type, mix, and intensity (number of different interventions undergone by the patient). No positive relationship was found between these measures and employment status, self-reported change in the problem, or self-reported improvement in functional status. Significant negative relationships were found between surgery, psychotherapeutic interventions, and outcomes. This was likely to have occurred because of a selection bias toward the more chronic and severely disabled patients for these treatments. However, the relative ineffectiveness of such intensive interventions as surgery
Noble, Simon; Pease, Nikki; Sui, Jessica; Davies, James; Lewis, Sarah; Malik, Usman; Alikhan, Raza; Prout, Hayley; Nelson, Annmarie
Objectives Cancer-associated thrombosis (CAT) complex condition, which may present to any healthcare professional and at any point during the cancer journey. As such, patients may be managed by a number of specialties, resulting in inconsistent practice and suboptimal care. We describe the development of a dedicated CAT service and its evaluation. Setting Specialist cancer centre, district general hospital and primary care. Participants Patients with CAT and their referring clinicians. Intervention A cross specialty team developed a dedicated CAT service , including clear referral pathways, consistent access to medicines, patient's information and a specialist clinic. Primary and secondary outcome measures The service was evaluated using a mixed-methods evaluation , including audits of clinical practice, clinical outcomes, staff surveys and qualitative interviewing of patients and healthcare professionals. Results Data from 457 consecutive referrals over an 18-month period were evaluated. The CAT service has led to an 88% increase in safe and consistent community prescribing of low-molecular-weight heparin, with improved access to specialist advice and information. Patients reported improved understanding of their condition, enabling better self-management as well as better access to support and information. Referring clinicians reported better care standards for their patients with improved access to expertise and appropriate management. Conclusions A dedicated CAT service improves overall standards of care and is viewed positively by patients and clinicians alike. Further health economic evaluation would enhance the case for establishing this as the standard model of care. PMID:27895068
Rhodes, Nathaniel J; Liu, Jiajun; McLaughlin, Milena M; Qi, Chao; Scheetz, Marc H
Predicted and observed failures at higher cefepime MICs have prompted the Clinical and Laboratories Standards Institute (CLSI) to lower the susceptible breakpoint for Enterobacteriaceae to ≤2mg/L, with dose-dependent susceptibility at 4-8mg/L, while the susceptibility breakpoint for nonfermentative organisms remain unchanged at ≥8mg/L. The contribution of increasing cefepime MIC to mortality risk in the setting of aggressive cefepime dosing is not well defined. Patients who were treated with cefepime for Gram-negative blood stream infections (GNBSIs), including both Enterobacteriaceae and nonfermentative organisms, were screened for inclusion in this retrospective cohort study. Demographic and microbiologic variables were collected, including pathogen, cefepime MIC, dosage, and interval. The objective was to define a risk-adjusted mortality breakpoint for cefepime MICs. Secondarily, we looked at time to death and length of stay (LOS) postculture. Ninety-one patients were included in the analysis. Overall, 19 patients died and 72 survived. Classification and Regression Tree analysis identified an inhospital mortality breakpoint at a cefepime MIC between 2 and 4mg/L for patients with a modified Acute Physiology and Chronic Health Evaluation II score ≤16.5 (4.2% versus 25%, respectively). Multivariate logistic regression revealed increased odds of mortality at a cefepime MIC of 4mg/L (adjusted odds ratio [aOR] 6.47; 95% confidence interval [CI] 1.25-33.4) and 64mg/L (aOR 6.54, 95% CI 1.03-41.4). Those with cefepime MICs ≥4mg/L experienced a greater median intensive care unit LOS for survivors (16 versus 2days; P=0.026). Increasing cefepime MIC appears to predict inhospital mortality among patients who received aggressive doses of cefepime for GNBSIs, supporting a clinical breakpoint MIC of 2mg/L.
Kautz, Donald D; Kuiper, RuthAnne; Pesut, Daniel J; Knight-Brown, Phyllis; Daneker, Darlene
Promoting clinical reasoning in undergraduate nursing students through application of the Outcome Present State Test (OPT) Model of Clinical Reasoning, is a challenge that can be successfully managed through effective teaching-learning strategies. Empirical evidence to support teaching strategies that foster both cognitive and metacognitive skill acquisition is limited. The purpose of this research was to evaluate the development of clinical reasoning skills among nursing students through the application and evaluation of teaching-learning strategies associated with self-regulated learning and the OPT model (Pesut & Herman, 1998; 1999; Pesut, 2004). The model and self-regulated learning prompts were used to structure learning with junior level baccalaureate nursing students during a ten-week, medical-surgical clinical experience in acute care telemetry units. Data analysis revealed students effectively made gains in learning associated with the OPT model. Qualitative analysis of self-regulated learning prompt journal data revealed students made significant gains in self-observation, self-judgment, knowledge work and use of health care personnel resources during clinical experiences. Results indicated the intentional use of guided reflection coupled with structure and learning tools of the OPT model significantly enhanced clinical reasoning skill acquisition, and provided evidence for the effectiveness of structured teaching learning strategies.
Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong
Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view.
Aghaeepour, Nima; Chattopadhyay, Pratip; Chikina, Maria; Dhaene, Tom; Van Gassen, Sofie; Kursa, Miron; Lambrecht, Bart N.; Malek, Mehrnoush; Qian, Yu; Qiu, Peng; Saeys, Yvan; Stanton, Rick; Tong, Dong; Vens, Celine; Walkowiak, Sławomir; Wang, Kui; Finak, Greg; Gottardo, Raphael; Mosmann, Tim; Nolan, Garry; Scheuermann, Richard H.; Brinkman, Ryan R.
The Flow Cytometry: Critical Assessment of Population Identification Methods (FlowCAP) challenges were established to compare the performance of computational methods for identifying cell populations in multidimensional flow cytometry data. Here we report the results of FlowCAP-IV where algorithms from seven different research groups predicted the time to progression to AIDS among a cohort of 384 HIV+ subjects, using antigen-stimulated peripheral blood mononuclear cell (PBMC) samples analyzed with a 14-color staining panel. Two approaches (FlowReMi.1 and flowDensity-flowType-RchyOptimyx) provided statistically significant predictive value in the blinded test set. Manual validation of submitted results indicated that unbiased analysis of single cell phenotypes could reveal unexpected cell types that correlated with outcomes of interest in high dimensional flow cytometry datasets. PMID:26447924
Jalil, Sakib; Myers, Trina; Atkinson, Ian
A worldwide demographic shift is in progress and the aged population proportion is projected to more than double across the next four decades. Our current healthcare models may not be adequate to handle this shift in demography, which may have serious consequences for the ageing population who are more prone to chronic diseases. One proposed remediation is to provide in-home assisted healthcare with technology-intervened approaches. Telemedicine, telehealth, e-health are paradigms found in scientific literature that provide clinical treatment through a technology intervention. In evidence-based medical science, these technology interventions are evaluated through clinical trials, which are targeted to measure improvements in medical conditions and the treatment's cost effectiveness. However, effectiveness of a technology also depends on the interaction pattern between the technology and its' users, especially the patients. This paper presents (1) a meta-synthesis of clinical trials for technology-intervened treatments of type 2 diabetes and (2) the Clinical User-Experience Evaluation (CUE). CUE is a recommendation for future telemedicine clinical trials that focuses on the patient as the user from Human-Computer Interaction (HCI) perspective and was developed as part of this research. The clinical trials reviewed were interpreted from a technology perspective and the non-medical or non-biological improvements of the users (patients) rather than the medical outcome. Results show that technology-intervened treatments provide positive behavior changes among patients and are potentially highly beneficial for chronic illness management such as type 2 diabetes. The results from the CUE method show how it complements clinical trials to capture patients' interaction with a technology.
Lee, Kun-Yu; Chen, David Yen-Ting; Hsu, Hui-Ling; Chen, Chi-Jen
Background Severe intracranial arterial stenosis results in more than 10% incidence of stroke and transient ischemic attack. Using undersized angioplasty with off-label closed-cell Enterprise stent may be a feasible alternative option for treating patients with intracranial atherosclerotic disease who fail dual-antiplatelet medical therapy. The results of the authors’ study are presented in this paper. Materials and methods Between January 2013 and July 2014, 24 symptomatic patients with a total of 30 intracranial arterial stenotic lesions refractory to medical therapy, who underwent undersized angioplasty and Enterprise stenting, were retrospectively reviewed in the authors’ institution. The results evaluated include technical success rate, clinical outcome measured as modified Rankin Scale at presentation and follow-up, peri-procedural morbidity within 30 days and 1 year, and follow-up vessel patency. Results Stent deployment was successfully achieved in all stenotic lesions (30/30). Mean pre-stent and post-stent diameter residual stenosis was 81% and 18%, respectively. The peri-procedural complication rate during 30 days after stenting was 10% per lesion (3/30), including intracranial hemorrhage, in-stent thrombosis and ischemic stroke. No further thromboembolic event or complication occurred in any patient more than 30 days after stenting. Modified Rankin scale ≤ 2 was observed in 64% and 83% of patients at initial presentation and follow-up (mean 15.8 months), respectively. Imaging follow-up was available in 17 of 24 patients (70.8%) and 20 of 30 treated lesions (66.6%) with a mean follow-up period of 15.4 months. Only one asymptomatic in-stent restenosis occurred in 20 available lesions (5.0%). Conclusion This preliminary study suggests that using undersized angioplasty and Enterprise stenting may effectively treat high-degree symptomatic intracranial arterial stenosis with favorable clinical and angiographic outcome. PMID:26542728
Allen, J; Annells, M; Nunn, R; Petrie, E; Clark, E; Lang, L; Robins, A
The study aimed to explore the effectiveness of a mental health screening and referral clinical pathway for generalist community nursing care of war veterans and war widow(er)s in Australia on outcomes of client self-reported mental health, quality of life, and client and carer satisfaction. The pathway was developed by literature review and consultation, then trialled and evaluated. Validated screening tools were embedded within the pathway to support generalist nurses' mental health decision making. Pre- and post-measures were applied. Clients on whom the pathway was trialled were invited to complete an evaluation survey questionnaire, as were their informal carers. Most clients and carers who responded to these questionnaires were highly satisfied or satisfied with care provided through application of the pathway. This study adds understanding about one way that community nurses might identify people with mental health difficulties. The trialled pathway, which was modified and refined following the study, is now available on the Internet as an evidence-based resource for community nurses in Australia to guide practice and maximize holistic care for war veterans and war widow(er)s where that care is funded by Department of Veterans' Affairs.
Freehill, Michael T; Mannava, Sandeep; Safran, Marc R
The high-level athletic population poses difficulty when evaluating outcomes in orthopedic surgery, given generally good overall health and high function at baseline. Subtle differences in performance following injury or orthopedic surgery are hard to detect in high-performance athletes using standard outcome metrics; however, attaining these subtle improvements after injury or surgery are key to an athletes' livelihood. Outcome measures serve as the cornerstone for critical evaluation of clinical outcomes following orthopedic surgery or injury. In the age of "evidence-based medicine" and "pay-for-performance" accountability for surgical intervention, understanding clinically relevant outcome measures is essential for careful review of the published literature, as well as one's own critical review of surgical performance. The purpose of this manuscript is to evaluate clinical outcome measures in the context of the athletic elbow. An emphasis will be placed on evaluation of the 5 most clinically relevant outcome measures for sports-related elbow outcomes: (1) American Shoulder and Elbow Committee; (2) Mayo Elbow Performance Index; (3) Andrews-Timmerman [and its precursor the (4) Andrews-Carson]; and (5) Kerlan-Jobe Orthopaedic Clinic overhead athlete score. A final outcome measure that will be analyzed is "return to play" statistics, which has been published in various studies of athletes' recovery from elbow surgery, as well as, the outcomes metric known as the "Conway-Jobe scale." Although there is no perfect outcomes score for the athletic elbow, the Kerlan-Jobe Orthopaedic Clinic score is the only outcomes tool developed and validated for outcomes for elbow injuries in the overhead athlete, as compared with the Andrew-Timmerman and Conway-Jobe metrics, which were not validated outcome measures for the elbow in this patient population. Despite the Disabilities of Arm, Shoulder, Hand (DASH) (and DASH-Sport module) being validated in the general population, this
Nieto Pol, Enrique
Both the initial evaluation and follow-up of patients with osteoarthritis require systematic evaluation of the indicators that provide information on the degree of involvement of the disease and allow its quantification. Reliable measures of disease progression help decision-making by clinicians and provide valid information on treatment response and the effectiveness of the distinct therapeutic interventions. The instruments recommended in research, as outcome measures in osteoarthritis, are pain evaluation, assessment of physical function, and self-reported global evaluation. In studies lasting more than 1 year, structural changes are evaluated through simple X-ray. Self-reported quality of life assessment and physician global assessment are also recommended as options. These indicators should be incorporated into routine clinical practice for adequate evaluation and correct follow-up of patients with osteoarthritis. The recommended pain evaluation method for use in clinical practice is the visual analog scale (VAS). The best instrument to evaluate physical function in patients with hip or knee osteoarthritis is the WOMAC scale (Western Ontario and McMaster Universities Osteoarthritis Index). For patient-reported global assessment in routine practice, the recommended scales are VAS or the SF-12 (12-item short-form health survey).
Bonifati, C; Berardesca, E
Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria).
Efficace, Fabio; Kemmler, Georg; Vignetti, Marco; Mandelli, Franco; Molica, Stefano; Holzner, Bernhard
Health-related quality of life (HRQOL) is increasingly reported as an important outcome in cancer clinical trials. However, very little evidence exists on the impact of such evaluation in randomised controlled trials (RCTs) of leukaemia patients. A systematic search of the literature from 1980 to 2007 was undertaken and studies were identified and evaluated independently, according to a pre-defined coding scheme, by three reviewers. Both HRQOL outcomes and traditional clinical reported outcomes were systematically analysed to evaluate their consistency and their relevance for supporting clinical decision making. Nine RCTs were identified, involving 3838 patients overall. There were four RCTs involving acute myeloid leukaemia patients (AML), three with chronic myeloid leukaemia (CML) and two with chronic lymphocytic leukaemia (CLL). Six studies were published after 2000 and provided fairly robust methodological quality. Imatinib greatly improved HRQOL compared to interferon based treatments in CML patients and fludarabine plus cyclophosphamide does not seem to have a deleterious impact on patient's HRQOL when compared to fludarabine alone or chlorambucil in CLL patients. This study revealed the paucity of HRQOL research in leukaemia patients. Nonetheless, HRQOL assessment is feasible in RCTs and has the great potential of providing valuable outcomes to further support clinical decision making.
Naves, Luciana Ansaneli; Porto, Lara Benigno; Rosa, João Willy Corrêa; Casulari, Luiz Augusto; Rosa, José Wilson Corrêa
Geographical information systems (GIS) have emerged as a group of innovative software components useful for projects in epidemiology and planning in Health Care System. This is an original study to investigate environmental and geographical influences on epidemiology of acromegaly in Brazil. We aimed to validate a method to link an acromegaly registry with a GIS mapping program, to describe the spatial distribution of patients, to identify disease clusters and to evaluate if the access to Health Care could influence the outcome of the disease. Clinical data from 112 consecutive patients were collected and home addresses were plotted in the GIS software for spatial analysis. The buffer spatial distribution of patients living in Brasilia showed that 38.1% lived from 0.33 to 8.66 km, 17.7% from 8.67 to 18.06 km, 22.2% from 18.07 to 25.67 km and 22% from 25.68 to 36.70 km distant to the Reference Medical Center (RMC), and no unexpected clusters were identified. Migration of 26 patients from 11 others cities in different regions of the country was observed. Most of patients (64%) with adenomas bigger than 25 mm lived more than 20 km away from RMC, but no significant correlation between the distance from patient's home to the RMC and tumor diameter (r = 0.45 p = 0.20) nor for delay in diagnosis (r = 0.43 p = 0.30) was found. The geographical distribution of diagnosed cases did not impact in the latency of diagnosis or tumor size but the recognition of significant migration denotes that improvements in the medical assistance network are needed.
Boguniewicz, Mark; Abramovits, William; Paller, Amy; Whitaker-Worth, Diane L; Prendergast, Mary; Cheng, J Wang; Wang, Patrick; Tong, Kuo B
Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases patient/parent productivity, and adds to health care costs. Few studies have examined the effect of specific treatment modalities across a variety of AD-related outcomes. This prospective, multicenter, open-label longitudinal study of adult and pediatric patients with moderate to severe AD was conducted to evaluate the effect of a specific therapeutic intervention on AD-related outcomes over a period of 6 months. Surveys collected physician clinical assessments and patient- and caregiver-reported data across the following domains: clinical outcome, health care utilization/costs, quality of life, physical appearance, productivity/absenteeism, and medication compliance. This study is intended to help guide future research efforts on the net costs and benefits of different interventions across a diverse set of domains and in larger populations.
van der Veeken, Frida C. A.
Background Rehabilitation in forensic psychiatry is achieved gradually with different leave modules, in line with the Risk Need Responsivity model. A forensic routine outcome monitoring tool should measure treatment progress based on the rehabilitation theory, and it should be predictive of important treatment outcomes in order to be usable in decision-making. Therefore, this study assesses the predictive validity for both positive (i.e., leave) and negative (i.e., inpatient incidents) treatment outcomes with the Instrument for Forensic Treatment Evaluation (IFTE). Methods Two-hundred and twenty-four patients were included in this study. ROC analyses were conducted with the IFTE factors and items for three leave modules: guided, unguided and transmural leave for the whole group of patients. Predictive validity of the IFTE for aggression in general, physical aggression specifically, and urine drug screening (UDS) violations was assessed for patients with the main diagnoses in Dutch forensic psychiatry, patients with personality disorders and the most frequently occurring co-morbid disorders: those with combined personality and substance use disorders. Results and Conclusions Results tentatively imply that the IFTE has a reasonable to good predictive validity for inpatient aggression and a marginal to reasonable predictive value for leave approvals and UDS violations. The IFTE can be used for information purposes in treatment decision-making, but reports should be interpreted with care and acknowledge patients’ personal risk factors, strengths and other information sources. PMID:27517721
Lahav, Amit; Burks, Robert T; Greis, Patrick E; Chapman, Andrew W; Ford, Gregory M; Fink, Barbara P
This study evaluated the clinical outcome in 21 patients (22 knees) undergoing osteochondral autologous transplantation (OATS) in the knee over a 5-year period. Sixteen knees in 15 patients were available for follow-up at an average of 40 months after the procedure. The clinical outcome was analyzed using the IKDC and Knee and Osteoarthritis Outcome Score (KOOS) evaluation forms, a subjective questionnaire, and a clinical examination. At final follow-up, the average KOOS result for pain was 80.6 (range: 56-94), symptoms 53.6 (range: 25-71), function of activities of daily living 93.4 (range: 79-100), function of sports and recreational activities 65.3 (range: 20-100), and quality of life 51.0 (range: 6-88). The average IKDC score was 68.2. On our subjective questionnaire, the average preoperative grade given was 3.1 (range: 1-7) with an improvement at the most recent follow-up to a grade of 8.0 (range: 5-10) (P < .00001). Thirteen (86%) patients reported that they would have the surgery again if they had to make the decision a second time. Age did not correlate with subjective results on the IKDC evaluation (P = .7048) or score difference on our questionnaire (P = .9175). This procedure provides an option for articular resurfacing of the femoral condyles for focal areas of chondral defects with promising results regarding subjective improvement.
Nicholson, Karl G.; Lim, Wei Shen; Read, Robert C.; Taylor, Bruce L.; Brett, Stephen J.; Openshaw, Peter J. M.; Enstone, Joanne E.; McMenamin, James; Bannister, Barbara; Nguyen-Van-Tam, Jonathan S.
During severe influenza pandemics healthcare demand can exceed clinical capacity to provide normal standards of care. Community Assessment Tools (CATs) could provide a framework for triage decisions for hospital referral and admission. CATs have been developed based on evidence that supports the recognition of severe influenza and pneumonia in the community (including resource limited settings) for adults, children and infants, and serious feverish illness in children. CATs use six objective criteria and one subjective criterion, any one or more of which should prompt urgent referral and admission to hospital. A retrospective evaluation of the ability of CATs to predict use of hospital-based interventions and patient outcomes in a pandemic was made using the first recorded routine clinical assessment on or shortly after admission from 1520 unselected patients (800 female, 480 children <16 years) admitted with PCR confirmed A(H1N1)pdm09 infection (the FLU-CIN cohort). Outcome measures included: any use of supplemental oxygen; mechanical ventilation; intravenous antibiotics; length of stay; intensive or high dependency care; death; and “severe outcome” (combined: use of intensive or high dependency care or death during admission). Unadjusted and multivariable analyses were conducted for children (age <16 years) and adults. Each CATs criterion independently identified both use of clinical interventions that would in normal circumstances only be provided in hospital and patient outcome measures. “Peripheral oxygen saturation ≤92% breathing air, or being on oxygen” performed well in predicting use of resources and outcomes for both adults and children; supporting routine measurement of peripheral oxygen saturation when assessing severity of disease. In multivariable analyses the single subjective criterion in CATs “other cause for clinical concern” independently predicted death in children and in adults predicted length of stay, mechanical ventilation and
Although there are limited data available on gender as an outcome variable in the treatment of onychomycosis, differences in disease prevalence and impact in males versus females have been observed. This article provides a gender subgroup analysis based on results from recent studies evaluating the efficacy, safety, and tolerability of efinaconazole topical solution 10% in the treatment of onychomycosis. Data were collected from two 52-week, prospective, multicenter, randomized, double-blind studies of patients (age range, 18-70 years) randomized to receive either efinaconazole topical solution 10% or vehicle for treatment of onychomycosis. Results from this analysis indicated that once-daily application of efinaconazole topical solution 10% may provide a useful topical option for treatment of mild to moderate toenail onychomycosis, especially in female patients.
O. Bachmann, Max; Loke, Yoon Kong; D. Musgrave, Stanley; Price, Gill M.; Hale, Rachel; Metcalf, Anthony Kneale; Turner, David A.; Day, Diana J.; A. Warburton, Elizabeth; Potter, John F.
Abstract Background although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods data from a prospective multicentre study (2009–12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results a total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11–28% (P < 0.0001) and in 1-year mortality of 8–12% (P < 0.001). Conclusions there appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors. PMID:28181626
Background The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. Methods In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed ‘different’, and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Results Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Conclusions Multiple approaches to data
Swaroopa, Deme; Bhaskar, Kakarla; Mahathi, T.; Katkam, Shivakrishna; Raju, Y. Satyanarayana; Chandra, Naval; Kutala, Vijay Kumar
Background and Aim: Studies on potential biomarkers in experimental models of acute lung injury (ALI) and clinical samples from patients with ALI have provided evidence to the pathophysiology of the mechanisms of lung injury and predictor of clinical outcome. Because of the high mortality and substantial variability in outcomes in patients with acute respiratory distress syndrome (ARDS), identification of biomarkers such as cytokines is important to determine prognosis and guide clinical decision-making. Materials and Methods: In this study, we have included thirty patients admitted to Intensive Care Unit diagnosed with ARDS, and serum samples were collected on day 1 and 7 and were analyzed for serum interleukin-6 (IL-6) and IL-8 by ELISA method, and Acute Physiology and Chronic Health Evaluation II (APACHE II) scoring was done on day 1. Results: The mortality in the patients observed with ARDS was 34%. APACHE II score was significantly higher in nonsurvivors as compared to survivors. There were no significant differences in gender and biochemical and hematological parameters among the survivors and nonsurvivors. Serum IL-6 and IL-8 levels on day 1 were significantly higher in all the ARDS patients as compared to healthy controls and these levels were returned to near-normal basal levels on day 7. The serum IL-6 and IL-8 levels measured on day 7 were of survivors. As compared to survivors, the IL-6 and IL-8 levels were significantly higher in nonsurvivors measured on day 1. Spearman's rank correlation analysis indicated a significant positive correlation of APACHE II with IL-8. By using APACHE II score, IL-6, and IL-8, the receiver operating characteristic curve was plotted and the provided predictable accuracy of mortality (outcome) was 94%. Conclusion: The present study highlighted the importance of measuring the cytokines such as IL-6 and IL-8 in patients with ARDS in predicting the clinical outcome. PMID:27688627
Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali
Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325
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…
Parikh, Coral; Gutgarts, Victoria; Eisenberg, Elliot; Melamed, Michal L.
Most dialysis patients are vitamin D deficient, including deficiencies in both activated vitamin D (1, 25-dihydroxyvitamin D) and the less active 25-hydroxyvitamin D. These and other abnormalities associated with chronic kidney disease (CKD), if they remain untreated, lead to secondary hyperparathyroidism and bone changes, such as osteitis fibrosa cystica. Activated vitamin D has been proven to decrease parathyroid hormone (PTH) levels in dialysis patients and is currently used for this indication. There are multiple other potential “pleotrophic” effects associated with vitamin D therapy. These include associations with lower all-cause and cardiovascular mortality, lower rates of infections and improved glycemic indexes. Meta-analyses of multiple observational studies have shown activated vitamin D therapy to be associated with improved survival. Observational data also suggest fewer infections and better glucose control. There have been no randomized clinical trials powered to evaluate mortality or other clinical outcomes. Small trials of nutritional vitamin D (ergocalciferol and cholecalciferol) showed increases in 25-hydroxyvitamin D levels without hypercalcemia or hyperphosphatemia, even when given in addition to activated vitamin D therapy. While activated vitamin D therapy is associated with improved outcomes, it also leads to higher fibroblast growth factor 23 (FGF-23) levels, which may be detrimental in dialysis patients. Further research is needed to evaluate whether activated or nutritional vitamin D therapy are beneficial in dialysis patients for outcomes other than secondary hyperparathyroidism. PMID:26424141
Smith, Stephanie L; Misago, Claire Nancy; Osrow, Robyn A; Franke, Molly F; Iyamuremye, Jean Damascene; Dusabeyezu, Jeanne D'Arc; Mohand, Achour A; Anatole, Manzi; Kayiteshonga, Yvonne; Raviola, Giuseppe J
Introduction Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system. Methods and analysis A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members. Ethics and dissemination This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review
Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.
Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch
Zoccali, Giovanni; Cinque, Benedetta; La Torre, Cristina; Lombardi, Francesca; Palumbo, Paola; Romano, Lucia; Mattei, Antonella; Orsini, Gino; Cifone, Maria Grazia; Giuliani, Maurizio
As known, fractional CO2 resurfacing treatments are more effective than non-ablative ones against aging signs, but post-operative redness and swelling prolong the overall downtime requiring up to steroid administration in order to reduce these local systems. In the last years, an increasing interest has been focused on the possible use of probiotics for treating inflammatory and allergic conditions suggesting that they can exert profound beneficial effects on skin homeostasis. In this work, the Authors report their experience on fractional CO2 laser resurfacing and provide the results of a new post-operative topical treatment with an experimental cream containing probiotic-derived active principles potentially able to modulate the inflammatory reaction associated to laser-treatment. The cream containing DermaACB (CERABEST™) was administered post-operatively to 42 consecutive patients who were treated with fractional CO2 laser. All patients adopted the cream twice a day for 2 weeks. Grades were given according to outcome scale. The efficacy of the cream containing DermaACB was evaluated comparing the rate of post-operative signs vanishing with a control group of 20 patients topically treated with an antibiotic cream and a hyaluronic acid based cream. Results registered with the experimental treatment were good in 22 patients, moderate in 17, and poor in 3 cases. Patients using the study cream took an average time of 14.3 days for erythema resolution and 9.3 days for swelling vanishing. The post-operative administration of the cream containing DermaACB induces a quicker reduction of post-operative erythema and swelling when compared to a standard treatment.
Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure
Purpose. To review the clinical outcome of patients with hypertensive uveitis. Methods. Retrospective review of uveitis patients with elevated intraocular pressure (IOP) > 25 mmHg and >1-year follow-up. Data are uveitis type, etiology, viral (VU) and nonviral uveitis (NVU), IOP, and medical and/or surgical treatment. Results. In 61 patients, IOP values are first 32.9 mmHg (SD: 9.0), highest 36.6 mmHg (SD: 9.9), 3 months after the first episode 19.54 mmHg (SD: 9.16), and end of follow-up 15.5 mmHg (SD: 6.24). Patients with VU (n = 25) were older (50.6 y/35.7 y, p = 0.014) and had more unilateral disease (100%/72.22% p = 0.004) than those with NVU (n = 36). Thirty patients (49.2%) had an elevated IOP before topical corticosteroid treatment. Patients with viral uveitis might have higher first elevated IOP (36.0/27.5 mmHg, p = 0,008) and maximal IOP (40.28/34.06 mmHg, p = 0.0148) but this was not significant when limited to the measurements before the use of topical corticosteroids (p = 0.260 and 0.160). Glaucoma occurred in 15 patients (24.59%) and was suspected in 11 (18.03%) without difference in viral and nonviral groups (p = 0.774). Conclusion. Patients with VU were older and had more unilateral hypertensive uveitis. Glaucoma frequently complicates hypertensive uveitis. Half of the patients had an elevated IOP before topical corticosteroid treatment. PMID:26504598
Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.
Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406
Harris, Stewart B.; Naqshbandi Hayward, Mariam; Tompkins, Jordan W.
Abstract Rationale, aims and objectives Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real‐world evaluation. Method Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real‐world comprehensive evaluations in health care settings. Results The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub‐steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built‐in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. Conclusions This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale‐up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. PMID:26804339
Zellers, Jennifer A.; Cortes, Daniel H.
Introduction Achilles tendon rupture results in significant functional deficits regardless of treatment strategy (surgical versus non-surgical intervention). Recovery post-rupture is highly variable, making comprehensive patient assessment critical. Assessment tools may change along the course of recovery as the patient progresses – for instance, moving from a seated heel-rise to standing heel-rise to jump testing. However, tools that serve as biomarkers for early recovery may be particularly useful in informing clinical decision-making. The purpose of this case report was to describe the progress of a young, athletic individual following Achilles tendon rupture managed non-surgically, using patient reported and functional performance outcome measures and comprehensively evaluating Achilles tendon structure and function incorporating a novel imaging technique (cSWE). Subject Description The subject is a 26 year-old, female basketball coach who sustained an Achilles tendon rupture and was managed non-surgically. Outcome The subject was able to steadily progress using a gradual tendon loading treatment approach well-supported by the literature. Multiple evaluative techniques including the addition of diagnostic ultrasound imaging and continuous shear wave elastography (cSWE) to standard clinical tests and measures were used to assess patient-reported symptoms, tendon structure, and tendon functional performance. Five assessments were performed over the course of 2-14 months post-rupture. By the 14-month follow-up, the subject had achieved full self-reported function. Tendon structural and mechanical properties showed similar shear modulus by 14 months, however, viscosity continued to be lower and tendon length longer on the ruptured side. Functional performance, evidenced by the heel-rise test and jump tests, also showed a positive trajectory, however, deficits of 12-28% remained between ruptured and non-ruptured sides at 14 months. Discussion This case report
Towards empirical identification of a clinically meaningful indicator of treatment outcome: Features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes
Carroll, Kathleen M.; Kiluk, Brian D.; Nich, Charla; DeVito, Elise E.; Decker, Suzanne; LaPaglia, Donna; Duffey, Dianne; Babuscio, Theresa A.; Ball, Samuel A.
Background Selection of an appropriate indictor of treatment response in clinical trials is complex, particularly for the various illicit drugs of abuse. Most widely-used indicators have been selected based on expert group recommendation or convention rather than systematic empirical evaluation. Absence of an evidence-based, clinically meaningful index of treatment outcome hinders cross-study evaluations necessary for progress in addiction treatment science. Method Fifteen candidate indicators used in multiple clinical trials as well as some proposed recently are identified and discussed in terms of relative strengths and weaknesses (practicality, cost, verifiability, sensitivity to missing data). Using pooled data from five randomized controlled trials of cocaine dependence (N = 434), the indicators were compared in terms of sensitivity to the effects of treatment and relationship to cocaine use and general functioning during follow-up. Results Commonly used outcome measures (percent negative urine screens; percent days of abstinence) performed relatively well in that they were sensitive to the effects of the therapies evaluated. Others, including complete abstinence and reduction in frequency of use, were less sensitive to effects of specific therapies and were very weakly related to cocaine use or functioning during follow-up. Indicators more strongly related to cocaine use during follow-up were those that reflected achievement of sustained periods of abstinence, particularly at the end of treatment. Conclusions These analyses did not demonstrate overwhelming superiority of any single indicator, but did identify several that performed particularly poorly. Candidates for elimination included retention, complete abstinence, and indicators of reduced frequency of cocaine use. PMID:24556275
Sander, Rebecca; Trible, Karen A
Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed.
Background Schizophrenia is a chronic mental health disorder associated with increased hospital admissions and excessive utilization of outpatient services and long-term care. This analysis examined health care resource utilization from a 24-month observational study of patients with schizophrenia initiated on risperidone long-acting therapy (RLAT). Methods Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE) was a 24-month observational study designed to examine real-world treatment outcomes by prospectively following patients with schizophrenia initiated on RLAT. At baseline visit, prior hospitalization and ER visit dates were obtained for the previous 12 months and subsequent hospitalization visit dates were obtained at 3-month visits, if available. The health care resource utilization outcomes measures observed in this analysis were hospitalizations for any reason, psychiatric-related hospitalizations, and emergency room (ER) visits. Incidence density analysis was used to assess pre-event and postevent rates per person-year (PY). Results The primary medical resource utilization analysis included 435 patients who had a baseline visit, ≥1 postbaseline visits after RLAT initiation, and valid hospitalization dates. The number of hospitalizations and ER visits per PY declined significantly (p < .0001) after initiation with RLAT. A 41% decrease (difference of -0.29 hospitalizations per PY [95% CI: -0.39 to -0.18] from baseline) in hospitalizations for any reason, a 56% decrease (a difference of -0.35 hospitalizations per PY [95% CI: -0.44 to -0.26] from baseline) in psychiatric-related hospitalizations, and a 40% decrease (-0.26 hospitalizations per PY [95% CI: -0.44 to -0.10] from baseline) in ER visits were observed after the baseline period. The percentage of psychiatric-related hospitalizations decreased significantly after RLAT initiation, and patients had fewer inpatient hospitalizations and ER visits (all p < .0001). Conclusion The
Frank, Rachel M.; Mellano, Chris; Shin, Jason J.; Feldheim, Terrence F.; Mascarenhas, Randhir; Yanke, Adam Blair; Cole, Brian J.; Nicholson, Gregory P.; Romeo, Anthony A.; Verma, Nikhil N.
Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (p<0.001) in ASES (63.7 to 85.1), SST (6.2 to 9.1), and VAS pain scores (2.89 to 0.81). Recurrent instability occurred in 12 of 63 shoulders (19%); the number of prior surgeries and baseline hyperlaxity were significant risk factors for failure (p<0.001 and p=0.04, respectively). No patients developed clinical or radiographic evidence of arthritis. A total of 28 shoulders in 28 patients (21 male, 7 female) with an average age of 27.5 years (range 14 to 45) were included in the Latarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (p<0.001) in ASES (65.7 to 87.0), SST (7.2 to 10.3), and VAS (3.1 to 1.1). Recurrent instability occurred in 2 of 28 shoulders
Cantarini, Luca; Fabbroni, Marta; Talarico, Rosaria; Costa, Luisa; Caso, Francesco; Cuneo, Gian Luca; Frediani, Bruno; Faralli, Gabriele; Vitale, Antonio; Brizi, Maria Giuseppina; Sabadini, Luciano; Galeazzi, Mauro
The primary aim of the study was to evaluate the long-term effectiveness of adalimumab (ADA) in a cohort of non-radiographic axial spondyloarthritis (nr-axSpA), and the secondary aims were to identify predictive factors of response and evaluate radiological progression.We evaluated 37 patients (male/female: 12/25; mean age 49 ± 14; mean disease duration: 6.3 ± 5.8) with active nr-axSpA (Assessment of SpondyloArthritis International Society criteria), despite the treatment with ≥1 nonsteroidal anti-inflammatory drug for at least 3 months, initiating the treatment with ADA 40 mg every other week. Patients were treated for 24 months, and evaluated at baseline, 6, 12, and 24 months. Outcome measures included Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index. Radiograph of the spine and sacroiliac joints and magnetic resonance of the sacroiliac joints were performed at baseline and according to the standard of assessment for the disease.The proportion of patients that achieved a BASDAI50 response at 6, 12 and 24 months was 51.3%, 70.3%, and 76.8%, respectively. Treatment was well tolerated with no unexpected adverse events and/or serious adverse events. All patients remained on treatment for 2 years, with a good compliance. We did not identify any predictive factor of response to therapy. Moreover, modified Stoke Ankylosing Spondylitis Spine Score and Spondyloarthritis Research Consortium of Canada scores showed a trend of improvement during the study period.ADA was effective on clinical and radiological outcomes at 2-year follow-up; thus, early treatment with ADA may prevent radiographic damage and be associated with low disease activity or remission. Moreover, data from this cohort study have confirmed safety and tolerability profile of ADA in nr-axSpA in the long term.
Ikemoto, Roberto Yukio; Murachovsky, Joel; Nascimento, Luís Gustavo Prata; Bueno, Rogério Serpone; Almeida, Luis Henrique; Strose, Eric; Castiglia, Marcello Teixeira
Objective: To evaluate the clinical and functional outcomes from arthroscopic repairs on small and medium-sized tears of the supraspinatus muscle tendon. Methods: 129 cases of isolated small and medium tears of the supraspinatus muscle tendon were evaluated retrospectively. The average duration of pain was 29 months. The average joint range of motion comprised active elevation of 136°, lateral rotation of 58° and medial rotation at T12 level; and the preoperative functional UCLA score averaged 17 points. In all the cases, complete repair could be achieved. Results: The average score on the UCLA functional scale in the postoperative period was 32 points. The average length of follow-up was 39 months. Seventy-five cases (58%) had excellent results and 42 (32%) had good results. The average final active elevation was 156° with an average gain of 20°, and the average final lateral rotation was 57° with an average gain of 9°. Both of these were statistically significant (P < 0.05). The patients who underwent tenotomy of the long head of the biceps (LHB), with or without tenodesis, did not present statistically inferior functional outcomes, in comparison with the patients who only underwent decompression and lesion repair (P = 1.00). Fourteen cases (10.8%) presented complications during the postoperative period. Six (4.6%) developed adhesive capsulitis and four (3.1%) presented re-rupture of the tendon, proven by means of magnetic resonance imaging. Conclusions: Arthroscopic repair of small and medium tears of the supraspinatus muscle tendon provided a functional clinical improvement, with good and excellent results in 90% of the cases. PMID:27047846
Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton
To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.
Braswell, H R; Williamson, J W
The application of a protocol for the initial assessment of medical care outcomes of geriatric depression management in four multispecialty group practice clinics is described. The clinical findings of this study are limited, but the protocol for the assessment of depression outcomes was found to be feasible, practical and acceptable in all four clinics. The success of the study has positive implications both for improving management of depressed clinic patients and for adapting this quality assurance approach to other health conditions and care settings. PMID:507262
This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.
Trent, Maria; Bass, Debra; Ness, Roberta B; Haggerty, Catherine
PEACH trial data were used to evaluate the relationship between subsequent sexually transmitted infection and recurrent pelvic inflammatory disease on infertility and chronic pelvic pain (CPP). Recurrent pelvic inflammatory disease was associated with an almost 2-fold increase in infertility and more than 4-fold increase in CPP. Subsequent sexually transmitted infection was associated with CPP, but not infertility.
Heinemann, Allen W; Connelly, Lauri; Ehrlich-Jones, Linda; Fatone, Stefania
Outcome measurement is crucial to assuring high-quality patient services and improving the quality of services provided by prosthetists. This article summarizes recent evidence on the measurement properties of outcome measures, and updates previously published summaries of outcome instruments. The review focuses on measures of mobility, functional status, quality of life, and patient satisfaction, and includes both performance-based and patient-reported outcomes. Amputation-specific and general measures that are suitable for patients served by prosthetists are discussed. It is encouraging that responsiveness of measures is often reported, as this information is needed to improve clinical utility.
Weimar, Dawn; Gray, Jeffrey; Davies, Bud
As Medicaid expands in scope and influence, it is evolving toward being a “purchaser” of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid. PMID:26945295
Background The purpose of this study was to compare two impression techniques from the perspective of patient preferences and treatment comfort. Methods Twenty-four (12 male, 12 female) subjects who had no previous experience with either conventional or digital impression participated in this study. Conventional impressions of maxillary and mandibular dental arches were taken with a polyether impression material (Impregum, 3 M ESPE), and bite registrations were made with polysiloxane bite registration material (Futar D, Kettenbach). Two weeks later, digital impressions and bite scans were performed using an intra-oral scanner (CEREC Omnicam, Sirona). Immediately after the impressions were made, the subjects’ attitudes, preferences and perceptions towards impression techniques were evaluated using a standardized questionnaire. The perceived source of stress was evaluated using the State-Trait Anxiety Scale. Processing steps of the impression techniques (tray selection, working time etc.) were recorded in seconds. Statistical analyses were performed with the Wilcoxon Rank test, and p < 0.05 was considered significant. Results There were significant differences among the groups (p < 0.05) in terms of total working time and processing steps. Patients stated that digital impressions were more comfortable than conventional techniques. Conclusions Digital impressions resulted in a more time-efficient technique than conventional impressions. Patients preferred the digital impression technique rather than conventional techniques. PMID:24479892
Tong, Yi Cai Isaac; Kaye, Alan David; Urman, Richard D
In the multimodal approach to the management of postoperative pain, local infiltration and regional blocks have been increasingly utilized for pain control. One of the limitations of local anesthetics in the postoperative setting is its relatively short duration of action. Multivesicular liposomes containing bupivacaine have been increasingly utilized for their increased duration of action. Compared with bupivacaine HCl, local infiltration of liposomal bupivacaine has shown to have an increase in duration of action and causes delay in peak plasma concentration. In this article, we attempt to review the clinical literature surrounding liposomal bupivacaine and its evolving role in perioperative analgesia. This new bupivacaine formation may have promising implications in postoperative pain control, resulting in increased patient satisfaction and a decrease in both hospital stay and opioid-induced adverse events (AEs). Although more studies are needed, the preliminary clinical trials suggest that liposomal bupivacaine has predictable pharmacokinetics, a similar side effect profile compared with bupivacaine HCl, and is effective in providing increased postoperative pain control.
Choi, Keum-Hyeong; Buskey, Wendy; Johnson, Bonita
The main purpose of this study was to investigate how receiving personal counseling at a university counseling center helps students deal with their personal problems and facilitates academic functioning. To that end, this study used both clinical and academic outcome measures that are relevant to the practice of counseling provided at a…
Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton
Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome.
Yakimo, Richard; Kurlowicz, Lenore H; Murray, Ruth Beckmann
This report describes and evaluates the current status of outcome analysis in Psychiatric Consultation-Liaison Nursing (PCLN) and offers suggestions for future development. The status of outcome evaluation generally in psychiatric nursing is described with attention given to the scope of practice of PCLN and outcomes used by psychiatric consultation-liaison nurses (PCLNs) to evaluate their interventions. An evaluation framework based on Donabedian's paradigm of structure, process, and outcome is presented and its applicability shown to PCLN. This framework is further explicated with regard to a review of published studies of PCLN within the outcome domains of cost reduction, satisfaction with services, changes in clinical status, and perceptions of work environment. Finally, recommendations for further development of outcomes in PCLN are offered, based on the strengths and limitations of the extant literature.
Coates, Dominiek; Woodford, Patricia; Higgins, Oliver; Grover, Deborah
The present study is a review of a cardiometabolic clinic for consumers taking clozapine. This clinic was recently established and co-located with the clozapine clinic at a regional hospital in New South Wales, Australia, to enhance engagement and improve the physical health outcomes of consumers taking antipsychotic medication. A descriptive analysis of clients' (n = 73) information collected during routine care for the first 6 months of the clinic's operation, from January 2016 to July 2016, was conducted. First-visit data were analysed to establish a client profile, consisting of weight, height, blood pressure, pulse, a range of blood measurements, smoking status, alcohol consumption, and eating and exercise habits. Data collected for clients who had three or more visits with the general practitioner (n = 40) were analysed separately for outcomes. Two case studies are used to depict the service received and client profile. At the first appointment, the majority of clients had metabolic syndrome that was mostly left untreated; many of these clients were commenced on metformin. The outcomes are positive, and show that the majority of clients lost weight (82.5%) and had a reduction in body mass index (84.6%); nearly half (44.4%) had a reduction in waist circumference. The majority of clients self-reported increased physical activity (72.5%, n = 29) and positive dietary changes (77.5%, n = 31) since their first appointment. The model trialled by the cardiometabolic clinic integrated a specialist mental health and primary care service, and demonstrates success in engaging clients with severe mental illness in physical health care. Co-location is conceptualized as critical for positive patient outcomes and high levels of engagement.
Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T
Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer
Viala-Danten, Muriel; Martin, Susan; Guillemin, Isabelle; Hays, Ron D
Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and
Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino
Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of "personalized spine care."
Stonestreet, J S; Prevost, S S
This article describes how organizations devise strategic directions. The process of focused strategic or hoshin planning is introduced and reviewed. This model illustrates how a nursing department planned a focused strategic direction for outcomes evaluation. This discussion includes the dedication of resources, the focusing of research priorities and a summary of the outcomes evaluation program, and the method used for implementation of the priorities. Finally, benefits of both the focused planning process and the outcomes evaluation program are discussed.
Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J
The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality.
Blesneag, AV; Slăvoacă, DF; Popa, L; Stan, AD; Jemna, N; Isai Moldovan, F; Mureșanu, DF
Rationale: Repetitive transcranial magnetic stimulation (rTMS) is used alone or in combination with physiotherapy for rehabilitation of stroke patients. TMS mapping can also quantify the excitability of the motor area in both the ipsilesional (IL) and contralateral (CL) hemisphere. Objective: This study is the first to measure the dynamics of cortical excitability by TMS mapping before and after treatment with low-frequency (LF) rTMS in the contralesional hemisphere at three different timepoints. Furthermore, the patients were clinically evaluated during the same visit as the mapping to establish both short and long-term outcomes after rTMS treatment. Methods and Results: A total of 16 participants with acute ischemic stroke were assessed 10 days post-stroke by TMS mapping. The patients were randomized into two equal groups: a real rTMS group and a sham group. The rTMS group received LF-rTMS to the contralesional hemisphere for 10 days, starting on the first day after the first mapping. Each subject was also evaluated by mapping on days 45 and 90 after stroke onset. The primary clinical outcome measured was the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) on days 10, 45 and 90 post-stroke. At 10 days after stroke onset, both groups presented low excitability in the lesion side and high excitability in the non-affected side. In the real rTMS group, at 45 days after stroke, a downward trend in the excitability of the contralesional hemisphere and an upward trend in the excitability of the lesioned side were observed. At 90 days after stroke, a tendency toward balanced excitability between both hemispheres was observed. In the sham group, at both 45 and 90 days, we observed increased excitability in the non-affected side compared to the side with the lesioned motor area. At 45 days, the real rTMS group demonstrated a better recovery of the upper limb motor function than the sham group, but at 90 days, there was no significant difference between the two groups
Rogers, Katherine; Evans, Chris; Campbell, Malcolm; Young, Alys; Lovell, Karina
Previous research has argued that the mental well-being of d/Deaf people is poorer than that of hearing populations. However, there is a paucity of valid and reliable mental health instruments in sign language that have been normalised with d/Deaf populations. The aim of this study was to determine the reliability of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) with d/Deaf populations. A British Sign Language (BSL) version was produced using a team approach to forward translation, and a back-translation check. The CORE-OM was incorporated into an online survey, to be completed in either BSL or English, as preferred by the participant. From December 2010 to March 2011, data were collected from 136 d/Deaf people. Cronbach's α was used to measure the internal consistency of items in the CORE-OM. Comparisons were made between versions, including comparisons with the non-clinical hearing population (not in receipt of mental health services) in a previous study. The reliability of the overall score, as well as the non-risk items in both the BSL and English versions, was satisfactory. The internal reliability of each domain in the BSL version was good (Cronbach's α > 0.70) and comparable to the English version in the hearing population. This was true for most domains of the CORE-OM in the English version completed by d/Deaf people, although the Functioning domain had a relatively low α of 0.79 and the Risk domain had an α of only 0.66 This raised the question whether it is advisable to use a mental health assessment with d/Deaf populations that has been standardised with hearing populations. Nevertheless, this study has shown that it is possible to collect data from d/Deaf populations in the UK via the web (both in BSL and English), and an online BSL version of the CORE-OM is recommended for use with Deaf populations in the community.
Kinnison, Charles J.
An outcomes orientation is examined as the dominant focus for formulating improvements in a college's planning, management, and evaluation (PME) system. Outcomes are seen as individual (produced by college personnel or students), program related, or institutional. An outcomes orientation to PME has the advantages of relating to the quality of…
Jia, Pu; Tang, Hai; Chen, Hao; Bao, Li; Feng, Fei; Yang, He; Li, Jinjun
A sandwich vertebra is formed after multiple osteoporotic vertebral fractures treated by percutaneous vertebroplasty, which has a risk of developing new fractures. The purpose of our study was to (i) investigate the occurrence of new fractures in sandwich vertebra after cement augmentation procedures and to (ii) evaluate the clinical outcomes after prophylactic vertebral reinforcement applied with resorbable bone cement. From June 2011 to 2014, we analysed 55 patients with at least one sandwich vertebrae and treated with percutaneous vertebroplasty. Eighteen patients were treated by prophylactic vertebroplasty with a resorbable bone cement to strengthen the sandwich vertebrae as the prevention group. The others were the non-prevention group. All patients were examined by spinal radiographs within 1 day, 6 months, 12 months, 24 months and thereafter. The incidence of sandwich vertebra is 8.25% (55/667) in our study. Most sandwich vertebrae (69.01%, 49/71) are distributed in the thoracic–lumbar junction. There are 24 sandwich vertebrae (18 patients) and 47 sandwich vertebrae (37 patients) in either prevention group or non-prevention group, respectively. No significant difference is found between age, sex, body mass index, bone mineral density, cement disk leakage, sandwich vertebrae distribution or Cobb angle in the two groups. In the follow-up, 8 out of 37 (21.6%) patients (with eight sandwich vertebrae) developed new fractures in non-prevention’ group, whereas no new fractures were detected in the prevention group. Neither Cobb angle nor vertebral compression rate showed significant change in the prevention group during the follow-up. However, in the non-prevention group, we found that Cobb angle increased and vertebral height lost significantly (P < 0.05). Prophylactic vertebroplasty procedure applied with resorbable bone cement could decrease the rate of new fractures of sandwich vertebrae. PMID:28149529
Rice, Kenneth G.; Suh, Hanna; Ege, Engin
Data from clinical and nonclinical samples ("Ns" = 2,096, 618) were used to evaluate and replicate the measurement structure of the Outcome Questionnaire-45.2. Different measurement models and invariance tests were evaluated and the best psychometric support was found for a shortened measure of two factors: overall maladjustment and…
Consolaro, Alessandro; Giancane, Gabriella; Schiappapietra, Benedetta; Davì, Sergio; Calandra, Serena; Lanni, Stefano; Ravelli, Angelo
Juvenile idiopathic arthritis (JIA), as a chronic condition, is associated with significant disease- and treatment-related morbidity, thus impacting children's quality of life. In order to optimize JIA management, the paediatric rheumatologist has begun to regularly use measurements of disease activity developed, validated and endorsed by international paediatric rheumatology professional societies in an effort to monitor the disease course over time and assess the efficacy of therapeutic interventions in JIA patients.A literature review was performed to describe the main outcome measures currently used in JIA patients to determine disease activity status.The Juvenile Disease Activity Score (JADAS), in its different versions (classic JADAS, JADAS-CRP and cJADAS) and the validated definitions of disease activity and response to treatment represent an important tool for the assessment of clinically relevant changes in disease activity, leading more and more to a treat-to-target strategy, based on a tight and thorough control of the patient condition. Moreover, in recent years, increasing attention on the incorporation of patient-reported or parent-reported outcomes (PRCOs), when measuring the health state of patients with paediatric rheumatic diseases has emerged.We think that the care of JIA patients cannot be possible without taking into account clinical outcome measures and, in this regard, further work is required.
DeVito, Elise E.; Babuscio, Theresa A.; Nich, Charla; Ball, Samuel A.; Carroll, Kathleen M.
Background Despite extensive research on gender differences in addiction, there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials. Methods An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence (N = 434) was evaluated for gender differences in clinical outcomes. Secondary analyses compared gender differences in outcome by medication condition (disulfiram versus no medication) and across multiple behavioral treatment conditions. Results Women, compared with men, had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up. These results appear to be primarily accounted for by disulfiram being less effective in women compared with men. There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated. Conclusions These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction. Conversely, some addiction pharmacotherapies, such as disulfiram, may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation. PMID:25457739
Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.
(pre-IMM analysis) and overall mitigation of the mission medical impact (IMM analysis); 2) refine the procedure outcome and clinical outcome metrics themselves; 3) refine or develop innovative medical training products and solutions to maximize CMO performance; and 4) validate the methods and products of this experiment for operational use in the planning, execution, and quality assurance of the CMO training process The team has finalized training protocols and developed a software training/testing tool in collaboration with Butler Graphics (Detroit, MI). In addition to the "hands on" medical procedure modules, the software includes a differential diagnosis exercise (limited clinical decision support tool) to evaluate the diagnostic skills of participants. Human subject testing will occur over the next year.
Henggeler, Scott W; Schaeffer, Cindy M
Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes.
Nursing educators and preceptors often find it difficult to evaluate prelicensure students' clinical judgment development. Clinical judgment is critical to excellent patient care decisions and outcomes. The Lasater Clinical Judgment Rubric, a validated, evidence-based clinical judgment rubric, is described as a tool that offers a common language for students, nurse educators, and preceptors and a trajectory for students' clinical judgment development. The rubric has been used to provide feedback for reflective journals and a means for self-evaluation in addition to a guide for formulating higher level thought questions to shape students' thinking like a nurse.
Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A
Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878
Iselin, Anne-Marie R.; Gully, Kevin J.
This paper examines the sustainability and outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) as delivered by practitioners in a community-based child protection program who had received training in the model several years earlier. Formerly described as Abuse-Focused CBT, AF-CBT is an evidence-based treatment (EBT) for child physical abuse and family aggression/conflict that was included in the National Child Traumatic Stress Network’s initial EBT dissemination efforts in 2002. Seven practitioners participated in a year-long Learning Collaborative in AF-CBT and in similar training programs for 4 other EBTs. The agency’s routine data collection system was used to document the clinical and adjustment outcomes of 52 families presenting with a physically abused child who received their services between 2 and 5 years after the AF-CBT training had ended. Measures of the use of all 5 EBTs documented their frequency, internal consistency, and intercorrelations. Controlling for the unique content of the other four EBTs, the amount of AF-CBT Abuse-specific content delivered was related to improvements on standardized parent rating scales (i.e., child externalizing behavior, anger, anxiety, social competence) and both parent and clinician ratings of the child’s adjustment at discharge (i.e., child more safe, less scared/sad, more appropriate with peers). The amount of AF-CBT General content was related to a few discharge ratings (better child prognosis, helpfulness to parents). These novel data provide suggestive evidence for the sustainability and clinical benefits of AF-CBT in an existing community clinic serving physically abused children and their families, and are discussed in the context of key developments in the treatment model and dissemination literature. PMID:21354619
Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo
Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures.
Storrs, Mark J; Alexander, Heather; Sun, Jing; Kroon, Jeroen; Evans, Jane L
Previous research on interprofessional education (IPE) assessment has shown the need to evaluate the influence of team-based processes on the quality of clinical education. This study aimed to develop a valid and reliable instrument to evaluate the effectiveness of interprofessional team-based treatment planning (TBTP) on the quality of clinical education at the Griffith University School of Dentistry and Oral Health, Queensland, Australia. A scale was developed and evaluated to measure interprofessional student team processes and their effect on the quality of clinical education for dental, oral health therapy, and dental technology students (known more frequently as intraprofessional education). A face validity analysis by IPE experts confirmed that items on the scale reflected the meaning of relevant concepts. After piloting, 158 students (61% response rate) involved with TBTP participated in a survey. An exploratory factor analysis using the principal component method retained 23 items with a total variance of 64.6%, suggesting high content validity. Three subscales accounted for 45.7%, 11.4%, and 7.5% of the variance. Internal consistency of the scale (α=0.943) and subscales 1 (α=0.953), 2 (α=0.897), and 3 (α=0.813) was high. A reliability analysis yielded moderate (rs=0.43) to high correlations (0.81) with the remaining scale items. Confirmatory factor analyses verified convergent validity and confirmed that this structure had a good model fit. This study suggests that the instrument might be useful in evaluating interprofessional or intraprofessional team-based processes and their influence on the quality of clinical education in academic dental institutions.
Amodio-Groton, Maria; Rashid, Mohamad; Lamp, Kenneth C.; Hoffman-Roberts, Holly L.; Sakoulas, George; Yoon, Min J.; Schweitzer, Suzanne; Rastogi, Anjay
Patients with underlying renal disease may be vulnerable to vancomycin-mediated nephrotoxicity and Staphylococcus aureus bacteremia treatment failure. In light of recent data demonstrating the successful use of β-lactam plus daptomycin in very difficult cases of S. aureus bacteremia, we examined safety and clinical outcomes for patients who received daptomycin with or without concomitant β-lactams. We identified 106 patients who received daptomycin for S. aureus bacteremia, had mild or moderate renal insufficiency according to FDA criteria, and enrolled in the Cubicin Outcomes Registry and Experience (CORE), a multicenter registry, from 2005 to 2009. Daptomycin treatment success was 81%. Overall treatment efficacy was slightly enhanced with the addition of a β-lactam (87% versus 78%; P = 0.336), but this trend was most pronounced for bacteremia associated with endocarditis or bone/joint infection or bacteremia from an unknown source (90% versus 57%; P = 0.061). Factors associated with reduced daptomycin efficacy (by logistic regression) were an unknown source of bacteremia (odds ratio [OR] = 7.59; 95% confidence interval [CI] = 1.55 to 37.2), moderate renal impairment (OR = 9.11; 95% CI = 1.46 to 56.8), and prior vancomycin failure (OR = 11.2; 95% CI = 1.95 to 64.5). Two patients experienced an increase in creatine phosphokinase (CPK) that resolved after stopping daptomycin. No patients developed worsening renal insufficiency related to daptomycin. In conclusion, daptomycin appeared to be effective and well tolerated in patients with S. aureus bacteremia and mild to moderate renal insufficiency. Daptomycin treatment efficacy might be enhanced with β-lactam combination therapy in primary endovascular and bone/joint infections. Additional studies will be necessary to confirm these findings. PMID:23254428
Mullins, C. Daniel; Quintana, Alvaro; Eckmann, Christian; Shelbaya, Ahmed; Ernst, Frank R.; Krukas, Michelle R.; Reisman, Arlene
Abstract Background: The utility of tigecycline as compared with other antibiotic therapies in the treatment of patients with complicated intra-abdominal infection (cIAI) and the short- and long-term outcomes of a large cohort of severely ill patients were examined. We provide the first published data on post-discharge events for these patients. Methods: Retrospective data for the cIAI cohort were obtained from a large clinical database. Patients aged ≥18 y were selected for inclusion based on hospitalization with a relevant diagnosis code and procedure code, and guideline-compliant antimicrobial therapy. Propensity scoring was used to reduce treatment-selection bias introduced by the use of observational data. Tigecycline patients were placed into quintiles based on propensity score and were matched 1:3. Results: The final model based on propensity score matching included 2,424 patients: Tigecycline (n = 606) and other antibiotic therapy (n = 1,818). Treatment was successful in 426 (70.3%) tigecycline-treated patients and in 1,294 (71.2%) patients receiving other antibiotics. Similar treatment success occurred across all infection sites. Among survivors, treatment failure was associated with a greater need for all-cause re-hospitalization at 30 d and 180 d. No differences in cIAI-related re-hospitalization and discharge status were observed. Conclusions: Using propensity scores to match populations, similar outcomes were demonstrated between treatment with tigecycline and other antibiotics as expressed by treatment success, the need for re-admission, similar 30-d discharge status, and the need for re-admission at 180 d. PMID:26981640
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...
Camara-Lemarroy, Carlos Rodrigo; González-Moreno, Emmanuel Irineo; Rodríguez-Gutiérrez, René; Rendón-Ramírez, Erick Joel; Ayala-Cortés, Ana Sofía; Fraga-Hernández, Martha Lizeth; García-Labastida, Laura; Galarza-Delgado, Dionicio Ángel
Mucormycosis (MCM) is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65). Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia). Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors. PMID:25210515
Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P
The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.
Adinolfi, Barbara; Gava, Nicoletta
Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.
Komaba, Hirotaka; Fukagawa, Masafumi
Secondary hyperparathyroidism (SHPT) is a common complication of end-stage renal disease and is one of the most prominent causes of a markedly increased risk of death and cardiovascular disease in this patient population. Cinacalcet hydrochloride is a new option for the treatment of SHPT, and the efficacy and effectiveness to lower parathyroid hormone levels and to improve control of mineral metabolism, even in patients with severe disease, has been well established in many clinical trials and observational studies. Currently, the focus has moved to the impact of cinacalcet on hard clinical outcomes, and two randomized controlled trials, ADVANCE and EVOLVE, have been performed to assess the effects of cinacalcet on cardiovascular calcification and the risk of cardiovascular events and mortality, respectively. Although the primary analysis of both trials did not find significant effects of cinacalcet, the benefit of cinacalcet was suggested in the subanalyses in which the potential problems of the trials were taken into account. These positive results are consistent with experimental studies showing favorable effects of cinacalcet on bone metabolism and vascular calcification, providing plausibility to support the beneficial effects of cinacalcet. Definitive evidence is, however, still lacking, and further efforts should be made to establish the optimal role of cinacalcet in the treatment of SHPT.
Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.
Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to
Mukherjee, Shiuli; Sharma, Sunita; Chakravarty, B N
OBJECTIVES: A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate. MATERIALS AND METHODS: The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles) with polycystic ovarian syndrome (PCOS) (n=911/2573 cycles) and unexplained infertility (n=616/1808 cycles) were randomized into two groups. Group A received single dose of uFSH on D3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups. RESULTS: Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001). The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99). Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001) in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11%) and Group B(6.3%). Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility. CONCLUSION: Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II). Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect. PMID:21209751
The diagnosis of a chronic disease such as diabetes generally evokes strong emotions and often brings with it the need to make changes in lifestyle behaviours, such as diet, exercise, medication management and monitoring clinical and metabolic parameters. The diagnosis thus affects not only the person diagnosed but also the family members. Chronic illnesses are largely self-managed with ∼99% of the care becoming the responsibility of patients and their families or others involved in the daily management of their illnesses. While the responsibility for outcomes, such as metabolic control and chronic complications, are shared with the health care team, the daily decisions and behaviours adopted by patients clearly have a strong influence on their future health and well-being. While diabetes self-management education is essential, it is generally not sufficient for patients to sustain behaviours and cope with a lifetime of diabetes. Peers have been proposed as one method for assisting patients to deal with the behavioural and affective components of diabetes and to provide ongoing self-management support. This paper first describes effective behavioural strategies in diabetes, based on multiple studies and/or meta-analyses, and then provides examples of their use by peers or in peer-based programmes in diabetes. A comprehensive search using the MEDLINE® and Cinahl databases was conducted. Key search terms included peer mentors, peer leaders, peer educators, lay health workers and community health workers. Studies that clearly identified behavioural strategies used by peers were included. PMID:19509083
Sadeghi-Bojd, Simin; Kajbafzadeh, Abdol-Mohammad; Ansari-Moghadam, Alireza; Rashidi, Somaye
Background: Prenatal hydronephrosis (PNH) is dilation in urinary collecting system and is the most frequent neonatal urinary tract abnormality with an incidence of 1% to 5% of all pregnancies. PNH is defined as anteroposterior diameter (APD) of renal pelvis ≥ 4 mm at gestational age (GA) of < 33 weeks and APD ≥ 7 mm at GA of ≥ 33 weeks to 2 months after birth. All patients need to be evaluated after birth by postnatal renal ultrasonography (US). In the vast majority of cases, watchful waiting is the only thing to do; others need medical or surgical therapy. Objectives: There is a direct relationship between APD of renal pelvis and outcome of PNH. Therefore we were to find the best cutoff point APD of renal pelvis which leads to surgical outcome. Patients and Methods: In this retrospective cohort study we followed 200 patients 1 to 60 days old with diagnosis of PNH based on before or after birth ultrasonography; as a prenatal or postnatal detected, respectively. These patients were referred to the nephrology clinic in Zahedan Iran during 2011 to 2013. The first step of investigation was a postnatal renal US, by the same expert radiologist and classifying the patients into 3 groups; normal, mild/moderate and severe. The second step was to perform voiding cystourethrogram (VCUG) for mild/moderate to severe cases at 4 - 6 weeks of life. Tc-diethylene triamine-pentaacetic acid (DTPA) was the last step and for those with normal VCUG who did not show improvement in follow-up examination, US to evaluate obstruction and renal function. Finally all patients with mild/moderate to severe PNH received conservative therapy and surgery was preserved only for progressive cases, obstruction or renal function ≤35%. All patients’ data and radiologic information was recorded in separate data forms, and then analyzed by SPSS (version 22). Results: 200 screened PNH patients with male to female ratio 3.5:1 underwent first postnatal control US, of whom 65% had normal, 18% mild
Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area. PMID:19293400
The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.
Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran
Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929
Silva, S.C.; Baggio-Zappia, G.L.; Brunialti, M.K.C.; Assunçao, M.S.C.; Azevedo, L.C.P.; Machado, F.R.; Salomao, R.
Recognition of pathogens is performed by specific receptors in cells of the innate immune system, which may undergo modulation during the continuum of clinical manifestations of sepsis. Monocytes and neutrophils play a key role in host defense by sensing and destroying microorganisms. This study aimed to evaluate the expression of CD14 receptors on monocytes; CD66b and CXCR2 receptors on neutrophils; and TLR2, TLR4, TLR5, TLR9, and CD11b receptors on both cell types of septic patients. Seventy-seven septic patients (SP) and 40 healthy volunteers (HV) were included in the study, and blood samples were collected on day zero (D0) and after 7 days of therapy (D7). Evaluation of the cellular receptors was carried out by flow cytometry. Expression of CD14 on monocytes and of CD11b and CXCR2 on neutrophils from SP was lower than that from HV. Conversely, expression of TLR5 on monocytes and neutrophils was higher in SP compared with HV. Expression of TLR2 on the surface of neutrophils and that of TLR5 on monocytes and neutrophils of SP was lower at D7 than at D0. In addition, SP who survived showed reduced expression of TLR2 and TLR4 on the surface of neutrophils at D7 compared to D0. Expression of CXCR2 for surviving patients was higher at follow-up compared to baseline. We conclude that expression of recognition and cell signaling receptors is differentially regulated between SP and HV depending on the receptor being evaluated. PMID:24728213
Rosenstein, Alan H; O'Daniel, Michelle
Providing safe, error-free care is the number-one priority of all health care professionals. Excellent outcomes have been associated with procedural efficiency, the implementation of evidence-based standards, and the use of tools designed to reduce the likelihood of medical error (such as computerized medication orders and bar-coded patient identification). But the impact of work relationships on clinical outcomes isn't as well documented. The current survey was designed as a follow-up to a previous VHA West Coast survey that examined the prevalence and impact of physicians' disruptive behavior on the job satisfaction and retention of nurses (see "Nurse-Physician Relationships: Impact on Nurse Satisfaction and Retention," June 2002). Based on the findings of that survey and subsequent comments on it, the follow-up survey examined the disruptive behavior of both physicians and nurses, as well as both groups' and administrators' perceptions of its effects on providers and its impact on clinical outcomes. Surveys were distributed to 50 VHA hospitals across the country, and results from more than 1,500 survey participants were evaluated. Nurses were reported to have behaved disruptively almost as frequently as physicians. Most respondents perceived disruptive behavior as having negative or worsening effects, in both nurses and physicians, on stress, frustration, concentration, communication, collaboration, information transfer, and workplace relationships. Even more disturbing was the respondents' perceptions of negative or worsening effects of disruptive behavior on adverse events, medical errors, patient safety, patient mortality, the quality of care, and patient satisfaction. These findings suggest that the consequences of disruptive behavior go far beyond nurses' job satisfaction and morale, affecting communication and collaboration among clinicians, which may well, in turn, have a negative impact on clinical outcomes. Strategies aimed at reducing the incidence and
Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.
Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M
There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.
Yamashita, Takanori; Wakata, Yoshifumi; Hamai, Satoshi; Nakashima, Yasuharu; Iwamoto, Yukihide; Franagan, Brendan; Nakashima, Naoki; Hirokawa, Sachio
Recently the clinical pathway has progressed with digitalization and the analysis of activity. There are many previous studies on the clinical pathway but not many feed directly into medical practice. We constructed a mind map system that applies the spanning tree. This system can visualize temporal relations in outcome variances, and indicate outcomes that affect long-term hospitalization.
Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B
An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to
Bark, C M; Dietze, R; Okwera, A; Quelapio, M I; Thiel, B A; Johnson, J L
During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients' clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an international phase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months. Symptom resolution during treatment did not differ between those who relapsed and those who did not. Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture as surrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials.
Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim; Wikkelsoe, Mette; Jürgens, Gesche
Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms were contacted. A total of 181 patients were registered (112 children). Ingested LT dose ranged from 10 to 9000 mcg (median 275 mcg). A total of 29 of 181 (16%) patients were symptomatic at the time of enquiry, and there was no difference in ingested LT dose between asymptomatic and symptomatic patients, neither in children nor in adults (age 16-92 years) (p < 0.68 and p < 0.47, respectively). In total, 153 of 181 (85%) patients did not have symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases, hospital contact was needed and there were no reports of long-term sequelae. Acute LT poisoning often follows a benign course. The occurrence of symptoms appears not to be dose dependent. Late-onset symptoms seem to be common. However, all symptoms resolved spontaneously without need of medical care.
Parodis, Ioannis; Zickert, Agneta; Sundelin, Birgitta; Axelsson, Magnus; Gerhardsson, Jakob; Svenungsson, Elisabet; Malmström, Vivianne; Gunnarsson, Iva
Objectives Lupus nephritis (LN) is a major cause of morbidity in patients with systemic lupus erythematosus (SLE). B cells have a central role in the pathogenesis of SLE. B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL) are pivotal in B cell homeostasis. We aimed to investigate a potential role of serum BLyS and APRIL as biomarkers in LN, especially as predictors of treatment response. Methods Sixty-four patients with active LN (52 proliferative lupus nephritis (PLN); 12 membranous LN) were included. Renal biopsies were performed at baseline and after immunosuppressive treatment. Serum levels of BLyS, APRIL and autoantibodies were measured on both biopsy occasions and in 64 individually matched controls. Renal biopsies were evaluated using the International Society of Nephrology/Renal Pathology Society classification, and scored for Activity Index and Chronicity Index. Clinical responders (CR) were required to have ≥50% reduction in proteinuria, normal or improved renal function, and inactive urinary sediment. Histopathological responders (HR) were required to have ≥50% improvement in Activity Index. Results Baseline BLyS levels were significantly higher in LN patients compared with controls (p<0.001) and remained unchanged following induction treatment. APRIL levels were significantly higher in patients compared with controls at baseline (p=0.005) and decreased following treatment (p<0.001). Among PLN patients, APRIL levels decreased significantly only in responders (CR: p=0.009; HR: p=0.01). Baseline BLyS levels <1.5 ng/mL predicted treatment response, attaining a positive predictive value of 92% for CR with PLN at baseline. Conclusions BLyS and APRIL were affected differently by immunosuppression; BLyS levels remained unchanged following therapy while APRIL levels decreased. Despite unchanged BLyS levels following therapy, low baseline levels predicted both clinical and histopathological improvement. Our data support APRIL as a
Kolko, David J.; Iselin, Anne-Marie R.; Gully, Kevin J.
This paper examines the sustainability and outcome of Alternatives for Families: A Cognitive-Behavioral Therapy (AF-CBT) as delivered by practitioners in a community-based child protection program who had received training in the model several years earlier. Formerly described as Abuse-Focused CBT, AF-CBT is an evidence-based treatment (EBT) for…
Andresen, Morten; Bartek, Jiri; Cortsen, Marie; Eskesen, Vagn; Wagner, Aase
Intra-arterial nimodipine (IAN) has shown a promising effect on cerebral vasospasm (CV) after aneurysmal subarachnoid haemorrhage. At our institution, Rigshospitalet, IAN treatment has been used since 2009, but the short- and long-term clinical efficacy of IAN has not yet been assessed. The purpose was to evaluate the efficacy and clinical outcome of IAN treatment of symptomatic CV, and to assess the predictors of clinical outcome. Medical records of 25 patients undergoing a total of 41 IAN treatment sessions were retrospectively reviewed. Data on angiographic results, blood-flow velocities and the clinical condition before and after the IAN treatment were recorded. Predictors of the clinical outcome were assessed with a linear regression model. Positive angiographic response was achieved in 95.1% of 41 IAN treatment sessions. Flow-velocity measurements showed no relationship with angiographic responses of IAN. The immediate clinical improvement was observed in three patients (12%). Five patients (20%) had a favourable outcome at discharge and at three-month follow-up; 10 patients (40%) had a moderate to poor outcome; and the rest (40%) died. Increased number of affected vessels and number of procedures carried out per patient, and a trend toward an increased delay time from symptomatic CV to confirming angiographic CV and thus instituting IAN treatment predicted the poor clinical outcome. IAN treatment appears to be effective in reversing angiographic CV. However, it is not always effective in reversing clinical deterioration, as several other factors including treatment delay affect the clinical course. PMID:26825134
Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying
Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133
McAllister, M; Dearing, A
Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS.
Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; Gibson, C. R.
The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.
Li, Chen-long; Chen, Ying; Chen, Yong-zheng; Fu, Yao-yao; Zhang, Tian-yu
The aim of the present study was to comprehensively evaluate the clinical features and long-term outcomes of congenital aural stenosis (CAS). This study presents a retrospective review of patients who underwent meatoplasty for CAS at a tertiary referral hospital from 2008 to 2015. A total of 246 meatoplasty procedures were performed on 232 patients in the present study. We performed multivariate regression analysis. Except in the age < 6 years group, no significant difference was observed among different age groups for cholesteatoma formation, p > 0.05. Except for the stenosis of the external auditory canal (EAC) (>4 mm) group, the other stenosis of EAC groups were not associated with cholesteatoma formation, p > 0.05. Postoperative air-bone gaps (ABG) less than 30 dB occurred in 77.3% (99/128) of the patients, and the Jahrsdoerfer score was associated with postoperative ABG, p < 0.001. The complication rate of CAS was 13.8% (20/144), and males showed a higher risk for postoperative complications (OR, 6.563; 95% CI, 1.268–33.966, p = 0.025). These results indicate that meatoplasty was an effective surgical intervention for CAS, showing a stable hearing outcome with prolonged follow-up. There was no significant difference between the cholesteatoma and no cholesteatoma groups for hearing outcomes, p > 0.05. PMID:27257165
Mavrogenis, Andreas F; Angelini, Andrea; Panagopoulos, Georgios N; Pala, Elisa; Calabrò, Teresa; Igoumenou, Vasilios G; Katzouraki, Galatia; Megaloikonomos, Panayiotis D; Pneumaticos, Spyros G; Papagelopoulos, Panayiotis J; Ruggieri, Pietro
The authors reviewed the files of all patients with chordomas who were admitted and treated at their institutions from 1975 to 2012. Patients were categorized by early local recurrence and metastasis. Aggressive clinical behavior was defined as local recurrence and metastasis within 24 months of diagnosis and adequate treatment (wide en bloc resection with microscopically negative tumor margins). According to these criteria, 13 patients (14.3%) had aggressive chordomas, including 7 men and 6 women, with mean age of 54 years (range, 37-65 years) at diagnosis and treatment. All patients had preoperative tumor biopsy, followed by resection with partial (7 patients) or total sacrectomy (6 patients). In all cases, biopsy and histologic analysis of resected tumor specimens showed conventional chordomas. Resection margins were wide (grossly negative) in 6 patients and wide contaminated in 7 patients. Mean maximum tumor diameter was 11.8 cm (range, 5-21 cm). Mean follow-up was 43 months (range, 8-131 months). Rates of local recurrence, metastasis, and death were evaluated. At the last follow-up, all patients had local recurrence at a mean of 13 months (range, 5-22 months). Histologic examination of recurrent tumors showed a dedifferentiated chordoma with a fibrosarcoma component in 2 patients and no histologic change in the remaining patients. In addition, 8 patients had metastases at a mean of 13 months (range, 4-24 months) and died of their disease. All histologic findings of metastatic lesions were similar to those of primary tumors. Early diagnosis of aggressive tumors requires close follow-up of patients with chordomas. Metastasis is common, with resultant poor survival. [Orthopedics. 2017; 40(2):e248-e254.].
Almubarak, Salah; Wong, Peter K H
The aim of the study is to determine how specific EEG findings during neonatal period correlate with clinical outcome on follow-up. This is a retrospective study of 118 term newborns who had EEG in the first month of life and subsequent clinical assessment between 4 and 16 years. Clinical neurologic outcome was classified into "favorable" when patients had no or only mild limitation in assessment, "unfavorable" when patients had moderate to severe abnormalities in assessment, and "epilepsy" when patients had seizures. Of the 118 neonates, 36 (30.5%) had favorable and 82 (69.5%) had unfavorable outcome; 89 (75.4%) had epilepsy and 28 (23.7%) had not. Sixty-seven (57%) had abnormal EEG background of which 56 had both unfavorable outcome and epilepsy; 102 (86%) had sharp transient discharges of which 75 had unfavorable outcome; 20 (17%) had ictal epileptiform discharges of which 18 had unfavorable outcome; 98 (83%) had abnormal overall EEG impression of which 77 had unfavorable outcome and 80 had epilepsy. Abnormal EEG background (particularly suppression) during neonatal period may be predictive of Unfavorable outcome. Overall impression of EEG may be predictive of clinical outcome, even when individual parameters were not predictive. Other findings did not appear to be predictive.
Doolittle, B R; Justice, A C; Fiellin, D A
This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.
Novo-Matos, José; Hurter, Karin; Bektas, Rima; Grest, Paula; Glaus, Tony
Right-sided congestive heart failure (CHF) developed secondary to severe pulmonary hypertension (PH) in an 8-year-old cat with a left-to-right shunting patent ductus arteriosus (PDA). Vascular reactivity was tested prior to shunt ligation by treatment with oxygen and sildenafil. This treatment was associated with a significant decrease in pulmonary artery pressure as assessed by echocardiography. Subsequently surgical shunt ligation was planned. During thoracotomy, digital occlusion of the PDA was performed for 10 min with simultaneous catheter measurement of right ventricular pressure, which did not increase. Permanent shunt ligation resulted in a complete and sustained clinical recovery. A lung biopsy sample obtained during thoracotomy demonstrated histopathological arterial changes typical of PH. Cats can develop clinically severe PH and right-sided CHF secondary to a left-to-right PDA even at an advanced age. Assuming there is evidence of pulmonary reactivity, PDA occlusion might be tolerated and can potentially produce long-term clinical benefits.
Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado
OBJECTIVE: To identify prognostic factors of postoperative functional outcomes. METHODS: Retrospective case series evaluating patients undergoing rotator cuff repair, analyzed by the UCLA score (pre and 12-month postoperative) and Magnetic Resonance Imaging (preoperative). Patients' intrinsic variables related to the injury and intervention were evaluated. Multivariate linear regression analysis was performed to determine variables impact on postoperative functional assessment. RESULTS: 131 patients were included. The mean UCLA score increased from 13.17 ± 3.77 to 28.73 ± 6.09 (p<0,001). We obtained 65.7% of good and excellent results. Age (r= 0.232, p= 0.004) and reparability of posterosuperior injuries (r= 0.151, p= 0.043) correlated with the functional assessment at 12 months. After multivariate linear regression analysis, only age was associated (p = 0.008). CONCLUSIONS: The surgical treatment of rotator cuff tears lead to good and excellent results in 65.6% of patients. Age was an independent predictor factor with better clinical outcomes by UCLA score in older patients. Level of Evidence IV, Case Series. PMID:26207092
Rivers, Joynelle L.
Nursing education faces many challenges such as faculty shortages, inadequate clinical site placements, the inability to accept qualified students because of limited resources, and how to effectively educate students who are tech savvy, confident, highly motivated yet have differing needs from previous generations. This study sought to explore how…
Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; McGuire, Kerry; Sargsyan, Ashot
The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.
Mathisen, G E; Meyer, R D; Thompson, J M; Finegold, S M
Moxalactam was administered intravenously or intramuscularly or both in doses of 1 to 12 g/day to 45 patients with clinically significant infections (17 soft tissue or bone, 9 pleuropulmonary, 9 septicemic, 6 urinary tract, and 4 intraabdominal infections). Mean 0.5-h postinfusion levels were 105 micrograms/ml for a 4.0-g dose, 44.7 micrograms/ml for a 2.0-g dose, and 18 micrograms/ml for a 1.0-g dose. We identified 28 isolates of Enterobacteriaceae, 10 Pseudomonas aeruginosa isolates, 9 Staphylococcus aureus isolates, and 15 anaerobic bacterial isolates. A total of 15 patients were clinically cured, 8 patients improved, 13 patients improved initially but suffered subsequent relapses or superinfections, and 10 patients failed therapy. Toxicity was generally minimal (reversible eosinophilia, and mild liver function abnormalities, and elevated prothrombin time). The selection or emergence of resistant organisms in 17 patients during treatment (particularly Pseudomonas, enterococci, and Candida) was a disturbing feature of therapy. Our results were generally favorable, considering the complicated underlying medical problems of this group of patients. PMID:6213198
Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo
A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…
Ayeni, Olufemi R; Sansone, Mikael; de Sa, Darren; Simunovic, Nicole; Bedi, Asheesh; Kelly, Bryan T; Farrokhyar, Forough; Karlsson, Jon
Femoro-acetabular impingement (FAI) is increasingly recognized as an important cause of hip pain in the young adult. However, the methods of evaluating the efficacy of surgical intervention are often not validated and/or inconsistently reported. Important clinical, gait, radiographic and biomarker outcomes are discussed. This article (1) presents the rationale for considering a composite outcome for FAI patients; (2) examines a variety of important end points currently used to evaluate FAI surgery; (3) discusses a strategy to generate a composite outcome by combining these end points; and (4) highlights the challenges and current areas of controversy that such an approach to evaluating symptomatic FAI patients may present.
Lajoie, Travis; Sonkiss, Joshua; Rich, Anne
Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…
Parker, Richard I.; Hagan-Burke, Shanna
The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance"…
Sullivan, F M; Hoare, T; Gilmour, H
A cohort of 392 patients referred to six outpatient clinics by general practitioners during 1987 with diagnoses of rheumatoid arthritis, osteoarthritis, peripheral vascular disease, psoriasis or eczema, were studied from the time of their first attendance until up to two years later. Six consultant clinics were studied in the three specialties: rheumatology, vascular surgery and dermatology. For each specialty a clinic in both a teaching hospital and a district general hospital were included. The cohort members were predominantly middle-aged or elderly people, with a greater proportion of women, except at the vascular surgery clinic where 65% of patients were men. The 392 patients made a total of 936 visits (median two, range one-eight) during the study period; 91 patients were still attending up to two years after the first visit. Patients referred by their general practitioner for therapy were less likely to be discharged than those referred for other reasons. The principal reason for continuing attendance as perceived by patients, general practitioners and hospital doctors was the necessity for consultant supervision, although agreement was far from complete in individual cases. Junior staff tended to see a higher proportion of patients at follow-up visits than did consultants, and were found to have lower discharge rates than consultants. Analyses of data showed that at the first visit, diagnosis, disease severity and the grade of doctor seeing the patient in the clinic was significantly associated with patient discharge at the P < 0.05 level of significance. Patients considered that their visits had produced improvement in their condition in 38% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)
Encouraging Early Clinical Outcomes With Helical Tomotherapy-Based Image-Guided Intensity-Modulated Radiation Therapy for Residual, Recurrent, and/or Progressive Benign/Low-Grade Intracranial Tumors: A Comprehensive Evaluation
Purpose: To report early clinical outcomes of helical tomotherapy (HT)-based image-guided intensity-modulated radiation therapy (IMRT) in brain tumors of varying shape, size, and location. Materials and Methods: Patients with residual, recurrent, and/or progressive low-grade intracranial and skull-base tumors were treated on a prospective protocol of HT-based IMRT and followed clinicoradiologically. Standardized metrics were used for plan evaluation and outcome analysis. Results: Twenty-seven patients with 30 lesions were treated to a median radiotherapy dose of 54 Gy in 30 fractions. All HT plans resulted in excellent target volume coverage with steep dose-gradients. The mean (standard deviation) dose homogeneity index and conformity index was 0.07 (0.05) and 0.71 (0.08) respectively. At first response assessment, 20 of 30 lesions were stable, whereas 9 showed partial regression. One patient with a recurrent clival chordoma though neurologically stable showed imaging-defined progression, whereas another patient with stable disease on serial imaging had sustained neurologic worsening. With a median follow-up of 19 months (interquartile range, 11-26 months), the 2-year clinicoradiological progression-free survival and overall survival was 93.3% and 100% respectively. Conclusions: Careful selection of radiotherapy technique is warranted for benign/low-grade brain tumors to achieve durable local control with minimum long-term morbidity. Large or complex-shaped tumors benefit most from IMRT. Our early clinical experience of HT-based IMRT for brain tumors has been encouraging.
A prospective two-center study on the associations between microalbuminuria, coronary atherosclerosis and long-term clinical outcome in asymptomatic patients with type 2 diabetes mellitus: evaluation by coronary CT angiography.
Kim, Jin-Jin; Hwang, Byung-Hee; Choi, Ik Jun; Choo, Eun-Ho; Lim, Sungmin; Koh, Yoon-Seok; Lee, Jong Min; Kim, Pum-Joon; Seung, Ki-Bae; Lee, Seung-Hwan; Cho, Jae-Hyung; Jung, Jung Im; Chang, Kiyuk
This study assessed the associations between microalbuminuria in asymptomatic patients with type 2 diabetes and the presence, extent, and severity of coronary atherosclerosis, as measured by coronary computed tomography angiography (CCTA), and the long-term clinical outcomes. In total, the study enrolled 284 consecutive eligible asymptomatic patients with type 2 diabetes and without known coronary artery disease (CAD), who then underwent CCTA and 24 h urine albumin measurements. Microalbuminuria was defined as 30-300 mg/day urinary albumin excretion. Obstructive CAD, as measured by CCTA, was defined as maximum intra-luminal stenosis ≥50 %. Patients with and without microalbuminuria were compared in terms of obstructive CAD prevalence, and the extent and severity of coronary atherosclerosis. They were evaluated using the following data: coronary artery calcium score (CACS), atheroma burden obstructive score (ABOS), segment involvement score (SIS) and segment stenosis score (SSS). All-cause mortality within a follow-up period of 5 years was also compared. Compared to patients without microalbuminuria, patients with microalbuminuria were more likely to have obstructive CAD (p = 0.004). Microalbuminuria was associated with higher ABOS (p = 0.010), SIS (p = 0.029), and SSS (p = 0.011), except for CACS (p = 0.058). Multivariable analyses adjusted for conventional cardiovascular risk factors revealed that microalbuminuria was an independent predictor of obstructive CAD [odds ratio 2.255, confidence intervals (CI) 1.121-4.538, p = 0.023] and all-cause mortality (hazard ratio 3.469, CI 1.319-9.121, p = 0.012). In asymptomatic patients with type 2 diabetes, microalbuminuria was associated with increased risk of CAD and poorer clinical outcomes.
Śmietanka, Krzysztof; Olszewska, Monika; Domańska-Blicharz, Katarzyna; Bocian, A Lukasz; Minta, Zenon
The virulence of pigeon paramyxovirus type 1 (PPMV-1) for different species of birds was investigated in two independent sets of experiments in which groups of pigeons, chickens, turkeys, quails, and geese (10 birds per group) were inoculated with 10(6) median embryo infectious doses of PPMV-1 isolate: 1) nonpassaged (nPPMV-1, intracerebral pathogenicity [ICPI] value = 1.27) and 2) after six passages in specific-pathogen-free chickens (pPPMV-1, ICPI = 1.46) via the oculonasal route. Naive birds were placed in contact with infected birds (two birds per group) to monitor virus transmission. Clinical observation was performed daily. Additionally, cloacal swabs, oropharyngeal swabs, and selected organ samples were collected on days 2, 4, 7, 10, and 14 postinfection and tested by real-time reverse transcriptase-PCR for estimation of viral shedding and distribution in tissues. Infected pigeons exhibited nervous and digestive tract symptoms, mortality, shedding, and transmission to contact birds. Chickens, turkeys, quails, and geese did not exhibit any clinical signs regardless of the PPMV-1 strain used for inoculation. However, in contrast to quails and geese, chickens and turkeys shed the virus via the oral cavity and cloaca, and transmission to contact birds was also observed. Viral RNA was identified in tissues collected from all pPPMV-1-infected birds, whereas negative results were obtained in the case of tissues taken from nPPMV-1-infected quails and geese. We conclude that the PPMV-1 used in this study was most virulent to pigeons, followed by chickens and turkeys, while quails and geese seem to have the highest level of innate resistance to this strain. However, passaging of PPMV-1 in chickens resulted in the increase of ICPI and noticeable but sometimes contrasting changes in the replication capacities of the virus.
Shin, Minho; Choi, Namkyu; Yoo, Youngsun; Kim, Yooseok; Kim, Sungsoo
Purpose Laparoscopic subtotal cholecystectomy (LSC) can be an alternative surgical technique for difficult cholecystectomies. Surgeons performing LSC sometimes leave the posterior wall of the gallbladder (GB) to shorten the operation time and avoid liver injury. However, leaving the inflamed posterior GB wall is a major concern. In this study, we evaluated the clinical outcomes of standard laparoscopic cholecystectomy (SLC), LSC, and LSC removing only anterior wall of the GB (LSCA). Methods We retrospectively reviewed the medical records of laparoscopic cholecystectomies performed between January 2006 to December 2015 and analyzed the outcomes of SLC, LSC, and LSCA. Results A total of 1,037 patients underwent SLC. 22 patients underwent LSC; and 27 patients underwent LSCA. The mean operating times of SLC, LSC, and LSCA were 41, 74, and 68 minutes, respectively (P < 0.01). Blood loss was 5, 45, and 33 mL (P < 0.05). The mean lengths of postoperative hospitalization were 3.4, 5.4, and 5.8 days. Complications occurred in 24 SLC patients (2.3%), 2 LSC patients (9%), and 1 LSCA patient (3.7%). There was no mortality among the LSC and LSCA patients. Conclusion LSC and LSCA are safe and feasible alternatives for difficult cholecystectomies. These procedures help surgeons avoid bile duct injury and conversion to laparotomy. LSCA has the benefits of shorter operation time and less bleeding compared to LSC. PMID:27847794
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be measured in high throughput toxicity testing and the organism or population-level events that are commonly relevant in defining risk. Recognizing the importance of this emerging framework, the Organisation for Economic Co-operation and Development (OECD) launched a program to support the development, documentation and consideration of AOPs by the international community in 2012 (http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm). In 2014, a handbook (https://aopkb.org/common/AOP_Handbook.pdf) was developed to guide users in the documentation and evaluation of AOPs and their entry into an official knowledgebase. The handbook draws on longstanding experience in consideration of mechanistic data (e.g., mode of action analysis) to inform risk assessment. To further assist users, a training program was developed by members of the OECD Extended Advisory Group to teach users the basic principles of AOP development and the best practices as outlined in the OECD AOP handbook. Training sessions began in early 2015, and this course will provide training for interested SOT scientists. Following this course, all participants will be familiar w
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…
McCarthy, Colin J.; Behravesh, Sasan; Naidu, Sailendra G.; Oklu, Rahmi
Air embolism is a rare but potentially fatal complication of surgical procedures. Rapid recognition and intervention is critical for reducing morbidity and mortality. We retrospectively characterized our experience with air embolism during medical procedures at a tertiary medical center. Electronic medical records were searched for all cases of air embolism over a 25-year period; relevant medical and imaging records were reviewed. Sixty-seven air embolism cases were identified; the mean age was 59 years (range, 3–89 years). Ninety-four percent occurred in-hospital, of which 77.8% were during an operation/invasive procedure. Vascular access-related procedures (33%) were the most commonly associated with air embolism. Clinical signs and symptoms were related to the location the air embolus; 36 cases to the right heart/pulmonary artery, 21 to the cerebrum, and 10 were attributed to patent foramen ovale (PFO). Twenty-one percent of patients underwent hyperbaric oxygen therapy (HBOT), 7.5% aspiration of the air, and 63% had no sequelae. Mortality rate was 21%; 69% died within 48 hours. Thirteen patients had immediate cardiac arrest where mortality rate was 53.8%, compared to 13.5% (p = 0.0035) in those without. Air emboli were mainly iatrogenic, primarily associated with endovascular procedures. High clinical suspicion and early treatment are critical for survival. PMID:28106717
Nahm, Eun-Shim; Vaydia, Vinay; Ho, Danny; Scharf, Barbara; Seagull, Jake
Healthcare information systems (HIS) play a vital role in quality of care and the organization's daily operations. Consequently, increasing numbers of clinicians have been involved in HIS implementation, particularly for clinical information systems (CIS). Implementation of these systems is a major organizational investment, and its outcomes must be assessed. The purpose of this article is to provide clinicians and frontline informaticians with a practical guide to assess these outcomes, focusing on outcome variables, assessment methods, and timing of assessment. Based on in-depth literature reviews and their empirical experiences, the authors identified 3 frequently used outcomes: user satisfaction, clinical outcomes, and financial impact. These outcomes have been assessed employing various methods, including randomized controlled trials, pre- and post-test studies, time and motion studies, surveys, and user testing. The timing for outcomes assessments varied depending on several factors, such as learning curves or patients conditions. In conclusion, outcomes assessment is essential for the success of healthcare information technology, and the CIS implementation team members must be prepared to conduct and/or facilitate these studies.
Spineli, Loukia M; Fleming, Padhraig S; Pandis, Nikolaos
Missing outcome data are common in clinical trials and despite a well-designed study protocol, some of the randomized participants may leave the trial early without providing any or all of the data, or may be excluded after randomization. Premature discontinuation causes loss of information, potentially resulting in attrition bias leading to problems during interpretation of trial findings. The causes of information loss in a trial, known as mechanisms of missingness, may influence the credibility of the trial results. Analysis of trials with missing outcome data should ideally be handled with intention to treat (ITT) rather than per protocol (PP) analysis. However, true ITT analysis requires appropriate assumptions and imputation of missing data. Using a worked example from a published dental study, we highlight the key issues associated with missing outcome data in clinical trials, describe the most recognized approaches to handling missing outcome data, and explain the principles of ITT and PP analysis.
Despas, Noémie; Larock, Anne-Sophie; Jacqmin, Hugues; Douxfils, Jonathan; Chatelain, Bernard; Chatelain, Marc; Mullier, François
Traditional anticoagulant agents such as unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, danaparoid and bivalirudine are used in the prevention and treatment of thromboembolic diseases. However, these agents have limitations: their constraining parenteral route of administration and the need for regular coagulation monitoring for HNF. The LMWHs, with their more predictable anticoagulant response, don't require a systematic monitoring. The usefulness of LMWHs monitoring in several clinical situations such as pregnancy, obesity and renal insufficiency is a matter of debate. Indeed, there is no agreement between French and American recommendations on this question. Others aspects are also controversial: the measure of trough anti-Xa activity during pregnancy and the optimal monitoring of LMWHs for patients with antithrombin deficiency (hepatic disease, new-borns). Different tests are available to ensure the monitoring of these drugs, we will see in this review their principle, their advantages and inconvenients. The management of heparin induced thrombocytopenia also needs parenteral anticoagulants: danaparoïd, bivalirudine or argatroban. The modalities of their monitoring are relatively unknown and are presented. Furthermore, platelet monitoring is capital. This article aims to provide guidance about laboratory testing of classic parenteral anticoagulants.
Chadha, M.; Coderre, J.A.; Chanana, A.D.
A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.
Macdermid, Joy C; Silbernagel, Karin Grävare
Synopsis Clinical measurement studies that address outcome evaluation for patients with tendinopathy should consider conceptual, clinical, practical, and measurement issues to guide the selection of valid measures. Clinical outcomes reported in research studies can provide benchmarks that assist with interpretation of scores during clinical decision making. Given the pathophysiology and functional impacts of tendinopathy, there is a need for outcome measures that assess physical impairments, activity performance, and patient-reported symptoms and function. Tendinopathy-specific patient-reported outcome measures have been shown to be superior to more generic tools for some conditions, such as lateral epicondyle tendinopathy (Patient-Rated Tennis Elbow Evaluation) and Achilles tendinopathy (Victorian Institute of Sport Assessment-Achilles), whereas both generic shoulder outcome measures and disease-specific measures perform similarly in individuals with rotator cuff tendinopathy. A patient-reported outcome measure that captures pain and limitation in function should be fundamental to outcome evaluation in patients with tendinopathy. The current measurement literature does not yet provide comprehensive empirical data to define optimal outcome measures for all types of tendinopathy. This article reviews concepts, instruments, and measurement properties that should provide clinicians with a foundation for assessment of condition severity and treatment outcomes in patients with tendinopathy. J Orthop Sports Phys Ther 2015;45(11):950-964. Epub 15 Oct 2015. doi:10.2519/jospt.2015.6054.
de Jong, Kaz; Ariti, Cono; van der Kam, Saskia; Mooren, Trudy; Shanks, Leslie; Pintaldi, Giovanni; Kleber, Rolf
Existing tools for evaluating psychosocial interventions (un-validated self-reporting questionnaires) are not ideal for use in non-Western conflict settings. We implement a generic method of treatment evaluation, using client and counsellor feedback, in 18 projects in non-Western humanitarian settings. We discuss our findings from the perspective of validity and suggestions for future research. A retrospective analysis is executed using data gathered from psychosocial projects. Clients (n = 7,058) complete two (complaints and functioning) rating scales each session and counsellors rate the client’s status at exit. The client-completed pre- and post-intervention rating scales show substantial changes. Counsellor evaluation of the clients’ status shows a similar trend in improvement. All three multivariable models for each separate scale have similar associations between the scales and the investigated variables despite different cultural settings. The validity is good. Limitations are: ratings give only a general impression and clinical risk factors are not measured. Potential ceiling effects may influence change of scales. The intra and inter-rater reliability of the counsellors’ rating is not assessed. The focus on client and counsellor perspectives to evaluate treatment outcome seems a strong alternative for evaluation instruments frequently used in psychosocial programming. The session client rated scales helps client and counsellor to set mutual treatment objectives and reduce drop-out risk. Further research should test the scales against a cross-cultural valid gold standard to obtain insight into their clinical relevance. PMID:27315263
van Munster, Caspar E P; Uitdehaag, Bernard M J
Due to the heterogeneous nature of the disease, it is a challenge to capture disease activity of multiple sclerosis (MS) in a reliable and valid way. Therefore, it can be difficult to assess the true efficacy of interventions in clinical trials. In phase III trials in MS, the traditionally used primary clinical outcome measures are the Expanded Disability Status Scale and the relapse rate. Secondary outcome measures in these trials are the number or volume of T2 hyperintense lesions and gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) of the brain. These secondary outcome measures are often primary outcome measures in phase II trials in MS. Despite several limitations, the traditional clinical measures are still the mainstay for assessing treatment efficacy. Newer and potentially valuable outcome measures increasingly used or explored in MS trials are, clinically, the MS Functional Composite and patient-reported outcome measures, and on MRI, brain atrophy and the formation of persisting black holes. Several limitations of these measures have been addressed and further improvements will probably be proposed. Major improvements are the coverage of additional functional domains such as cognitive functioning and assessment of the ability to carry out activities of daily living. The development of multidimensional measures is promising because these measures have the potential to cover the full extent of MS activity and progression. In this review, we provide an overview of the historical background and recent developments of outcome measures in MS trials. We discuss the advantages and limitations of various measures, including newer assessments such as optical coherence tomography, biomarkers in body fluids and the concept of 'no evidence of disease activity'.
Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas
Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase in melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication.
Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation
Managed Diabetes Foot Clinic 5b. GRANT NUMBER HU0001-04-1-TS10 5c. PROGRAM ELEMENT NUMBER N/A 6. AUTHOR(S) 5d. PROJECT NUMBER N04-017...measured outcomes of a nurse-managed diabetes foot clinic on foot wound rates, health care costs, and changes in health status in adults with... diabetes . Design: This study reflects results of a two-group randomized, controlled trial. Sample: Participants were 126 adults with diabetes for more
Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh
Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849
Manabe, Yasuhiro; Kono, Syoichiro; Tanaka, Tomotaka; Narai, Hisashi; Omori, Nobuhiko
This study aimed to evaluate the prognostic value of acute phase blood pressure in patients with acute ischemic stroke by determining whether or not it contributes to clinical outcome. We studied 515 consecutive patients admitted within the first 48 hours after the onset of ischemic strokes, employing systolic and diastolic blood pressure measurements recorded within 36 hours after admission. High blood pressure was defined when the mean of at least 2 blood pressure measurements was ≥200 mmHg systolic and/or ≥110 mmHg diastolic at 6 to 24 hours after admission or ≥180 mmHg systolic and/or ≥105 mmHg diastolic at 24 to 36 hours after admission. The high blood pressure group was found to include 16% of the patients. Age, sex, diabetes mellitus, hypercholesterolemia, atrial fibrillation, ischemic heart disease, stroke history, carotid artery stenosis, leukoaraiosis, NIH Stroke Scale (NIHSS) on admission and mortality were not significantly correlated with either the high blood pressure or non-high blood pressure group. High blood pressure on admission was significantly associated with a past history of hypertension, kidney disease, the modified Rankin Scale (mRS) on discharge and the length of stay. On logistic regression analysis, with no previous history of hypertension, diabetes mellitus, atrial fibrillation, and kidney disease were independent risk factors associated with the presence of high blood pressure [odds ratio (OR), 1.85 (95% confidence interval (CI): 1.06-3.22), 1.89 (95% CI: 1.11-3.22), and 3.31 (95% CI: 1.36-8.04), respectively]. Multi-organ injury may be presented in acute stroke patients with high blood pressure. Patients with high blood pressure had a poor functional outcome after acute ischemic stroke.
Mook, William R.; Petri, Maximilian; Greenspoon, Joshua A.; Horan, Marilee P.; Millett, Peter J.
Objectives: Although the Latarjet procedure for the treatment of recurrent shoulder instability is highly successful, reasons for failure are often unclear. The purpose of our study was to evaluate clinical and anatomic characteristics that were predictive of continued instability or poor outcomes following the Latarjet procedure. Methods: In this IRB approved study, patients who underwent open coracoid Latarjet procedures for anteroinferior instability with glenoid bone loss (>20%) prior to October of 2012 were included. Anatomic measurements of coracoid size (anteroposterior surface area, maximal coracoid width), conjoint and subscapularis tendon widths, estimated glenoid defect surface area, Hill-Sach's Interval, and projected postoperative glenoid track engagement were obtained from preoperative cross-sectional imaging. When the projected glenoid track was smaller than the Hill-Sach's interval, the lesion was determined to be outside-&-engaged compared to inside-&-non-engaged. Patient reported subjective data that was prospectively collected and retrospectively reviewed included patient satisfaction, instability events, SANE score, ASES score, DASH score, and SF-12 PCS. Patients that progressed to another shoulder surgery not related to instability were considered complications and patients that continued to experience dislocations or who underwent revision instability surgeries were considered failures. Results: Thirty-nine shoulders in 39 patients (34 men, 5 women) with a mean age of 26 (range 16-43) were included at a mean follow-up was 3.3 years (2- 7.9 years). There were 25 out of 39 that had prior stabilization surgery and 6 workman's compensation claims. One patient was revised due to broken hardware at 2 months and one because of coracoid nonunion at 18 months. One patient experienced postsurgical adhesive capsulitis treated surgically at a year. All subjective outcome scores significantly improved (p<.05) and a 9 out of 10 median satisfaction score was
Matucci-Cerinic, Marco; Steen, Virginia D; Furst, Daniel E; Seibold, James R
The pathogenesis of systemic sclerosis (SSc) is complex and largely unclear. The clinical heterogeneity of the disease and its progression over a number of years makes the choice of endpoints in the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment that potentially can alter the clinical disease course. To achieve this, innumerable challenges must be overcome. This article reviews data from recent clinical trials and the lessons derived from retrospective observational studies, databases, and patient registries. Taken together, these observations will help to improve our understanding of the diverse clinical course of SSc and permit refinement of existing outcome measures for the design of future clinical trials, in which the likelihood of observing a positive treatment effect with the drugs at our disposal will be maximized. PMID:17767745
Stetter, Friedhelm; Kupper, Sirko
Autogenic training (AT) is a self-relaxation procedure by which a psychophysiological determined relaxation response is elicited. A meta-analysis was performed to evaluate the clinical effectiveness of AT. Seventy-three controlled outcome studies were found (published 1952-99). Sixty studies (35 randomized controlled trials [RCT]) qualified for inclusion in the meta-analysis. Medium-to-large effect sizes (ES) occurred for pre-post comparisons of disease-specific AT-effects, with the RCTs showing larger ES. When AT was compared to real control conditions, medium ES were found. Comparisons of AT versus other psychological treatment mostly resulted in no effects or small negative ES. This pattern of results was stable at follow-up. Unspecific AT-effects (i.e., effects on mood, cognitive performance, quality of life, and physiological variables) tended to be even larger than main effects. Separate meta-analyses for different disorders revealed a significant reduction of the heterogeneity of ES. Positive effects (medium range) of AT and of AT versus control in the meta-analysis of at least 3 studies were found for tension headache/migraine, mild-to-moderate essential hypertension, coronary heart disease, asthma bronchiale, somatoform pain disorder (unspecified type), Raynaud's disease, anxiety disorders, mild-to-moderate depression/dysthymia, and functional sleep disorders.
Kanno, T; Nagata, J; Hoshino, M; Nakagawa, T; Chaudhari, M; Sano, H; Katada, K
A retrospective analysis of our series of 355 cases of putaminal hemorrhage revealed some interesting aspects of its pathogenesis. All the cases were studied in detail with special attention to clinical presentation, diagnostic findings and the long-term clinical outcome. Role of surgery in management of putaminal hemorrhage is still controversial. Inability to form proper useful classification has been one of the reasons responsible for this controversy. A new classification is formulated which divides putaminal hemorrhage into four types. Mild type has hematoma localized to external capsule while moderate type shows hematoma extension to corona radiata from external capsule. In severe type, hematoma extends to internal capsule also while in very severe type it further extends to midbrain. These four types could be very well correlated to long-term clinical outcome. Accessory hematoma is discussed in detail. It is found to be more common in severe and very severe types. Its presence in mild or moderate types results in worse clinical outcome. Hypertension (BP greater than 200 mm of Hg) may play an important role in further extension of hematoma.
Schoolcraft, V; Delaney, C
The use of contracts in grading clinical performance has provided faculty with a solution to two important problems. One has been how to ensure that students are graded consistently among the various faculty who are grading the same clinical component of a course. The second has been to increase the opportunity for individualized attention to student learning needs. We have been pleased to see all the faculty members increase their input and involvement in the continuing modifications of the contract. Although we have taken the major responsibility for the semi-annual revisions of the contract, other faculty members have been increasingly more explicit in their evaluations and suggestions as their experience with the contract has expanded. Their confidence in this method of clinical evaluation has increased with each semester of use. We plan to continue in the refinement of the instrument and will develop materials for the use of other faculty groups who are interested in developing similar contracts. We are also designing a survey to attempt to discover how widespread is the use of contract grading in clinical areas.
Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru
The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…
Patel, Twisha S.
The Clinical and Laboratory Standards Institute (CLSI) lowered the MIC breakpoints for meropenem and imipenem from 4 mg/liter to 1 mg/liter for Enterobacteriaceae in 2010. The breakpoint change improves the probability of pharmacodynamic target attainment and eliminates the need for microbiology labs to perform confirmatory testing for Klebsiella pneumoniae carbapenemase (KPC) production or other beta-lactamases that hydrolyze carbapenems. However, there are limited data evaluating clinical outcomes of the affected breakpoints, and it is unknown if patients infected with Enterobacteriaceae with reduced susceptibility are more likely to have poor outcomes when treated with a carbapenem. We conducted a single-center retrospective matched-cohort analysis in adult patients with Enterobacteriaceae infections treated with meropenem, imipenem, or doripenem. Patients with Enterobacteriaceae infection with a carbapenem MIC of 2 to 8 mg/liter were matched based on pathogen, source of infection, comorbidities, and disease severity (1:1 ratio) to those with a carbapenem MIC of ≤1 mg/liter. A total of 36 patients were included in the study. The group with carbapenem MICs of 2 to 8 mg/liter had a significantly higher 30-day mortality than the group with carbapenem MICs of ≤1 mg/liter (38.9% compared to 5.6%, P = 0.04). Total hospital length of stay (LOS) and intensive care unit (ICU) LOS were longer in the group with MICs of 2 to 8 mg/liter than in the group with MICs of ≤1 mg/liter (57.6 days compared to 34.4 days [P = 0.06] and 56.6 days compared to 21.7 days [P < 0.01], respectively). Patients infected with Enterobacteriaceae with a carbapenem MIC of 2, 4, or 8 mg/liter had higher mortality rates and longer ICU LOS than matched cohorts with carbapenem MICs of ≤1 mg/liter, which supports CLSI's recommendation to lower susceptibility breakpoints for carbapenems. PMID:25378572
Oruç, Melike; Ozer, Kadri; Çolak, Özlem; Kankaya, Yüksel; Koçer, Uğur
Digital nerve injuries are the mostly detected nerve injury in the upper extremity. However, since the clinical phenomenon of crossover innervation at some degree from uninjured digital nerve to the injured side occurs after digital nerve injuries is sustained, one could argue that this concept might even result in the overestimation of the outcome of the digital nerve repair. With this knowledge in mind, this study aimed to present novel, pure, focused and valuable clinical data by comparing the outcomes of bilateral and unilateral digital nerve repair. A retrospective review of 28 fingers with unilateral or bilateral digital nerve repair using end-to-end technique in 19 patients within 2 years was performed. Weber's two-point discrimination, sharp/dull discrimination, warm/cold sensation and Visual Analog Scale scoring were measured at final 12-month follow ups in all patients. There was no significant difference in recovery of sensibility after unilateral and bilateral digital nerve repairs. Though there is crossover innervation microscopically, it is not important in the clinical evaluation period. According to clinical findings from this study, crossover innervations appear to be negligible in the estimation of outcomes of digital neurorrhaphy.
Valier, Alison R.; Lam, Kenneth C.
The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…
Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul
This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.
Diefenbeck, Cynthia; Herrman, Judith; Wade, Gail; Hayes, Evelyn; Voelmeck, Wayne; Cowperthwait, Amy; Norris, Susan
The Clinical Immersion Model is an innovative baccalaureate nursing curriculum that has demonstrated successful outcomes over the past 10 years. For those intending to adopt the model, individual components in isolation may prove ineffective. This article describes three core components of the curriculum that form the foundation of preparation for the senior-year clinical immersion. Detailed student-centered outcomes evaluation of these critical components is shared. Results of a mixed-methods evaluation, including surveys and focus groups, are presented. Implications of this curricular evaluation and future directions are explored.
Qi, Peter; Abdullahi, Abdikarim; Stanojcic, Mile; Patsouris, David; Jeschke, Marc G.
Recent discoveries have highlighted the novel metabolic functions of adipose tissue in enhancing hypermetabolism after trauma. As the exact function and expression profiles of serum lipids and free fatty acids (FFA) are essentially unknown, we determined the lipidomic expression profile after burn in correlation to clinical outcomes to identify important lipid mediators affecting post-burn outcomes. We conducted a prospective cohort study with 46 adult burn patients and 5 healthy controls at the Ross Tilley Burn Center in Toronto, Canada. Patients were stratified based on major demographic and clinical variables, including age, burn severity, mortality, and sepsis. Serum FFAs and inflammatory markers were measured during acute hospital stay. We found that FFAs were acutely elevated post-burn and returned to baseline over time. Greater burn severity and age were associated with an impaired acute response in unsaturated FFAs and pro-inflammatory cytokines. Elevations in saturated and mono-unsaturated FFAs correlated significantly to increased mortality. In summary, persistent elevation of unsaturated lipids was associated with a functionally altered inflammatory-immunological milieu and worse clinical outcomes. The present lipidomic analysis indicates profound alterations in the lipid profile after burn by characterizing key lipids as potential diagnostic and outcome indicators in critically injured patients. PMID:27982130
Dietrich, Martin; Renner, Simone
This study analyzes the impact of subjective quality information in the form of aggregate patient experience outcomes on respondent evaluation and intended choice of hospitals. We compared clinical performance-based quality measures (i.e., wound infection rates) with participant evaluations and choice intentions when they were additionally provided with subjective quality information (i.e., patient experience outcomes in different display formats). Results suggest that patient experience outcomes significantly affected the evaluations and choice intentions. Additionally, we found significant effects of subjective information display formats. Limitations, directions for future research, and implications for publishing subjective quality information in health care markets are discussed.
Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614
Turocy, Paula Sammarone; Comfort, Ronald E.; Perrin, David H.; Gieck, Joe H.
Objective: To determine the efficacy of the National Athletic Trainers' Association Board of Certification (NATABOC) clinical experience requirements and individual student characteristics to predict candidate outcomes on the NATABOC certification examination. Design and Setting: For all subjects, we gathered survey information and examination scores. The survey information included age, sex, route to certification, previous athletic training and allied health experience, and clinical education experiences. Subjects: A total of 269 subjects, 22.25% of all first-time candidates for the June and November 1993 NATABOC examinations, were included in this study. Measurements: Data were analyzed for standard descriptive statistics and parametric linear regression and correlational relationships. Results: Total clinical hours, high-risk sport experiences, and previous athletic training experience were not predictive of examination outcomes. Although our results indicated a relationship between previous allied health experience and both outcome on the written section of the examination and age and outcome on the oral/practical section, these characteristics also were not predictive of examination outcomes. Conclusions: Gaining clinical experience hours in excess of 400 hours beyond the 800-or 1500-hour requirement may yield no greater benefit for an entry-level professional than less time. The quality, rather than the quantity, of clinical experiences should be evaluated. More emphasis should be placed on the achievement of an entry level of clinical competency, rather than on total hour collection. Also, because high-risk sport experiences did not predict outcomes on the NATABOC examination, the emphasis of clinical education should be on students' receiving a more structured clinical experience, in which they are progressively required to assume greater responsibilities integrating both cognitive and psychomotor skills, while working under the supervision of a certified
Carr, Gemma; Bloeschl, Guenter; Loucks, Daniel Pete
Evaluation of participation programmes, projects and activities is essential to identify whether stakeholder involvement has been successful in achieving its aims. Aims may include an improvement in water resource management such as enhanced ecological functioning, an improvement in human wellbeing and economic conditions, or overcoming a conflict between interest groups. Evaluating against "interest-based" resource management criteria requires that a desirable outcome can be identified, agreed upon and be measured at the time of evaluation. In many water management situations where collaborative approaches are applied, multiple interests and objectives are present, or stakeholders have not yet identified their own positions and priorities. Even if a resource management objective has been identified and strategy agreed upon, resource management changes tend to emerge over longer timescales and evaluation frequently takes place before they can be recognised. Evaluating against resource management criteria may lead evaluators to conclude that a programme has failed because it has not achieved a resource management objective at the time of evaluation. This presents a critical challenge to researchers assessing the effectiveness of stakeholder participation programmes. One strategy to overcome this is to conduct "goal-free" evaluation to identify what the programme is actually achieving. An evaluation framework that includes intermediary outcomes that are both tangible achievements such as innovation, creation of new organisations, and shared information and knowledge, as well as intangible achievements such as trust and network development can be applied to more broadly assess a programme's success. Analysis of case-studies in the published literature for which a resource management outcome has been achieved shows that intermediary outcomes frequently precede resource management outcomes. They seem to emerge over shorter timescales than resource management outcomes
Avery, Robert A.; Allen, Jeffrey C.; Ardern-Holmes, Simone L.; Bilaniuk, Larissa T.; Ferner, Rosalie E.; Gutmann, David H.; Listernick, Robert; Martin, Staci; Ullrich, Nicole J.; Liu, Grant T.
Objective: The goal of the Response Evaluation in Neurofibromatosis and Schwannomatosis Visual Outcomes Committee is to define the best functional outcome measures for future neurofibromatosis type 1 (NF1)-associated optic pathway glioma (OPG) clinical trials. Methods: The committee considered the components of vision, other ophthalmologic parameters affected by OPG, potential biomarkers of visual function, and quality of life measures to arrive at consensus-based, evidence-driven recommendations for objective and measurable functional endpoints for OPG trials. Results: Visual acuity (VA) assessments using consistent quantitative testing methods are recommended as the main functional outcome measure for NF1-OPG clinical trials. Teller acuity cards are recommended for use as the primary VA endpoint, and HOTV as a secondary endpoint once subjects are old enough to complete it. The optic disc should be assessed for pallor, as this appears to be a contributory variable that may affect the interpretation of VA change over time. Given the importance of capturing patient-reported outcomes in clinical trials, evaluating visual quality of life using the Children's Visual Function Questionnaire as a secondary endpoint is also proposed. Conclusions: The use of these key functional endpoints will be essential for evaluating the efficacy of future OPG clinical trials. PMID:24249802
Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.
Kwok, Man Leung; Yuen, Hon; Lai, Sik To
Severe acute respiratory syndrome (SARS) poses a major threat to the health of people worldwide. We performed a retrospective case series analysis to assess clinical outcome and identify pretreatment prognostic correlates of SARS, managed under a standardized treatment protocol. We studied 127 male and 196 female patients with a mean age of 41±14 (range 18–83). All patients, except two, received ribavirin and steroid combination therapy. In 115 (36%) patients, the course of disease was limited. Pneumonitis progressed rapidly in the remaining patients. Sixty-seven (21%) patients required intensive care, and 42 (13%) required ventilator support. Advanced age, high admission neutrophil count, and high initial lactate dehydrogenase level were independent correlates of an adverse clinical outcome. SARS-associated coronavirus caused severe illnesses in most patients, despite early treatment with ribavirin and steroid. This study has identified three independent pretreatment prognostic correlates. PMID:14519241
McNeil, Rita C.
Outcomes-based program evaluation is a systematic approach to identifying outcome indicators and measuring results against those indicators. One dimension of program evaluation is assessing the level of learner acquisition to determine if learning objectives were achieved as intended. The purpose of the proposed model is to use Bloom's Taxonomy to…
Deggs, David; Weaver, Sue W.
Student feedback is essential to improving the quality of instruction in higher education. This article chronicles the process by which an end-of-course reflection exercise was used to gather additional feedback from students and to determine learning outcomes in online course for adult learners. Students were given guiding questions for the…
The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...
Castagnini, Luis A; Munoz, Flor M
We describe the features and outcomes of neonatal pertussis and compare these with neonates with non-pertussis acute respiratory illness from July 2000 through December 2007. Patients with pertussis had a more severe course of disease as evidenced by the clinical presentation, length of hospitalization, and oxygen requirement. Clinicians should have a high index of suspicion so that appropriate supportive care can be initiated promptly.
Bliss, Joseph M.; Wong, Angela Y.; Bhak, Grace; Laforce-Nesbitt, Sonia S.; Taylor, Sarah; Tan, Sylvia; Stoll, Barbara J.; Higgins, Rosemary D.; Shankaran, Seetha; Benjamin, Daniel K.
Objective To determine if premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. Study design Clinical isolates were studied from 2 populations; premature infants colonized with Candida (commensal, n=27), and those with invasive candidiasis (n=81). Individual isolates of C. albicans and C. parapsilosis were tested for virulence in each of 3 assays: phenotypic switching, adhesion, and cytotoxicity. Invasive isolates were considered to have enhanced virulence if they measured more than 1 SD above the mean for the commensal isolates in at least 1 assay. Outcomes of patients with invasive isolates with enhanced virulence were compared with those with invasive isolates lacking enhanced virulence characteristics. Results 61% of invasive isolates of C. albicans and 42% of invasive isolates of C. parapsilosis had enhanced virulence. All C. albicans cerebrospinal fluid (CSF) isolates (n=6) and 90% of urine isolates (n=10) had enhanced virulence, compared with 48% of blood isolates (n=40). Infants with more virulent isolates were younger at the time of positive culture and had higher serum creatinine. Conclusions Individual isolates of Candida species vary in their virulence properties. Strains with higher virulence are associated with certain clinical outcomes. PMID:22504098
Ha, Sang Woo; Kim, Seok Won; Lee, SeungMyung; Kim, Yong Hyun; Kim, Hyeun Sung
Objective Discal cyst is rare and causes indistinguishable symptoms from lumbar disc herniation. The clinical manifestations and pathological features of discal cyst have not yet been completely known. Discal cyst has been treated with surgery or with direct intervention such as computed tomography (CT) guided aspiration and steroid injection. The purpose of this study is to evaluate the safety and efficacy of the percutaneous endoscopic surgery for lumbar discal cyst over at least 6 months follow-up. Methods All 8 cases of discal cyst with radiculopathy were treated by percutaneous endoscopic surgery by transforaminal approach. The involved levels include L5-S1 in 1 patient, L3-4 in 2, and L4-5 in 5. The preoperative magnetic resonance imaging and 3-dimensional CT with discogram images in all cases showed a connection between the cyst and the involved intervertebral disc. Over a 6-months period, self-reported measures were assessed using an outcome questionaire that incorporated total back-related medical resource utilization and improvement of leg pain [visual analogue scale (VAS) and Macnab's criteria]. Results All 8 patients underwent endoscopic excision of the cyst with additional partial discectomy. Seven patients obtained immediate relief of symptoms after removal of the cyst by endoscopic approach. There were no recurrent lesions during follow-up period. The mean preoperative VAS for leg pain was 8.25±0.5. At the last examination followed longer than 6 month, the mean VAS for leg pain was 2.25±2.21. According to MacNab' criteria, 4 patients (50%) had excellent results, 3 patients (37.5%) had good results; thus, satisfactory results were achieved in 7 patients (87.5%). However, one case had unsatisfactory result with persistent leg pain and another paresthesia. Conclusion The radicular symptoms were remarkably improved in most patients immediately after percutaneous endoscopic cystectomy by transforaminal approach. PMID:22737300
Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan
Abstract The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage. Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect. Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients’ symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires. Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure. PMID:28248874
Iqbal, Nousheen; Irfan, Muhammad; Zubairi, Ali Bin Sarwar; Jabeen, Kauser; Awan, Safia; Khan, Javaid A
Introduction Pulmonary aspergillosis has variable course of illness, severity and outcomes depending on underlying conditions. There is limited data available on the clinical manifestations and outcome of pulmonary aspergillosis from Pakistan. Methods To determine the clinical manifestations and outcome of pulmonary aspergillosis in a tertiary care hospital a retrospective study was conducted from 2004 to 2014 in patients admitted with pulmonary aspergillosis at the Aga Khan University Hospital Karachi, Pakistan. Results Of the 280 cases with provisional diagnosis of aspergillosis 69 met the inclusion criteria. The mean age was 45±15.7 years, 48 (69.6%) were men and 21 (30.4%) had diabetes mellitus (DM). The average length of hospital stay (LOS) was 10.61±9.08 days. Aspergillus fumigatus was the most common (42.0%), followed by Aspergillus flavus (28.9%). More than one-third of patients previously had tuberculosis (TB) (39.13%). The commonest pulmonary manifestation was chronic pulmonary aspergillosis (CPA) 47 (68.1%) followed by invasive pulmonary aspergillosis (IPA) 12 (17.4%) and subacute invasive aspergillosis (SAIA) 8 (11.6%). Surgical excision was performed in 28 patients (40.57%). Intensive care unit admission was required for 18 patients (26.08%). Case fatality rate was 14/69 (20.3%). DM, mean LOS and hypoxic respiratory failure were identified as independent risk factors of mortality on multivariate analysis. Conclusion A. fumigatus was the most frequent species found especially in patients with prior TB. CPA was the commonest pulmonary manifestation seen as post TB sequel. Diabetes, hypoxic respiratory failure and increased LOS were independent predictors of poor outcomes. Overall patients had good outcome with CPA compared with SAIA and IPA. PMID:28074136
Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike
Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.
Berent, Dominika; Zboralski, Krzysztof; Orzechowska, Agata; Gałecki, Piotr
The clinical implications of thyroid hormones in depression have been studied extensively and still remains disputable. Supplementation of thyroid hormones is considered to augment and accelerate antidepressant treatment. Studies on the role of thyroid hormones in depression deliver contradictory results. Here we assess theirs impact on depression severity and final clinical outcome in patients with major depression. Thyrotropin, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations were measured with automated quantitative enzyme immunoassay. Depression severity and final clinical outcome were rated with 17-itemic Hamilton Rating Scale for Depression [HDRS(17)] and Clinical Global Impression Scales for severity and for improvement (CGIs, CGIi). FT3 and FT4 concentrations were significantly positively correlated with clinical improvement evaluated with CGIi (R = 0.38, P = 0.012; R = 0.33, P = 0.034, respectively). There was a significant correlation between FT4 concentrations and depression severity assessed in HDRS(17) (R = 0.31, P = 0.047). Male patients presented significantly higher FT3 serum levels (Z = 2.34, P = 0.018) and significantly greater clinical improvement (Z = 2.36, P = 0.018) when compared to female patients. We conclude that free thyroid hormones concentrations are associated with depression severity and have an impact on final clinical outcome. It can be more efficient to augment and accelerate the treatment of major depressive disorder with triiodothyronine instead of levothyroxine because of individual differences in thyroid hormones metabolism.
Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Woo Sik
Objective Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. Methods This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. Results For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. Conclusion The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option. PMID:27689039
Kear, Mavra E; Bear, Mary
Portfolio evaluation is an efficient and effective strategy to objectively demonstrate the accomplishment of program objectives using students' perceptions of their academic experiences. A portfolio evaluation tool was developed to quantitatively measure students' perceptions of their achievement of the nursing program's goals and objectives. Data were collected from a convenience sample of 26 portfolio evaluations. Reliability testing showed the tool has high interrater reliability, with Cohen's Kappa >0.80 for most items. Individual achievement of program goals and objectives ranged from 53.6% to 100%. These data will be used in the next formative evaluation of the curriculum to revise program objectives and correspondneing course objectives and assignments.ty
Chia, Chih-Chun; Rubinfeld, Ilan; Scirica, Benjamin M; McMillan, Sean; Gurm, Hitinder S; Syed, Zeeshan
Conventional algorithms for modeling clinical events focus on characterizing the differences between patients with varying outcomes in historical data sets used for the model derivation. For many clinical conditions with low prevalence and where small data sets are available, this approach to developing models is challenging due to the limited number of positive (that is, event) examples available for model training. Here, we investigate how the approach of developing clinical models might be improved across three distinct patient populations (patients with acute coronary syndrome enrolled in the DISPERSE2-TIMI33 and MERLIN-TIMI36 trials, patients undergoing inpatient surgery in the National Surgical Quality Improvement Program registry, and patients undergoing percutaneous coronary intervention in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry). For each of these cases, we supplement an incomplete characterization of patient outcomes in the derivation data set (uncensored view of the data) with an additional characterization of the extent to which patients differ from the statistical support of their clinical characteristics (censored view of the data). Our approach exploits the same training data within the derivation cohort in multiple ways to improve the accuracy of prediction. We position this approach within the context of traditional supervised (2-class) and unsupervised (1-class) learning methods and present a 1.5-class approach for clinical decision-making. We describe a 1.5-class support vector machine (SVM) classification algorithm that implements this approach, and report on its performance relative to logistic regression and 2-class SVM classification with cost-sensitive weighting and oversampling. The 1.5-class SVM algorithm improved prediction accuracy relative to other approaches and may have value in predicting clinical events both at the bedside and for risk-adjusted quality of care assessment.
North Carolina State Dept. of Public Instruction, Raleigh. Div. of Accountability Services/Research.
In 1996, North Carolina began a 5-year evaluation of Alternative Learning Programs (ALPs). This report describes selected outcomes for students who participated in ALPs during 1995-96. These outcomes include performance on North Carolina End-of-Grade tests (elementary school) and performance on the End-of-Course(EOC) tests (high school) for…
Wolf, Kenneth; Goodwin, Laura
Accreditation is a mark of distinction indicating that an institution has met high standards set by the profession, and an increasingly important feature of the accreditation process in higher education is "outcomes assessment." This article presents two rubrics for evaluating the quality of an institution's outcomes assessment system. One rubric…
Kober, Ralph; Eggleton, Ian R. C.
Evaluating the outcomes achieved by service providers who assist people with intellectual disabilities is extremely important in terms of ascertaining whether service providers achieve their goals. Furthermore, knowledge of the outcomes achieved by service providers better equips those charged with managing them to make strategic decisions to…
The role of evaluation is to determine whether a project achieves what it sets out to do. Using a strategy often referred to as "backwards planning" or "backwards research design," the evaluation process operationalizes project goals and then, asking the question "What would success look like?" identifies measurable indices of success (Friedman,…
Yang, Qiwei; Tang, Ping; Gu, Ruolei; Luo, Wenbo; Luo, Yue-jia
Efficient implicit emotion regulation processes, which run without awareness, are important for human well-being. In this study, to investigate the influence of implicit emotion regulation on psychological and electrophysiological responses to gains and losses, participants were required to select between two Chinese four-character idioms to match the meaning of the third one before they performed a monetary gambling task. According to whether their meanings were related to emotion regulation, the idioms fell into two categories. Event-related potentials and self-rating emotional experiences to outcome feedback were recorded during the task. Priming emotion regulation reduced subjective emotional experience to both gains and losses and the amplitudes of the feedback-related negativity, while the P3 component was not influenced. According to these results, we suggest that the application of implicit emotion regulation effectively modulated the subjective emotional experience and the motivational salience of current outcomes without the cost of cognitive resources. This study implicates the potential significance of implicit emotion regulation in decision-making processes.
The combined evaluation of interim contrast-enhanced computerized tomography (CT) and FDG-PET/CT predicts the clinical outcomes and may impact on the therapeutic plans in patients with aggressive non-Hodgkin's lymphoma.
Yang, Deok-Hwan; Min, Jung-Joon; Jeong, Yong Yeon; Ahn, Jae-Sook; Kim, Yeo-Kyeoung; Cho, Sang-Hee; Chung, Ik-Joo; Bom, Hee-Seung; Kim, Hyeoung-Joon; Lee, Je-Jung
We investigated the concomitant interim response of patients with aggressive non-Hodgkin's lymphoma (NHL) using multi-detector row computerized tomography (CT) and (18)F-fluoro-2-deoxy-D: -glucose-positron emission tomography (PET)/CT for prediction of clinical outcomes. One hundred six newly diagnosed patients with aggressive NHL were enrolled. Both the CT and PET/CT were serially performed at the time of diagnosis and after three to four cycles of chemotherapy (interim). The patients were categorized into four different responsive groups according to the interim PET/CT and CT: (1) complete metabolic response (CMR)-complete response unconfirmed (CRu), (2) CMR-partial response (PR), (3) partial metabolic response (PMR)-Cru, and (4) PMR-PR. Fifty-five patients with CMR-CRu, 20 patients with CMR-PR, seven patients with PMR-Cru, and 23 patients with PMR-PR were distributed. In addition, one patient experienced a disease progression. There was a significant difference in relapse rates between PET/CT-positive (67.3%) and PET/CT-negative patients (17.3%; P < 0.01). Also, there was a significant difference between patients with PMR-PR (32.0% and 26.1%) and CMR-CRu (89.3% and 80.0%) for 3-year overall survival (OS) and event-free survival (EFS), respectively. A multivariate analysis revealed that high international prognostic index (> or =3) at diagnosis, T-cell phenotype, and PMR-PR in interim PET/CT and CT were independent prognostic significances for OS. Moreover, bulky disease (>10 cm), T-cell phenotype, and PMR-PR showed significant associations for EFS. PMR-PR in interim response was the predictive prognostic determinant for both OS and EFS, with a hazard ratio of 3.93 (1.61-9.60) and 3.60 (1.62-7.98), respectively. The combined evaluation of interim PET/CT and CT was found to be a significant predictor of disease progression, OS, and EFS.
CANO, STEFAN J.; MAYHEW, ANNA; GLANZMAN, ALLAN M.; KROSSCHELL, KRISTIN J.; SWOBODA, KATHRYN J.; MAIN, MARION; STEFFENSEN, BIRGIT F.; BÉRARD, CAROLE; GIRARDOT, FRANÇOISE; PAYAN, CHRISTINE A.M.; MERCURI, EUGENIO; MAZZONE, ELENA; ELSHEIKH, BAKRI; FLORENCE, JULAINE; HYNAN, LINDA S.; IANNACCONE, SUSAN T.; NELSON, LESLIE L.; PANDYA, SHREE; ROSE, MICHAEL; SCOTT, CHARLES; SADJADI, REZA; YORE, MACKENSIE A.; JOYCE, CYNTHIA; KISSEL, JOHN T.
Introduction Trial design for SMA depends on meaningful rating scales to assess outcomes. In this study Rasch methodology was applied to 9 motor scales in spinal muscular atrophy (SMA). Methods Data from all 3 SMA types were provided by research groups for 9 commonly used scales. Rasch methodology assessed the ordering of response option thresholds, tests of fit, spread of item locations, residual correlations, and person separation index. Results Each scale had good reliability. However, several issues impacting scale validity were identified, including the extent that items defined clinically meaningful constructs and how well each scale measured performance across the SMA spectrum. Conclusions The sensitivity and potential utility of each SMA scale as outcome measures for trials could be improved by establishing clear definitions of what is measured, reconsidering items that misfit and items whose response categories have reversed thresholds, and adding new items at the extremes of scale ranges. PMID:23836324
Silvey, Kerry; Stock, Jacquie; Hasegawa, Lianne E; Au, Sylvia Mann
Third party payers, funding agencies, and lawmakers often require clinicians and public health agencies to justify programs and services by documenting results. This article describes two assessment tools--"Defining Genetics Services Framework" and "Genetics Services Outcomes Menu," created to assist public health professionals, clinicians, family advocates, and researchers to plan, evaluate, and demonstrate the effectiveness of genetics services. The tools were developed by a work group of the Western States Genetics Services Collaborative (WSGSC) consisting of public health genetics and newborn screening professionals, family representatives, a medical geneticist, and genetic counselors from Alaska, California, Hawaii, Idaho, Oregon, and Washington. The work group created both tools by an iterative process of combining their ideas with findings from a literature and World Wide Web review. The Defining Genetics Services Framework reflects the diversity of work group members. Three over-lapping areas of genetics services from public health core functions to population screening to clinical genetics services are depicted. The Genetics Services Outcomes Menu lists sample long-term outcomes of genetics services. Menu outcomes are classified under impact areas of Knowledge and Information; Financing; Screening and Identification; Diagnosis, Treatment, and Management; and Population Health. The WSGSC incorporated aspects of both tools into their Regional Genetics Plan.
Arboix, Adrià; García-Eroles, Luis; Vicens, Adela; Oliveres, Montserrat; Massons, Joan
Purpose. Primary hemorrhage in the ventricular system without a recognizable parenchymal component is very rare. This single-center retrospective study aimed to further characterize the clinical characteristics and early outcome of this stroke subtype. Methods. All patients with primary intraventricular hemorrhage included in a prospective hospital-based stroke registry over a 19-year period were assessed. A standardized protocol with 161 items, including demographics, risk factors, clinical data, neuroimaging findings, and outcome, was used for data collection. A comparison was made between the groups of primary intraventricular hemorrhage and subcortical intracerebral hemorrhage. Predictors of primary intraventricular hemorrhage were identified by logistic regression analysis. Results. There were 12 patients with primary intraventricular hemorrhage (0.31% of all cases of stroke included in the database) and 133 in the cohort of subcortical hemorrhage. Very old age (≥85 years) (odds ratio (OR) 9.89), atrial fibrillation (OR 8.92), headache (OR 6.89), and altered consciousness (OR 4.36) were independent predictors of intraventricular hemorrhage. The overall in-hospital mortality rate was 41.7% (5/12) but increased to 60% (3/5) in patients aged 85 years or older. Conclusion. Although primary intraventricular hemorrhage is uncommon, it is a severe clinical condition with a high early mortality. The prognosis is particularly poor in very old patients. PMID:22966468
ARI Research Note 88-99 Evaluation of the Job Skills N Education Program: Learning Outcomes Lf Ln Lee M. Hoffman, Clifford P. Hahn, Diane M. Hoffman...IDENTIFICATION NUMBER ORGANIZATION (If applicable) Soldier Education Division DAPC-PDE MDA 903-87-C-0081 Sc. ADDRESS(City, State, and ZIP Code) 10...R.1 11. TITLE (Incluce Security Classification) Evaluation of the Job Skills Education Program: Learning Outcomes 12. PERSONAL AUTHOR(S) Hoffman, Lee
Sorensen, Amelia; Howard, Daniel; Hui Tan, Wen; Ketchersid, Jeffrey; Calfee, Ryan P.
Purpose Patient-rated instruments are increasingly used to measure orthopaedic outcomes. However, the clinical relevance of modest score changes on such instruments is often unclear. This study was designed to define the minimal clinically important differences (MCID) of the Disabilities of the Arm, Shoulder, and Hand (DASH), QuickDASH, and Patient Rated Wrist Evaluation (PRWE) for atraumatic conditions of the hand, wrist, and forearm. Methods One hundred two patients undergoing nonoperative treatment for isolated tendonitis, arthritis, or nerve compression syndromes from the forearm to the hand were analyzed prospectively. Patients completed the DASH, Quick DASH (subset of DASH), and PRWE at enrollment, 2 weeks (n=78 used in analysis), and 4 weeks (n=24 used in analysis) after initiating treatment by telephone. Patients reporting clinical improvement each contributed a single data point categorized as no change (n=41), minimal improvement (n=30), or marked improvement (n=31) via a validated anchor-based approach. The minimal clinically important difference was calculated as the mean change score for each outcome measure in the minimal improvement group. Results The MCID (95%CI) for the DASH was 10 (5-15). The MCID for the Quick DASH was 14 (9-20). The MCID was 14 (8-20) for the PRWE. MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement. MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores. Discussion Longitudinal changes on the DASH of 10 points, the Quick DASH of 14 points, and the PRWE of 14 points represent minimal clinically important changes. We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients. These MCID values may provide a basis for sample size calculations for future
Fervaha, Gagan; Agid, Ofer; Takeuchi, Hiroyoshi; Foussias, George; Lee, Jimmy; Remington, Gary
Optimal outcome in schizophrenia is thought to include remission of symptoms, functional recovery, and improved subjective well-being. The present study examined the characteristics of individuals with schizophrenia who report being satisfied with their life in general. Individuals with schizophrenia who participated in the Clinical Antipsychotic Trial of Intervention Effectiveness study were included in the present analysis. Approximately half of the individuals evaluated reported a high level of life satisfaction, even while many concurrently described themselves as at least moderately ill and experiencing moderate-severe symptoms and manifested severe functional deficits. Of all individuals evaluated, only about 1% experienced what was considered to be optimal outcome. Individuals with schizophrenia are able to experience a high level of life satisfaction, despite experiencing severe illness and functional deficits. Those involved in care should be aware that life satisfaction as an outcome is not necessarily associated with symptom remission and superior functioning.
Ehrlich, Shelley; Smith, Kristen; Williams, Paige L.; Chavarro, Jorge E.; Batsis, Maria; Toth, Thomas L.; Hauser, Russ
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
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
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
Newnham, Elizabeth A; Doyle, Emma L; Sng, Adelln A H; Hooke, Geoffrey R; Page, Andrew C
Patient-focused research, which uses clinical characteristics to predict outcomes, is a field in which information technology has been effectively integrated with practice. The present research used touch-screen technology to monitor the daily self-report measures of 1,308 consecutive inpatients and day patients participating in a 2-week cognitive-behavioral therapy group. Providing regular feedback was effective in reducing symptoms for patients at risk of poor outcomes (Newnham, Hooke, & Page, 2010b). The use of touch screens in psychiatric monitoring encourages a collaborative dialogue between patients and therapists and promotes engagement in the process of progress monitoring and treatment evaluation.
McLain, Nina E; Biddle, Chuck; Cotter, J James
The purpose of this study was to compare traditional methods of instruction to the use of audiovisual patient safety vignettes in terms of their impact on student registered nurse anesthetists' recall and subsequent clinical performance. These vignettes used simulated, crisis-oriented anesthetic events known to be associated with catastrophic patient outcomes. Using a randomized controlled crossover trial, 24 student registered nurse anesthetists encountered either a malfunctioning suction device vignette or a stuck expiratory unidirectional valve vignette. Recall and clinical performances were measured after exposure to a lecture and written case studies or to lecture and patient safety vignettes. Of the 24 students, 23 were able to recognize the malfunctioning components and take corrective action. In this research study, memory and clinical performance were significantly affected when the anesthesia provider incorporated the correct anesthesia apparatus checkout process and crisis management skills into practice. This research demonstrated that under the conditions of this study, teaching methods had an impact on some areas of clinical performance. In this study, crisis-oriented, anesthesia patient safety vignettes had the potential to affect recall and clinical performance in a simulated environment.
Serrano, Carolina; Diaz, Maria Ines; Valdivia, Alejandra; Godoy, Alex; Peña, Alfredo; Rollan, Antonio; Kirberg, Arturo; Hebel, Eduardo; Fierro, Jaqueline; Klapp, Gerardo; Venegas, Alejandro; Harris, Paul R.
H. pylori infection is highly prevalent in Chile (73%). Usually a minority of infected patients develops complications such as ulcers and gastric cancer that have been associated with the presence of virulence factors (cagA, vacA) and host T helper response (Th1/Th2). Our aim was to evaluate the relationship between strain virulence and host immune response, using a multiple regression approach for the development of a model based on data collected from H. pylori infected patients in Chile. We analyzed levels of selected cytokines determined by ELISA (IL-12, IL-10, IFN-γ and IL-4) and the presence of cagA and vacA alleles polymorphisms determined by PCR in antral biopsies of 41 patients referred to endoscopy. By multiple regression analysis we established a correlation between bacterial and host factors using clinical outcome (gastritis and duodenal ulcer) as dependent variables. The selected model was described by: clinical outcome = 0.867491 (cagA) + 0.0131847 (IL-12/IL-10) + 0.0103503 (IFN-γ/IL-4) and it was able to explain over 90% of clinical outcomes observations (R2=96.4). This model considers that clinical outcomes are better explained by the interaction of host immune factors and strain virulence as a complex and interdependent mechanism. PMID:17336120
Bland, Adrienne Lynn
The Instant Word Notebook study was a program evaluation completed by two educators who saw a need for an instructional tool to teach and assess Instant Words. In order to address reading deficits of students in first and second grades, teachers were expected to teach Instant Words. Unfortunately, teachers did not have a systematic process to…
Case, Annette; Burchfield, Erin; Sommers, Paul
Unemployment wage data were evaluated to assess employment, job retention, and wage progression for graduates of Community Jobs (CJ), a short-term public job creation program for the hard to employ in the state of Washington. The following were among the findings: (1) 66% of all participants were employed after graduating from CJ; (2) 53% were…
Khatun, S; Huq, M Z; Islam, M A; Uddin, M W; Asaduzzaman, M; Hossain, M M
The purpose of the present study was to investigate two years clinical outcome of patients having myofacial pain dysfunction syndrome (MPDS). A total of 50 patients (male: 15, Female: 35, age: raged from 20 to 65 years) were included for this study. Clinical diagnosis for the assessment of anxiety and depression of each patient was performed by Hospital anxiety and depression (HAD) scale. Patients were then received either one of the following treatments: Occlusion correction only (n=14), Muscle Relaxant + anti-depressant drug (n=26), Physiotherapy + antidepressant drug + muscle relaxant (n=6) and Appliance + muscle relaxant (n= 4). Following two years observation, it was revealed that the treatment was apparently successful in 95% case; only 5% case was not successful due to their irregular visit. It can be concluded that MPDS is not primarily related to occlusal factors and a complex psycho physiological mechanism is involved in this type of pain problems.
Burritt, Joan E; Wallace, Patricia; Steckel, Cynthia; Hunter, Anita
Contemporary patient care requires sophisticated clinical judgment and reasoning in all nurses. However, the level of development regarding these abilities varies within a staff. Traditional care models lack the structure and process to close the expertise gap creating potential patient safety risks. In an innovative model, senior, experienced nurses were relieved of direct patient care assignments to oversee nursing care delivery. Evaluation of the model showed significant impact on quality and fiscal outcomes.
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;…
This review of controlled outcome research on Autogenic Training complements the literature by pooling narrative and quantitative approaches, by including only studies with experimental controls, by integrating the English and German literature, and by adding research findings published since the last review. Whereas previous reviews have already reported positive effects of Autogenic Training for migraine, insomnia, and test anxiety, additional supportive findings for angina pectoris, asthma, childbirth, eczema, hypertension, infertility, Raynaud's disease, and recovery from myocardial infarction are discussed here. The impact of protocol variations on outcome is described, and the specificity of Autogenic Training relative to other stress management techniques is highlighted. Quantitative findings suggested that Autogenic Training was associated with medium-sized pre- to posttreatment effects ranging from d = .43 for biological indices of change to d = .58 for psychological and behavioral indices thus matching effect sizes for other biobehavioral treatment techniques like biofeedback and muscular relaxation. Length of treatment did not affect clinical outcome. The discussion emphasizes how narrative and quantitative strategies complement one another.
Massof, Robert W
Comparative effectiveness research in rehabilitation medicine requires the development and validation of clinically meaningful and scientifically rigorous measurements of patient states and theories that explain and predict outcomes of intervention. Patient traits are latent (unobservable) variables that can be measured only by inference from observations of surrogate manifest (observable) variables. In the behavioral sciences, latent variables are analogous to intensive physical variables such as temperature and manifest variables are analogous to extensive physical variables such as distance. Although only one variable at a time can be measured, the variable can have a multidimensional structure that must be understood in order to explain disagreements among different measures of the same variable. The use of Rasch theory to measure latent trait variables can be illustrated with a balance scale metaphor that has randomly added variability in the weights of the objects being measured. Knowledge of the distribution of the randomly added variability provides the theoretical structure for estimating measures from ordinal observation scores (e.g., performance measures or rating scales) using statistical inference. In rehabilitation medicine, the latent variable of primary interest is the patient's functional ability. Functional ability can be estimated from observations of surrogate performance measures (e.g., speed and accuracy) or self-report of the difficulty the patient experiences performing specific activities. A theoretical framework borrowed from project management, called the Activity Breakdown Structure (ABS), guides the choice of activities for assessment, based on the patient's value judgments, to make the observations clinically meaningful. In the case of low vision, the functional ability measure estimated from Rasch analysis of activity difficulty ratings was discovered to be a two-dimensional variable. The two visual function dimensions are independent
Al-Naimi, Abdulla; Alobaidy, Abdulqadir; Majzoub, Ahmad; Ibrahim, Tarek Ahmed Amin
Objective To evaluate factors affecting semi-rigid ureteroscopy (URS) results highlighting the influence of teaching on its outcomes. Material and methods We reviewed the files of 891 adult patients who had undergone 1182 ureteroscopies at our institute during the period from July 2008 to June 2011. The outcomes of all URSs were evaluated. Outcomes were measured by stone- free rate and presence of complications, which were assessed using the Clavien-Dindo system. Patients were divided into 2 groups; Group 1 (favorable outcome) became stone- free after the first URS and had no documented complications, while Group 2 (unfavorable outcome) had residual stones and/or complications. Group 2 was subdivided according to the skill level of the operating surgeon into two subgroups. Patients belonging to subgroup A had their procedures performed by urology trainees under direct supervision of expert urologists, while those in subgroup B had their procedures performed by the expert urologists themselves. All groups were compared using univariate (chi-square and t tests) and multivariate (logistic regression) statistical tests to identify significant risk factors. All data was analyzed using SPSS. Results A total of 1182 URSs were evaluated. 958 patients had a favorable outcome (Group 1) while 224 patients had an unfavorable outcome (Group 2). Factors associated with an unfavorable outcome include location of the presenting stone (p<0.001) and presence of stone impaction (p<0.001). No statistically significant differences were detected in the overall complication rate between trainees and expert urologists. Trainees stone- free rate was comparable to that of experts; 90.3% vs. 91.1%, respectively, p=0.6. Conclusion Factors such as stone impaction and proximal location are associated with an unfavorable surgical outcome. In a high- volume teaching hospital, semi-rigid URS done by trainees under direct supervision is safe and their outcome is comparable to literature findings
Pookamala, S; Kumar, Rakesh; Thakar, Alok; Venkata Karthikeyan, C; Bhalla, Ashu Seith; Deka, R C
Despite the availability of various surgical options, management of laryngotracheal stenosis (LTS) still remains an enigma. Proper selection of surgical technique in each clinical setting is the key for successful outcome. The purpose of this article is to guide one in selection of appropriate surgical procedures depending upon various stenosis parameters. Aim To record the clinical profile of cases with LTS. To assess the outcome following various surgical interventions based on site, severity, cause of stenosis and to derive conclusions regarding treatment options in various stenosis. Materials and Methods It is a study of 60 cases with chronic LTS. It includes retrospective study of 30 cases treated from 2004 and prospective study of 30 cases from Jan 2007 to Dec 2009. A total of 60 cases with LTS were enrolled in the study. Patients were assessed clinically by eliciting detailed history and analyzing previous records. After assessment of extent of stenosis, they were subjected to surgical interventions (endoscopic/open approach). Outcome after surgical interventions was assessed. Results 60 patients were included in the study, in the age group of 2.5-50 years. There were 46 (77%) male patients and 14 (23%) female patients. Intrinsic trauma, secondary to prolonged intubation was the most common cause of LTS, seen in 23 (38%) cases followed by post traumatic stenosis (strangulation-18 (30%), blunt injury-15 (25%), penetrating neck injury-4 (7%)). Stenosis was divided into 6 types based on subsite involvement. Of which, cervical trachea was the commonest site of involvement (25/60 cases). Majority of cases had fixed vocal cords at presentation (55%), more commonly due to post traumatic injury. 60 cases had undergone a total of 110 surgical procedures (endoscopic-56,open approach-54). In the end, overall decannulation rate is 93.3%. In site wise tracheal stenosis, isolated subglottis, combined glottis and subglottic stenosis had decannulation rate of 100% each and
Bertoletti, L; Quenet, S; Mismetti, P; Hernández, L; Martín-Villasclaras, J J; Tolosa, C; Valdés, M; Barrón, M; Todolí, J A; Monreal, M
Chronic obstructive pulmonary disease (COPD) is a moderate risk factor for venous thromboembolism (VTE), but neither the clinical presentation nor the outcome of VTE in COPD patients is well known. The clinical presentation of VTE, namely pulmonary embolism (PE) or deep venous thrombosis (DVT), and the outcome at 3 months (death, recurrent VTE or bleeding) were compared between 2,984 COPD patients and 25,936 non-COPD patients included in the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry. This ongoing international, multi-centre registry includes patients with proven symptomatic PE or DVT. PE was the more frequent VTE presentation in COPD patients (n = 1,761, 59%). PE presentation was more significantly associated with COPD patients than non-COPD patients (OR 1.64, 95% CI 1.49-1.80). During the 3-month follow-up, mortality (10.8% versus 7.6%), minor bleeding (4.5% versus 2.3%) or first VTE recurrences as PE (1.5% versus 1.1%) were significantly higher in COPD patients than in non-COPD patients. PE was the most common cause of death. COPD patients presented more frequently with PE than DVT. It may explain the worse prognosis of COPD patients, with a higher risk of death, bleeding or VTE recurrences as PE compared with non-COPD patients. Further therapeutic options are needed.
Price, James; Baker, Gillian; Heath, Ian; Walker-Bone, Karen; Cubbon, Marc; Curtis, Sally; Enright, Mark C; Lindsay, Jodi; Paul, John; Llewelyn, Martin
Staphylococcus aureus bacteraemia (SAB) is commonly complicated by metastatic infection or relapse after treatment. Objectives. The study aim was to determine the role of bacterial, host, and management factors in development of complicated SAB. Methods. A prospectively-conducted observational study gathered data on predisposition, management and outcome of 100 consecutive SAB cases. Antibiotic susceptibilities and genetic lineage of bacterial isolates were determined. Further clinical and microbiological data were gathered on two retrospective series from 1999-2000 (n = 57) and 2004 (n = 116). Results. In the prospective cases, 27% met our definition of complicated disease. Expressed as RR and 95% CI, complicated disease was associated with diabetes (1.58, 1.00-2.48), injecting-drug use (5.48, 0.88-33.49), community-onset of symptoms (1.4, 1.02-1.92), and symptom duration >/=48 hours prior to starting effective antibiotic therapy (2.10, 1.22-3.61). Uncomplicated disease was associated with the presence of a central line (0.69, 0.55-0.88) and prompt removal of a primary focus (0.71, 0.57-0.90). Neither methicillin resistance nor genetic lineage was associated with complicated disease, but methicillin resistance was associated with higher mortality. Conclusions. This study demonstrates that clinical rather than microbial factors are the major determinants of SAB outcome and underscores the importance of early treatment.
Tan, Chai Lee; Fhun, Lai Chan; Abdul Gani, Nor Hasnida; Muhammed, Julieana; Tuan Jaafar, Tengku Norina
Background. Ocular bartonellosis can present in various ways, with variable visual outcome. There is limited data on ocular bartonellosis in Malaysia. Objective. We aim to describe the clinical presentation and visual outcome of ocular bartonellosis in Malaysia. Materials and Methods. This was a retrospective review of patients treated for ocular bartonellosis in two ophthalmology centers in Malaysia between January 2013 and December 2015. The diagnosis was based on clinical features, supported by a positive Bartonella spp. serology. Results. Of the 19 patients in our series, females were predominant (63.2%). The mean age was 29.3 years. The majority (63.2%) had unilateral involvement. Five patients (26.3%) had a history of contact with cats. Neuroretinitis was the most common presentation (62.5%). Azithromycin was the antibiotic of choice (42.1%). Concurrent systemic corticosteroids were used in approximately 60% of cases. The presenting visual acuity was worse than 6/18 in approximately 60% of eyes; on final review, 76.9% of eyes had a visual acuity better than 6/18. Conclusion. Ocular bartonellosis tends to present with neuroretinitis. Azithromycin is a viable option for treatment. Systemic corticosteroids may be considered in those with poor visual acuity on presentation. PMID:28265290
Aman, Michael G.; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D.; King, Bryan H.; Pearson, Deborah A.; Gernsbacher, Morton Ann; Chez, Michael
This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no “perfect” choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across the age range. In trials where the intention is to alter core features of ASDs, adaptive behavior scales are also worthy of consideration. Several “behavior complexes” common to ASDs are identified, and instruments are recommended for assessment of these. Given the prevalence of cognitive impairment in ASDs, it is important to assess any cognitive effects, although cognitive data from ASD randomized clinical trials, thus far, are minimal. Guidance from trials in related pharmacologic areas and behavioral pharmacology may be helpful. We recommend routine elicitation of side effects, height and weight, vital signs, and (in the case of antipsychotics) extrapyramidal side-effects assessment. It is often appropriate to include laboratory tests and assessments for continence and sleep pattern. PMID:14999174
Sirotkina, Meeli; Douroudis, Konstantinos; Papadogiannakis, Nikos; Westgren, Magnus
Introduction Chorangiomas (CAs) are the most common non-trophoblastic tumor-like-lesions of the placenta. Although the clinical significance of small CAs is unknown, the large lesions are often associated with maternal and fetal complications. The aim of our study was to assess the maternal clinical characteristics and neonatal outcome in singleton and multiple pregnancies with placental CA. Materials and Methods Among 15742 selected placentas 170 CAs were diagnosed. Pregnancy and neonatal outcomes were analyzed in singleton (n = 121) and multiple (n = 49) pregnancy groups including 121 and 100 neonates, respectively. Results The frequency of APGAR score <7 at 5 minutes (p = 0,012), abnormal pulsatility index (p = 0,034), and abnormal blood flow class (p = 0,011) were significantly higher in neonates from singleton compared to multiple pregnancies. Significantly smaller CAs in singleton pregnancies were related to small for gestational age neonates (p = 0,00040) and neonates admitted to the neonatal care unit (p = 0,028). In singleton pregnancies, significantly smaller CAs were associated to maternal preeclampsia (p = 0,039) and larger CAs to multiparity (p = 0,005) and smoking (p = 0,001) groups. The frequency of preeclampsia was high in both singleton and multiple pregnancy groups (41,32% vs 26,53%, respectively), however, the difference did not reach the level of statistical significance. Discussion A high incidence of preeclampsia in cohort of placental CA might lead to a possible recognition of CAs as potential morphologic indicator of placental hypoxia. Conclusion A more favorable pregnancy outcome in multiple gestations compared to the singleton gestations with CAs might reflect an adaptive mechanism for increased demand of oxygen and associated placental tissue hypoxia in this group. PMID:27835686
Lee, Sang-Hoon; Park, Kyung-Jae; Park, Dong-Hyuk; Kang, Shin-Hyuk; Park, Jung-Yul; Jung, Yong-Gu
Background Primary intraventricular hemorrhage (PIVH) is an uncommon type of intracerebral hemorrhage. Owing to its rarity, the clinical and radiological factors affecting outcomes in patients with PIVH have not been widely studied. Material/Methods We retrospectively reviewed 112 patients (mean age 53 years) treated for PIVH at our institution from January 2004 to December 2014. Clinical and radiological parameters were analyzed 3 months after initial presentation to identify factors associated with clinical outcomes, as assessed by the Glasgow Outcome Scale (favorable ≥4, unfavorable <4). Results Of the 99 patients who underwent angiography, causative vascular abnormalities were found in 46%, and included Moyamoya disease, arteriovenous malformation, and cerebral aneurysm. At 3 months after initial presentation, 64% and 36% of patients were in the favorable and unfavorable outcome groups, respectively. The mortality rate was 19%. However, most survivors had no or mild deficits. Age, initial Glasgow Coma Scale (GCS) score, simplified acute physiology score (SAPS II), modified Graeb score, and various radiological parameters reflecting ventricular dilatation were significantly different between the groups. Specifically, a GCS score of less than 13 (p=0.015), a SAPS II score of less than 33 (p=0.039), and a dilated fourth ventricle (p=0.043) were demonstrated to be independent predictors of an unfavorable clinical outcome. Conclusions In this study we reveal independent predictors of poor outcome in primary intraventricular hemorrhage patients, and show that nearly half of the patients in our study had predisposing vascular abnormalities. Routine angiography is recommended in the evaluation of PIVH to identify potentially treatable etiologies, which may enhance long-term prognosis. PMID:28325888
Stephenson-Jones, Marcus; Yu, Kai; Ahrens, Sandra; Tucciarone, Jason M; van Huijstee, Aile N; Mejia, Luis A; Penzo, Mario A; Tai, Lung-Hao; Wilbrecht, Linda; Li, Bo
The basal ganglia, a group of subcortical nuclei, play a crucial role in decision-making by selecting actions and evaluating their outcomes. While much is known about the function of the basal ganglia circuitry in selection, how these nuclei contribute to outcome evaluation is less clear. Here we show that neurons in the habenula-projecting globus pallidus (GPh) in mice are essential for evaluating action outcomes and are regulated by a specific set of inputs from the basal ganglia. We find in a classical conditioning task that individual mouse GPh neurons bidirectionally encode whether an outcome is better or worse than expected. Mimicking these evaluation signals with optogenetic inhibition or excitation is sufficient to reinforce or discourage actions in a decision-making task. Moreover, cell-type-specific synaptic manipulations reveal that the inhibitory and excitatory inputs to the GPh are necessary for mice to appropriately evaluate positive and negative feedback, respectively. Finally, using rabies-virus-assisted monosynaptic tracing, we show that the GPh is embedded in a basal ganglia circuit wherein it receives inhibitory input from both striosomal and matrix compartments of the striatum, and excitatory input from the 'limbic' regions of the subthalamic nucleus. Our results provide evidence that information about the selection and evaluation of actions is channelled through distinct sets of basal ganglia circuits, with the GPh representing a key locus in which information of opposing valence is integrated to determine whether action outcomes are better or worse than expected.
Wade, Patricia C.
In its sixth year of evaluating children's services, the Children's Program Outcome Review Team (C-PORT), under the direction of the Tennessee Commission on Children and Youth, continued to collect and analyze data to improve implementation of service delivery to 11,800 children and families involved in state custody. The C-PORT evaluation for…
Objective To report long-term clinical and radiological outcomes of minimally invasive posterior cervical foraminotomy (MI-PCF) performed in patients with unilateral single-level cervical radiculopathy. Methods Of forty-six patients who underwent MI-PCF for unilateral single-level radiculopathy between 2005 and 2013, 33 patients were included in the study, with a mean follow-up of 32.7 months. Patients were regularly followed for clinical and radiological assessment. Clinical outcome was measured by visual analogue scale (VAS) for the neck/shoulder and arm, and the neck disability index (NDI). Radiological outcome was measured by focal/global angulation and disc height index (DHI). Outcomes after MI-PCF were evaluated as changes of clinical and radiological parameters from the baseline. Mixed effect model with random patients' effect was used to test for differences in the clinical and radiological parameters repeat measures. Results There were no complications and all patients had an uneventful recovery during the early postoperative period. VAS scores for neck/shoulder and arm improved significantly in the early postoperative period (3 months) and were maintained with time (p<0.001). NDI improved significantly post-operatively and tended to decrease gradually during the follow-up period (p<0.001). There were no statistically significant changes in focal and global angulation at follow-up. Percent DHIs of the upper adjacent or operated disc were maintained without significant changes with time. During the follow-up, same site recurrence was not noted and adjacent segment disease requiring additional surgery occurred in two patients (6%) on the contra-lateral side. Conclusion MI-PCF provides long-term pain relief and functional restoration, accompanied by good long-term radiological outcome. PMID:25368765
Feng, Fan; Tian, Yangzi; Liu, Zhen; Xu, Guanghui; Liu, Shushang; Guo, Man; Lian, Xiao; Fan, Daiming; Zhang, Hongwei
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
Mayhew, Jill E; Florence, Julaine M; Mayhew, Thomas P; Henricson, Erik K; Leshner, Robert T; McCarter, Robert J; Escolar, Diana M
We studied the reliability of a series of endpoints in an evaluation of subjects with Duchenne muscular dystrophy (DMD). The endpoints included quantitative muscle tests (QMTs), timed function tests, forced vital capacity (FVC), and manual muscle tests (MMT). Thirty-one ambulatory subjects with DMD (mean age 8.9 years; range 5-16 years) were evaluated at eight sites by 15 newly trained evaluators as a test of interrater reliability of outcome measures. Both total QMT score [intraclass correlation coefficient (ICC) 0.96] and individual QMT assessments (ICC 0.85-0.96) were highly reliable. Forced vital capacity and all timed function tests were also highly reliable (ICC 0.97-0.99). MMT was the least reliable assessment method (ICC 0.61). These data suggest that primary surrogate outcome measures in large multicenter clinical trials in DMD should use QMT, FVC, or time function tests to obtain maximum power and greatest sensitivity.
Knight, Jennifer M.; Rizzo, J. Douglas; Logan, Brent R.; Wang, Tao; Arevalo, Jesusa M.G.; Ma, Jeffrey; Cole, Steve W.
Purpose Low socioeconomic status (SES) is associated with adverse outcomes among unrelated donor hematopoietic stem cell transplant (HCT) recipients, but the biological mechanisms contributing to this health disparity are poorly understood. Therefore, we examined whether social environment affects expression of a stress-related gene expression profile known as the conserved transcriptional response to adversity (CTRA), which involves up-regulation of pro-inflammatory genes and down-regulation of genes involved in type I IFN response and antibody synthesis. Experimental Design We compared pre-transplant leukocyte CTRA gene expression between a group of 78 high vs. low SES recipients of unrelated donor HCT for acute myelogenous leukemia in first remission. Post hoc exploratory analyses also evaluated whether CTRA gene expression was associated with poor clinical outcomes. Results Peripheral blood mononuclear cells collected pre-HCT from low SES individuals demonstrated significant CTRA up-regulation compared to matched HCT recipients of high SES. Promoter-based bioinformatics implicated distinct patterns of transcription factor activity including increased CREB signaling and decreased IRF and GR signaling. High expression of the CTRA gene profile was also associated with increased relapse risk and decreased leukemia-free survival. Conclusions Low SES is associated with increased expression of the CTRA gene profile, and CTRA gene expression is associated with adverse HCT clinical outcomes. These findings provide a biologic framework within which to understand how social environmental conditions may influence immune function and clinical outcomes in allogeneic HCT. PMID:26286914
Ruknuddeen, Mohammed Ishaq; Ramadoss, Rajaram; Rajajee, V.; Grzeskowiak, Luke E.; Rajagopalan, Ram E.
Background: Therapeutic hypothermia (TH) may improve neurological outcome in comatose patients following out of hospital cardiac arrest (OHCA). The reliability of clinical prediction of neurological outcome following TH remains unclear. In particular, there is very limited data on survival and predictors of neurological outcome following TH for OHCA from resource-constrained settings in general and South Asia in specific. Objective: The objective was to identify factors predicting unfavorable neurological outcome at hospital discharge in comatose survivors of OHCA treated with hypothermia. Design: Retrospective chart review. Setting: Urban 200-bed hospital in Chennai, India. Methods: Predictors of unfavorable neurological outcome (cerebral performance category score [3–5]) at hospital discharge were evaluated among patients admitted between January 2006 and December 2012 following OHCA treated with TH. Hypothermia was induced with cold intravenous saline bolus, ice packs and cold-water spray with bedside fan. Predictors of unfavorable neurological outcome were examined through multivariate exact logistic regression analysis. Results: A total of 121 patients were included with 106/121 (87%) experiencing the unfavorable neurological outcome. Independent predictors of unfavorable neurological outcome included: Status myoclonus <24 h (odds ratio [OR] 21.79, 95% confidence interval [CI] 2.89-Infinite), absent brainstem reflexes (OR 50.09, 6.55-Infinite), and motor response worse than flexion on day 3 (OR 99.41, 12.21-Infinite). All 3 variables had 100% specificity and positive predictive value. Conclusion: Status myoclonus within 24 h, absence of brainstem reflexes and motor response worse than flexion on day 3 reliably predict unfavorable neurological outcome in comatose patients with OHCA treated with TH. PMID:26195855
Background Traumatic Brain Injury (TBI) is a major cause of death and disability. It has been postulated that brain metabolic status, intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are related to patients' outcome. The aim of this study was to investigate the relationship between CPP, ICP and microdialysis parameters and clinical outcome in TBIs. Results Thirty four individuals with severe brain injury hospitalized in an intensive care unit participated in this study. Microdialysis data were collected, along with ICP and CPP values. Glasgow Outcome Scale (GOS) was used to evaluate patient outcome at 6 months after injury. Fifteen patients with a CPP greater than 75 mmHg, L/P ratio lower than 37 and Glycerol concentration lower than 72 mmol/l had an excellent outcome (GOS 4 or 5), as opposed to the remaining 19 patients. No patient with a favorable outcome had a CPP lower than 75 mmHg or Glycerol concentration and L/P ratio greater than 72 mmol/l and 37 respectively. Data regarding L/P ratio and Glycerol concentration were statistically significant at p = 0.05 when patients with favorable and unfavorable outcome were compared. In a logistic regression model adjusted for age, sex and Glasgow Coma Scale on admission, a CPP greater than 75 mmHg was marginally statistically significantly related to outcome at 6 months after injury. Conclusions Patients with favorable outcome had certain common features in terms of microdialysis parameters and CPP values. An individualized approach regarding CPP levels and cut -off points for Glycerol concentration and L/P ratio are proposed. PMID:22168902
Irby, David; Rakestraw, Philip
Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)
Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo
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.
Fernandes, Ashley K; Borges, Nicole; Rodabaugh, Heather
Medical schools universally accept the idea that bioethics courses are essential components of education, but few studies which measure outcomes (i.e., knowledge or retention) have demonstrated their educational value in the literature. The goal of this study was to examine whether core concepts of a pre-clinical bioethics course were learned and retained. Over the course of 2 years, a pre-test comprising 25 multiple-choice questions was administered to two classes (2008-2010) of first-year medical students prior to the start of a 15-week ethics course, and an identical post-test was administered at the end of the course. A total of 189 students participated. Paired t tests showed a significant difference between pre-test scores and post-test scores. The pre-test average score was 69.8 %, and the post-test average was 82.6 %, an increase of 12.9 % after the ethics course. The pre- and post-test results also suggested a shift in difficulty level of the questions, with students finding identical questions easier after the intervention. Given the increase in post-test scores after the 15-week intervention, the study suggests that core concepts in medical ethics were learned and retained. These results demonstrate that an introductory bioethics course can improve short-term outcomes in knowledge and comprehension, and should provide impetus to educators to demonstrate improved educational outcomes in ethics at higher levels of B.S. Bloom's Taxonomy of Learning.
Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H
Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.
Erchull, Mindy J; Liss, Miriam
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.
Dolgun, Zehra Nihal; Inan, Cihan; Altintas, Ahmet Salih; Okten, Sabri Berkem; Sayin, Niyazi Cenk
Objective: To document the neonatal outcomes of preterm birth in twin pregnancies and to investigate whether perinatal and obstetric parameters are associated with clinical outcomes. Methods: This retrospective trial was conducted on data gathered from 176 preterm twins delivered in the obstetrics and gynecology department of our tertiary care center. Data extracted from medical files of 88 pregnant women who gave preterm birth (at 260/7 to 366/7 gestational weeks) to twins were analyzed. Maternal/fetal descriptive and obstetric parameters, sonographic data, route of delivery, indication for cesarean section, birth weight, Apgar scores, head circumference, umbilical cord length and placental weight were noted. Results: The average age of the pregnant women was 28.8±6.4 years and ultrasonographic gestational age was 31.9±2.6 weeks. Apgar scores at 1st minute were affected significantly by fetal body weight (p=0.001), gestational age (p=0.001), height (p=0.004) and head circumference (p=0.011). None of these variables exhibited a noteworthy effect on Apgar scores at 5th minute. Conclusion: Efforts must be made to achieve advancement of gestational age until delivery in the follow-up preterm of twins. A well-established algorithm with special emphasis to risk factors is necessary to standardize and popularize the appropriate management strategy. PMID:27648040
Waller, D; Krishna, S; Crawley, J; Miller, K; Nosten, F; Chapman, D; ter Kuile, F O; Craddock, C; Berry, C; Holloway, P A
The clinical and laboratory features of severe falciparum malaria in 180 Gambian children were studied between 1985 and 1989. Of the 180 children, 118 (66%) presented with seizures, 77 (43%) had cerebral malaria, 35 (20%) had witnessed seizures after admission, 29 (16%) were hypoglycemic, and 27 (15%) died. Respiratory distress was a common harbinger of a fatal outcome. The differences in admission parasite counts in the blood, hematocrit, and opening cerebrospinal pressures for patients who died and survivors were not significant. A multiple logistic regression model identified neurological status (coma, particularly if associated with extensor posturing), stage of parasite development on the peripheral blood film, pulse rate of > 150 or respiratory rate of > 50, hypoglycemia, and hyperlactatemia (plasma lactate level, > 5 mmol/L) as independent indicators of a fatal outcome. Biochemical evidence of hepatic and renal dysfunction was an additional marker of a poor prognosis, but, in contrast to severe malaria in adults, none of these children with severe malaria had acute renal failure.
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
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.
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
Bushby, Kate; Connor, Edward
In June 2010, 25 representatives from Europe and the US met in Washington, DC, USA, to discuss clinical outcome measures in Duchenne muscular dystrophy (DMD) in the context of clinical trial design and analysis. The workshop was organized in response to a September 2009 European Medicines Agency meeting where a clear directive was given that an international consensus needs to be developed that provides a foundation for age-appropriate clinical outcome measures for use in clinical trials of emerging therapeutics for DMD. Data were presented from eight multicenter longitudinal datasets, representing nearly 1900 patients over a 20-year time period. This experience confirmed the feasibility of repeated evaluations performed at multiple sites and addressed several core issues in drug development for DMD, such as the ‘new’ natural history in the steroidera, reliability and sensitivity of specific outcome measures, as well as disease staging and patient selection. These data form a valuable asset for academic investigators, pharmaceutical sponsors and regulatory agencies involved in DMD therapeutics. The group remains committed working together on a number of collaborative goals to support the therapeutics development effort in this orphan disease and to make these data available to stakeholders working in the field. PMID:22639722
Giordano, Antonio; Dincman, Toros; Clyburn, Benjamin E.; Steed, Lisa L.; Rockey, Don C.
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
Tokman, Sofya; Singer, Jonathan P.; Devine, Megan S.; Westall, Glen P.; Aubert, John-David; Tamm, Michael; Snell, Gregory I.; Lee, Joyce S.; Goldberg, Hilary J.; Kukreja, Jasleen; Golden, Jeffrey A.; Leard, Lorriana E.; Garcia, Christine K.; Hays, Steven R.
Background Successful lung transplantation (LT) for patients with pulmonary fibrosis from telomerase mutations is limited by systemic complications of telomerase dysfunction including myelosuppression, cirrhosis, and malignancy. We describe clinical outcomes among 14 LT recipients with telomerase mutations. Methods Subjects underwent LT between February 2005 and April 2014 at 5 LT centers. We abstracted data from medical records, focusing on outcomes reflecting post-LT treatment effects likely to be complicated by telomerase mutations. Results The median age of subjects was 60.5 years (IQR 52.0–62.0), 64.3% were male, and the mean post-LT observation time was 3.2 years (SD ±2.9). Eleven subjects had a mutation in telomerase reverse transcriptase, 2 in telomerase RNA component, and 1 had an uncharacterized mutation. Ten subjects were leukopenic post-LT; leukopenia prompted cessation of mycophenolate mofetil in 5 and treatment with filgrastim in 4. Six subjects had recurrent lower respiratory tract infections (LRTI), 7 had acute cellular rejection (ACR) (A1), and 4 developed chronic lung allograft dysfunction (CLAD). Ten LT recipients developed chronic renal insufficiency and 8 experienced acute, reversible renal failure. Three developed cancer, none had cirrhosis. Thirteen subjects were alive at data censorship. Conclusions The clinical course for LT recipients with telomerase mutations is complicated by renal disease, leukopenia prompting a change in the immunosuppressive regimen, and recurrent LTRI. In contrast, cirrhosis was absent, ACR was mild, and development of CLAD was comparable to other LT populations. While posing challenges, lung transplantation may be feasible for patients with pulmonary fibrosis due to telomerase mutations. PMID:26169663
Benedetti, Fabrizio; Dogue, Sara
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.
Lutgendorf, Susan K.; De Geest, Koen; Bender, David; Ahmed, Amina; Goodheart, Michael J.; Dahmoush, Laila; Zimmerman, M. Bridget; Penedo, Frank J.; Lucci, Joseph A.; Ganjei-Azar, Parvin; Thaker, Premal H.; Mendez, Luis; Lubaroff, David M.; Slavich, George M.; Cole, Steven W.; Sood, Anil K.
Purpose Previous research has demonstrated relationships of social support with disease-related biomarkers in patients with ovarian cancer. However, the clinical relevance of these findings to patient outcomes has not been established. This prospective study examined how social support relates to long-term survival among consecutive patients with ovarian cancer. We focused on two types of social support: social attachment, a type of emotional social support reflecting connections with others, and instrumental social support reflecting the availability of tangible assistance. Patients and Methods Patients were prospectively recruited during a presurgical clinic visit and completed surveys before surgery. One hundred sixty-eight patients with histologically confirmed epithelial ovarian cancer were observed from the date of surgery until death or December 2010. Clinical information was obtained from medical records. Results In a Cox regression model, adjusting for disease stage, grade, histology, residual disease, and age, greater social attachment was associated with a lower likelihood of death (hazard ratio [HR], 0.87; 95% CI, 0.77 to 0.98; P = .018). The median survival time for patients with low social attachment categorized on a median split of 15 was 3.35 years (95% CI, 2.56 to 4.15 years). In contrast, by study completion, 59% of patients with high social attachment were still alive after 4.70 years. No significant association was found between instrumental social support and survival, even after adjustment for covariates. Conclusion Social attachment is associated with a survival advantage for patients with ovarian cancer. Clinical implications include the importance of screening for deficits in the social environment and consideration of support activities during adjuvant treatment. PMID:22802321
Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald L; Marquis, Patrick; Vamvakas, Sprios; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan J; Burke, Laurie
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 in order 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 in 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
Stucken, Emily Z; Brown, Kevin; Selesnick, Samuel H
In the past century, significant advances have been made in understanding the clinical features of acoustic neuromas. Furthermore, rapid technological advances have led to the development of sensitive, rapid, and relatively noninvasive diagnostic modalities, which has allowed for earlier discovery of acoustic neuromas and has reduced the average tumor size at time of diagnosis. The ultimate result has been improved clinical outcomes after surgery and radiotherapy.
With the increasing emphasis on evaluating the effectiveness of community-based organizations' HIV prevention programs, the needs, concerns, and strategies related to having stakeholders participate in designing and conducting an outcome evaluation need to be discussed. Stakeholders' participation in outcome evaluation ensures its relevancy and fairness. Participatory outcome evaluation starts with assessing the feasibility of conducting an outcome evaluation and determining whether stakeholders have a need for an outcome evaluation. If an outcome evaluation is possible and needed, the areas in which stakeholders can make important contributions to the evaluation are negotiated with the stakeholders. The article also discusses strategies to improve stakeholders' use of the results of outcome evaluation.
Yehia, Baligh R; Schranz, Asher J; Momplaisir, Florence; Keller, Sara C; Gross, Robert; Frank, Ian; Metlay, Joshua P; Brady, Kathleen A
Receiving care at multiple clinics may compromise the therapeutic patient-provider alliance and adversely affect the treatment of people living with HIV. We evaluated 12,759 HIV-infected adults in Philadelphia, PA between 2008 and 2010 to determine the effects of using multiple clinics for primary HIV care. Using generalized estimating equations with logistic regression, we examined the relationship between receiving care at multiple clinics (≥ 1 visit to two or more clinics during a calendar year) and two outcomes: (1) use of ART and (2) HIV viral load ≤ 200 copies/mL for patients on ART. Overall, 986 patients (8 %) received care at multiple clinics. The likelihood of attending multiple clinics was greater for younger patients, women, blacks, persons with public insurance, and for individuals in their first year of care. Adjusting for sociodemographic factors, patients receiving care at multiple clinics were less likely to use ART (AOR = 0.62, 95 % CI 0.55-0.71) and achieve HIV viral suppression (AOR = 0.78, 95 % CI 0.66-0.94) than individuals using one clinic. Qualitative data are needed to understand the reasons for visiting multiple clinics.
Bates, Reid; Coyne, Thomas H.
This paper describes a project designed to evaluate a 5-day clinical supervision workshop. The failure of Kirkpatrick's 4-level evaluation model to include key contextual input variables is demonstrated to be a critical evaluative shortcoming. The project shows how the use of valid diagnostic tools like the Learning Transfer Systems Inventory can…
Hollinger, Charlotte; Libarkin, Julie C; Stickle, Julia E; Hauptman, Joe G; Henry, Rebecca; Scott, Michael A
A mixed-methods evaluation was conducted to study learner attitudes and knowledge about clinical pathology across a curricular change that instituted a stand-alone clinical pathology course in place of content within a previously integrated pathology course structure. Groups of pre- and post-change students were assessed three times across the two semesters leading up to graduation. At each time, rank-ordered and open-ended response items probed attitudes, and multiple-choice items assessed knowledge. Data about student clinical pathology performance were also collected from clinical pathology instructors and supervising clinicians. Student rank-ordered items were evaluated by factor analysis; resulting factor-scale scores, multiple-choice scores, and rank responses from study cohorts were statistically assessed between groups and within each group over time. Intraclass correlations were calculated for the coding of student open-ended responses, and all coded responses were compared among groups. Analysis revealed that students in the revised curriculum had greater satisfaction with their training and greater confidence in data interpretation compared to students without exposure to an independent clinical pathology course. Although differences in knowledge of clinical pathology were not detected, it was also apparent that the independent clinical pathology course filled a student-perceived curricular need without raising criticisms related to diminished integration with anatomic pathology. Secondary study outcomes included formative feedback for course improvement, evidence of clerkship efficacy, and baseline data for further studies.
Lin, Lin; Finak, Greg; Ushey, Kevin; Seshadri, Chetan; Hawn, Thomas R; Frahm, Nicole; Scriba, Thomas J; Mahomed, Hassan; Hanekom, Willem; Bart, Pierre-Alexandre; Pantaleo, Giuseppe; Tomaras, Georgia D; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Michael, Nelson L; Kim, Jerome H; Robb, Merlin L; O'Connell, Robert J; Karasavvas, Nicos; Gilbert, Peter; C De Rosa, Stephen; McElrath, M Juliana; Gottardo, Raphael
Advances in flow cytometry and other single-cell technologies have enabled high-dimensional, high-throughput measurements of individual cells as well as the interrogation of cell population heterogeneity. However, in many instances, computational tools to analyze the wealth of data generated by these technologies are lacking. Here, we present a computational framework for unbiased combinatorial polyfunctionality analysis of antigen-specific T-cell subsets (COMPASS). COMPASS uses a Bayesian hierarchical framework to model all observed cell subsets and select those most likely to have antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, and human subject-level responses are quantified by two summary statistics that describe the quality of an individual's polyfunctional response and can be correlated directly with clinical outcome. Using three clinical data sets of cytokine production, we demonstrate how COMPASS improves characterization of antigen-specific T cells and reveals cellular 'correlates of protection/immunity' in the RV144 HIV vaccine efficacy trial that are missed by other methods. COMPASS is available as open-source software.
Lin, Lin; Finak, Greg; Ushey, Kevin; Seshadri, Chetan; Hawn, Thomas R.; Frahm, Nicole; Scriba, Thomas J.; Mahomed, Hassan; Hanekom, Willem; Bart, Pierre-Alexandre; Pantaleo, Giuseppe; Tomaras, Georgia D.; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Michael, Nelson L.; Kim, Jerome H.; Robb, Merlin L.; O’Connell, Robert J.; Karasavvas, Nicos; Gilbert, Peter; DeRosa, Stephen; McElrath, M. Juliana
Advances in flow cytometry and other single-cell technologies have enabled high-dimensional, high-throughput measurements of individual cells and allowed interrogation of cell population heterogeneity. Computational tools to take full advantage of these technologies are lacking. Here, we present COMPASS, a computational framework for unbiased polyfunctionality analysis of antigen-specific T-cell subsets. COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, while subject-level responses are quantified by two novel summary statistics that can be correlated directly with clinical outcome, and describe the quality of an individual’s (poly)functional response. Using three clinical datasets of cytokine production we demonstrate how COMPASS improves characterization of antigen-specific T cells and reveals novel cellular correlates of protection in the RV144 HIV vaccine efficacy trial that are missed by other methods. COMPASS is available as open-source software. PMID:26006008
Ebola virus disease is caused by a highly contagious and pathogenic threadlike RNA virus of the Filoviridae family. The index human case is usually a zoonosis that launches human-to-human transmission interface with varying levels of sustainability of the epidemic depending on the level of public health preparedness of the affected country and the Ebola virus strain. The disease affects all age groups in the population. Clinical diagnosis is challenging in index cases especially in the early stages of the disease when the presenting features are usually nonspecific and only similar to a flu-like illness. However, in the agonal stages, hemorrhage frequently occurs in a high proportion of cases. The diagnostic gold standard is by detecting the antigen using reverse transcription-polymerase chain reaction. Mortality rates in the past 28 outbreaks since 1976 have ranged from 30% to 100% in different settings among adults, but lower mortality rates have been documented in children. This review aims to describe Ebola virus infection, clinical presentation, diagnosis and outcomes in children.
de Wit, Niek J
Computer support is considered by many to be a promising strategy for improving healthcare interventions, especially in the management of chronic diseases. So far, however, evidence of the effectiveness of ICT support in healthcare is limited. Recently, computer-supported cardiovascular disease management was compared with usual care during an RCT comprised of 1100 primary care patients. This trial demonstrated that neither the clinical outcome nor the cardiovascular morbidity rate improved, even though management of the risk factors improved over 1 year of follow-up. The pragmatic design of the RCT in daily general practice may have restricted implementing the computer support, and may also have hampered the evaluation of the cardiovascular effects. The results demonstrate that although computer support may help improve the performance of disease management, its impact on disease outcomes is questionable. ICT innovations in healthcare require rigorous investigative evaluation before their implementation in daily practice can be justified.
Middleton, S; Lumby, J
Reviews of the structure of the health system and the processes that contributed to them were the main forms of evaluation within nursing in Australia during the 1970s and 1980s. The documentation of the end result of care, or outcome evaluation, was rarely undertaken until more recent times. The development and implementation of formal assessment tools such as Qualpacs, the Phaneuf Nursing Audit, the Rush Medicus Nursing Process Methodology, Monitor, and Senior Monitor indicated the focus on structure and process evaluation. This paper examines how nursing care delivered to patients during the l970s and 1980s was evaluated, and explores why structure and process review were necessary precursors to outcome evaluation in the nineties. The necessity of linking structure and process analysis is discussed, in order to perform effective outcome evaluation to close the feedback loop between quality assessment and quality improvement. Peer review is one mechanism that can be used to achieve this. How this may also be a form of evidence-based practice which results in health gains for patients is also explored.
Crandal, Brent R.; Foster, Sharon L.; Chapman, Jason E.; Cunningham, Phillippe B.; Brennan, Patricia A.; Whitmore, Elizabeth A.
Effective evaluation of treatment requires the use of measurement tools producing reliable scores that can be used to make valid decisions about the outcomes of interest. Therapist-rated treatment outcome scores that are obtained within the context of empirically supported treatments (EST) could provide clinicians and researchers with data that are easily accessible and complimentary to existing instrumentation. We examined the psychometric properties of scores from the Therapist Perception of Treatment Outcome: Youth Antisocial Behavior (TPTO:YAB), an instrument developed to assess therapist judgments of treatment success among families participating in an EST, Multsystemic Therapy (MST), for youth with antisocial behavior problems. Data were drawn from a longitudinal study of MST. The initial 20-item TPTO was completed by therapists of 111 families at mid-treatment and 163 families at treatment termination. Rasch model dimensionality analyses provided evidence for two dimensions reflecting youth- and caregiver-related aspects of treatment outcome, although a bifactor analyses suggested that these dimensions reflected a single more general construct. Rasch analyses were also used to assess item and rating scale characteristics and refine the number of items. These analyses suggested items performed similarly across time and that scores reflect treatment outcome in similar ways at mid and post-treatment. Multilevel and zero-order analyses provided evidence for the validity of TPTO scores. TPTO scores were moderately correlated with scores of youth and caregiver behaviors targeted in treatment, adding support to its use as a treatment outcome measurement instrument. PMID:25642936
Crandal, Brent R; Foster, Sharon L; Chapman, Jason E; Cunningham, Phillippe B; Brennan, Patricia A; Whitmore, Elizabeth A
Effective evaluation of treatment requires the use of measurement tools producing reliable scores that can be used to make valid decisions about the outcomes of interest. Therapist-rated treatment outcome scores that are obtained within the context of empirically supported treatments (ESTs) could provide clinicians and researchers with data that are easily accessible and complimentary to existing instrumentation. We examined the psychometric properties of scores from the Therapist Perception of Treatment Outcome: Youth Antisocial Behavior (TPTO:YAB), an instrument developed to assess therapist judgments of treatment success among families participating in an EST, Multisystemic Therapy (MST), for youth with antisocial behavior problems. Data were drawn from a longitudinal study of MST. The initial 20-item TPTO:YAB was completed by therapists of 111 families at midtreatment and 163 families at treatment termination. Rasch model dimensionality analyses provided evidence for 2 dimensions reflecting youth- and caregiver-related aspects of treatment outcome, although a bifactor analyses suggested that these dimensions reflected a single more general construct. Rasch analyses were also used to assess item and rating scale characteristics and refine the number of items. These analyses suggested items performed similarly across time and that scores reflect treatment outcome in similar ways at mid and posttreatment. Multilevel and zero-order analyses provided evidence for the validity of TPTO:YAB scores. TPTO:YAB scores were moderately correlated with scores of youth and caregiver behaviors targeted in treatment, adding support to its use as a treatment outcome measurement instrument.
Stephenson-Jones, Marcus; Yu, Kai; Ahrens, Sandra; Tucciarone, Jason M.; van Huijstee, Aile N.; Mejia, Luis A.; Penzo, Mario A.; Tai, Lung-Hao; Wilbrecht, Linda; Li, Bo
The basal ganglia, a group of subcortical nuclei, play a crucial role in decision making by selecting actions and evaluating their outcomes1,2. While much is known about the function of the basal ganglia circuitry in selection1,3,4, how these nuclei contribute to outcome evaluation is less clear. Here we show that neurons in the habenula-projecting globus pallidus (GPh) are essential for evaluating action outcomes and are regulated by a specific set of inputs from the basal ganglia. We found in a classical conditioning task that individual mouse GPh neurons bidirectionally encode whether an outcome is better or worse than expected. Mimicking these evaluation signals with optogenetic inhibition or excitation is sufficient to reinforce or discourage actions in a decision making task. Moreover, cell-type-specific synaptic manipulations revealed that the inhibitory and excitatory inputs to the GPh are necessary for mice to appropriately evaluate positive and negative feedback, respectively. Finally, using rabies virus-assisted monosynaptic tracing5, we discovered that the GPh is embedded in a basal ganglia circuit wherein it receives inhibitory input from both striosomal and matrix compartments of the striatum, and excitatory input from the “limbic” regions of the subthalamic nucleus (STN). Our results provide the first direct evidence that information about the selection and evaluation of actions is channelled through distinct sets of basal ganglia circuits, with the GPh representing a key locus where information of opposing valence is integrated to determine whether action outcomes are better or worse than expected. PMID:27652894
Keystone, Edward C.; Pope, Janet E.; Thorne, J. Carter; Poulin-Costello, Melanie; Phan-Chronis, Krystene; Vieira, Andrew
Objective. To evaluate radiographic and clinical outcomes up to 24 months in patients with RA enrolled in the Canadian Methotrexate and Etanercept Outcome study. Methods. In this open-label non-inferiority trial, patients with inadequate response to MTX received etanercept plus MTX for 6 months and then were randomized to either etanercept monotherapy or continued etanercept plus MTX until 24 months. Radiographic data were analysed using the modified total Sharp score (mTSS), joint space narrowing and erosion scores. Secondary outcomes included the 28-joint DAS with ESR (DAS28-ESR), Simplified Disease Activity Index, Clinical Disease Activity Index, HAQ Disability Index (HAQ-DI) and safety. Results. Two hundred five of 258 patients enrolled were randomized (98 etanercept, 107 etanercept plus MTX). At month 24, the mean increase from baseline to month 24 for the etanercept and etanercept plus MTX arms, respectively, for the mTSS were 0.4 (s.d. 1.9) and 0.0 (s.d. 1.4); for joint space narrowing, 0.1 (s.d. 0.6) and 0.0 (s.d. 0.7) and for erosion, 0.3 (s.d. 1.5) and 0.0 (s.d. 1.0). At month 24, the mean increase from month 6 mean scores/count increases for DAS28-ESR were 0.56 (s.d. 1.26) and 0.08 (s.d. 1.50); for Simplified Disease Activity Index, 4.7 (s.d. 13.1) and 0.9 (s.d. 12.5); for Clinical Disease Activity Index, 4.1 (s.d. 12.3) and 1.0 (s.d. 12.3) and for HAQ-DI, 0.20 (s.d. 0.45) and 0.02 (s.d. 0.54). Patients with DAS28-ESR low disease activity (LDA)/remission at month 6 had numerically better outcomes at month 24 than patients with moderate to high disease activity at month 6. In patients with LDA/remission at month 6, outcomes were similar at month 24 between etanercept monotherapy and etanercept plus MTX, whereas patients with moderate to high disease activity at month 6 had numerically better outcomes with etanercept plus MTX than etanercept at month 24. There were no new safety signals and serious adverse events were not different between groups
Gould, Madelyn S.; Kalafat, John; HarrisMunfakh, Jimmie Lou; Kleinman, Marjorie
In this study we evaluated the effectiveness of telephone crisis services/hotlines, examining proximal outcomes as measured by changes in callers' suicide state from the beginning to the end of their calls to eight centers in the U.S. and again within 3 weeks of their calls. Between March 2003 and July 2004, 1,085 suicide callers were assessed…
Henry, Gary T.; Smith, Adrienne A.; Kershaw, David C.; Zulli, Rebecca A.
Performance-based accountability along with budget tightening has increased pressure on publicly funded organizations to develop and deliver programs that produce meaningful social benefits. As a result, there is increasing need to undertake formative evaluations that estimate preliminary program outcomes and identify promising program components…
Hachfeld, Gary A.; Bau, David B.; Holcomb, C. Robert; Craig, J. William
Dwindling public funding as well as greater competition for grant dollars create a challenge for Extension. For Extension to remain a financially viable organization, educators have to be able to produce substantive, measurable program outcomes and impacts. Evaluative data can inform program development and delivery, and helps administrators…
van der Linde, Chris
There is a gap in the current research literature regarding evaluation of TAFE outcomes and it stems from a predominant human capital focus. The existing paradigm of human capital, which values the acquisition of knowledge and skills for their economic value, has been of primary interest and significance, particularly in terms of government policy…
Pinheiro, Carlos Passos; Rezek, Daniele; Costa, Eduardo Paiva; de Carvalho, Edvagner Sergio Leite; Moscoso, Freddy Antonio Brito; Taborga, Percy Richard Chavez; Jeronimo, Andreia Dias; Abizaid, Alexandre Antonio Cunha; Ramos, Auristela Isabel de Oliveira
Background Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). Conclusion Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk. PMID:27305109
Background Interdisciplinary teamwork (ITW) is designed to promote the active participation of several disciplines in delivering comprehensive cancer care to patients. ITW provides mechanisms to support continuous communication among care providers, optimize professionals’ participation in clinical decision-making within and across disciplines, and foster care coordination along the cancer trajectory. However, ITW mechanisms are not activated optimally by all teams, resulting in a gap between desired outcomes of ITW and actual outcomes observed. The aim of the present study is to identify the conditions underlying outcome production by ITW in local oncology teams. Methods This retrospective multiple case study will draw upon realist evaluation principles to explore associations among context, mechanisms and outcomes (CMO). The cases are nine interdisciplinary cancer teams that participated in a previous study evaluating ITW outcomes. Qualitative data sources will be used to construct a picture of CMO associations in each case. For data collection, reflexive focus groups will be held to capture patients’ and professionals’ perspectives on ITW, using the guiding question, ‘What works, for whom, and under what circumstances?’ Intra-case analysis will be used to trace associations between context, ITW mechanisms, and patient outcomes. Inter-case analysis will be used to compare the different cases’ CMO associations for a better understanding of the phenomenon under study. Discussion This multiple case study will use realist evaluation principles to draw lessons about how certain contexts are more or less likely to produce particular outcomes. The results will make it possible to target more specifically the actions required to optimize structures and to activate the best mechanisms to meet the needs of cancer patients. This project could also contribute significantly to the development of improved research methods for conducting realist evaluations of
Datta, Adrija Kumar; Zosmer, Ariel; Tozer, Amanda; Sabatini, Luca; Davis, Colin; Al-Shawaf, Talha
This retrospective cohort study determined whether the total falls in serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection could predict clinical outcomes. Ninety-nine cycles, with gonadotrophin-releasing hormone-agonist down-regulation where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of severe ovarian hyperstimulation syndrome, were consecutively included. The primary clinical outcome was live-birth rate (LBR); other outcomes measured were number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates. LBR for FSH fall>10 IU/l compared with 5-10 and<5 IU/l were 45.4% versus 22.0% and 25.0%, respectively. Mean serum FSH fall was similar with and without live birth (8.4 ± 6.2 versus 7.3 ± 5.0 IU/l) as were mean oestradiol and FSH concentrations on HCG administration, oestradiol fall, percentage fall in FSH/oestradiol and duration of coasting. None of the variables efficiently predicted live birth on regression analysis. The AUC of FSH fall was 0.53 at 11.0 IU/l. Basal FSH, starting and total gonadotrophin dose and duration of coasting were positively correlated with FSH fall. A potentially clinically important association between live birth and FSH fall during coasting was apparent, which requires further evaluation. The purpose of this retrospective cohort study was to determine whether the magnitude of fall in the serum FSH and oestradiol concentrations from start to end of coasting in IVF/intracytoplasmic sperm injection cycles could predict the clinical outcomes. Gonadotrophin-releasing hormone-agonist down-regulated cycles (n=99), where coasting with serial serum oestradiol and FSH monitoring was adopted due to risk of ovarian hyperstimulation, were consecutively included. Live birth was the primary clinical outcome measured; number of oocytes retrieved and fertilization, implantation and clinical pregnancy rates were the other outcomes
Wang, Yuhan; Han, Yingying; Weng, Qiang; Yuan, Zhengrong
The Xeroderma pigmentosum complementation group G (XPG) rs2296147T>C polymorphism is suspected to associate with the clinical outcomes of cancer patients. However, the results are inconsistent. This meta-analysis aimed to evaluate the reliable predictive value of XPG rs2296147T>C polymorphism on clinical outcomes of cancer patients. A total of 11 eligible studies were enrolled in this meta-analysis. Our results indicated that the cancer patients with TT and CT genotypes were significantly associated with better respond rates when compared with the CC genotype (TT versus (vs.) CC: odds ratio (OR) = 2.05, 95% confidence intervals (CIs), 1.32-3.20, P = 0.002; TT+CT vs. CC: OR= 1.57, 95% CI, 1.14-2.17, P = 0.005). The TT genotype and/or T allele might be associated with higher survival time for cancer patients than the CC genotype and/or C allele. The cumulative meta-analyses showed an apparent beneficial objective response of TT genotype on cancer patients. In conclusion, this meta-analysis suggests that the XPG rs2296147T>C polymorphism is associated with the clinical outcomes of cancer patients. The XPG rs2296147T>C polymorphism might be a predictive factor of prognosis in cancers patients and contribute to individual treatment in the future. PMID:27588464
Adams, Zachary W.; Moreland, Angela; Cohen, Joseph R.; Lee, Robert C.; Hanson, Rochelle F.; Danielson, Carla Kmett; Self-Brown, Shannon; Briggs, Ernestine C.
Objective Exposure to multiple traumatic events (polyvictimization) is a reliable predictor of deleterious health outcomes and risk behaviors in adolescence. The current study extends the literature on the prevalence and consequences of adolescent trauma exposure by (a) empirically identifying and characterizing trauma exposure profiles in a large, ethnically diverse, multi-site, clinical sample of adolescents, and (b) evaluating relations among identified profiles with demographic characteristics and clinical correlates. Method Data from the National Child Traumatic Stress Network Core Data Set were used to identify and characterize victimization profiles using latent class analysis in a sample of 3,485 adolescents (ages 13–18, 63% female, 35.7% White, 23.2% Black/African American, 35.0% Hispanic/Latino). Multiple measures of psychological distress and risk behaviors were evaluated as covariates of trauma exposure classes. Results Five trauma exposure classes, or profiles, were identified. Four classes—representing approximately half the sample—were characterized by polyvictimization. Polyvictimization classes were differentiated on number of trauma types, whether emotional abuse occurred, and whether emotional abuse occurred over single or multiple developmental epochs. Unique relations with demographic characteristics and mental health outcomes were observed. Discussion Results suggest polyvictimization is not a unidimensional phenomenon but a diverse set of trauma exposure experiences with unique correlates among youth. Further research on prevention of polyvictimization and mechanisms linking chronic trauma exposure, gender, and ethnicity to negative outcomes is warranted. PMID:26958417
Arbelaez, María Clara; Vidal, Camila; Arba Mosquera, Samuel
Purpose To evaluate postoperative clinical outcomes, and corneal High Order Aberrations, among eyes with hyperopia up to +5 D of spherical equivalent, that have undergone LASIK treatments using the SCHWIND AMARIS laser system. Methods At six-month follow-up, 100 eyes with preoperative hyperopia or hyperopic astigmatism up to +5 D of spherical equivalent were retrospectively analysed. Standard examinations, pre- and postoperative wavefront analysis with a corneal-wavefront-analyzer (OPTIKON Scout) were performed. Aberration-Free aspheric treatments were planned with Custom Ablation Manager software and ablations performed using the SCHWIND AMARIS flying-spot excimer laser system (both SCHWIND eye-tech-solutions). LASIK flaps were created using a LDV femtosecond laser (Ziemer Group) in all cases. Clinical outcomes were evaluated in terms of predictability, refractive outcome, safety, and wavefront aberration. Results At six month, 90 % of eyes achieved ≥ 20/25 UCVA and 44 % achieved ≥ 20/16 UCVA. Seventy-four percent of eyes were within ± 0.25D of spherical equivalent and 89 % within ± 0.50D, with 94 % within 0.50D of astigmatism. Mean spherical equivalent was −0.12 ± 0.51D and 0.50 ± 0.51D for the astigmatism. Fifty-two percent of eyes improved BSCVA vs. only 19 % losing lines of BSCVA. Predictability slope for refraction was 1.03 and intercept +0.01 D. On average, negative corneal spherical aberrations were significantly increased by the treatments, no other aberration terms changed from pre- to postoperative values. Conclusions LASIK for hyperopia and hyperopic astigmatism with SCHWIND AMARIS yields very satisfactory visual outcomes. Preoperative refractions were postoperatively reduced to subclinical values with no clinically relevant induction of corneal HOA.
Mondelli, Mauro; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Cocito, Dario; Neuropathies, Italian Network for Traumatic
Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76), particularly in the S group (OR 7.25; CI 1.2–43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450
Background Polymerase chain reaction (PCR) assay can be a useful method for definitive diagnosis in paucibacillary infections such as ocular tuberculosis (TB). In this study, we have evaluated factors affecting PCR outcomes in patients with clinically suspected ocular TB. Patients with clinically suspected ocular TB were investigated by PCR of aqueous or vitreous samples. Three control groups were also tested: group 1 included culture-proven non-tuberculous endophthalmitis, group 2 culture-negative non-tuberculous endophthalmitis, and group 3 patients undergoing surgery for uncomplicated cataract. PCR targeted one or more of following targets: IS6110, MPB64, and protein b genes of Mycobacterium tuberculosis complex. Multiple regression analysis (5% level of significance) was done to evaluate the associations between positive PCR outcome and laterality of disease, tuberculin skin test (TST)/interferon-gamma release assay (IGRA), chest radiography, and type of sample (aqueous or vitreous). The main outcome measures were positive PCR by one or more gene targets, and factors influencing positive PCR outcomes. Results All 114 samples were tested for MPB64, 110 for protein b, and 88 for IS6110. MPB64 was positive in 70.2% (n = 80) of tested samples, protein b in 40.0% (n = 44), and IS6110 in only 9.1% (n = 8). DNA sequencing of amplicons from four randomly chosen PCR reactions showed homology for M. tuberculosis complex. Of the 80 PCR-positive patients, 71 completed a full course of antitubercular therapy, of which 65 patients (91.5%) had complete resolution of inflammation at final follow-up. Among controls, 12.5% (3 out of 24) in group 1 and 18.7% (6 out of 32) in group 2 also tested positive by PCR. No PCR-positive outcome was observed in control group 3 (n = 25). Multiple regression analysis revealed significant association of positive PCR outcome with bilateral presentation, but not with a positive TST/IGRA, chest radiography, or type of sample
Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin
Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781
Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat
Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553
Davis, C R; Trevatt, Aej; Dixit, A; Datta, V
Introduction Prophylactic appendicectomy is performed prior to military, polar and space expeditions to prevent acute appendicitis in the field. However, the risk-benefit ratio of prophylactic surgery is controversial. This study aimed to systematically review the evidence for prophylactic appendicectomy. It is supplemented by a clinical example of prophylactic surgery resulting in life-threatening complications. Methods A systematic review was performed using MEDLINE(®) and the Cochrane Central Register of Controlled Trials. Keyword variants of 'prophylaxis' and 'appendicectomy' were combined to identify potential papers for inclusion. Papers related to prophylactic appendicectomy risks and benefits were reviewed. Results Overall, 511 papers were identified, with 37 papers satisfying the inclusion criteria. Nine reported outcomes after incidental appendicectomy during concurrent surgical procedures. No papers focused explicitly on prophylactic appendicectomy in asymptomatic patients. The clinical example outlined acute obstruction secondary to adhesions from a prophylactic appendicectomy. Complications after elective appendicectomy versus the natural history of acute appendicitis in scenarios such as polar expeditions or covert operations suggest prophylactic appendicectomy may be appropriate prior to extreme situations. Nevertheless, the long-term risk of adhesion related complications render prophylactic appendicectomy feasible only when the short-term risk of acute appendicitis outweighs the long-term risks of surgery. Conclusions Prophylactic appendicectomy is rarely performed and not without risk. This is the first documented evidence of long-term complications following prophylactic appendicectomy. Surgery should be considered on an individual basis by balancing the risks of acute appendicitis in the field with the potential consequences of an otherwise unnecessary surgical procedure in a healthy patient.
Davis, CR; Trevatt, AEJ; Dixit, A; Datta, V
Introduction Prophylactic appendicectomy is performed prior to military, polar and space expeditions to prevent acute appendicitis in the field. However, the risk–benefit ratio of prophylactic surgery is controversial. This study aimed to systematically review the evidence for prophylactic appendicectomy. It is supplemented by a clinical example of prophylactic surgery resulting in life-threatening complications. Methods A systematic review was performed using MEDLINE® and the Cochrane Central Register of Controlled Trials. Keyword variants of ‘prophylaxis’ and ‘appendicectomy’ were combined to identify potential papers for inclusion. Papers related to prophylactic appendicectomy risks and benefits were reviewed. Results Overall, 511 papers were identified, with 37 papers satisfying the inclusion criteria. Nine reported outcomes after incidental appendicectomy during concurrent surgical procedures. No papers focused explicitly on prophylactic appendicectomy in asymptomatic patients. The clinical example outlined acute obstruction secondary to adhesions from a prophylactic appendicectomy. Complications after elective appendicectomy versus the natural history of acute appendicitis in scenarios such as polar expeditions or covert operations suggest prophylactic appendicectomy may be appropriate prior to extreme situations. Nevertheless, the long-term risk of adhesion related complications render prophylactic appendicectomy feasible only when the short-term risk of acute appendicitis outweighs the long-term risks of surgery. Conclusions Prophylactic appendicectomy is rarely performed and not without risk. This is the first documented evidence of long-term complications following prophylactic appendicectomy. Surgery should be considered on an individual basis by balancing the risks of acute appendicitis in the field with the potential consequences of an otherwise unnecessary surgical procedure in a healthy patient. PMID:27023639
Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867
Yang, Chenlong; Li, Guang; Fang, Jingyi; Wu, Liang; Yang, Tao; Deng, Xiaofeng; Xu, Yulun
Intramedullary spinal cord gangliogliomas are rare tumors composed of glial components and ganglion cells. These gangliogliomas are generally considered as slow-growing tumors, corresponding histologically to WHO grade I or II. There are few reports of large case series of intramedullary spinal cord gangliogliomas from a single center. We retrospectively reviewed a consecutive series of 18 patients with pathologically diagnosed ganglioglioma. Clinical manifestations, radiological features, treatment and follow-up data, and concomitant scoliosis were investigated. The mean age at diagnosis was 27.5 years, with a slight female predominance. The primary clinical symptoms were sensorimotor deficits. Magnetic resonance (MR) imaging manifestations varied considerably. Some associated, but not necessary, features were found, such as young age at onset, large tumor dimension, and bony changes. Scoliosis was observed in seven patients. Remnant tumor progression was observed in five patients during the follow-up period, and no deaths occurred. The last neurological evaluation showed functional improvement from preoperative status in five patients. Differential diagnosis of ganglioglioma based on MR images alone is challenging, but the combination of some characteristic features can be helpful. An accurate diagnosis of ganglioglioma depends on pathological criteria. Despite the benign course of ganglioglioma, considerable growth may affect its resectability and prognosis. The extent of resection should be meticulously planned, and the potential risk of recurrence and neurological deterioration should be evaluated. The concomitant scoliosis is noteworthy.
Adisasmita, Asri; Smith, Carl V; El-Mohandes, Ayman A E; Deviany, Poppy Elvira; Ryon, Judith J; Kiely, Michele; Rogers-Bloch, Quail; Gipson, Reginald F
This Indonesian study evaluates associations between near-miss status/death with maternal demographic, health care characteristics, and obstetrical complications, comparing results using retrospective and prospective data. The main outcome measures were obstetric conditions and socio-economic factors to predict near-miss/death. We abstracted all obstetric admissions (1,358 retrospective and 1,240 prospective) from two district hospitals in East Java, Indonesia between 4/1/2009 and 5/15/2010. Prospective data added socio-economic status, access to care and referral patterns. Reduced logistic models were constructed, and multivariate analyses used to assess association of risk variables to outcome. Using multivariate analysis, variables associated with risk of near-miss/death include postpartum hemorrhage (retrospective AOR 5.41, 95 % CI 2.64-11.08; prospective AOR 10.45, 95 % CI 5.59-19.52) and severe preeclampsia/eclampsia (retrospective AOR 1.94, 95 % CI 1.05-3.57; prospective AOR 3.26, 95 % CI 1.79-5.94). Associations with near-miss/death were seen for antepartum hemorrhage in retrospective data (AOR 9.34, 95 % CI 4.34-20.13), and prospectively for poverty (AOR 2.17, 95 % CI 1.33-3.54) and delivering outside the hospital (AOR 2.04, 95 % CI 1.08-3.82). Postpartum hemorrhage and severe preeclampsia/eclampsia are leading causes of near-miss/death in Indonesia. Poverty and delivery outside the hospital are significant risk factors. Prompt recognition of complications, timely referrals, standardized care protocols, prompt hospital triage, and structured provider education may reduce obstetric mortality and morbidity. Retrospective data were reliable, but prospective data provided valuable information about barriers to care and referral patterns.
Tomimaru, Y; Ito, T; Kawamoto, K; Hama, N; Wada, H; Kobayashi, S; Eguchi, H; Tanemura, M; Mori, M; Doki, Y; Nagano, H
In Japan, absolute shortage of donors still continues even after the law allowing organ transplantation from deceased donors came into force in 1997. With the passage of the waiting period after registration for pancreas transplantation (PTx), both deaths and serious cases of diabetic complications necessitating withdrawal of the registration have undoubtedly increased. Therefore, so-called "marginal donor" (MD) has been considered as a potential solution for shortage of donors in Japan. The aim of the present study is to evaluate feasibility of MD in terms of post-PTx outcomes using data from Japan Organ Transplantation Network. A total of 148 PTx were performed from deceased donors in Japan from 2000 to 2012. MD was defined as follows: (1) >45 years old; (2) hemodynamically unstable at harvest using a high-dose dopamine or more than 2 vasopressors; or (3) non-heart-beating status. Postoperative outcomes after PTx were compared between the MD group and the non-MD group. Among the 148 PTx donors, 108 donors (73.0%) satisfied the criteria of MD. Early graft loss of pancreas graft during 3 months post-transplant was observed in 15 patients (10.1%), and the marginality (MD vs non-MD) was not significantly correlated with the early loss of pancreas graft. The overall patient survival of the MD group (1, 3, 5 years: 94.7%, 94.7%, 94.7%) was not significantly different from that of the non-MD group (1, 3, 5 years: 95.0%, 95.0%, 95.0%). Pancreas graft survival in the MD group (1, 3, 5 years: 80.9%, 73.2%, 66.0%) seemed to be slightly lower than that in the non-MD group (1, 3, 5 years: 92.5%, 85.2%, 77.4%), but no statistically significant differences were found between the 2 groups. These results suggest the feasibility of the use of MD for PTx.
Funnyé, A. S.; Ganesan, K.; Yoshikawa, T. T.
This study examined the clinical characteristics and outcome of pulmonary tuberculosis in African Americans hospitalized in a teaching hospital in south-central Los Angeles from May 1992 through April 1994. The charts of 41 African Americans with culture-positive Mycobacterium tuberculosis were reviewed. Predisposing factors for pulmonary tuberculosis were identified in nearly half of cases. Cough and fever were the most common symptoms. Seventy-six percent had positive acid-fast bacilli (AFB) smears. Nine patients were human immunodeficiency virus (HIV)-positive, and 6 of 9 HIV-positive patients had positive AFB smears whereas 17 of 19 HIV-negative patients had positive AFB smears. Radiographic changes were not significantly different between HIV-positive and HIV-negative patients. Drug resistance was identified in nine of 31 patients (29%). Eight of 41 patients (19.5%) died, with 2 being drug resistant. Human immunodeficiency virus infection was a major predisposing factor for tuberculosis, and no statistical differences were found in radiographic features or AFB smear positivity between HIV-positive and HIV-negative patients. Drug resistance and mortality were disproportionately high. These results indicate that HIV infection and drug resistance are major problems that predispose for tuberculosis infection and make its treatment difficult. PMID:9510620
Rombi, Barbara; DeLaney, Thomas F.; MacDonald, Shannon M.; Huang, Mary S.; Ebb, David H.; Liebsch, Norbert J.; Raskin, Kevin A.; Yeap, Beow Y.; Marcus, Karen J.; Tarbell, Nancy J.; Yock, Torunn I.
Purpose: Proton radiotherapy (PT) has been prescribed similarly to photon radiotherapy to achieve comparable disease control rates at comparable doses. The chief advantage of protons in this setting is to reduce acute and late toxicities by decreasing the amount of normal tissue irradiated. We report the preliminary clinical outcomes including late effects on our pediatric Ewing's sarcoma patients treated with PT at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (Boston, MA). Methods and Materials: This was a retrospective review of the medical records of 30 children with Ewing's sarcoma who were treated with PT between April 2003 and April 2009. Results: A total of 14 male and 16 female patients with tumors in several anatomic sites were treated with PT at a median age of 10 years. The median dose was 54 Gy (relative biological effectiveness) with a median follow-up of 38.4 months. The 3-year actuarial rates of event-free survival, local control, and overall survival were 60%, 86%, and 89%, respectively. PT was acutely well tolerated, with mostly mild-to-moderate skin reactions. At the time of writing, the only serious late effects have been four hematologic malignancies, which are known risks of topoisomerase and anthracyline exposure. Conclusions: Proton radiotherapy was well tolerated, with few adverse events. Longer follow-up is needed to more fully assess tumor control and late effects, but the preliminary results are encouraging.
Bouali, Sofiene; Maatar, Nidhal; Bouhoula, Asma; Abderrahmen, Khansa; Said, Imed Ben; Boubaker, Adnen; Kallel, Jalel; Jemel, Hafedh
Purpose: The spinal epidural angiolipomas are rare expansive processes made of mature lipomatous and angiomatous elements. They often have a benign character. Their etiology, pathogenesis remains uncertain, and it is a cause of spinal cord compression. The magnetic resonance imaging is the most important neuroradiological examination. Histological examination is the only examination to confirm the diagnosis. Surgery is the treatment of choice. Methods: A retrospective study of all patients operated on for a spinal epidural angiolipoma at the Department of Neurosurgery at the National Institute of Neurology of Tunis between January 2000 and December 2014 (15 years) was performed. The aim of this study is to describe the clinical, radiological, histological characteristics and the treatment of this tumor. Results: A total of nine patients were operated from January 01, 2000 to November 30, 2014. The average age of our patients was 51 years with ages that ranged from 29 to 65 with a male predominance. The period between onset of symptoms and diagnosis ranged from 24 months with an average 12 months. Posterior localization of the tumor was seen in all patients. Surgical resection was performed for all cases. The postoperative course has been satisfactory, with a complete recovery of neurological functions in all patients. Conclusions: The spinal epidural angiolipomas is rare expansive process causing spinal cord compression. Treatment is exclusively surgical resection. The functional outcome of spinal epidural angiolipomas is particularly favorable with a complete neurological recovery is if the patient was quickly operated. PMID:27695535
Scolari, Maria Piera; Comai, G; La Manna, G; Liviano D'Arcangelo, G; Monti, M; Feliciangeli, G; Stefoni, S
When possible, living donor transplantation represents the best therapeutic strategy for patients suffering from chronic renal failure. Studying the donor allows a complete and thorough clinical, laboratory and instrumental assessment that guarantees good organ function whilst protecting the health of the donor. The main parameters considered within this framework are age, renal function, nephrological complications, comorbidities (diabetes, hypertension, obesity, etc.), malignancies, and infection. Moreover, particular attention is paid to the sociopsychological aspects of the donation, particularly related to the donor, the recipient, and the entire family situation.
SANT’ANA, Adriana Campos Passanezi; de CAMPOS, Marinele R.; PASSANEZI, Selma Campos; de REZENDE, Maria Lúcia Rubo; GREGHI, Sebastião Luiz Aguiar; PASSANEZI, Euloir
Objectives The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. Material and Methods Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG – "no intervention" (n=17) or IG- "intervention" (n=16). IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (<37 weeks), low birth weight (<2.5 kg), late abortion (14-24 weeks) or abortion (<14 weeks). The results obtained were statistically evaluated according to OR, unpaired t test and paired t test at 5% significance level. Results No significant differences were observed between groups at baseline examination. Periodontal treatment resulted in stabilization of CAL and PI (p>0.05) at IG and worsening of all periodontal parameters at NIG (p<0.0001), except for PI. Significant differences in periodontal conditions of IG and NIG were observed at 2nd examination (p<0.001). The rate of adverse pregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. Conclusions Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes. PMID:21552714
Park, Jong-Hwa; Lee, Ho-Jin; Shin, Byung-Kon
Background Laminoplasty is a surgical procedure frequently performed for cervical myelopathy. We investigated correlations between changes in the anteroposterior diameter (APD) of the spinal canal, spinal canal area (SCA), and laminar angle (LA) and clinical outcomes of laminoplasty. Methods Of the 204 cervical myelopathy patients who underwent laminoplasty from July 2010 to May 2015, 49 patients who were evaluated with pre- and postoperative computed tomography of the cervical vertebrae were included. The average age of the patients was 60.4 years (range, 31 to 82 years), and the average duration of follow-up was 31.6 months (range, 9 to 68 months). Changes in the APD and SCA were measured at the middle of the vertebral body. Changes in LA were measured where both pedicles were clearly visible. Clinical outcomes were assessed using the Japanese Orthopaedic Association (JOA) score and visual analog scale score for pain preoperatively (1 day before surgery) and postoperatively (last outpatient visit) and examining postoperative complications. Results The APD showed an average of 54.7% increase from 11.5 to 17.8 mm. The SCA showed an average of 57.7% increase from 225.9 to 356.3 mm2. The LA increased from 34.2° preoperatively to 71.9° postoperatively. The JOA score increased from an average of 9.1 preoperatively to 13.4 postoperatively. Three patients were found to have hinge fractures during surgery. Postoperative complications, including two cases of C5 palsy, were recorded. The correlation coefficient between the LA change and JOA score improvement was −0.449 (p < 0.05). Patients with a < 33° (25%) increase in the LA showed the most significant clinical improvement. Conclusions Patients with a < 33° (25%) change in the LA after laminoplasty with a titanium miniplate showed the most significant clinical improvement. Thus, LA changes can be useful in predicting the clinical outcome of laminoplasty. PMID:27904722
Zhu, Lixia; Xi, Qingsong; Zhang, Hanwang; Li, Yufeng; Ai, Jihui; Jin, Lei
Surplus embryos available for cryopreservation in fresh cycles are considered as having good potential for future use. However, the optimal stage of embryo cryopreservation remains unclear. In this study, 1190 patients with surplus embryos on day 3 were divided into two groups: cleavage-stage embryo cryopreservation (control group) and blastocyst cryopreservation (blastocyst group). The clinical outcomes of the subsequent warming cycles were evaluated. The proportion of cycles with blastocyst formation was 73.8% in the blastocyst group. Although in the blastocyst group, the cancellation rate of blastocyst transfer was increased due to lack of blastocysts available for cryopreservation, the blastocyst group achieved significantly higher rates of clinical pregnancy/cycle (43.2% versus 34.9%; P=0.003), pregnancy/transfer (59.5% versus 35.4%; P<0.001) and implantation (46.5% versus 22.2%; P<0.001) from the first warming cycle compared with the control group. In an embryo-number classified analysis, the clinical pregnancy rate was also higher in the blastocyst group. However, the cumulative pregnancy was similar between the two groups. Blastocyst culture as an embryo selection tool will not improve embryo viability but it will help patients to achieve pregnancy more quickly. Extended culture of surplus embryos to the blastocyst stage for cryopreservation optimizes the clinical outcomes.
The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light–especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or ‘spin’) in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government’s commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform’s champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended. PMID:27690131
The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light-especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or 'spin') in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government's commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform's champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended.
Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; Silva, Luciana Andrade; Eduardo, Cesar Moreira Mariz Pinto Rodrigo Tormin Ortiz; Checchia, Sergio Luiz
To assess the outcomes of the surgical treatment of extensive rotator cuff injuries through arthroscopy. Methods: Between June 1998 and October 2006, 61 patients with extensive rotator cuff injuries and submitted to surgical arthroscopy technique by the Shoulder and Elbow Group of the Department of Orthopaedics and Traumatology, Santa Casa de Misericórdia Medical School were reassessed. The study included all patients with at least two tendons affected or with retraction at least on two tendons up to the glenoidal cavity edge and with at least 12 months of follow-up. Results: According to UCLA's evaluation criteria, 54 (89%) patients showed excellent or good outcomes; no fair outcome in none of the patients; and seven (11%) poor outcomes. A satisfaction rate of 92% was reported. Postoperative joint motion went from a mean lifting value of 93° to 141°, the mean lateral rotation went from 32° to 48° and the mean medial rotation went from L1 to T10. These differences were regarded as statistically significant. Conclusion: The arthroscopic repair of extensive rotator cuff injuries leads to satisfactory outcomes for most of the patients, with a high satisfaction degree. PMID:26998466
Aiken, Leona S.; And Others
Used structural equation modeling for comparative treatment outcome research conducted with heterogeneous clinical subpopulations within large multimodality treatment settings. Evaluated effect of early period of treatment on daily lives of 486 clients in 2 drug abuse treatment modalities (methadone maintenance and outpatient counseling).…
Peregrin, Jan H. Koznar, Boris; Kovac, Josef; Lastovickova, Jarmila; Novotny, Jiri; Vedlich, Daniel; Skibova, Jelena
This study was a retrospective analysis of patients with CLI who underwent infrapopliteal percutaneous transluminal angioplasty (PTA). The main goal was to evaluate clinical and morphological factors that influence the clinical outcome of PTA in long-term follow-up. A total of 1,445 PTA procedures were performed in 1,268 patients. Main indications for PTA included gangrene, nonhealing ulcers, or rest pain. The mean number of treated arteries was 1.77 artery/limb, and the majority of lesions were type TASC D. The technical success rate of PTA was 89% of intended-to-treat arteries. The main criterion of clinical success was functional limb salvage (LS). One-year follow-up involved 1,069 limbs. Primary and secondary 1-year LS rates were 76.1 and 84.4%, respectively. The effect of clinical and morphological parameters on the 1-year LS was that the only associated disease with an adverse effect on LS rate was DM combined with dialysis. Regarding limb preprocedural status, gangrene was clearly a negative predictor. The most important factor affecting LS was the number of patent arteries post-PTA: patients with 0, 1, 2, and 3 patent arteries had 1-year primary LS rates of 56.4, 73.1, 80.4, and 83%, respectively. Long-term follow-up of LS rates demonstrated secondary LS rates of 84.4, 78.8, and 73.3% at 1, 5, and 10 years. Every effort should be made to perform PTA for as many arteries as possible, even if TASC D type, to improve clinical outcome. Our study shows that repeat PTA is capable of keeping the long-term LS rate close to 75%.
Feizi, Sepehr; Javadi, Mohammad Ali; Ghasemi, Hassan; Javadi, Fatemeh
Purpose: To evaluate the effect of donor and eye bank characteristics on graft rating and clinical outcomes after penetrating keratoplasty (PK) for keratoconus. Methods: This retrospective interventional case series included 252 keratoconic eyes which underwent PK. Donor data included age and sex, cause of death, death-to-preservation time, preservation-to-surgery time, epithelial and stromal status, endothelial cell density (ECD) and morphology, and graft rating. Postoperative outcomes included visual acuity, refractive error, epithelial problems, suture-related complications, graft rejection, and graft transparency. Multivariate regression analysis assessed correlations between donor and eye bank characteristics and graft quality, and postoperative outcomes. Results: Mean recipient and donor age was 29.7 ± 10.0 and 26.2 ± 8.8 years, respectively and mean follow-up period was 66.7 ± 38.5 months. Death-to-preservation time was significantly associated with the presence of graft epithelial sloughing (P = 0.005) and stromal cloudiness (P < 0.001). Donor age significantly influenced ECD (P = 0.02), mean cell area (P = 0.04), and hexagonality (P = 0.01). The presence of epithelial defects on postoperative day 1 correlated significantly with death-to-preservation time (P = 0.004). Graft stromal edema on postoperative day 1 was significantly associated with graft epithelial sloughing (P < 0.001). Postoperative visual and refractive outcomes, complications, and graft survival were not correlated with any donor or eye bank factors. Conclusion: Donor and eye bank variables affected the quality of donor corneas and early postoperative course. However, their long term effect on clinical outcomes, complications, and graft survival were insignificant. PMID:27051479
Choi, Hayoung; Kim, Su-Young; Lee, Hyun; Jhun, Byung Woo; Park, Hye Yun; Jeon, Kyeongman; Kim, Dae Hun; Huh, Hee Jae; Ki, Chang-Seok; Lee, Nam Yong; Lee, Seung-Heon; Shin, Sung Jae; Daley, Charles L; Koh, Won-Jung
Macrolide antibiotics are cornerstones in the treatment of Mycobacterium massiliense lung disease. Despite the emergence of resistance, limited data on macrolide-resistant M massiliense lung disease are available. This study evaluated the clinical features and treatment outcomes of patients and the molecular characteristics of macrolide-resistant M massiliense isolates. We performed a retrospective review of medical records and genetic analyses of clinical isolates from 15 patients who had macrolide-resistant M massiliense lung disease between September 2005 and February 2015. Nine patients (60%) had the nodular bronchiectatic form of the disease, and six (40%) had the fibrocavitary form. Before the detection of macrolide resistance, three patients (20%) were treated with macrolide monotherapy, four (27%) with therapy for presumed Mycobacterium avium complex infections, and eight (53%) with combination antibiotic therapy for M massiliense lung disease. The median treatment duration after the detection of resistance was 18.7 months (interquartile range, 11.2 to 39.8 months). Treatment outcomes were poor, with a favorable outcome being achieved for only one patient (7%), who underwent surgery in addition to antibiotic therapy. The 1-, 3-, and 5-year mortality rates were 7, 13, and 33%, respectively. Of the 15 clinical isolates, 14 (93%) had point mutations at position 2058 (n = 9) or 2059 (n = 5) of the 23S rRNA gene, resulting in macrolide resistance. Our study indicates that treatment outcomes are poor and mortality rates are high after the development of macrolide resistance in patients with M massiliense lung disease. Thus, preventing the development of macrolide resistance should be a key consideration during treatment.
Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun
Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.
Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei
Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.
Debarge, Romain; Philippot, Rémy; Viola, Jérémy; Besse, Jean Luc
The aim of this study was to evaluate the outcome of the percutaneous flexor tenotomy. We compared the results of two groups. The first group included 23 patients who underwent forefoot surgery without percutaneous flexor tenotomy, and the second group included 50 patients who underwent the same procedure combined with percutaneous flexor tenotomy for claw toe deformities, secondary to shortening metatarsal Scarf osteotomy. The average follow-up was 11.6 months. Three algoneurodystrophies were noted. No delayed wound healing was observed. Functional dissatisfaction rate (18% vs.17.4%) and toe pulp contact defect (12% vs. 8.7%) were not significantly different in the two groups. Toe grasping defect rate (10% vs. 4.3%) was superior in the tenotomy group. Five recurring claw toe deformities of the second toe were noted in the tenotomy group. Percutaneous flexor tenotomy is a simple, rapid, and efficient method to correct reducible secondary claw toe deformities. However, despite a significant postoperative loss of toe grasping function, no patient reported major dissatisfaction.
Coronary dominance and prognosis in patients undergoing coronary computed tomographic angiography: results from the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) registry
Gebhard, Catherine; Fuchs, Tobias A.; Stehli, Julia; Gransar, Heidi; Berman, Daniel S.; Budoff, Matthew J.; Achenbach, Stephan; Al-Mallah, Mouaz; Andreini, Daniele; Cademartiri, Filippo; Callister, Tracy Q.; Chang, Hyuk-Jae; Chinnaiyan, Kavitha M.; Chow, Benjamin J. W.; Cury, Ricardo C.; Delago, Augustin; Gomez, Millie J.; Hadamitzky, Martin; Hausleiter, Joerg; Hindoyan, Niree; Feuchtner, Gudrun; Kim, Yong-Jin; Leipsic, Jonathon; Lin, Fay Y.; Maffei, Erica; Pontone, Gianluca; Raff, Gilbert; Shaw, Leslee J.; Villines, Todd C.; Dunning, Allison M.; Min, James K.; Kaufmann, Philipp A.
Aims Coronary computed tomographic angiography (CCTA) has become an important tool for non-invasive diagnosis of coronary artery disease (CAD). Coronary dominance can be assessed by CCTA; however, the predictive value of coronary dominance is controversially discussed. The aim of this study was to evaluate the prevalence and prognosis of coronary dominance in a large prospective, international multicentre cohort of patients undergoing CCTA. Methods and results The study population consisted of 6382 patients with or without CAD (47% females, 53% males, mean age 56.9 ± 12.3 years) who underwent CCTA and were followed over a period of 60 months. Right or left coronary dominance was determined. Right dominance was present in 91% (n = 5817) and left in 9% (n = 565) of the study population. At the end of follow-up, outcome in patients with obstructive CAD (>50% luminal stenosis) and right dominance was similar compared with patients with left dominance [hazard ratio (HR) 0.46, 95% CI 0.16–1.32, P = 0.15]. Furthermore, no differences were observed for the type of coronary dominance in patients with non-obstructive CAD (HR 0.95, 95% CI 0.41–2.21, P = 0.8962) or normal coronary arteries (HR 1.04, 95% CI 0.68–1.59, P = 0.9). Subgroup analysis in patients with left main disease revealed an elevated hazard of the combined endpoint for left dominance (HR 6.45, 95% CI 1.66–25.0, P = 0.007), but not for right dominance. Conclusion In our study population, survival after 5 years of follow-up did not differ significantly between patients with left or right coronary dominance. Thus, assessment of coronary vessel dominance by CCTA may not enhance risk stratification in patients with normal coronary arteries or obstructive CAD, but may add prognostic information for specific subpopulations. PMID:25744341
Chalmers, Robert J G
Psoriasis is a complex disease. Dermatologists have not documented psoriasis severity, except in clinical trials; doing so requires tools for assessing psoriasis and an understanding of what changes in those assessments mean in terms of outcome. Two psoriasis assessment tools have dominated: The Psoriasis Area and Severity Index and the Dermatology Life Quality Index. There are advantages and disadvantages to each. Newer instruments may not be more suitable for documenting psoriasis. There may be benefits in terms of patient ownership of disease management from using self-assessment tools for documenting severity, for example, the Self-assessment version of the Simplified Psoriasis Index.
TERMS Prosthetics, Orthotics, Prosthesis, Orthosis , Amputation, Outcomes Based Evaluation 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF...10 in 28) What is the biomechanical system called that this orthosis uses to control genuvarus? ______3 – point pressure...Unloader type orthosis (Fig 2) have to be to statically hold the knee? 31) What would the Moments at M1 & M2 if the system was concentrated at the
Goodell, Teresa T.; Bargo, Paulo R.; Jacques, Steven L.
Background: Subjective measures are considered the gold standard in palliative care evaluation, but no studies have evaluated palliative photodynamic therapy (PDT) subjectively. If PDT is to be accepted as a palliative therapy for later-stage obstructing esophageal and lung cancer, evidence of its effectiveness and acceptability to patients must be made known. Study Design/Materials and Methods: This ongoing study's major aim is to evaluate subjective outcomes of PDT in patients with obstructing esophageal and lung cancer. Existing measures of health status, dysphagia and performance status were supplemented with an instrument developed to evaluate PDT symptom relief and side effect burden, the PDT Side Effects Survey (PSES). Results: PDT patients treated with porfimer sodium (Photofrin) and 630-nm light experienced reduced dysphagia grade and stable performance status for at least one month after PDT (N= 10-17), but these effects did not necessarily persist at three months. Fatigue, appetite and quality of life may be the most burdensome issues for these patients. Conclusions: Preliminary data suggest that the PSES is an acceptable and valid tool for measuring subjective outcomes of palliative PDT. This study is the first attempt to systematically evaluate subjective outcomes of palliative PDT. Multi-center outcomes research is needed to draw generalizable conclusions that will establish PDT's effectiveness in actual clinical practice and enhance the wider adoption of PDT as a cancer symptom relief modality.
Park, Jin-Young; Lee, Yoo-Young; Kim, Tae-Joong; Kim, Byoung-Gie; Bae, Duk-Soo
Objective Fertility-sparing surgery (FSS) is becoming an important technique in the surgical management of young women with early-stage epithelial ovarian cancer (EOC). We retrospectively evaluated the outcome of laparoscopic FSS in presumed clinically early-stage EOC. Methods We retrospectively searched databases of patients who received laparoscopic FSS for EOC between January 1999 and December 2012 at Samsung Medical Center. Women aged ≤40 years were included. The perioperative, oncological, and obstetric outcomes of these patients were evaluated. Results A total of 18 patients was evaluated. The median age of the patients was 33.5 years (range, 14 to 40 years). The number of patients with clinically stage IA and IC was 6 (33.3%) and 12 (66.7%), respectively. There were 7 (38.9%), 5 (27.8%), 3 (16.7%), and 3 patients (16.7%) with mucinous, endometrioid, clear cell, and serous tumor types, respectively. Complete surgical staging to preserve the uterus and one ovary with adnexa was performed in 4 patients (22.2%). Two out of them were upstaged to The International Federation of Gynecology and Obstetrics stage IIIA1. During the median follow-up of 47.3 months (range, 11.5 to 195.3 months), there were no perioperative or long term surgical complications. Four women (22.2%) conceived after their respective ovarian cancer treatments. Three (16.7%) of them completed full-term delivery and one is expecting a baby. One patient had disease recurrence. No patient died of the disease. Conclusion FSS in young patients with presumed clinically early-stage EOC is a challenging and cautious procedure. Further studies are urgent to determine the safety and feasibility of laparoscopic FSS in young patients with presumed clinically early-stage EOC. PMID:26768783
Park, Jung Gwan; Cho, Nam Su; Song, Jong Hoon; Baek, Jong Hun; Jeong, Ho Yeon
Background Some studies have shown significant functional improvement after rotator cuff (RC) repair in elderly patients. However, few studies have reported the healing potential of RC tears in elderly patients. Methods Twenty-five patients aged ≥ 75 years who underwent RC repair were enrolled. The mean age at the time of surgery was 78.3 years (range, 75 to 88 years) while the mean follow-up was 36.3 months (range, 18 to 114 months). We evaluated clinical and structural outcomes after RC repair in the retear and healed groups. Results Of 25 patients, 16 (64%) had healed RC lesions and 9 (36%) had retorn cuff lesions. The retear rate increased significantly with increasing initial tear size (small to medium, 13%; large, 60%; massive, 80%; p = 0.024) but not with increasing age (p = 0.072). The mean visual analog scale (VAS), University of California Los Angeles (UCLA), and Constant scores significantly improved from 5.2, 15.8, and 49.3 preoperatively to 1.4, 31.1, and 71.9 in the healed group and from 6.0, 14.4, and 39.5 preoperatively to 2.4, 28.3, and 63.6 in the retear group at the final follow-up (p < 0.05, respectively). There were no significant differences in clinical outcomes between the 2 groups at the final follow-up. Retear was significantly correlated with initial tear size (p = 0.001; odds ratio [OR], 2.771; 95% confidence interval [CI], 1.394 to 5.509 for large to massive tears) (p = 0.001; OR, 0.183; 95% CI, 0.048 to 0.692 for small to medium tears). Conclusions There were significant improvements in clinical outcomes after RC repair in patients ≥ 75 years. Structural integrity after cuff repair did not affect the final clinical outcome. Even in elderly patients aged ≥ 75 years, healing of repaired RC can be expected in cases of small to medium tears. Although the retear rate was relatively high for large to massive tears, clinical outcomes still showed significant improvement. PMID:27904725
Lin, Chia-Huei; Tzeng, Wen-Chii; Chiang, Shang-Lin; Chiang, Li-Chi
An extensive body of literature advocating a "patient-centered" approach to medical care has emerged over the past three decades. This approach is now a mainstream trend in healthcare. Despite its popularity, there remains little consensus regarding the content or definition of patient-centered care. Various quantitative and qualitative research studies have extracted core meanings from "doctor-patient relationship" perspectives and investigated the relationships of these meanings with patient satisfaction, compliance with health promoting behavior, and health status. Mead and Bower's review of the conceptual and empirical literature represented the first attempt to develop a model of the doctor-patient relationship that considered the multiple aspects embraced by the "patient-centered" approach. However, any interpretation of the "patient-centered" concept that fails to consider the perspective of nursing is likely incomplete, as patient-centered care is the essence of nursing. This paper reviewed the concept of "patient-centered care", conducted a systematic review of randomized control trials to explore the effectiveness of patient-centered care, and integrated nursing-related studies that focused on patient-centered care. Our search covered articles published through the end of February 2011 in the Cochrane Controlled Trials Register, JBI, MEDLINE, CINAHL, Pubmed, ProQuest, PsycInfo, and CEPS, with 13 relevant articles identified. The majority of trials addressed by these studies demonstrated a positive "patient-centered care" effect on self-care knowledge and skills but a limited/insignificant effect on disease improvement. The reviewed studies used traditional definitions of "patient-centered care" that were inconsistent with the concepts defined by Mead and Bower. Heterogeneities exist between reviewed studies and the lack of related research in Taiwan. We thus integrated outcome indicators related to "patient-centered care". This study may be referenced by
Childs, Stephanie K.; Kozak, Kevin R.; Friedmann, Alison M.; Yeap, Beow Y.; Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J.; Yock, Torunn I.
Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.
Filippo, Matthew; Labay, Edwardine; Beckett, Michael A.; Mauceri, Helena J.; Liang, Hua; Darga, Thomas E.; Perakis, Samantha; Khan, Sajid A.; Sutton, Harold G.; Zhang, Wei; Khodarev, Nikolai N.; Garcia, Joe G. N.; Weichselbaum, Ralph R.
Background Vascular endothelial cells contribute to the pathogenesis of numerous human diseases by actively regulating the stromal inflammatory response; however, little is known regarding the role of endothelial inflammation in the growth of human tumors and its influence on the prognosis of human cancers. Methods Using an experimental model of tumor necrosis factor-alpha (TNF-α)-mediated inflammation, we characterized inflammatory gene expression in immunopurified tumor-associated endothelial cells. These genes formed the basis of a multivariate molecular predictor of overall survival that was trained and validated in four types of human cancer. Results We report that expression of experimentally derived tumor endothelial genes distinguished pathologic tissue specimens from normal controls in several human diseases associated with chronic inflammation. We trained these genes in human cancer datasets and defined a six-gene inflammatory signature that predicted significantly reduced overall survival in breast cancer, colon cancer, lung cancer, and glioma. This endothelial-derived signature predicted outcome independently of, but cooperatively with, standard clinical and pathological prognostic factors. Consistent with these findings, conditioned culture media from human endothelial cells stimulated by pro-inflammatory cytokines accelerated the growth of human colon and breast tumors in immunodeficient mice as compared with conditioned media from untreated endothelial cells. Conclusions This study provides the first prognostic cancer gene signature derived from an experimental model of tumor-associated endothelial inflammation. These findings support the notion that activation of inflammatory pathways in non-malignant tumor-infiltrating endothelial cells contributes to tumor growth and progression in multiple human cancers. Importantly, these results identify endothelial-derived factors that could serve as potential targets for therapy in diverse human cancers
Prostate Specific Antigen (PSA) as Predicting Marker for Clinical Outcome and Evaluation of Early Toxicity Rate after High-Dose Rate Brachytherapy (HDR-BT) in Combination with Additional External Beam Radiation Therapy (EBRT) for High Risk Prostate Cancer.
Ecke, Thorsten H; Huang-Tiel, Hui-Juan; Golka, Klaus; Selinski, Silvia; Geis, Berit Christine; Koswig, Stephan; Bathe, Katrin; Hallmann, Steffen; Gerullis, Holger
High-dose-rate brachytherapy (HDR-BT) with external beam radiation therapy (EBRT) is a common treatment option for locally advanced prostate cancer (PCa). Seventy-nine male patients (median age 71 years, range 50 to 79) with high-risk PCa underwent HDR-BT following EBRT between December 2009 and January 2016 with a median follow-up of 21 months. HDR-BT was administered in two treatment sessions (one week interval) with 9 Gy per fraction using a planning system and the Ir192 treatment unit GammaMed Plus iX. EBRT was performed with CT-based 3D-conformal treatment planning with a total dose administration of 50.4 Gy with 1.8 Gy per fraction and five fractions per week. Follow-up for all patients was organized one, three, and five years after radiation therapy to evaluate early and late toxicity side effects, metastases, local recurrence, and prostate-specific antigen (PSA) value measured in ng/mL. The evaluated data included age, PSA at time of diagnosis, PSA density, BMI (body mass index), Gleason score, D'Amico risk classification for PCa, digital rectal examination (DRE), PSA value after one/three/five year(s) follow-up (FU), time of follow-up, TNM classification, prostate volume, and early toxicity rates. Early toxicity rates were 8.86% for gastrointestinal, and 6.33% for genitourinary side effects. Of all treated patients, 84.81% had no side effects. All reported complications in early toxicity were grade 1. PSA density at time of diagnosis (p = 0.009), PSA on date of first HDR-BT (p = 0.033), and PSA on date of first follow-up after one year (p = 0.025) have statistical significance on a higher risk to get a local recurrence during follow-up. HDR-BT in combination with additional EBRT in the presented design for high-risk PCa results in high biochemical control rates with minimal side-effects. PSA is a negative predictive biomarker for local recurrence during follow-up. A longer follow-up is needed to assess long-term outcome and toxicities.
Prostate Specific Antigen (PSA) as Predicting Marker for Clinical Outcome and Evaluation of Early Toxicity Rate after High-Dose Rate Brachytherapy (HDR-BT) in Combination with Additional External Beam Radiation Therapy (EBRT) for High Risk Prostate Cancer
Ecke, Thorsten H.; Huang-Tiel, Hui-Juan; Golka, Klaus; Selinski, Silvia; Geis, Berit Christine; Koswig, Stephan; Bathe, Katrin; Hallmann, Steffen; Gerullis, Holger
High-dose-rate brachytherapy (HDR-BT) with external beam radiation therapy (EBRT) is a common treatment option for locally advanced prostate cancer (PCa). Seventy-nine male patients (median age 71 years, range 50 to 79) with high-risk PCa underwent HDR-BT following EBRT between December 2009 and January 2016 with a median follow-up of 21 months. HDR-BT was administered in two treatment sessions (one week interval) with 9 Gy per fraction using a planning system and the Ir192 treatment unit GammaMed Plus iX. EBRT was performed with CT-based 3D-conformal treatment planning with a total dose administration of 50.4 Gy with 1.8 Gy per fraction and five fractions per week. Follow-up for all patients was organized one, three, and five years after radiation therapy to evaluate early and late toxicity side effects, metastases, local recurrence, and prostate-specific antigen (PSA) value measured in ng/mL. The evaluated data included age, PSA at time of diagnosis, PSA density, BMI (body mass index), Gleason score, D’Amico risk classification for PCa, digital rectal examination (DRE), PSA value after one/three/five year(s) follow-up (FU), time of follow-up, TNM classification, prostate volume, and early toxicity rates. Early toxicity rates were 8.86% for gastrointestinal, and 6.33% for genitourinary side effects. Of all treated patients, 84.81% had no side effects. All reported complications in early toxicity were grade 1. PSA density at time of diagnosis (p = 0.009), PSA on date of first HDR-BT (p = 0.033), and PSA on date of first follow-up after one year (p = 0.025) have statistical significance on a higher risk to get a local recurrence during follow-up. HDR-BT in combination with additional EBRT in the presented design for high-risk PCa results in high biochemical control rates with minimal side-effects. PSA is a negative predictive biomarker for local recurrence during follow-up. A longer follow-up is needed to assess long-term outcome and toxicities. PMID:27834929
Cooper, Andrew A; Kline, Alexander C; Graham, Belinda; Bedard-Gilligan, Michele; Mello, Patricia G; Feeny, Norah C; Zoellner, Lori A
Homework is often viewed as central to prolonged exposure (PE) for posttraumatic stress disorder (PTSD), but its relationship with treatment outcome is not well understood. We evaluated homework type, dose, and patients' perceptions of helpfulness as predictors of symptom change and posttreatment outcomes in PE. Patients with chronic PTSD received PE in a randomized clinical trial. Independent evaluators assessed PTSD severity at pre- and posttreatment. Patients reported homework adherence and perceived helpfulness at the beginning of each session, separately for in vivo and imaginal exposure assignments. These variables were examined as predictors of change in PTSD symptoms, PTSD remission, and good end-state functioning (GESF; low PTSD, depression, and anxiety) at posttreatment. Higher imaginal homework adherence predicted greater symptom improvement between sessions and across treatment, as well as twice the odds of achieving remission and GESF. Patients who were at least moderately adherent to imaginal homework assignments (two or more times a week) reported more symptom gains than those who were least adherent but did not differ from those who were most adherent. In vivo adherence was not consistently associated with better outcome, perhaps due to heterogeneity in form and function of weekly assignments. Higher ratings of helpfulness of both types of homework predicted greater symptom improvement from pre- to posttreatment and between sessions. Overall, imaginal exposure homework may complement in-session exposures by enhancing key change processes, though perfect adherence is not necessary. Patients' perceptions of helpfulness may reflect buy-in or perceived match between homework completion and functional impairment. Clinically, in addition to targeting adherence to homework assignments, querying about perceived helpfulness and adjusting assignments appropriately may help augment clinical gains.
Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo
A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a 3-year follow-up in all 41, and at least after 5 years in 36 patients. Symptoms were rated on the basis of the Positive and Negative Syndrome Scale (PANSS), integrating items from the Brief Psychiatric Rating Scale (BPRS) and the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). The Children Global Assessment Scale (C-GAS) and the Global Assessment Scale (GAF) were used to evaluate global functioning. Significant differences in clinical features were found in the three diagnostic groups as regards several parameters, some present on one and not on other rating scales, underscoring the insufficiency of a single scale for accurate analysis of the features of a psychotic disorder. At onset, a comparison using the simple presence/absence of symptoms showed scant differences among groups, while differences emerged if symptom severity was included in the comparison. Functioning at 3- and 5-year follow-ups showed a significantly better outcome in the BPP group and more substantial deterioration, with similar evolution, in the SPh and SA groups. The integration of several rating scales differentiated between diagnostic groups more effectively. The similar adult functioning outcome in the SPh and SA groups showed how difficult it is to clearly separate these two disorders.
Viets, J. L.; Foster, Scot D.
Baylor College of Medicine's system for evaluating the clinical progress of anesthesiology residents, developed in response to problems of standards, staff cooperation, and student dissatisfaction with evaluation, assesses resident progress in terms of performance levels based on case complexity and degree of staff intervention. (Author/MSE)
Qiu, Man; Zhou, Aiguo; Zhang, Jian; Jiang, Dianming
A significant cohort of patients is plagued by postoperative rotational instability after the anatomic anterior cruciate ligament (ACL) reconstruction surgery. Anatomic anterolateral ligament (ALL) reconstruction was performed in this study with the aim to assess the clinical role of ALL in knee’s stability and joint functions. Sixty patients were recruited and divided into three groups to perform the operations of anatomic single-bundle ACL reconstruction, anatomic double-bundle ACL reconstruction, and anatomic single-bundle ACL reconstruction + anterolateral ligament reconstruction, respectively. And then postoperative knee’s stability and joint functions were evaluated to compare the clinical outcomes among the three different kind of operations. The postoperative knee’s stability and joint functions of the anatomic double-bundle ACL reconstruction group and the anatomic single-bundle ACL reconstruction + ALL reconstruction group were better than the anatomic single-bundle ACL reconstruction group. No significant difference was observed between the anatomic double-bundle ACL reconstruction group and the anatomic single-bundle ACL reconstruction + ALL reconstruction group. The anatomic anterolateral ligament reconstruction could improve the clinical outcomes after patients performed the anatomic single-bundle anterior cruciate ligament reconstruction. This indicates that the anterolateral ligament plays a crucial role in knee’s stability and joint function, especially the rotational stability. Key points Anatomic anterolateral ligament reconstruction combined with anatomic anterior cruciate ligament reconstruction was performed to treat the patients with ACL rupture. Compared to the anatomic single-bundle ACL reconstruction group, the anatomic single-bundle ACL reconstruction + ALL reconstruction group achieve a better clinical outcomes. The results suggest that the anterolateral ligament plays a crucial role in knee’s stability and joint function
Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen
Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043
Smith, Lynette S; Branstetter, M Laurie
Electronic clinical tracking systems are used in many educational institutions of higher learning to document advanced practice registered nursing students' clinical experiences. Students' clinical experiences are constructed according to the National Organization of Nurse Practitioner Faculties core competencies. These competencies form a basis for evaluation of advanced practice registered nursing programs. However, no previous studies have evaluated the use of electronic clinical tracking systems to validate students' clinical experiences in meeting national core competencies. Medatrax, an electronic clinical tracking system, is evaluated using a formative program evaluation approach to determine if students' clinical documentations meet Family/Across the Lifespan Nurse Practitioner Competencies in a midsouthern family nurse practitioner program. This formative program evaluation supports the use of an electronic clinical tracking system in facilitating accreditation and program outcome goals. The significance of this study is that it provides novel evidence to support the use of an electronic clinical tracking system to assist a midsouthern school of nursing in meeting national core competencies.
Choy, Ernest H; Mease, Philip J
This article discusses the key symptom domains to be assessed in fibromyalgia. Development of a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials is needed to facilitate interpretation, pooling, and comparison of results. This aligns with the key objective of the Outcome Measures in Rheumatoid Arthritis Clinical Trials initiative to improve outcome measurement in rheumatic diseases through a data-driven interactive consensus process.
Finsen, V; Rod, O; Rød, K; Rajabi, B; Alm-Paulsen, P S; Russwurm, H
We reviewed 260 patients who had been treated non-operatively for a dorsally displaced distal radius fracture a mean 6.3 (range 2.5-12.7) years earlier, in an attempt to find the limits of displacement compatible with a good clinical outcome. We excluded patients with previous or later injuries to the same limb. Bivariate analysis revealed a highly statistically significant relationship between radiographic displacement at review and clinical outcome scores. Correlation coefficients varied between 0.14 and 0.30. However, multiple linear regression analysis using most factors commonly thought to be of importance in determining the clinical outcome as independent variables explained only 23% of the variability of the clinical outcome. Dorsal angulation, ulnar variance, and radial inclination together accounted for only 11% of the variability. We conclude that the final alignment of the distal radius as shown radiologically has only a minor influence on the clinical outcome of Colles' type distal radius fractures.
Introduction Sedation overuse is frequent and possibly associated with poor outcomes in the intensive care unit (ICU) patients. However, the association of early oversedation with clinical outcomes has not been thoroughly evaluated. The aim of this study was to assess the association of early sedation strategies with outcomes of critically ill adult patients under mechanical ventilation (MV). Methods A secondary analysis of a multicenter prospective cohort conducted in 45 Brazilian ICUs, including adult patients requiring ventilatory support and sedation in the first 48 hours of ICU admissions, was performed. Sedation depth was evaluated after 48 hours of MV. Multivariate analysis was used to identify variables associated with hospital mortality. Results A total of 322 patients were evaluated. Overall, ICU and hospital mortality rates were 30.4% and 38.8%, respectively. Deep sedation was observed in 113 patients (35.1%). Longer duration of ventilatory support was observed (7 (4 to 10) versus 5 (3 to 9) days, P = 0.041) and more tracheostomies were performed in the deep sedation group (38.9% versus 22%, P = 0.001) despite similar PaO2/FiO2 ratios and acute respiratory distress syndrome (ARDS) severity. In a multivariate analysis, age (Odds Ratio (OR) 1.02; 95% confidence interval (CI) 1.00 to 1.03), Charlson Comorbidity Index >2 (OR 2.06; 95% CI, 1.44 to 2.94), Simplified Acute Physiology Score 3 (SAPS 3) score (OR 1.02; CI 95%, 1.00 to 1.04), severe ARDS (OR 1.44; CI 95%, 1.09 to 1.91) and deep sedation (OR 2.36; CI 95%, 1.31 to 4.25) were independently associated with increased hospital mortality. Conclusions Early deep sedation is associated with adverse outcomes and constitutes an independent predictor of hospital mortality in mechanically ventilated patients. PMID:25047960
Lee, Yangsoon; Choi, Heekyeong; Yum, Jong Hwa; Kang, Girung; Bae, Il Kwon; Jeong, Seok Hoon; Lee, Kyungwon
We investigated the molecular mechanisms of carbapenem resistance in clinical isolates of Enterobacter cloacae and their clinical characteristics. Nonreplicable E. cloacae isolates were recovered from six cancer patients and one patient with liver cirrhosis at a tertiary-care hospital in Korea between 2002 and 2009. Two patients who were considered to have a true infection caused by these microorganisms have died. All isolates produced AmpC β-lactamases, including ACT-1, ACT-2, MIR-3 and DHA-1, and CTX-M- or SHV-type extended-spectrum β-lactamase. Two isolates produced plasmid-borne VIM-2 carbapenemase. All probes specific for bla(AmpC) genes hybridized with I-CeuI chromosomal fragments were also recognized by a probe specific for 16S rDNA, suggesting a chromosomal location. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis showed that a major outer membrane protein, OmpF, was absent in all isolates. PFGE of XbaI-digested DNA were considered to be unrelated. The results of our study suggest that the chromosomal AmpC β-lactamase with impermeability in E. cloacae clinical isolates implicated in reduced carbapenem susceptibility. Although carbapenem-resistant E. cloacae isolates were isolated in a few patients in our study, the clinical outcomes were grave. Therefore, the patients colonized or infected by carbapenem-resistant E. cloacae isolates should gain attention of antibiotic therapy.
The likelihood of being helped or harmed (LHH) ratio is an indirect measure of effect size. It tells the reader how much as likely a patient is to benefit from a treatment as to suffer from an adverse outcome with that treatment; larger values for LHH indicate more favorable treatment outcomes. The numerator for LHH is usually a measure of response or remission with a treatment, and the denominator is usually a measure of all-cause discontinuation or discontinuation due to adverse events; so, there can be more than 1 LHH statistic for a study. As an example, an LHH of 5 could indicate that after removal of placebo effects a patient is 5 times as likely to respond to a treatment as to drop out of treatment because of the experience of an adverse event. This article explains the LHH with the help of a worked example, shows how the LHH can be derived from the numbers needed to treat and harm (NNT, NNH) statistics, discusses practical issues related to the concept, and considers its limitations. The LHH is little used in clinical psychopharmacology, and authors who report or review clinical trial data should consider presenting all the LHH information that is clinically relevant in addition to NNT, NNH, and other information. Because LHH statistics present the results of risk-benefit trade-off analyses, they can help clinicians and patients more easily evaluate potential treatments during decision-making processes.
Neu, Alicia M; Frankenfield, Diane L
Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes.
van Swol, Christiaan F. P.; Verdaasdonck, Rudolf M.; van Venrooij, Ger E. P. M.; Boon, Tom A.
In the past years there has been a significant increase in the treatment of bladder outlet obstruction caused by benign prostatic hyperplasia. Transurethral electroresection of the abundant tissue (TURP) has since the early seventies been the golden standard. The main drawback of a TURP is the relative lack of hemostasis, due to a confined energy and heat distribution around the resection loop. As sufficient tissue needs to be removed to overcome the bladder outlet obstruction, the ideal treatment has to combine both ablative and hemostatic abilities. After 1992, endoscopic laser and 'non laser' treatment modalities have been introduced, that competed with TURP as to clinical outcome. These treatments have in common that a high amounts of energy is delivered to the prostate to remove tissue either indirectly by coagulation necrosis or directly by vaporization. Various in-vitro and clinical studies were performed using different energy sources, such as Nd:YAG and diode laser light in combination with a large variety of delivery devices. Also TURP was included in the evaluation. The in-vitro results provided understanding of the efficiency in energy delivery, the extent of heat induced in the prostatic tissue and possible side-effects, using thermal imaging techniques. Over the last five years clinical data have been collected for various techniques with a follow-up of two years showing the contact techniques to be superior over non-contact and comparable with the outcome of the 'standard' TURP.
Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun
Introduction Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor–mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results The results revealed that the redesigned mentoring program improved the mentors’ performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a physician. PMID
Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun
Introduction Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor-mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results The results revealed that the redesigned mentoring program improved the mentors' performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a physician.
Zhou, Huanfen; Xu, Quangang; Tan, Shaoying; Zhao, Shuo; Yang, Mo; Peng, Chunxia
Purpose. Although optic neuritis (ON) in children is relatively common, visual outcomes and factors associated with the condition have not been well documented. The aim of this study was to evaluate the clinical features and visual outcomes of ON in Chinese children. Methods. Patients with a first episode of ON at a tertiary neuroophthalmic centre in China were assessed and followed up for at least three months. Visual outcomes and clinical, laboratory, and neuroimaging findings were reviewed. In patients with bilateral ON, only the eyes with worse visual acuity (VA) at presentation were used for statistical analysis. Results. Seventy-six children (76 eyes) with a first episode of ON were included. The mean age was 11.8 years, 60.5% were females, and 48.7% had bilateral involvement. The children were followed up for an average of 18.5 months (age range, 3–48 months). Vision loss at presentation was severe, with VA < 20/200 in 37 eyes (48.7%). At the final visit, 3 (3.9%) eyes had VA of at least 20/20, and 41 (53.9%) eyes had VA of at least 20/40. The final VA in 35 eyes (46.1%) was worse than 20/40. Children aged ≤ 10 years had better predicted visual outcomes when compared to children over 10 years (odds ratio = 2.73, 95% confidential interval: 1.05–7.07, and P = 0.039). The other features of this cohort, such as sex, experienced bilateral attack, VA at presentation, presence of optic disc edema, systemic diseases, magnetic resonance imaging (MRI) findings, and aquaporin-4 (AQP-4) antibody status, were not significantly correlated with the final visual outcome. Conclusion. The data revealed the clinical characteristics and visual outcomes of ON in Chinese children. ON in children was associated with severe vision loss and relatively good visual recovery. The age at onset could predict the final visual function. PMID:27725883
Gayou, Olivier; Parda, David S.; Miften, Moyed
Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow
Gayou, Olivier; Parda, David S; Miften, Moyed
Treatment management decisions in three-dimensional conformal radiation therapy (3DCRT) and intensity-modulated radiation therapy (IMRT) are usually made based on the dose distributions in the target and surrounding normal tissue. These decisions may include, for example, the choice of one treatment over another and the level of tumour dose escalation. Furthermore, biological predictors such as tumour control probability (TCP) and normal tissue complication probability (NTCP), whose parameters available in the literature are only population-based estimates, are often used to assess and compare plans. However, a number of other clinical, biological and physiological factors also affect the outcome of radiotherapy treatment and are often not considered in the treatment planning and evaluation process. A statistical outcome analysis tool, EUCLID, for direct use by radiation oncologists and medical physicists was developed. The tool builds a mathematical model to predict an outcome probability based on a large number of clinical, biological, physiological and dosimetric factors. EUCLID can first analyse a large set of patients, such as from a clinical trial, to derive regression correlation coefficients between these factors and a given outcome. It can then apply such a model to an individual patient at the time of treatment to derive the probability of that outcome, allowing the physician to individualize the treatment based on medical evidence that encompasses a wide range of factors. The software's flexibility allows the clinicians to explore several avenues to select the best predictors of a given outcome. Its link to record-and-verify systems and data spreadsheets allows for a rapid and practical data collection and manipulation. A wide range of statistical information about the study population, including demographics and correlations between different factors, is available. A large number of one- and two-dimensional plots, histograms and survival curves allow
Kuptsova, Nataliya; Kopecky, Kenneth J; Godwin, John; Anderson, Jeanne; Hoque, Ashraful; Willman, Cheryl L; Slovak, Marilyn L; Ambrosone, Christine B
Repair of damage to DNA resulting from chemotherapy may influence drug toxicity and survival in response to treatment. We evaluated the role of polymorphisms in DNA repair genes APE1, XRCC1, ERCC1, XPD, and XRCC3 in predicting therapeutic outcomes of older adults with acute myeloid leukemia (AML) from 2 Southwest Oncology Group (SWOG) clinical trials. All patients received standard chemotherapy induction regimens. Using logistic and proportional hazards regression models, relationships between genotypes, haplotypes, and toxicities, response to induction therapy, and overall survival were evaluated. Patients with XPD Gln751C/Asp312G ('D') haplotype were more likely to have complete response (OR = 3.06; 95% CI, 1.44-6.70) and less likely to have resistant disease (OR = 0.32; 95%CI, 0.14-0.72) than patients with other haplotypes. ERCC1 polymorphisms were significantly associated with lung (P = .037) and metabolic (P = .041) toxicities, and patients with the XRCC3 241Met variant had reduced risk of liver toxicity (OR = 0.32; 95%CI, 0.11-0.95). Significant associations with other toxicities were also found for variant XPD genotypes/haplotypes. These data from clinical trials of older patients treated for AML indicate that variants in DNA repair pathways may have an impact on both outcomes of patients and toxicities associated with treatments. With validation of results in larger samples, these findings could lead to optimizing individual chemotherapy options.
Liu, Xiaohan; Li, Jiaying; Qu, Xinhua; Yan, Weili; Zhang, Ling; Zhang, Shanyong; Yang, Chi; Zheng, Jiawei
A meta-analysis was performed to evaluate the efficacy and safety of systemic corticosteroids versus those of vincristine in the treatment of kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).A literature search of PubMed, Embase, and Web of Science was performed for clinical studies on systemic corticosteroid versus vincristine therapies in treating KHE/TA. Pooled relative risks (RRs) and response rate with 95% confidence intervals (CIs) were used to measure outcomes. Heterogeneity, subgroup analysis, sensitivity analysis, and publication bias analysis were performed for result evaluation.Thirteen studies, comprising 344 participants, were used in the analysis. Vincristine therapy was found to be relatively more effective than systemic corticosteroids (RRs = 0.45, 95%CI: 0.35-0.58). The result of pooled adverse reactions response rate for systemic corticosteroids was 0.31 (95%CI, 0.18-0.43), significantly higher than that for vincristine, which was 0.12 (95%CI, 0.06-0.19). In subgroup analyses, factors including mean age and race of patients, and period of follow-up were examined as possible sources of heterogeneity.This is the first meta-analysis estimating the clinical outcomes of systemic corticosteroids in comparison with those of vincristine in the treatment of KHE/TA. The results showed that vincristine was considerably more effective with lower complication rates than systemic corticosteroids; thus, vincristine could be suggested as the first-line therapy for KHE/TA.
Feldman, Harold I; Santanna, Jill; Guo, Wensheng; Furst, Howard; Franklin, Eunice; Joffe, Marshall; Marcus, Sue; Faich, Gerald
To evaluate the impact of parenteral iron administration on the survival and rate of hospitalization of US hemodialysis patients, a nonconcurrent cohort study of 10,169 hemodialysis patients in the United States in 1994 was conducted. The main outcome measures were patient survival and rate of hospitalization. After adjusting for 23 demographic and comorbidity characteristics among 5833 patients included in multivariable analysis, bills for
Kallidonis, Panagiotis S.; Georgiopoulos, Ioannis S.; Kyriazis, Iason D.; Kontogiannis, Stavros; Al-Aown, Abdulrahman M.; Liatsikos, Evangelos N.
The full metallic double-J ureteral stent (MS) was introduced as a method for providing long-term drainage in malignant ureteral obstruction. Experimental evaluation of the MS revealed that its mechanical features allow efficient drainage in difficult cases, which could not be managed by the insertion of a standard polymeric double-J stent. Clinical experience with the MS showed controversial results. Careful patient selection results in efficient long-term management of malignant ureteral obstruction. The use of the MS should also be considered in selected benign cases. Major complications are uncommon and the minor complications should not hinder its use. Experience in pediatric patients is limited and warrants additional study. The cost-effectiveness of the MS seems to be appropriate for long-term treatment. Further investigation with comparative clinical trials would document the outcome more extensively and establish the indications as well as the selection criteria for the MS. PMID:25624569
Chen, Jiang; Xiao-Zhong, Guo; Qi, Xing-Shun
Specific immunotherapies, including vaccines with autologous tumor cells and tumor antigen-specific monoclonal antibodies, are important treatments for PC patients. To evaluate the clinical outcomes of PC-specific immunotherapy, we performed a systematic review and meta-analysis of the relevant published clinical trials. The effects of specific immunotherapy were compared with those of nonspecific immunotherapy and the meta-analysis was executed with results regarding the overall survival (OS), immune responses data, and serum cancer markers data. The pooled analysis was performed by using the random-effects model. We found that significantly improved OS was noted for PC patients utilizing specific immunotherapy and an improved immune response was also observed. In conclusion, specific immunotherapy was superior in prolonging the survival time and enhancing immunological responses in PC patients.
Specific immunotherapies, including vaccines with autologous tumor cells and tumor antigen-specific monoclonal antibodies, are important treatments for PC patients. To evaluate the clinical outcomes of PC-specific immunotherapy, we performed a systematic review and meta-analysis of the relevant published clinical trials. The effects of specific immunotherapy were compared with those of nonspecific immunotherapy and the meta-analysis was executed with results regarding the overall survival (OS), immune responses data, and serum cancer markers data. The pooled analysis was performed by using the random-effects model. We found that significantly improved OS was noted for PC patients utilizing specific immunotherapy and an improved immune response was also observed. In conclusion, specific immunotherapy was superior in prolonging the survival time and enhancing immunological responses in PC patients. PMID:28265583
Brat, Hugues G.; Bouziane, Tarik; Lambert, Jean; Divano, Luisa
Percutaneous Laser Disc Decompression (PLDD) is a minimal invasive and effective treatment for contained lumbar disc hernias with correspondent radicular pain. This prospective study evaluates clinical efficacy of patients treated with PLDD under CT-fluoroscopic guidance. An independent observer assessed clinical outcome in a series of 40 consecutive patients at a mean follow-up of 7.5 months after treatment. According to Mac Nab criteria, 80% of patients experienced a good response to PLDD, 12.5% a fair response and 7.5% a poor response. 37 patients (92.5%) were back at work after 3 weeks. This technique could represent an alternative and secure treatment to conventional surgery for contained disc hernias.
Röhricht, Frank; Elanjithara, Thomas
Aims and method Service utilisation and clinical outcomes of a newly developed specialist primary-secondary care liaison clinic for patients with medically unexplained symptoms (MUS) were evaluated in a cross-sectional and feasibility pilot study. The impact of body-oriented psychological therapy (BOPT) was explored in a small cohort of patients with an identified somatoform disorder. Results Of 147 consecutive referrals, 113 patients engaged with the assessment process. Of patients with MUS, 42% (n = 45) had a primary diagnosis of somatoform disorder, 36% (n = 38) depressive disorder, and depressive symptoms (even subsyndromal) mediated the effect of somatic symptoms. A marked variation of presenting complaints and service utilisation across ethnic groups was noted. A significant reduction in somatic symptom levels and service utilisation was achieved for patients undergoing BOPT. Clinical implications A high proportion of patients with MUS have undiagnosed and therefore untreated mental disorders. New and locally derived collaborative care models of active engagement in primary care settings are required. Patients with somatoform disorder may benefit from BOPT; this requires further evaluation in adequately powered clinical trials.
Egan, Katie G.; Israel, Jacqueline S.; Ghasemzadeh, Rezvaneh
Background: Social media have been used to study many aspects of health and human behavior. Although social media present a unique opportunity to obtain unsolicited patient-reported outcomes, its use has been limited in plastic and reconstructive surgical procedures, including migraine nerve surgery. The goal of this study was to utilize the most popular social media site, Facebook, to evaluate patients’ experience with migraine surgery. Methods: Six months of data regarding nerve surgery, nerve stimulators, and radiofrequency nerve ablation were collected from posts and comments written by members of 2 Facebook groups. Outcomes were classified by degree of resolution of symptoms. Results: A total of 639 posts related to migraine surgery. Of 304 posts commenting on postoperative success of nerve surgery, 16% reported elimination of headaches and 65% significant improvement (81% with complete or significant improvement), 5% partial improvement, 11% no change, and 3% worsening symptoms. Nerve surgery had a higher success rate than nerve stimulators and radiofrequency ablation. Nerve surgery was recommended by 90% of users. Conclusions: The 81% rate of complete or significant improvement of symptoms in this study is close to the 79% to 84% shown in current literature. Similar to the findings of a recent systematic review, surgery is more efficacious compared with nerve stimulators and ablation. This study adds to evidence favoring migraine surgery by removing evaluator bias and demonstrates that surgical outcomes and satisfaction data may be obtained from social media. PMID:27826478
Fendrick, A. Mark
Although medical innovation can reduce morbidity and mortality associated with diseases or their treatments, in most instances new interventions tend to increase the amount of resources expended on health care services. In this era of increasing cost consciousness, there is a perceived tension between the desire to improve health outcomes and the necessity to control the growth of health care costs. The dramatic changes in the organization, financing, and delivery of health care services, make it no longer acceptable to provide any and all services to every individual with only a remote probability of clinical benefit. An incentive structure which rewards the practice of cost-effective medical care is rapidly replacing the 'technological imperative' of decades past. As the expansion towards managed care continues, increasing scrutiny will be paid to the clinical and cost implications of our medical interventions.
Wong, Brian M; Holmboe, Eric S
The current health care delivery model continues to fall short in achieving the desired patient safety and quality-of-care outcomes for patients. And, until recently, an explicit acknowledgment of the role and influence of the clinical learning environment on professional development had been missing from physician-based competency frameworks. In this Perspective, the authors explore the implications of the insufficient integration of education about patient safety and quality improvement by academic faculty into the clinical learning environment in many graduate medical education (GME) programs, and the important role that academic faculty need to play to better align the educational and clinical contexts to improve both learner and patient outcomes. The authors propose a framework that closely aligns the educational and clinical contexts, such that both educational and clinical outcomes are centered around the patient. This will require a reorganization of academic faculty perspective and educational design of GME training programs that recognizes that (1) the dynamic interplay between the faculty, learner, training program, and clinical microsystem ultimately influences the quality of physician that emerges from the training program and environment, and (2) patient outcomes relate to the quality of education and the success of clinical microsystems. To enable this evolution, there is a need to revisit the core competencies expected of academic faculty, implement innovative faculty development strategies, examine closely faculty's current clinical super vision practices, and establish a training environment that supports bridging from clinician to educator, training program to clinical microsystem, and educational outcomes to clinical outcomes that benefit patients.
Moore, Jill M; Everly, Marcee; Bauer, Renee
Patient acuity in hospital settings continues to increase, and there is greater emphasis on patient outcomes. The current nursing workforce is comprised of four distinct generational cohorts that include veterans, baby boomers, millennials, and generation Xers. Each group has unique characteristics that add complexity to the workforce and this can add challenges to providing optimal patient care. Team building is one strategy to increase mutual understanding, communication, and respect, and thus potentially improve patient outcomes. In this article, we first briefly define generational cohorts by characteristics, and discuss differing expectations for work/life balance and potential negative outcomes. Our discussion offers team building strategies for positive outcomes, a case scenario, and concludes with resources for team building and organizational opportunities.
Bertolotti, Giorgio; Michielin, Paolo; Vidotto, Giulio; Sanavio, Ezio; Bottesi, Gioia; Bettinardi, Ornella; Zotti, Anna Maria
Background Cognitive behavioral assessment for outcome evaluation was developed to evaluate psychological treatment interventions, especially for counseling and psychotherapy. It is made up of 80 items and five scales: anxiety, well-being, perception of positive change, depression, and psychological distress. The aim of the study was to present the metric qualities and to show validity and reliability of the five constructs of the questionnaire both in nonclinical and clinical subjects. Methods Four steps were completed to assess reliability and factor structure: criterion-related and concurrent validity, responsiveness, and convergent–divergent validity. A nonclinical group of 269 subjects was enrolled, as was a clinical group comprising 168 adults undergoing psychotherapy and psychological counseling provided by the Italian public health service. Results Cronbach’s alphas were between 0.80 and 0.91 for the clinical sample and between 0.74 and 0.91 in the nonclinical one. We observed an excellent structural validity for the five interrelated dimensions. The clinical group showed higher scores in the anxiety, depression, and psychological distress scales, as well as lower scores in well-being and perception of positive change scales than those observed in the nonclinical group. Responsiveness was large for the anxiety, well-being, and depression scales; the psychological distress and perception of positive change scales showed a moderate effect. Conclusion The questionnaire showed excellent psychometric properties, thus demonstrating that the questionnaire is a good evaluative instrument, with which to assess pre- and post-treatment outcomes. PMID:26442466
Heinzmann-Filho, João Paulo; Pinto, Leonardo Araujo; Marostica, Paulo José Cauduro; Donadio, Márcio Vinícius Fagundes
ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk distance (6MWD), and lung function. The inclusion criterion was having undergone pulmonary function testing at least three times in the first year and at least once in each of the next two years. RESULTS: We evaluated 35 CF patients. The variation in FEV1 in the first year (ΔFEV1) was greater among those who, in the third year, showed reduced FEV1, had a below-average 6MWD, or were hospitalized than among those with normal FEV1, normal 6MWD, or no hospital admissions, in that same year (p < 0.05), although no such difference was found for antibiotic use in the third year. Subjects showing a ΔFEV1 ≥ 10% also showed a greater decline in FEV1 over the two subsequent years (p = 0.04). The ΔFEV1 also showed an inverse correlation with absolute FEV1 in the third year (r = −0.340, p = 0.04) and with the rate of FEV1 decline (r = −0.52, p = 0.001). Linear regression identified ΔFEV1 as a predictor of FEV1 decline (coefficient of determination, 0.27). CONCLUSIONS: Significant variation in lung function over one year seems to be associated with a higher subsequent rate of FEV1 decline and worse clinical outcomes in CF patients. Short-term ΔFEV1 might prove useful as a predictor of CF progression in clinical practice. PMID:26785959
Smidt, Andy; Balandin, Susan; Sigafoos, Jeff; Reed, Vicki A.
Background: Services employing staff to support people with disability usually provide training in a range of areas including communication and managing challenging behaviour. Given that such training can be costly and time-consuming, it is important to evaluate the evidence presented in support of such programs. Efficacy in clinical practice is…
Adams, William G; Anderson, Nicholas; Berner, Eta S; Schauer, Daniel P; Zottola, Ralph J; McClure, Elizabeth S; Wyatt, Matthew
There is a pressing need for better tools to support comparative effectiveness research (CER) on a national scale. In addition, little is known about within-class outcome disparities for commonly used cardiovascular and diabetes medications. In this presentation, we will describe our experience implementing a new i2b2 cell, the Health Outcome Monitoring and Evaluation Cell (HOME), at 5 collaborating Clinical Translational Science Award sites (CTSAs) in the U.S. We will also describe the motivations to developing a common query framework, and findings related to the implementation and use of the HOME cell, to perform distributed CER queries. Our focus is on the assessment of race, gender, and location-based disparities in outcomes for patients treated with similar mediations for hypertension, dyslipidemias, and diabetes.
Mares, Alvin S; Rosenheck, Robert A
This study examined the relationship between disability payment status and clinical outcomes among 305 homeless veterans entering VA treatment. Disability status and clinical outcomes were characterized using self-report data at program entry, and quarterly for 2 years thereafter. Seeking or already receiving disability benefits at program entry was not associated with any of the 8 clinical outcomes examined. Those seeking or receiving disability benefits during the 2 years that followed showed more serious mental health problems and lower levels of mental health functioning, but no greater risk of substance use or not being employed nor worse housing outcomes than those who remained uninterested in applying for disability benefits. This study does not, therefore, support the notion that disability orientation results in poorer clinical outcomes, at least not among homeless veterans.
Berger, Vance W.; Alperson, Sunny Y.
Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and other interests of those conducting the experiments and publishing the reports must cast suspicion on any inadequately reported aspect of clinical trial quality. Putting these ideas together, we see that an adequate evaluation of clinical quality would need to enumerate all known biases, update this list periodically, score the trial with regard to each potential bias on a scale of 0% to 100%, offer partial credit for only that which can be substantiated, and then multiply (not add) the component scores to obtain an overall score between 0% and 100%. We will demonstrate that current evaluations fall well short of these ideals. PMID:19463104
Murphy, Patricia Aikins; Fullerton, Judith T
Evaluating perinatal outcomes within a framework of normalcy is a new focus of measurement. As maternal and child health clinicians and researchers look to evaluate care practices that are both of high quality and cost-effective, it is important to have measurement tools that assess differences among all women giving birth. The Optimality Index-US shifts the focus from rare adverse events to evidence-based optimal events. This article describes the continuing development of the index and discusses clinical implications for obstetric nurse clinicians.
Schildmann, Jan; Molewijk, Bert; Benaroyo, Lazare; Forde, Reidun; Neitzke, Gerald
Evaluation of clinical ethics support services (CESS) has attracted considerable interest in recent decades. However, few evaluation studies are explicit about normative presuppositions which underlie the goals and the research design of CESS evaluation. In this paper, we provide an account of normative premises of different approaches to CESS evaluation and argue that normativity should be a focus of considerations when designing and conducting evaluation research of CESS. In a first step, we present three different approaches to CESS evaluation from published literature. Next to a brief sketch of the well-established approaches of 'descriptive evaluation' and 'evaluation of outcomes', we will give a more detailed description of a third approach to evaluation-'reconstructing quality norms of CESS'-which is explicit about the normative presuppositions of its research (design). In the subsequent section, we will analyse the normative premises of each of the three approaches to CESS evaluation. We will conclude with a brief argument for more sensitivity towards the normativity of CESS and its evaluation research.
Calfee, Ryan P.; Adams, Amelia A.
High quality clinical research incorporating standardized outcome assessments is necessary to advance the field of hand surgery. Although such research can be conducted with little direct cost, effectively answering clinical questions requires thoughtful study design. Relevant concepts to consider include sample size determination, study end-points, data management, and choice of outcome measures. Provided the emphasis on, and proliferation of, patient-rated outcome measures, the clinician-researcher should consider the unique aspects of commonly referenced outcome measures when initiating an investigation. PMID:22464236
Mannell, Jenevieve; Cornish, Flora; Russell, Jill
Introduction Contemporary HIV-related theory and policy emphasize the importance of addressing the social drivers of HIV risk and vulnerability for a long-term response. Consequently, increasing attention is being given to social and structural interventions, and to social outcomes of HIV interventions. Appropriate indicators for social outcomes are needed in order to institutionalize the commitment to addressing social outcomes. This paper critically assesses the current state of social indicators within international HIV/AIDS monitoring and evaluation frameworks. Methods We analyzed the indicator frameworks of six international organizations involved in efforts to improve and synchronize the monitoring and evaluation of the HIV/AIDS response. Our analysis classifies the 328 unique indicators according to what they measure and assesses the degree to which they offer comprehensive measurement across three dimensions: domains of the social context, levels of change and organizational capacity. Results and discussion The majority of indicators focus on individual-level (clinical and behavioural) interventions and outcomes, neglecting structural interventions, community interventions and social outcomes (e.g. stigma reduction; community capacity building; policy-maker sensitization). The main tool used to address social aspects of HIV/AIDS is the disaggregation of data by social group. This raises three main limitations. Indicator frameworks do not provide comprehensive coverage of the diverse social drivers of the epidemic, particularly neglecting criminalization, stigma, discrimination and gender norms. There is a dearth of indicators for evaluating the social impacts of HIV interventions. Indicators of organizational capacity focus on capacity to effectively deliver and manage clinical services, neglecting capacity to respond appropriately and sustainably to complex social contexts. Conclusions Current indicator frameworks cannot adequately assess the social
Tulsyan, Sonam; Chaturvedi, Pankaj; Singh, Abhishek Kumar; Agarwal, Gaurav; Lal, Punita; Agrawal, Sushma; Mittal, Rama Devi; Mittal, Balraj
Polymorphisms in genes encoding CYPs (Phase I) and ABCB1 (Phase III) enzymes may attribute to variability of efficacy of taxanes. The present study aims to find the influence of CYP and ABCB1 gene polymorphisms on taxanes based clinical outcomes. 132 breast cancer patients treated with taxanes based chemotherapy were genotyped for CYP3A4*1B, CYP3A5*3, CYP1B1*3, CYP2C8*3, ABCB1 1236C>T, 2677G>T/A and 3435C>T polymorphisms using PCR-RFLP. Associations of genetic variants with clinical outcomes in terms of response in 58 patients receiving neo-adjuvant chemotherapy (NACT), and chemo-toxicity in 132 patients were studied. Multifactor dimensionality reduction (MDR) analysis was performed to evaluate higher order gene-gene interactions with clinical outcomes. Pathological response to taxane based NACT was associated with GA genotype as well as A allele of CYP3A5*3 polymorphism (Pcorr=0.0465, Pcorr=0.0465). Similarly, association was found in dominant model of CYP3A5*3 polymorphism with responders (Pcorr=0.0465). Haplotype analysis further revealed ACYP3A4-ACYP3A5 haplotype to be significantly associated with responders (Pcorr=0.048). In assessing toxicity, significant association of variant (TT) genotype and T allele of ABCB1 2677G>T/A polymorphism, was found with 'grade 1 or no leucopenia' (Pcorr=0.0465, Pcorr=0.048). On evaluating higher order gene-gene interaction models by MDR analysis, CYP3A5*3; ABCB11236C>T and ABCB1 2677G>T/A; ABCB1 3435C>T and CYP1B1*3 showed significant association with treatment response, grade 2-4 anemia and dose delay/reduction due to neutropenia (P=0.024, P=0.004, P=0.026), respectively. Multi-analytical approaches may provide a better assessment of pharmacogenetic based treatment outcomes in breast cancer patients treated with taxanes.
Teleni, Laisa; Baker, Jacqueline; Koczwara, Bogda; Kimlin, Michael G; Walpole, Euan; Tsai, Kathy; Isenring, Elizabeth A
Results of recent studies suggest that circulating levels of vitamin D may play an important role in cancer-specific outcomes. The present systematic review was undertaken to determine the prevalence of vitamin D deficiency (<25 nmol/L) and insufficiency (25-50 nmol/L) in cancer patients and to evaluate the association between circulating calcidiol (the indicator of vitamin D status) and clinical outcomes. A systematic search of original, peer-reviewed studies on calcidiol at cancer diagnosis, and throughout treatment and survival, was conducted yielding 4,706 studies. A total of 37 studies met the inclusion criteria for this review. Reported mean blood calcidiol levels ranged from 24.7 to 87.4 nmol/L, with up to 31% of patients identified as deficient and 67% as insufficient. The efficacy of cholecalciferol supplementation for raising the concentration of circulating calcidiol is unclear; standard supplement regimens of <1,000 IU D₃ /day may not be sufficient to maintain adequate concentrations or prevent decreasing calcidiol. Dose-response studies linking vitamin D status to musculoskeletal and survival outcomes in cancer patients are lacking.
Kim, Sung Eun; Jang, Hye-In; Chang, Kylie Hae-jin; Sung, Ji-Hee; Lee, Jiwon; Lee, Jeehun; Choi, Suk-Joo; Roh, Cheong-Rae; Kim, Jong-Hwa
Objective With recent advances and frequent use of prenatal ultrasound, the antenatal diagnosis of agenesis of the corpus callosum (ACC) is not rare in obstetrics practices. However, information regarding the long-term neurological outcome remains uncertain. The aim of this study was to investigate clinical outcomes of prenatally diagnosed ACC and to analyze postnatal neurodevelopmental outcomes of ACC neonates born in our single center. Methods We retrospectively reviewed 56 cases of prenatally suspected ACC referred to our center. Results Fifty-six fetuses were diagnosed with ACC, and 12 of those were followed-up in our center until delivery. Of the remaining 44, 7 were delivered after being referred back to the original hospital, 23 were lost to follow-up, and 14 had unknown outcomes. Among all 56, 29 were considered to have isolated ACC and 27 were considered to have non-isolated ACC. Of the 10 live fetuses delivered in our center, four had isolated ACC, three had non-isolated ACC, and the rest had outcomes unrelated to ACC. Neurodevelopmental outcome was followed-up until approximately age 3 years. Of the four with isolated ACC, three (75%) had normal neurodevelopmental outcomes. Conclusion Similar to other studies, the results of our single-center study included positive neurodevelopmental outcomes for those with isolated ACC. However, despite our endeavor to counsel patients with prenatally diagnosed ACC, the delivery rate in our center was quite low. Therefore, larger, multicenter, retrospective studies including long-term neurological development outcomes are crucial and urgently needed to provide better counseling. PMID:28217666
Gerard, Emilie; Prevezas, Christos; Doutre, Marie-Sylvie; Beylot-Barry, Marie; Cogrel, Olivier
Retronychia is a form of post-traumatic ingrowing nail disease that involves proximal nail plate embedding into the proximal nail fold, with multiple generations of nail plate beneath the proximal nail. This disease is probably underdiagnosed because of incomplete clinical forms. The aim of this study was to report clinical and aetiological variants of retronychia and to evaluate their therapeutic outcome. A retrospective review was performed on 18 patients who were seen in our institution between 2007 and 2013. The diagnostic criteria for retronychia were paronychia and interruption of nail growth. A female predominance (83.3%) was reported. Various precipitating factors were found, including traumatisms in 10 patients (55%), pregnancy and postpartum period in two patients (11%), and compartment syndrome in one patient (5%). The mean duration of paronychia was eight months (15 days to four years). The fingers most affected were the great toes. Retronychia occurred bilaterally in five cases (27%) and unilaterally in one case (61%). The commonest signs were, in decreasing order, xanthonychia (yellow discolouration of nail plate), longitudinal nail over-curvature, swelling of proximal nail fold, elevation of the proximal nail plate, granulation tissue, subungual hyperkeratosis, superficial leuconychia, distal onycholysis, subungueal haemorrhage, and Beau's lines. Most of the cases improved after proximal nail plate avulsion. Recurrence occurred in three cases (16.6%). In our opinion, ischaemic damage is the main cause of retronychia. Evaluation of clinical variants is mandatory to propose appropriate treatment. The limitations of this study include the retrospective design.
Danza, Matteo; Grecchi, Francesco; Zollino, Ilaria; Casadio, Claudia; Carinci, Francesco
A spiral implant (SPI) is a conical internal helix implant with a variable thread design which confers the characteristic of self drilling, self tapping, and self bone condensing. The effectiveness of this type of implant has been reported in several clinical situations. However, because there are no reports that specifically focus on one of the biggest challenges in oral rehabilitation, that is, full arch rehabilitation, it was decided to perform a retrospective study. The study population was composed of 23 patients (12 women and 11 men, median age 57 years) for evaluation and implant treatment between January 2005 and June 2009. Two-hundred six spiral family implants (SFIs) were inserted with a mean postloading follow-up of 23 months. Several variables were investigated: demographic (age and gender), anatomic (maxilla and mandible, tooth site), implant (type, length, and diameter), surgical (surgeon, postextractive, flapless technique, grafts), and prosthetic (implant/crown ratio, dentition in the antagonist arch, type of loading, and computerized tomography [CT] planning) variables. Implant loss and peri-implant bone resorption were evaluated. Univariate and multivariate tests were performed. Survival and success rates were 97.1% and 82.5%, respectively. Only implant length and implant/crown ratio showed statistical significance in determining a better clinical outcome. In conclusion, SFIs are a reliable tool for the most difficult cases of oral rehabilitation. No differences were detected among implant type. Length and implant/crown ratio can influence the crestal bone resorption with better result for longer fixtures and a higher implant/crown ratio. In addition, banked bone derived from living donors can be used to restore alveolar ridge augmentation without adverse effects. Finally, flapless and CT-planned surgery did not significantly increase the clinical outcome in most complex rehabilitation.
Budassi, Piero; Bischof, Andreas; Agneskirchner, Jens; Domenghini, Christian; Frattini, Marco; Borroni, Mario; Zoni, Sabine; Castagna, Alessandro
Background The aim of this multicentre retrospective study was to compare reverse total shoulder arthroplasty clinical outcomes with glenospheres of different diameters, designs and materials. Methods Between 2003 and 2008, 133 patients were divided into three groups: 60 (45%) with 36-mm standard CoCrMo (group A), 21 (16%) with 36-mm eccentric cobalt-chromium-molybdenum (CoCrMo) (group B) and 52 (39%) with 44-mm cross-linked ultra-high molecular weight polyethylene (X-UHMWPE) (group C) glenospheres. Mean (SD) follow-up was 38.7 (17.4) months. Clinical evaluation included Constant score and range of motion. Radiographic analysis included radiolucent lines, instability, loosening and assessment of scapular notching. Results Mean Constant score significantly increased for all groups (Wilcoxon test, p < 0.001). Group C allowed a higher and stable increase in range of motion. After 12 months and 24 months, groups C and B showed less pain than group A (Mann–Whitney U-test, p < 0.05). Group C had significantly lower scapular notching than group B (Mann–Whitney U-test, p = 0.001) and A (Mann–Whitney U-test, p = 0.009) at 12 months, 24 months and 36 months. Groups A and C presented 5 (8.3%) and 4 (7.6%) early complications, respectively. Conclusions The present study reported good results for all groups, although groups C and A presented better clinical outcomes, significantly lower notching and instability. A 44-mm X-UHMWPE glenosphere allowed a faster and more stable functional recovery, despite poorest pre-operative conditions. Additional long-term studies are needed to evaluate survivorship. PMID:27582931
Pornpattananangkul, Narun; Nadig, Ajay; Heidinger, Storm; Walden, Keegan; Nusslock, Robin
Although waiting for a reward reduces or discounts its value, some people have a stronger tendency to wait for larger rewards and forgo smaller-but-immediate rewards. This ability to delay gratification is captured by individual differences in so-called intertemporal choices in which individuals are asked to choose between larger-but-delayed versus smaller-but-immediate rewards. The current study used event-related potentials (ERPs) to examine whether enhancement in two neurocognitive processes, outcome anticipation and outcome evaluation, modulate individual variability in intertemporal responses. After completing a behavioral intertemporal choice task, 34 participants performed an ERP gambling task. From this ERP task, we separately examined individual differences in outcome anticipation (stimulus-preceding negativity; SPN), early outcome valuation (feedback-related negativity; FRN), and late outcome evaluation (P3). We observed that both elevated outcome-anticipation (SPN) and late outcome-evaluation (P3) neural processes predicted a stronger preference toward larger-but-delayed rewards. No relationship was observed between intertemporal responses and early outcome evaluation (FRN), indicating that the relationship between outcome evaluation and intertemporal responses was specific to the late outcome-evaluation processing stream. Moreover, multiple regression analyses indicated that the SPN and P3 independently modulate individual differences in intertemporal responses, suggesting separate mechanisms underlie the relationship between these two neurocognitive processes and intertemporal responses. Accordingly, we identify two potential neurocognitive modulators of individual variability in intertemporal responses. We discuss the mechanisms underlying these modulators in terms of anticipation-related processing (SPN) and a saliency bias toward gain (compared to loss) outcomes (P3).
Gupta, Manish; Chauhan, Komal
Background: Antioxidants have a preventive or therapeutic role in oxygen free radical–mediated cell and tissue damage. The study aimed to investigate the therapeutic effects of antioxidants and intranasal steroid fluticasone furoate (FF) on the clinical outcome of patients with perennial allergic rhinitis. Methods: Subjects with perennial allergic rhinitis (n = 61) were randomly divided into two groups, group A (n = 30) received FF and group B (n = 31) received FF with antioxidants for 6 weeks. Nasal and ocular symptoms were evaluated weekly by using a four-point categoric scale. The efficacy of the study drug was assessed based on the mean change from baseline of the total daytime nasal symptom scores, total nighttime nasal symptom scores, and the composite symptom scores. Results: The combined therapy (FF with antioxidants) resulted in marked improvements (p ≤ 0.05) in the mean total daytime nasal symptom scores, total nighttime nasal symptom scores, and composite symptom scores of subjects compared with ones treated with intranasal steroid (FF) alone, which highlighted the therapeutic effect of antioxidants in allergic rhinitis. Conclusion: Significant improvement in clinical outcome was observed in subjects who received antioxidants along with FF. However, because this was an open-label study, the results must be interpreted with caution, and further double-blind, placebo-controlled, dose-ranging trials supplemented with different antioxidants together with intranasal steroids are suggested. PMID:27658183
Xia, Wei; Chiu, Yu-Han; Afeiche, Myriam C.; Williams, Paige L.; Ford, Jennifer B.; Tanrikut, Cigdem; Souter, Irene; Hauser, Russ; Chavarro, Jorge E.
SUMMARY Intake of full-fat dairy has been linked to lower semen quality but whether this leads to decreased fertility is unknown. To address this question, we prospectively evaluated the association of men's dairy intake with treatment outcomes of subfertile couples undergoing assisted reproductive technology (ART). We followed 142 men from couples undergoing infertility treatment with ART at an academic fertility center between 2007 and 2014. Couples completed dietary assessments prior to treatment, and the female partners underwent a total of 248 ART cycles. Multivariable generalized linear mixed models were used to examine the association of dairy intake with fertilization, implantation, clinical pregnancy and live birth rates adjusting for age, body mass index (BMI), smoking status, total exercise time, dietary patterns, alcohol, caffeine, total energy intake, and female dairy intake. Intake of dairy foods, regardless of their fat content, was not associated with fertilization, implantation, clinical pregnancy, or live birth rates. The adjusted live birth rates (95% Confidence Interval) for couples in increasing quartiles of men's dairy intake were 0.42 (0.25, 0.60), 0.25 (0.13, 0.42), 0.26 (0.15, 0.41), and 0.44 (0.27, 0.63) (p, linear trend = 0.73). Results remained similar after adjustment for female partner intake of dairy foods. Overall, men's dairy intake was not associated with treatment outcomes of couples undergoing ART. PMID:26825777
Xia, Wei; Chiu, Yu-Han; Afeiche, Myriam C; Williams, Paige L; Ford, Jennifer B; Tanrikut, Cigdem; Souter, Irene; Hauser, Russ; Chavarro, Jorge E
Intake of full-fat dairy has been linked to lower semen quality but whether this leads to decreased fertility is unknown. To address this question, we prospectively evaluated the association of men's dairy intake with treatment outcomes of subfertile couples undergoing assisted reproductive technology (ART). We followed 142 men from couples undergoing infertility treatment with ART at an academic fertility centre between 2007 and 2014. Couples completed dietary assessments prior to treatment, and the female partners underwent a total of 248 ART cycles. Multivariable generalized linear mixed models were used to examine the association of dairy intake with fertilization, implantation, clinical pregnancy and live birth rates adjusting for age, body mass index, smoking status, total exercise time, dietary patterns, alcohol, caffeine, total energy intake, and female dairy intake. Intake of dairy foods, regardless of their fat content, was not associated with fertilization, implantation, clinical pregnancy or live birth rates. The adjusted live birth rates (95% confidence interval) for couples in increasing quartiles of men's dairy intake were 0.42 (0.25, 0.60), 0.25 (0.13, 0.42), 0.26 (0.15, 0.41), and 0.44 (0.27, 0.63) (p linear trend = 0.73). Results remained similar after adjustment for female partner intake of dairy foods. Overall, men's dairy intake was not associated with treatment outcomes of couples undergoing ART.
Rugno, Fernanda Capella; Carlo, Marysia Mara Rodrigues do Prado De
ABSTRACT Objective: to identify and evaluate the evidence found in the international scientific literature on the application of the Palliative Outcome Scale (POS) in clinical practice and research in Palliative Care (PC). Method: integrative literature review, through the search of publications in journals indexed in PubMed / MEDLINE, LILACS, SciELO and CINAHL databases, between the years 1999 and 2014. Results: the final sample consisted of 11 articles. In the data analysis, the articles were classified into 2 units of analysis (studies using the POS as a resource in research and studies using the POS in clinical practice), in which the information was presented in the form of sub-themes related to publications of the selected studies, highlighting the synthesis of the results. Conclusion: POS emerged as an important tool for measuring outcomes to assess the quality of life of patients and families, of the quality of care provided and the PC service organization. The international scientific literature on the application of POS proved to be relevant to the advancement and consolidation of the field of knowledge related to PC. PMID:27533273
Patterson, G. R.; Forgatch, Marion S.
Issues related to the use of outcome and process data from the treatment of antisocial children to predict future childhood adjustment were examined through a study of 69 children. Data supported the hypothesis that measures of processes thought to produce changes in child behavior would serve to predict future adjustment. (SLD)
Amland, Robert C; Haley, James M; Lyons, Jason J
Sepsis is an inflammatory response triggered by infection, with risk of in-hospital mortality fueled by disease progression. Early recognition and intervention by multidisciplinary sepsis programs may reverse the inflammatory response among at-risk patient populations, potentially improving outcomes. This retrospective study of a sepsis program enabled by a 2-stage sepsis Clinical Decision Support (CDS) system sought to evaluate the program's impact, identify early indicators that may influence outcomes, and uncover opportunities for quality improvement. Data encompassed 16 527 adult hospitalizations from 2014 and 2015. Of 2108 non-intensive care unit patients screened-in by sepsis CDS, 97% patients were stratified by 177 providers. Risk of adverse outcome improved 30% from baseline to year end, with gains materializing and stabilizing at month 7 after sepsis program go-live. Early indicators likely to influence outcomes include patient age, recent hospitalization, electrolyte abnormalities, hypovolemic shock, hypoxemia, patient location when sepsis CDS activated, and specific alert patterns.
Lu, Yongda; Zhang, Deqing; Jia, Zhenyu; Zhuang, Xiaohui; Shi, Yuqi; Xu, Ting; Xing, Lihua; Shen, Jiaqing
Acute pancreatitis (AP) is a common disease in the department of gastroenterology with variable severity, from being mild and self-limited to severe and fatal. The early diagnosis and accurate prediction of AP severity are of great importance. Our primary observation showed that fatty liver (FL) was frequently detected in patients with AP. In this retrospective study, we aimed to evaluate the relation between FL and the severity and outcomes of AP. The medical records of 2671 patients with AP were reviewed retrospectively, and characteristics of AP patients were recorded. FL was assessed by abdominal CT scan, and AP patients were categorized by the occurrence of FL for the analysis. The variation of mortality, clinical severity and the appearance of CT were analyzed between the non-FL group and FL groups. Compared with patients without FL, an obviously higher rate of death and higher frequency of severe AP (SAP) and necrotizing AP (ANP) were observed in patients with FL, as well as the incidence of local complications and systemic complications. Taking obesity into consideration, a higher rate of death and more severe AP were found in patients with FL, no matter whether they were obese or not. Alcoholic fatty liver (AFL) and non-alcoholic fatty liver (NAFL) were also separated for comparison in this study; the incidence of ANP and the clinical severity had no significant difference between the AFL and NAFL groups. In conclusion, FL could influence the severity and clinical outcome and may play a prognostic role in AP. This study is of clinical significance, because few reports have been previously issued on FL and AP. PMID:26571385
Gibbons, Carly R.; Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Newman, Cory F.; Beck, Aaron T.
Objective To compare the outcomes of cognitive therapy for depression under controlled and clinically representative conditions, while holding several therapist and clinical assessment factors constant. Method Treatment outcomes for a sample of 23 adults with a primary diagnosis of Major Depressive Disorder who received cognitive therapy in an outpatient clinic were compared with outcomes of 18 clients who were treated in the cognitive therapy condition of a large, multi-site randomized clinical trial of treatments for depression. All participants had been treated by one of two therapists who served as clinicians in both settings. Individuals in the two samples were diagnostically and demographically similar (approximately 50% Female, 83% White). A variety of client characteristics, assessed prior to treatment, as well as the outcomes of treatment, were examined. Results Significantly superior treatment outcomes were observed in the individuals treated in the research study, relative to clients in the outpatient clinic, and the difference was not accounted for by intake characteristics. Individuals treated by the therapists in the RCT experienced almost three times as much improvement in depressive symptoms as clients seen in the outpatient setting. Conclusions If replicated, the findings suggest that differences exist between treatment outcomes in research and outpatient settings and that these differences may not simply be due to therapist experience and training, or differences in patient populations. Future research should further examine the impact of fidelity monitoring, treatment expectation and motivation, and the duration and timing of treatment protocols on clinical outcomes. PMID:23710102
Isaksen, Jytte Kjaergaard
Background: Measuring or evaluating outcomes is a common activity for many speech-language therapists (SLTs). A major focus has been on external forces claiming outcome evaluation to optimize quality and the use of resources without integrating the viewpoints of SLTs. Aims: To identify the purpose of outcome evaluation by letting SLTs identify not…
Feng, Guixue; Zhang, Bo; Zhou, Hong; Shu, Jinhui; Gan, Xianyou; Wu, Fangrong; Deng, Xihe
Selective single-blastocyst transfer (SBT) in fresh cycles has been effective in reducing multiple pregnancies. However, we do not know whether this successful strategy of fresh transfer cycles is suitable for cryopreserved cycles. The present study was undertaken to evaluate the feasibility and value of SBT in vitrified-warmed cycles. Clinical pregnancy rate (CPR) was similar with vitrified and fresh SBT (46.61% versus 52.15% respectively). Of the pregnant patients, monozygotic twin, miscarriage and ectopic pregnancy rates were similar with vitrified and fresh SBT. For the newborns, no significant difference was observed in live birth, low birthweight, premature delivery and birth defects rates between vitrified and fresh SBT. With respect to the quality of transferred blastocysts (from BB to AA), a similar CPR and miscarriage rate was obtained for both vitrified and fresh SBT when a similar blastocyst cohort graded ≥ 3BB was transferred. The data show that vitrified SBT is an effective means of reducing multiple pregnancy and that comparable clinical outcomes and live births are achieved if single blastocysts graded ≥ 3BB are transferred for both vitrified and fresh SBT. These data should encourage clinics to evaluate their embryo transfer policy and adopt vitrified SBT as everyday practice. Selective single-blastocyst transfer in fresh cycles has been an effective method to reduce the multiple pregnancies. However, due to a lack of adequate studies, we do not know whether this successful strategy in fresh transfer cycles is suitable in cryopreserved cycles. The present study was undertaken to explore the feasibility and value of single-blastocyst transfer in vitrified-warmed cycles. We found that single-blastocyst transfer in vitrified-warmed cycles is an effective means of reducing multiple pregnancy, and comparable clinical outcomes and live births were achieved if single blastocysts graded ≥ 3BB were transferred for both vitrified-warmed and fresh
Zhang, Guobin; Huang, Shengyue; Zhang, Junting; Wu, Zhen; Lin, Song; Wang, Yonggang
Gliosarcoma (GSM) is a rare biphasic neoplasms of the central nervous system composed of a glioblastoma multiforme (GBM) admixed with a sarcomatous component. In clinical practice GSM is generally managed similarly to GBM. However, there are conflicting reports regarding their clinical aggressiveness, cell line of origin and possible prognosis compared with those of GBM. The objective of this study was to compare clinic-pathological features in GSM patients with the GBM patients during the same study period. 518 patients with GBM were treated at our hospital between 2008 and 2013, among them 51 were GSM. In this series the GSMs represented 9.8% of all GBMs and included 58.8% male with a median age of 44.7 years. The locations, all supratentorial, included temporal in 41.2%, frontal in 25.5%, parietal in 19.6%, and occipital in 13.7%. All patients underwent tumor resection followed by post-operative radiation and adjuvant chemotherapy. The O6-methylguanine-DNA methyltransferase promoter methylation studies were significantly more frequent in the GBMs than GSMs (80.1% vs. 44.7%, P < 0.001). The median progression free survival and overall survival for the patients with GSM were 8.0 and 13.0 months, respectively, as compared with 9.0 and 14.0 months in the GBM group (log rank test P = 0.001 and 0.004, respectively). The Cox proportional hazards regression model indicated that the extent of tumor resection (HR = 1.518, P = 0.009) and pathological types (HR = 0.608, P = 0.002) were the significant prognostic factors in our own series. With regard to clinical features and outcomes, GSM and GBM cannot be distinguished clinically. GSM in China may be managed similarly to GBM, with maximal safe surgical resection followed by chemo-radiotherapy. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM.
Cordingley, Dean; Girardin, Richard; Reimer, Karen; Ritchie, Lesley; Leiter, Jeff; Russell, Kelly; Ellis, Michael J
OBJECTIVE The objectives of this study were 2-fold: 1) to evaluate the safety, tolerability, and clinical use of graded aerobic treadmill testing in pediatric patients with sports-related concussion (SRC), and 2) to evaluate the clinical outcomes of treatment with a submaximal aerobic exercise program in patients with physiological post-concussion disorder (PCD). METHODS The authors conducted a retrospective chart review of pediatric patients (age < 20 years) with SRC who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Clinical assessments were carried out by a single neurosurgeon and included clinical history taking, physical examination, and recording specific patient-reported concussion-related symptoms using the Post-Concussion Symptom Scale (PCSS). Graded aerobic treadmill testing using a modified Balke protocol for incremental increases in intensity was used as a diagnostic tool to assess physiological recovery, classify post-concussion syndrome (PCS) subtype, and reassess patients following treatment. Patients with a symptom-limited threshold on treadmill testing (physiological PCD) were treated with an individually tailored submaximal exercise prescription and multidisciplinary targeted therapies. RESULTS One hundred six patients (mean age 15.1 years, range 11-19 years) with SRC underwent a total of 141 treadmill tests. There were no serious complications related to treadmill testing in this study. Overall, 138 (97.9%) of 141 tests were well tolerated and contributed valuable clinical information. Treadmill testing confirmed physiological recovery in 63 (96.9%) of 65 patients tested, allowing successful return to play in 61 (93.8%). Treadmill testing was used to diagnose physiological PCD in 58 patients and cervicogenic PCD in 1 patient. Of the 41 patients with physiological PCD who had complete follow-up and were treated with tailored submaximal
Hafner, Brian J.; Morgan, Sara J.; Askew, Robert L.; Salem, Rana
Documentation of clinical outcomes is increasingly expected in delivery of prosthetic services and devices. However, many outcome measures suitable for use in clinical care and research have not been psychometrically tested with prosthesis users. The aim of this study was to determine test-retest reliability, mode-of-administration (MoA) equivalence, standard error of measurement (SEM), and minimal detectable change (MDC) of standardized, self-report instruments that assess constructs of importance to people with lower limb loss. Prosthesis users (n=201) were randomly assigned to groups based on MoA (i.e., paper, electronic, or mixed-mode). Participants completed two surveys 2-3 days apart. Instruments included the Prosthetic Limb Users Survey of Mobility, Prosthesis Evaluation Questionnaire–Mobility Subscale, Activities-Specific Balance Confidence Scale, Quality of Life in Neurological Conditions–Applied Cognition/General Concerns, Patient Reported Outcomes Measurement Information System Profile, and Socket Comfort Score. Intraclass correlation coefficients indicated all instruments are appropriate for group-level comparisons and select instruments are suitable for individual-level applications. Several instruments showed evidence of possible floor and ceiling effects. All were equivalent across MoAs. SEM and MDC were quantified to facilitate interpretation of outcomes and change scores. These results can enhance clinicians' and researchers' ability to select, apply, and interpret scores from instruments administered to prosthesis users. PMID:28273329
Pao, Jwo-Luen; Chen, Wein-Chin; Chen, Po-Quang
The goal of surgical treatment for degenerative lumbar spinal stenosis (LSS) is to effectively relieve the neural structures by various decompressive techniques. Microendoscopic decompressive laminotomy (MEDL) is an attractive option because of its minimally invasive nature. The aim of prospective study was to investigate the effectiveness of MEDL by evaluating the clinical outcomes with patient-oriented scoring systems. Sixty consecutive patients receiving MEDL between December 2005 and April 2007 were enrolled. The indications of surgery were moderate to severe stenosis, persistent neurological symptoms, and failure of conservative treatment. The patients with mechanical back pain, more than grade I spondylolisthesis, or radiographic signs of instability were not included. A total of 53 patients (36 women and 17 men, mean age 62.0) were included. Forty-five patients (84.9%) were satisfied with the treatment result after a follow-up period of 15.7 months (12-24). The clinical outcomes were evaluated with the Oswestry disability index (ODI) and the Japanese Orthopedic Association (JOA) score. Of the 50 patients providing sufficient data for analysis, the ODI improved from 64.3 +/- 20.0 to 16.7 +/- 20.0. The JOA score improved from 9.4 +/- 6.1 to 24.2 +/- 6.0. The improvement rate was 73.9 +/- 30.7% and 40 patients (80%) had good or excellent results. There were 11 surgical complications: dural tear in 5, wrong level operation in 2, and transient neuralgia in 4 patients. No wound-related complication was noted. Although the prevalence of pre-operative comorbidities was very high (69.8%), there was no serious medical complication. There was no post-operative instability at the operated segment as evaluated with dynamic radiographs at final follow-up. We concluded that MEDL is a safe and very effective minimally invasive technique for degenerative LSS. With an appropriate patient selection, the risk of post-operative instability is minimal.
lateral flexion. d. rotation. 26. The Polio virus attacks the __________ of the spinal cord. a. meninges b. ventral horn cells c. dorsal horn...KAFOs. b. Hip abduction orthosis. c. Parapodium. d. RGO. 65. A 20 year old female, post polio , is seen in clinic. Upon evaluation it was...Rosebrock, CO. Kate Muller is the Lead Orthotic Instructor, and has written new Orthotics curricula, including Upper Extremity Orthotics, Spinal
Xu, David S; Levitt, Michael R; Kalani, M Yashar S; Rangel-Castilla, Leonardo; Mulholland, Celene B; Abecassis, Isaac J; Morton, Ryan P; Nerva, John D; Siddiqui, Adnan H; Levy, Elad I; Spetzler, Robert F; Albuquerque, Felipe C; McDougall, Cameron G
OBJECTIVE Fusiform dolichoectatic vertebrobasilar aneurysms are rare, challenging lesions. The natural history of these lesions and medium- and long-term patient outcomes are poorly understood. The authors sought to evaluate patient prognosis after diagnosis of fusiform dolichoectatic vertebrobasilar aneurysms and to identify clinical and radiographic predictors of neurological deterioration. METHODS The authors reviewed multiple, prospectively maintained, single-provider databases at 3 large-volume cerebrovascular centers to obtain data on patients with unruptured, fusiform, basilar artery dolichoectatic aneurysms diagnosed between January 1, 2000, and January 1, 2015. RESULTS A total of 50 patients (33 men, 17 women) were identified; mean clinical follow-up was 50.1 months and mean radiographic follow-up was 32.4 months. At last follow-up, 42% (n = 21) of aneurysms had progressed and 44% (n = 22) of patients had deterioration of their modified Rankin Scale scores. When patients were dichotomized into 2 groups- those who worsened and those who did not-univariate analysis showed 5 variables to be statistically significantly different: sex (p = 0.007), radiographic brainstem compression (p = 0.03), clinical posterior fossa compression (p < 0.001), aneurysmal growth on subsequent imaging (p = 0.001), and surgical therapy (p = 0.006). A binary logistic regression was then created to evaluate these variables. The only variable found to be a statistically significant predictor of clinical worsening was clinical symptoms of posterior fossa compression at presentation (p = 0.01). CONCLUSIONS Fusiform dolichoectatic vertebrobasilar aneurysms carry a poor prognosis, with approximately one-half of the patients deteriorating or experiencing progression of their aneurysm within 5 years. Despite being high risk, intervention-when carefully timed (before neurological decline)-may be beneficial in select patients.
Background Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. Methods/Design This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. Discussion The US health care
Santos Dias, José
Benign prostatic hyperplasia (BPH) is a very common condition, related to aging and causing symptoms, called lower urinary tract symptoms. On account of its huge prevalence, it is important for clinicians who are involved in the management of patients with BPH to be aware of the very strict recommendations for BPH evaluation. In this article, we describe the different steps and procedures doctors should follow to evaluate these patients; symptoms and signs of BPH are reviewed, as well as the clinical evaluation steps and examinations available. The basic evaluation of the patients with BPH should include, according to the recommendations of the most relevant international guidelines, lower urinary tract symptoms evaluation with appropriate symptom scores, digital rectal examination, voiding charts, prostate-specific antigen and creatinine measurement, urinalysis, and imaging of the urinary tract.
Bergmann, Martin; Oberkircher, Ludwig; Bliemel, Christopher; Frangen, Thomas Manfred; Ruchholtz, Steffen; Krüger, Antonio
The treatment of painful osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly over the last two decades. The benefits of balloon kyphoplasty compared to conservative treatment remain controversial and are discussed in the literature. The complication rates of vertebroplasty and kyphoplasty are considered to be low. The focus of this study was the analysis of acute and clinically relevant complications related to this procedure. In our department, all patients treated between February 2002 and February 2011 with percutaneous cement augmentation (372 patients, 522 augmented vertebral bodies) were prospectively recorded. Demographic data, comorbidities, fracture types, intraoperative data and all complications were documented. The pre- and postoperative pain-level and neurological status (Frankel-Score) were evaluated. All patients underwent a standardized surgical procedure. Two hundred and ninety-seven patients were treated solely by balloon kyphoplasty; 216 females (72.7%) and 81 males (27.3%). Average patient age was 76.21 years (±10.71, range 35-98 years). Average American Society Anestesiologists score was 3.02. According to the Orthopedic Trauma Association classification, there were 69 A 1.1 fractures, 177 A 1.2 fractures, 178 A 3.1.1 fractures and 3 A 3.1.3 fractures. Complications were divided into preoperative, intraoperative and postoperative events. There were 4 preoperative complications: 3 patients experienced persistent pain after the procedure. In one case, the pedicles could not be visualized during the procedure and the surgery was terminated. One hundred and twenty-nine (40.06%) of the patients showed intraoperative cement leaking outside the vertebras, one severe hypotension and tachycardia as reaction to the inflation of the balloons, and there was one cardiac arrest during surgery. Postoperative subcutaneous hematomas were observed in 3 cases, 13 patients developed a urinary tract
Eizadi-Mood, Nastaran; Sabzghabaee, Ali Mohammad; Hosseini, Hossein; Soltaninejad, Forough; Massoumi, Gholamreza; Farajzadegan, Ziba; Yaraghi, Ahmad
Background: Disorders of serum sodium concentration are some of the most electrolyte abnormalities in the intensive care unit (ICU) patients. These disorders adversely affect the function of vital organs and are associated with increased hospital mortality. Purpose: In the present study we aimed to evaluate the effects of serum sodium concentration abnormalities at the time of hospital admission on the clinical outcome of therapy in a cohort of critically ill poisoned patients. Methods: In this cross-sectional study, 184 critically ill poisoned patients aged >18 years and in the first 8 hours of their poisoning, hospitalized in the ICU of a tertiary care university hospital (Isfahan, Iran) between 2010-2012, were evaluated at the admission time and 24 hours later for serum sodium concentration abnormalities and its relationship with age, gender, consciousness status, ingested drugs and clinical outcome of therapy. The clinical outcome was considered as recovery and mortality. Logistic Regression analysis was performed for predictive variables including serum sodium concentration abnormalities in patients’ clinical outcome. Findings: On admission, 152 patients (82.6%) were eunatremic, 21 patients (11.4%) were hyponatremic and 11 patients (6%) were hypernatremic. In the second day eunatremia, hyponatremia and hypernatremia was observed in 84.4%, 13% and 2.2% respectively. Age (OR=1.92; CI=1.18-3.12) and severity of toxicity (OR=1.32; CI=1.12-2.41) were predicting factors of mortality in ICU poisoning patients. Conclusions: Serum sodium concentration abnormalities are prevalent in critically ill poisoned patient but do not seem to have a predictive value for the clinical outcome of therapy. PMID:26543310
Yuan, Ting; Wang, Wei; Li, Xue-Lan; Li, Chun-Fang; Li, Chao; Gou, Wen-Li; Han, Zhen
Abstract The aim of our study was to compare the clinical characteristics of fetal and neonatal outcomes in twin pregnancies between women with preeclampsia (PE) and those with normotension in a Chinese population. There were 143 preeclamptic women and 367 normotensive women with twin pregnancies included in this retrospective case–control study. The baseline characteristics and perinatal outcomes were collected and compared between the groups. Multiple logistic regression and linear regression were used to assess the correlations between PE and the outcomes. Significant increases were observed in the frequencies of preterm delivery (OR = 2.75, P < 0.001), iatrogenic preterm birth (OR = 3.52, P < 0.001), and IUGR (OR = 2.94, P = 0.001) in the PE group, and the PE group had more than a 2-fold risk of adverse neonatal outcomes. Preeclamptic twin neonates had lower birth weights (β = −147.34, P = 0.005; β = −169.47, P = 0.001). The comparison on the discordance of intertwin weight was not significantly different. Twin pregnancies with PE are associated with worse perinatal outcomes. The adverse outcomes of preeclamptic twin pregnancies may be associated with lower birth weights rather than the discordance of the intertwin weight, which requires further confirmation. The results may provide helpful references for better clinical assessments, evaluations of prognosis, and a deeper understanding of preeclamptic twin pregnancies. PMID:27787375
Hootkani, Alireza; Jarahi, Lida; Rezvan, Manizheh; Moayedpour, Amir
Background Surgical techniques used in the treatment of patients with high grade lumbar spondylolisthesis (> 50% slippage) are usually associated with a great deal of controversies. We aim to evaluate the surgical outcomes of high grade spondylolisthesis treated with an intraoperative temporary distraction rod. Methods We retrospectively studied 21 patients (14 females and 7 males), aged 50.4 ± 9.2 years, who had high grade lumbar spondylolisthesis that was treated with intraoperative temporary distraction rods, neural decompression, pedicular screw fixation, and posterolateral fusion involving one more intact upper vertebra. The mean follow-up period was 39.2 months. Radiologic and clinical outcomes were measured by slip angle, slip percentage, correction rate, Oswestry Disability Index (ODI), visual analogue scale (VAS), patient's satisfaction rate in the pre- and postoperative period. Data were analyzed by SPSS ver. 11.5. Results Analysis of the preoperative visits and final follow-up visits indicated that surgery could improve ODI, lumbar VAS, and leg VAS from 60.5% to 8.2%, from 6.7 to 2.2, and from 6.9 to 1.3, respectively. Slip angle and slip percentage were also changed from -8° to -15° and from 59.2% to 21.4%, respectively. Mean correction rate at the final follow-up visit was 64.1%. Loss of correction was insignificant and a neurologic complication occurred in one patient due to misplacement of one screw. Excellent and good levels of satisfaction were observed in 90.5% of the patients. Conclusions In the surgical treatment of refractory high grade spondylolisthesis, the use of a temporary distraction rod to reduce the slipped vertebra in combination with neural decompression, posterolateral fusion, and longer instrumentation is associated with satisfactory clinical and radiologic outcomes. PMID:25729523
Cha, Ra Ri; Lee, Sang Soo; Lee, Chang Min; Ji, Sung Bok; Jung, Hee Cheul; Cho, Hyun Chin; Kim, Jin Joo; Lee, Jae Min; Kim, Hong Jun; Ha, Chang Yoon; Kim, Hyun Jin; Kim, Tae-Hyo; Jung, Woon Tae; Lee, Ok-Jae
Abstract Hepatitis C virus (HCV) genotype 3 infection is very rare in high-income Asia Pacific. The aim of our retrospective observational study was to evaluate the incidence, clinical features, and treatment outcomes of patients with a genotype 3 HCV infection in the Gyeongnam Province of Korea. Ninety-eight consecutive patients diagnosed with a genotype 3 HCV infection at Gyeongsang National University Hospital, between January 2005 and December 2014, were enrolled into the study. Relevant characteristics of the study group included: 80.6% men, mean age of 41.8 years, and including 69 patients with chronic hepatitis, 25 with liver cirrhosis, and 4 with hepatocellular carcinoma (HCC). Risk factors for HCV infection, sustained virologic response rate, development of HCC, and mortality in patients with genotype 3 were retrospectively analyzed. Among all patients diagnosed with a HCV infection during the study period, the prevalence of genotype 3 was 7.3%. The incidence of genotype 3 was higher in young patients with a risk factor of IVDU (54.0%) and tattooing (62.3%). Among 45 treatment-naive genotype 3 patients, sustained virologic response was achieved with a combination of pegylated-interferon alpha and ribavirin in 75.6%. The cumulative 5-year incidence of HCC was 13.6%, and 8.9% for overall mortality. Liver cirrhosis at enrollment was an independent risk factor for HCC development. This is the first study to elucidate the clinical features and outcomes among the patients with HCV genotype 3 infection in Korea. Further prospective studies are needed to investigate transmission routes and outcomes for HCV genotype 3 infections. PMID:26871824
Gillis, Anne M
Sex-specific differences in the epidemiology, pathophysiology, clinical presentation, clinical treatment, and clinical outcomes of atrial fibrillation (AF), sustained ventricular arrhythmias, and sudden cardiac death are recognized. Sex hormones cause differences in cardiac electrophysiological parameters between men and women that may affect the risk for arrhythmias. The incidence and prevalence of AF is lower in women than in men. However, because women live longer and AF prevalence increases with age, the absolute number of women with AF exceeds that of men. Women with AF are more symptomatic, present with more atypical symptoms, and report worse quality of life in comparison with men. Female sex is an independent risk factor for death or stroke attributable to AF. Oral anticoagulation therapy for stroke prevention has similar efficacy for men and women, but older women treated with warfarin have a higher residual risk of stroke in comparison with men. Women with AF are less likely to receive rhythm control antiarrhythmic drug therapy, electric cardioversion, or catheter ablation in comparison with men. The incidence and prevalence of sustained ventricular arrhythmias and sudden cardiac death are lower in women than in men. Women receiving implantable cardioverter defibrillators for primary prevention of sudden cardiac death are less likely to experience sustained ventricular arrhythmias in comparison with men. In contrast, women receiving a cardiac resynchronization therapy implantable cardioverter defibrillator for the treatment of heart failure are more likely to benefit than men. Women are less likely to be referred for implantable cardioverter defibrillator therapy despite current guideline recommendations. Women are more likely to experience a significant complication related to implantable cardioverter defibrillator implantation in comparison with men. Whether sex differences in treatment decisions reflect patient preferences or treatment biases requires
... HUMAN SERVICES Food and Drug Administration Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is...
Cvjetkovic, Dragana Dragicevic; Bijeljac, Sinisa; Palija, Stanislav; Talic, Goran; Radulovic, Tatjana Nozica; Kosanovic, Milkica Glogovac; Manojlovic, Slavko
Introduction: Numerous rehab protocols have been used in rehabilitation after ACL reconstruction. Isokinetic testing is an objective way to evaluate dynamic stability of the knee joint that estimates the quality of rehabilitation outcome after ACL reconstruction. Our investigation goal was to show importance of isokinetic testing in evaluation thigh muscle strength in patients which underwent ACL reconstruction and rehabilitation protocol. Subjects and methods: In prospective study, we evaluated 40 subjects which were divided into two groups. Experimental group consisted of 20 recreational males which underwent ACL reconstruction with hamstring tendon and rehabilitation protocol 6 months before isokinetic testing. Control group (20 subjects) consisted of healthy recreational males. In all subjects knee muscle testing was performed on a Biodex System 4 Pro isokinetic dynamo-meter et velocities of 60°/s and 180°/s. We followed average peak torque to body weight (PT/BW) and classic H/Q ratio. In statistical analysis Student’s T test was used. Results: There were statistically significant differences between groups in all evaluated parameters except of the mean value of PT/BW of the quadriceps et velocity of 60°/s (p>0.05). Conclusion: Isokinetic testing of dynamic stabilizers of the knee is need in diagnostic and treatment thigh muscle imbalance. We believe that isokinetic testing is an objective parameter for return to sport activities after ACL reconstruction. PMID:25870471
Walter, S D; Cook, D J; Guyatt, G H; King, D; Troyan, S
Considerable effort is often expended to adjudicate outcomes in clinical trials, but little has been written on the administration of the adjudication process and its possible impact on study results. As a case study, we describe the function and performance of an adjudication committee in a large randomized trial of two diagnostic approaches to potentially operable lung cancer. Up to five independent adjudicators independently determined two primary outcomes: tumor status at death or at final follow-up and the cause of death. Patients for whom there was any disagreement were discussed in committee until a consensus was achieved. We describe the pattern of agreement among the adjudicators and with the final consensus result. Additionally, we model the adjudication process and predict the results if a smaller committee had been used. We found that reducing the number of adjudicators from five to two or three would probably have changed the consensus outcome in less than 10% of cases. Correspondingly, the effect on the final study results (comparing primary outcomes in both randomized arms) would have been altered very little. Even using a single adjudicator would not have affected the results substantially. About 90 minutes of person-time per patient was required for activities directly related to the adjudication process, or approximately 6 months of full time work for the entire study. This level of effort could be substantially reduced by using fewer adjudicators with little impact on the results. Thus, we suggest that when high observer agreement is demonstrated or anticipated, adjudication committees should consist of no more than three members. Further work is needed to evaluate if smaller committees are adequate to detect small but important treatment effects or if they compromise validity when the level of adjudicator agreement is lower.
Lester, Rachael A; Brown, Lindsay C; Eckel, Laurence J; Foote, Robert T; NageswaraRao, Amulya A; Buckner, Jan C; Parney, Ian F; Wetjen, Nicholas M; Laack, Nadia N
Central nervous system primitive neuroectodermal tumors (CNS PNETs) predominantly occur in children and rarely in adults. Because of the rarity of this tumor, its outcomes and prognostic variables are not well characterized. The purpose of this study was to evaluate clinical outcomes and prognostic factors for children and adults with CNS PNET. The records of 26 patients (11 children and 15 adults) with CNS PNET from 1991 to 2011 were reviewed retrospectively. Disease-free survival (DFS) and overall survival (OS) were estimated with the Kaplan-Meier method, and relevant prognostic factors were analyzed. For the cohort, both the 5-year DFS and the OS were 46 %. For pediatric patients, the 5-year DFS was 78 %; for adult patients, it was 22 % (P = 0.004). Five-year OS for the pediatric and adult patients was 67 and 33 %, respectively (P = 0.07). With bivariate analysis including chemotherapy regimen (high dose vs. standard vs. nonstandard) or risk stratification (standard vs. high) and age, the increased risk of disease recurrence in adults persisted. A nonsignificant tendency toward poorer OS in adult patients relative to pediatric patients also persisted. High-dose chemotherapy with stem cell rescue was associated with a statistically significant improvement in OS and a tendency toward improved DFS, although the findings were mitigated when the effect of age was considered. Local recurrence was the primary pattern of treatment failure in both adults and children. Our results suggest that adult patients with CNS PNETs have inferior outcomes relative to the pediatric cohort. Further research is needed to improve outcomes for CNS PNET in populations of all ages.
Watson, A; Watson, B
The general aim of designated driver programs is to reduce the level of drink driving by encouraging potential drink drivers to travel with a driver who has abstained from (or at least limited) consuming alcohol. Designated driver programs appear to be quite widespread around the world, however a limited number have been subject to rigorous evaluation. This paper reports results from an outcome evaluation of a designated driver program called 'Skipper', which was trialled in a provincial city in Queensland, Australia. The outcome evaluation included surveys three weeks prior to (baseline), four months following (1st follow-up), and 16 months following (2nd follow-up) the commencement of the trial in both the 'intervention area' (baseline, n=202; 1st follow-up, n=211; 2nd follow-up, n=200) and a 'comparison area'(baseline, n=203; 1st follow-up, n=199; 2nd follow-up, n=201); and a comparison of random breath testing and crash data before and after the trial. The survey results indicate that awareness of the program in the intervention area was quite high four months following its introduction and that this was maintained at 16 months. The results also suggest that the 'Skipper' program and the related publicity had positive impacts on behaviour with an increase in the proportion of people participating in designated driver as a passenger. It is less clear, however, whether the 'Skipper' program impacted on other behaviours of interest, such as drink driving or involvement in alcohol-related crashes. Suggestions for further research and program improvement are discussed as well as limitations of the research.
Samaranayake, Premaratne; Dadich, Ann; Fitzgerald, Anneke; Zeitz, Kathryn
Purpose The purpose of this paper is to present lessons learnt through the development of an evaluation framework for a clinical redesign programme - the aim of which was to improve the patient journey through improved discharge practices within an Australian public hospital. Design/methodology/approach The development of the evaluation framework involved three stages - namely, the analysis of secondary data relating to the discharge planning pathway; the analysis of primary data including field-notes and interview transcripts on hospital processes; and the triangulation of these data sets to devise the framework. The evaluation framework ensured that resource use, process management, patient satisfaction, and staff well-being and productivity were each connected with measures, targets, and the aim of clinical redesign programme. Findings The application of business process management and a balanced scorecard enabled a different way of framing the evaluation, ensuring measurable outcomes were connected to inputs and outputs. Lessons learnt include: first, the importance of mixed-methods research to devise the framework and evaluate the redesigned processes; second, the need for appropriate tools and resources to adequately capture change across the different domains of the redesign programme; and third, the value of developing and applying an evaluative framework progressively. Research limitations/implications The evaluation framework is limited by its retrospective application to a clinical process redesign programme. Originality/value This research supports benchmarking with national and international practices in relation to best practice healthcare redesign processes. Additionally, it provides a theoretical contribution on evaluating health services improvement and redesign initiatives.
Hassett, Afton L; Wasserman, Ronald; Goesling, Jenna; Rakovitis, Kevin; Shi, Baorong; Brummett, Chad M
Data to fully evaluate the effectiveness of many commonly used interventions in the clinical pain management setting are inadequate. Clinical data collected for patient management often are not based on validated instruments, and this impedes the ability to conduct longitudinal research. To address these needs, modified patient intake and return visit forms were established and the Assessment of Pain Outcomes Longitudinal Electronic Data Capture system was developed. Data collection has been underway since November 22, 2010. As of December 7, 2011, 951 New Patient and 688 Return Visit forms had been entered. The forms have been well received, with less than 6.5% failing to complete at least 90% of the data requested. Accuracy of data entry is excellent, with an error rate of 1 in 11,250 potential data points. Data output converts easily to standard statistical programs. The creation of a pain outcomes database using validated measures and clinically relevant data is feasible.
Gugerty, Brian; Maranda, Michael; Rook, Dona
Measurement instruments to assess user satisfaction with Clinical Information Systems (CIS) and with the implementation of CIS are needed as part of multi-faceted evaluation of CIS. Seven years of experience in developing measurement instruments to assess staff satisfaction with CIS preceded the development effort that created the Clinical Information System Evaluation Scale (CISIES). The scale was developed using precursors of the CISIES and it was guided by an expert panel. Following its construction the 37-item measurement instrument was piloted as part of the assessment of a Critical Care Clinical Information System implementation at a medical center in Florida, USA. Results indicated satisfaction with the implementation, although not strong, at the time of administration. The results of the CISIES administration were used by informaticians at the research site to plan and execute an intervention to improve satisfaction with the implementation. Re-administration of the CISIES at the site to evaluate the success of this intervention is planned. The CISIES was found to be a useful instrument, easy to administer, acceptable to respondents, easy to score and understandable by non-researcher at the study site. Early indications are that it will be useful in the formative and summative evaluation of CIS implementations.
Novascone, M A
The focus of this study was on the development and field-testing of a set of behaviorally anchored rating scales for evaluating the clinical performance of dietetic students. The scales emphasized the application of skills and knowledge. A variation of the Smith-Kendall technique was used to develop the scales. The 42 participants involved in instrument development included dietetic students, didactic and clinical instructors, and dietetic practitioners. The completed instrument contained 8 dimension statements and 70 behavioral anchors. The instrument was field-tested in 16 clinical rotations within 8 dietetic education programs. Evaluators not only rated student performance but also critiqued the format and content of the scales. The mid-to-upper portions of each scale were used most frequently, and little score variation within or across programs was noted. The scales were deemed appropriate for formative evaluation; however, some evaluators who had to grade students' performance expressed a desire for performance standards defined in terms of grades. Because the process used to develop the instrument facilitated the articulation of performance criteria, it is recommended as a practical approach to setting performance standards.
Rahman, Mahboob; Hu, Bo; Appel, Lawrence J.; Charleston, Jeanne; Contreras, Gabriel; Faulkner, Marquetta L.; Hiremath, Leena; Jamerson, Kenneth A.; Lea, Janice P.; Lipkowitz, Michael S.; Pogue, Velvie A.; Rostand, Stephen G.; Smogorzewski, Miroslaw J.; Wright, Jackson T.; Greene, Tom; Gassman, Jennifer; Wang, Xuelei; Phillips, Robert A.
Summary Background and objectives Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for renal and cardiovascular outcomes is uncertain. This study assessed the relationship of baseline ABP profiles with CKD progression and subsequent cardiovascular outcomes to determine the prognostic value of ABP beyond that of clinic BP measurements. Design, setting, participants, & measurements Between 2002 and 2003, 617 African Americans with hypertensive CKD treated to a clinic BP goal of <130/80 mmHg were enrolled in this prospective, observational study. Participants were followed for a median of 5 years. Primary renal outcome was a composite of doubling of serum creatinine, ESRD, or death. The primary cardiovascular outcome was a composite of myocardial infarction, hospitalized congestive heart failure, stroke, revascularization procedures, cardiovascular death, and ESRD. Results Multivariable Cox proportional hazard analysis showed that higher 24-hour systolic BP (SBP), daytime, night-time, and clinic SBP were each associated with subsequent renal (hazard ratio, 1.17–1.28; P<0.001) and cardiovascular outcomes (hazard ratio, 1.22–1.32; P<0.001). After controlling for clinic SBP, ABP measures were predictive of renal outcomes in participants with clinic SBP <130 mmHg (P<0.05 for interaction). ABP predicted cardiovascular outcomes with no interaction based on clinic BP control. Conclusions ABP provides additional information beyond that of multiple clinic BP measures in predicting renal and cardiovascular outcomes in African Americans with hypertensive CKD. The primary utility of ABP in these CKD patients was to identify high-risk individuals among those patients with controlled clinic BP. PMID:22935847
Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun
Abstract Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients. HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization. A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan–Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21–2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00–1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12–2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08–2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables. Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients. PMID:27175661
Carlier, Pierre G.; Marty, Benjamin; Scheidegger, Olivier; Loureiro de Sousa, Paulo; Baudin, Pierre-Yves; Snezhko, Eduard; Vlodavets, Dmitry
Recent years have seen tremendous progress towards therapy of many previously incurable neuromuscular diseases. This new context has acted as a driving force for the development of novel non-invasive outcome measures. These can be organized in three main categories: functional tools, fluid biomarkers and imagery. In the latest category, nuclear magnetic resonance imaging (NMRI) offers a considerable range of possibilities for the characterization of skeletal muscle composition, function and metabolism. Nowadays, three NMR outcome measures are frequently integrated in clinical research protocols. They are: 1/ the muscle cross sectional area or volume, 2/ the percentage of intramuscular fat and 3/ the muscle water T2, which quantity muscle trophicity, chronic fatty degenerative changes and oedema (or more broadly, “disease activity”), respectively. A fourth biomarker, the contractile tissue volume is easily derived from the first two ones. The fat fraction maps most often acquired with Dixon sequences have proven their capability to detect small changes in muscle composition and have repeatedly shown superior sensitivity over standard functional evaluation. This outcome measure will more than likely be the first of the series to be validated as an endpoint by regulatory agencies. The versatility of contrast generated by NMR has opened many additional possibilities for characterization of the skeletal muscle and will result in the proposal of more NMR biomarkers. Ultra-short TE (UTE) sequences, late gadolinium enhancement and NMR elastography are being investigated as candidates to evaluate skeletal muscle interstitial fibrosis. Many options exist to measure muscle perfusion and oxygenation by NMR. Diffusion NMR as well as texture analysis algorithms could generate complementary information on muscle organization at microscopic and mesoscopic scales, respectively. 31P NMR spectroscopy is the reference technique to assess muscle energetics non-invasively during and
Netzer, R; Zollinger, E; Seiler, C; Cerny, A
OBJECTIVE—To evaluate recent changes in the spectrum and clinical presentation of infective endocarditis and to determine predictors of outcome. DESIGN—A retrospective case study. METHODS—Demographic, clinical, and echocardiographic characteristics were examined in 212 patients who fulfilled the Duke criteria for infective endocarditis between January 1980 and December 1995 to assess changes in clinical presentation and survival. RESULTS—Clinical presentation and course did not change significantly during the study period despite the concurrent introduction of new diagnostic tools (for example, transoesophageal echocardiography). In-hospital mortality was 15% and remained unchanged. Neurological symptoms on admission, arthralgia, and weight loss were all independent risk factors for adverse outcome (odds ratios 26.1, 6.2, and 4.2, respectively). Age, prosthetic valve disease, previous antibiotic treatment, renal insufficiency, surgical treatment, and the type of valve involved were not predictive of mortality. In contrast to all other major reports, Streptococcus viridans was the most common causative organism in intravenous drug users (52%). CONCLUSIONS—Despite the introduction of new diagnostic tools, the course of infective endocarditis has remained unchanged over a period of 16 years. Evidence of early dissemination of the disease to other sites was associated with adverse outcome. Even in elderly patients, early aggressive treatment seems to be effective. Keywords: infective endocarditis; outcome; prognostic factors PMID:10862581
Tracy, S M; Marino, G J; Richo, K M; Daly, E M
Dynamic healthcare market forces impel educators to search for innovative methods of academic assessment to measure learning outcomes. The clinical achievement portfolio is a creative and systematic tool for documenting continuous improvement of student clinical learning. The authors describe the use of the portfolio as a pilot project aimed at introducing reflective thinking and measuring clinical learning in undergraduate nursing education. Potential benefits of the clinical portfolio and implications for future research are proposed.
Lemma, Be-ede; Taye, Mulat; Hawando, Tegene; Bakke, August
Eighty-four urethral stricture patients and 73 controls were studied prospectively over a 6 months period in Tikur Anbessa Hospital from April to August 2000. The purpose of the study was to evaluate the use of International Prostate Symptom Score (IPSS) as an outcome measurement instrument for urethral stricture patients in Ethiopia. The Amharic translation of IPSS (IPSS Amh) was used in this study. Internal consistency was 0.91. Construct validity was 0.73. Test-retest reliability was 0.95. Sensitivity and specificity were 76% and 71% respectively. In conclusion the IPSS Amh was found to be valid for use in urethral stricture patients in Ethiopia. We recommend the wide use of this cheap and easily available clinical measurement instrument.
El-Hamamsy, Manal; Ghali, Ramy R; Saad, Amr S; Shaheen, Sara M; Salem, Ahmed M
Background FAS-670 A>G (rs1800682) and FASL-844 C>T (rs763110) polymorphisms have been previously correlated with clinical outcome of non-small cell lung cancer (NSCLC) and breast and bladder cancers. We investigated the influence of these polymorphisms on clinical outcome of malignant pleural mesothelioma (MPM) patients. Patients and methods In this cohort study (NCT02269878), 68 epithelioid MPM Egyptian patients treated with first-line platinum-based chemotherapy were recruited in the period between April 2014 and May 2015. The genotype analysis was performed using TaqMan® single-nucleotide polymorphism genotyping assay. The association between the selected polymorphisms and response rate, progression-free survival (PFS) and overall survival (OS) at 18 months was evaluated. Results The median age of patients was 55 years and 45.6% of them received platinum in combination with pemetrexed, while 54.4% received platinum in combination with gemcitabine. FASL-844 CC genotype was more common than expected in early-stage tumor (P=0.042). It was found that there was no association between the investigated polymorphisms and response rate or 18-month OS. However, the PFS rate at 18 months for FASL-844 CC genotype carriers was 45% versus 10.6% for FASL-844 CT/TT genotypes carriers (log-rank: 6.2; P=0.013). Also, the number of platinum-based cycles and tumor stage were found to be significant variables for PFS by univariate analysis (P≤0.001 and P=0.006, respectively). Stratified Cox regression showed that the carriers of FASL-844 CT/TT genotypes were still more susceptible to disease progression than carriers of FASL-844 CC genotype (adjusted HR =3.77, 95% CI: 1.34–10.62, P=0.012). Conclusion The results of this study suggest that FASL-844 C/T polymorphism could predict PFS in MPM patients receiving platinum-based chemotherapy; therefore, this should be further evaluated as a potential marker for the prediction of clinical outcome in patients with MPM. PMID:27853379
Wallace, C J; Lecomte, T; Wilde, J; Liberman, R P
This paper reports the psychometric characteristics of a measure that assesses the treatment outcomes of individuals with serious and persistent mental illness. Unlike other outcome measures, this one is designed to be embedded in the clinical process of planning and evaluating treatment. It collects individualized data, structures how the data are used to plan and evaluate a client's treatment, and produces aggregate information relevant for research and program purposes. Two parallel versions were developed: one for the client's self-report, and one for an informant's report. The self-report measure was administered by peer-interviewers to 244 community interviewees, and by inpatient peer-interviewers to 93 inpatient interviewees. The community interviewees also completed the BASIS-32 and SF-36. Informants for 103 of the community interviewees completed the informant version of the measure, and the CCAR. Inpatient staff completed the informant version for 161 inpatient residents without regard for matching the 93 inpatient interviewees. The two versions had acceptable internal consistency, test--retest, and interrater reliabilities. Correlations of the community interviewees' and informants' results with the BASIS-32, SF-36, and CCAR provided evidence of convergent and discriminant validity, as did contrasts between community and inpatients interviewees. The usefulness of the instrument for clinical, program and research purposes is discussed, with emphasis on the characteristics that enhance its value in clinical practice --- assessment of meaningful outcomes, operationalization of client empowerment, comprehensiveness, easy administration, and continuity across time and provider. Also discussed is a computer-based program to summarize and present the results in a rapid, clinically meaningful manner.
Sedehizadeh, Saam; Brook, J David; Maddison, Paul
Myotonic Dystrophy type 1 (DM1) is the most common form of adult onset muscular dystrophy. In this study we compared body composition in DM1 and matched controls and evaluated the relationship between these parameters and clinical outcome measures in DM1 patients. In addition we established the sensitivity to change of these measures in a prospective 18 month longitudinal study of the DM1 patient cohort. Clinical data, manual muscle testing (MMT), quantitative muscle testing (QMT) of ankle dorsiflexion, bilateral grip dynamometry, 6 minute walk test and a DM1 functional rating scale (DM1-Activ) were collected at baseline (n = 38) and 18 month follow-up (n = 36). The case-control analysis was performed comparing baseline data with 31 anthropometrically matched controls. Dual-energy X-ray absorptiometry (DEXA) was used to obtain regional measurements of fat-free mass index (FFMI) and fat mass index (FMI) and demonstrated significant reduction of FFMI in the legs (left p = 0.004; right p = 0.017) and trunk (p < 0.0001) and increased FMI localised to the trunk (p < 0.0001) in DM1 patients compared to controls. Regional left and right arm FFMI and FMI significantly positively and negatively correlated with grip strength and both total FFMI (p = 0.0009) and FMI (p = 0.02) decreased and increased by 0.38 kg/m(2) and 0.31 kg/m(2) respectively after 18 month follow-up. DEXA is likely to provide a useful secondary outcome measurement of disease progression in addition to muscle strength and timed functional tasks in clinical trials.
Remark, Romain; Lupo, Audrey; Alifano, Marco; Biton, Jerome; Ouakrim, Hanane; Stefani, Alessandro; Cremer, Isabelle; Goc, Jeremy; Régnard, Jean-Francois; Dieu-Nosjean, Marie-Caroline; Damotte, Diane
There is now growing evidence that the immune contexture influences cancer progression and clinical outcome of patients with non-small cell lung cancer (NSCLC). If chemotherapy is widely used to treat patients with advanced-stage NSCLC, it remains unclear how it could modify the immune contexture and impact its prognostic value. Here, we analyzed two retrospective cohorts, respectively composed of 122 stage III-N2 NSCLC patients treated with chemotherapy before surgery and 39 stage-matched patients treated by surgery only. In patients treated with neoadjuvant chemotherapy, the histological characteristics, the expression of PD-L1 protein, and the tumor immune microenvironment (CD8(+) T cells, DC-LAMP(+) mature dendritic cells, and CD68(+) macrophages) were evaluated and their prognostic value assessed together with standard clinical parameters. By analyzing pre- and post-treatment specimens, we did not find any changes in the PD-L1 expression. We also found that the tumor immune contexture in patients treated with neoadjuvant chemotherapy exhibited a similar pattern that the one found in chemotherapy-naive patients, with comparable densities of tumor-infiltrating CD8(+) and DC-LAMP(+) cells and a similar spatial organization. The percentage of residual viable tumor cells and the immune pattern (CD8(+) and DC-LAMP(+) cell densities) were significantly associated with the clinical outcome and allowed the identification of short- and long-term survivors, respectively. In multivariate analysis, the immune pattern was found to be the strongest independent prognostic factor. In conclusion, this study decrypts the complex interplay between cancer and immune cells in patients undergoing chemotherapy and supports potential beneficial synergistic effect of immunotherapy and chemotherapy.
Kawakita, Daisuke; Hosono, Satoyo; Ito, Hidemi; Oze, Isao; Watanabe, Miki; Hanai, Nobuhiro; Hasegawa, Yasuhisa; Tajima, Kazuo; Murakami, Shingo; Tanaka, Hideo; Matsuo, Keitaro
The association between smoking status and survival in oral cavity squamous cell carcinoma (OSCC) patients remains unclear. Therefore, we evaluated the association between smoking status before treatment and clinical outcome in OSCC patients. We conducted a retrospective cohort study of 222 OSCC patients who were treated at Aichi Cancer Center in Japan. Of these, 82 patients (36.9%) were non-smokers, 65 (29.3%) were light smokers (pack-years smoking (PY) <30), 54 (24.3%) were moderate smokers (30≤PY<60), and 21 (9.5%) were heavy smokers (60≤PY). The survival impact of pre-treatment smoking status was evaluated using multivariate proportional hazard models. Five-year overall survival for non-, light, moderate, and heavy smokers was 72.9% (95% confidence interval CI): (61.4-81.5), 85.5% (74.0-92.2), 59.9% (44.3-72.4) and 69.0% (42.8-85.0). Adjusted hazard ratios (HRs) for moderate and heavy smokers in comparison with light smokers were 2.44 (1.07-5.57, P=0.034) and 2.66 (0.97-7.33, P=0.058) and the dose-response relationship among smokers was statistically significance (P(trend)=0.024). In addition, adjusted HR for non-smokers relative to light smokers was 2.27 (0.84-6.15, P=0.108). We observed a suggestive heterogeneity in the impact of smoking status by treatment method (P for heterogeneity=0.069). Effect of smoking was evident only among the chemoradiotherapy or radiotherapy group. In this study, we found the significant positive dose-response relationship among smokers on clinical outcome in OSCC patients and that non-smokers were worse prognosis than light smokers. In addition, this effect might differ by treatment method.
Lu, Kang; Liliang, Po-Chou; Wang, Hao-Kuang; Chen, Jui-Sheng; Chen, Te-Yuan; Huang, Ruyi; Chen, Han-Jung
Background/objective Internal disk disruption (IDD), an early event of lumbar disk degeneration, is the most common cause of low back pain. Since increased intradiskal pressure (IDP) is associated with symptoms and progression of disk degeneration, unloading a painful disk with an interspinous process device (IPD) is a rational treatment option. The goal of this study was to evaluate the effectiveness of dynamic stabilization with an IPD in the treatment of symptomatic IDD of the lumbar spine. Patients and methods Patients with symptomatic IDD were treated with implantation of an IPD, the device for intervertebral assisted motion (DIAM). Diagnosis of IDD was based on typical MRI finding of posterior annular high-intensity zone and positive provocative test on discography. IDP was analyzed intraoperatively. Axial back and leg pain was evaluated with visual analog scale, functional status with Oswestry Disability Index, and final clinical outcomes with Odom criteria. Data from 34 patients followed up for at least 3 years were collected. Results DIAM implantation significantly reduced IDP (n=11, P<0.0001). All 34 patients reported symptom relief. Thirty-one patients (91%) remained symptom free until the last followups. Three patients (9%) experienced recurrence of pain, of which the causes were unrelated to the IDD or surgery. Disk status at the DIAM-implanted segments remained stable. Segmental flexion/extension mobility was preserved in 27 of 30 patients with preoperative mobility. No proximal or distal adjacent segment degeneration was observed. The final clinical outcomes were excellent/good in 31 and fair/poor in three patients. Conclusion For patients with symptomatic IDD, dynamic stabilization with DIAM provides pain relief and functional improvement. The implantation maintains disk status and prevents progression of disk degeneration, without compromising segmental flexion/extension mobility or causing adjacent segment degeneration. PMID:27826214
Casanova, J M; Sanmartín, V; Martí, R M; Morales, J L; Soler, J; Purroy, F; Pujol, R
The acquisition of competences (the set of knowledge, skills and attitudes required to perform a job to a professional level) is considered a fundamental part of medical training. Dermatology competences should include, in addition to effective clinical interviewing and detailed descriptions of skin lesions, appropriate management (diagnosis, differentiation, and treatment) of common skin disorders and tumors. Such competences can only be acquired during hospital clerkships. As a way of certifying these competences, we propose evaluating the different components as follows: knowledge, via clinical examinations or critical incident discussions; communication and certain instrumental skills, via structured workplace observation and scoring using a set of indicators; and attitudes, via joint evaluation by staff familiar with the student.
García Villar, C
Clinical guidelines are documents to help professionals and patients select the best diagnostic or therapeutic option. Elaborating guidelines requires an efficient literature search and a critical evaluation of the articles found to select the most appropriate ones. After that, the recommendations are formulated and then must be externally evaluated before they can be disseminated. Even when the guidelines are very thorough and rigorous, it is important to know whether they fulfill all the methodological requisites before applying them. With this aim, various scales have been developed to critically appraise guidelines. Of these, the AGREE II instrument is currently the most widely used. This article explains the main steps in elaborating clinical guidelines and the main aspects that should be analyzed to know whether the guidelines are well written.
Kvitland, Levi Røstad; Ringen, Petter Andreas; Aminoff, Sofie Ragnhild; Demmo, Christine; Hellvin, Tone; Lagerberg, Trine Vik; Andreassen, Ole Andreas; Melle, Ingrid
There is little knowledge about the role of the duration of untreated bipolar (DUB) illness in first-treatment bipolar disorder I (BD I), its association with symptoms at start of first treatment, and development over the first year, and limited knowledge about factors that influence the length of DUB. Substance use has shown to delay identification of primary psychiatric disorders, and while cannabis use is common in BD the role of cannabis in relationship to DUB is unclear. The aim of the present study is to examine the associations between DUB and key clinical outcomes at baseline in BD I, and at one year follow-up, and to evaluate the influence of cannabis use. Patients with first-treatment BD I (N=62) completed comprehensive clinical evaluations, which included both DUB and the number of previous episodes. There were no significant associations between DUB and key clinical outcomes. Longer duration from first manic episode to treatment was associated with risk of starting excessive cannabis use after onset of the bipolar disorder. The main finding is the lack of significant associations between features of previous illness episodes and clinical outcomes. Long duration of untreated mania seems to increase the risk for later cannabis use.
Gould, Madelyn S; Kalafat, John; Harrismunfakh, Jimmie Lou; Kleinman, Marjorie
In this study we evaluated the effectiveness of telephone crisis services/hotlines, examining proximal outcomes as measured by changes in callers' suicide state from the beginning to the end of their calls to eight centers in the U.S. and again within 3 weeks of their calls. Between March 2003 and July 2004, 1,085 suicide callers were assessed during their calls and 380 (35.0%) participated in the follow-up assessment. Several key findings emerged. Seriously suicidal individuals reached out to telephone crisis services. Significant decreases in suicidality were found during the course of the telephone session, with continuing decreases in hopelessness and psychological pain in the following weeks. A caller's intent to die at the end of the call was the most potent predictor of subsequent suicidality. The need to heighten outreach strategies and improve referrals is highlighted.
McNair, Peter D.; Fang, Jade; Schwarzwaelder, Stephan; Jackson, Terri
Background: Hospital-based clinicians have little information about the outcomes of their care, much less how those outcomes compare with those of their peers. A variety of care quality indicators have been developed, but comparisons tend to be hospitalwide, and often irrelevant to the practice and patient group of many hospital clinicians. Moreover, information is not enough to transform clinical practice, as the human response to such comparisons is, “I’m doing the best I know how.” What is needed is granular, clinically specific feedback with peer-mediated advice about how “positive deviants” achieve better results. Objective: This case study reports on the development and implementation of a web-accessible comparative outcomes tool, ExPLORE Clinical Practice, for hospitals and clinicians in California. Methods: We use iterative development and refinement of web tools to report comparative outcomes; incremental development of suites of procedure-patient outcome pairs specific to particular medical specialty groups; testing and refinement of response time metrics to reduce delays in report generation; and introduction of a comments section for each measure that assists with interpretation and ties results to strategies found to lead to better clinical outcomes. Results: To date, 76 reports, each with 115 to 251 statistically evaluated outcomes, are available electronically to compare individual hospitals in California to statewide outcomes. Discussion and Conclusions: ExPLORE Clinical Practice is one of a number of emerging systems that attempt to lever available data to improve patient outcomes. The ExPLORE Clinical Practice system combines a clinical focus on highly specific outcome measures with attention to technical issues such as crafting an intuitive user interface and graphic presentation. This case study illustrates the important advances made in using data to support clinicians to improve care for patients. We see this information as a way to
Irvine, D; Sidani, S; Hall, L M
Fiscal constraints have heightened attention to health care costs and patient outcomes as measures of health care system effectiveness. Determining which patient and costs outcomes nurses may be held accountable for requires differentiating the impact of dependent, independent and interdependent nursing activities. A nursing role effectiveness model that includes a number of structural variables is offered to help track quality improvement and research activities. Some of the nurse-sensitive patient outcomes that have been identified include: freedom from complications, clinical outcomes, functional health outcomes, knowledge outcomes, perceived health benefit (or satisfaction), and costs outcomes. This model can be used to evaluate the effectiveness of current as well as evolving nurse roles, processes, and structural changes.
Khoja, L; Horsley, L; Heesters, A; Machin, J D; Mitchell, C; Clamp, AR; Jayson, GC; Hasan, J
Introduction Treatment on a clinical trial is considered to be beneficial to oncology patients. However, supportive evidence for this is scarce. Trial effect describes the phenomenon of improved health outcomes in patients treated with standard of care (SOC) on trial compared to those receiving SOC outside of a clinical trial. We evaluated trial effect in patients with ovarian cancer treated at our tertiary cancer centre. Methods We performed a retrospective cohort study of patients with ovarian cancer treated at The Christie National Health Service Foundation Trust. Patients treated on one of three first-line clinical trials: (SCOTROC-4, ICON-5, ICON-7) were matched (for age, International Federation of Gynaecology and Obstetrics stage, surgical status and performance status) with individuals receiving the same SOC off trial. Survival was calculated using Kaplan-Meier methodology. Results 60 patients were evaluated; 30 on trial and 30 on SOC off trial. The median progression-free survival (PFS) was 21.8 months (control group) and 25.9 months (trial group), median overall survival (OS) was 64.3 months (control group) and 68.9 months (trial group). There was no difference in PFS (log-rank test: HR 0.87 (95% CI 0.48 to 1.54), p=0.6) or OS (log-rank test: HR 0.87 (95% CI 0.46 to 1.64), p=0.7) between groups. Conclusions Patient survival was similar regardless if treated on trial or as SOC. Our findings do not support trial effect, at least in a tertiary cancer centre. Clinical trial participation in specialised cancer centres promotes best practice to the benefit of all patients. These findings may impact discussions round consent of patients to trials and organisation of oncology services. PMID:27843621
Goble, John C.; Kronander, Torbjorn; Wilske, Nils-Olof; Yngvesson, Jonas T.; Ejderholm, Henrik; Ekstrom, Marie
We describe our experience in the design, installation and clinical evaluation o fan ultra-reliable PACS - a system in which the fundamental design constraint was system availability. This syste has ben constructed using commercial, off-the-shelf hardware and software, using an open system, standards-based approach. The system is deployed in the film-free Department of Pediatric Radiology at the Astrid Lindgren Barnsjukhus a nit of the Karolinska Institute in Stockholm, Sweden.
Chang, Ting-Chen; Hsiao, Sheng-Mou; Chen, Chi-Hau; Wu, Wen-Yih; Lin, Ho-Hsiung
Objective. To evaluate the clinical outcomes and urodynamic effects of tailored anterior transvaginal mesh surgery (ATVM) and tailored posterior transvaginal mesh surgery (PTVM). Methods. We developed ATVM for the simultaneous correction of cystocele and stress urinary incontinence and PTVM for the simultaneous correction of enterocoele, uterine prolapse, vaginal stump prolapse, and rectocele. Results. A total of 104 women enrolled. The median postsurgical follow-up was 25.5 months. The anatomic cure rate was 98.1% (102/104). Fifty-eight patients underwent urodynamic studies before and after surgeries. The pad weight decreased from 29.3 ± 43.1 to 6.4 ± 20.9 g at 3 months. Among the 20 patients with ATVM, 13 patients had objective stress urinary incontinence (SUI) at baseline while 8 patients came to have no demonstrated SUI (NDSUI), and 2 improved after surgery. Among the 38 patients who underwent ATVM and PTVM, 24 had objective SUI at baseline while 18 came to have NDSUI, and 2 improved after surgery. Mesh extrusion (n = 4), vaginal hematoma (n = 3), and voiding difficulty (n = 2) were noted postoperatively. Quality of life was substantially improved. Conclusions. Our findings document the advantages of these two novel pelvic reconstructive surgeries for pelvic organ prolapse, which had a positive impact on quality of life. ATVM surgery additionally provided an anti-incontinence effect. This clinical trial is registered at ClinicalTrials.gov (NCT02178735). PMID:26634203
Campos, Fábio Guilherme; Martinez, Carlos Augusto Real; Novaes, Marleny; Nahas, Sérgio Carlos; Cecconello, Ivan
Background/Aims Desmoid tumors (DTs) are rare, locally invasive neoplasms that may affect 10-25% of familial adenomatous polyposis (FAP) patients. Our aim was to evaluate incidence and clinical presentation among our patients, the potential impact on FAP outcome and to discuss treatment. Materials and methods Charts from 133 FAP (1977-2013) were reviewed. Patients with DTs were separated to retrieve demographic, clinical and management data. Follow-up was focused on disease evolution causing complications or death. Results 19 (14.3%) DTs were diagnosed, either after previous trauma (16) or during FAP surgery (3). This group comprised 8 men (42.1%) and 11 women (57.9%) with an average age of 32.9 years. Intervals from surgical trauma to DTs ranged from 7 to 60 months. ECMs were detected in 12 (63.1%) patients. DTs were located in the abdominal wall (8), abdominal cavity (8), abdominal wall and cavity (2) and left arm (1). Five patients (26.3%) referred family history of DTs. Patients presented severe complications such as small bowel obstruction (4) and hydronephrosis (2), being directly responsible for death in three patients. Conclusions (1) DTs developed in 14.3% of FAP, mostly after surgical trauma; (2) 30% caused severe morbidity; (3) identification of clinical risk factors may help surgeons to develop screening and therapeutic decisions.
Malekolkottab, Masoume; Shojaei, Lida; Khalili, Hossein; Doomanlou, Mahsa
Objective: In this study, frequency and antimicrobial sensitivity pattern of multidrug resistant (MDR) microorganisms were evaluated in a referral teaching hospital in Iran. Methods: Patients with MDR Gram-negative pathogens were followed during the course of hospitalization. Demographic data, baseline diseases, type of biological sample, isolated microorganism, type of infection, antibiotic regimen before the availability of the culture result and change in the antibiotic regimen following receiving the antibiogram results, response to the treatment regimen, and duration of hospitalization and patient's outcome were considered variables for each recruited patient. Findings: In 71% of the patients, antibiotic regimens were changed according to the antibiogram results. A carbapenem alone or plus amikacin or ciprofloxacin were selected regimens for patients with extended-spectrum beta-lactamase (ESBL) infections. For patients with probable carbapenem-resistant Enterobacteriaceae infections, a carbapenem plus colistin was the most common antibiotic regimen. Clinical response was detected in 54.5% of the patients who were treated based on the antibiogram results. Clinical response was higher in the ESBL producers (ESBL-P) than the non-ESBL-P infections (75% vs. 52%). However, this difference was not significant (P = 0.09). Most nonresponders (80%) had sepsis due to Klebsiella species. Finally, 41.9% of the patients were discharged from the hospital and 58.2% died. Conclusion: Same as other countries, infections due MDR microorganisms is increasing in the recent years. This type of resistance caused poor clinical response and high rate mortality in the patients. PMID:28331866
Khursheed, Omar; Haq, Ansarul; Rashid, Shakir; Manzoor, Nazeefa; Shiekh, Sarwar; Mushtaq, Muzaffar
Objectives Dislocation of the metacarpophalangeal joint of the thumb in children is an uncommon entity. The aim of this study was to evaluate the clinical outcome of pediatric patients with metacarpophalangeal joint dislocation of the thumb. Patients and Methods Ten pediatric patients with metacarpophalangeal joint dislocation of the thumb were evaluated. Patients were studied prospectively over a period of 3 years. Parameters studied included patient demographics, type of dislocation, management, and any complications. Results Mean age of patients was 6.8 years (range: 3–12 years). Seven patients underwent closed reduction and three patients were managed by open reduction. Of the total 10 patients, excellent results were obtained in 9 patients. One of the patients who reported on the fourth day of trauma and was managed by open reduction had mild joint stiffness with a range of motion of 10 to 40 degrees at final follow-up. None of these patients had infection or instability. Conclusion After thorough clinical and radiological examination, closed reduction can be done in incomplete and simple complete dislocations of metacarpophalangeal joint of the thumb. Repeated closed reduction should be avoided in complex complete injuries. Early mobilization is advised to prevent joint stiffness. PMID:27616822
Bersan, E; Volk, H A; Ros, C; De Risio, L
The aim of this retrospective study was to assess prevalence, risk factors, clinical presentation and outcome of phenobarbitone induced haematological abnormalities (PBIHA) in dogs. The medical records of two veterinary referral institutions were searched for dogs diagnosed with idiopathic epilepsy and treated with PB as monotherapy or polytherapy between March 2003 and September 2010. Sixteen dogs had PBIHA; the median age at diagnosis was 69.5 months. Phenobarbitone was administered at a median dose of 3 mg/kg twice a day for a median period of 100.5 days and the median serum phenobarbitone level was 19 μg/ml. Two dogs had neutropenia, three had anaemia and thrombocytopenia, two had anaemia and neutropenia; the remaining nine had pancytopenia. All dogs were referred for non-specific clinical signs. Phenobarbitone was discontinued after diagnosis, and the median time to resolution of PBIHA was 17 days. The prevalence and risk factors for PBIHA were evaluated from a questionnaire survey of referring practices to obtain more detailed follow-up on cases diagnosed with idiopathic epilepsy. The prevalence rate of PBIHA was 4.2%, and the condition occurred in dogs treated with standard therapeutic doses often within the first three months after starting treatment. Serial haematological evaluations should be therefore considered from the beginning of phenobarbitone therapy to allow early diagnosis and treatment of PBIHA.
Gao, Chong; Li, Li; Chen, Baoan; Song, Huihui; Cheng, Jian; Zhang, Xiaoping; Sun, Yunyu
Background The purpose of this study was to evaluate the clinical outcomes of transfusion-associated iron overload in patients with chronic refractory anemia. Methods Clinical manifestations, main organ function, results of computed tomography (CT), endocrine evaluation, and serum ferritin levels were analyzed retrospectively in 13 patients who were transfusion-dependent for more than 1 year (receiving >50 units of red blood cells) to determine the degree of iron overload and efficacy of iron-chelating therapy. Results Serum ferritin levels increased to 1,830–5,740 ng/mL in all patients. Ten patients had abnormal liver function. The CT Hounsfield units in the liver increased significantly in eleven patients, and were proportional to their serum ferritin levels. Skin pigmentation, liver dysfunction, and endocrine dysfunction were observed in nine patients with serum ferritin >3,500 ng/mL, eight of whom have since died. Interestingly, serum ferritin levels did not decrease significantly in nine transfusion-dependent patients who had received 15–60 days of iron-chelating therapy. Conclusion Transfusion-dependent patients may progress to secondary iron overload with organ impairment, which may be fatal in those who are heavily iron-overloaded. The CT Hounsfield unit is a sensitive indicator of iron overload in the liver. Iron chelation therapy should be initiated when serum ferritin is >1,000 ng/mL and continued until it is <1,000 ng/mL in transfusional iron-overloaded patients. PMID:24790419
Bernaldo-de-Quirós, Mónica; Estupiñá, Francisco J; Labrador, Francisco J; Fernández-Arias, Ignacio; Gómez, Laura; Blanco, Carmen; Alonso, Pablo
The aims of this paper are to analyze differences in sociodemographic and clinical characteristics among the various anxiety disorders treated in a Psychology Clinic, and the results of treatment in each anxiety disorder. Data from 282 patients of University Psychology Clinic at the Complutense University of Madrid, who had at least one diagnosis of anxiety according to DMS-IV-TR criteria, were analyzed. The most frequent anxiety disorders were nonspecific anxiety disorder (19.1%) and social phobia (18.8%). Significant differences were observed according to sex (in all disorders, the percentage of women was significantly higher than that of men, except for obsessive-compulsive disorder). Unspecific anxiety disorder required a smaller number of assessment and treatment sessions, whereas obsessive-compulsive disorder required a greater number of sessions. There were no significant differences between the percentage of patients who completed treatment and dropout rates in specific phobia, general anxiety disorder and obsessive-compulsive disorder. Differences between epidemiological and clinical data are discussed.
Singhi, Pratibha; Sahu, Jitendra Kumar; Sarkar, Jhuma; Bansal, Deepak
The opsoclonus-myoclonus syndrome is a distinct disorder characterized by opsoclonus, myoclonus, and ataxia, along with marked irritability and behavioral changes. Worldwide, data on its epidemiology, clinical features, and outcome are scarce. The aim of the study was to determine the clinical profile and outcome of children with this disorder. A retrospective study of all children admitted with a diagnosis of opsoclonus-myoclonus from 2000 to 2012 was done. Outcome was assessed on follow-up by direct assessment and by telephonic interview. Eleven patients with a diagnosis of opsoclonus-myoclonus were admitted over a 12-year period. Of the 11, 4 had paraneoplastic etiology. Children with paraneoplastic opsoclonus had more relapses and a poor outcome as compared to an idiopathic group. Paraneoplastic opsoclonus had a poor outcome in our experience.
VanDevanter, Donald R; Konstan, Michael W
Cystic fibrosis (CF) is a complex genetic disease characterized by death from loss of lung function. Therapies target pathophysiologic changes associated with pulmonary disease progression. Although therapeutic mechanisms differ, efficacy demonstration is limited to a few accepted outcome measures, each with shortcomings that are becoming more pronounced as CF population health improves. Pulmonary function improvement (as forced expiratory volume in 1 s [FEV1]) and reduction of pulmonary exacerbation risk are commonly used outcomes. Changes in FEV1 decline rate, quality of life, linear growth and/or weight gain are less utilized outcomes. Validated outcomes tend to work best in subjects with more aggressive or advanced lung disease and less so in healthier subjects. Assays of effects on primary therapeutic targets have yet to be validated as surrogate measures of clinical efficacy. As CF population health improves, it will become increasingly difficult to employ current clinical outcome measures to demonstrate efficacy. PMID:26146539
Kim, Chang-Wan; Lee, Chang-Rack; Seo, Seung-Suk; Gwak, Heui-Chul; Kim, Jung-Han; Park, Joon-Ho
Recently, some authors have performed partial lateral patellar facetectomy in total knee arthroplasty (TKA) and reported good results. However, research on partial lateral patellar facetectomy in TKA is still lacking. The aim of this study was to evaluate the clinical and radiologic results of partial lateral patellar facetectomies in patellar non-resurfacing and resurfacing TKAs. Total 251 TKAs (patellar non-resurfacing: 131; resurfacing: 120) that were followed up for at least 24 months to evaluate the clinical and radiologic results of partial lateral patellar facetectomies in patellar non-resurfacing and resurfacing TKAs were retrospectively reviewed. The radiologic evaluations involved assessments of the patellar tilt angle and the lateral patellar displacement, and the clinical evaluations involved assessments of the Knee Society knee score, Knee Society function score, Feller patellar score, and Kujala score. In patellar non-resurfacing TKA, the average postoperative patellar tilt angle and lateral patellar displacement of the group that did not undergo facetectomy were 7.0 ± 4.8 degrees and 2.4 ± 3.6 mm, respectively, and the average postoperative patellar tilt angle and lateral patellar displacement of the group that did undergo facetectomy were 4.0 ± 3.8 degrees and 0.7 ± 2.5 mm, respectively. Significant differences were observed in the postoperative patellar tilt angle and lateral patellar displacement (p < 0.001 and p = 0.004, respectively). In patellar resurfacing TKA, while the patellar tilt angle showed a significant difference between the group that underwent facetectomy (6.7 ± 3.1 degrees) and the group that did not (8.3 ± 4.4 degrees) (p = 0.023), it exhibited no difference in the lateral patellar displacement between the two groups. In both patellar non-resurfacing TKA and resurfacing TKA, the postoperative clinical results did not show any difference between no-facetectomy group and facetectomy
Meredith, Ian T; Verheye, Stefan; Weissman, Neil J; Barragan, Paul; Scott, Douglas; Chávarri, Mariano Valdés; West, Nick E J; Kelbæk, Henning; Whitbourn, Robert; Walters, Darren L; Kubica, Jacek; Thuesen, Leif; Masotti, Monica; Banning, Adrian; Sjögren, Iwar; Stables, Rod H; Allocco, Dominic J; Dawkins, Keith D
Aims: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. Methods and results: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40±5.06% for PROMUS Element (PE) vs. 2.68±4.60% for SYNERGY (p=0.34) and 3.09±4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. Conclusions: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.
Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark
Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107
Asher, Lucy; Dean, Rachel S.
Objective To record and categorize the outcome measures used in dogs with naturally occurring osteoarthritis (OA) by systematically reviewing the peer reviewed publications on OA in dogs. Study Design Systematic literature review. Study Population Peer reviewed literature on canine OA. Methods A computer‐based bibliographic search was performed on PubMed and CAB Abstracts in August 2013 to find peer reviewed publications relevant to canine OA. Inclusion and exclusion criteria were applied. The outcome measures reported within each publication were recorded and categorized for comparison. Adequately described outcome measures were assessed for uniqueness and evidence of prior validation. Results Of 3,697 publications identified and screened, 117 were deemed eligible for inclusion. Within eligible publications, outcome measures were used 618 times (median of 4 outcome measures per publication). Outcomes measured were divided into 5 groups containing 65 categories. The most frequently assessed outcomes were lameness assessment with no stated gait/mixed gaits (66 outcomes), radiography (58), and lameness single gait/lateral motion (55). Of 618 outcome measures reported, 491 were assessed for uniqueness and 348 (71%) were unique to a single publication. Ten outcome measures were reported to have been validated. Conclusion Many outcome measures have been used to assess canine OA. There is no consensus on which are the most useful outcomes or by which method they should be assessed. There is a pressing need for agreement on outcomes reporting in canine OA and for validation of outcome measures used for these assessments. Until consensus is reached, we recommend at least one validated outcome measure be used in every clinical study. PMID:27120270
Berenson, Ariana; Vardanyan, Suzie; David, Michael; Wang, James; Harutyunyan, Nika Manik; Gottlieb, Jillian; Halleluyan, Ran; Spektor, Tanya M; Udd, Kyle A; Eshaghian, Shahrooz; Nassir, Youram; Eades, Benjamin; Swift, Regina; Berenson, James R
Despite recent advances made in its treatment, multiple myeloma (MM) remains an incurable B cell malignancy. Thus, the objective for treating these patients is to prolong overall survival (OS) and preserve patients' quality of life. We have analyzed data from 264 consecutive MM patients who had their initial visit between July 1, 2004 and December 1, 2014 and have received treatment in a single clinic specializing in MM. We determined their progression-free survival (PFS, OS, and 5-year OS). The PFS for frontline (n = 165 treatments), salvage (n = 980), and all treatments (n = 1145) were 13.9, 4.6, and 5.5 months, respectively. The median OS of all patients was 98 months with a 5-year survival of 74%. The results of this study show a marked improvement in OS for unselected MM patients compared with historical data. There were no significant differences in OS between patients with different International Staging System (ISS) stages. Younger patients (<65 years old) showed a longer OS. The results of this study should help physicians predict outcomes for MM patients and be encouraging for patients with this B cell malignancy.
Matsuda, Satoru; Takeuchi, Hiroya; Kawakubo, Hirofumi; Shimada, Ayako; Fukuda, Kazumasa; Nakamura, Rieko; Takahashi, Tsunehiro; Wada, Norihito; Kameyama, Kaori; Kitagawa, Yuko
Abstract The number of dissected lymph nodes (LNs), surgical outcomes, and postoperative recurrence-free survival (RFS) were compared between thoracic duct (TD)-preserved and TD-resected groups. The distribution of metastasis in LNs around TD (TDLN) was reviewed. Transthoracic esophagectomy (TTE) with TD resection for esophageal cancer patients has been one of the standard procedures. Because the adipose tissue surrounding the TD contains LNs, TD resection might be necessary for radical LN dissection. However, few studies have investigated the oncological outcome of TTE with TD resection. Two hundred fifty-six consecutive patients who underwent TTE between 2004 and 2015 were retrospectively reviewed and classified into TD-preserved or TD-resected groups. The number of dissected LNs for each LN station and surgical outcomes were compared. RFS was analyzed in 155 patients who underwent TTE before December 2012. Since 2013, the TDLN number was prospectively examined, independent of the regional LNs (n = 72). Of these, the TDLN number for each location (TDLN-Ut/Mt/Lt) was investigated and the correlation between TDLN metastasis and clinicopathological factors was analyzed. The TD was preserved in 89 patients and resected in 167 patients. Patients with TD resection showed significant advanced stage. There was no significant difference in the incidence of postoperative complications, including pneumonia, anastomotic leakage, and chylothorax. The number of dissected mediastinal LNs was significantly increased in the TD-resected group. The 5-year RFS rate of cStage I patients was 67.3% in the TD-preserved group against 90.3% in the TD-resected group, showing a tendency towards RFS extension that did not quite reach statistical significance (P = 0.055). The mean TDLN-Ut/Mt/Lt numbers were 0.89/0.56/0.44, respectively. Eight of 72 (11%) patients displayed TDLN metastasis. Metastatic TDLNs were observed on the same or cranial level of the primary lesion in 7 of 8 patients
Schmitt, Jochen; Langan, Sinéad; Stamm, Tanja; Williams, Hywel C
There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for "controlled trials" and "clinical recordkeeping". A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set.
Shenker, Rosalee C.
Background: There will always be a place for stuttering treatments designed to eliminate or reduce stuttered speech. When those treatments are required, direct speech measures of treatment process and outcome are needed in clinical practice. Aims: Based on the contents of published clinical trials of such treatments, three "core" measures of…
Lemos, Laurinda; Alegria, Carlos; Oliveira, Joana; Machado, Ana; Oliveira, Pedro; Almeida, Armando
In idiopathic trigeminal neuralgia (TN) the neuroimaging evaluation is usually normal, but in some cases a vascular compression of trigeminal nerve root is present. Although the latter condition may be referred to surgery, drug therapy is usually the first approach to control pain. This study compared the clinical outcome and direct costs of (1) a traditional treatment (carbamazepine [CBZ] in monotherapy [CBZ protocol]), (2) the association of gabapentin (GBP) and analgesic block of trigger-points with ropivacaine (ROP) (GBP+ROP protocol), and (3) a common TN surgery, microvascular decompression of the trigeminal nerve (MVD protocol). Sixty-two TN patients were randomly treated during 4 weeks (CBZ [n = 23] and GBP+ROP [n = 17] protocols) from cases of idiopathic TN, or selected for MVD surgery (n = 22) due to intractable pain. Direct medical cost estimates were determined by the price of drugs in 2008 and the hospital costs. Pain was evaluated using the Numerical Rating Scale (NRS) and number of pain crises; the Hospital Anxiety and Depression Scale, Sickness Impact Profile, and satisfaction with treatment and hospital team were evaluated. Assessments were performed at day 0 and 6 months after the beginning of treatment. All protocols showed a clinical improvement of pain control at month 6. The GBP+ROP protocol was the least expensive treatment, whereas surgery was the most expensive. With time, however, GBP+ROP tended to be the most and MVD the least expensive. No sequelae resulted in any patient after drug therapies, while after MDV surgery several patients showed important side effects. Data reinforce that, (1) TN patients should be carefully evaluated before choosing therapy for pain control, (2) different pharmacological approaches are available to initiate pain control at low costs, and (3) criteria for surgical interventions should be clearly defined due to important side effects, with the initial higher costs being strongly reduced with time. PMID:21941455
Patel, Devangkumar Rajnikant; O'Brien, Tim; Petrie, Aviva; Petridis, Haralampos
Purpose The purpose of this systematic review was to review clinical studies of fixed tooth-supported prostheses, and to assess the quality of evidence with an emphasis on the assessment of the reporting of outcome measurements. Multiple hypotheses were generated to compare the effect of study type on different outcome modifiers and to compare the quality of publications before and after January 2005. Materials and Methods An electronic search was conducted using specific databases (MEDLINE via Ovid, EMBASE via Ovid, Cochrane Library) through July 2012. This was complemented by hand searching the past 10 years of issues of the Journal of Oral Rehabilitation, Journal of Prosthetic Dentistry, Journal of Prosthodontics, and the International Journal of Prosthodontics. All experimental and observational clinical studies evaluating survival, success, failure, and complications of tooth-supported extracoronal fixed partial dentures, crowns, and onlays were included. No restrictions on age or follow-up time were placed. Results The electronic search generated 14,869 papers, of which 206 papers were included for full-text review. Hand-searching added 23 papers. Inclusion criteria were met by 182 papers and were included for the review. The majority were retrospective studies. Only 8 (4.4%) were randomized controlled trials. The majority of the studies measured survival and failure, and few studies recorded data on success; however, more than 60% of the studies failed to define survival, success, and failure. Many studies did not use any standardized criteria for assessment of the quality of the restorations and, when standardized criteria were used, they were modified, thereby not allowing for comparisons with other studies. There was an increase of 21.8% in the number of studies evaluating outcome measurements of all-ceramic restorations in past 8 years. Conclusions Prosthodontic literature presents with a reduced percentage of RCTs compared to other disciplines in
Lubiński, Wojciech; Kaźmierczak, Beata; Gronkowska-Serafin, Jolanta; Podborączyńska-Jodko, Karolina
Purpose. To evaluate the clinical outcomes after uncomplicated cataract surgery with implantation of an aspheric toric intraocular lens (IOL) during a 6-month follow-up. Methods. Prospective study including 27 consecutive eyes of 18 patients (mean age: 66.1 ± 11.4 years) with a visually significant cataract and corneal astigmatism ≥ 0.75 D and undergoing uncomplicated cataract surgery with implantation of the Tecnis ZCT toric IOL (Abbott Medical Optics). Visual, refractive, and keratometric outcomes as well as IOL rotation were evaluated during a 6-month follow-up. At the end of the follow-up, patient satisfaction and perception of optical/visual disturbances were also evaluated using a subjective questionnaire. Results. At 6 months after surgery, mean LogMAR uncorrected (UDVA) and corrected distance visual acuity (CDVA) were 0.19 ± 0.12 and 0.14 ± 0.10, respectively. Postoperative UDVA of 20/40 or better was achieved in 92.6% of eyes. Mean refractive cylinder decreased significantly from −3.73 ± 1.96 to −1.42 ± 0.88 D (p < 0.001), while keratometric cylinder did not change significantly (p = 0.44). Mean absolute IOL rotation was 1.1 ± 2.4°, with values of more than 5° in only 2 eyes (6.9%). Mean patient satisfaction score was 9.70 ± 0.46, using a scale from 0 (not at all satisfied) to 10 (very satisfied). No postoperative optical/visual disturbances were reported. Conclusion. Cataract surgery with implantation of the Tecnis toric IOL is an effective method of refractive correction in eyes with corneal astigmatism due to the good IOL positional stability, providing high levels of patient's satisfaction. PMID:27022478
McDonald, Craig M; McDonald, Dawn A; Bagley, Anita; Sienko Thomas, Susan; Buckon, Cathleen E; Henricson, Eric; Nicorici, Alina; Sussman, Michael D
In Duchenne muscular dystrophy, data directly linking changes in clinical outcome measures to patient-perceived well-being are lacking. This study evaluated the relationship between clinical outcome measures used in clinical trials of ambulatory Duchenne muscular dystrophy (Vignos functional grade, quantitative knee extension strength, timed functional performance measures, and gait velocity) and 2 health-related quality of life measures--the Pediatric Outcomes Data Collection Instrument and Pediatric Quality of Life Inventory-in 52 ambulatory Duchenne muscular dystrophy subjects and 36 controls. Those with the disease showed significant decrements in parent proxy-reported health-related quality of life measures versus controls across all domains. The Pediatric Outcomes Data Collection Instrument transfers/basic mobility and sports/ physical function and the Pediatric Quality of Life Inventory physical functioning domains had significant associations with age (and hence disease progression) and traditional clinical outcome measures employed in clinical trials of ambulatory boys with Duchenne muscular dystrophy. Selected domains of the Pediatric Outcomes Data Collection Instrument and generic Pediatric Quality of Life Inventory are potential patient-reported outcome measures for clinical trials in ambulatory individuals with the disease.
Emery, Paul; Solem, Caitlyn; Majer, Istvan; Cappelleri, Joseph C; Tarallo, Miriam
This retrospective medical chart review aimed to provide a current, real-world overview of biologic usage in patients with rheumatoid arthritis (RA) in Germany, Spain, and the UK, and estimate clinical and healthcare utilization outcomes associated with early versus late treatment. Adults (≥18 years) with a confirmed RA diagnosis between January 2008 and December 2010, who received biologic treatment for ≥3 months and had ≥12 months of follow-up were included. Early treatment was receipt of biologic agent ≤1 year after RA diagnosis. Outcomes included 28-joint disease activity score (DAS28) reduction of ≥1.2 from biologic start and remission (DAS28 < 2.6). Time to outcome was evaluated using Kaplan-Meier curves and log-rank tests. Of 328 patients enrolled (Germany [n = 111], Spain [n = 106], UK [n = 111]), 58.2 % received early biologic (Germany: 55.0 %, UK: 55.9 %, Spain: 64.2 %; p = 0.321). First-line biologics were more frequent in Spain (26.4 %) and Germany (19.8 %) versus the UK (7.2 %; p < 0.001). Late-treated patients were hospitalized more often than early-treated patients (10.5 vs 2.9 % [p = 0.006] for 9.0 vs 5.4 mean inpatient days [p = 0.408]). DAS28 was 5.1 at biologic initiation (n = 310); 73.5 % of patients had a DAS28 decrease of ≥1.2 and 44.5 % achieved remission. More patients had DAS28 decrease of ≥1.2 (79.2 vs 65.9 %; p = 0.009) and remission (51.1 vs 35.6 %; p = 0.007) with early versus late treatment, with a significant difference in Kaplan-Meier curves when indexing on time since diagnosis (p < 0.001) and biologic start (p = 0.024). In RA patients receiving biologic therapy, over half received biologic therapy early. Early initiation was associated with improved clinical outcomes and reduced hospitalization rates versus late treatment.
Li, Li; Lin, Chunqing; Guan, Jihui
Background The standardized patient approach has proved to be an effective training tool for medical educators. This article explains the process of employing standardized patients in an HIV stigma reduction intervention in healthcare settings in China. Methods The study was conducted in 40 hospitals in two provinces of China. One year after the stigma reduction intervention, standardized patients made unannounced visits to participating hospitals, randomly approached service providers on duty and presented symptoms related to HIV and disclosed HIV-positive test results. After each visit, the standardized patients evaluated their providers’ attitudes and behaviours using a structured checklist. Standardized patients also took open-ended observation notes about their experience and the evaluation process. Results Seven standardized patients conducted a total of 217 assessments (108 from 20 hospitals in the intervention condition; 109 from 20 hospitals in the control condition). Based on a comparative analysis, the intervention hospitals received a better rating than the control hospitals in terms of general impression and universal precaution compliance as well as a lower score on stigmatizing attitudes and behaviours toward the standardized patients. Conclusion Standardized patients are a useful supplement to traditional self-report assessments, particularly for measuring intervention outcomes that are sensitive or prone to social desirability. PMID:24369433
Wallace, C J
The purpose of this article is to use Senge's concepts of organizational learning as a framework for discussing issues and challenges in clinical outcomes research. Clinical outcomes research is about learning how to improve clinical practice. A learning organization balances attention to the structure and the culture in order to produce effective results. Future health care leaders will need to understand and attend to the importance of the organization's structure, but their greatest contribution will be in attending to the organizational culture to produce enduring organizational change.
Bae, Dong-Hyun; Won, Yu-Deok; Choi, Kyu-Sun; Cheong, Jin-Hwan; Yi, Hyeong-Joong; Kim, Choong-Hyun
Objective Because of the complex anatomical association among vascular, dural, and bony structures, paraclinoid internal carotid artery (ICA) aneurysms remain a major challenge for vascular neurosurgeons. We studied the clinical outcomes of 61 paraclinoid ICA aneurysms after microsurgical clipping in comparison with endovascular coiling. Materials and Methods Between January 2008 and December 2012, we treated 61 paraclinoid ICA aneurysms created by surgical clipping or endovascular coiling. Preoperative neurologic status and postoperative outcome were evaluated using the Glasgow coma scale (GCS) and the modified Rankin scale (mRS). Postoperative hydrocephalus and vasospasm were reviewed using the patients' medical charts. Results Most patients were in good clinical condition before the operations and had good treatment outcomes. Clinical vasospasm was observed after the operation in five patients, and hydrocephalus occurred in six patients. No statistically significant difference regarding aneurysm size, sex, GCS score, H-H grade, and mRS was observed between the surgical clipping group and the endovascular coiling group. In addition, the treatment results and complications did not show statistically significant difference in either group. Conclusion Surgical occlusion of paraclinoid ICA aneurysms is difficult; however, no significant differences were observed in the treatment results or complications when compared with coil embolization. In particular, use of an adequate surgical technique may lead to better outcomes than those for coil embolization in the treatment of large and/or wide-neck paraclinoid ICA aneurysms. PMID:25340024
Dunn, Clare Newton; Zhang, Qianpian; Sia, Josh Tjunrong; Assam, Pryseley Nkouibert; Tagore, Shephali; Sng, Ban Leong
Background and Aims: A decision-to-delivery interval (DDI) of 30 min for category-one caesarean section (CS) deliveries is the standard of practice recommended by clinical guidelines. Our institution established a protocol for category-one (‘crash’) CS to expedite deliveries. The aim of this study is to evaluate DDI, factors that affect DDI and the mode of anaesthesia for category-one CS. Methods: This retrospective cohort study evaluated 390 women who underwent category-one CS in a tertiary obstetric centre. We analysed the factors associated with DDI, mode of anaesthesia and perinatal outcomes. Summary statistics were performed for the outcomes. The association factors were considered significant at P < 0.05. Results: The mean (standard deviation) DDI was 9.4 (3.2) min with all deliveries achieved within 30 min. The longest factor in the DDI was time taken to transfer patients. A shorter DDI was not significantly associated with improved perinatal outcomes. The majority (88.9%) of women had general anaesthesia (GA) for category-one CS. Of those who had an epidural catheter already in situ (34.4%), 25.6% had successful epidural extension. GA was associated with shorter DDI, but worse perinatal outcomes than regional anaesthesia (RA). Conclusions: Our ‘crash’ CS protocol achieved 100% of deliveries within 30 min. The majority (88.9%) of the patients had GA for category-one CS. GA was found to be associated with shorter anaesthesia and operation times, but poorer perinatal outcomes compared to RA. PMID:27601736
Hara, Hironori; Aoki, Jiro; Tanabe, Kengo; Nishi, Akihiro; Tanimoto, Shuzou; Nakajima, Yoshifumi; Yahagi, Kazuyuki; Nakashima, Makoto; Hashimoto, Takuya; Asami, Masahiko; Watanabe, Mika; Yoshida, Eri; Nakajima, Hiroyoshi; Hara, Kazuhiro
The SYNTAX score stratifies risk among drug-eluting stent-treated patients and is based on lesion characteristics alone. The Clinical SYNTAX Score (CSS) combines the SYNTAX score with age, ejection fraction, and creatinine clearance. We assessed its ability to stratify long-term outcomes in sirolimus-eluting stents (SES)-treated patients. Between August 2004 and March 2005, 249 patients were treated with SES. Clinical follow-up was evaluated at more than 5 years. The CSS was available for 206 patients. More than 5-year clinical follow-up data (mean 2114 ± 107 days) and CSS (range 1-322, mean 35.3 ± 49.9, median 17.5) were available for 201 patients. We divided these scores into tertiles: CSS-LOW ≤ 9.5, 9.5 < CSS-MID ≤ 28, and CSS-HIGH > 28. CSS-HIGH was associated with a higher death rate (CSS-LOW 9.0 %, CSS-MID 11.9 %, CSS-HIGH 41.8 %; log-rank p < 0.001) and major adverse cardiovascular events (MACE) (CSS-LOW 29.8 %, CSS-MID 35.8 %, CSS-HIGH 61.2 %; log-rank p = 0.004). Independent predictors for death were hemodialysis [hazard ratio (HR) 3.82; p < 0.001], age (HR 1.67; p = 0.003), ejection fraction (HR 0.98, p = 0.012) and CSS (HR 1.73, p = 0.028), and those for MACE were hemodialysis (HR 2.53, p = 0.002) and CSS (HR 1.40, p = 0.028). Areas under the curve for the SYNTAX score and CSS for death were 0.60 and 0.78 (p < 0.001), whereas those for MACE were 0.58 and 0.68 (p < 0.001), respectively. The CSS predicts long-term outcomes among SES-treated patients better than the SYNTAX score.
Song, Jessica C; Stevens, David A
Over the past decade, echinocandins have emerged as first-line antifungal agents for many Candida infections. The echinocandins have a unique mechanism of action, inhibiting the synthesis of β-1,3-d-glucan polymers, key components of the cell wall in pathogenic fungi. Caspofungin was the first echinocandin antifungal agent to become licensed for use. The objectives of this review are to summarize the existing published data on caspofungin, under the subject headings of chemistry and mechanism of action, spectrum of activity, pharmacodynamics, pharmacokinetics, clinical studies, safety, drug interactions, dosing, and an overview of the drug's current place in therapy.
Hussain, Samia; Knight, Simon R
Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.
Xiang, Youqun; Chen, Yizuo; Qu, Jinmiao
Although a few studies have assessed the prognostic value of long noncoding RNA HOTTIP in patients with malignant tumors, the relationship between HOTTIP and clinical outcome of breast cancer remains elusive. The aim of this study is to explore the prognostic significance of HOTTIP in breast cancer patients. A meta-analysis was performed to involve the eligible studies to investigate the association of HOTTIP expression level with outcome in cancer patients. Pooled hazard ratios (HRs) and 95% confidence interval (CI) of HOTTIP for cancer survival were calculated. Five relevant articles involving 460 patients with various solid carcinomas were included in this meta-analysis. For overall survival, high HOTTIP expression could significantly predict worse outcome with the pooled HR of 2.29 (95 % CI 1.72–3.03, P < 0.00001). Furthermore, Gene Expression Omnibus was performed to evaluate the association of HOTTIP expression with the prognosis in breast cancer patients. It was also found an indication that high HOTTIP expression was associated with worse survival in breast cancer patients by microarray analysis (GSE20711, GSE16446 and GSE9195). Finally, association between HOTTIP levels and clinicopathological factors and prognosis was also analyzed in an independent validation cohort including 100 breast cancer cases. HOTTIP expression was correlated with tumor size (P=0.025), lymph node status (P=0.009) and TNM stage (P=0.0001) in the breast cancer validation cohort. The Kaplan-Meier survival curves indicated that breast cancer patients with high HOTTIP expression had worse overall survival (P=0.0139) and disease-free survival (P=0.0003). Multivariate survival analysis based on the Cox proportional hazards model showed that HOTTP is considered as an independent prognostic factor in breast cancer patients. Together, our combined results suggest that high HOTTIP expression may be serving as an unfavorable prognosis predictor for breast cancer patients. PMID:28036281
Lingman, G; Lundström, N R; Marsál, K
By means of abdominal fetal ECG and non-invasive ultrasound blood flow studies 113 cases of fetal cardiac arrhythmia were classified according to the origin of arrhythmia. Pregnancy outcome was characterized by an increased frequency of fetal distress and heart malformation, and increased fetal and neonatal mortality. The following types of arrhythmia were identified: supraventricular extrasystoles (n = 84), paroxysmal tachycardia (n = 6), sinus bradycardia (n = 3), atrial flutter (n = 1), ventricular extrasystoles (n = 14), and atrioventricular block (n = 5). In 37 cases the combined Doppler and real-time ultrasound technique was used to measure fetal aortic blood flow as a means of studying the circulatory effects of the arrhythmia. Increased peak velocity, rising slope and acceleration were found in the first post-pausal beat after a supraventricular extrasystole or a missed beat; this supports the validity of Frank-Starling law for the fetal heart and suggests that a strong relationship exists between these variables and myocardial contractility. In two cases of intra-uterine heart failure, the effect of digoxin treatment in utero on the fetal aortic flow variables was studied, results indicating a positive inotropic effect of the drug on the fetal myocardium. The estimation of fetal aortic volume blood flow in cases of fetal cardiac arrhythmia is useful for early detection of fetal cardiac failure, and for monitoring the effects of intra-uterine treatment.
de Andrea, Carlos E; Petrilli, Antonio Sergio; Jesus-Garcia, Reynaldo; Bleggi-Torres, Luiz F; Alves, Maria Teresa S
Osteosarcoma is the most frequent primary malignant bone tumor. Distinct histological features are distinguishable based on the morphology of the tumor. Differences in nuclei size and shape are often observed in osteosarcoma reflecting its broad histopathological heterogeneity. This study explores the relevance of two nuclear parameters in osteosarcoma: large area and round shape. Computerized nuclear morphometry was performed in 56 conventional osteosarcoma preoperative biopsies. The mean patient follow-up time was 35.1 months. Based on the nuclear area, no significant difference (P = 0.09) in overall survival between patients with large (> 42.5 μm2) and small (< 42.5 μm2) tumor nuclei was found. However, when cases with large and round nuclei were analyzed jointly (> 42.5 μm2 and coefficient of nuclear roundness > 0.7), these two parameters together were likely to be a predictive factor (P = 0.05). Osteosarcoma patients with large and round tumor nuclei had a better outcome than patients with small and polymorphic (ovoid or spindle-shaped) nuclei. In this study, nuclear morphometry proved to be a useful tool to shed light on the biology of osteosarcoma showing that some morphometric parameters can be easily applied to help identifying patients with a good prognosis. PMID:21326812
Shapiro, Melissa; Bires, Angela Macci; Waterstram-Rich, Kristen; Cline, Thomas W
Heart failure (HF) is a serious medical problem in the United States and is placing a financial strain on the health care system. It is the leading cause of mortality and as the overall incidence continues to increase, so does the economic impact on the health care system. Innovative treatment options, in the form of disease management programs and implantable cardiac devices, such as the CorVue capable implantable cardioverter defibrillator (ICD) pacemaker, offer the promise of an enhanced quality of life and reduced mortality. Even with these advances, HF continues to be a challenge. Studies reviewing HF management programs have shown promising results. However, more studies are needed to determine which combination of HF management interventions has the greatest financial impact and yields the best patient outcomes. The objective of the research study was to compare 30-day readmission rates of patients implanted with the CorVue capable ICD pacemaker with patients with congestive heart failure (CHF) with no implanted device. The aim of the research focused on the usefulness of intrathoracic impedance monitoring alerts in guiding empirical treatment of patients with CHF to prevent HF readmissions. Methodology included a retrospective medical chart review, comparing 30-day readmission events among patients with class III CHF who received home health intervention with similar patients implanted with the CorVue ICD.
Agnelli, Giancarlo; Bolis, Giorgio; Capussotti, Lorenzo; Scarpa, Roberto Mario; Tonelli, Francesco; Bonizzoni, Erminio; Moia, Marco; Parazzini, Fabio; Rossi, Romina; Sonaglia, Francesco; Valarani, Bettina; Bianchini, Carlo; Gussoni, Gualberto
Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21–5.71), previous VTE (5.98, 2.13–16.80), advanced cancer (2.68, 1.37–5.24), anesthesia lasting more than 2 hours (4.50, 1.06–19.04), and bed rest longer than 3 days (4.37, 2.45–7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion
Nambudiri, V E; Dwyer, R C; Camargo, C A; Kupper, T S; Pallin, D J
The US Food and Drug Administration has scrutinized clinical trial methodology in cellulitis, partly because the definition and timing of cure are debatable. We analysed the validity of telephone self-report as a proxy for in-person follow up in a cellulitis treatment trial comparing cephalexin alone with cephalexin-plus-trimethoprim/sulfamethoxazole. Our results demonstrate poor agreement between these two methods of outcome determination and have implications for future cellulitis clinical trial design and clinical management.
Matsuhashi, Tomoya; Iwasaki, Norimasa; Kato, Hiroyuki; Minami, Michio; Minami, Akio
We have carried out a replacement of the lunate in 12 patients with advanced Kienböck's disease, with excision of the lunate and insertion of an iliac bone flap wrapped into palmaris longus. The aims of this study were to determine the effect of this procedure for advanced Kienböck's disease. At a mean follow-up period of 45.3 months, the mean clinical score was excellent in all cases. Radiographically, progression of osteoarthritis (OA) in the radiocarpal joint was found in two patients. At follow-up, the X-ray findings indicated a reduced of osseous core in four patients. On the other hand, carpal height ratio showed no significant change at follow-up. Excision arthroplasty using a tendon ball with osseous core for advanced Kienböck's disease leads to OA progression in some cases. However, clinical results were excellent in all cases. Therefore, this current study provides effective therapeutic procedure for advanced Kienböck's disease.
Zhang, Xiao-Ying; Zhang, Pei-Ying
Combination approach could be easily considered as the future of therapeutics in all pathological states including cancer. Scientists are trying different combinations in order to determine synergism among different therapeutics which ultimately helps in the improved and more efficient management of the affected patients. Combination of multi-chemotherapeutic agents, or multi-drug therapy, may be the most commonly used strategy for cancer treatment. Monotherapy causes drug resistance and loses its response in patients after several cycles of treatmen