Impact of tofacitinib on patient outcomes in rheumatoid arthritis – review of clinical studies

Directory of Open Access Journals (Sweden)

Boyce EG

2016-01-01

Full Text Available Eric G Boyce, Deepti Vyas, Edward L Rogan, Cynthia S Valle-Oseguera, Kate M O'Dell Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USAAbstract: Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0–100 mm visual analog scale, patient global assessment of disease (using a 0–100 mm visual analog scale, patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other

Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

International Nuclear Information System (INIS)

Costalat, V.; Lobotesis, K.; Machi, P.; Mourand, I.; Maldonado, I.; Heroum, C.; Vendrell, J.F.; Milhaud, D.; Riquelme, C.; Bonafé, A.; Arquizan, C.

2012-01-01

Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

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Costalat, V., E-mail: vincentcost@hotmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Lobotesis, K., E-mail: kyriakos@lobotesis.co.uk [CHU Montpellier, Neuroradiology, Montpellier (France); Machi, P., E-mail: paolo.machi@gmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Mourand, I., E-mail: i-mourand@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Maldonado, I., E-mail: imaldonado@terra.com.br [CHU Montpellier, Neuroradiology, Montpellier (France); Heroum, C., E-mail: c-heroum@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Vendrell, J.F., E-mail: jf-vendrell@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Milhaud, D., E-mail: d-milhaud@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Riquelme, C., E-mail: c-riquelme@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Bonafé, A., E-mail: a-bonafe@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Arquizan, C., E-mail: c-arquizan@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France)

2012-12-15

Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

Science.gov (United States)

Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

2017-05-01

According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

CLINICAL OUTCOME AFTER OPERATIVE TREATMENT IN FLOATING SHOULDER- A PROSPECTIVE STUDY

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Nabarun Saha

2017-06-01

Full Text Available BACKGROUND The ‘floating shoulder’ is a rare injury consisting of ipsilateral fractures of the clavicle and glenoid neck. Although it may appear to be bony injury, studies suggest that ligamentous disruption associated with ipsilateral clavicle fracture and scapular neck fracture contributes to such entity. More commonly floating shoulder is defined as double disruption of the superior shoulder suspensory complex. Open reduction and internal fixation of both the fractures is the treatment of choice. We have made this study to assess clinical outcome after operative treatment of floating shoulder by DASH score. MATERIALS AND METHODS This is a study of 10 cases of floating shoulder injury operated in the same sitting by anterior approach for fracture clavicle and Judet’s posterior approach for scapula fracture from Jan 2014 to Oct 2016. All cases were assessed with DASH score at the end of six months. RESULTS Results of our study shows that majority of patients had excellent to good results with improvement in DASH score from 92.8 to 16.8 at final follow up. No major complications. All patients had radiological signs of union at the end of 1 year. CONCLUSION Surgical intervention should be considered for all floating shoulder injuries. open reduction and internal fixation not only increases stability but also to improves functional outcome of the patient. DASH score is an effective method to assess clinicofunctional outcome in post-operative cases of floating shoulder.

Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

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Doolittle, B R; Justice, A C; Fiellin, D A

2018-06-01

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.

Basic clinical characteristics and hospital outcomes of acute ...

African Journals Online (AJOL)

Basic clinical characteristics and hospital outcomes of acute coronary syndrome patients - Sudan. A.M. Taha, H.O. Mirghani. Abstract. Background: There are Variation in the presentation of the acute coronary syndrome between countries. The present study aimed to investigate the basic clinical characteristics and ...

Clinical patterns and outcomes of ischaemic colitis: results of the Working Group for the Study of Ischaemic Colitis in Spain (CIE study).

Science.gov (United States)

Montoro, Miguel A; Brandt, Lawrence J; Santolaria, Santos; Gomollon, Fernando; Sánchez Puértolas, Belén; Vera, Jesús; Bujanda, Luis; Cosme, Angel; Cabriada, José Luis; Durán, Margarita; Mata, Laura; Santamaría, Ana; Ceña, Gloria; Blas, Jose Manuel; Ponce, Julio; Ponce, Marta; Rodrigo, Luis; Ortiz, Jacobo; Muñoz, Carmen; Arozena, Gloria; Ginard, Daniel; López-Serrano, Antonio; Castro, Manuel; Sans, Miquel; Campo, Rafael; Casalots, Alex; Orive, Víctor; Loizate, Alberto; Titó, Lluçia; Portabella, Eva; Otazua, Pedro; Calvo, M; Botella, Maria Teresa; Thomson, Concepción; Mundi, Jose Luis; Quintero, Enrique; Nicolás, David; Borda, Fernando; Martinez, Benito; Gisbert, Javier P; Chaparro, María; Jimenez Bernadó, Alfredo; Gómez-Camacho, Federico; Cerezo, Antonio; Casal Nuñez, Enrique

2011-02-01

There is a lack of prospective studies evaluating the natural history of colonic ischaemia (CI). We performed such a study to evaluate the clinical presentation, outcome, and mortality as well as clinical variables associated with poor prognosis. An open, prospective, and multicentre study was conducted in 24 Spanish hospitals serving a population of 3.5 million people. The study included only patients who met criteria for definitive or probable CI. A website (www.colitisisquemica.org) provided logistical support. A total of 364 patients met criteria for inclusion. CI was suspected clinically in only 24.2% of cases. The distribution of clinical patterns was as follows: reversible colopathy (26.1%), transient colitis (43.7%), gangrenous colitis (9.9%), fulminant pancolitis (2.5%), and chronic segmental colitis (17.9%). A total of 47 patients (12.9%) had an unfavorable outcome as defined by mortality and/or the need for surgery. Multivariate analysis identified the following signs as independent risk factors for an unfavorable outcome: abdominal pain without rectal bleeding [odds ratio (OR) 3.9; 95% confidence interval (CI) = 1.6-9.3], non-bloody diarrhoea (OR 10; 95% CI = 3.7-27.4), and peritoneal signs (OR 7.3; 95% CI = 2.7-19.6). Unfavorable outcomes also were more frequent in isolated right colon ischaemia (IRCI) compared with non-IRCI (40.9 vs. 10.3%, respectively; p < 0.0001). The overall mortality rate was 7.7%. The clinical presentation of CI is very heterogeneous, perhaps explaining why clinical suspicion of this disease is so low. The presence of IRCI, and occurrence of peritoneal signs or onset of CI as severe abdominal pain without bleeding, should alert the physician to a potentially unfavorable course.

Physiotherapy-led arthroplasty review clinic: a preliminary outcomes analysis.

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Large, Kate E; Page, Carolyn J; Brock, Kim; Dowsey, Michelle M; Choong, Peter F M

2014-11-01

With the rising demand for Orthopaedics in the healthcare sector, service delivery innovations need to be explored to accommodate the increasing workload. Senior Musculoskeletal Physiotherapists have the specialised skills in the assessment of musculoskeletal conditions to determine the impact of surgery on patient outcomes. The aim of the present study was to compare outcomes between a physiotherapy-led arthroplasty review clinic (PT clinic) and the traditional model of orthopaedic surgeon review (OS clinic) after hip and knee replacement. This study was a retrospective case-controlled audit using a comprehensive database. Twenty-four patients who had a hip arthroplasty and 52 patients who had a knee arthroplasty were reviewed solely by the PT clinic at 3, 6 and 12 months after surgical reviews. These patients were matched 1:2 against patients seen only by the OS clinic. The outcome measures included International Knee Score (IKS), Harris Hip Score (HHS) and the Short Form (SF)-12. There were no significant differences in HHS or SF-12 scores for patients after hip arthroplasty. Significant differences for knee arthroplasty were observed favouring the PT clinic; IKS, PT clinic 147.6 (37.07), OS clinic 135.4 (35.68), P≤0.01, and physical component of the SF-12, PT clinic 41.98 (10.45), OS clinic 37.20 (10.44), Pphysiotherapy-led arthroplasty review clinic appears to be a safe and effective service alternative to reviews conducted by orthopaedic surgeons. WHAT IS KNOWN ABOUT THE TOPIC?: Osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability and the burden of the disease is rapidly increasing. Joint arthroplasty surgery is the mainstay of treatment for people with end-stage OA; it is a high-cost, high-volume procedure that dominates surgical wait lists around Australia. Long-term follow up is encouraged by the Arthroplasty Society of Australia and endorsed by the Australian Orthopaedics Association, but it is acknowledged that it is impossible

The Clinical Research Office of the Endourological Society Ureteroscopy Global Study: Indications, Complications, and Outcomes in 11885 Patients

DEFF Research Database (Denmark)

De La Rosette, Jean; Denstedt, John D; Geavlete, Petrisor A

2013-01-01

Purpose: To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system. Patients and Methods: The Clinical Research Office of the Endourological Society (CROES) collected...... prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. Stone size and location were recorded and postoperative outcome and complications, graded...

Clinical Outcome Metrics for Optimization of Robust Training

Science.gov (United States)

Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

2016-01-01

Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (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. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

Prolactinomas : clinical studies

NARCIS (Netherlands)

Kars, Marleen

2008-01-01

Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

Correlating nerve conduction studies and clinical outcome measures on carpal tunnel syndrome: lessons from a randomized controlled trial

NARCIS (Netherlands)

Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; Vet, de H.C.W.; Bouter, L.M.

2005-01-01

0.4) were found between the neurophysiologic and clinical outcome measures after 12 months, and between the changes in these different categories of outcome measures. This study confirms that the parameters of NCS improve significantly after treatment for CTS, but the modest correlations between

Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study

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Tadesse Melaku Abegaz

2017-01-01

Full Text Available Background. There is paucity of data on prevalence of Adverse Drug Reactions (ADRs and adherence and clinical outcomes of antidepressants. The present study determined the magnitude of ADRs of antidepressants and their impact on the level of adherence and clinical outcome. Methods. A prospective cross-sectional study was conducted among depression patients from September 2016 to January 2017 at Gondar University Hospital psychiatry clinic. The Naranjo ADR probability scale was employed to assess the ADRs. The rate of medication adherence was determined using Morisky Medication Adherence Measurement Scale-Eight. Results. Two hundred seventeen patients participated in the study, more than half of them being males (122; 56.2%. More than one-half of the subjects had low adherence to their medications (124; 57.1% and about 186 (85.7% of the patients encountered ADR. The most common ADR was weight gain (29; 13.2%. More than one-half (125; 57.6% of the respondents showed improved clinical outcome. Optimal level of medication adherence decreased the likelihood of poor clinical outcome by 56.8%. Conclusion. ADRs were more prevalent. However, adherence to medications was very poor in the setup. Long duration of depression negatively affects the rate of adherence. In addition, adherence was found to influence the clinical outcome of depression patients.

Clinical characteristics and outcomes of septic bursitis.

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Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

2017-12-01

Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.

Antenatal clinical pelvimetry in primigravidae and outcome of labour ...

African Journals Online (AJOL)

Method: A retrospective study of clinical pelvimetry and outcome of labour in primigravidae. Results: The total number of primigravidae included in the study was 268 and of these, 74 were adjudged to have adequate pelvis at antenatal clinical pelvimetry. The APGAR scores at one and five minutes were significantly higher ...

Clinical predictors of outcome in vitiligo

Directory of Open Access Journals (Sweden)

Dave Shriya

2002-11-01

Full Text Available The significant inter-patient variability in progression, and response to therapy makes it a great challenge for the physician to predict the outcome of vitiligo at the very outset. Subjective factors like stress, pregnancy, sunburn and illness have been identified as aggravating factors for vitiligo. However, a few studies have evaluated the statistical significance of objective clinical parameters in predicting the outcome of vitiligo. Our retrospective analysis of 199 consecutive patients with vitiligo who presented to our OPD was aimed at evaluation of these objective clinical parameters utilizing a standard proforma. Patients already on treatment, and those with duration of disease less than 6 months were excluded from the study. Progression was defined as an increase in size or number of lesions in the 3 months prior to presentation. In all 76. 9% patients had progression of vitiligo. The clinical parameters significantly associated with progression were a positive family history (p=0. 027, mucosal involvement (p=0. 032, Koebner′s phenomenon (p=0. 036 and nonsegmental vitiligo (p=0. 033. Thrichrome sign, leucotrichia, longer duration and higher age at onset did not correlate significantly with progression. The one significant observation that we found to have the poor prognostic implication in vitiligo is the presence of mucosal vitiligo. The clinical prediction of disease progression at the outset enables the physician to set realistic treatment goals and optimize the therapeutic regimen for the individual patient.

Social cognitive markers of short-term clinical outcome in first-episode psychosis.

Science.gov (United States)

Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

2010-07-01

In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (psocial cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

Predictors of clinical outcome following lumbar disc surgery

DEFF Research Database (Denmark)

Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.

2016-01-01

scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability....... CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

Science.gov (United States)

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

Common Factor Mechanisms in Clinical Practice and Their Relationship with Outcome.

Science.gov (United States)

Gaitan-Sierra, Carolina; Hyland, Michael E

2015-01-01

This study investigates three common factor mechanisms that could affect outcome in clinical practice: response expectancy, the affective expectation model and motivational concordance. Clients attending a gestalt therapy clinic (30 clients), a sophrology (therapeutic technique) clinic (33 clients) and a homeopathy clinic (31 clients) completed measures of expectancy and the Positive Affect and Negative Affect Schedule (PANAS) before their first session. After 1 month, they completed PANAS and measures of intrinsic motivation, perceived effort and empowerment. Expectancy was not associated with better outcome and was no different between treatments. Although some of the 54 clients who endorsed highest expectations showed substantial improvement, others did not: 19 had no change or deteriorated in positive affect, and 18 had the same result for negative affect. Intrinsic motivation independently predicted changes in negative affect (β = -0.23). Intrinsic motivation (β = 0.24), effort (β = 0.23) and empowerment (β = 0.20) independently predicted positive affect change. Expectancy (β = -0.17) negatively affected changes in positive affect. Clients found gestalt and sophrology to be more intrinsically motivating, empowering and effortful compared with homeopathy. Greater improvement in mood was found for sophrology and gestalt than for homeopathy clients. These findings are inconsistent with response expectancy as a common factor mechanism in clinical practice. The results support motivational concordance (outcome influenced by the intrinsic enjoyment of the therapy) and the affective expectation model (high expectations can lead for some clients to worse outcome). When expectancy correlates with outcome in some other studies, this may be due to confound between expectancy and intrinsic enjoyment. Common factors play an important role in outcome. Intrinsic enjoyment of a therapeutic treatment is associated with better outcome. Active engagement with a

Predictors of Clinical Outcomes in Sexually Abused Adolescents.

Science.gov (United States)

Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

2017-01-01

This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

Ebola outbreak in Conakry, Guinea: Epidemiological, clinical, and outcome features

OpenAIRE

Barry, M; Traoré, F A; Sako, F B; Kpamy, D O; Bah, E I; Poncin, M; Keita, S; Cisse, M; Touré, A

2014-01-01

The authors studied the epidemiological, clinical, and outcome features of the Ebola virus disease in patients hospitalized at the Ebola treatment center (ETC) in Conakry to identify clinical factors associated with death.

Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

Science.gov (United States)

Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

2016-05-01

Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

Science.gov (United States)

Ashley, Laura; Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

2013-10-25

Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both Pplanning and for targeting service provision.

Clinical Operations Variables are Associated With Blood Pressure Outcomes.

Science.gov (United States)

Kressin, Nancy R; Lasser, Karen E; Paasche-Orlow, Michael; Allison, Jeroan; Ash, Arlene S; Adams, William G; Shanahan, Christopher W; Legler, Aaron; Pizer, Steven D

2015-06-01

Uncontrolled blood pressure (BP), among patients diagnosed and treated for the condition, remains an important clinical challenge; aspects of clinical operations could potentially be adjusted if they were associated with better outcomes. To assess clinical operations factors' effects on normalization of uncontrolled BP. Observational cohort study. Patients diagnosed with hypertension from a large urban clinical practice (2005-2009). We obtained clinical data on BP, organized by person-month, and administrative data on primary care provider (PCP) staffing. We assessed the resolution of an episode of uncontrolled BP as a function of time-varying covariates including practice-level appointment volume, individual clinicians' appointment volume, overall practice-level PCP staffing, and number of unique PCPs. Among the 7409 unique patients representing 50,403 person-months, normalization was less likely for the patients in whom the episode starts during months when the number of unique PCPs were high [the top quintile of unique PCPs was associated with a 9 percentage point lower probability of normalization (Ppercentage point reduction in the probability of normalization (P=0.01)]. Neither clinician appointment volume nor practice clinician staffing levels were significantly associated with the probability of normalization. Findings suggest that clinical operations factors can affect clinical outcomes like BP normalization, and point to the importance of considering outcome effects when organizing clinical care.

Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

Science.gov (United States)

Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

2013-04-08

The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

Science.gov (United States)

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

Clinical characteristics and outcomes of familial and idiopathic ...

African Journals Online (AJOL)

Clinical characteristics and outcomes of familial and idiopathic dilated cardiomyopathy in Cape Town: A comparative study of 120 cases followed up over 14 years. NBA Ntusi, M Badri, F Gumedze, A Wonkam, BM Mayosi ...

Community to clinic navigation to improve diabetes outcomes

Directory of Open Access Journals (Sweden)

Nancy E. Schoenberg

2017-03-01

Full Text Available Rural residents experience rates of Type 2 Diabetes Mellitus (T2DM that are considerably higher than their urban or suburban counterparts. Two primary modifiable factors, self-management and formal clinical management, have potential to greatly improve diabetes outcomes. “Community to Clinic Navigation to Improve Diabetes Outcomes,” is the first known randomized clinical trial pilot study to test a hybrid model of diabetes self-management education plus clinical navigation among rural residents with T2DM. Forty-one adults with T2DM were recruited from two federally qualified health centers in rural Appalachia from November 2014–January 2015. Community health workers provided navigation, including helping participants understand and implement a diabetes self-management program through six group sessions and, if needed, providing assistance in obtaining clinic visits (contacting providers' offices for appointments, making reminder calls, and facilitating transportation and dependent care. Pre and post-test data were collected on T2DM self-management, physical measures, demographics, psychosocial factors, and feasibility (cost, retention, and satisfaction. Although lacking statistical significance, some outcomes indicate trends in positive directions, including diet, foot care, glucose monitoring, and physical health, including decreased HbA1c and triglyceride levels. Process evaluations revealed high levels of satisfaction and feasibility. Due to the limited intervention dose, modest program expenditures (~$29,950, and a severely affected population most of whom had never received diabetes education, outcomes were not as robust as anticipated. Given high rates of satisfaction and retention, this culturally appropriate small group intervention holds promise for hard to reach rural populations. Modifications should include expanded recruitment venues, sample size, intervention dosage and longer term assessment.

Computed tomography and clinical outcome in patients with severe traumatic brain injury.

Science.gov (United States)

Stenberg, Maud; Koskinen, Lars-Owe D; Jonasson, Per; Levi, Richard; Stålnacke, Britt-Marie

2017-01-01

To study: (i) acute computed tomography (CT) characteristics and clinical outcome; (ii) clinical course and (iii) Corticosteroid Randomisation after Significant Head Injury acute calculator protocol (CRASH) model and clinical outcome in patients with severe traumatic brain injury (sTBI). Initial CT (CT i ) and CT 24 hours post-trauma (CT 24 ) were evaluated according to Marshall and Rotterdam classifications. Rancho Los Amigos Cognitive Scale-Revised (RLAS-R) and Glasgow Outcome Scale Extended (GOSE) were assessed at three months and one year post-trauma. The prognostic value of the CRASH model was evaluated. Thirty-seven patients were included. Marshall CT i and CT 24 were significantly correlated with RLAS-R at three months. Rotterdam CT 24 was significantly correlated with GOSE at three months. RLAS-R and the GOSE improved significantly from three months to one year. CRASH predicted unfavourable outcome at six months for 81% of patients with bad outcome and for 85% of patients with favourable outcome according to GOSE at one year. Neither CT nor CRASH yielded clinically useful predictions of outcome at one year post-injury. The study showed encouragingly many instances of significant recovery in this population of sTBI. The combination of lack of reliable prognostic indicators and favourable outcomes supports the case for intensive acute management and rehabilitation as the default protocol in the cases of sTBI.

Clinical profile and outcome of myasthenic crisis in a tertiary care hospital: A prospective study.

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Sharma, Sudhir; Lal, Vivek; Prabhakar, Sudesh; Agarwal, Ritesh

2013-04-01

The present understanding of the clinical course, complications, and outcome of myasthenic crisis (MC) is based chiefly on observational studies and retrospective case series. To study the baseline demographic and clinical variables, risk factors, complications, outcome, and mortality in patients of MC. All patients of myasthenia gravis (MG) who presented with myasthenic crisis between July 2009 and December 2010 were included. Ten patients of MC were included in this study. The median age of the patients was 40.5 years (range 14-71 years). Seven were females and three were males. Nine had generalized MG and one patient had oculobulbar involvement only. Median duration of disease was 3 years (range 1 month to17 years). Two patients had thymoma. Two patients had history of thymectomy in the past. Infection was the most common triggering factor accounting for five cases (50%) followed by inadequate treatment/drug withdrawal in three (30%) and steroid initiation and hypokalemia in the remaining two patients (20%). Median duration of MC was 12 days (range 3-28 days). Mortality was in 3 out of 10 (30%) during MC. Management in the intensive care unit (ICU) and treatment with plasma exchange/intravenous immunoglobulins were associated with good outcome. Ventilator support and management in intensive care unit are the most important components in the management of MC. The high mortality rate seen in present study may be more reflective of the actual ground reality in resource constrained developing countries, however, larger prospective studies are needed to confirm these findings.

CLINICAL OUTCOME OF PENETRATING KERATOPLASTY IN CORNEAL OPACITIES OF DIFFERENT AETIOLOGY- A CLINICAL STUDY

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Dipak Bhuyan

2017-01-01

Full Text Available BACKGROUND Corneal transplantation or grafting is an operation in which abnormal corneal host tissue is replaced by healthy donor cornea. According to the World Health Organization (WHO, corneal diseases are among the major causes of vision loss and blindness in the world today after cataract and glaucoma. The aim of the study is to- 1. Evaluate the different aetiology of corneal opacity including active infective aetiology as indicated for penetrating keratoplasty. 2. Determine the clinical outcome of penetrating keratoplasty in relation to graft survival, graft rejection and peri-operative complications in different aetiology groups. 3. Determine the final visual outcome. MATERIALS AND METHODS Candidates for keratoplasty were selected from- 1. Eye Bank of Regional Institute of Ophthalmology (R.I.O. 2. R.I.O OPD. The study period was from September 2014 to August 2015. 30 cases were taken in the study. Descriptive statistics were applied to analyse the data wherever necessary. RESULTS 34.6±19.73 yrs. (mean±SD was the mean age at which transplants were done in the study. Out of total 30 cases, 13 (43.33% and 17 (56.66% were male and female, respectively. The different indications for penetrating keratoplasty are- Post ulcer corneal opacity in 14 cases (46.66%, posttraumatic corneal opacity 9 cases (30%, pseudophakic bullous keratopathy 4 cases (13.33%, corneal dystrophy in 2 cases (6.66% and non-healing corneal ulcer in 1 case (3.33%. 16 cases (53.33% showed clear graft till the last follow up while 11 (33.33% cases showed partially clear graft resulting in improved visual outcome while 3 cases (10.00% of the grafts were opaque due to graft failure. CONCLUSION The major indications for penetrating keratoplasty in this part of the world are post ulcer and posttraumatic corneal opacity and majority of them are illiterate agricultural workers who failed to get adequate treatment on time. Graft survival rate is high, which can be attributed to the

Clinical outcomes in traumatic pseudophacocele: A rare clinical entity.

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Narang, Priya; Agarwal, Amar

2017-12-01

The purpose of this study is to evaluate the clinical outcomes in patients with traumatic pseudophacocele. In this retrospective, interventional case series, scleral wound repair with pars plana vitrectomy and glued intrascleral fixation of an intraocular lens (glued IOL) was performed in 5 eyes of 5 patients. Pupilloplasty was performed in 3 cases whereas aniridia glued IOL fixation was done in 1 case that had total avulsion and loss of iris tissue. The main outcome measures were best-corrected visual acuity (BCVA), intraoperative and postoperative complications during the entire follow-up period. The preoperative vision ranged from hand movement to perception of light in all the patients. The mean postoperative BCVA was 0.42 ± 0.21 Snellen's decimal equivalent (SDE) at final follow-up. Postoperatively, all the cases retained good visual acuity with case 1 and case 2 reporting 0.5 SDE, case 3 had 0.33 SDE, case 5 had 0.67 SDE whereas case 4 had a final visual acuity limited to 0.1 SDE due to associated corneal opacity. The mean follow-up period was 20.2 ± 11.7 months (range from 9 months to 36 months). The IOL was well centered, all the wounds were well apposed and the mean postoperative intraocular pressure was 14.6 ± 1.95 mm Hg. No complications were reported in the entire follow-up period. The clinical outcomes of management of pseudophacocele were encouraging with retention of reasonably good visual potential in all cases.

Autogenic training: a meta-analysis of clinical outcome studies.

Science.gov (United States)

Stetter, Friedhelm; Kupper, Sirko

2002-03-01

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.

Depressive symptoms, HIV medication adherence, and HIV clinical outcomes in Tanzania: a prospective, observational study.

Directory of Open Access Journals (Sweden)

Nadya M Belenky

Full Text Available Depressive symptoms have been shown to independently affect both antiretroviral therapy (ART adherence and HIV clinical outcomes in high-income countries. We examined the prospective relationship between depressive symptoms and adherence, virologic failure, and suppressed immune function in people living with HIV/AIDS in Tanzania. Data from 403 study participants who were on stable ART and engaged in HIV clinical care were analyzed. We assessed crude and adjusted associations of depressive symptoms and ART adherence, both at baseline and at 12 months, using logistic regression. We used logistic generalized estimating equations to assess the association and 95% confidence intervals (CI between depressive symptoms and both virologic failure and suppressed immune function. Ten percent of participants reported moderate or severe depressive symptoms at baseline and 31% of participants experienced virologic failure (>150 copies/ml over two years. Depressive symptoms were associated with greater odds of reported medication nonadherence at both baseline (Odds Ratio [OR] per 1-unit increase = 1.18, 95% CI [1.12, 1.24] and 12 months (OR = 1.08, 95% CI [1.03, 1.14]. By contrast, increases in depressive symptom score were inversely related to both virologic failure (OR = 0.93, 95% CI [0.87, 1.00] and immune system suppression (OR = 0.88, 95% CI [0.79, 0.99], though the association between depressive symptoms and clinical outcomes was less precise than for the association with nonadherence. Findings indicate a positive association between depressive symptoms and nonadherence, and also an inverse relationship between depressive symptoms and clinical outcomes, possibly due to informative loss to follow-up.

Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

Science.gov (United States)

Stenberg, Maud; Godbolt, Alison K.; Nygren De Boussard, Catharina; Levi, Richard; Stålnacke, Britt-Marie

2015-01-01

Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI) from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS) and the Hospital Anxiety and Depression Scale (HADS). Outcome measures were Glasgow Outcome Scale Extended (GOSE) and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R). Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting. PMID:26783381

Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

Directory of Open Access Journals (Sweden)

Maud Stenberg

2015-01-01

Full Text Available Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS and the Hospital Anxiety and Depression Scale (HADS. Outcome measures were Glasgow Outcome Scale Extended (GOSE and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R. Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting.

Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

Science.gov (United States)

Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

2016-01-01

Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes.

Hyperglycemia and Clinical Outcome in Aneurysmal Subarachnoid Hemorrhage A Meta-Analysis

NARCIS (Netherlands)

Kruyt, Nyika D.; Biessels, Geert Jan; de Haan, Rob J.; Vermeulen, Marinus; Rinkel, Gabriel J. E.; Coert, Bert; Roos, Yvo B. W. E. M.

2009-01-01

Background and Purpose-Hyperglycemia may worsen outcome after aneurysmal subarachnoid hemorrhage. We performed a systematic review to investigate the relation between admission hyperglycemia and outcome after aneurysmal subarachnoid hemorrhage. Methods-We included cohort studies or clinical trials

Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

Science.gov (United States)

Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

2014-01-01

In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

DEFF Research Database (Denmark)

Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

2013-01-01

Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

Early-Onset Bipolar Disorder: Characteristics and Outcomes in the Clinic.

Science.gov (United States)

Connor, Daniel F; Ford, Julian D; Pearson, Geraldine S; Scranton, Victoria L; Dusad, Asha

2017-12-01

To assess patient characteristics and clinician-rated outcomes for children diagnosed with early-onset bipolar disorder in comparison to a depressive disorders cohort from a single clinic site. To assess predictors of bipolar treatment response. Medical records from 714 consecutive pediatric patients evaluated and treated at an academic tertiary child and adolescent psychiatry clinic between 2006 and 2012 were reviewed. Charts of bipolar children (n = 49) and children with depressive disorders (n = 58) meeting study inclusion/exclusion criteria were compared on variables assessing clinical characteristics, treatments, and outcomes. Outcomes were assessed by using pre- and post-Clinical Global Impressions (CGI)-Severity and Children's Global Assessment Scale (CGAS) scores, and a CGI-Improvement score ≤2 at final visit determined responder status. Bipolar outcome predictors were assessed by using multiple linear regression. Clinic prevalence rates were 6.9% for early-onset bipolar disorder and 1.5% for very early-onset bipolar disorder. High rates of comorbid diagnoses, symptom severity, parental stress, and child high-risk behaviors were found in both groups. The bipolar cohort had higher rates of aggression and higher lifetime systems of care utilization. The final CGI and CGAS outcomes for unipolar depression patients differed statistically significantly from those for the bipolar cohort, reflecting better clinical status and more improvement at outcome for the depression patients. Both parent-reported Child Behavior Checklist total T-score at clinic admission and the number of lifetime systems-of-care for the child were significantly and inversely associated with improvement for the bipolar cohort. Early-onset bipolar disorder is a complex and heterogeneous psychiatric disorder. Evidence-based treatment should emphasize psychopharmacology with adjunctive family and individual psychotherapy. Strategies to improve engagement in treatment may be especially

Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

Science.gov (United States)

Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

2016-04-01

To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study.

Science.gov (United States)

Mager, R; Kurosch, M; Höfner, T; Frees, S; Haferkamp, A; Neisius, A

2018-01-22

The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-X C , Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm 2 and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.

A systematic literature search to identify performance measure outcomes used in clinical studies of racehorses.

Science.gov (United States)

Wylie, C E; Newton, J R

2018-05-01

Racing performance is often used as a measurable outcome variable in research studies investigating clinical diagnoses or interventions. However, the use of many different performance measures largely precludes conduct of meaningful comparative studies and, to date, those being used have not been collated. To systematically review the veterinary scientific literature for the use of racing performance as a measurable outcome variable in clinical studies of racehorses, collate and identify those most popular, and identify their advantages and disadvantages. Systematic literature search. The search criteria "((racing AND performance) AND (horses OR equidae))" were adapted for both MEDLINE and CAB Abstracts databases. Data were collected in standardised recording forms for binary, categorical and quantitative measures, and the use of performance indices. In total, 217 studies that described racing performance were identified, contributing 117 different performance measures. No one performance measure was used in all studies, despite 90.3% using more than one variable. Data regarding race starts and earnings were used most commonly, with 88.0% and 54.4% of studies including at least one measure of starts and earnings, respectively. Seventeen variables were used 10 times or more, with the top five comprising: 'return to racing', 'number of starts', 'days to first start', 'earnings per period of time' and 'earnings per start'. The search strategies may not have identified all relevant papers, introducing bias to the review. Performance indices have been developed to improve assessment of interventions; however, they are not widely adopted in the scientific literature. Use of the two most commonly identified measures, whether the horse returned to racing and number of starts over a defined period of time, would best facilitate future systematic reviews and meta-analyses in advance of the development of a gold-standard measure of race performance outcome. © 2017 EVJ Ltd.

Effect of prehospital ultrasound on clinical outcomes of non-trauma patients

DEFF Research Database (Denmark)

Rudolph, Søren Steemann; Sørensen, Martin Kryspin; Svane, Christian

2014-01-01

BACKGROUND: Advances in technology have made prehospital ultrasound (US) examination available. Whether US in the prehospital setting can lead to improvement in clinical outcomes is yet unclear. OBJECTIVE: The aim of this systematic review was to assess whether prehospital US improves clinical...... studies for additional relevant studies. We then performed a risk of bias analysis and descriptive data analysis. RESULTS: We identified 1707 unique citations and included ten studies with a total of 1068 patients undergoing prehospital US examination. Included publications ranged from case series to non...... studies were of large heterogeneity and all showed a high risk of bias. We were thus unable to assess the effect of prehospital US on clinical outcomes. However, consistent reports suggested that US may improve patient management with respect to diagnosis, treatment, and hospital referral....

Scrub typhus: Clinical spectrum and outcome.

Science.gov (United States)

Venkategowda, Pradeep M; Rao, S Manimala; Mutkule, Dnyaneshwar P; Rao, Mallela V; Taggu, Alai N

2015-04-01

Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. A prospective observational study was conducted on 109 patients with febrile illness and thrombocytopenia during a period of 12 months. All 109 patients were tested with both Immune-chromatography test and Weil felix test. Patients having either Immune-chromatography test/Weil felix test positive have been included and considered as scrub typhus positive whereas negative for both Immune-chromatography and Weil felix test were excluded. Clinical features, lab parameters, and outcome were evaluated in all patients with scrub typhus. Statistical analysis used in this study was T-test. Among 58 patients who were included (After exclusion of 51 patients among total of 109 patients) 34 patients had no ARDS and 24 patients had ARDS. The clinical feature like dyspnoea, cough, low blood pressure (MAPscrub typhus patients group with ARDS. The higher titers of Weil-felix can be correlated with more severe form of disease according to our observation. All 34 Scrub typhus patients without ARDS recovered completely. Among 24 Scrub typhus patients with ARDS, 22 patients recovered, and 2 patients died. Scrub typhus is an important differential diagnosis in a patients having fever with thrombocytopenia. Scrub typhus associated with ARDS has high morbidity and mortality. Early diagnosis and treatment with doxycycline can prevent the occurrence of ARDS.

Villitis of unknown aetiology: correlation of recurrence with clinical outcome.

LENUS (Irish Health Repository)

Feeley, L

2010-01-01

Villitis of unknown aetiology (VUA) is associated with adverse pregnancy outcome. Consequently, an ability to predict recurrence could be clinically relevant. We examined placentas where villitis was diagnosed in a previous pregnancy to establish the risk of recurrence and outcome. A total of 304 cases of VUA were diagnosed in our laboratory over a 4-year period. Subsequently, 19 of this cohort had a second placenta examined histologically. Recurrence and clinical outcome were recorded. Villitis recurred in 7 of 19 cases (37%). There was a high level of adverse pregnancy outcome in this cohort overall, characterised by small for gestational age infants and stillbirth, particularly in cases with high-grade villitis. We identified recurrent villitis more frequently than previously reported. Our findings confirm an association between high-grade villitis and poor outcome. Adequately powered prospective studies are required to determine if enhanced surveillance of subsequent pregnancies is indicated following a diagnosis of villitis.

Outcome measures used in clinical studies on neonatal brachial plexus palsy: A systematic literature review using the International Classification of Functioning, Disability and Health.

Science.gov (United States)

Sarac, Cigdem; Duijnisveld, Bouke J; van der Weide, Amber; Schoones, Jan W; Malessy, Martijn J A; Nelissen, Rob G H H; Vlieland, Thea P M Vliet

2015-01-01

Symptoms of a neonatal brachial plexus palsy (NBPP) can vary widely among individuals and numerous clinical studies have been performed to identify the natural history and to improve treatment. The aim of this study was to identify and describe all outcome measures used in clinical studies on patients with an NBPP and categorize these outcome measures according to the International Classification of Functioning, Disability and Health (ICF). Electronic searches of different databases were carried out. All clinical studies describing one or more outcomes of NBPP were selected. Data on outcome measures was systematically extracted and the contents were analyzed and linked to the ICF. A total of 217 full texts were selected and 59 different outcome measures were identified. The 5 most frequently used outcome measures included range of motion of the shoulder (n= 166 studies, 76%), range of motion of the elbow (n= 87 studies, 40%), the Mallet scale (n= 66 studies, 30%), Magnetic Resonance Imaging (n= 37 studies, 17%) and the Medical Research Council motor grading scale (n= 31 studies, 14%). Assessments related to Body functions and Structures were most frequent, whereas assessments associated with Activities and Participation and Environmental Factors were relatively uncommon. There was a high variability among the outcome measures used, with measures within the ICF component Body Functions being most common. These results underscore the need for the development and usage of outcome measures representing all domains of health status in patients with NBPP.

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design.

Science.gov (United States)

Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D'Arcy, Ryan C N; Song, Xiaowei

2018-04-19

Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors' quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging

Perioperative vitamin D levels correlate with clinical outcomes after ankle fracture fixation.

Science.gov (United States)

Warner, Stephen J; Garner, Matthew R; Nguyen, Joseph T; Lorich, Dean G

2016-03-01

Hypovitaminosis D is common in patients undergoing orthopaedic trauma surgery. While previous studies have shown that vitamin D levels correlate with functional outcome after hip fracture surgery, the significance of vitamin D levels on outcomes after surgery in other orthopaedic trauma patients is unknown. The purpose of this study was to determine if vitamin D levels correlated with outcomes in ankle fracture patients. We reviewed a prospective registry of patients who underwent operative treatment for ankle fractures from 2003 to 2012. Preoperative serum 25-hydroxyvitamin D (25[OH]D) levels were measured, and the primary and secondary outcomes included foot and ankle outcome scores (FAOS) and ankle range of motion. Data were also collected on patient comorbidities, articular malreductions, and wound complications. Included patients had at least 12 months of clinical outcome data. Ninety-eight patients operatively treated for ankle fractures met our inclusion criteria. Of these 98 patients, 36 (37%) were deficient in vitamin D (ankle fractures, preoperative vitamin D deficiency correlated with inferior clinical outcomes at a minimum of 1 year follow-up. Our study suggests that deficient vitamin D levels may result in worse outcomes in orthopaedic trauma patients recovering from fracture fixation.

Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

Science.gov (United States)

Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

2017-01-01

We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

Directory of Open Access Journals (Sweden)

S. Nicole Culos-Reed

2012-01-01

Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

Intracranial tuberculosis in children: CT appearance and clinical outcome

Energy Technology Data Exchange (ETDEWEB)

Wallace, R C; Burton, E M; Gerald, B E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Radiology Tennessee Univ., Memphis (United States); Barrett, F F; Leggiadro, R J [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pediatrics Tennessee Univ., Memphis (United States); Lasater, O E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pathology Tennessee Univ., Memphis (United States)

1991-05-01

We retrospectively evaluated the CT studies of 9 children who presented with intracranial tuberculosis during 1981-1987, and compared their radiographic appearance with the clinical outcome. The most common radiographic findings were: 1) Ventriculomegaly (7/9), 2) tuberculoma formation (6/9), and 3) infarction (4/9). Of 7 patients with ventriculomegaly, 3 required a ventricular shunt and 2 had spontaenous resolution of ventricular dilatation. Four children with ventriculomegaly were moderately or severely retarded, one had cognitive dysfunction, and one was neurologically normal. Four of six children with tuberculoma also had infarction and/or ventriculomegaly; of these four children, three were moderately or severely retarded. Two patients with tuberculoma as the only intracranial abnormality had complete resolution or the granuloma with normal neurologic outcome following antituberculous therapy. The four children with large vessel infarction also had ventriculomegaly; three had poor clinical outcome. The presence of tuberculoma alone is not necessarily predictive of poor neurologic outcome; age less than 20 months, infarct, and/or ventriculomegaly are usually associated with sequelae. (orig.).

Clinical outcomes resulting from telemedicine interventions: a systematic review

Directory of Open Access Journals (Sweden)

Kraemer Dale

2001-11-01

Full Text Available Abstract Background The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. Methods Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis. All included articles were abstracted and graded for quality and direction of the evidence. Results A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. Conclusions Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective.

Evaluation of multi-outcome longitudinal studies

DEFF Research Database (Denmark)

Jensen, Signe Marie; Pipper, Christian Bressen; Ritz, Christian

2015-01-01

Evaluation of intervention effects on multiple outcomes is a common scenario in clinical studies. In longitudinal studies, such evaluation is a challenge if one wishes to adequately capture simultaneous data behavior. In this situation, a common approach is to analyze each outcome separately...... conservative conclusions. We propose an alternative approach for multiplicity adjustment that incorporates dependence between outcomes, resulting in an appreciably less conservative evaluation. The ability of the proposed method to control the familywise error rate is evaluated in a simulation study...

Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

Science.gov (United States)

Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

2016-01-01

This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (pincome was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

Core outcome sets for research and clinical practice

NARCIS (Netherlands)

Chiarotto, Alessandro; Ostelo, Raymond W.; Turk, Dennis C.; Buchbinder, Rachelle; Boers, Maarten

2017-01-01

Background This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. Method A core outcome set is a minimum consensus-based set of outcomes that should be

Survival and clinical outcome of dogs with ischaemic stroke

DEFF Research Database (Denmark)

Gredal, Hanne Birgit; Toft, Nils; Westrup, Ulrik

2013-01-01

The objectives of the present study were to investigate survival time, possible predictors of survival and clinical outcome in dogs with ischaemic stroke. A retrospective study of dogs with a previous diagnosis of ischaemic stroke diagnosed by magnetic resonance imaging (MRI) was performed....... The association between survival and the hypothesised risk factors was examined using univariable exact logistic regression. Survival was examined using Kaplan-Meier and Cox regression. Twenty-two dogs were identified. Five dogs (23%) died within the first 30days of the stroke event. Median survival in 30-day...... survivors was 505days. Four dogs (18%) were still alive by the end of the study. Right-sided lesions posed a significantly increased risk of mortality with a median survival time in dogs with right-sided lesions of 24days vs. 602days in dogs with left sided lesions (P=0.006). Clinical outcome was considered...

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

Science.gov (United States)

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

Clinical characteristics and outcome of heart failure and captagon amphetamine use: An observational prospective study

OpenAIRE

Abdelfatah A. Elasfar; Kamal Eldein Ahmad; Waleed AlShaghaa

2014-01-01

The fenetylline (captagon) tablets (an amphetamine like substance) are a stimulant drugs which are widely used in the Arabian Peninsula. Objectives: The aim of this study was to evaluate the clinical characteristics and outcome of acute heart failure in patients using captagon tablets. Methods: From September, 2009, through December, 2011, 280 consecutive patients with acute dilated cardiomyopathy and acute heart failure syndrome presented to emergency department in one tertiary care ce...

A study of the clinical profile and outcome of spina bifida

Directory of Open Access Journals (Sweden)

Theophilus Nikita Kumar

2016-02-01

Full Text Available Neural tube defects (NTDs are a group of congenital anomalies characterized by defects in dorsal midline structures, including neural tissue, dura, muscle, bone and/or skin. The clinical presentations and the follow-up of these patients requires attention to various end organs besides the nervous system. To evaluate the clinical profile and surgical outcome of children with spina bifida. Out of a total of 74 patients treated at our institute for spina bifida between June 2013 to august 2015, 74 cases of spina bifida were analyzed retrospectively and prospectively. The clinical profile, radiological findings and urodynamic studies were recorded. Craniospinal MRI was done in patients to screen for Arnold Chiari malformations and monitoring of hydrocephalus was done as a management protocol at our institute for these children. All these patients except two underwent surgery for correction and closure of the spinal defect. Associated anomalies were treated accordingly. They were clinically assessed over a mean follow up period of 1.3years, ranging from 2months to 2½ years. 73% of the patients presented in the neonatal age group. Of which, 72% presented with a visible sac over the back.72% of the cases were Myelomeningocoeles. 79% of the defects were in the lumbosacral region.30% presented with sensorimotor loss or bladder bowel incontinence. Sensorimotor improvement was seen in 12.5% after repairing the defect with the help of physiotherapy and braces. 30% of the patients were diagnosed to have hydrocephalus, of which 33% required a CSF diversion procedure. The postoperative course of spina bifida repair was found to be uneventful in 90% of the patients

Clinical features and outcome analysis of intracranial hydatid cysts

International Nuclear Information System (INIS)

Khan, M.M.; Shah, M.; Ayub, S.; Ahmad, A.; Aman, A.; Shah, M.A.; Rehman, R.U.

2016-01-01

Background: Hydatid cyst of the brain is a serious zoonotic parasitic infection which have profound health consequences if left untreated. The surgical excision of the cysts are rewarding for both the patient the neurosurgeon. Methods: The study was conducted prospectively at Department of Neurosurgery Hayatabad Medical Complex Peshawar from January 2013 to December 2014. Patients with a diagnosis of intracranial hydatid cysts were included, clinical and radiological features recorded, intervention and postoperative outcome were analysed. Results: Eleven patients with a male to female ratio of 1.7:1. Mean age was 12.4 (SD±6.5) years with median GCS on arrival of 10 (SD±2.5). Clinical features were headache (81.8 percentage), vomiting (90.9 percentage), seizures (36.4 percentage), focal deficits (54.5 percentage) and papilloedema (72.7 percentage). The median GCS on discharge was 13 (SD±1.1) while GOS at 1 month follow up was 4 (SD±0.7). The bivariate analysis showed inverse correlation (R2=-0.68; p=0.02) between duration of symptoms and outcome while GCS on admission was positively correlated (rs=0.75; p=0.007) with the outcome. There was no mortality. Conclusion: Despite its rarity the clinical features are non-specific while radiological features help in establishing diagnosis. Earlier diagnosis and prompt intervention is the key to favourable outcome. (author)

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

Science.gov (United States)

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

2008-06-01

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

Clinical Features, Complications and Treatment Outcome of Brucella ...

African Journals Online (AJOL)

Purpose: Brucellosis is a multi-systemic infection that is endemic in some parts of the world. The purpose of this study was to examine the epidemiology as well as the clinical and haematological characteristics, complications, and treatment outcome of patients with brucellosis at the King Fahd Hospital of the University ...

Clinical Outcomes of Self-Expandable Metal Stents for Malignant Rectal Obstruction.

Science.gov (United States)

Lee, Hyun Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho; Park, Soo Jung

2018-01-01

Self-expandable metal stents are widely used to treat malignant colorectal obstruction. However, data on clinical outcomes of stent placement for rectal obstruction specifically are lacking. We aimed to investigate the clinical outcomes of self-expandable metal stents in malignant rectal obstruction in comparison with those in left colonic obstruction and to identify factors associated with clinical failure and complication. This was a retrospective study. The study was conducted at a tertiary care center. Between January 2005 and December 2013, medical charts of patients who underwent stent placement for malignant rectal or left colonic obstruction were reviewed retrospectively. Study intervention included self-expandable metal stent placement. Technical success, clinical success, and complications were measured. Technical success rates for the 2 study groups (rectum vs left colon, 93.5% vs 93.1%; p = 0.86) did not differ significantly; however, the clinical success rate was lower in patients with rectal obstruction (85.4% vs 92.1%; p = 0.02). In addition, the complication rate was higher in patients with rectal obstruction (37.4% vs 25.1%; p = 0.01). Patients with rectal obstruction showed higher rates of obstruction because of extracolonic malignancy (33.8% vs 15.8%; p stent use for palliation (78.6% vs 56.3%; p stent usage to be independent risk factors for clinical failure. Factors predictive of complications in the palliative group were total obstruction, obstruction because of extracolonic malignancy, and covered stent usage. This was a retrospective, single-center study. The efficacy and safety of stent placement for malignant rectal obstruction were comparable with those for left colonic obstruction. However, obstruction attributed to extracolonic malignancy, use of covered stents, and total obstruction negatively impacted clinical outcomes of self-expandable metal stent placement and must be considered by endoscopists. See Video Abstract at http

Survival and clinical outcome of dogs with ischaemic stroke.

Science.gov (United States)

Gredal, H; Toft, N; Westrup, U; Motta, L; Gideon, P; Arlien-Søborg, P; Skerritt, G C; Berendt, M

2013-06-01

The objectives of the present study were to investigate survival time, possible predictors of survival and clinical outcome in dogs with ischaemic stroke. A retrospective study of dogs with a previous diagnosis of ischaemic stroke diagnosed by magnetic resonance imaging (MRI) was performed. The association between survival and the hypothesised risk factors was examined using univariable exact logistic regression. Survival was examined using Kaplan-Meier and Cox regression. Twenty-two dogs were identified. Five dogs (23%) died within the first 30days of the stroke event. Median survival in 30-day survivors was 505days. Four dogs (18%) were still alive by the end of the study. Right-sided lesions posed a significantly increased risk of mortality with a median survival time in dogs with right-sided lesions of 24days vs. 602days in dogs with left sided lesions (P=0.006). Clinical outcome was considered excellent in seven of 17 (41%) 30-day survivors. Another seven 30-day survivors experienced new acute neurological signs within 6-17months of the initial stroke event; in two of those cases a new ischaemic stroke was confirmed by MRI. In conclusion, dogs with ischaemic stroke have a fair to good prognosis in terms of survival and clinical outcome. However, owners should be informed of the risk of acute death within 30days and of the possibility of new neurological events in survivors. Mortality was increased in dogs with right-sided lesions in this study. Copyright © 2012 Elsevier Ltd. All rights reserved.

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice.

Science.gov (United States)

Janicak, Philip G; Dunner, David L; Aaronson, Scott T; Carpenter, Linda L; Boyadjis, Terrence A; Brock, David G; Cook, Ian A; Lanocha, Karl; Solvason, Hugh B; Bonneh-Barkay, Dafna; Demitrack, Mark A

2013-12-01

Transcranial magnetic stimulation (TMS) is an effective and safe therapy for major depressive disorder (MDD). This study assessed quality of life (QOL) and functional status outcomes for depressed patients after an acute course of TMS. Forty-two, U.S.-based, clinical TMS practice sites treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite prior adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the approved TMS device. Patient self-reported QOL outcomes included change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the EuroQol 5-Dimensions (EQ-5D) ratings from baseline to end of the acute treatment phase. Statistically significant improvement in functional status on a broad range of mental health and physical health domains was observed on the SF-36 following acute TMS treatment. Similarly, statistically significant improvement in patient-reported QOL was observed on all domains of the EQ-5D and on the General Health Perception and Health Index scores. Improvement on these measures was observed across the entire range of baseline depression symptom severity. These data confirm that TMS is effective in the acute treatment of MDD in routine clinical practice settings. This symptom benefit is accompanied by statistically and clinically meaningful improvements in patient-reported QOL and functional status outcomes.

Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

Science.gov (United States)

Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

2017-03-01

Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; Poverdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

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Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

2012-04-01

Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

Long-Chain Polyunsaturated Fatty Acids and Clinical Outcomes of Preterm Infants.

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Lapillonne, Alexandre; Moltu, Sissel J

2016-01-01

Long-chain polyunsaturated fatty acids (LCPUFAs) play specific roles during the perinatal period and are very important nutrients to consider. The possible effects of LCPUFAs, particularly docosahexaenoic acid (DHA), on various clinical outcomes of preterm infants are discussed in this paper. Since DHA accumulates in the central nervous system during development, a lot of attention has focused on the effects of DHA on neurodevelopment. Experimental studies as well as recent clinical trials show that providing larger amounts of DHA than currently and routinely provided is associated with better neurological outcomes at 18 months to 2 years. This early advantage, however, does not seem to translate into detectable change in visual and neurodevelopmental outcomes or behavior when assessed in childhood. There is growing evidence that, in addition to effects on development, omega-3 LCPUFAs may reduce the incidence or severity of neonatal morbidities by affecting different steps of the immune and anti-inflammatory response. Studies in preterm infants suggest that the omega-3 LCPUFAs may play a significant role by reducing the risk of bronchopulmonary dysplasia, necrotizing enterocolitis and possibly retinopathy of prematurity and sepsis. Overall, evidence is increasing to support the benefits of high-dose DHA for various health outcomes of preterm infants. These findings are of major clinical relevance mainly because infants born preterm are at particularly high risk for a nutritional deficit in omega-3 fatty acids, predisposing to adverse neonatal outcomes. Further studies are warranted to address these issues as well as to more precisely determine the LCPUFA requirement in order to favor the best possible outcomes of preterm infants. © 2016 S. Karger AG, Basel.

Clinical outcome of narrow diameter implants inserted into allografts

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Maurizio Franco

2009-08-01

Full Text Available OBJECTIVE: Narrow diameter implants (NDI (i.e. diameter <3.75 mm are a potential solution for specific clinical situations, such as reduced interradicular bone, thin alveolar crest and replacement of teeth with small cervical diameter. NDI have been available in clinical practice since the 1990s, but only few studies have analyzed their clinical outcome and no study have investigated NDI inserted in fresh-frozen bone (FFB grafts. Thus, a retrospective study on a series of NDI placed in homologue FFB was designed to evaluate their clinical outcome. MATERIAL AND METHODS: In the period between December 2003 and December 2006, 36 patients (22 females and 14 males, mean age 53 years with FFB grafts were selected and 94 different NDI were inserted. The mean follow-up was 25 months. To evaluate the effect of several host-, surgery-, and implant-related factors, marginal bone loss (MBL was considered an indicator of success rate (SCR. The Kaplan Meier algorithm and Cox regression were used. RESULTS: Only 5 out of 94 implants were lost (i.e. survival rate - SVR 95.7% and no differences were detected among the studied variables. On the contrary, the Cox regression showed that the graft site (i.e. maxilla reduced MBL. CONCLUSIONS: NDI inserted in FFB have a high SVR and SCR similar to those reported in previous studies on regular and NDI inserted in non-grafted jaws. Homologue FFB is a valuable material in the insertion of NDI.

Effectiveness of nurse-led clinics on service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints: a systematic review.

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Whiteford, Caroline; White, Sarahlouise; Stephenson, Matthew

2016-04-01

Ear, nose and throat complaints are very common and can cause significant disruption to patients' lives. Many conditions are of a chronic nature and are not currently managed in a timely manner by general practitioners in the community. This may be due to a lack of specialized knowledge, necessary diagnostic equipment or time for lengthy patient education on management of their condition. A nurse-led model of care may be an effective alternative. To examine the effectiveness of nurse-led clinics on adults with chronic ear, nose and throat complaints. Adult patients, aged 18 years and older, attending ear, nose and throat clinics, regardless of the complaint. Nurse-led care in general practice and acute care in which the nurse was identified as taking a lead role in the care of the patients with chronic ear, nose and throat complaints. General practitioner-led care, or ear, nose and throat consultant-led care, sometimes described as "standard care". Service delivery outcomes, clinical and health outcomes and financial outcomes. Any relevant quantitative studies published in English between 1980 and 2013 were considered. A standardized three-step search strategy aimed to find both published and unpublished studies. Databases searched include PubMed, CINAHL, Cochrane Library (CENTRAL), Scopus, Embase, MedNar and ProQuest Theses and Dissertations. Methodological validity was assessed independently by two reviewers using standardized critical appraisal instruments from the Joanna Briggs Institute. Due to methodological heterogeneity of the included studies, no statistical pooling was possible and all results are presented narratively. The search identified 13,536 titles, of which 20 potentially relevant articles were retrieved. Of these 20, 17 were excluded following full-text review leaving three studies that were assessed for methodological quality and included in the review. Service delivery outcome findings were that patient satisfaction was equal or higher and

The first pharmacist-managed anticoagulation clinic under a collaborative practice agreement in Qatar: clinical and patient-oriented outcomes.

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Elewa, H F; AbdelSamad, O; Elmubark, A E; Al-Taweel, H M; Mohamed, A; Kheir, N; Mohamed Ibrahim, M I; Awaisu, A

2016-08-01

Optimal outpatient anticoagulation management requires a systematic and coordinated approach. Extensive evidence regarding the benefits of pharmacist-managed anticoagulation services has been reported in the literature. The quality and outcomes associated with pharmacist-managed anticoagulation clinics under collaborative practice agreements in the Middle East have rarely been reported. The first pharmacist-managed ambulatory anticoagulation clinic in Qatar was launched at Al-Wakrah Hospital in March 2013. The objectives of this study were to: (i) describe the practice model of the clinic, (ii) evaluate the quality of the clinic [i.e. the time in therapeutic range (TTR)] and the clinical outcomes (i.e. the efficacy and safety), and (iii) determine the patients' satisfaction and overall quality of life (QoL). Clinical outcome data were collected through a retrospective chart review of all patients managed from March 2013 to October 2014 at the pharmacist-managed anticoagulation clinic. Furthermore, the patient-oriented outcomes data were prospectively collected using the 24-item Duke Anticoagulation Satisfaction Scale (DASS). Each item was assessed using a 7-point Likert-type scale on which lower scores indicated better QoL and greater satisfaction. The clinical outcome data analyses included 119 patients who were enrolled at the clinic during the 19-month study period. The mean number of international normalized ratio (INR) tests/month was 65 ± 9, the average testing frequency was 2·7 ± 1·6 weeks, and the average %TTR was 76·8 ± 22·9%. There was one major bleeding event (0·67%/year), 12 minor bleeding events (8%/year) and two thromboembolic events (1·35%/year) recorded during the study period. Of the 119 patients, 50 participated in the satisfaction and QoL survey. The median (IQR) total QoL score of these subjects was 63 (48) (minimum-maximum achievable score: 24-168). Seventy-six per cent of the patients indicated 'a lot to very much' in terms of their

The effect of a clinical medical librarian on in-patient care outcomes.

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Esparza, Julia M; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E

2013-07-01

The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective.

Surgical Stabilization of Pelvic and Acetabular Fractures: A Review on the Determinants of Clinical Outcomes

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SS Sathappan

2010-03-01

Full Text Available AIM: Pelvic and acetabular fractures are associated with high-energy trauma. The aim of this study was to identify factors that are associated with specific clinical outcomes following treatment for these fractures. METHODS: A consecutive series of 30 patients who had surgical intervention for either pelvic or acetabular fractures formed the sample for this study. Clinical variables reviewed were: age, associated injuries, number of surgical procedures, time to surgery and post-operative complications. Clinical outcomes were assessed using Matta’s grading of post- operative fracture reduction alignment, and functional outcomes were graded using D'Aubigne & Postel’s Hip scoring system. RESULTS: Study subjects included twelve pelvic fractures and eighteen acetabular fractures. Patients older than 50 years of age had poorer hip scores despite surgery. Earlier fracture fixation (within five days was associated with better hip scores. Patients with acetabular fractures generally had better functional outcomes than patients with pelvic fractures (mean hip score 15.0 vs. 13.5. Closer anatomical reduction of acetabular fractures was associated with better functional outcome. CONCLUSION: Improved clinical outcomes are associated with younger age, fewer concomitant injuries, shorter time interval to surgery and more closely approximated anatomical fracture reduction.

Clinical outcome of parotidectomy with reconstruction: Experience of ...

African Journals Online (AJOL)

The comprehensive clinical outcome of the malignant cases could not be objectively assessed, as the OS and DFS were 50% at 2-years follow-up. It is our submission that a larger sample size is utilized in subsequent studies and quality of life evaluation is included in the methodology. Keywords: Facial re-animation, neural ...

Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

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Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

2016-07-01

The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

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Muppidi, Srikanth

2017-03-01

The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review.

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Dewan Md Emdadul Hoque

Full Text Available Clinical quality registries (CQRs are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research.To synthesise the impact of clinical quality registries (CQRs as an 'intervention' on (I mortality/survival; (II measures of outcome that reflect a process or outcome of health care; (III health care utilisation; and (IV healthcare-related costs.The following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted.We identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11 followed by cohort design (#2, randomised controlled trial (#2, experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17

Procalcitonin levels in sepsis and its association with clinical outcome in southern India.

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Rebello, Alex; Thabah, Molly Mary; Dutta, Tarun Kumar; Bobby, Zachariah; Harish, B N; Mehalingam, Vadivelan

2017-10-01

Procalcitonin has been found to be a good marker for the diagnosis of sepsis. However, data on procalcitonin levels to predict the clinical outcome in patients with sepsis are limited. The aim of our study was to estimate serum procalcitonin levels in patients with sepsis and to identify its relationship with the clinical outcome. This was a prospective observational study conducted on 112 patients with sepsis admitted to the medical wards and medical intensive care unit of a tertiary care teaching hospital. Serum procalcitonin was measured at baseline before antibiotic administration and on day 5. The clinical outcome studied was death or survival on day 28. Baseline mean serum procalcitonin was highest in patients with septic shock and lowest in patients having sepsis without organ dysfunction. Mean values of procalcitonin at baseline and on day 5 were significantly higher in non-survivors when compared with survivors. There was a significant difference in the change in procalcitonin levels from baseline to day 5 between survivors and non-survivors, with survivors having declining values on day 5 while non-survivors had increasing values from baseline. The baseline APACHE II and SOFA scores also showed a significant correlation with the baseline procalcitonin level. Declining values of procalcitonin therefore indicate a favourable clinical outcome in patients with sepsis.

Does crossover innervation really affect the clinical outcome? A comparison of outcome between unilateral and bilateral digital nerve repair

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Melike Oruç

2016-01-01

Full Text Available 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.

Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair.

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Perser, Karen; Godfrey, David; Bisson, Leslie

2011-05-01

Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. The literature was systematically searched, and 5 level I and II studies were found comparing clinical outcomes of single-row and double-row rotator cuff repair. Coleman methodology scores were calculated for each article. Meta-analysis was performed, with treatment effect between single row and double row for clinical outcomes and with odds ratios for radiographic results. The sample size necessary to detect a given difference in clinical outcome between the 2 methods was calculated. Three level I studies had Coleman scores of 80, 74, and 81, and two level II studies had scores of 78 and 73. There were 156 patients with single-row repairs and 147 patients with double-row repairs, both with an average follow-up of 23 months (range, 12-40 months). Double-row repairs resulted in a greater treatment effect for each validated outcome measure in 4 studies, but the differences were not clinically or statistically significant (range, 0.4-2.2 points; 95% confidence interval, -0.19, 4.68 points). Double-row repairs had better radiographic results, but the differences were also not statistically significant (P = 0.13). Two studies had adequate power to detect a 10-point difference between repair methods using the Constant score, and 1 study had power to detect a 5-point difference using the UCLA (University of California, Los Angeles) score. Double-row rotator cuff repair does not show a statistically significant improvement in clinical outcome or radiographic healing with short-term follow-up.

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

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Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Henley, Jill K; Ashchyan, Hovik J; Kurta, Anastasia O; Patel, Payal M; Sheikh, Umar A; Franklin, Matthew J; Hanna, Courtney C; Chen, Brian R; Chiren, Sarah G; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Maher, Ian A; Cartee, Todd V; Sobanko, Joseph F; Alam, Murad

2017-08-01

Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28

A systematic review of preoperative predictors for postoperative clinical outcomes following lumbar discectomy.

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Wilson, Courtney A; Roffey, Darren M; Chow, Donald; Alkherayf, Fahad; Wai, Eugene K

2016-11-01

Sciatica is often caused by a herniated lumbar intervertebral disc. When conservative treatment fails, a lumbar discectomy can be performed. Surgical treatment via lumbar discectomy is not always successful and may depend on a variety of preoperative factors. It remains unclear which, if any, preoperative factors can predict postsurgical clinical outcomes. This review aimed to determine preoperative predictors that are associated with postsurgical clinical outcomes in patients undergoing lumbar discectomy. This is a systematic review. This systematic review of the scientific literature followed the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. MEDLINE and PubMed were systematically searched through June 2014. Results were screened for relevance independently, and full-text studies were assessed for eligibility. Reporting quality was assessed using a modified Newcastle-Ottawa Scale. Quality of evidence was assessed using a modified version of Sackett's Criteria of Evidence Support. No financial support was provided for this study. No potential conflict of interest-associated biases were present from any of the authors. The search strategy yielded 1,147 studies, of which a total of 40 high-quality studies were included. There were 17 positive predictors, 20 negative predictors, 43 non-significant predictors, and 15 conflicting predictors determined. Preoperative predictors associated with positive postoperative outcomes included more severe leg pain, better mental health status, shorter duration of symptoms, and younger age. Preoperative predictors associated with negative postoperative outcomes included intact annulus fibrosus, longer duration of sick leave, worker's compensation, and greater severity of baseline symptoms. Several preoperative factors including motor deficit, side and level of herniation, presence of type 1 Modic changes and degeneration, age, and gender had non-significant associations with postoperative clinical

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

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Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

2018-06-01

In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects

Comparison between Modified Neuroendoscopy and Craniotomy Evacuation of Spontaneous Intra-Cerebral Hemorrhages: Study of Clinical Outcome and Glasgow Outcome Score

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Arie Ibrahim

2016-08-01

Full Text Available Background and Purposes: Stroke is still one of a leading health-care problem in industrial country and in the developing country. Spontaneous Intra-cerebral Hemorrhage accounts for 30–60% of all stroke admissions into a hospital. Presence of intra-cerebral hemorrhage is considered a poor prognostic factor due to the resultant obstruction to the mass effect following the presence of blood resulting in raised intracranial pressure. While the craniotomy procedure failed to show more benefits over functional outcome, a less invasive and quicker surgical decompression might improve the outcome. Neuroendoscopy is one of promising optional  on minimal invasive  treatment  for spontaneous intra-cerebral hemorrhage. Material and Methods: We evaluated Glasgow Outcome Score and clinical outcome of patients with Spontaneous Intra-cerebral Hemorrhage who underwent modified neuroendoscopic surgery and craniotomy. Randomized control trial was performed during 27 months in 43 patients. Twenty-five patients treated with neuroendoscopy surgery and 18 patients with craniotomy. The removal of intra-cerebral hemorrhage was done by a modified neuroendoscopic transparent sheath made of silastic material, derived from pieces of thoracic tube No. 21F as a conduit working channel. Results: We analyzed statistically, clinical outcome assessment and Glasgow Outcome Scale 6 months post operative follow-up period. The mortality rate was significantly higher by Pearson chi-square methods, in craniotomy group n=12 (63.2% compared with neuroendoscopy group, n=7 (36.8% (p<.005. Patients with Glasgow Outcome Scale score 3–5 was higher in neuroendoscopy group, n=18 (75% compared with craniotomy group n=6 (25%. The survival rate analyzed by Kaplan Meier methods, found that patients in the neuroendoscopy group were a significantly longer survival rate compare with the craniotomy group during 6 months post operative follow-up period. Conclusions: Treatment of spontaneous

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

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Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

2018-01-01

Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

Interprofessional teamwork skills as predictors of clinical outcomes in a simulated healthcare setting.

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Shrader, Sarah; Kern, Donna; Zoller, James; Blue, Amy

2013-01-01

Teaching interprofessional (IP) teamwork skills is a goal of interprofessional education. The purpose of this study was to examine the relationship between IP teamwork skills, attitudes and clinical outcomes in a simulated clinical setting. One hundred-twenty health professions students (medicine, pharmacy, physician assistant) worked in interprofessional teams to manage a "patient" in a health care simulation setting. Students completed the Interdisciplinary Education Perception Scale (IEPS) attitudinal survey instrument. Students' responses were averaged by team to create an IEPS attitudes score. Teamwork skills for each team were rated by trained observers using a checklist to calculate a teamwork score (TWS). Clinical outcome scores (COS) were determined by summation of completed clinical tasks performed by the team based on an expert developed checklist. Regression analyses were conducted to determine the relationship of IEPS and TWS with COS. IEPS score was not a significant predictor of COS (p=0.054), but TWS was a significant predictor (pstudents' interprofessional teamwork skills are significant predictors of positive clinical outcomes. Interprofessional curricular models that produce effective teamwork skills can improve student performance in clinical environments and likely improve teamwork practice to positively affect patient care outcomes.

Fibrocartilaginous embolic myelopathy: demographics, clinical presentation, and functional outcomes.

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Moore, Brittany J; Batterson, Anna M; Luetmer, Marianne T; Reeves, Ronald K

2018-05-25

Retrospective cohort study. To describe the demographics, clinical presentation, and functional outcomes of fibrocartilaginous embolic myelopathy (FCEM). Academic inpatient rehabilitation unit in the midwestern United States. We retrospectively searched our database to identify patients admitted between January 1, 1995 and March 31, 2016, with a high probability of FCEM. Demographic, clinical, and functional outcome measures, including Functional Independence Measure (FIM) information was obtained by chart review. We identified 31 patients with findings suggestive of FCEM (52% male), which was 2% of the nontraumatic spinal cord injury population admitted to inpatient rehabilitation. The age distribution was bimodal, with peaks in the second and sixth-to-seventh decades. The most common clinical presentation was acute pain and rapid progression of neurologic deficits consistent with a vascular myelopathy. Only three patients (10%) had FCEM documented as a diagnostic possibility. Most patients had paraplegia and neurologically incomplete injuries and were discharged to home. Nearly half of the patients required no assistive device for bladder management at discharge, but most were discharged with medications for bowel management. Median FIM walking locomotion score for all patients was 5, but most patients were discharged using a wheelchair for primary mobility. Median motor FIM subscale score was 36 at admission and 69 at discharge, with a median motor efficiency of 1.41. FCEM may be underdiagnosed and should be considered in those with the appropriate clinical presentation, because their functional outcomes may be more favorable than those with other causes of spinal cord infarction.

Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

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Lappin Martha S

2010-02-01

Full Text Available Abstract 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.

Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

Science.gov (United States)

2010-01-01

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

Imaging characteristics associated with clinical outcomes in posterior reversible encephalopathy syndrome

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Schweitzer, Andrew D.; Nemade, Ajay [Weill Cornell Medicine, Department of Radiology, New York, NY (United States); Parikh, Neal S.; Navi, Babak B. [Weill Cornell Medicine, Department of Neurology, New York, NY (United States); Weill Cornell Medicine, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, NY (United States); Askin, Gulce [Weill Cornell Medicine, Department of Healthcare Policy and Research, Division of Biostatistics and Epidemiology, New York, NY (United States); Lyo, John; Karimi, Sasan; Knobel, Anna; Young, Robert J. [Memorial Sloan Kettering Cancer Center, Department of Radiology, New York, NY (United States); Gupta, Ajay [Weill Cornell Medicine, Department of Radiology, New York, NY (United States); Weill Cornell Medicine, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, NY (United States)

2017-04-15

Posterior reversible encephalopathy syndrome (PRES) is a disorder of cerebrovascular autoregulation that can result in brain edema, hemorrhage, and infarction. We sought to investigate whether certain imaging characteristics in PRES are associated with clinically significant patient outcomes. We retrospectively reviewed all cases of PRES occurring between 2008 and 2014 at two major academic medical centers. Demographic, clinical, and radiographic data were collected. We analyzed imaging studies for vasogenic edema, hemorrhage, and diffusion restriction. We performed univariate analysis and stepwise logistic regression to assess the association between our radiologic findings of interest and clinical outcomes as defined by hospital discharge disposition and modified Rankin scale (mRS) at time of discharge. We identified 99 cases of PRES in 96 patients. The median age was 55 years (IQR 30-65) and 74% were women. In 99 cases, 60% of patients had active cancer, 19% had history of bone marrow or organ transplantation, 14% had autoimmune disease, and 8% were peripartum. Imaging at clinical presentation showed extensive vasogenic edema in 39%, hemorrhage in 36%, hemorrhage with mass effect in 7%, and restricted diffusion in 16%. In our final logistic regression models, the presence of extensive vasogenic edema, hemorrhage with mass effect, or diffusion restriction was associated with worse clinical outcome as defined by both discharge disposition (OR = 4.3; 95% CI: 1.4-36.3; p = 0.047) and mRS (OR = 3.6; 95% CI: 1.2-10.7; p = 0.019). Extensive vasogenic edema, hemorrhage, and restricted diffusion on initial imaging in PRES are associated with worse clinical outcomes. (orig.)

Imaging characteristics associated with clinical outcomes in posterior reversible encephalopathy syndrome

International Nuclear Information System (INIS)

Schweitzer, Andrew D.; Nemade, Ajay; Parikh, Neal S.; Navi, Babak B.; Askin, Gulce; Lyo, John; Karimi, Sasan; Knobel, Anna; Young, Robert J.; Gupta, Ajay

2017-01-01

Posterior reversible encephalopathy syndrome (PRES) is a disorder of cerebrovascular autoregulation that can result in brain edema, hemorrhage, and infarction. We sought to investigate whether certain imaging characteristics in PRES are associated with clinically significant patient outcomes. We retrospectively reviewed all cases of PRES occurring between 2008 and 2014 at two major academic medical centers. Demographic, clinical, and radiographic data were collected. We analyzed imaging studies for vasogenic edema, hemorrhage, and diffusion restriction. We performed univariate analysis and stepwise logistic regression to assess the association between our radiologic findings of interest and clinical outcomes as defined by hospital discharge disposition and modified Rankin scale (mRS) at time of discharge. We identified 99 cases of PRES in 96 patients. The median age was 55 years (IQR 30-65) and 74% were women. In 99 cases, 60% of patients had active cancer, 19% had history of bone marrow or organ transplantation, 14% had autoimmune disease, and 8% were peripartum. Imaging at clinical presentation showed extensive vasogenic edema in 39%, hemorrhage in 36%, hemorrhage with mass effect in 7%, and restricted diffusion in 16%. In our final logistic regression models, the presence of extensive vasogenic edema, hemorrhage with mass effect, or diffusion restriction was associated with worse clinical outcome as defined by both discharge disposition (OR = 4.3; 95% CI: 1.4-36.3; p = 0.047) and mRS (OR = 3.6; 95% CI: 1.2-10.7; p = 0.019). Extensive vasogenic edema, hemorrhage, and restricted diffusion on initial imaging in PRES are associated with worse clinical outcomes. (orig.)

Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

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Tian, Shaoqi; Liu, Jiangjun; Yuan, Wanqing; Wang, Yuanhe; Ha, Chengzhi; Liu, Lun; Li, Qicai; Yang, Xu; Sun, Kang

2017-01-01

The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR) for medial knee arthropathy through a minimally invasive approach (MIA). From January 2006 to June 2010, 442 consecutive patients (485 knees) were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA) from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score), the Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index and visual analog scale (VAS) for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter. Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees) were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS) were significantly different (p clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer-term follow-up studies should be performed in these patients.

Clinical outcomes of first-line antiretroviral therapy in Latin America: analysis from the LATINA retrospective cohort study.

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Angriman, Federico; Belloso, Waldo H; Sierra-Madero, Juan; Sánchez, Jorge; Moreira, Ronaldo Ismerio; Kovalevski, Leandro O; Orellana, Liliana C; Cardoso, Sandra Wagner; Crabtree-Ramirez, Brenda; La Rosa, Alberto; Losso, Marcelo H

2016-02-01

Nearly 2 million people are infected with human immunodeficiency virus (HIV) in Latin America. However, information regarding population-scale outcomes from a regional perspective is scarce. We aimed to describe the baseline characteristics and therapeutic outcomes of newly-treated individuals with HIV infection in Latin America. A Retrospective cohort study was undertaken. The primary explanatory variable was combination antiretroviral therapy based on either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). The main outcome was defined as the composite of all-cause mortality and the occurrence of an AIDS-defining clinical event or a serious non-AIDS-defining event during the first year of therapy. The secondary outcomes included the time to a change in treatment strategy. All analyses were performed according to the intention to treat principle. A total of 937 treatment-naive patients from four participating countries were included (228 patients with PI therapy and 709 with NNRTI-based treatment). At the time of treatment initiation, the patients had a mean age of 37 (SD: 10) years and a median CD4 + T-cell count of 133 cells/mm(3) (interquartile range: 47.5-216.0). Patients receiving PI-based regimens had a significantly lower CD4 + count, a higher AIDS prevalence at baseline and a shorter time from HIV diagnosis until the initiation of treatment. There was no difference in the hazard ratio for the primary outcome between groups. The only covariates associated with the latter were CD4 + cell count at baseline, study site and age. The estimated hazard ratio for the time to a change in treatment (NNRTI vs PI) was 0.61 (95% CI 0.47-0.80, p America present with similar clinical outcomes regardless of the choice of initial therapy. Patients treated with PIs are more likely to require a treatment change during the first year of follow up. © The Author(s) 2015.

Does quality improvement work in neonatology improve clinical outcomes?

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Ellsbury, Dan L; Clark, Reese H

2017-04-01

Quality improvement initiatives in neonatology have been promoted as an important way of improving outcomes of newborns. The purpose of this review is to examine the effectiveness of recent quality improvement work in improving the outcomes of infants requiring neonatal intensive care. Quality improvement collaboratives and single-center projects demonstrate improvement of clinical processes and outcomes in neonatology that impact both preterm and term infants. Declines in morbidities, resource use, and length of stay have been associated with reductions in healthcare costs. Recent quality improvement work has shown evidence of improvement in clinical outcomes in neonatal intensive care patients. These improvements have important implications for the reduction of healthcare costs in this population.

Risk Factors, Clinical Presentation, and Outcomes in Overdose With Acetaminophen Alone or With Combination Products: Results From the Acute Liver Failure Study Group.

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Serper, Marina; Wolf, Michael S; Parikh, Nikhil A; Tillman, Holly; Lee, William M; Ganger, Daniel R

2016-01-01

Acetaminophen (APAP) is the most common cause of acute liver failure (ALF) in the west. It is unknown if APAP overdose in combination with diphenhydramine or opioids confers a different clinical presentation or prognosis. Study objectives were to compare (1) baseline patient characteristics; (2) initial clinical presentation; and (3) clinical outcomes among patients with ALF due to APAP alone or in combination with diphenhydramine or opioids. We analyzed 666 cases of APAP-related liver failure using the Acute Liver Failure Study Group database from 1998 to 2012. The database contains detailed demographic, laboratory, and clinical outcome data, including hemodialysis, transplantation, and death and in-hospital complications such as arrhythmia and infection. The final sample included 666 patients with APAP liver injury. A total 30.3% of patients were overdosed with APAP alone, 14.1% with APAP/diphenhydramine, and 56.6% with APAP/opioids. Patients taking APAP with opioids were older, had more comorbidities, and were more likely to have unintentional overdose (all Ppresentation, 58% in the APAP/opioid group had advanced encephalopathy as compared with 43% with APAP alone (P=0.001) The APAP/diphenhydramine group presented with the highest serum aminotransferase levels, no differences in laboratory values were noted at 3 days postenrollment. No significant differences were observed in clinical outcomes among the groups. Most patients with APAP-induced ALF were taking APAP combination products. There were significant differences in patient characteristics and clinical presentation based on the type of product ingested, however, there were no differences noted in delayed hepatotoxicity or clinical outcomes.

Clinical and neurocognitive outcome in symptomatic isovaleric acidemia

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Grünert Sarah C

2012-01-01

Full Text Available Abstract Background Despite its first description over 40 years ago, knowledge of the clinical course of isovaleric acidemia (IVA, a disorder predisposing to severe acidotic episodes during catabolic stress, is still anecdotal. We aimed to investigate the phenotypic presentation and factors determining the neurological and neurocognitive outcomes of patients diagnosed with IVA following clinical manifestation. Methods Retrospective data on 21 children and adults with symptomatic IVA diagnosed from 1976 to 1999 were analyzed for outcome determinants including age at diagnosis and number of catabolic episodes. Sixteen of 21 patients were evaluated cross-sectionally focusing on the neurological and neurocognitive status. Additionally, 155 cases of patients with IVA published in the international literature were reviewed and analyzed for outcome parameters including mortality. Results 57% of study patients (12/21 were diagnosed within the first weeks of life and 43% (9/21 in childhood. An acute metabolic attack was the main cause of diagnostic work-up. 44% of investigated study patients (7/16 showed mild motor dysfunction and only 19% (3/16 had cognitive deficits. No other organ complications were found. The patients' intelligence quotient was not related to the number of catabolic episodes but was inversely related to age at diagnosis. In published cases, mortality was high (33% if associated with neonatal diagnosis, following manifestation at an average age of 7 days. Conclusions Within the group of "classical" organic acidurias, IVA appears to be exceptional considering its milder neuropathologic implications. The potential to avoid neonatal mortality and to improve neurologic and cognitive outcome under early treatment reinforces IVA to be qualified for newborn screening.

The effect of a clinical medical librarian on in-patient care outcomes*

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Esparza, Julia M.; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E.

2013-01-01

Objective: The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. Methods: A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Results: Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. Conclusions: This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective. PMID:23930088

Histological outcome of duodenal biopsies in patients with clinically suspected celiac disease - a study of 100 cases

International Nuclear Information System (INIS)

Sarfraz, T.; Khan, S.A.; Tariq, H.

2018-01-01

To see the histological outcome of duodenal biopsies done in patients clinically suspected of celiac disease. Study Design: Prospective descriptive study. Place and Duration of Study: Histopathology Department, Army Medical College Rawalpindi, from 1 Jan 2017 to 30 Jun 2017. Material and Methods: One hundred (100) cases were included in the study. Duodenal biopsies done in patients clinically suspected of celiac disease were included in the study. Inadequate biopsies were excluded from the study. All the normal and abnormal histological features were noted to make the diagnosis. Data was entered and analyzed by using SPSS version 17. Results: Duodenal biopsies of 100 patients, done in clinically suspected cases of celiac disease were analyzed histologically. Out of these 100 cases, 46 cases (46%) showed histological features consistent with celiac disease, while 38 cases (38%) revealed chronic non specific duodenitis, 2 cases (2%) were of giardiasis, while 14 biopsies (14%) were unremarkable with no significant pathology. Conclusion: A significant number of cases clinically suspected of celiac disease may not be showing histological features consistent with celiac disease on duodenal biopsies. Due to the changing presentation of disease, as well as the recognition of a number of potential clinical and histopathological mimics, communication between pathologists and gastroenterologists is essential for appropriate interpretation of duodenal biopsy specimens. (author)

The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).

Science.gov (United States)

Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

2013-01-01

Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study.

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Lee, Jaewon; Kim, Hong-Sik; Shim, Kyu-Dong; Park, Ye-Soo

2017-06-01

The aim of this study is to evaluate the effect of depression, anxiety, and optimism on postoperative satisfaction and clinical outcomes in patients who underwent less than two-level posterior instrumented fusions for lumbar spinal stenosis and degenerative spondylolisthesis. Preoperative psychological status of subjects, such as depression, anxiety, and optimism, was evaluated using the Hospital Anxiety and Depression Scale (HADS) and the Revised Life Orientation Test (LOT-R). Clinical evaluation was determined by measuring changes in a visual analogue scale (VAS) and the Oswestry Disability Index (ODI) before and after surgery. Postoperative satisfaction of subjects assessed using the North American Spine Society lumbar spine questionnaire was comparatively analyzed against the preoperative psychological status. The correlation between patient's preoperative psychological status (depression, anxiety, and optimism) and clinical outcomes (VAS and ODI) was evaluated. VAS and ODI scores significantly decreased after surgery ( p optimism) was not related to the degree of improvement in clinical outcomes (VAS and ODI) after surgery. However, postoperative satisfaction was moderately correlated with optimism. Anxiety and optimism were more correlated with patient satisfaction than clinical outcomes. Accordingly, the surgeon can predict postoperative satisfaction of patients based on careful evaluation of psychological status before surgery.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

Science.gov (United States)

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

Directory of Open Access Journals (Sweden)

Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

Directory of Open Access Journals (Sweden)

Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

Markers of neuroinflammation and neuronal injury in bipolar disorder: Relation to prospective clinical outcomes.

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Isgren, Anniella; Sellgren, Carl; Ekman, Carl-Johan; Holmén-Larsson, Jessica; Blennow, Kaj; Zetterberg, Henrik; Jakobsson, Joel; Landén, Mikael

2017-10-01

Neuroimmune mechanisms have been linked to the pathophysiology of bipolar disorder based on studies of biomarkers in plasma, cerebrospinal fluid (CSF), and postmortem brain tissue. There are, however, no longitudinal studies investigating if CSF markers of neuroinflammation and neuronal injury predict clinical outcomes in patients with bipolar disorder. We have in previous studies found higher CSF concentrations of interleukin-8 (IL-8), monocyte chemoattractant protein 1 (MCP-1/CCL-2), chitinase-3-like protein 1 (CHI3L1/YKL-40), and neurofilament light chain (NF-L) in euthymic patients with bipolar disorder compared with controls. Here, we investigated the relationship of these CSF markers of neuroinflammation and neuronal injury with clinical outcomes in a prospective study. 77 patients with CSF analyzed at baseline were followed for 6-7years. Associations of baseline biomarkers with clinical outcomes (manic/hypomanic and depressive episodes, suicide attempts, psychotic symptoms, inpatient care, GAF score change) were investigated. Baseline MCP-1 concentrations were positively associated with manic/hypomanic episodes and inpatient care during follow-up. YKL-40 concentrations were negatively associated with manic/hypomanic episodes and with occurrence of psychotic symptoms. The prospective negative association between YKL-40 and manic/hypomanic episodes survived multiple testing correction. Concentrations of IL-8 and NF-L were not associated with clinical outcomes. High concentrations of these selected CSF markers of neuroinflammation and neuronal injury at baseline were not consistently associated with poor clinical outcomes in this prospective study. The assessed proteins may be involved in adaptive immune processes or reflect a state of vulnerability for bipolar disorder rather than being of predictive value for disease progression. Copyright © 2017 Elsevier Inc. All rights reserved.

Stakeholder Perceptions, Learning Opportunities, and Student Outcomes in Three Clinical Learning Models.

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Hendricks, Susan; DeMeester, Deborah; Stephenson, Evelyn; Welch, Janet

2016-05-01

Understanding the strengths and challenges of various clinical models is important for nursing education. Three long-standing clinical models (preceptored, hybrid, and traditional) were compared on several outcome measures related to satisfaction, learning opportunities, and student outcomes. Students, faculty, and preceptors participated in this study. Although no differences were noted in satisfaction or standardized examination scores, students in the preceptored clinical model were able to practice more psychomotor skills. Although participants in the preceptored model reported spending more time communicating with staff nurses than did those in the other models, students in the traditional model spent more time with faculty. No differences were noted among groups in student clinical observation time. All clinical learning models were focused on how clinical time was structured, without an emphasis on how faculty and preceptors work with students to develop nursing clinical reasoning skills. Identifying methodology to impact thinking in the clinical environment is a key next step. [J Nurs Educ. 2016;55(5):271-277.]. Copyright 2016, SLACK Incorporated.

Clinical outcome in measles patients hospitalized with complications

International Nuclear Information System (INIS)

Rehman, A.U.; Saeed, T.

2008-01-01

Measles is a highly communicable viral illness and is common cause of childhood mortality and morbidity. Keeping in view the high prevalence of measles in the developing world, we carried out this study to look into the complicated measles cases and clinical outcome in patients admitted in children ward of Ayub Teaching Hospital. Detailed history and physical examination of all the hospitalized patients with complication of measles were recorded in a proforma. Immunization and nutritional status of each admitted patient was assessed and the clinical outcome of measles was compared with demographic profile. one hundred thirty six hospitalized patients with complications of measles were studied. There was 60.3% male and 57.3% of patients were vaccinated against measles. Malnourished patients were 71.35% and had longer hospital stay (>5 days). Pneumonia (39.7%) and diarrhoea (38.2%) were the commonest complications. Seven children died and encephalitis (57.1%) was the commonest cause of death. The most common complications of measles are pneumonia and diarrhoea with dehydration requiring admission. Malnutrition results in more complications and longer hospital stay. Mortality is significantly associated with encephalitis. (author)

Outcomes of treatment of drug-susceptible tuberculosis at public sector primary healthcare clinics in Johannesburg, South Africa: A retrospective cohort study.

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Budgell, E P; Evans, D; Schnippel, K; Ive, P; Long, L; Rosen, S

2016-09-05

Despite the large number of tuberculosis (TB) patients treated in South Africa (SA), there are few descriptions in the published literature of drug-susceptible TB patient characteristics, mode of diagnosis or treatment outcomes in routine public sector treatment programmes. To enhance the evidence base for public sector TB treatment service delivery, we reported the characteristics of and outcomes for a retrospective cohort of adult TB patients at public sector clinics in the Johannesburg Metropolitan Municipality (JHB), SA. We collected medical record data for a retrospective cohort of adult (≥18 years) TB patients registered between 1 April 2011 and 31 March 2012 at three public sector clinics in JHB. Data were abstracted from National TB Programme clinic cards and the TB case registers routinely maintained at study sites. We report patient characteristics, mode of diagnosis, mode of treatment supervision, treatment characteristics, HIV status and treatment outcomes for this cohort. A total of 544 patients were enrolled in the cohort. Most (86%) were new TB cases, 81% had pulmonary TB, 58% were smear-positive at treatment initiation and 71% were HIV co-infected. Among 495 patients with treatment outcomes reported, 80% (n=394) had successful outcomes, 11% (n=55) were lost to follow-up, 8% (n=40) died and 1% (n=6) failed treatment. Primary healthcare clinics in JHB are achieving relatively high rates of success in treating drug-susceptible TB. Missing laboratory results were common, including follow-up smears, cultures and drug susceptibility tests, making it difficult to assess adherence to guidelines and leaving scope for substantial improvements in record-keeping at the clinics involved.

Subacute Thyroiditis: Clinical Presentation and Long Term Outcome

Science.gov (United States)

Alfadda, Assim A.; Sallam, Reem M.; Elawad, Ghadi E.; AlDhukair, Hisham; Alyahya, Mossaed M.

2014-01-01

Few studies have been reported from the Kingdom of Saudi Arabia (SA) to describe the clinical presentation and long term outcomes of subacute thyroiditis (SAT). Our aim was to review the demographic, anthropometric, clinical presentation, laboratory results, treatment, and disease outcome in Riyadh region and to compare those with results from different regions of the Kingdom and different parts of the world. We reviewed the medical files of patients who underwent thyroid uptake scan during an 8-year period in King Khalid University Hospital. Only 25 patients had confirmed diagnosis of thyroiditis. Age and gender distribution were similar to other studies. Most patients presented with palpitation, goiter, and weight change. Elevated thyroid hormones, suppressed thyroid-stimulating hormone, and elevated ESR were reported. Among those, 7 cases of SAT were recorded. β-Blockers were prescribed to 57% and nonsteroidal anti-inflammatory drugs to 29% of SAT. Long follow-up demonstrated that 85.7% of SAT cases recovered, while 14.3% developed permanent hypothyroidism. In conclusion, SAT is uncommon in the central region of SA. Compared to the western region, corticosteroid is not commonly prescribed, and permanent hypothyroidism is not uncommon. A nation-wide epidemiological study to explain these interprovincial differences is warranted. PMID:24803929

The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery : A Prospective Longitudinal Cohort Study

NARCIS (Netherlands)

Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K.

2016-01-01

BACKGROUND: Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether

The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study

NARCIS (Netherlands)

Koorevaar, R.C.; Riet, E. van 't; Gerritsen, M.J.P.; Madden, K.; Bulstra, S.K.

2016-01-01

BACKGROUND: Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether

Pyogenic sacroiliitis: diagnosis, management and clinical outcome

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Kucera, Tomas; Sponer, Pavel [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Orthopaedic Surgery, Hradec Kralove (Czech Republic); Brtkova, Jindra [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Diagnostic Radiology, Hradec Kralove (Czech Republic); Ryskova, Lenka [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Clinical Microbiology, Hradec Kralove (Czech Republic); Popper, Eduard [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Rehabilitation, Hradec Kralove (Czech Republic); Frank, Martin [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Surgery, Hradec Kralove (Czech Republic); Kucerova, Marie [Regional Hospital in Pardubice, Department of Neurosurgery, Hradec Kralove (Czech Republic)

2015-01-15

The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

Pyogenic sacroiliitis: diagnosis, management and clinical outcome

International Nuclear Information System (INIS)

Kucera, Tomas; Sponer, Pavel; Brtkova, Jindra; Ryskova, Lenka; Popper, Eduard; Frank, Martin; Kucerova, Marie

2015-01-01

The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

Science.gov (United States)

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome

Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

Science.gov (United States)

Grieve, Sharon; Perez, Roberto SGM; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden R, Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

2017-01-01

Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. ‘What is the clinical presentation and course of CRPS, and what factors influence it?’ was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally. PMID:28178071

The impact of HIV clinical pharmacists on HIV treatment outcomes: a systematic review

Directory of Open Access Journals (Sweden)

Saberi P

2012-04-01

Full Text Available Parya Saberi1, Betty J Dong2, Mallory O Johnson1, Ruth M Greenblatt2, Jennifer M Cocohoba21Department of Medicine, 2Department of Clinical Pharmacy, University of California, San Francisco, CA, USAObjective: Due to the rapid proliferation of human immunodeficiency virus (HIV treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes.Methods: We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist's roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD4+ cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables.Results: Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies.Conclusion: This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research.Keywords: pharmacist, HIV/AIDS, clinical, adherence, impact

Diagnostic issues, clinical characteristics, and outcomes for patients with fungemia

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

2011-01-01

This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

Diagnostic Issues, Clinical Characteristics, and Outcomes for Patients with Fungemia

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

2011-01-01

This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

Bonding to oxide ceramics—laboratory testing versus clinical outcome.

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Kern, Matthias

2015-01-01

Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Clinical Presentation and Outcome of Patients With Optic Pathway Glioma.

Science.gov (United States)

Robert-Boire, Viviane; Rosca, Lorena; Samson, Yvan; Ospina, Luis H; Perreault, Sébastien

2017-10-01

Optic pathway gliomas (OPGs) occur sporadically or in patients with neurofibromatosis type 1 (NF1). The purpose of this study was to evaluate the clinical presentation at diagnosis and at progression of patients with OPGs. We conducted a chart review of patients with OPGs diagnosed in a single center over a period of 15 years. Demographic data including age, sex, NF1 status, clinical presentation, and outcome were collected. Of the 40 patients who were identified, 23 had sporadic tumors (57.5%) and 17 had NF1-related tumors (42.5%). Among the children with NF1, there was a significant overrepresentation of girls (82.3%) (P = 0.02), while among the children without NF1, there were slightly more boys (56.5%) than girls (43.5%). The presence of nystagmus was strongly associated with sporadic optic pathway gliomas. Poor visual outcome was related to tumor affecting both optic pathways, hydrocephalus at diagnosis, and optic nerve atrophy. Of the 40 patients, five died of OPG complications (12.5%) and all had sporadic tumors. Our cohort is one of the largest with OPGs and a detailed description of the clinical presentation both at diagnosis and at progression. We observed a significant difference between sporadic and NF1 optic pathway gliomas in terms of demographics, clinical presentation, and outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

The clinical outcomes of surgical treatment of noncontiguous spinal tuberculosis: a retrospective study in 23 cases.

Directory of Open Access Journals (Sweden)

Jia Huang

Full Text Available STUDY DESIGN: A retrospective clinical study. OBJECTIVE: To evaluate the clinical efficacy of the surgical treatment of noncontiguous spinal tuberculosis (NSTB, and to discuss its therapeutic strategies. METHODS: We performed a retrospective review of clinical and radiographic data that were prospectively collected on 550 consecutive spinal tubercular patients including 27 patients who were diagnosed and treated as NSTB in our institution from June 2005 to June 2011. Apart from 4 patients being treated conservatively, the remainder received surgery by posterior transforaminal debridement, interbody fusion with instrumentation, posterior instrumentation and anterior debridement with fusion in a single or two-stage operation. The clinical outcomes were evaluated before and after treatment in terms of hematologic and radiographic examinations, bone fusion and neurologic status. The Oswestry Disability Index score was determined before treatment and at the last follow-up visit. RESULTS: 23 patients (15 M/8F, averaged 44.6 ± 14.2 years old (range, 19 to 70 yd, who received surgical treatment, were followed up after surgery for a mean of 52.5 ± 19.5 months (range, 24 to 72 months. The kyphotic angle was changed significantly between pre- and postoperation (P<0.05. The mean amount of correction was 12.6 ± 7.2 degrees, with a small loss of correction at last follow-up. All patients achieved solid bone fusion. No patients with neurological deficit deteriorated postoperatively. Neither mortalities nor any major complications were found. There was a significant difference of Oswestry Disability Index scores between preoperation and the final follow-up. CONCLUSION: The outcomes of follow-up showed that posterior and posterior-anterior surgical treatment methods were both viable surgical options for NSTB. Posterior transforaminal debridement, interbody fusion and posterior instrumentation, as a less invasive technique, was feasible and effective to treat

Clinical outcomes for young people with screening-detected and clinically-diagnosed rheumatic heart disease in Fiji.

Science.gov (United States)

Engelman, Daniel; Mataika, Reapi L; Ah Kee, Maureen; Donath, Susan; Parks, Tom; Colquhoun, Samantha M; Carapetis, Jonathan R; Kado, Joseph H; Steer, Andrew C

2017-08-01

Echocardiographic screening is under consideration as a disease control strategy for rheumatic heart disease (RHD). However, clinical outcomes of young people with screening-detected RHD are unknown. We aimed to describe the outcomes for a cohort with screening-detected RHD, in comparison to patients with clinically-diagnosed RHD. A retrospective cohort study included all young people with screening-detected RHD in the Central Division of Fiji in the primary cohort. Screen-negative and clinically-diagnosed comparison groups were matched 1:1 to the primary cohort. Data were collected on mortality, clinical complications and healthcare utilisation from the electronic and paper health records and existing databases. Seventy participants were included in each group. Demographic characteristics of the groups were similar (median age 11years, 69% female, median follow-up 7years). There were nine (12.9%) RHD-related deaths in the clinically-diagnosed group and one (1.4%) in the screening-detected group (Incident Rate Ratio: 9.6, 95% CI 1.3-420.6). Complications of RHD were observed in 39 (55.7%) clinically-diagnosed cases, four (20%) screening-detected cases and one (1.4%) screen-negative case. There were significant differences in the cumulative complication curves of the groups (pFiji. The prognosis of clinically-diagnosed RHD remains poor, with very high mortality and complication rates. Further studies in other settings will inform RHD screening policy. Comprehensive control strategies are required for disease prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

Severe hyperthyroidism: aetiology, clinical features and treatment outcome.

Science.gov (United States)

Iglesias, P; Dévora, O; García, J; Tajada, P; García-Arévalo, C; Díez, J J

2010-04-01

Severe hyperthyroidism (SH) is a serious medical disorder that can compromise life. There have not been systematic studies in which SH has been evaluated in detail. Here, our aims were: (1) to analyse both clinical and analytical features and outcome in patients with SH and (2) to compare these data with those found in more usual forms of hyperthyroidism. Patients and methods All patients diagnosed of SH (free thyroxine, FT4 > 100 pmol/l, NR: 11-23) seen in our endocrinology clinic in the last 15 years were studied and compared with a sample of patients with mild (mH; FT4, 23-50 pmol/l) and moderate (MH; FT4, 51-100 pmol/l) hyperthyroidism. Aetiology, clinical analytical and imaging data at diagnosis, therapeutic response and outcome were registered. Results A total of 107 patients with overt hyperthyroidism (81 females, mean age +/- SD 46.9 +/- 16.1 years) were evaluated. We studied a historic group with SH (n = 21; 14 females, 40.9 +/- 17.2 years) and, as a comparator group, we analyszed the data of 86 hyperthyroid patients (67 females, 48.4 +/- 15.5.6 years, NS) comparable in age and gender. The comparator group was classified in MH (n = 37, 26 females, 47.2 +/- 16.6 years) and mH (n = 49, 41 females, 49.4 +/- 14.8 years). In comparison with mH group, SH patients were significantly (P hyperthyroidism. FT4 was the only independent predictor of cure [OR 0.98 (CI 95%, 0.97-0.99), P hyperthyroidism is usually de novo and is accompanied by more clinical signs, symptoms, and analytical derangements, as well as higher titres of TRAb at diagnosis than milder forms of hyperthyroidism. The present data are not able to show differences in treatment modality, time to achieve cure, and remission rate among patients with mild, moderate and severe hyperthyroidism.

Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

Science.gov (United States)

De Simone, Antonio; Leoni, Loira; Luzi, Mario; Amellone, Claudia; Stabile, Giuseppe; La Rocca, Vincenzo; Capucci, Alessandro; D'onofrio, Antonio; Ammendola, Ernesto; Accardi, Francesco; Valsecchi, Sergio; Buja, Gianfranco

2015-08-01

Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P Remote arm. Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. URL: http://clinicaltrials.gov/ Identifier: NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

DEFF Research Database (Denmark)

Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos

2011-01-01

This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database.......This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database....

Relationship between the iceA gene of Helicobacter pylori and clinical outcomes.

Science.gov (United States)

Huang, Xiaojun; Deng, Zhaomin; Zhang, Qiang; Li, Wanyi; Wang, Baoning; Li, Mingyuan

2016-01-01

The complex pathogenesis of Helicobacter pylori (H. pylori) and the features of the host influence the diverse clinical outcomes. A mass of studies about virulence genes have accelerated the exploration of pathogenesis of H. pylori infection. Induced by contact with epithelium gene A (iceA) is one of the biggest concerned virulence genes. In this study, we explored the relationship between iceA and the magnitude of the risk for clinical outcomes and the prevalence of iceA-positive H. pylori in People's Republic of China and other countries. We searched the electronic databases of PubMed, Embase, CNKI, VIP, and Wanfang by literature search strategy. The studies conforming to the inclusion criteria were assessed. With these data, we systematically analyzed the relationship between the iceA gene of H. pylori and clinical outcomes. Nineteen articles with 22 studies, a total of 2,657 cases, were involved in the study. The iceA1 gene was significantly associated with peptic ulcer disease (odds ratio =1.28, 95% confidence interval =1.03-1.60; P=0.03), especially in People's Republic of China (odds ratio =1.40, 95% confidence interval =1.07-1.83; P=0.01). Moreover, the prevalence of iceA1 was significantly higher than iceA2 in People's Republic of China (P<0.0001). The prevalence of both iceA1 and iceA2 was significantly different (P<0.0001) in People's Republic of China and in other countries. The system analysis showed that infection with the iceA1-positive H. pylori significantly increased the overall risk for peptic ulcer disease, especially in People's Republic of China. The iceA2 gene status and clinical outcome of H. pylori infection have no significant correlation. H. pylori iceA1 genotype is the major epidemic strain in People's Republic of China.

Implementation of a clinical pathway may improve alcohol treatment outcome

DEFF Research Database (Denmark)

Nielsen, Anette Søgaard; Nielsen, Bent

2015-01-01

This article describes the design, implementation, and evaluation of a clinical pathway system in a two-cohort quasi-experimental study before and after implementation, controlling for confounders. The main outcome measures were retention in care and sensible alcohol use (defined as abstinent...

Problem-based learning in pre-clinical medical education: 22 years of outcome research.

Science.gov (United States)

Hartling, Lisa; Spooner, Carol; Tjosvold, Lisa; Oswald, Anna

2010-01-01

To conduct a systematic review of problem-based learning (PBL) in undergraduate, pre-clinical medical education. A research librarian developed comprehensive search strategies for MEDLINE, PSYCINFO, and ERIC (1985-2007). Two reviewers independently screened search results and applied inclusion criteria. Studies were included if they had a comparison group and reported primary data for evaluative outcomes. One reviewer extracted data and a second reviewer checked data for accuracy. Two reviewers independently assessed methodological quality. Quantitative synthesis was not performed due to heterogeneity. A qualitative review with detailed evidence tables is provided. Thirty unique studies were included. Knowledge acquisition measured by exam scores was the most frequent outcome reported; 12 of 15 studies found no significant differences. Individual studies demonstrated either improved clerkship (N = 3) or residency (N = 1) performance, or benefits on some clinical competencies during internships for PBL (N = 1). Three of four studies found some benefits for PBL when evaluating diagnostic accuracy. Three studies found few differences of clinical (or practical) importance on the impact of PBL on practicing physicians. Twenty-two years of research shows that PBL does not impact knowledge acquisition; evidence for other outcomes does not provide unequivocal support for enhanced learning. Work is needed to determine the most appropriate outcome measures to capture and quantify the effects of PBL. General conclusions are limited by methodological weaknesses and heterogeneity across studies. The critical appraisal of previous studies, conducted as part of this review, provides direction for future research in this area.

Herpes simplex and varicella zoster CNS infections: clinical presentations, treatments and outcomes.

Science.gov (United States)

Kaewpoowat, Quanhathai; Salazar, Lucrecia; Aguilera, Elizabeth; Wootton, Susan H; Hasbun, Rodrigo

2016-06-01

To describe the clinical manifestations, cerebrospinal fluid (CSF) characteristics, imaging studies and prognostic factors of adverse clinical outcomes (ACO) among adults with herpes simplex virus (HSV) or varicella zoster virus (VZV) CNS infections. Retrospective review of adult patients with positive HSV or VZV polymerase chain reaction on CSF from an observational study of meningitis or encephalitis in Houston, TX (2004-2014), and New Orleans, LA (1999-2008). Ninety-eight adults patients were identified; 25 had encephalitis [20 (20.4 %) HSV, 5 (5.1 %) VZV], and 73 had meningitis [60 (61.1 %) HSV and 13 (13.3 %) VZV]. HSV and VZV had similar presentations except for nausea (P 1 and an encephalitis presentation were independently associated with an ACO. The treatment for HSV meningitis was variable, and all patients had a good clinical outcome. Alpha herpes CNS infections due to HSV and VZV infections have similar clinical and laboratory manifestations. ACO was observed more frequently in those patients with comorbidities and an encephalitis presentation.

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

Science.gov (United States)

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

2015-01-01

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

Clinical Infectious Outcomes Associated with Biofilm-related Infections: a Retrospective Chart Review

Science.gov (United States)

2015-06-07

infectious outcomes. Methods: 221 clinical isolates collected from 2005 to 2012 and previously characterized for biofilm formation were studied. Clinical...chronic infection on multivariate analysis. Conclusions: Bacteria species, but not clinical characteristics, were associated with biofilm formation on...the implication of biofilms in a majority of human infections [2]. Biofilm formation also has been linked with poor wound healing [3], burn wound

Clinical and entomological factors influence the outcome of sting challenge studies.

Science.gov (United States)

Golden, David B K; Breisch, Nancy L; Hamilton, Robert G; Guralnick, Miles W; Greene, Albert; Craig, Timothy J; Kagey-Sobotka, Anne

2006-03-01

The reported frequency of systemic reactions to challenge sting varies greatly. To evaluate the interaction of clinical and entomological factors that determine the outcome of a challenge sting. Patients allergic to yellow jacket were stung and monitored for systemic reaction. The frequency and severity of sting reactions were analyzed in relation to the species of insect used and patient characteristics. Objective systemic reactions occurred in 21 of 69 patients (30%) stung with Vespula maculifrons and in 8 of 71 patients (11%) with Vespula germanica (P=.005). Systemic reactions were more frequent in patients with a severe history (9/30; 30%) than in those with a mild or moderate history (21/145; 14%; P=.04). In only 1 of 111 patients (0.9%) was the reaction to sting challenge more severe than previous reactions. The reaction rate was higher when venom skin tests were positive at <1.0 microg/mL (17/75=23%) than when sensitivity was milder (9/100=9%; P=.012). We compared sting outcome and venom-induced histamine release in relation to insects collected in July or in October, and found no difference. Allergic reactions to sting challenge are determined by the species of yellow jacket used, the severity of previous sting reactions, and the degree of skin test sensitivity, but not by the time of year. These factors are important to clinicians when they evaluate the chance of reaction to a future sting and to researchers when they design and report sting challenge studies.

The role of clinical pathway on the outcomes of ischemic stroke patients at Bethesda Hospital Yogyakarta

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Francisca Diana Alexandra, Iwan Dwiprahasto, Rizaldy Pinzon

2014-04-01

Full Text Available Stroke becomes world health problem all over the world because it is the causal factor of high mortality and disability. Good and well-organized process of healthcare service will improve the outcome of the patients with stroke. Clinical pathway may be used as clear standard to help reduce unnecessary variations of medical treatment and measure. The study aimed at finding out the correlation between the use of clinical pathway and the outcome of the patients with ischemic stroke in Bethesda Hospital Yogyakarta. It was an observational and analytic study with cohort restorative study design. The author compared the outcomes of acute ischemic stroke between the group with clinical pathway and the group without the clinical pathway. Data was collected using consecutive sampling from the electronic registry and medical record data of the patients from January 1st, 2011 to December 31st, 2011. It was conducted to 124 patients with ischemic stroke assigned to two groups (the first groups of 62 patients with clinical pathway and the second groups of 62 patients without clinical pathway. The basic characteristics of the two groups were the same. The results of the analysis showed that there was a significant decrease in the incidence of complication and a significant increase in the use of antiplatelete drugs, antidiabetic drugs and statin as secondary preventive measure of the recurrent stroke. There was not any significant difference in the duration of the hospitalized healthcare, the financing and the mortality between the two observation groups. The study indicated that the use of the clinical pathway in the stroke treatment improved the outcome of the patients with stroke. It was necessary to conduct further study to evaluate the effectiveness of the clinical pathway in improving the outcome of the patients with bigger number of the subjects and the longer period of time.

ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance

DEFF Research Database (Denmark)

Lønborg, Jacob; Holmvang, Lene; Kelbæk, Henning

2010-01-01

Ischemic postconditioning (IPost) during primary percutaneous coronary intervention (PPCI) is suggested to reduce myocardial damage. However, the association with ST-segment resolution (STR) and clinical outcome is not determined. The primary aim of this study was to evaluate the association of I...... of IPost with STR and clinical outcome. Secondly, we sought to determine the relationship between STR and cardiac magnetic resonance (CMR) parameters in these patients....

Beta-blocker use and clinical outcomes after primary vascular surgery

DEFF Research Database (Denmark)

Høgh, A.; Lindholt, J.S.; Nielsen, Henrik

2013-01-01

To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction.......To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction....

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

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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

2017-01-01

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 of

Victorian Audit of Surgical Mortality is associated with improved clinical outcomes.

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Beiles, C Barry; Retegan, Claudia; Maddern, Guy J

2015-11-01

Improved outcomes are desirable results of clinical audit. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM) and the Victorian Admitted Episodes Dataset (VAED) to highlight specific areas of clinical improvement and reduction in mortality over the duration of the audit process. This study used retrospective, observational data from VASM and VAED. VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Aggregated VAED data were supplied by the Victorian Department of Health. Assessment of outcomes was performed using chi-squared trend analysis over successive annual audit periods. Because initial collection of data was incomplete in the recruitment phase, statistical analysis was confined to the last 3-year period, 2010-2013. A 20% reduction in surgical mortality over the past 5 years has been identified from the VAED data. Progressive increase in both surgeon and hospital participation, significant reduction in both errors in management as perceived by assessors and increased direct consultant involvement in cases returned to theatre have been documented. The benefits of VASM are reflected in the association with a reduction of mortality and adverse clinical outcomes, which have clinical and financial benefits. It is a purely educational exercise and continued participation in this audit will ensure the highest standards of surgical care in Australia. This also highlights the valuable collaboration between the Victorian Department of Health and the RACS. © 2014 Royal Australasian College of Surgeons.

Clinical outcomes in hypertensive or diabetes patients who ...

African Journals Online (AJOL)

Background: The use of complementary medicines in addition to medical prescription by patients with hypertension, diabetes and other chronic diseases presents a challenge for healthcare providers in Nigeria and globally. There is very little data on the clinical outcomes in these patients. Objectives: To evaluate clinical ...

A Comparison of Medical Birth Register Outcomes between Maternity Health Clinics and Integrated Maternity and Child Health Clinics in Southwest Finland.

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Tuominen, Miia; Kaljonen, Anne; Ahonen, Pia; Mäkinen, Juha; Rautava, Päivi

2016-07-08

Primary maternity care services are globally provided according to various organisational models. Two models are common in Finland: a maternity health clinic and an integrated maternity and child health clinic. The aim of this study was to clarify whether there is a relation between the organisational model of the maternity health clinics and the utilisation of maternity care services, and certain maternal and perinatal health outcomes. A comparative, register-based cross-sectional design was used. The data of women (N = 2741) who had given birth in the Turku University Hospital area between 1 January 2009 and 31 December 2009 were collected from the Finnish Medical Birth Register. Comparisons were made between the women who were clients of the maternity health clinics and integrated maternity and child health clinics. There were no clinically significant differences between the clients of maternity health clinics and integrated maternity and child health clinics regarding the utilisation of maternity care services or the explored health outcomes. The organisational model of the maternity health clinic does not impact the utilisation of maternity care services or maternal and perinatal health outcomes. Primary maternity care could be provided effectively when integrated with child health services.

Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

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Shaoqi Tian

Full Text Available The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR for medial knee arthropathy through a minimally invasive approach (MIA.From January 2006 to June 2010, 442 consecutive patients (485 knees were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score, the Western Ontario and McMaster Universities Arthritis Index (WOMAC osteoarthritis index and visual analog scale (VAS for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter.Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS were significantly different (p < 0.05 from pre and post-operative evaluations. The survival rate was 99.1% at 73 months, and the revision rate was 0.9%.The midterm clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer

Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair

OpenAIRE

Perser, Karen; Godfrey, David; Bisson, Leslie

2011-01-01

Context: Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. Objective: To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Data Sources: Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. Study Sele...

THORACOLUMBAR BURST FRACTURE: STRUCTURAL CHANGES AND CLINICAL OUTCOME OF TREATMENT

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Rodrigo Arnold Tisot

2016-03-01

Full Text Available ABSTRACT Objective: To evaluate the correlation between structural changes in burst fractures of thoracic and lumbar spine with clinical outcome of the treatment. Methods: A retrospective study in 25 patients with fractures of thoracic and lumbar spine burst fractures without neurological deficit. Eleven patients underwent conservative treatment and for the remaining the treatment was surgical. All patients were followed up for at least 24 months. The cases were evaluated by a protocol that included: posttraumatic measurement of kyphosis, vertebral body collapse and narrowing of the spinal canal, the visual analog scale of pain, and the quality of life questionnaire SF-36 at the follow-up. For statistical analysis, the significance level was 5% and the software SPSS 18.0 was used. Results: No statistically significant difference was observed when comparing the clinical outcomes of one treatment over another. Similarly, there was no statistically significant correlation between kyphosis and post-traumatic narrowing of the spinal canal with clinical worsening in the follow-up, regardless of the treatment used. We found a positive correlation (p<0.05 between initial collapse and SF-36 domains in both groups (operated and non-operated. Conclusion: There was no significant superiority of one treatment over the other, and no correlation was found between kyphosis and spinal canal narrowing in burst fractures of the thoracic and lumbar spine without neurological deficit. However, there was correlation between initial collapse and clinical outcome in some domains of the SF-36 questionnaire.

Association between in vitro susceptibility to natamycin and voriconazole and clinical outcomes in fungal keratitis.

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Sun, Catherine Q; Lalitha, Prajna; Prajna, N Venkatesh; Karpagam, Rajarathinam; Geetha, Manoharan; O'Brien, Kieran S; Oldenburg, Catherine E; Ray, Kathryn J; McLeod, Stephen D; Acharya, Nisha R; Lietman, Thomas M

2014-08-01

To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Experimental study using data from a randomized comparative trial. Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. The Mycotic Ulcer Treatment Trial I was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate or scar size; corneal perforation and/or therapeutic penetrating keratoplasty; and time to re-epithelialization. A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size (0.21 mm; 95% confidence interval [CI], 0.10-0.31; P < 0.001) and increased odds of perforation (odds ratio, 1.32; 95% CI, 1.04-1.69; P = 0.02). No correlation was found between MIC and 3-month visual acuity. For natamycin-treated cases, an association was found between higher natamycin MIC with larger 3-month infiltrate or scar size (0.29 mm; 95% CI, 0.15-0.43; P < 0.001) and increased perforations (odds ratio, 2.41; 95% CI, 1.46-3.97; P < 0.001). Among voriconazole-treated cases, the voriconazole MIC did not correlate with any of the measured outcomes in the study. Decreased susceptibility to natamycin was associated with increased infiltrate or scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Solitary rectal ulcer syndrome: clinical findings, surgical treatment, and outcomes.

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Torres, Carlos; Khaikin, Marat; Bracho, Jorge; Luo, Cheng Hua; Weiss, Eric G; Sands, Dana R; Cera, Susan; Nogueras, Juan J; Wexner, Steven D

2007-11-01

Solitary rectal ulcer syndrome (SRUS) is a rare disorder often misdiagnosed as a malignant ulcer. Histopathological features of SRUS are characteristic and pathognomonic; nevertheless, the endoscopic and clinical presentations may be confusing. The aim of the present study was to assess the clinical findings, surgical treatment, and outcomes in patients who suffer from SRUS. A retrospective chart review was undertaken, from January 1989 to May 2005 for all patients who were diagnosed with SRUS. Data recorded included: patient's age, gender, clinical presentation, past surgical history, diagnostic and preoperative workup, operative procedure, complications, and outcomes. During the study period, 23 patients were diagnosed with SRUS. Seven patients received only medical treatment, and in three patients, the ulcer healed after medical treatment. Sixteen patients underwent surgical treatment. In four patients, the symptoms persisted after surgery. Two patients presented with postoperative rectal bleeding requiring surgical intervention. Three patients developed late postoperative sexual dysfunction. One patient continued suffering from rectal pain after a colostomy was constructed. Median follow-up was 14 (range 2-84) months. The results of this study show clearly that every patient with SRUS must be assessed individually. Initial treatment should include conservative measures. In patients with refractory symptoms, surgical treatment should be considered. Results of anterior resection and protocolectomy are satisfactory for solitary rectal ulcer.

TIAM1 variants improve clinical outcome in neuroblastoma.

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Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

2017-07-11

Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

Predictors of functional and clinical outcome in early-onset first-episode psychosis: the child and adolescent first episode of psychosis (CAFEPS) study.

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Parellada, Mara; Castro-Fornieles, Josefina; Gonzalez-Pinto, Ana; Pina-Camacho, Laura; Moreno, Dolores; Rapado-Castro, Marta; Otero, Soraya; de la Serna, Elena; Moreno, Carmen; Baeza, Inmaculada; Graell, Montserrat; Arango, Celso

2015-11-01

The objective of this study was to study baseline clinical and biological predictors of 2-year outcome in a cohort of children and adolescents with a first episode of psychosis. Standard instruments were used to evaluate symptoms and functioning in 110 children and adolescents (mean age = 15.47 years) with first episode of psychosis at admission (between 2003 and 2005) and after 2-year follow-up. Clinical assessments included diagnostic assessment to yield DSM-IV diagnosis, developmental, premorbid, and past-year data, together with structural neuroimaging and other biological parameters (genetics and oxidative stress). Eighty-three subjects had assessments at baseline (including the Strauss-Carpenter Outcome Scale [SCOS]) and at 2-year follow-up. Association and multistep regression analyses were conducted to show correlates and predictors of primary outcome measures: functional outcome (Children's Global Assessment Scale [CGAS]), improvement (CGAS change), and primary negative symptoms (Proxy for the Deficit Syndrome Scale). The SCOS predicted 27.46% (P < .001) of the variance in CGAS score at 2 years. Baseline severity (measured by CGAS) predicted 30.9% (P < .001) of CGAS improvement after 2 years, and SCOS total score predicted an added 24.1% (P < .001). A diagnosis of nonaffective psychosis, primary negative symptoms, and less white matter at baseline predicted more primary negative symptoms at follow-up. The prediction of functional outcome was not increased by genetic, oxidative stress, or neurostructural markers. Baseline clinical assessments have a better predictive value than biological assessments for 2-year follow-up functioning of children and adolescents with a first episode of psychosis. Patients with primary negative symptoms at baseline continue to have negative symptoms 2 years later, and neurostructural markers predict these. Clinicians must still rely on clinical variables to judge the functional prognosis of early-onset first psychotic episodes

Relationship between Illness Perceptions, Treatment Adherence, And Clinical Outcomes in Patients On Maintenance Hemodialysis

OpenAIRE

Kim, Youngmee; Evangelista, Lorraine S.

2010-01-01

Previous data indicate that negative perception of disease and non-adherence to recommended treatment may lead to unfavorable clinical outcomes in patients on maintenance hemodialysis (HD). However, a paucity of research addresses clinical outcomes in the end stage renal disease (ESRD) population as a function of patients’ illness perceptions and their degree of adherence to recommended treatment. The study was conducted to examine illness perceptions and treatment adherence rates in patients...

Wound healing outcomes in a diabetic foot ulcer outpatient clinic at an acute care hospital: a retrospective study.

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Lu, S H; McLaren, A-M

2017-10-01

Patients with diabetic foot ulcers (DFU) have an increased risk of lower extremity amputation. A retrospective chart review of patients with DFUs attending the Foot Treatment and Assessment chiropodist-led outpatient clinic at an inner-city academic hospital was conducted to determine wound healing outcomes and characteristics contributing to outcomes. We reviewed the complete clinical history of 279 patients with 332 DFUs spanning over a five-year period. The mean age of patients was 61.5±12.5 years and most patients (83.5%) had one DFU. The majority of wounds (82.5%) were in the forefoot. Overall, 267/332 (80.5%) wounds healed. A greater proportion of wounds healed in the forefoot (82.5%) and midfoot (87.1%) than hindfoot (51.9%; phealing. Our findings are the first to demonstrate the benefits of chiropodists leading an acute care outpatient clinic in the management of DFUs in Canada and delivers wound healing outcomes equivalent to or exceeding those previously published.

Comparing 2 Whiplash Grading Systems to Predict Clinical Outcomes.

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Croft, Arthur C; Bagherian, Alireza; Mickelsen, Patrick K; Wagner, Stephen

2016-06-01

Two whiplash severity grading systems have been developed: Quebec Task Force on Whiplash-Associated Disorders (QTF-WAD) and the Croft grading system. The majority of clinical studies to date have used the modified grading system published by the QTF-WAD in 1995 and have demonstrated some ability to predict outcome. But most studies include only injuries of lower severity (grades 1 and 2), preventing a broader interpretation. The purpose of this study was assess the ability of these grading systems to predict clinical outcome within the context of a broader injury spectrum. This study evaluated both grading systems for their ability to predict the bivalent outcome, recovery, within a sample of 118 whiplash patients who were part of a previous case-control designed study. Of these, 36% (controls) had recovered, and 64% (cases) had not recovered. The discrete bivariate distribution between recovery status and whiplash grade was analyzed using the 2-tailed cross-tabulation statistics. Applying the criteria of the original 1993 Croft grading system, the subset comprised 1 grade 1 injury, 32 grade 2 injuries, 53 grade 3 injuries, and 32 grade 4 injuries. Applying the criteria of the modified (QTF-WAD) grading system, there were 1 grade 1 injury, 89 grade 2 injuries, and 28 grade 3 injuries. Both whiplash grading systems correlated negatively with recovery; that is, higher severity grades predicted a lower probability of recovery, and statistically significant correlations were observed in both, but the Croft grading system substantially outperformed the QTF-WAD system on this measure. The Croft grading system for whiplash injury severity showed a better predictive measure for recovery status from whiplash injuries as compared with the QTF-WAD grading system.

Outcome of self-expandable metallic stent deployment in patients with malignant gastroduodenal outlet obstruction and Niti-S and WallFlex comparison: a multicenter retrospective clinical study.

Science.gov (United States)

Kato, Hironari; Kawamoto, Hirofumi; Matsumoto, Kazuya; Moriyama, Ichiro; Kamada, Hideki; Tsutsumi, Koichiro; Goto, Daisuke; Fukuba, Nobuhiko; Kato, Kiyohito; Sonoyama, Hiroki; Isomoto, Hajime; Okada, Hiroyuki

2016-08-01

Several studies report on the outcomes of self-expandable metallic stents (SEMSs) deployment for malignant gastric outlet obstruction (GOO). However, data was mostly based on the analysis of single-center studies including only a small number of patients. This study aimed to evaluate clinical outcomes after the deployment of SEMS in patients with malignant GOO and to compare the clinical outcomes of two metallic stents with different designs. Altogether 125 consecutive patients from five institutions were included. Clinical outcomes were evaluated according to technical success, clinical success, stent patency period, survival period and complications. A comparison of clinical outcomes between Niti-S pyloric/duodenal and WallFlex duodenal stents was also undertaken. Rates for clinical and technical success were 100% and 92.0%, respectively. The median stent patency and survival periods were 72.0 days (range 3-775 days) and 75.0 days (range 3-775 days), respectively. The rate of overall adverse events was 28.8%. The rate of stent dysfunction was 16.8%, and that of adverse events, except stent dysfunction was 12.0%. Massive bleeding occurred in two patients as a late complication. The clinical success rate for Niti-S stent was significantly higher than that for WallFlex stent (96.2% vs 84.8%, P = 0.023). We successfully deployed a SEMS in malignant GOO. The selection of a SEMS with a lower axial force may be important for patients to resume the oral food intake. Additionally, consideration must be given to the appropriate management of fatal bleeding as a late complication. © 2016 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Subjective versus objective assessment in early clinical outcome of modified Lapidus procedure for hallux valgus deformity.

Science.gov (United States)

Chopra, S; Moerenhout, K; Crevoisier, X

2016-02-01

Studies have assessed the outcome of hallux valgus surgeries based on subjective questionnaires, usually the American Orthopaedic Foot and Ankle Society Score, and radiographic results reporting good to excellent outcome at 6-12 months postoperatively. However, contrasting results were reported by gait studies at 12-24 months postoperatively. In a previous study, we found nine gait parameters which can describe the altered gait in hallux valgus deformity. This study aimed, to assess the outcome of modified Lapidus at 6 months postoperatively, using gait assessment method, to determine if the nine specified gait parameters effectively relates with the clinical scores and the radiological results or add information missed by these commonly used clinical assessments. We assessed 21 participants including 11 controls and 10 patients with moderate to severe hallux valgus deformity. The patient group was followed 6 months postoperatively. The ambulatory gait assessment was performed utilizing pressure insoles and inertial sensors. Clinical assessment includes foot and ankle questionnaires along with radiographic results. Comparison was made using non parametric tests, Phallux valgus surgeries. The existing clinical assessment overestimates the functional outcome at the early postoperative phase. Copyright © 2015 Elsevier Ltd. All rights reserved.

Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

Directory of Open Access Journals (Sweden)

Jensen Gunnar

2011-01-01

Full Text Available Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA, which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%. Mean age was 15.7 years (range 10-18 and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4. The largest groups of main diagnostic conditions were affective (28% and externalizing (26% disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement in the HoNOSCA total score was 5.1 (SD 6.2, with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission

The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study.

Science.gov (United States)

Buxbaum, James; Quezada, Michael; Chong, Bradford; Gupta, Nikhil; Yu, Chung Yao; Lane, Christianne; Da, Ben; Leung, Kenneth; Shulman, Ira; Pandol, Stephen; Wu, Bechien

2018-03-15

The Pancreatitis Activity Scoring System (PASS) has been derived by an international group of experts via a modified Delphi process. Our aim was to perform an external validation study to assess for concordance of the PASS score with high face validity clinical outcomes and determine specific meaningful thresholds to assist in application of this scoring system in a large prospectively ascertained cohort. We analyzed data from a prospective cohort study of consecutive patients admitted to the Los Angeles County Hospital between March 2015 and March 2017. Patients were identified using an emergency department paging system and electronic alert system. Comprehensive characterization included substance use history, pancreatitis etiology, biochemical profile, and detailed clinical course. We calculated the PASS score at admission, discharge, and at 12 h increments during the hospitalization. We performed several analyses to assess the relationship between the PASS score and outcomes at various points during hospitalization as well as following discharge. Using multivariable logistic regression analysis, we assessed the relationship between admission PASS score and risk of severe pancreatitis. PASS score performance was compared to established systems used to predict severe pancreatitis. Additional inpatient outcomes assessed included local complications, length of stay, development of systemic inflammatory response syndrome (SIRS), and intensive care unit (ICU) admission. We also assessed whether the PASS score at discharge was associated with early readmission (re-hospitalization for pancreatitis symptoms and complications within 30 days of discharge). A total of 439 patients were enrolled, their mean age was 42 (±15) years, and 53% were male. Admission PASS score >140 was associated with moderately severe and severe pancreatitis (OR 3.5 [95% CI 2.0, 6.3]), ICU admission (OR 4.9 [2.5, 9.4]), local complications (3.0 [1.6, 5.7]), and development of SIRS (OR 2.9 [1

Clinical Characteristics, Risk Factors, and Outcomes Associated With Neonatal Hemorrhagic Stroke: A Population-Based Case-Control Study.

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Cole, Lauran; Dewey, Deborah; Letourneau, Nicole; Kaplan, Bonnie J; Chaput, Kathleen; Gallagher, Clare; Hodge, Jacquie; Floer, Amalia; Kirton, Adam

2017-03-01

Hemorrhage into the brain of term newborns often results in major injury and lifelong disability. The clinical epidemiology of neonatal hemorrhagic stroke (NHS) remains undefined, hindering the development of strategies to improve outcomes. To characterize the incidence, types, presentations, associated factors, and outcomes of neonatal hemorrhagic stroke. Population-based, nested case-control study. The Alberta Perinatal Stroke Project, a provincial registry, ascertained NHS cases using exhaustive diagnostic code searching (1992-2010, >2500 medical record reviews). Prospective cases were captured through the Calgary Pediatric Stroke Program (2007-2014). Participants included term neonates with magnetic resonance imaging-confirmed NHS including primary and secondary intracerebral hemorrhage, hemorrhagic transformation of ischemic injury, and presumed perinatal hemorrhagic stroke. Control infants with common data were recruited from a population-based study (4 to 1 ratio). Infants with NHS underwent structured medical record review using data-capture forms and blinded scoring of neuroimaging. Clinical risk factor common data elements were explored using logistic regression. Provincial live births were obtained from Statistics Canada. Outcomes were extrapolated to the Pediatric Stroke Outcome Measure. We identified 86 cases: 51 infants (59%) with NHS, of which 32 (67%) were idiopathic, 30 (35%) were hemorrhagic transformation of primary ischemic injuries (14 with neonatal cerebral sinovenous thrombosis, 11 with hypoxic ischemic encephalopathy, and 5 with neonatal arterial ischemic stroke), and 5 were presumed perinatal hemorrhagic stroke. Sixty-two percent were male. Incidence of pure NHS was 1 in 9500 live births and 1 in 6300 for all forms. Most presented in the first week of life with seizures and encephalopathy. Acute neurosurgical intervention was rare (3 of 86 total cases; 3.5%). Temporal lobe was the most common NHS location (16 of 51 pure NHS cases; 31%). A

Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.

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Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver

2017-03-01

Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

Myasthenia gravis and pregnancy: clinical implications and neonatal outcome

Directory of Open Access Journals (Sweden)

Estanol Bruno

2004-11-01

Full Text Available Abstract Background The myasthenia gravis is twice as common in women as in men and frequently affects young women in the second and third decades of life, overlapping with the childbearing years. Generally, during pregnancy in one third of patients the disease exacerbates, whereas in two thirds it remains clinically unchanged. Complete remission can occur in some patients. Methods To describe the clinical course, delivery and neonatal outcome of 18 pregnant women with the diagnosis of myasthenia gravis. Retrospective chart review of pregnant patients with myasthenia gravis, followed at the National Institute of Perinatology in Mexico City over an 8-year period. Data was abstracted from the medical records on the clinical course during pregnancy, delivery and neonatal outcome. Results From January 1, 1996 to December 31, 2003 18 patients with myasthenia gravis were identified and included in the study. The mean ± SD maternal age was 27.4 ± 4.0 years. During pregnancy 2 women (11% had an improvement in the clinical symptoms of myasthenia gravis, 7 women (39% had clinical worsening of the condition of 9 other patients (50% remained clinically unchanged. Nine patients delivered vaginally, 8 delivered by cesarean section and 1 pregnancy ended in fetal loss. Seventeen infants were born at mean ± SD gestational age of 37.5 ± 3.0 weeks and a mean birth weight of 2710 ± 73 g. Only one infant presented with transient neonatal myasthenia gravis. No congenital anomalies were identified in any of the newborns. Conclusions The clinical course of myasthenia gravis during pregnancy is variable, with a significant proportion of patients experiencing worsening of the clinical symptoms. However, neonatal transient myasthenia was uncommon in our patient population.

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

Science.gov (United States)

Kelly, Peter James

2010-01-01

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

Prospective clinical study of prosthetic treatment outcome of implantretained-removable-partial-denture during 5 year-follow-ups

OpenAIRE

Mehran Bahrami; Mohammed Hussein Mahmood Alsharbaty

2017-01-01

Background IRRPD offers patients the ability to upgrade their treatment planning to implant-supported-overdentures (ISOs) or implant-supported-fixed-prostheses (ISFPs) through insertion of more implants in the future after the loss of the remaining natural teeth. Aims The purpose of this prospective-clinical-study was to evaluate the success rate and treatment outcome of IRRPD for 15 patients, during at least 5-year-follow-ups after prosthetic rehabilitation with respect to implant ...

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

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Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

2012-10-01

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

Energy Technology Data Exchange (ETDEWEB)

Murthy, Vedang, E-mail: vmurthy@actrec.gov.in [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Bakshi, Ganesh; Prakash, Gagan [Department of Surgical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Joshi, Amit; Prabhash, Kumar [Department of Medical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Ghonge, Sujata; Shrivastava, Shyamkishore [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India)

2016-01-01

Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2]{sub 10} = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder

Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

International Nuclear Information System (INIS)

Murthy, Vedang; Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh; Bakshi, Ganesh; Prakash, Gagan; Joshi, Amit; Prabhash, Kumar; Ghonge, Sujata; Shrivastava, Shyamkishore

2016-01-01

Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2] 10  = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder preservation

Clinical outcome after endovascular coil embolization in elderly patients with subarachnoid hemorrhage

International Nuclear Information System (INIS)

Johansson, M.; Cesarini, K.G.; Ronne-Engstroem, E.; Enblad, P.; Norbaeck, O.; Gal, G.; Tovi, M.; Solander, S.; Contant, C.F.

2004-01-01

Subarachnoid hemorrhage (SAH) is not an unusual disease in an elderly population. The clinical outcome has improved over time. It has been suggested that elderly SAH patients would benefit from endovascular aneurysm treatment. The aim of this study was to evaluate technical results and clinical outcome in a series of elderly SAH-patients treated with endovascular coil embolization. Sixty-two patients (≥ 65 years) presenting with aneurysmal SAH underwent early endovascular coil embolization at Uppsala University Hospital between September 1996 and December 2000. In all 62 cases included in the study, endovascular coil embolization was considered the first line of treatment. Admission variables, specific information on technical success, degree of occlusion and procedural complications, and outcome figures were recorded. Clinical grade on admission was Hunt and Hess (H and H) I-II in 39%, H and H III in 27% and H and H IV-V in 34% of the patients. The proportion of posterior circulation aneurysms was 24%. Coil embolization was successfully completed in 94%. The degree of occlusion of the treated aneurysm was complete occlusion in 56%, neck remnant in 21%, residual filling in 11%, other remnant in 5% and not treated in 6%. The rate of procedural complications was 11%. Outcome after 6 months was favorable in 41%, severe disability in 36% and poor in 22%. Favorable outcome was achieved in 57% of the H and H I-II patients, 47% of the H and H III patients and 17% of the H and H IV-V patients. Endovascular aneurysm treatment can be performed in elderly patients with SAH with a high level of technical success, acceptable aneurysm occlusion results, an acceptable rate of procedural complications and fair outcome results. (orig.)

Clinical outcome and radiographic results after operative treatment of Scheuermann's disease

NARCIS (Netherlands)

Poolman, R. W.; Been, H. D.; Ubags, L. H.

2002-01-01

The aim of this prospective study was to evaluate radiographic findings, patient satisfaction and clinical outcome, and to report complications and instrumentation failure after operative treatment of Scheuermann's disease using a combined anterior and posterior spondylodesis. The loss of sagittal

Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries

DEFF Research Database (Denmark)

Reaney, Matthew; Mathieu, Chantal; Ostenson, Claes-Göran

2013-01-01

who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes. CONCLUSIONS: These data from a clinical practice study support those from clinical...... clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. METHODS: CHOICE was a 24-month, prospective observational study conducted in six European......BACKGROUND: Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine...

Outcome prediction in mild traumatic brain injury: age and clinical variables are stronger predictors than CT abnormalities.

NARCIS (Netherlands)

Jacobs, B.; Beems, T.; Stulemeijer, M.; Vugt, A.B. van; Vliet, A.M. van der; Borm, G.F.; Vos, P.E.

2010-01-01

Mild traumatic brain injury (mTBI) is a common heterogeneous neurological disorder with a wide range of possible clinical outcomes. Accurate prediction of outcome is desirable for optimal treatment. This study aimed both to identify the demographic, clinical, and computed tomographic (CT)

Clinical Manifestations and Outcome of Syphilitic Uveitis

NARCIS (Netherlands)

Bollemeijer, Jan G.; Wieringa, Wietse G.; Missotten, Tom O. A. R.; Meenken, Ina; ten Dam-van Loon, Ninette H.; Rothova, Aniki; Los, Leonoor I.

PURPOSE. To analyze visual outcome, effectiveness of various modes of antibiotic treatment, and prognostic factors in patients with serologically proven syphilitic uveitis. METHODS. The clinical records of 85 patients (139 eyes) diagnosed with syphilitic uveitis between 1984 and 2013 at tertiary

Clinical Profile and Visual Outcome of Ocular Bartonellosis in Malaysia

OpenAIRE

Tan, Chai Lee; Fhun, Lai Chan; Tai, Evelyn Li Min; Abdul Gani, Nor Hasnida; Muhammed, Julieana; Tuan Jaafar, Tengku Norina; Ahmad Tajudin, Liza Sharmini; Wan Hitam, Wan-Hazabbah

2017-01-01

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, support...

The Clinical Outcomes of Lower Gastrointestinal Bleeding Are Not Better than Those of Upper Gastrointestinal Bleeding.

Science.gov (United States)

Kwak, Min Seob; Cha, Jae Myung; Han, Yong Jae; Yoon, Jin Young; Jeon, Jung Won; Shin, Hyun Phil; Joo, Kwang Ro; Lee, Joung Il

2016-10-01

The incidence of lower gastrointestinal bleeding (LGIB) is increasing; however, predictors of outcomes for patients with LGIB are not as well defined as those for patients with upper gastrointestinal bleeding (UGIB). The aim of this study was to identify the clinical outcomes and the predictors of poor outcomes for patients with LGIB, compared to outcomes for patients with UGIB. We identified patients with LGIB or UGIB who underwent endoscopic procedures between July 2006 and February 2013. Propensity score matching was used to improve comparability between LGIB and UGIB groups. The clinical outcomes and predictors of 30-day rebleeding and mortality rate were analyzed between the two groups. In total, 601 patients with UGIB (n = 500) or LGIB (n = 101) were included in the study, and 202 patients with UGIB and 101 patients with LGIB were analyzed after 2:1 propensity score matching. The 30-day rebleeding and mortality rates were 9.9% and 4.5% for the UGIB group, and 16.8% and 5.0% for LGIB group, respectively. After logistic regression analysis, the Rockall score (P = 0.013) and C-reactive protein (CRP; P = 0.047) levels were significant predictors of 30-day mortality in patients with LGIB; however, we could not identify any predictors of rebleeding in patients with LGIB. The clinical outcomes for patients with LGIB are not better than clinical outcomes for patients with UGIB. The clinical Rockall score and serum CRP levels may be used to predict 30-day mortality in patients with LGIB.

Abdominal tuberculosis: clinical presentation and outcome

International Nuclear Information System (INIS)

Kumar, R.; Saddique, M.; Iqbal, P.

2007-01-01

To study the clinical presentation and outcome of cases of Abdominal Tuberculosis. Fifty four patients of Abdominal Tuberculosis were seen during the study period. Four patients were lost to follow-up, which were excluded. Detailed information of all the patients including age, sex, symptoms, signs, investigations and management was recorded, analyzed and compared with local and international data. Out of the 50 patients with Abdominal Tuberculosis, 31 were females and 19 males. Their ages ranged from 17 to 63 years, with a mean age of 25.1 years. Thirty five cases were admitted through Emergency and 15 through Outpatients departments. Abdominal pain was the most common symptom found in 44 (88%) patients followed by vomiting in 33 (66%). Abdominal tenderness was seen in 22 (44%) patients, while 16 (32%) patients had rigidity and other features of peritonitis. Surgery was performed in all these patients, limited right hemicolectomy in 17 (34%), segmental resection and anastomosis in 12 (24%), ileostomy and strictureplasty in six (12%) each, repair of perforation in five (10%) and adhesiolysis in four (8%) patients. Overall mortality was 8% due to septicaemia and multiorgan failure. Abdominal Tuberculosis is a significant clinical entity with lethal complications in neglected cases. It affects a younger age group and is more common in females. Clinical features are rather non-specific but vague ill health, low grade fever, weight loss and anorexia may help to diagnose the case. (author)

Traumatic Brain Injury Severity, Neuropathophysiology, and Clinical Outcome: Insights from Multimodal Neuroimaging

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Andrei Irimia

2017-10-01

Full Text Available BackgroundThe relationship between the acute clinical presentation of patients with traumatic brain injury (TBI, long-term changes in brain structure prompted by injury and chronic functional outcome is insufficiently understood. In this preliminary study, we investigate how acute Glasgow coma score (GCS and epileptic seizure occurrence after TBIs are statistically related to functional outcome (as quantified using the Glasgow Outcome Score and to the extent of cortical thinning observed 6 months after the traumatic event.MethodsUsing multivariate linear regression, the extent to which the acute GCS and epileptic seizure occurrence (predictor variables correlate with structural brain changes (relative cortical atrophy was examined in a group of 33 TBI patients. The statistical significance of the correlation between relative cortical atrophy and the Glasgow Outcome Score was also investigated.ResultsA statistically significant correlative relationship between cortical thinning and the predictor variables (acute GCS and seizure occurrence was identified in the study sample. Regions where the statistical model was found to have highest statistical reliability in predicting both gray matter atrophy and neurological outcome include the frontopolar, middle frontal, postcentral, paracentral, middle temporal, angular, and lingual gyri. In addition, relative atrophy and GOS were also found to be significantly correlated over large portions of the cortex.ConclusionThis study contributes to our understanding of the relationship between clinical descriptors of acute TBI, the extent of injury-related chronic brain changes and neurological outcome. This is partly because the brain areas where cortical thinning was found to be correlated with GCS and with seizure occurrence are implicated in executive control, sensory function, motor acuity, memory, and language, all of which may be affected by TBI. Thus, our quantification suggests the existence of a

Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

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Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

Outcomes of Revision Hip Arthroscopy: 2-Year Clinical Follow-up.

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Gupta, Asheesh; Redmond, John M; Stake, Christine E; Dunne, Kevin F; Hammarstedt, Jon E; Domb, Benjamin G

2016-05-01

To evaluate clinical outcomes, pain, and patient satisfaction following revision hip arthroscopy with a minimum 2-year follow-up. From April 2008 to October 2011, data were prospectively collected on all patients undergoing revision hip arthroscopy. All patients were assessed pre- and postoperatively with 4 patient-reported outcome (PRO) measures: the modified Harris hip score (mHHS), nonarthritic hip score (NAHS), hip outcome score-activities of daily living (HOS-ADL), and hip outcome score-sport-specific subscales (HOS-SSS). Pain was estimated on the visual analog scale (VAS). Patient satisfaction was measured on a scale from 0 to 10. The number of patients who underwent subsequent revision arthroscopy or total hip arthroplasty during the study period is also reported. Eighty-seven patients underwent revision hip arthroscopy during the study period. Seventy (80.5%) patients were included in our study. Average follow-up time was 28 months (range, 20 to 47.4 months). In terms of residual femoroacetabular impingement morphology, 45.7% of patients had preoperative alpha angles ≥ 55°, and 7.14% of patients had a lateral center-edge angle ≥ 40°. The score improvement from preoperative to 2-year follow-up was 57.84 to 73.65 for mHHS, 62.79 to 83.04 for HOS-ADL, 37.33 to 54.93 for HOS-SSS, and 55.65 to 70.79 for NAHS. VAS decreased from 6.72 to 4.08. All scores demonstrated statistically significant improvement (P arthroscopy during the study period. We found an overall minor complication rate of 10%. Revision hip arthroscopy for all procedures performed on aggregate has improved clinical outcomes for all PROs, high survivorship, and high patient satisfaction scores at short-term follow-up. Patients should be counseled regarding the potential progression of degenerative change leading to arthroplasty and the potential for revision surgery. Level IV retrospective case series. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc

Clinical and economic outcomes assessment in nuclear cardiology

International Nuclear Information System (INIS)

Shaw, L.J.; Miller, D.D.; Berman, D.S.; Hachamovitch, R.

2000-01-01

The future of nuclear medicine procedures, as understood within our current economic climate, depends upon its ability to provide relevant clinical information at similar or lower comparative costs. With an ever-increasing emphasis on cost containment, outcome assessment forms the basis of preserving the quality of patient care. Today, outcomes assessment encompasses a wide array of subjects including clinical, economic, and humanistic (i.e., quality of life) outcomes. For nuclear cardiology, evidence-based medicine would require a threshold level of evidence in order to justify the added cost of any test in a patient's work-up. This evidence would include large multicenter, observational series as well as randomized trial data in sufficiently large and diverse patient populations. The new movement in evidence-based medicine is also being applied to the introduction of new technologies, in particular when comparative modalities exist. In the past 5 years, it has seen a dramatic shift in the quality of outcomes data published in nuclear cardiology. This includes the use of statistically rigorous risk-adjusted techniques as well as large populations (i.e., >500 patients) representing multiple diverse medical care settings. This has been the direct result of the development of multiple outcomes databases that have now amassed thousands of patients worth of data. One of the benefits of examining outcomes in large patient datasets is the ability to assess individual endpoints (e.g., cardiac death) as compared with smaller datasets that often assess combined endpoints (e.g., death, myocardial infarction, or unstable angina). New technologies for the diagnosis of coronary artery disease have contributed to the rising costs of care. In the United States and in Europe, costs of care have risen dramatically, consuming an ever-increasing amount of available resources. The overuse of diagnostic angiography often leads to unnecessary revascularization that does not lead to

The effect of platelet-rich plasma on clinical outcomes in lateral epicondylitis.

Science.gov (United States)

Ahmad, Zafar; Brooks, Roger; Kang, Sertaz-Niel; Weaver, Holly; Nunney, Ian; Tytherleigh-Strong, Graham; Rushton, Neil

2013-11-01

To evaluate the evidence for application of platelet-rich plasma (PRP) in lateral epicondylitis. We carried out a systematic review of the current evidence on the effects of PRP in lateral epicondylitis on clinical outcomes. We performed a comprehensive search of the PubMed, Medline, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases using various combinations of the commercial names of each PRP preparation and "lateral epicondylitis" (with its associated terms), looking specifically at human studies. Data validity was assessed and collected on clinical outcome. Nine studies met the inclusion criteria, of which 5 were randomized controlled trials. Two cohort studies showed that PRP improved clinical satisfaction scores. One case-control study showed that PRP yielded a significantly greater improvement in symptoms compared with bupivacaine. Two randomized controlled trials compared the effect of injections of PRP and blood. Only 1 of the studies noted a significant difference at the 6-week time point. Three randomized controlled trials compared corticosteroids with PRP. Two of the smaller trials, which had follow-up periods of 6 weeks and 3 months, showed no significant difference between treatment groups. The largest randomized controlled trial found that PRP had significant benefit compared with corticosteroids with regard to pain and Disabilities of the Arm, Shoulder and Hand scores at 1- and 2-year time points. This review highlights the limited but evolving evidence for the use of PRP in lateral epicondylitis; however, further research is required to understand the concentration and preparation that facilitate the best clinical outcome. Characterizing the timing of the intervention would optimize the health economics behind the decision to treat for the patient and health care provider. Level III, systematic review of Level I to III studies. Copyright © 2013 Arthroscopy Association of North America. Published by

Sleep quality, the neglected outcome variable in clinical studies focusing on locomotor system; a construct validation study

Directory of Open Access Journals (Sweden)

Röder Christoph

2010-09-01

Full Text Available Abstract Background In addition to general health and pain, sleep is highly relevant to judging the well-being of an individual. Of these three important outcome variables, however, sleep is neglected in most outcome studies. Sleep is a very important resource for recovery from daily stresses and strains, and any alteration of sleep will likely affect mental and physical health, especially during disease. Sleep assessment therefore should be standard in all population-based or clinical studies focusing on the locomotor system. Yet current sleep assessment tools are either too long or too specific for general use. Methods Based on a literature review and subsequent patient-based rating of items, an expert panel designed a four-item questionnaire about sleep. Construct validation of the questionnaire in a random sample of the German-speaking Swiss population was performed in 2003. Reliability, correlation, and tests for internal consistency and validity were analyzed. Results Overall, 16,634 (70% out of 23,763 eligible individuals participated in the study. Test-retest reliability coefficients ranged from 0.72 to 0.87, and a Cronbach's alpha of 0.83 indicates good internal consistency. Results show a moderate to good correlation between sleep disturbances and health perception, and between sleep disturbances and overall pain. Conclusions The Sleep Standard Evaluation Questionnaire (SEQ-Sleep is a reliable and short tool with confirmed construct validity for sleep assessment in population-based observational studies. It is easy to administer and therefore suitable for postal surveys of the general population. Criterion validity remains to be determined.

Clinical capabilities of graduates of an outcomes-based integrated medical program

Directory of Open Access Journals (Sweden)

Scicluna Helen A

2012-06-01

Full Text Available Abstract Background The University of New South Wales (UNSW Faculty of Medicine replaced its old content-based curriculum with an innovative new 6-year undergraduate entry outcomes-based integrated program in 2004. This paper is an initial evaluation of the perceived and assessed clinical capabilities of recent graduates of the new outcomes-based integrated medical program compared to benchmarks from traditional content-based or process-based programs. Method Self-perceived capability in a range of clinical tasks and assessment of medical education as preparation for hospital practice were evaluated in recent graduates after 3 months working as junior doctors. Responses of the 2009 graduates of the UNSW’s new outcomes-based integrated medical education program were compared to those of the 2007 graduates of UNSW’s previous content-based program, to published data from other Australian medical schools, and to hospital-based supervisor evaluations of their clinical competence. Results Three months into internship, graduates from UNSW’s new outcomes-based integrated program rated themselves to have good clinical and procedural skills, with ratings that indicated significantly greater capability than graduates of the previous UNSW content-based program. New program graduates rated themselves significantly more prepared for hospital practice in the confidence (reflective practice, prevention (social aspects of health, interpersonal skills (communication, and collaboration (teamwork subscales than old program students, and significantly better or equivalent to published benchmarks of graduates from other Australian medical schools. Clinical supervisors rated new program graduates highly capable for teamwork, reflective practice and communication. Conclusions Medical students from an outcomes-based integrated program graduate with excellent self-rated and supervisor-evaluated capabilities in a range of clinically-relevant outcomes. The program

Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

Science.gov (United States)

Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

2018-05-23

Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

Does cruciate retention primary total knee arthroplasty affect proprioception, strength and clinical outcome?

Science.gov (United States)

Vandekerckhove, Pieter-Jan T K; Parys, Roel; Tampere, Thomas; Linden, Patrick; Van den Daelen, Luc; Verdonk, Peter C

2015-06-01

It remains unclear what the contribution of the PCL is in total knee arthroplasty (TKA). The goal of this study was to investigate the influence of the PCL in TKA in relationship to clinical outcome, strength and proprioception. Two arthroplasty designs were compared: a posterior cruciate-substituting (PS) and a posterior cruciate-retaining (CR) TKA. A retrospective analysis was performed of 27 CR and 18 PS implants with a minimum of 1 year in vivo. Both groups were compared in terms of clinical outcome (range of motion, visual analogue scale for pain, Hospital for Special Surgery Knee Scoring system, Lysholm score and Knee Injury and Osteoarthritis Outcome Score), strength (Biodex System 3 Dynamometer(®)) and proprioception (balance and postural control using the Balance Master system(®)). Each design was also compared to the non-operated contralateral side in terms of strength and proprioception. There were no significant differences between both designs in terms of clinical outcome and strength. In terms of proprioception, only the rhythmic weight test at slow and moderate speed shifting from left to right was significant in favour of the CR design. None of the unilateral stance tests showed any significant difference between both designs. There was no difference in terms of strength and proprioception between the operated side and the non-operated side. Retaining the PCL in TKA does not result in an improved performance in terms of clinical outcome and proprioception and does not show any difference in muscle strength. III.

The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

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Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K

2016-01-01

Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were

Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol

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Scott Shannon D

2011-12-01

Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.

Clinical Outcomes of Extreme Lateral Interbody Fusion in the Treatment of Adult Degenerative Scoliosis

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Adam M. Caputo

2012-01-01

Full Text Available Introduction. The use of extreme lateral interbody fusion (XLIF and other lateral access surgery is rapidly increasing in popularity. However, limited data is available regarding its use in scoliosis surgery. The objective of this study was to evaluate the clinical outcomes of adults with degenerative lumbar scoliosis treated with XLIF. Methods. Thirty consecutive patients with adult degenerative scoliosis treated by a single surgeon at a major academic institution were followed for an average of 14.3 months. Interbody fusion was completed using the XLIF technique with supplemental posterior instrumentation. Validated clinical outcome scores were obtained on patients preoperatively and at most recent follow-up. Complications were recorded. Results. The study group demonstrated improvement in multiple clinical outcome scores. Oswestry Disability Index scores improved from 24.8 to 19.0 (P < 0.001. Short Form-12 scores improved, although the change was not significant. Visual analog scores for back pain decreased from 6.8 to 4.6 (P < 0.001 while scores for leg pain decreased from 5.4 to 2.8 (P < 0.001. A total of six minor complications (20% were recorded, and two patients (6.7% required additional surgery. Conclusions. Based on the significant improvement in validated clinical outcome scores, XLIF is effective in the treatment of adult degenerative scoliosis.

Clinical outcome and risk stratification in Brugada syndrome

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Tadashi Wada, MD

2013-04-01

Full Text Available Since the first report on Brugada syndrome, various risk markers for the prediction of ventricular fibrillation (VF in patients with Brugada syndrome have been reported. Multicenter trials reported spontaneous type 1 electrocardiogram (ECG and disease symptoms as prognostic predictors. VF induction by programmed electrical stimulation is still controversial, and most of the studies have failed to prove its significance for the prediction of spontaneous VF episodes. In Japan, although most multicenter studies have shown that patients with type 1 ECG were at high risk, it is difficult to determine the indication for implantation of an implantable cardioverter defibrillator only based on the ECG type. Recent studies have added new risk markers, such as inferolateral early repolarization, fragmented QRS, and shorter effective refractory periods of the ventricle, in addition to type 1 ECG and symptoms. Here, we review the clinical outcome and indices reported as reliable prognostic factors of Brugada syndrome with a focus on the clinical and ECG markers for risk stratification.

Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

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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

2017-01-01

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

Pulmonary hydatidosis patterns and clinical outcomes

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Shadi Hamouri

2018-02-01

Full Text Available Background Pulmonary hydatidosis remains a significant health problem in endemic areas. The clinical patterns and presentation vary according to the size, number, location and integrity of the cyst. Aims The aim of this study is to retrospectively evaluate the pattern and outcomes of patients diagnosed with pulmonary hydatidosis treated surgically in a tertiary hospital in northern Jordan. Methods A retrospective review of patients with pulmonary hydatidosis between December 2009 and December 2017 were performed. Data regarding demographic features, clinical presentation, serology testing, clinical outcomes and duration of medical treatment after surgery were obtained. Chest X-Ray and computerized tomography as well as liver ultrasound were the main methods of diagnosis. Parenchyma preserving excisions of the laminated membrane with capitonnage of the remaining cavity were performed in all patients. Albendazole was prescribed for 3– 6 months postoperatively. Results Eighty-eight patients were involved. Mean age was 29.5±16.7 years (range 8–75. Females comprised 52 per cent of the patients. The main presenting symptoms were cough, dyspnea and chest pain. Thirty-two (37 per cent patients had rupture of the cyst at the time of the presentation; 15 patients had direct rupture, 10 had communicating rupture and contained rupture was diagnosed in seven patients. Multiple and/or bilateral lesions were encountered in 25/88 (28.5 per cent and 15 (17 per cent patients respectively. Lower lobes were involved in 73.8 per cent of the cases. The mean hospital stay was 6.53±2.83 days. Post-operative morbidities were developed in 12/88 (13 per cent patients with air leak (5 per cent as the most common morbidity. No recurrences or mortalities were reported in the follow up period. Conclusion Parenchyma preserving cyst excision with capitonnage provides a low postoperative morbidity in patients with both intact and complicated pulmonary hydatidosis. To

Clinical outcomes and development of children born to couples with obstructive and nonobstructive azoospermia undergoing testicular sperm extraction-intracytoplasmic sperm injection: A comparative study

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Yi-Ru Tsai

2015-04-01

Conclusion: In our study, there were no differences in the fertility rate and clinic pregnancy rate between the OA and NOA groups using TESE-ICSI. Also, the clinical outcomes and development of children were similar between the OA and the NOA groups using TESE-ICSI.

Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

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Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

2017-08-01

Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

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Turley, Ryan S; Mi, Xiaojuan; Qualls, Laura G; Vemulapalli, Sreekanth; Peterson, Eric D; Patel, Manesh R; Curtis, Lesley H; Jones, W Schuyler

2017-06-12

Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Body Composition in Relation to Clinical Outcomes in Renal Cell Cancer

NARCIS (Netherlands)

Vrieling, Alina; Kampman, Ellen; Knijnenburg, Nathalja C.; Mulders, Peter F.; Sedelaar, J.P.M.; Baracos, Vickie E.; Kiemeney, Lambertus A.

2016-01-01

Context: Several studies suggest that body composition (ie, body proportions of muscle and fat defined by computed tomography) is associated with clinical outcomes of several cancer types, including renal cell cancer (RCC). Objective: To conduct a systematic review and meta-analysis of the evidence

Outcome Measures for Clinical Trials in Down Syndrome.

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Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

2017-05-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

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

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Chadha, M. [Beth Israel Medical Center, NY (United States). Dept. of Radiation Oncology; Coderre, J.A.; Chanana, A.D. [Brookhaven National Lab., Upton, NY (United States)] [and others

1996-12-31

A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

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

International Nuclear Information System (INIS)

Chadha, M.

1996-01-01

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

INFLUENCE OF THE SAGITTAL BALANCE ON THE CLINICAL OUTCOME IN SPINAL FUSION

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Marcela Almeida Campos Coutinho

2016-03-01

Full Text Available ABSTRACT Objective: Evaluates which radiographic parameters of the sagittal and spinopelvic balance influence the clinical and functional outcomes of a sample of patients undergoing spinal fusion. Methods: We studied 32 patients who underwent spinal fusion. Radiographs of the total spine were obtained from all patients. The clinical and functional parameters studied were analysis of pain by visual analogic scale (VAS and Oswestry and SRS-30 questionnaires. We analyzed the correlation between the clinical and functional parameters and radiographic parameters of the sagittal and spinopelvic balance. Results: There was no significant correlation between parameters pelvic incidence (PI, pelvic tilt (PT, lumbar lordosis (LL and difference between PI and LL (PI-LL and clinical parameters (p > 0.05 and r <0.2. Significant correlation were identified only between Sagittal Vertical Axis (SVA and Satisfaction with Treatment domain of SRS-30 (r = 0.402 e p = 0.023 and between thoracic kyphosis (TK and the total SRS-30 (r = 0.419 and p = 0.017. Conclusions: According to the study results, it was not possible to precisely characterize the role of the parameters of the sagittal and spinopelvic balance in the post-operative analysis of the clinical outcome of spinal fusion. There was a significant correlation only between SVA and the Satisfaction with Treatment domain of SRS-30 and between TK and total SRS-30.

Integrating Interactive Web-Based Technology to Assess Adherence and Clinical Outcomes in Pediatric Sickle Cell Disease

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Lori E. Crosby

2012-01-01

Full Text Available Research indicates that the quality of the adherence assessment is one of the best predictors for improving clinical outcomes. Newer technologies represent an opportunity for developing high quality standardized assessments to assess clinical outcomes such as patient experience of care but have not been tested systematically in pediatric sickle cell disease (SCD. The goal of the current study was to pilot an interactive web-based tool, the Take-Charge Program, to assess adherence to clinic visits and hydroxyurea (HU, barriers to adherence, solutions to overcome these barriers, and clinical outcomes in 43 patients with SCD age 6–21 years. Results indicate that the web-based tool was successfully integrated into the clinical setting while maintaining high patient satisfaction (>90%. The tool provided data consistent with the medical record, staff report, and/or clinical lab data. Participants reported that forgetting and transportation were major barriers for adherence to both clinic attendance and HU. A greater number of self-reported barriers (P<.01 and older age (P<.05 were associated with poorer clinic attendance and HU adherence. In summary, the tool represents an innovative approach to integrate newer technology to assess adherence and clinical outcomes for pediatric patients with SCD.

Core outcome domains for clinical trials in non-specific low back pain.

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Chiarotto, Alessandro; Deyo, Richard A; Terwee, Caroline B; Boers, Maarten; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Lin, Chung-Wei Christine; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

2015-06-01

Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and

Clinical and nutritional outcomes in children with idiopathic superior mesenteric artery syndrome.

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Shiu, Jr-Rung; Chao, Hsun-Chin; Luo, Chih-Cheng; Lai, Ming-Wei; Kong, Man-Shan; Chen, Shih-Yen; Chen, Chien-Chang; Wang, Chao-Jan

2010-08-01

There are no available data for outcomes in children's idiopathic superior mesenteric artery syndrome (SMAS) strictly treated conservatively. The aim of the study was to evaluate clinical and nutritional outcome in children with idiopathic SMAS. A 1-year prospective observation study of effects of treatment and outcome was performed in 27 children (8 boys, 19 girls) with idiopathic SMAS who underwent an upper gastrointestinal (UGI) series, ultrasound measurement of the aortomesenteric angle, treatment, clinical assessment, growth evaluation, and regular clinical visits for more than 12 months. Mean age of the patients was 11.77 +/- 2.15 years. The major clinical complaints were postprandial pain or fullness (88.9%), vomiting (55.6%), and early satiety (51.9%). Eight patients (29.6%) had weight loss. The UGI series revealed typical features of SMAS. The aortomesenteric angle on ultrasound was 10 degrees to 19 degrees. The height of most patients (92.6%) was above the 10th percentile, whereas 15 (55.6%) patients weighed below the 10th percentile. Six patients underwent surgical intervention (3 for obstruction and 3 for persistent anorexia with weight loss), and their clinical symptoms and weight status improved steadily during the follow-up months. Among the 21 patients not subject to surgical intervention, 11 (52.4%) experienced a reduction of symptoms >50% after 3 months of treatment, and weight-for-age percentile increased significantly after 6 months of treatment. Overall, a significant increase in the weight-for-age status was seen in the patients with surgical treatment or with medication only after 6 and 12 months of treatment. An aortomesenteric angle children with idiopathic SMAS. A duodenojejunostomy can effectively relieve the obstructive symptoms, such as anorexia, and improve nutritional status, whereas long-term medical treatment may aid in relieving the clinical symptoms, promoting appetite, and improving nutritional status in pediatric patients with

Clinical and radiological outcome after periacetabular osteotomy

DEFF Research Database (Denmark)

Dahl, Line B; Dengsø, Kristine; Bang-Christiansen, Karl

2014-01-01

PURPOSE: Few papers have described results after periacetabular osteotomy (PAO) and risk factors for conversion to total hip arthroplasty (THA). The aim of the present paper was to analyse clinical and radiographic outcome, survival of the hip joint and risk factors of early conversion to THA in ...

Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

International Nuclear Information System (INIS)

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

2015-01-01

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

A Comparative Study of Clinical Presentation and Risk Factors for Adverse Outcome in Patients Hospitalised with Acute Respiratory Disease Due to MERS Coronavirus or Other Causes.

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Musa A Garbati

Full Text Available Middle East Respiratory syndrome (MERS first emerged in Saudi Arabia in 2012 and remains a global health concern. The objective of this study was to compare the clinical features and risk factors for adverse outcome in patients with RT-PCR confirmed MERS and in those with acute respiratory disease who were MERS-CoV negative, presenting to the King Fahad Medical City (KFMC in Riyadh between October 2012 and May 2014. The demographics, clinical and laboratory characteristics and clinical outcomes of patients with RT-PCR confirmed MERS-CoV infection was compared with those testing negative MERS-CoV PCR. Health care workers (HCW with MERS were compared with MERS patients who were not health care workers. One hundred and fifty nine patients were eligible for inclusion. Forty eight tested positive for MERS CoV, 44 (92% being hospital acquired infections and 23 were HCW. There were 111 MERS-CoV negative patients with acute respiratory illnesses included in this study as "negative controls". Patient with confirmed MERS-CoV infection were not clinically distinguishable from those with negative MERS-CoV RT-PCR results although diarrhoea was commoner in MERS patients. A high level of suspicion in initiating laboratory tests for MERS-CoV is therefore indicated. Variables associated with adverse outcome were older age and diabetes as a co-morbid illness. Interestingly, co-morbid illnesses other than diabetes were not significantly associated with poor outcome. Health care workers with MERS had a markedly better clinical outcome compared to non HCW MERS patients.

Associations between HIV-RNA-based indicators and virological and clinical outcomes

DEFF Research Database (Denmark)

Laut, Kamilla G; Shepherd, Leah C; Pedersen, Court

2016-01-01

OBJECTIVES: To evaluate and compare the performance of six HIV-RNA-based quality of care indicators for predicting short-term and long-term outcomes. DESIGN: Multinational cohort study. METHODS: We included EuroSIDA patients on antiretroviral therapy (ART) with at least three viral load measureme......OBJECTIVES: To evaluate and compare the performance of six HIV-RNA-based quality of care indicators for predicting short-term and long-term outcomes. DESIGN: Multinational cohort study. METHODS: We included EuroSIDA patients on antiretroviral therapy (ART) with at least three viral load...... measurements after baseline (the latest of 01/01/2001 or entry into EuroSIDA). Using multivariate Poisson regression, we modelled the association between short-term (resistance, triple-class failure) and long-term (all-cause mortality, any AIDS/non-AIDS clinical event) outcomes and the indicators: viraemia...

BAX protein expression and clinical outcome in epithelial ovarian cancer.

Science.gov (United States)

Tai, Y T; Lee, S; Niloff, E; Weisman, C; Strobel, T; Cannistra, S A

1998-08-01

Expression of the pro-apoptotic protein BAX sensitizes ovarian cancer cell lines to paclitaxel in vitro by enhancing the pathway of programmed cell death. The present study was performed to determine the relationship between BAX expression and clinical outcome in 45 patients with newly diagnosed ovarian cancer. BAX protein expression was analyzed by immunohistochemistry, and its relationship with clinical outcome was determined. Assessment of BAX mRNA transcript levels and mutational analysis of the BAX coding region were also performed. BAX protein was expressed at high levels (defined as > or = 50% of tumor cells positive) in tumor tissue from 60% of newly diagnosed patients. All patients whose tumors expressed high levels of BAX achieved a complete response (CR) to first-line chemotherapy that contained paclitaxel plus a platinum analogue, compared with 57% of patients in the low-BAX group (P = .036). After a median follow-up of 1.9 years, the median disease-free survival (DFS) of patients in the high-BAX group has not been reached, compared with a median DFS of 1.1 years for low-BAX expressors (P = .0061). BAX retained independent prognostic significance in multivariate analysis when corrected for stage and histology. BAX mRNA transcripts were easily detected in samples with low BAX protein expression, and no BAX mutations were identified. The correlation between high BAX levels and improved clinical outcome suggests that an intact apoptotic pathway is an important determinant of chemoresponsiveness in ovarian cancer patients who receive paclitaxel.

Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text].

Science.gov (United States)

Lew, Charles Chin Han; Yandell, Rosalie; Fraser, Robert J L; Chua, Ai Ping; Chong, Mary Foong Fong; Miller, Michelle

2017-07-01

Malnutrition is associated with poor clinical outcomes among hospitalized patients. However, studies linking malnutrition with poor clinical outcomes in the intensive care unit (ICU) often have conflicting findings due in part to the inappropriate diagnosis of malnutrition. We primarily aimed to determine whether malnutrition diagnosed by validated nutrition assessment tools such as the Subjective Global Assessment (SGA) or Mini Nutritional Assessment (MNA) is independently associated with poorer clinical outcomes in the ICU and if the use of nutrition screening tools demonstrate a similar association. PubMed, CINAHL, Scopus, and Cochrane Library were systematically searched for eligible studies. Search terms included were synonyms of malnutrition, nutritional status, screening, assessment, and intensive care unit. Eligible studies were case-control or cohort studies that recruited adults in the ICU; conducted the SGA, MNA, or used nutrition screening tools before or within 48 hours of ICU admission; and reported the prevalence of malnutrition and relevant clinical outcomes including mortality, length of stay (LOS), and incidence of infection (IOI). Twenty of 1168 studies were eligible. The prevalence of malnutrition ranged from 38% to 78%. Malnutrition diagnosed by nutrition assessments was independently associated with increased ICU LOS, ICU readmission, IOI, and the risk of hospital mortality. The SGA clearly had better predictive validity than the MNA. The association between malnutrition risk determined by nutrition screening was less consistent. Malnutrition is independently associated with poorer clinical outcomes in the ICU. Compared with nutrition assessment tools, the predictive validity of nutrition screening tools were less consistent.

Clinical outcome after unilateral oophorectomy in patients with polycystic ovary syndrome

NARCIS (Netherlands)

Kaaijk, E. M.; Hamerlynck, J. V.; Beek, J. F.; van der Veen, F.

1999-01-01

The objective of this study is to report retrospectively on the clinical outcome of unilateral oophorectomy in 14 women with polycystic ovary syndrome who had undergone this treatment 14-18 years ago in our hospital for clomiphene citrate-resistant anovulation and long standing infertility or for

Clinical validation of nursing outcome mobility in patients with cerebrovascular accidents.

Science.gov (United States)

Moreira, Rafaella Pessoa; Araujo, Thelma Leite de; Lopes, Marcos Venicios de Oliveira; Cavalcante, Tahissa Frota; Guedes, Nirla Gomes; Chaves, Emília Soares; Portela, Regiane Campos; Holanda, Rose-Eloise

2016-12-15

To clinically validate the nursing outcome Mobility in patients with cerebrovascular accidents. Descriptive study, conducted in July 2011, with 38 outpatients, in northeastern Brazil. Data collection took place by evaluating two pairs of specialist nurses, where one pair used the instrument containing the constitutive and operational definitions of the indicators and magnitudes of the Mobility Outcome and the other pair without such definitions. When analyzing the evaluations among nurses, all indicators showed significant differences by the Friedman test (p cerebrovascular accident patient's mobility state.

CAsubtype: An R Package to Identify Gene Sets Predictive of Cancer Subtypes and Clinical Outcomes.

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Kong, Hualei; Tong, Pan; Zhao, Xiaodong; Sun, Jielin; Li, Hua

2018-03-01

In the past decade, molecular classification of cancer has gained high popularity owing to its high predictive power on clinical outcomes as compared with traditional methods commonly used in clinical practice. In particular, using gene expression profiles, recent studies have successfully identified a number of gene sets for the delineation of cancer subtypes that are associated with distinct prognosis. However, identification of such gene sets remains a laborious task due to the lack of tools with flexibility, integration and ease of use. To reduce the burden, we have developed an R package, CAsubtype, to efficiently identify gene sets predictive of cancer subtypes and clinical outcomes. By integrating more than 13,000 annotated gene sets, CAsubtype provides a comprehensive repertoire of candidates for new cancer subtype identification. For easy data access, CAsubtype further includes the gene expression and clinical data of more than 2000 cancer patients from TCGA. CAsubtype first employs principal component analysis to identify gene sets (from user-provided or package-integrated ones) with robust principal components representing significantly large variation between cancer samples. Based on these principal components, CAsubtype visualizes the sample distribution in low-dimensional space for better understanding of the distinction between samples and classifies samples into subgroups with prevalent clustering algorithms. Finally, CAsubtype performs survival analysis to compare the clinical outcomes between the identified subgroups, assessing their clinical value as potentially novel cancer subtypes. In conclusion, CAsubtype is a flexible and well-integrated tool in the R environment to identify gene sets for cancer subtype identification and clinical outcome prediction. Its simple R commands and comprehensive data sets enable efficient examination of the clinical value of any given gene set, thus facilitating hypothesis generating and testing in biological and

Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

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Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

42 CFR 482.80 - Condition of participation: Data submission, clinical experience, and outcome requirements for...

Science.gov (United States)

2010-10-01

..., clinical experience, and outcome requirements for initial approval of transplant centers. 482.80 Section... Hospitals Transplant Center Data Submission, Clinical Experience, and Outcome Requirements § 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for initial...

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study.

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Thomas, Kim S; Ormerod, Anthony D; Craig, Fiona E; Greenlaw, Nicola; Norrie, John; Mitchell, Eleanor; Mason, James M; Johnston, Graham A; Wahie, Shyamal; Williams, Hywel C

2016-11-01

Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a prospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confidence interval, 96 days to ∞). Initial ulcer size was a significant predictor of time to healing (hazard ratio, 0.94 [95% confidence interval, 0.88-1.00); P = .043). Four patients (15%) had a recurrence. Our study did not include a randomized comparator. Topical therapy is potentially an effective first-line treatment for PG that avoids the possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

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Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

2006-02-01

A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

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Mehrfam Khoshkhounejad

2015-11-01

Full Text Available 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.

Magnetic resonance imaging of injuries to the ankle joint: can it predict clinical outcome?

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Zanetti, M; De Simoni, C; Wetz, H H; Zollinger, H; Hodler, J

1997-02-01

To predict clinical outcome after ankle sprains on the basis of magnetic resonance (MR) findings. Twenty-nine consecutive patients (mean age 32.9 years, range 13-60 years) were examined clinically and with MR imaging both after trauma and following standardized conservative therapy. Various MR abnormalities were related to a clinical outcome score. There was a tendency for a better clinical outcome in partial, rather than complete, tears of the anterior talofibular ligament and when there was no fluid within the peroneal tendon sheath at the initial MR examination (P = 0.092 for either abnormality). A number of other MR features did not significantly influence clinical outcome, including the presence of a calcaneofibular ligament lesion and a bone bruise of the talar dome. Clinical outcome after ankle sprain cannot consistently be predicted by MR imaging, although MR imaging may be more accurate when the anterior talofibular ligament is only partially torn and there are no signs of injury to the peroneal tendon sheath.

Clinical results and functional outcomes after direct intralaminar screw repair of spondylolysis.

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Menga, Emmanuel N; Kebaish, Khaled M; Jain, Amit; Carrino, John A; Sponseller, Paul D

2014-01-01

Prospective analysis. Our objective was to analyze clinical and functional results of patients with spondylolysis treated via direct intralaminar screw fixation and autograft, a minimally invasive and motion-preserving surgery. Spondylolysis is usually treated nonoperatively; multiple surgical techniques are available when nonoperative measures fail. No studies evaluate the clinical and functional outcomes and their correlation with pars defect size and disc morphology on magnetic resonance imaging. We reviewed patients with spondylolysis treated with intralaminar screw fixation and bone grafting from 2000 through 2010. Of the 31 patients (mean age, 16 yr; range, 10-37 yr), 25 (81%) were competitive athletes. Preoperative computed tomographic scans were used to measure the pars defect size, and preoperative magnetic resonance images were graded using Pfirrmann classification for correlation with postoperative outcomes. Student t test was used for analysis (significance, P spondylolysis repair for persistent pain starting 18 months after intralaminar screw fixation, 2 patients sustained unilateral intralaminar screw fractures at L5, and 1 patient required irrigation and debridement for a superficial postoperative infection. There was no correlation among preoperative magnetic resonance imaging disc morphology, defect size on computed tomography, patient age, and clinical outcomes. Direct repair of spondylolysis with intralaminar screws offers a low profile, reliable treatment with good functional outcome and a low complication rate in active patients. 4.

The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

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Small, M; Vickers, A; Anderson, P; Kay, S

2010-09-01

It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

Treatment outcomes in a rural HIV clinic in South Africa: Implications ...

African Journals Online (AJOL)

Objective: To assess the treatment outcomes of an HIV clinic in rural Limpopo province, South Africa. Methods: A retrospective cohort study involving medical records review of HIV-positive patients initiated on antiretroviral treatment (ART) was conducted from December 2007 to November 2008 at Letaba Hospital. Data on ...

Comparison of statistical and clinical predictions of functional outcome after ischemic stroke.

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Douglas D Thompson

Full Text Available To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor's clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs.A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS. Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3 using five previously described CPMs. The specificity of a doctor's informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97 and similar to CPMs (range 0.94 to 0.96; however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49 and clinical prediction models (range 0.38 to 0.45 was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76 and CPMs (range 0.69 to 0.75. No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients.CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined.

Six-year clinical outcome of single implant-retained mandibular overdentures--a pilot study.

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Passia, Nicole; Wolfart, Stefan; Kern, Matthias

2015-10-01

The aim of this prospective pilot study was to evaluate the prosthodontic maintenance as well as the implant outcome of single implant-retained mandibular overdentures over an observation period of 6 years. Eleven edentulous patients received one single implant in the midline of the mandible. Denture bases were temporarily relined and 2 months later provided with a ball attachment for implant retention. Implant related parameters and prosthodontic maintenance interventions were assessed 4 weeks after implant loading and then once a year. Over a mean observation period of 75.9 months, no implant was lost. The most frequent prosthetic maintenance intervention was activation of the matrix due to loss of retention, followed by exchange of the female part. Eight denture bases had to be repaired after a fracture in the midline area. Within the limitations of this preliminary clinical study, the concept of a single midline implant to retain a mandibular complete denture was a successful treatment option for elderly edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

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Girija Madhavanprabhakaran

2015-01-01

Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

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Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

2017-04-01

Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review.

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Choi, Wook Jin; Kim, Jeongseon

2016-04-01

The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

Relationship between drug interactions and drug-related negative clinical outcomes in two community pharmacies

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Gonzalo M

2009-03-01

Full Text Available Drug interactions may represent an iatrogenic risk that should be controlled in community pharmacies at the dispensing level. Aim: We analyzed the association between potential drug-drug interactions (DDIs and negative clinical outcomes.Methods: We used dispensing data from two community pharmacies: instances where drug dispensing was associated with a potential DDI and a comparison group of randomized dispensing operations with no potential DDI. In cases where potential DDIs were detected, we analyzed the underlying negative clinical outcomes. Age and gender data were included in the analysis.Results: During the study period, we registered 417 potential DDIs. The proportion of women and age were higher in the study group than in the comparison group. The average potential DDIs per patient was 1.31 (SD=0.72. The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF database did not produce an alert in 2.4% of the cases. Over-the-counter medication use was observed in 5% of the potential DDI cases. The drugs most frequently involved in potential DDIs were acenocoumarol, calcium salts, hydrochlorothiazide, and alendronic acid, whereas the most predominant potential DDIs were calcium salts and bisphosphonates, oral antidiabetics and thiazide diuretics, antidiabetics and glucose, and oral anticoagulant and paracetamol. The existence of a drug-related negative clinical outcome was observed only in 0.96% of the potential DDI cases (50% safety cases and 50% effectiveness cases. Conclusions: Only a small proportion of the detected potential DDIs lead to medication negative outcomes. Considering the drug-related negative clinical outcomes encountered, tighter control would be recommended in potential DDIs with NSAIDs or benzodiazepines.

Clinical predictors of facial nerve outcome after translabyrinthine resection of acoustic neuromas.

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Shamji, Mohammed F; Schramm, David R; Benoit, Brien G

2007-01-01

The translabyrinthine approach to acoustic neuroma resection offers excellent exposure for facial nerve dissection with 95% preservation of anatomic continuity. Acceptable outcome in facial asymptomatic patients is reported at 64-90%, but transient postoperative deterioration often occurs. The objective of this study was to identify preoperative clinical presentation and intraoperative surgical findings that predispose patients to facial nerve dysfunction after acoustic neuroma surgery. The charts of 128 consecutive translabyrinthine patients were examined retrospectively to identify new clinical and intraoperative predictors of facial nerve outcome. Postoperative evaluation of patients to normal function or mild asymmetry upon close inspection (House-Brackmann grades of I or II) was defined as an acceptable outcome, with obvious asymmetry to no movement (grades III to VI) defined as unacceptable. Intraoperative nerve stimulation was performed in all cases, and clinical grading was performed by a single neurosurgeon in all cases. Among patients with no preoperative facial nerve deficit, 87% had an acceptable result. Small size (P mA (P< 0.01) were reaffirmed as predictive of functional nerve preservation. Additionally, preoperative tinnitus (P = 0.03), short duration of hearing loss (P< 0. 01), and lack of subjective tumour adherence to the facial nerve (P = 0.02) were independently correlated with positive outcome. Our experience with the translabyrinthine approach reveals the previously unestablished associations of facial nerve outcome to include presence of tinnitus and duration of hypoacusis. Independent predictors of tumour size and nerve stimulation thresholds were reaffirmed, and the subjective description of tumour adherence to the facial nerve making dissection more difficult appears to be important.

New onset status epilepticus in older patients: Clinical characteristics and outcome.

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Malter, M P; Nass, R D; Kaluschke, T; Fink, G R; Burghaus, L; Dohmen, C

2017-10-01

We here evaluated (1) the differential characteristics of status epilepticus (SE) in older (≥60 years) compared to younger adults (18-59 years). In particular, we were interested in (2) the proportion and characteristics of new onset SE in patients with no history of epilepsy (NOSE) in older compared to younger adults, and (3) predictive parameters for clinical outcome in older subjects with NOSE. We performed a monocentric retrospective analysis of all adult patients (≥18years) admitted with SE to our tertiary care centre over a period of 10 years (2006-2015) to evaluate clinical characteristics and short-time outcome at discharge. One-hundred-thirty-five patients with SE were included in the study. Mean age at onset was 64 years (range 21-90), eighty-seven of the patients (64%) were older than 60 years. In 76 patients (56%), SE occurred as NOSE, sixty-seven percent of them were aged ≥60 years. There was no age-dependent predominance for NOSE. NOSE was not a relevant outcome predictor, especially regarding age-related subgroups. Older patients with NOSE had less frequently general tonic clonic SE (GTCSE; p=0.001) and were more often female (p=0.01). Regarding outcome parameters and risk factors in older patients with NOSE, unfavourable outcome was associated with infections during in-hospital treatment (0.04), extended stay in ICU (p=0.001), and generally in hospital (p<0.001). In our cohort, older patients represented the predominant subgroup in patients with SE. Older patients suffered more often from non-convulsive semiology and had a less favourable short-time outcome. NOSE was not a predictive outcome parameter in older patients. Data suggest that avoiding infections should have a priority because higher infection rates were associated with unfavourable outcome. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Clinical outcomes and survival in AA amyloidosis patients

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Yavuz Ayar

Full Text Available Abstract Aim Amyloid A amyloidosis is a rare complication of chronic inflammatory conditions. Most patients with amyloid A amyloidosis present with nephropathy and it leads to renal failure and death. We studied clinical characteristics and survival in patients with amyloid A amyloidosis. Methods: A total of 81 patients (51 males, 30 females with renal biopsy proven amyloid A amyloidosis were analyzed retrospectively. The patients were divided into good and poor outcomes groups according to survival results. Results: Most of the patients (55.6% had nephrotic range proteinuria at diagnosis. Most frequent underlying disorders were familial Mediterranean fever (21.2% and rheumatoid arthritis (10.6% in the good outcome group and malignancy (20% in the poor outcome group. Only diastolic blood pressure in the good outcome group and phosphorus level in the poor outcome group was higher. Serum creatinine levels increased after treatment in both groups, while proteinuria in the good outcome group decreased. Increase in serum creatinine and decrease in estimated glomerular filtration rate of the poor outcome group were more significant in the good outcome group. At the time of diagnosis 18.5% and 27.2% of all patients had advanced chronic kidney disease (stage 4 and 5, respectively. Median duration of renal survival was 65 ± 3.54 months. Among all patients, 27.1% were started dialysis treatment during the follow-up period and 7.4% of all patients underwent kidney transplantation. Higher levels of systolic blood pressure [hazard ratios 1.03, 95% confidence interval: 1-1.06, p = 0.036], serum creatinine (hazard ratios 1.25, 95% confidence interval: 1.07-1.46, p = 0.006 and urinary protein excretion (hazard ratios 1.08, 95% confidence interval: 1.01-1.16, p = 0.027 were predictors of end-stage renal disease. Median survival of patients with organ involvement was 50.3 ± 16 months. Conclusion Our study indicated that familial Mediterranean fever constituted

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation.

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Assem, Yusuf; Mobbs, Ralph J; Pelletier, Matthew H; Phan, Kevin; Walsh, William R

2017-03-01

The primary objective of this paper was to provide a systematic review of the available clinical studies of Ti/PEEK combined cages in spinal interbody fusion surgeries, focusing on their radiological and clinical outcomes. A secondary aim was to provide a review and evaluation of the in vitro and preclinical studies reported on Ti/PEEK-coated implants. A systematic search of the literature was performed in March 2015 via three databases: Medline, Embase and Cochrane library. The following key search terms were combined with synonyms to identify relevant articles: "spinal fusion," "PEEK," "titanium" and "cage." The novelty of this intervention translates into a paucity of clinical trials, albeit the results of the seven clinical studies that met the criteria for inclusion are promising. All studies reported rate of fusion as a primary outcome. Two studies reported slightly improved fusion in the experimental Ti/PEEK combination cohort, one study identical fusion (91.7 %) and three studies excellent fusion (96, 100 and 94 %) in the Ti/PEEK cohort, although no differences reached statistical significance. Clinical studies at this early stage demonstrate that Ti/PEEK implants are safe and efficacious, exhibiting similar fusion rates and clinical outcomes compared to the current standard PEEK. There is clinical evidence substantiating the improved radiographic fusion of Ti/PEEK, albeit the differences were not significant. This field is promising, gaining substantial popularity, and further clinical trials are needed in the future to establish Ti/PEEK cages as a mainstay of clinical practice.

The relationship of individual characteristics, perceived worksite support and perceived creativity to clinical nurses' innovative outcome.

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Tsai, Hsiu-Min; Liou, Shwu-Ru; Hsiao, Ya-Chu; Cheng, Ching-Yu

2013-09-01

To understand the relationship of individual characteristics, perceived worksite support and perceived personal creativity to clinical nurses' innovative outcome (receiving the Nursing Innovation Award). Since the idea of applying creativity and innovation to clinical nursing practice and management was first advocated in the Nursing Administration Quarterly in 1982, the topic of nursing innovation has gained worldwide attention. To increase the prevalence of nursing innovation, it is important to identify and understand the related factors that influence nurses' innovative outcome. This study used a cross-sectional descriptive survey design. A self-administered questionnaire was completed by 32 award winners and 506 nonawarded clinical nurses in Taiwan. The level of creativity perceived by all participants was moderate-to-high. Individual characteristics (r = 0·61) and worksite support (r = 0·27) were both correlated with perceived creativity. Individual characteristics and worksite support showed some correlation as well (r = 0·21). Individual characteristics and worksite support could predict perceived creativity after controlling for demographic variables, but only individual characteristics had an effect on innovative outcome. Perceived creativity did not have mediation effects either between individual characteristics and innovative outcome or between worksite support and innovative outcome. Clinical nurses' individual characteristics had a direct relationship to innovative outcome, whereas neither worksite support nor creativity was correlated with innovative outcome. Although worksite support did not show effects on innovative outcome, it was related to both perceived creativity and individual characteristics. As suggested by other scholars, there might be other related factors between creativity and innovative outcome. Although worksite support did not have effect on clinical nurses' innovative outcome, it was related to individual characteristics

Clinical profile and outcomes of acute cardiorenal syndrome type-5 in sepsis: An eight-year cohort study.

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Vallabhajosyula, Saraschandra; Sakhuja, Ankit; Geske, Jeffrey B; Kumar, Mukesh; Kashyap, Rahul; Kashani, Kianoush; Jentzer, Jacob C

2018-01-01

To evaluate the clinical features and outcomes of acute cardiorenal syndrome type-5 in patients with severe sepsis and septic shock. Historical cohort study of all adult patients with severe sepsis and septic shock admitted to the intensive care units (ICU) at Mayo Clinic Rochester from January 1, 2007 through December 31, 2014. Patients with prior renal or cardiac dysfunction were excluded. Patients were divided into groups with and without cardiorenal syndrome type-5. Acute Kidney Injury (AKI) was defined by both serum creatinine and urine output criteria of the AKI Network and the cardiac injury was determined by troponin-T levels. Outcomes included in-hospital mortality, ICU and hospital length of stay, and one-year survival. Of 602 patients meeting the study inclusion criteria, 430 (71.4%) met criteria for acute cardiorenal syndrome type-5. Patients with cardiorenal syndrome type-5 had higher severity of illness, greater vasopressor and mechanical ventilation use. Cardiorenal syndrome type-5 was associated higher unadjusted in-hospital mortality, ICU and hospital lengths of stay, and lower one-year survival. When adjusted for age, gender, severity of illness and mechanical ventilation, cardiorenal syndrome type-5 was independently associated with 1.7-times greater odds of in-hospital mortality (p = .03), but did not predict one-year survival (p = .06) compared to patients without cardiorenal syndrome. In sepsis, acute cardiorenal syndrome type-5 is associated with worse in-hospital mortality compared to patients without cardiorenal syndrome.

Functional heartburn: clinical characteristics and outcome.

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Surdea Blaga, Teodora; Dumitrascu, Dan; Galmiche, Jean-Paul; Bruley des Varannes, Stanislas

2013-03-01

Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60 ± 45 vs. 31 ± 19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.

Description of Common Clinical Presentations and Associated Short-Term Physical Therapy Clinical Outcomes in Patients With Neck Pain.

Science.gov (United States)

Horn, Maggie E; Brennan, Gerard P; George, Steven Z; Harman, Jeffrey S; Bishop, Mark D

2015-10-01

To determine the effect of clinical presentations of neck pain on short-term physical therapy outcomes. Retrospective analysis of pair-matched groups from a clinical cohort. Thirteen outpatient physical therapy clinics in 1 health care system. Patients (N=1069) grouped by common clinical presentations of neck pain: nonspecific neck pain (NSNP) with duration 4 weeks; neck pain with arm pain; neck pain with headache; and neck pain from whiplash. Conservative interventions provided by physical therapists. Neck Disability Index (NDI) and numerical pain rating scale (NPRS) recorded at the initial and last visits. The main outcome of interest was achieving recovery status on the NDI. Changes in NDI and NPRS were compared between clinical presentation groups. Compared with patients presenting with NSNP >4 weeks, patients with NSNP neck pain and arm pain demonstrated an increased odds of achieving recovery status on the NDI (P=.04) compared with patients presenting with NSNP >4 weeks. Treating patients with NSNP within <4 weeks of onset of symptoms may lead to improved clinical outcomes from physical therapy compared with other common clinical presentations. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Is the radiographic subsidence of stand-alone cages associated with adverse clinical outcomes after cervical spine fusion? An observational cohort study with 2-year follow-up outcome scoring.

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Zajonz, Dirk; Franke, Anne-Catherine; von der Höh, Nicolas; Voelker, Anna; Moche, Michael; Gulow, Jens; Heyde, Christoph-Eckhard

2014-01-01

The stand-alone treatment of degenerative cervical spine pathologies is a proven method in clinical practice. However, its impact on subsidence, the resulting changes to the profile of the cervical spine and the possible influence of clinical results compared to treatment with additive plate osteosynthesis remain under discussion until present. This study was designed as a retrospective observational cohort study to test the hypothesis that radiographic subsidence of cervical cages is not associated with adverse clinical outcomes. 33 cervical segments were treated surgically by ACDF with stand-alone cage in 17 patients (11 female, 6 male), mean age 56 years (33-82 years), and re-examined after eight and twenty-six months (mean) by means of radiology and score assessment (Medical Outcomes Study Short Form (MOS-SF 36), Oswestry Neck Disability Index (ONDI), painDETECT questionnaire and the visual analogue scale (VAS)). Subsidence was observed in 50.5% of segments (18/33) and 70.6% of patients (12/17). 36.3% of cases of subsidence (12/33) were observed after eight months during mean time of follow-up 1. After 26 months during mean time of follow-up 2, full radiographic fusion was seen in 100%. MOS-SF 36, ONDI and VAS did not show any significant difference between cases with and without subsidence in the two-sample t-test. Only in one type of scoring (painDETECT questionnaire) did a statistically significant difference in t-Test emerge between the two groups (p = 0.03; α = 0.05). However, preoperative painDETECT score differ significantly between patients with subsidence (13.3 falling to 12.6) and patients without subsidence (7.8 dropped to 6.3). The radiological findings indicated 100% healing after stand-alone treatment with ACDF. Subsidence occurred in 50% of the segments treated. No impact on the clinical results was detected in the medium-term study period.

Time to Angiographic Reperfusion and Clinical Outcome after Acute Ischemic Stroke in the Interventional Management of Stroke Phase III (IMS III) Trial: A Validation Study

Science.gov (United States)

Khatri, Pooja; Yeatts, Sharon D.; Mazighi, Mikael; Broderick, Joseph P.; Liebeskind, David S.; Demchuk, Andrew M.; Amarenco, Pierre; Carrozzella, Janice; Spilker, Judith; Foster, Lydia D.; Goyal, Mayank; Hill, Michael D.; Palesch, Yuko Y.; Jauch, Edward C.; Haley, E. Clarke; Vagal, Achala; Tomsick, Thomas A.

2014-01-01

BACKGROUND The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. METHODS The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. FINDINGS Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). INTERPRETATION We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support). PMID:24784550

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

Science.gov (United States)

Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve

Comparison of three scoring systems in predicting clinical outcomes in patients with acute upper gastrointestinal bleeding: a prospective observational study.

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Zhong, Min; Chen, Wan Jun; Lu, Xiao Ye; Qian, Jie; Zhu, Chang Qing

2016-12-01

To compare the performances of the Glasgow-Blatchford score (GBS), modified GBS (mGBS) and AIMS65 in predicting clinical outcomes in patients with acute upper gastrointestinal bleeding (AUGIB). This study enrolled 320 consecutive patients with AUGIB. Patients at high and low risks of developing adverse clinical outcomes (rebleeding, the need of clinical intervention and death) were categorized according to the GBS, mGBS and AIMS65 scoring systems. The outcome of the patients were the occurrences of adverse clinical outcomes. The areas under the receiver operating characteristics curve (AUROC) of three scoring systems were compared. Irrespective of the systems used, the high-risk groups showed higher rates of rebleeding, intervention and death compared with the low-risk groups (P < 0.05). For the prediction of rebleeding, AIMS65 (AUROC 0.735, 95% CI 0.667-0.802) performed significantly better than GBS (AUROC 0.672, 95% CI 0.597-0.747; P < 0.01) and mGBS (AUROC 0.677, 95% CI 0.602-0.753; P < 0.01). For the prediction of interventions, there was no significant difference among the three systems (GBS: AUROC 0.769, 95% CI 0.668-0.870; mGBS: AUROC 0.745, 95% CI 0.643-0.847; AIMS65: AUROC 0.746, 95% CI 0.640-0.851). For the prediction of in-hospital mortality, there was no significant difference among the three systems (GBS: AUROC 0.796, 95% CI 0.694-0.898; mGBS: AUROC 0.803, 95% CI 0.703-0.904; AIMS65: AUROC 0.786, 95% CI 0.670-0.903). The three scoring systems are reliable and accurate in predicting the rates of rebleeding, surgery and mortality in AUGIB. However, AIMS65 outperforms GBS and mGBS in predicting rebleeding. © 2016 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Sarcoidosis in Israel: Clinical Outcome Status, Organ Involvement, and Long-Term Follow-Up.

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Markevitz, Natalia; Epstein Shochet, Gali; Levi, Yair; Israeli-Shani, Lilach; Shitrit, David

2017-08-01

Sarcoidosis is a chronic granulomatous inflammatory disease of unknown etiology with heterogeneous outcomes. This study reviewed the clinical outcome status (COS) and organ involvement of Israeli sarcoidosis patients during a five-year period. Further, we compared our results to the 'World Association of Sarcoidosis and Other Granulomatous Disease' (WASOG) COS and the 'A Case Control Etiologic Study of Sarcoidosis' (ACCESS) instruments in order to evaluate their relevance to the Israeli population. The retrospective study group consisted of 166 sarcoidosis patients for the period of 2010-2015. Data on demographic characteristics, presenting symptoms, co-morbidities, disease duration, lung function tests, treatment program, chest X-ray, and chest high-resolution computed tomography were collected. The median patient age was 62 ± 14, which was significantly higher than the WASOG and ACCESS cohorts (p Israel is a unique and challenging disease with its clinical presentations that differ from previously reported studies.

Prostate Zonal Volumetry as a Predictor of Clinical Outcomes for Prostate Artery Embolization

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Assis, André Moreira de, E-mail: andre.assis@criep.com.br, E-mail: andre.maa@gmail.com; Maciel, Macello Sampaio, E-mail: macielmjs@gmail.com; Moreira, Airton Mota, E-mail: airton.mota@criep.com.br; Paula Rodrigues, Vanessa Cristina de, E-mail: vanessapaular@yahoo.com.br [University of Sao Paulo Medical School, Vascular and Interventional Radiology Unit, Radiology Institute (Brazil); Antunes, Alberto Azoubel, E-mail: antunesuro@uol.com.br; Srougi, Miguel, E-mail: srougi@uol.com.br [University of Sao Paulo Medical School, Urology Department (Brazil); Cerri, Giovanni Guido, E-mail: giovanni-cerri@uol.com.br [University of Sao Paulo Medical School, Radiology Institute (Brazil); Carnevale, Francisco Cesar, E-mail: francisco.carnevale@criep.com.br [University of Sao Paulo Medical School, Vascular and Interventional Radiology Unit, Radiology Institute (Brazil)

2017-02-15

PurposeTo determine prostate baseline zonal volumetry and correlate these findings with clinical outcomes for patients who underwent prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).Materials and MethodsThis is a retrospective study that included patients treated by PAE from 2010 to 2014. Baseline and 6-month follow-up evaluations included prostate MRI with whole prostate (WP) and central gland (CG) volume measurements—as well as prostate zonal volumetry index (ZVi) calculation, defined as the CG/WP volumes relation—the International Prostate Symptom Score (IPSS), and the Quality of life (QoL) index. Baseline WP, CG, and ZVi were statistical compared to IPSS and QoL values at 6 months.ResultsA total of 93 consecutive patients were included, with mean age of 63.4 years (range, 51–86). Clinical failure, defined as IPSS > 7 or QoL > 2, was seen in four cases (4.3%). Mean reductions in prostate volumes after PAE were of 30.6% and 31.2% for WP and CG, respectively (p < 0.0001). Clinical parameters had mean decrease from 21 to 3.3 points for IPSS, and from 4.7 to 1.2 points for QoL (p < 0.0001). Baseline WP, CG, and ZVi correlated to the degree of clinical improvement (p < 0.05 for all). The baseline ZVi cut-off calculated for better clinical outcomes was > 0.45, with 85% sensitivity and 75% specificity.ConclusionsBaseline CG and WP volumes as well as ZVi presented strong correlation with clinical outcomes in patients undergoing PAE, and its assessment should be considered in pre-treatment evaluation whenever possible. Both patients and medical team should be aware of the possibility of less favorable outcomes when ZVi < 0.45.

Prostate Zonal Volumetry as a Predictor of Clinical Outcomes for Prostate Artery Embolization

International Nuclear Information System (INIS)

Assis, André Moreira de; Maciel, Macello Sampaio; Moreira, Airton Mota; Paula Rodrigues, Vanessa Cristina de; Antunes, Alberto Azoubel; Srougi, Miguel; Cerri, Giovanni Guido; Carnevale, Francisco Cesar

2017-01-01

PurposeTo determine prostate baseline zonal volumetry and correlate these findings with clinical outcomes for patients who underwent prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).Materials and MethodsThis is a retrospective study that included patients treated by PAE from 2010 to 2014. Baseline and 6-month follow-up evaluations included prostate MRI with whole prostate (WP) and central gland (CG) volume measurements—as well as prostate zonal volumetry index (ZVi) calculation, defined as the CG/WP volumes relation—the International Prostate Symptom Score (IPSS), and the Quality of life (QoL) index. Baseline WP, CG, and ZVi were statistical compared to IPSS and QoL values at 6 months.ResultsA total of 93 consecutive patients were included, with mean age of 63.4 years (range, 51–86). Clinical failure, defined as IPSS > 7 or QoL > 2, was seen in four cases (4.3%). Mean reductions in prostate volumes after PAE were of 30.6% and 31.2% for WP and CG, respectively (p < 0.0001). Clinical parameters had mean decrease from 21 to 3.3 points for IPSS, and from 4.7 to 1.2 points for QoL (p < 0.0001). Baseline WP, CG, and ZVi correlated to the degree of clinical improvement (p < 0.05 for all). The baseline ZVi cut-off calculated for better clinical outcomes was > 0.45, with 85% sensitivity and 75% specificity.ConclusionsBaseline CG and WP volumes as well as ZVi presented strong correlation with clinical outcomes in patients undergoing PAE, and its assessment should be considered in pre-treatment evaluation whenever possible. Both patients and medical team should be aware of the possibility of less favorable outcomes when ZVi < 0.45.

Moderate efficiency of clinicians' predictions decreased for blurred clinical conditions and benefits from the use of BRASS index. A longitudinal study on geriatric patients' outcomes.

Science.gov (United States)

Signorini, Giulia; Dagani, Jessica; Bulgari, Viola; Ferrari, Clarissa; de Girolamo, Giovanni

2016-01-01

Accurate prognosis is an essential aspect of good clinical practice and efficient health services, particularly for chronic and disabling diseases, as in geriatric populations. This study aims to examine the accuracy of clinical prognostic predictions and to devise prediction models combining clinical variables and clinicians' prognosis for a geriatric patient sample. In a sample of 329 consecutive older patients admitted to 10 geriatric units, we evaluated the accuracy of clinicians' prognosis regarding three outcomes at discharge: global functioning, length of stay (LoS) in hospital, and destination at discharge (DD). A comprehensive set of sociodemographic, clinical, and treatment-related information were also collected. Moderate predictive performance was found for all three outcomes: area under receiver operating characteristic curve of 0.79 and 0.78 for functioning and LoS, respectively, and moderate concordance, Cohen's K = 0.45, between predicted and observed DD. Predictive models found the Blaylock Risk Assessment Screening Score together with clinicians' judgment relevant to improve predictions for all outcomes (absolute improvement in adjusted and pseudo-R(2) up to 19%). Although the clinicians' estimates were important factors in predicting global functioning, LoS, and DD, more research is needed regarding both methodological aspects and clinical measurements, to improve prognostic clinical indices. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of continuous glucose monitoring as an outcome measure in clinical trials.

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Beck, Roy W; Calhoun, Peter; Kollman, Craig

2012-10-01

Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; Pblood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

Collateral vessels on magnetic resonance angiography in endovascular-treated acute ischemic stroke patients associated with clinical outcomes.

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Jiang, Liang; Su, Hao-Bo; Zhang, Ying-Dong; Zhou, Jun-Shan; Geng, Wen; Chen, Huiyou; Xu, Quan; Yin, Xindao; Chen, Yu-Chen

2017-10-06

Collateral vessels were considered to be related with outcome in endovascular-treated acute ischemic stroke patients. This study aimed to evaluate whether the collateral vessels on magnetic resonance angiography (MRA) could predict the clinical outcome. Acute stroke patients with internal carotid artery or middle cerebral artery occlusion within 6 hours of symptom onset were included. All patients underwent MRI and received endovascular treatment. The collateral circulations at the Sylvian fissure and the leptomeningeal convexity were evaluated. The preoperative and postoperative infarct volume was measured. The clinical outcome was evaluated by mRS score at 3 months after stroke. Of 55 patients, Cases with insufficient collateral circulation at the Sylvian fissure and leptomeningeal convexity showed that the NIHSS score at arrival and preoperative infarct volume were significantly lower in mRS score of 0-2 (both P collateral status at the leptomeningeal convexity were independent of the clinical outcome at 3 months after stroke (odds ratio (95% confidence interval): 1.094 (1.025-1.168); 9.542 (1.812-50.245) respectively). The change of infarct volume in the group with mRS score of 0-2 was smaller than that with mRS score of 3-6. While multivariate logistic models showed that postoperative infarct volume was non-significant in predicting the clinical outcome after stroke. The extent of collateral circulation at the leptomeningeal convexity may be useful for predicting the functional recovery while the relationship between postoperative infarct volume and clinical outcome still requires for further study.

Clinical Features and Outcomes of Gastric Ischemia.

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Sharma, Ayush; Mukewar, Saurabh; Chari, Suresh T; Wong Kee Song, Louis M

2017-12-01

Gastric ischemia is a rare condition associated with poor prognosis. Our study aim was to highlight the clinical features and outcomes of patients with gastric ischemia. A retrospective review of patients diagnosed with isolated gastric ischemia at our institution from January 1, 2000, to May 5, 2016, was performed. Demographic, clinical, endoscopic, radiologic, and outcome variables were abstracted for analysis. Seventeen patients (65% men) with mean age of 69.3 ± 11.3 years and body mass index of 28.8 ± 11.1 were identified. The etiologies for gastric ischemia included local vascular causes (n = 8), systemic hypoperfusion (n = 4), and mechanical obstruction (n = 5). The most common presenting symptoms were abdominal pain (65%), gastrointestinal bleeding (47%), and altered mental status (23%). The typical endoscopic appearance was mucosal congestion and erythema with or without ulceration. Gastric pneumatosis and portal venous air were more commonly seen on CT imaging. Radiologic and/or surgical intervention was needed in 9 patients, while the remaining 8 patients were managed conservatively with acid suppression, antibiotics, and nasogastric tube decompression. The median duration of hospital stay was 15 days (range 1-36 days). There were no cases of rebleeding and the mortality rate as a direct result of gastric ischemia was 24% within 6 months of diagnosis. Although uncommon, gastric ischemia is associated with significant mortality. Endoscopy and CT imaging play an important role in its diagnosis. The management of gastric ischemia is dictated by its severity and associated comorbidities.

Accuracy of glenoid component placement in total shoulder arthroplasty and its effect on clinical and radiological outcome in a retrospective, longitudinal, monocentric open study.

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Thomas M Gregory

Full Text Available BACKGROUND: The success of Total Shoulder Arthroplasty (TSA is believed to depend on the restoration of the natural anatomy of the joint and a key development has been the introduction of modular humeral components to more accurately restore the patient's anatomy. However, there are no peer-reviewed studies that have reported the degree of glenoid component mal-position achieved in clinical practice and the clinical outcome of such mal-position. The main purpose of this study was to assess the accuracy of glenoid implant positioning during TSA and to relate it to the radiological (occurrence of radiolucent lines and osteolysis on CT and clinical outcomes. METHODS: 68 TSAs were assessed with a mean follow-up of 38+/-27 months. The clinical evaluation consisted of measuring the mobility as well as of the Constant Score. The radiological evaluation was performed on CT-scans in which metal artefacts had been eliminated. From the CT-scans radiolucent lines and osteolysis were assessed. The positions of the glenoid and humeral components were also measured from the CT scans. RESULTS: Four position glenoid component parameters were calculated The posterior version (6°±12°; mean ± SD, the superior tilt (12°±17°, the rotation of the implant relative to the scapular plane (3°±14° and the off-set distance of the centre of the glenoid implant from the scapular plane (6±4 mm. An inferiorly inclined implant was found to be associated with higher levels of radiolucent lines while retroversion and non-neutral rotation were associated with a reduced range of motion. CONCLUSION: this study demonstrates that glenoid implants of anatomic TSA are poorly positioned and that this malposition has a direct effect on the clinical and radiological outcome. Thus, further developments in glenoid implantation techniques are required to enable the surgeon to achieve a desired implant position and outcome.

Symptomatic lumbosacral transitional vertebra: a review of the current literature and clinical outcomes following steroid injection or surgical intervention

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Holm Emil Kongsted

2017-01-01

Full Text Available Bertolotti’s syndrome (BS refers to the possible association between the congenital malformation lumbosacral transitional vertebra (LSTV, and low back pain (LBP. Several treatments have been proposed including steroid injections, resections of the LSTV, laminectomy, and lumbar spinal fusion. The aim of this review was to compare the clinical outcomes in previous trials and case reports for these treatments in patients with LBP and LSTV. A PubMed search was conducted. We included English studies of patients diagnosed with LSTV treated with steroid injection, laminectomy, spinal fusion or resection of the transitional articulation. Of 272 articles reviewed 20 articles met the inclusion criteria. Their level of evidence were graded I–V and the clinical outcomes were evaluated. Only 1 study had high evidence level (II. The remainders were case series (level IV. Only 5 studies used validated clinical outcome measures. A total of 79 patients were reported: 31 received treatment with steroid injections, 33 were treated with surgical resection of the LSTV, 8 received lumbar spinal fusion, and 7 cases were treated with laminectomy. Surgical management seems to improve the patient’s symptoms, especially patients diagnosed with “far out syndrome” treated with laminectomy. Clinical outcomes were more heterogenetic for patient’s treated with steroid injections. The literature regarding BS is sparse and generally with low evidence. Non-surgical management (e.g., steroid injections and surgical intervention could not directly be compared due to lack of standardization in clinical outcome. Generally, surgical management seems to improve patient’s clinical outcome over time, whereas steroid injection only improves the patient’s symptoms temporarily. Further studies with larger sample size and higher evidence are warranted for the clinical guidance in the treatment of BS.

Symptomatic lumbosacral transitional vertebra: a review of the current literature and clinical outcomes following steroid injection or surgical intervention.

Science.gov (United States)

Holm, Emil Kongsted; Bünger, Cody; Foldager, Casper Bindzus

2017-01-01

Bertolotti's syndrome (BS) refers to the possible association between the congenital malformation lumbosacral transitional vertebra (LSTV), and low back pain (LBP). Several treatments have been proposed including steroid injections, resections of the LSTV, laminectomy, and lumbar spinal fusion. The aim of this review was to compare the clinical outcomes in previous trials and case reports for these treatments in patients with LBP and LSTV. A PubMed search was conducted. We included English studies of patients diagnosed with LSTV treated with steroid injection, laminectomy, spinal fusion or resection of the transitional articulation. Of 272 articles reviewed 20 articles met the inclusion criteria. Their level of evidence were graded I-V and the clinical outcomes were evaluated. Only 1 study had high evidence level (II). The remainders were case series (level IV). Only 5 studies used validated clinical outcome measures. A total of 79 patients were reported: 31 received treatment with steroid injections, 33 were treated with surgical resection of the LSTV, 8 received lumbar spinal fusion, and 7 cases were treated with laminectomy. Surgical management seems to improve the patient's symptoms, especially patients diagnosed with "far out syndrome" treated with laminectomy. Clinical outcomes were more heterogenetic for patient's treated with steroid injections. The literature regarding BS is sparse and generally with low evidence. Non-surgical management (e.g., steroid injections) and surgical intervention could not directly be compared due to lack of standardization in clinical outcome. Generally, surgical management seems to improve patient's clinical outcome over time, whereas steroid injection only improves the patient's symptoms temporarily. Further studies with larger sample size and higher evidence are warranted for the clinical guidance in the treatment of BS. © The Authors, published by EDP Sciences, 2017.

Clinical characteristics, microbiology, and outcomes of prosthetic joint infection in Taiwan.

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Tsai, Jen-Chih; Sheng, Wang-Huei; Lo, Wan-Yu; Jiang, Ching-Chuan; Chang, Shan-Chwen

2015-04-01

Prosthetic joint infection (PJI) after total knee or hip replacement is a devastating complication associated with substantial morbidity and economic cost. The incidence of prosthetic joint infection is increasing as the use of mechanical joint replacement increases. The treatment approach to prosthetic joint infection is based on different clinical situations such as a patient's comorbidities, epidemic microbiology data, and surgical procedures. The aim of our study was to understand clinical characteristics of prosthetic joint infection, the microbiology of the prosthetic joint infection, and the outcomes of different treatment strategies during 2006-2011. We retrospectively collected cases of prosthetic joint infection in the National Taiwan University Hospital between January 1, 2006 and December 31, 2011. The patients' characteristics, microbiology, outcomes, and factors associated with treatment success were recorded. One hundred and forty-four patients were identified as having PJI. Of these, 92 patients were entered into per-protocol analysis. Staphylococcus aureus was the most common causative organism (29.9%), followed by coagulase-negative Staphylococci (16.7%), and Enterococci (9.7%). The overall treatment success rate was 50%. Patients who received a two-stage revision had a better outcome, compared to patients who underwent other types of surgeries (70% vs. 32.7%, respectively; p < 0.001). In multivariate analysis, the two-stage revision was significantly associated with treatment success (odds ratio = 3.923, 95% confidence interval = 1.53-10.04). Our study demonstrates that Staphylococcus aureus was the most common causative organisms in PJI. Performing two-stage revisions was significantly associated with a better outcome. Copyright © 2013. Published by Elsevier B.V.

Clinical presentation and outcome of avoidant/restrictive food intake disorder in a Japanese sample.

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Nakai, Yoshikatsu; Nin, Kazuko; Noma, Shun'ichi; Hamagaki, Seiji; Takagi, Ryuro; Teramukai, Satoshi; Wonderlich, Stephen A

2017-01-01

We conducted a study of the clinical presentation and outcome in patients with avoidant/restrictive food intake disorder (ARFID), aged 15-40years, and compared this group to an anorexia nervosa (AN) group in a Japanese sample. A retrospective chart review was completed on 245 patients with feeding and eating disorders (FEDs), analyzing prevalence, clinical presentation, psychopathological properties, and outcomes. Using the DSM-5 criteria, 27 (11.0%) out of the 245 patients with a FED met the criteria for ARFID at entry. All patients with ARFID were women. In terms of eating disorder symptoms, all patients with ARFID had restrictive eating related to emotional problems and/or gastrointestinal symptoms. However, none of the ARFID patients reported food avoidance related to sensory characteristics or functional dysphagia. Additionally, none of them exhibited binge eating or purging behaviors, and none of them reported excessive exercise. The ARFID group had a significantly shorter duration of illness, lower rates of admission history, and less severe psychopathology than the AN group. The ARFID group reported significantly better outcome results than the AN group. These results suggest that patients with ARFID in this study were clinically distinct from those with AN and somewhat different from pediatric patients with ARFID in previous studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

Science.gov (United States)

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

2016-05-01

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 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.

Clinical outcomes of patients living with HIV visiting ART centre at a ...

African Journals Online (AJOL)

The present retrospective study was aimed to provide information about the prevalence and clinical outcomes of patients living with HIV in Warangal District, in the Northern Telangana region, India. The national AIDS control organization and Kakatiya Medical College (KMC) Institutional Review Board reviewed and ...

Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.

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Hunter, Robert; Cameron, Rosie; Norrie, John

2009-02-01

The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine

CORRELATION BETWEEN OBESITY, SAGITTAL BALANCE AND CLINICAL OUTCOME IN SPINAL FUSION

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Marcel Machado da Motta

2015-09-01

Full Text Available Objective:To correlate obesity with radiographic parameters of spinal and spinopelvic balance in patients undergoing spinal arthrodesis, and to correlate obesity with clinical outcome of these patients.Methods:Observational retrospective study including patients who underwent spinal arthrodesis, with minimum follow-up period of three months. We measured waist circumference, as well as height and weight to calculate body mass index (BMI and obtained radiographs of the total column. The clinical parameters studied were pain by visual analog scale (VAS and the Oswestry questionnaire (ODI. Obesity correlated with radiographic parameters of the sagittal and spinopelvic balance and postoperative clinical parameters.Results:32 patients were analyzed. The higher the BMI, the greater the value of VAS found, but without statistical significance (p=0.83. There was also no correlation between BMI and the ODI questionnaire. Analyzing the abdominal circumference, there was no correlation between the VAS and ODI. There was no correlation between BMI or waist circumference and the radiographic parameters of global spinopelvic sagittal alignment. Regarding the postoperative results, there was no correlation between the mean BMI and waist circumference and the postoperative results for ODI and VAS (p=0.75 and p=0.7, respectively.Conclusions:The clinical outcomes of patients who undergone spinal fusion were not affected by the BMI and waist circumference. Also, there was no correlation between radiographic parameters of spinal and spinopelvic sagittal balance with obesity in patients previously treated with arthrodesis of the spine.

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

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Gibson EJ

2018-03-01

Full Text Available EJ Gibson,1 N Begum,1 I Koblbauer,1 G Dranitsaris,2 D Liew,3 P McEwan,4 AA Tahami Monfared,5,6 Y Yuan,7 A Juarez-Garcia,7 D Tyas,8 M Lees9 1Wickenstones Ltd, Didcot, UK; 2Augmentium Pharma Consulting Inc, Toronto, ON, Canada; 3Department of Epidemiology and Preventive Medicine, Alfred Hospital, Monash University, Melbourne, VIC, Australia; 4Health Economics and Outcomes Research Ltd, Cardiff, UK; 5Bristol-Myers Squibb Canada, Saint-Laurent, QC Canada; 6Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada; 7Bristol-Myers Squibb, Princeton, NJ, USA; 8Bristol-Myers Squibb, Uxbridge, UK; 9Bristol-Myers Squibb, Rueil-Malmaison, France Background: Economic models in oncology are commonly based on the three-state partitioned survival model (PSM distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods: This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs. Results: The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%. Conclusion: Increased sophistication in the representation of disease dynamics in economic models

Classification of non-aneurysmal subarachnoid haemorrhage: CT correlation to the clinical outcome

International Nuclear Information System (INIS)

Nayak, S.; Kunz, A.B.; Kieslinger, K.; Ladurner, G.; Killer, M.

2010-01-01

Aim: To propose a new computed tomography (CT)-based classification system for non-aneurysmal subarachnoid haemorrhage (SAH), which predicts patients' discharge clinical outcome and helps to prioritize appropriate patient management. Methods and materials: A 5-year, retrospective, two-centre study was carried out involving 1486 patients presenting with SAH. One hundred and ninety patients with non-aneurysmal SAH were included in the study. Initial cranial CT findings at admission were correlated with the patients' discharge outcomes measured using the Modified Rankin Scale (MRS). A CT-based classification system (type 1-4) was devised based on the topography of the initial haemorrhage pattern. Results: Seventy-five percent of the patients had type 1 haemorrhage and all these patients had a good clinical outcome with a discharge MRS of ≤1. Eight percent of the patients presented with type 2 haemorrhage, 62% of which were discharged with MRS of ≤1 and 12% of patients had MRS 3 or 4. Type 3 haemorrhage was found in 10%, of which 16% had good clinical outcome, but 53% had moderate to severe disability (MRS 3 and 4) and 5% were discharged with severe disability (MRS 5). Six percent of patients presented with type 4 haemorrhage of which 42% of the patients had moderate to severe disability (MRS 3 and 4), 42% had severe disability and one-sixth of the patients died. Highly significant differences were found between type 1(1a and 1b) and type 2 (p = 0.003); type 2 and type 3 (p = 0.002); type 3 and type 4 (p = 0.001). Conclusion: Haemorrhages of the type 1 category are usually benign and do not warrant an extensive battery of clinical and radiological investigations. Type 2 haemorrhages have a varying prognosis and need to be investigated and managed along similar lines as that of an aneurysmal haemorrhage with emphasis towards radiological investigation. Type 3 and type 4 haemorrhages need to be extensively investigated to find an underlying cause.

Clinical Outcomes of Colorectal Cancer in Kenya | Saidi | Annals of ...

African Journals Online (AJOL)

Background The incidence of colorectal cancer in Africa is increasing. True data on clinical outcomes of the disease is hampered by follow up challenges. Method Follow up data of 233 patients treated for colorectal cancer between 2005 and 2010 at various Nairobi hospitals were evaluated. The primary outcome was ...

[Hepatic transit times and liver elasticity compared with meld in predicting a 1 year adverse clinical outcome of a clinically diagnosed cirrhosis].

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Koller, Tomáš; Piešťanská, Zuzana; Hlavatý, Tibor; Holomáň, Jozef; Glasa, Jozef; Payer, Juraj

Hepatic transit times measured by the contrast enhanced ultrasonography and liver elasticity were found to predict a clinically significant portal hypertension. However, these modalities we not yet sufficiently evaluated in predicting adverse clinical outcome in patients with clinically diagnosed cirrhosis (D´Amico stages > 1), having a clinically significant portal hypertension. The aim of our study was to assess the predictive power of the liver transit times and the liver elasticity on an adverse clinical outcome of clinically diagnosed cirrhosis compared with the MELD score. The study group included 48 consecutive outpatients with cirrhosis in the 2., 3. and 4. DAmico stages. Patients with stage 4 could have jaundice, patients with other complications of portal hypertension were excluded. Transit times were measured from the time of intravenous administration of contrast agent (Sonovue) to a signal appearance in a hepatic vein (hepatic vein arrival time, HVAT) or time difference between the contrast signal in the hepatic artery and hepatic vein (hepatic transit time, HTT) in seconds. Elasticity was measured using the transient elastography (Fibroscan). The transit times and elasticity were measured at baseline and patients were followed for up for 1 year. Adverse outcome of cirrhosis was defined as the appearance of clinically apparent ascites and/or hospitalization for liver disease and/or death within 1 year. The mean age was 61 years, with female/male ratio 23/25. At baseline, the median Child-Pugh score was 5 (IQR 5.0-6.0), MELD 9.5 (IQR 7.6 to 12.1), median HVAT was 22 s (IQR 19-25) and HTT 6 (IQR 5-9). HTT and HVAT negatively correlated with Child-Pugh (-0.351 and -0.441, p = 0.002) and MELD (-0.479 and -0.388, p = 0.006) scores. The adverse outcome at 1-year was observed in 11 cases (22.9 %), including 6 deaths and 5 hospitalizations. Median HVAT in those with/without the adverse outcome was 20 seconds (IQR 19.3-23.5) compared with 22 s (IQR 19-26, p

The clinical outcome of childhood masturbation.

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Unal, F

2000-01-01

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.

Caustic Ingestion in the Elderly: Influence of Age on Clinical Outcome

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Blazena Caganova

2017-10-01

Full Text Available Caustic poisonings are still associated with many fatalities. Studies focusing on the elderly are rare. The purpose of the present study was to compare the clinical outcomes of caustic ingestion injury in elderly and non-elderly adults with regard to gender, intent of exposure, substance ingested, severity of mucosal injury, complications, and mortality. Caustic substance exposures reported to the National Toxicological Information Centre in Slovakia during 1998–2015 were reviewed retrospectively. The patients were divided into two groups: the non-elderly (<60 years and elderly adults (≥60 years. The mortality rate in the elderly was significantly higher (elderly 23.0% vs. non-elderly 11.3%; p = 0.041. The risk of fatal outcome in the elderly was increased by acid ingestion (OR = 7.822; p = 0.002, particularly hydrochloric acid (OR = 5.714, p = 0.006. The incidence of respiratory complications was almost two times higher in the elderly was 31.1% vs. 17.4% for the non-elderly (p = 0.037. Respiratory complications significantly correlated with an increased mortality rate (p = 0.001 in the elderly whereas there was no association between GI complications and mortality in the elderly (p = 0.480. Elderly patients with respiratory complications had the poorest clinical outcomes. The highest risk of complications and fatalities was observed in patients after hydrochloric acid ingestion.

Nutrition-Related Cardiovascular Disease Risk Factors In Chronic Kidney Disease: Relationship With Clinical Outcome

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Emma McMahon

2012-06-01

Traditional CV-risk factors in this CKD population were not associated with clinical outcome. Despite being within clinical reference range, serum phosphate and albumin were independently associated with clinical outcome. This may highlight a potential therapeutic target for risk management to delay or prevent renal end-points in CKD.

Relationship between the iceA gene of Helicobacter pylori and clinical outcomes

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Huang XJ

2016-07-01

Full Text Available Xiaojun Huang,1,2 Zhaomin Deng,1 Qiang Zhang,1 Wanyi Li,1 Baoning Wang,1 Mingyuan Li1,3 1Department of Microbiology, West China School of Preclinical and Forensic Medicine, Sichuan University, Chengdu, People’s Republic of China; 2Department of Microbiology, School of Medicine, Hubei University for Nationalities, Enshi, People’s Republic of China; 3State Key Laboratory of Oral Diseases, Chengdu, People’s Republic of China Background: The complex pathogenesis of Helicobacter pylori (H. pylori and the features of the host influence the diverse clinical outcomes. A mass of studies about virulence genes have accelerated the exploration of pathogenesis of H. pylori infection. Induced by contact with epithelium gene A (iceA is one of the biggest concerned virulence genes. In this study, we explored the relationship between iceA and the magnitude of the risk for clinical outcomes and the prevalence of iceA-positive H. pylori in People’s Republic of China and other countries.Methods: We searched the electronic databases of PubMed, Embase, CNKI, VIP, and Wanfang by literature search strategy. The studies conforming to the inclusion criteria were assessed. With these data, we systematically analyzed the relationship between the iceA gene of H. pylori and clinical outcomes.Results: Nineteen articles with 22 studies, a total of 2,657 cases, were involved in the study. The iceA1 gene was significantly associated with peptic ulcer disease (odds ratio =1.28, 95% confidence interval =1.03–1.60; P=0.03, especially in People’s Republic of China (odds ratio =1.40, 95% confidence interval =1.07–1.83; P=0.01. Moreover, the prevalence of iceA1 was significantly higher than iceA2 in People’s Republic of China (P<0.0001. The prevalence of both iceA1 and iceA2 was significantly different (P<0.0001 in People’s Republic of China and in other countries.Conclusion: The system analysis showed that infection with the iceA1-positive H. pylori significantly

42 CFR 482.82 - Condition of participation: Data submission, clinical experience, and outcome requirements for re...

Science.gov (United States)

2010-10-01

..., clinical experience, and outcome requirements for re-approval of transplant centers. 482.82 Section 482.82... Hospitals Transplant Center Data Submission, Clinical Experience, and Outcome Requirements § 482.82 Condition of participation: Data submission, clinical experience, and outcome requirements for re-approval...

Clinical Manifestations and Outcomes of West Nile Virus Infection

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James J. Sejvar

2014-02-01

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

Low Triiodothyronine Syndrome in Patients With Radiation Enteritis: Risk Factors and Clinical Outcomes an Observational Study.

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Fan, Shengxian; Ni, Xiaodong; Wang, Jian; Zhang, Yongliang; Tao, Shen; Chen, Mimi; Li, Yousheng; Li, Jieshou

2016-02-01

The implications of low triiodothyronine syndrome (LT3S) in patients with radiation enteritis (RE) have not been properly investigated. As such, we conducted this cohort study to investigate the association between LT3S and RE, to explore the etiology of LT3S in RE, to evaluate the clinical features and clinical outcomes of LT3S patients, and to inspect the correlation of clinical variables and LT3S in RE.This prospective study included 39 RE patients. Medical records and various laboratory parameters (including thyroidal, tumorous, nutritional, and radiotherapy variables) were collected in all participants.Our results showed that the incidence of LT3S was 84.6% in patients with RE. Total protein (71.7 ± 5.7 vs 63.2 ± 9.6 g/L, P = 0.04) and albumin (ALB, 46.0 ± 4.6 vs 38.7 ± 5.3 g/L, P = 0.01) were significantly lower in LT3S group compared with those in euthyroid group. Standard thyroid-stimulating hormone index (-0.89 ± 2.11 vs -2.39 ± 1.33, P = 0.03) and sum activity of deiodinases (19.74 ± 4.19 vs 12.55 ± 4.32 nmol/L, P = 0.01) were significantly lower in LT3S group. Patients with LT3S suffered longer duration of hospitalization (48.25 ± 23.29 days in LT3S vs 26.75 ± 10.56 days in euthyroid, P = 0.036). Low serum ALB (β = 0.694, 95% CI = 0.007-0.190, P = 0.037) was the only significant predictor of LT3S.LT3S was common in RE patients. A hypodeiodination condition and a potential pituitary-thyrotroph dysfunction might play a role in the pathophysiology of LT3S in RE. Worse nutritional status and clinical outcomes were confirmed in RE patients with LT3S. Furthermore, total protein and ALB were observed as protective and differentiating parameters of LT3S in RE. In summary, this was the 1st investigation to evaluate the clinical correlation between RE and LT3S, investigate the prevalence of LT3S in RE, and explore the pathogenesis of LT3S, despite the limitation of a

Clinical outcomes of neonatal onset proximal versus distal urea cycle disorders do not differ.

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Ah Mew, Nicholas; Krivitzky, Lauren; McCarter, Robert; Batshaw, Mark; Tuchman, Mendel

2013-02-01

To compare the clinical course and outcome of patients diagnosed with one of 4 neonatal-onset urea cycle disorders (UCDs): deficiency of carbamyl phosphate synthase 1 (CPSD), ornithine transcarbamylase (OTCD), argininosuccinate synthase (ASD), or argininosuccinate lyase (ALD). Clinical, biochemical, and neuropsychological data from 103 subjects with neonatal-onset UCDs were derived from the Longitudinal Study of Urea Cycle Disorders, an observational protocol of the Urea Cycle Disorders Consortium, one of the Rare Disease Clinical Research Networks. Some 88% of the subjects presented clinically by age 7 days. Peak ammonia level was 963 μM in patients with proximal UCDs (CPSD or OTCD), compared with 589 μM in ASD and 573 μM in ALD. Roughly 25% of subjects with CPSD or OTCD, 18% of those with ASD, and 67% of those with ALD had a "honeymoon period," defined as the time interval from discharge from initial admission to subsequent admission for hyperammonemia, greater than 1 year. The proportion of patients with a poor outcome (IQ/Developmental Quotient <70) was greatest in ALD (68%), followed by ASD (54%) and CPSD/OTCD (47%). This trend was not significant, but was observed in both patients aged <4 years and those aged ≥ 4 years. Poor cognitive outcome was not correlated with peak ammonia level or duration of initial admission. Neurocognitive outcomes do not differ between patients with proximal UCDs and those with distal UCDs. Factors other than hyperammonemia may contribute to poor neurocognitive outcome in the distal UCDs. Copyright © 2013 Mosby, Inc. All rights reserved.

Percutaneous coronary intervention in asians- are there differences in clinical outcome?

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Chua Terrance S

2011-05-01

Full Text Available Abstract Background Ethnic differences in clinical outcome after percutaneous coronary intervention (PCI have been reported. Data within different Asian subpopulations is scarce. We aim to explore the differences in clinical profile and outcome between Chinese, Malay and Indian Asian patients who undergo PCI for coronary artery disease (CAD. Methods A prospective registry of consecutive patients undergoing PCI from January 2002 to December 2007 at a tertiary care center was analyzed. Primary endpoint was major adverse cardiovascular events (MACE of myocardial infarction (MI, repeat revascularization and all-cause death at six months. Results 7889 patients underwent PCI; 7544 (96% patients completed follow-up and were included in the analysis (79% males with mean age of 59 years ± 11. There were 5130 (68% Chinese, 1056 (14% Malays and 1001 (13.3% Indian patients. The remaining 357 (4.7% patients from other minority ethnic groups were excluded from the analysis. The primary end-point occurred in 684 (9.1% patients at six months. Indians had the highest rates of six month MACE compared to Chinese and Malays (Indians 12% vs. Chinese 8.2% vs. Malays 10.7%; OR 1.55 95%CI 1.24-1.93, p Conclusion These data indicate that ethnic variations in clinical outcome exist following PCI. In particular, Indian patients have higher six month event rates compared to Chinese and Malays. Future studies are warranted to elucidate the underlying mechanisms behind these variations.

[Differences in clinical characteristics and outcomes of diabetic ketoacidosis (DKA) in Jewish and Bedouin patients].

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Rabaev, Elena; Sagy, Iftach; Zaid, Eed Abu; Nevzorov, Roman; Harman-Boehm, Ilana; Zeller, Lior; Barski, Leonid

2014-01-01

The aim of this study was to compare clinical characteristics and outcomes of diabetic ketoacidosis (DKA) in the Jewish and Bedouin populations. A retrospective analysis was conducted of hospital admissions for diabetic ketoacidosis in adult patients between 2003 and 2010. The clinical and biochemical characteristics and outcomes of diabetic ketoacidosis patients of Jewish origin were compared with those of Bedouin origin. The primary outcome was in-hospital all-cause mortality. The study cohort included 220 consecutive patients for whom the admission diagnosis was diabetic ketoacidosis. The cohort was categorized according to Jewish and Bedouin origin as follows: 177 (80.5%) Jewish and 43 (19.5%) Bedouin patients. The Jewish patients were significantly older than the Bedouin patients (45.8 +/- 18.9 vs. 32.9 +/- 15.3, p ventilation and bed-ridden state were independent predictors of 30-day mortality in both ethnic groups.

Etiology, clinical spectrum and outcome of metabolic liver diseases in children

International Nuclear Information System (INIS)

Roy, A.; Samanta, T.; Purkait, R.; Mukherji, A.

2013-01-01

Objective: To determine the etiology, clinical spectrum and outcome of metabolic liver diseases (MLD) in children admitted in a tertiary care hospital of Eastern India. Study Design: An observational study. Place and Duration of Study: Paediatric Liver Clinic and Paediatrics Inpatient Department of Nilratan Sircar Medical College and Hospital, Kolkata, Eastern India, from April 2009 to March 2011. Methodology: All children aged 0 - 12 years having characteristic clinical features along with diagnostic hallmark of any MLDs were included in this study and data were collected on a pre-designed proforma. After appropriate management and discharge, all patients were followed-up for next 6 months. Results: Fifty one children with mean age 4.34 +- 3.78 years (range 2 days +- 12 years), male: female ratio 1.55:1, were studied. The etiologies were Wilson's disease (33.33%, n = 17); glycogen storage disorder (23.53%, n = 12); galactosemia (19.61%, n = 10); non-alcoholic fatty liver disease (11.76%, n = 6); Gaucher disease (5.88%, n = 3); mucopolysaccharidoses (3.92%, n = 2) and familial hyperlipoproteinemia type-I (1.96%, n = 1). Jaundice (n = 24) and hepatomegaly (n = 47), was the commonest symptom and sign respectively. Of the 17 non-responders, most were Wilson's disease (n = 7) cases. There was statistical difference in outcome with respect to INR > 1.3 at diagnosis (p = 0.026). Conclusion: High index of suspicion, early detection and screening, simple dietary modification and cost effective drugs along with good compliance are sufficient to treat and even prevent evolution of most causes of the MLDs. (author)

Clinical features and outcomes in patients with disseminated toxoplasmosis admitted to intensive care: a multicenter study.

Science.gov (United States)

Schmidt, Matthieu; Sonneville, Romain; Schnell, David; Bigé, Naike; Hamidfar, Rebecca; Mongardon, Nicolas; Castelain, Vincent; Razazi, Keyvan; Marty, Antoine; Vincent, François; Dres, Martin; Gaudry, Stephane; Luyt, Charles Edouard; Das, Vincent; Micol, Jean-Baptiste; Demoule, Alexandre; Mayaux, Julien

2013-12-01

Characteristics and outcomes of adult patients with disseminated toxoplasmosis admitted to the intensive care unit (ICU) have rarely been described. We performed a retrospective study on consecutive adult patients with disseminated toxoplasmosis who were admitted from January 2002 through December 2012 to the ICUs of 14 university-affiliated hospitals in France. Disseminated toxoplasmosis was defined as microbiological or histological evidence of disease affecting >1 organ in immunosuppressed patients. Isolated cases of cerebral toxoplasmosis were excluded. Clinical data on admission and risk factors for 60-day mortality were collected. Thirty-eight patients were identified during the study period. Twenty-two (58%) had received an allogeneic hematopoietic stem cell transplant (median, 61 [interquartile range {IQR}, 43-175] days before ICU admission), 4 (10%) were solid organ transplant recipients, and 10 (27%) were infected with human immunodeficiency virus (median CD4 cell count, 14 [IQR, 6-33] cells/µL). The main indications for ICU admission were acute respiratory failure (89%) and shock (53%). The 60-day mortality rate was 82%. Allogeneic hematopoietic stem cell transplant (hazard ratio [HR] = 2.28; 95% confidence interval [CI], 1.05-5.35; P = .04) and systolic cardiac dysfunction (HR = 3.54; 95% CI, 1.60-8.10; P toxoplasmosis leading to ICU admission has a poor prognosis. Recipients of allogeneic hematopoietic stem cell transplant appear to have the highest risk of mortality. We identified systolic cardiac dysfunction as a major determinant of outcome. Strategies aimed at preventing this fatal opportunistic infection may improve outcomes.

Impact of relational coordination on staff and patient outcomes in outpatient surgical clinics.

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Gittell, Jody Hoffer; Logan, Caroline; Cronenwett, Jack; Foster, Tina C; Freeman, Richard; Godfrey, Marjorie; Vidal, Dale Collins

2018-01-05

Pressures are increasing for clinicians to provide high-quality, efficient care, leading to increased concerns about staff burnout. This study asks whether staff well-being can be achieved in ways that are also beneficial for the patient's experience of care. It explores whether relational coordination can contribute to both staff well-being and patient satisfaction in outpatient surgical clinics where time constraints paired with high needs for information transfer increase both the need for and the challenge of achieving timely and accurate communication. We studied relational coordination among surgeons, nurses, residents, administrators, technicians, and secretaries in 11 outpatient surgical clinics. Data were combined from a staff and a patient survey to conduct a cross-sectional study. Data were analyzed using ordinary least squares and random effects regression models. Relational coordination among all workgroups was significantly associated with staff outcomes, including job satisfaction, work engagement, and burnout. Relational coordination was also significantly associated with patients' satisfaction with staff and their overall visit, though the association between relational coordination and patients' satisfaction with their providers did not reach statistical significance. Even when patient-staff interactions are relatively brief, as in outpatient settings, high levels of relational coordination among interdependent workgroups contribute to positive outcomes for both staff and patients, and low levels tend to have the opposite effect. Clinical leaders can increase the expectation of positive outcomes for both staff and their patients by implementing interventions to strengthen relational coordination.

The natural language of the surgeon's clinical note in outcomes assessment: a qualitative analysis of the medical record.

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Miller, J Michael; Velanovich, Vic

2010-06-01

Physician-generated clinical notes are the central document in recording the clinical decision-making and outcome of care. This is particularly true in an environment where outcomes assessment is becoming increasingly important. The hypothesis of this study is that these notes are inadequate to assess patient-centered outcomes and determine surgeons' core competencies. We preformed a retrospective review of postoperative clinical notes of general surgery patients for a 1-month period. Information from these notes underwent qualitative analysis using the reductionist thematic approach for patient-centered and physician-centered outcomes. Outcomes included 2 physician-centered items (physical examination and objective tests) and 3 patient-centered items (postoperative complications, functional status, and satisfaction). The presence or absence of each item in the clinical note was recorded. Six hundred eighty-one patients of 18 general surgeons were included. Among the surgeons, 28% failed to document symptomatic change in even 1 patient; similarly, 67% failed to document functional change, and 50% failed to document satisfaction. Among all 681 clinical notes only 7% of records mentioned symptomatic change, 1% functional change, 87% physical examination, 26% objective tests, and 3% patient satisfaction. These results were not affected by procedure type or number of patients seen. In general surgery practice, the surgeon's clinical note is a poor measure of physician-centered or patient-centered outcomes, implying that an audit of clinical notes would be an inaccurate method to assess patient outcomes. This has implications for issues surrounding maintenance of certification. Copyright 2010 Elsevier Inc. All rights reserved.

Impact of early surgical evacuation of sylvian hematoma on clinical course and outcome after subarachnoid hemorrhage

International Nuclear Information System (INIS)

Mutoh, Tatsushi; Ishikawa, Tatsuya; Moroi, Junta; Suzuki, Akifumi; Yasui, Nobuyuki

2010-01-01

The present study aimed to evaluate the impact of early surgical evacuation of sylvian hematoma caused by ruptured middle cerebral artery (MCA) aneurysm on clinical outcome after subarachnoid hemorrhage. Hospital records and computed tomography scans for 26 patients with MCA aneurysm who underwent surgical clipping between June 2001 and January 2008 were retrospectively reviewed. All patients presented with sylvian hematoma associated with subarachnoid hemorrhage and received surgery at 7.9±3.6 (mean±standard deviation) hours of ictus. They were divided postoperatively into two groups, achievement (n=16) and non-achievement (n=10) of extensive hematoma evacuation, and their clinical course and functional outcomes were compared. The frequencies of delayed ischemic neurological deficit and vasospasm-related cerebral infarction were significantly less (p<0.05) in the achievement group. Better functional outcomes were obtained in patients with successful evacuation (p<0.05), as assessed by improvement of hemiparesis on manual muscle testing scale at postoperative 1-month follow up and by the modified Rankin scale at postoperative 3 and 6 months. Clinical outcomes were also better in the achievement group. These results suggest that better clinical course and outcome can be expected in patients who undergo early successful hematoma evacuation with surgical clipping of a ruptured MCA aneurysm. (author)

77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

Science.gov (United States)

2012-11-07

...] Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation... Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co... (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related...

Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

Science.gov (United States)

Sakoulas, G

2009-12-01

The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

Radiation Therapy Noncompliance and Clinical Outcomes in an Urban Academic Cancer Center

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Ohri, Nitin [Department of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York (United States); Rapkin, Bruce D. [Department of Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York (United States); Guha, Chandan; Kalnicki, Shalom [Department of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York (United States); Garg, Madhur, E-mail: mgarg@montefiore.org [Department of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York (United States)

2016-06-01

Purpose: To examine associations between radiation therapy (RT) noncompliance and clinical outcomes. Methods and Materials: We reviewed all patients who completed courses of external beam RT with curative intent in our department from the years 2007 to 2012 for cancers of the head and neck, breast, lung, cervix, uterus, or rectum. Patients who missed 2 or more scheduled RT appointments (excluding planned treatment breaks) were deemed noncompliant. Univariate, multivariable, and propensity-matched analyses were performed to examine associations between RT noncompliance and clinical outcomes. Results: Of 1227 patients, 266 (21.7%) were noncompliant. With median follow-up of 50.9 months, 108 recurrences (8.8%) and 228 deaths (18.6%) occurred. In univariate analyses, RT noncompliance was associated with increased recurrence risk (5-year cumulative incidence 16% vs 7%, P<.001), inferior recurrence-free survival (5-year actuarial rate 63% vs 79%, P<.001), and inferior overall survival (5-year actuarial rate 72% vs 83%, P<.001). In multivariable analyses that were adjusted for disease site and stage, comorbidity score, gender, ethnicity, race, and socioeconomic status (SES), RT noncompliance was associated with inferior recurrence, recurrence-free survival, and overall survival rates. Propensity score–matched models yielded results nearly identical to those seen in univariate analyses. Low SES was associated with RT noncompliance and was associated with inferior clinical outcomes in univariate analyses, but SES was not associated with inferior outcomes in multivariable models. Conclusion: For cancer patients being treated with curative intent, RT noncompliance is associated with inferior clinical outcomes. The magnitudes of these effects demonstrate that RT noncompliance can serve as a behavioral biomarker to identify high-risk patients who require additional interventions. Treatment compliance may mediate the associations that have been observed linking SES and

Clinical features, microbiology and surgical outcomes of infective endocarditis: a 13-year study from a UK tertiary cardiothoracic referral centre.

Science.gov (United States)

Marks, D J B; Hyams, C; Koo, C Y; Pavlou, M; Robbins, J; Koo, C S; Rodger, G; Huggett, J F; Yap, J; Macrae, M B; Swanton, R H; Zumla, A I; Miller, R F

2015-03-01

Infective endocarditis (IE) causes substantial morbidity and mortality. Patient and pathogen profiles, as well as microbiological and operative strategies, continue to evolve. The impact of these changes requires evaluation to inform optimum management and identify individuals at high risk of early mortality. Identification of clinical and microbiological features, and surgical outcomes, among patients presenting to a UK tertiary cardiothoracic centre for surgical management of IE between 1998 and 2010. Retrospective observational cohort study. Clinical, biochemical, microbiological and echocardiographic data were identified from clinical records. Principal outcomes were all-cause 28-day mortality and duration of post-operative admission. Patients (n = 336) were predominantly male (75.0%); median age 52 years (IQR = 41-67). Most cases involved the aortic (56.0%) or mitral (53.9%) valves. Microbiological diagnoses, obtained in 288 (85.7%) patients, included streptococci (45.2%); staphylococci (34.5%); Haemophilus, Actinobacillus, Cardiobacterium, Eikenella, Kingella (HACEK) organisms (3.0%); and fungi (1.8%); 11.3% had polymicrobial infection. Valve replacement in 308 (91.7%) patients included mechanical prostheses (69.8%), xenografts (24.0%) and homografts (6.2%). Early mortality was 12.2%, but fell progressively during the study (P = 0.02), as did median duration of post-operative admission (33.5 to 10.5 days; P = 0.0003). Multivariable analysis showed previous cardiothoracic surgery (OR = 3.85, P = 0.03), neutrophil count (OR = 2.27, P = 0.05), albumin (OR = 0.94, P = 0.04) and urea (OR = 2.63, P < 0.001) predicted early mortality. This study demonstrates reduced post-operative early mortality and duration of hospital admission for IE patients over the past 13 years. Biomarkers (previous cardiothoracic surgery, neutrophil count, albumin and urea), predictive of early post-operative mortality, require prospective evaluation to refine algorithms, further improve

Mapping clinical outcomes expectations to treatment decisions: an application to vestibular schwannoma management.

Science.gov (United States)

Cheung, Steven W; Aranda, Derick; Driscoll, Colin L W; Parsa, Andrew T

2010-02-01

Complex medical decision making obligates tradeoff assessments among treatment outcomes expectations, but an accessible tool to perform the necessary analysis is conspicuously absent. We aimed to demonstrate methodology and feasibility of adapting conjoint analysis for mapping clinical outcomes expectations to treatment decisions in vestibular schwannoma (VS) management. Prospective. Tertiary medical center and US-based otologists/neurotologists. Treatment preference profiles among VS stakeholders-61 younger and 74 older prospective patients, 61 observation patients, and 60 surgeons-were assessed for the synthetic VS case scenario of a 10-mm tumor in association with useful hearing and normal facial function. Treatment attribute utility. Conjoint analysis attribute levels were set in accordance to the results of a meta-analysis. Forty-five case series were disaggregated to formulate microsurgery facial nerve and hearing preservation outcomes expectations models. Attribute utilities were computed and mapped to the realistic treatment choices of translabyrinthine craniotomy, middle fossa craniotomy, and gamma knife radiosurgery. Among the treatment attributes of likelihoods of causing deafness, temporary facial weakness for 2 months, and incurable cancer within 20 years, and recovery time, permanent deafness was less important to tumor surgeons, and temporary facial weakness was more important to tumor surgeons and observation patients (Wilcoxon rank-sum, p knife radiosurgery. Mapping clinical outcomes expectations to treatment decisions for a synthetic clinical scenario revealed inhomogeneous drivers of choice selection among study cohorts. Medical decision engines that analyze personal preferences of outcomes expectations for VS and many other diseases may be developed to promote shared decision making among health care stakeholders and transparency in the informed consent process.

Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study.

Science.gov (United States)

Yen, Tin-Wing; Payne, Beth; Qu, Ziguang; Hutcheon, Jennifer A; Lee, Tang; Magee, Laura A; Walters, Barry N; von Dadelszen, Peter

2011-08-01

Preeclampsia is a leading cause of maternal morbidity. The clinical challenge lies in predicting which women with preeclampsia will suffer adverse outcomes and would benefit from treatment, while minimizing potentially harmful interventions. Our aim was to determine the ability of maternal symptoms (i.e., severe nausea or vomiting, headache, visual disturbance, right upper quadrant pain or epigastric pain, abdominal pain or vaginal bleeding, and chest pain or dyspnea) to predict adverse maternal or perinatal outcomes. We used data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study, a multicentre, prospective cohort study designed to investigate the maternal risks associated with preeclampsia. Relative risks and receiver operating characteristic (ROC) curves were assessed for each preeclampsia symptom and outcome pair. Of 2023 women who underwent assessment, 52% experienced at least one preeclampsia symptom, with 5.2% and 5.3% respectively experiencing an adverse maternal or perinatal outcome. No symptom and outcome pair, in either of the maternal or perinatal groups, achieved an area under the ROC curve value > 0.7, which would be necessary to demonstrate a discriminatory predictive value. Maternal symptoms of preeclampsia are not independently valid predictors of maternal adverse outcome. Caution should be used when making clinical decisions on the basis of symptoms alone in the preeclamptic patient.

Use of outcome measures in pulmonary hypertension clinical trials.

Science.gov (United States)

Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

2015-09-01

To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

Science.gov (United States)

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other

Effects of albendazole on the clinical outcome and immunological responses in helminth co-infected tuberculosis patients: a double blind randomised clinical trial.

Science.gov (United States)

Abate, E; Elias, D; Getachew, A; Alemu, S; Diro, E; Britton, S; Aseffa, A; Stendahl, O; Schön, T

2015-02-01

Despite several review papers and experimental studies concerning the impact of chronic helminth infection on tuberculosis in recent years, there is a scarcity of data from clinical field studies in highly endemic areas for these diseases. We believe this is the first randomised clinical trial investigating the impact of albendazole treatment on the clinical and immunological outcomes of helminth co-infected tuberculosis patients. A randomised, double-blind, placebo-controlled trial of albendazole (400mg per day for 3 days) in helminth-positive tuberculosis patients was conducted in Gondar, Ethiopia. The primary outcome was clinical improvement (ΔTB score) after 2 months. Among secondary outcomes were changes in the levels of eosinophils, CD4+ T cells, regulatory T cells, IFN-γ, IL-5 and IL-10 after 3 months. A total of 140 helminth co-infected tuberculosis patients were included with an HIV co-infection rate of 22.8%. There was no significant effect on the primary outcome (ΔTB score: 5.6±2.9 for albendazole versus 5.9±2.5 for placebo, P=0.59). The albendazole-treated group showed a decline in eosinophil cells (P=0.001) and IL-10 (P=0.017) after 3 months. In an exploratory analysis after 12 weeks, the albendazole treated group showed a trend towards weight gain compared with the placebo group (11.2±8.5 kg versus 8.2±8.7 kg, P=0.08)). The reductions in eosinophil counts and IL-10 show that asymptomatic helminth infection significantly affects host immunity during tuberculosis and can be effectively reversed by albendazole treatment. The clinical effects of helminth infection on chronic infectious diseases such as tuberculosis merit further characterisation. Copyright © 2014 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.

A comparable study of clinical and optical outcomes after 1.8, 2.0 mm microcoaxial and 3.0 mm coaxial cataract surgery.

Science.gov (United States)

Yu, Yi-Bo; Zhu, Ya-Nan; Wang, Wei; Zhang, Yi-Dong; Yu, Yin-Hui; Yao, Ke

2016-01-01

To evaluate the clinical and optical outcomes after clear corneal incision cataract surgery (CICS) with three different incision sizes (1.8, 2.0 and 3.0 mm). Eyes of 150 patients with age-related cataract scheduled for coaxial cataract surgery were randomized to three groups: 1.8, 2.0, or 3.0 mm CICS. Intraoperative data and postoperative outcomes including surgically induced astigmatism (SIA), the corneal incision thickness, wavefront aberrations and modulation transfer function (MTF) of cornea were obtained. There were no significant differences among the three groups in demographic characteristics and intraoperative outcome. The 1.8 and 2.0 mm microincisions showed more satisfactory clinical outcomes than the 3.0 mm incision. The 1.8 mm incision showed significantly less SIA than the 2.0 mm incision until postoperative 1mo (P0.05). Converting from 3.0 mm CICS to 1.8 or 2.0 mm CICS result in better clinical and optical outcomes. However, when incision is 1.8 mm, the benefits from further reduction in size compared with 2.0 mm are limited. The necessity to reduce the incision size is to be deliberated.

Stem cell transplantation as a dynamical system: are clinical outcomes deterministic?

Science.gov (United States)

Toor, Amir A; Kobulnicky, Jared D; Salman, Salman; Roberts, Catherine H; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A; Clark, William B; McCarty, John M; Chung, Harold M; Manjili, Masoud H; Sabo, Roy T; Neale, Michael C

2014-01-01

Outcomes in stem cell transplantation (SCT) are modeled using probability theory. However, the clinical course following SCT appears to demonstrate many characteristics of dynamical systems, especially when outcomes are considered in the context of immune reconstitution. Dynamical systems tend to evolve over time according to mathematically determined rules. Characteristically, the future states of the system are predicated on the states preceding them, and there is sensitivity to initial conditions. In SCT, the interaction between donor T cells and the recipient may be considered as such a system in which, graft source, conditioning, and early immunosuppression profoundly influence immune reconstitution over time. This eventually determines clinical outcomes, either the emergence of tolerance or the development of graft versus host disease. In this paper, parallels between SCT and dynamical systems are explored and a conceptual framework for developing mathematical models to understand disparate transplant outcomes is proposed.

The importance of exercise self-efficacy for clinical outcomes in pulmonary rehabilitation.

Science.gov (United States)

Selzler, Anne-Marie; Rodgers, Wendy M; Berry, Tanya R; Stickland, Michael K

2016-11-01

Pulmonary rehabilitation (PR) improves functional exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD), although these outcomes are often not maintained following PR. Self-efficacy is a precursor to outcomes achievement, yet few studies have examined the importance of self-efficacy to outcome improvement during PR, or how it develops over time. Further, the contribution of exercise-specific self-efficacy to outcomes in PR is unknown. The aims of this study were to determine (a) whether baseline exercise self-efficacy predicts PR attendance and change in functional exercise capacity and health status over PR, and (b) if exercise self-efficacy changes with PR. Fifty-eight out of 64 patients with COPD completed PR and assessments of exercise self-efficacy (task, coping, scheduling), the 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ) at the beginning and end of PR. Analyses were conducted to predict attendance, and change in 6MWT and SGRQ, while controlling for baseline demographic and clinical indicators. Change in 6MWT, SGRQ, and self-efficacy with PR was also examined. Clinically significant increases in the 6MWT and SGRQ were achieved with PR. Stronger task self-efficacy predicted better attendance, while stronger coping self-efficacy predicted greater 6MWT improvement. No variables predicted SGRQ change. Scheduling self-efficacy significantly improved with PR, whereas task and coping self-efficacy did not. Baseline exercise self-efficacy appears to be a determinant of rehabilitation attendance and functional exercise improvement with PR. Clinicians should evaluate and target exercise self-efficacy to maximize adherence and health outcome improvement with PR. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Disability outcome measures in multiple sclerosis clinical trials

DEFF Research Database (Denmark)

Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

2012-01-01

Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated with Eribulin

NARCIS (Netherlands)

Van Hasselt, J. G C; Gupta, A.; Hussein, Z.; Beijnen, J. H.; Schellens, J. H M; Huitema, A. D R

2015-01-01

Frameworks that associate cancer dynamic disease progression models with parametric survival models for clinical outcome have recently been proposed to support decision making in early clinical development. Here we developed such a disease progression clinical outcome model for castration-resistant

Association between oral nutritional supplementation and clinical outcomes among patients with ESRD.

Science.gov (United States)

Cheu, Christine; Pearson, Jeffrey; Dahlerus, Claudia; Lantz, Brett; Chowdhury, Tania; Sauer, Peter F; Farrell, Robert E; Port, Friedrich K; Ramirez, Sylvia P B

2013-01-01

Oral nutritional supplementation (ONS) was provided to ESRD patients with hypoalbuminemia as part of Fresenius Medical Care Health Plan's (FMCHP) disease management. This study evaluated the association between FMCHP's ONS program and clinical outcomes. Analyses included FMCHP patients with ONS indication (n=470) defined as 2-month mean albumin management setting.

Clinical features, management and outcomes of progressive outer retinal necrosis (PORN) in southern Thailand.

Science.gov (United States)

Sittivarakul, Wantanee; Aui-aree, Nipat

2009-03-01

To study the demographics, clinical features, treatment, and visual outcomes of progressive outer retinal necrosis (PORN) in a group of Thai patients. All cases of AIDS with a clinical diagnosis of PORN in a major tertiary referral hospital in southern Thailand between January 2003 and June 2007 were retrospectively reviewed. Demographic data, clinical features, treatment regimens, and visual outcomes were analyzed. Seven patients (11 eyes) were studied. The mean age was 44.7 years. The median CD4 count was 12 cells/mm3. A known history of cutaneous zoster was documented in 57% of cases. The median follow-up period was 17 weeks. Fifty-seven percent of the patients had bilateral disease. A majority of eyes (45.4%) had initial visual acuity of less than 20/50 to equal to or better than 20/200. About two-thirds of the eyes had anterior chamber cells. Vitritis and retinal lesions scattered throughout both posterior pole and peripheral retina were found in 72.7%. Either intravenous acyclovir in combination with intravitreal ganciclovir injections or intravenous aclyclovir alone was used for initial treatment. Retinal detachment occurred in 54.5%. Final visual acuity worsened (loss of 3 lines on the ETDRS chart or more) in 60%. Visual acuity was no light perception in 45.5% at the final recorded follow-up. Demographics, clinical features and treatment outcomes of PORN in this group of Thai patients were comparable with studies from other countries. Visual prognosis is still poor with current treatment regimens.

Tibial internal rotation negatively affects clinical outcomes in total knee arthroplasty: a systematic review.

Science.gov (United States)

Panni, Alfredo Schiavone; Ascione, Francesco; Rossini, Marco; Braile, Adriano; Corona, Katia; Vasso, Michele; Hirschmann, Michael T

2017-12-15

The aim of this systematic review is to analyze the effect of tibial rotational alignment after total knee arthroplasty (TKA) on clinical outcomes and assess the eventual cut-off values for tibial TKA rotation leading to poor outcomes. A detailed and systematic search from 1997 to 2017 of the Pubmed, Medline, Cochrane Reviews, and the Google Scholar databases was performed using the keyword terms "total knee arthroplasty", "total knee replacement", "tibial alignment", "tibial malalignement", "tibial rotation", "rotational error", "axis", "angle", "tibial malrotation", "clinical outcome", in several combinations. The modified Coleman scoring methodology (mCMS) was used. All the primary TKAs studies analyzing correlation between clinical results and tibial rotation were included. Five articles met the inclusion criteria. A total of 333 arthroplasties were included in this review; 139 had tibial component malalignment, while 194 were in control groups. The mean age of patients was 67.3 (SD 0.57) years. The mean average postoperative follow-up delay was 34.7 months (range 21-70). The mean mCMS score was 59.2 points indicating good methodological quality in the included studies. Functional outcomes were assessed through KSS, OKS, KOOS and VAS, negatively related to tibial internal rotation. Our review confirmed that excessive internal rotation of the tibial TKA component represents a significant risk factor for pain and inferior functional outcomes after TKA (> 10° of internal rotation demonstrated the common value), since external rotation does not affect the results. However, a universal precise cut-off value has not been found in the available literature and there remains a debate about CT rotation assessment and surgical intra-operative landmarks. III.

Hippocampal volume in relation to clinical and cognitive outcome after electroconvulsive therapy in depression.

Science.gov (United States)

Nordanskog, P; Larsson, M R; Larsson, E-M; Johanson, A

2014-04-01

In a previous magnetic resonance imaging (MRI) study, we found a significant increase in hippocampal volume immediately after electroconvulsive therapy (ECT) in patients with depression. The aim of this study was to evaluate hippocampal volume up to 1 year after ECT and investigate its possible relation to clinical and cognitive outcome. Clinical and cognitive outcome in 12 in-patients with depression receiving antidepressive pharmacological treatment referred for ECT were investigated with the Montgomery-Asberg Depression Rating Scale (MADRS) and a broad neuropsychological test battery within 1 week before and after ECT. The assessments were repeated 6 and 12 months after baseline in 10 and seven of these patients, respectively. Hippocampal volumes were measured on all four occasions with 3 Tesla MRI. Hippocampal volume returned to baseline during the follow-up period of 6 months. Neither the significant antidepressant effect nor the significant transient decrease in executive and verbal episodic memory tests after ECT could be related to changes in hippocampal volume. No persistent cognitive side effects were observed 1 year after ECT. The immediate increase in hippocampal volume after ECT is reversible and is not related to clinical or cognitive outcome. © 2013 The Authors. Acta Psychiatrica Scandinavica published by John Wiley & Sons Ltd.

CKD Self-management: Phenotypes and Associations With Clinical Outcomes.

Science.gov (United States)

Schrauben, Sarah J; Hsu, Jesse Y; Rosas, Sylvia E; Jaar, Bernard G; Zhang, Xiaoming; Deo, Rajat; Saab, Georges; Chen, Jing; Lederer, Swati; Kanthety, Radhika; Hamm, L Lee; Ricardo, Ana C; Lash, James P; Feldman, Harold I; Anderson, Amanda H

2018-03-24

To slow chronic kidney disease (CKD) progression and its complications, patients need to engage in self-management behaviors. The objective of this study was to classify CKD self-management behaviors into phenotypes and assess the association of these phenotypes with clinical outcomes. Prospective cohort study. Adults with mild to moderate CKD enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study. 3,939 participants in the CRIC Study recruited between 2003 and 2008 served as the derivation cohort and 1,560 participants recruited between 2013 and 2015 served as the validation cohort. CKD self-management behavior phenotypes. CKD progression, atherosclerotic events, heart failure events, death from any cause. Latent class analysis stratified by diabetes was used to identify CKD self-management phenotypes based on measures of body mass index, diet, physical activity, blood pressure, smoking status, and hemoglobin A 1c concentration (if diabetic); Cox proportional hazards models. 3 identified phenotypes varied according to the extent of implementation of recommended CKD self-management behaviors: phenotype I characterized study participants with the most recommended behaviors; phenotype II, participants with a mixture of recommended and not recommended behaviors; and phenotype III, participants with minimal recommended behaviors. In multivariable-adjusted models for those with and without diabetes, phenotype III was strongly associated with CKD progression (HRs of 1.82 and 1.49), death (HRs of 1.95 and 4.14), and atherosclerotic events (HRs of 2.54 and 1.90; each P diabetes. No consensus definition of CKD self-management; limited to baseline behavior data. There are potentially 3 CKD self-management behavior phenotypes that distinguish risk for clinical outcomes. These phenotypes may inform the development of studies and guidelines regarding optimal self-management. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights

Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome

Science.gov (United States)

Broeg-Morvay, Anne; Meisterernst, Julia; Schlager, Markus; Mono, Marie-Luise; El-Koussy, Marwan; Kägi, Georg; Jung, Simon; Sarikaya, Hakan

2016-01-01

Background Reported frequency of post-stroke dysphagia in the literature is highly variable. In view of progress in stroke management, we aimed to assess the current burden of dysphagia in acute ischemic stroke. Methods We studied 570 consecutive patients treated in a tertiary stroke center. Dysphagia was evaluated by using the Gugging Swallowing Screen (GUSS). We investigated the relationship of dysphagia with pneumonia, length of hospital stay and discharge destination and compared rates of favourable clinical outcome and mortality at 3 months between dysphagic patients and those without dysphagia. Results Dysphagia was diagnosed in 118 of 570 (20.7%) patients and persisted in 60 (50.9%) at hospital discharge. Thirty-six (30.5%) patients needed nasogastric tube because of severe dysphagia. Stroke severity rather than infarct location was associated with dysphagia. Dysphagic patients suffered more frequently from pneumonia (23.1% vs. 1.1%, pdysphagia. At 3 months, dysphagic patients less often had a favourable outcome (35.7% vs. 69.7%; pdysphagia to be an independent predictor of discharge destination and institutionalization at 3 months, while severe dysphagia requiring tube placement was strongly associated with mortality. Conclusion Dysphagia still affects a substantial portion of stroke patients and may have a large impact on clinical outcome, mortality and institutionalization. PMID:26863627

Low Plasma alpha-Tocopherol Concentrations and Adverse Clinical Outcomes in Diabetic Hemodialysis Patients

NARCIS (Netherlands)

Espe, K.M.; Raila, J.; Henze, A.; Blouin, K.; Schneider, A.; Schmiedeke, D.; Krane, V.; Pilz, S.; Schweigert, F.J.; Hocher, B.; Wanner, C.; Drechsler, C.

2013-01-01

Background and objectives Trials with the antioxidant vitamin E have failed to show benefit in the general population. Considering the different causes of death in ESRD, this study investigated the association between plasma concentrations of α-tocopherol and specific clinical outcomes in diabetic

The development of a clinical outcomes survey research application: Assessment Center.

Science.gov (United States)

Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

2010-06-01

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

Science.gov (United States)

Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M; Madison, Cindee M; Haense, Cathleen; Herholz, Karl; Reiman, Eric M; Jagust, William J; Frisoni, Giovanni B

2015-01-01

The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aβ1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.

The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

Science.gov (United States)

Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

2017-02-01

Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Directory of Open Access Journals (Sweden)

Ignacio Segarra

2017-07-01

Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

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

Science.gov (United States)

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

2017-01-01

Introduction The purpose of this study was to assess the clinical and financial outcomes of a novel outreach syncope clinic. Methods We compared the clinical outcome of the Faint and Fall Clinic at the American Center (January-June 2016) with that of the University of Wisconsin Health and Clinics Faint and Fall Clinic (January 2013-December 2014). The American Center-Faint and Fall Clinic is run solely by a nurse practitioner, assisted by online faint-decision software and consultancy of a faint specialist through video-conferencing. Results Five hundred and twenty-eight consecutive patients were seen at the University of Wisconsin Hospital and Clinics-Faint and Fall Clinic and 68 patients at the American Center-Faint and Fall Clinic. The patients' clinical characteristics were similar except for a lower age in the American Center patients (45 ± 18 vs 51 ± 22, p = 0.03). Overall, a diagnosis was made within 45 days in 70% (95% confidence interval 66-74%) of the University of Wisconsin Hospital and Clinics patients and 69% (95% confidence interval 58-80%) of the American Center patients, ( p = 0.9). A mean of 3.0 ± 1.6 tests per patient was used in the University of Wisconsin Hospital and Clinics group compared to 1.5 ± 0.8 tests per patient in the American Center group, p = 0.001. Over the six-month study period, the total revenue at the American Center was US$152,597 (contribution margin of US$122,393 plus professional revenue of US$30,204). The total cost of the nurse practitioner including benefits was US$66,662 ((US$98,466 salary/year + 35.4% benefits)/2). Total revenue minus expenses resulted in a net profit of US$85,935. Discussion A nurse practitioner-run outreach syncope-clinic equipped with online faint-decision software and consultancy of a faint specialist through vedio-conferencing is feasible and financially self-sustainable. It allows the dissemination of standardized high-quality syncope care to patients who have

Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes.

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Johnson, Nils P; Tóth, Gábor G; Lai, Dejian; Zhu, Hongjian; Açar, Göksel; Agostoni, Pierfrancesco; Appelman, Yolande; Arslan, Fatih; Barbato, Emanuele; Chen, Shao-Liang; Di Serafino, Luigi; Domínguez-Franco, Antonio J; Dupouy, Patrick; Esen, Ali M; Esen, Ozlem B; Hamilos, Michalis; Iwasaki, Kohichiro; Jensen, Lisette O; Jiménez-Navarro, Manuel F; Katritsis, Demosthenes G; Kocaman, Sinan A; Koo, Bon-Kwon; López-Palop, Ramón; Lorin, Jeffrey D; Miller, Louis H; Muller, Olivier; Nam, Chang-Wook; Oud, Niels; Puymirat, Etienne; Rieber, Johannes; Rioufol, Gilles; Rodés-Cabau, Josep; Sedlis, Steven P; Takeishi, Yasuchika; Tonino, Pim A L; Van Belle, Eric; Verna, Edoardo; Werner, Gerald S; Fearon, William F; Pijls, Nico H J; De Bruyne, Bernard; Gould, K Lance

2014-10-21

Fractional flow reserve (FFR) has become an established tool for guiding treatment, but its graded relationship to clinical outcomes as modulated by medical therapy versus revascularization remains unclear. The study hypothesized that FFR displays a continuous relationship between its numeric value and prognosis, such that lower FFR values confer a higher risk and therefore receive larger absolute benefits from revascularization. Meta-analysis of study- and patient-level data investigated prognosis after FFR measurement. An interaction term between FFR and revascularization status allowed for an outcomes-based threshold. A total of 9,173 (study-level) and 6,961 (patient-level) lesions were included with a median follow-up of 16 and 14 months, respectively. Clinical events increased as FFR decreased, and revascularization showed larger net benefit for lower baseline FFR values. Outcomes-derived FFR thresholds generally occurred around the range 0.75 to 0.80, although limited due to confounding by indication. FFR measured immediately after stenting also showed an inverse relationship with prognosis (hazard ratio: 0.86, 95% confidence interval: 0.80 to 0.93; p < 0.001). An FFR-assisted strategy led to revascularization roughly half as often as an anatomy-based strategy, but with 20% fewer adverse events and 10% better angina relief. FFR demonstrates a continuous and independent relationship with subsequent outcomes, modulated by medical therapy versus revascularization. Lesions with lower FFR values receive larger absolute benefits from revascularization. Measurement of FFR immediately after stenting also shows an inverse gradient of risk, likely from residual diffuse disease. An FFR-guided revascularization strategy significantly reduces events and increases freedom from angina with fewer procedures than an anatomy-based strategy. Copyright © 2014. Published by Elsevier Inc.

Neurosurgeon academic impact is associated with clinical outcomes after clipping of ruptured intracranial aneurysms.

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Alotaibi, Naif M; Ibrahim, George M; Wang, Justin; Guha, Daipayan; Mamdani, Muhammad; Schweizer, Tom A; Macdonald, R Loch

2017-01-01

Surgeon-dependent factors such as experience and volume are associated with patient outcomes. However, it is unknown whether a surgeon's research productivity could be related to outcomes. The main aim of this study is to investigate the association between the surgeon's academic productivity and clinical outcomes following neurosurgical clipping of ruptured aneurysms. We performed a post-hoc analysis of 3567 patients who underwent clipping of ruptured intracranial aneurysms in the randomized trials of tirilazad mesylate from 1990 to 1997. These trials included 162 centers and 156 surgeons from 21 countries. Primary and secondary outcomes were: Glasgow outcome scale score and mortality, respectively. Total publications, H-index, and graduate degrees were used as academic indicators for each surgeon. The association between outcomes and academic factors were assessed using a hierarchical logistic regression analysis, adjusting for patient covariates. Academic profiles were available for 147 surgeons, treating a total of 3307 patients. Most surgeons were from the USA (62, 42%), Canada (18, 12%), and Germany (15, 10%). On univariate analysis, the H-index correlated with better functional outcomes and lower mortality rates. In the multivariate model, patients under the care of surgeons with higher H-indices demonstrated improved neurological outcomes (p = 0.01) compared to surgeons with lower H-indices, without any significant difference in mortality. None of the other academic indicators were significantly associated with outcomes. Although prognostication following surgery for ruptured intracranial aneurysms primarily depends on clinical and radiological factors, the academic impact of the operating neurosurgeon may explain some heterogeneity in surgical outcomes.

Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

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Trujillo A

2016-06-01

Full Text Available Adriana Trujillo,1,2 Guillem Feixas,1,2 Arturo Bados,1 Eugeni García-Grau,1 Marta Salla,1 Joan Carles Medina,1 Adrián Montesano,1,2 José Soriano,3 Leticia Medeiros-Ferreira,4 Josep Cañete,5 Sergi Corbella,6 Antoni Grau,7 Fernando Lana,8 Chris Evans9 1Department of Personality, Assessment and Psychological Treatments, Faculty of Psychology, 2Institute for Brain, Cognition and Behaviour, University of Barcelona, 3Hospital of the Holy Cross and Saint Paul, 4Nou Barris Mental Health Center, Barcelona, 5Hospital of Mataró, Sanitary Consortium of Maresme, Mataró, 6FPCEE, Blanquerna, Universitat Ramon Llull, 7Institute of Eating Disorders, Barcelona, 8MAR Health Park, CAEMIL, Santa Coloma de Gramenet, Spain; 9East London NHS Foundation Trust, NPDDNet, London, UK 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

Posterior lumbar interbody fusion using nonresorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices: a prospective, randomized study to assess fusion and clinical outcome

NARCIS (Netherlands)

Jiya, T.U.; Smit, T.H.; Deddens, J.; Mullender, M.G.

2009-01-01

STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications. SUMMARY OF BACKGROUND DATA: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within

Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

DEFF Research Database (Denmark)

Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.

2008-01-01

of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

Clinical outcomes of temporary shunting for infants with cerebral pseudomeningocele.

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Mattei, Tobias A; Sambhara, Deepak; Bond, Brandon J; Lin, Julian

2014-02-01

Although in the case of subdural collections temporary shunting has been suggested as a viable alternative for definitive drainage of the accumulated fluid until restoration of the normal CSF dynamics, there is no agreement on the best management strategy for pseudomeningocele. The authors performed a retrospective chart review in order to evaluate the clinical outcomes of infants temporarily shunted for pseudomeningocele without encephalocele at our institution (The University of Illinois at Peoria/Illinois Neurological Institute) in the period from 2004 to 2012. The epidemiological characteristics, clinical management, and final outcomes of such subpopulation were compared with a control group which received temporary shunting for subdural hematomas (SDH) during the same period. Four patients (100% male) ranging in age from 8.9 to 27.1 months (mean = 13.88) with pseudomeningocele and 17 patients (64.7% male) ranging in age from 1.9 to 11.8 months (mean = 4.15) with SDH were identified. Although the initial management included sequential percutaneous subdural tapping in 82% of the patients, all children ultimately failed such strategy, requiring either subdural-peritoneal (81% of the cases) or subgaleal-peritoneal (19% of the cases) shunting. The mean implant duration was 201 days for the pseudomeningocele group and 384 days for the SDH one. Mean post-shunt hospitalization was 2 days for patients with pseudomeningocele and 4 days for patients with SDH. There was no statistical difference in terms of complications, length of hospitalization post-shunting, or clinical outcomes between the patients with pseudomeningocele and those with SDH. Temporary shunting of infants with pseudo-meningocele constitutes a viable therapeutic alternative with favorable clinical outcomes and a low risk of shunt dependency similar to those of children with SDH.

Clinical phenotype and outcome of hepatitis E virus-associated neuralgic amyotrophy

NARCIS (Netherlands)

Eijk, J.J.J. van; Dalton, H.R.; Ripellino, P.; Madden, R.G.; Jones, C.; Fritz, M.; Gobbi, C.; Melli, G.; Pasi, E.; Herrod, J.; Lissmann, R.F.; Ashraf, H.H.; Abdelrahim, M.; Masri, O.; Fraga, M.; Benninger, D.; Kuntzer, T.; Aubert, V.; Sahli, R.; Moradpour, D.; Blasco-Perrin, H.; Attarian, S.; Gerolami, R.; Colson, P.; Giordani, M.T.; Hartl, J.; Pischke, S.; Lin, N.X.; McLean, B.N.; Bendall, R.P.; Panning, M.; Peron, J.M.; Kamar, N.; Izopet, J.; Jacobs, B.C.; Alfen, N. van; Engelen, B.G.M. van

2017-01-01

OBJECTIVE: To determine the clinical phenotype and outcome in hepatitis E virus-associated neuralgic amyotrophy (HEV-NA). METHODS: Cases of NA were identified in 11 centers from 7 European countries, with retrospective analysis of demographics, clinical/laboratory findings, and treatment and

Persistent systemic inflammation is associated with poor clinical outcomes in COPD

DEFF Research Database (Denmark)

Agustí, Alvar; Edwards, Lisa D; Rennard, Stephen I

2012-01-01

Because chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, the identification of specific clinical phenotypes is key to developing more effective therapies. To explore if the persistence of systemic inflammation is associated with poor clinical outcomes in COPD we assessed...

Moxifloxacin susceptibility mediates the relationship between causative organism and clinical outcome in bacterial keratitis.

Science.gov (United States)

Oldenburg, Catherine E; Lalitha, Prajna; Srinivasan, Muthiah; Manikandan, Palanisamy; Bharathi, M Jayahar; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Nardone, Natalie; Ray, Kathryn J; Glidden, David V; Acharya, Nisha R; Lietman, Thomas M

2013-02-28

Bacterial keratitis is a sight-threatening infection of the cornea that is one of the leading causes of blindness globally. In this report, we analyze the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacteria keratitis. A mediation analysis is used to assess the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacterial keratitis using data collected in a randomized, controlled trial. In the Steroids for Corneal Ulcers Trial (SCUT), 500 corneal infections were treated with topical moxifloxacin. The outcome of 3-week best spectacle-corrected visual acuity was significantly associated with an organism (Streptococcus pneumoniae, Pseudomonas aeruginosa, etc., P = 0.008). An indirect effects mediation model suggests that MIC accounted for approximately 13% (95% confidence interval, 3%-24%, P = 0.015) of the effect of the organism on 3-week visual acuity. Moxifloxacin mediates the relationship between causative organisms and clinical outcome in bacterial keratitis, and is likely on the causal pathway between the organism and outcome. (ClinicalTrials.gov number, NCT00324168.).

Dimensions of socioeconomic status and clinical outcome after primary percutaneous coronary intervention

DEFF Research Database (Denmark)

Jakobsen, Lars; Niemann, Troels; Thorsgaard, Niels

2012-01-01

The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood.......The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood....

Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery?

DEFF Research Database (Denmark)

Sangesland, Anders; Støren, Carl; Vaegter, Henrik B.

2017-01-01

of surgery, QST variables, clinical pain outcome measure and main result. Results Most studies showed moderate to high risk of bias. Type of surgery investigated include 7 studies on total knee replacement, 5 studies on caesarean section, 4 studies on thoracic surgery, 2 studies on herniotomy, 2 studies......Background Pain after surgery is not uncommon with 30% of patients reporting moderate to severe postoperative pain. Early identification of patients prone to postoperative pain may be a step forward towards individualized pain medicine providing a basis for improved clinical management through......, and (3) the association between QST and pain after surgery was investigated. Forty-four unique studies were identified, with 30 studies on 2738 subjects meeting inclusion criteria. The methodological quality of the include studies was assessed and data extraction included study population, type...

Admission Hyperglycemia and Clinical Outcome in Cerebral Venous Thrombosis

NARCIS (Netherlands)

Zuurbier, Susanna M.; Hiltunen, Sini; Tatlisumak, Turgut; Peters, Guusje M.; Silvis, Suzanne M.; Haapaniemi, Elena; Kruyt, Nyika D.; Putaala, Jukka; Coutinho, Jonathan M.

2016-01-01

Background and Purpose-Admission hyperglycemia is associated with poor clinical outcome in ischemic and hemorrhagic stroke. Admission hyperglycemia has not been investigated in patients with cerebral venous thrombosis. Methods-Consecutive adult patients with cerebral venous thrombosis were included

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

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

2013-08-01

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

Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

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Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

2016-02-01

Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

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

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

2016-01-01

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

A systematic review of clinical supervision evaluation studies in nursing.

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Cutcliffe, John R; Sloan, Graham; Bashaw, Marie

2018-02-15

According to the international, extant literature published during the last 20 years or so, clinical supervision (CS) in nursing is now a reasonably common phenomenon. Nevertheless, what appears to be noticeably 'thin on the ground' in this body of literature are empirical evaluations of CS, especially those pertaining to client outcomes. Accordingly, the authors undertook a systematic review of empirical evaluations of CS in nursing to determine the state of the science. Adopting the approach documented by Stroup et al. (JAMA, 283, 2000, 2008), the authors searched for reports of evaluation studies of CS in nursing - published during the years 1995 to 2015. Keywords for the search were 'clinical supervision', 'evaluation', 'efficacy', 'nursing', and combinations of these keywords. Electronic databases used were CINAHL, MEDLINE, PsychLIT, and the British Nursing Index. The research evidence from twenty-eight (28) studies reviewed is presented, outlining the main findings with an overview of each study presented. The following broad themes were identified and are each discussed in the study: narrative/anecdotal accounts of positive outcomes for clinical supervision, narrative/anecdotal accounts of negative outcomes for clinical supervision, empirical positive outcomes reported by supervisee, and empirical findings showing no effect by supervisee. © 2018 Australian College of Mental Health Nurses Inc.

Total elbow arthroplasty: a radiographic outcome study

Energy Technology Data Exchange (ETDEWEB)

Bai, Xue Susan [University of Washington, Department of Radiology, Box 357115, Seattle, WA (United States); Petscavage-Thomas, Jonelle M. [Penn State Hershey Medical Center, Department of Radiology, Hershey, PA (United States); Ha, Alice S. [University of Washington, Department of Radiology, Box 354755, Seattle, WA (United States)

2016-06-15

Total elbow arthroplasty (TEA) is becoming a popular alternative to arthrodesis for patients with end-stage elbow arthrosis and comminuted distal humeral fractures. Prior outcome studies have primarily focused on surgical findings. Our purpose is to determine the radiographic outcome of TEA and to correlate with clinical symptoms such as pain. This is an IRB-approved retrospective review from 2005 to 2015 of all patients with semiconstrained TEA. All available elbow radiographs and clinical data were reviewed. Data analysis included descriptive statistics and Kaplan-Meier survival curves for radiographic and clinical survival. A total of 104 total elbow arthroplasties in 102 patients were reviewed; 75 % were in women and the mean patient age was 63.1 years. Mean radiographic follow-up was 826 days with average of four radiographs per patient. Seventy TEAs (67 %) developed radiographic complications, including heterotopic ossification (48 %), perihardware lucency (27 %), periprosthetic fracture (23 %), hardware subluxation/dislocation (7 %), polyethylene wear (3 %), and hardware fracture/dislodgement (3 %); 56 patients (55 %) developed symptoms of elbow pain or instability and 30 patients (30 %) underwent at least one reoperation. In patients with radiographic complications, 66 % developed elbow pain, compared to 19 % of patients with no radiologic complications (p = 0.001). Of the patients with radiographic complications, 39 % had at least one additional surgery compared to 0 % of patients without radiographic complications (p = 0.056). Radiographic complications are common in patients after total elbow arthroplasty. There is a strong positive association between post-operative radiographic findings and clinical outcome. Knowledge of common postoperative radiographic findings is important for the practicing radiologist. (orig.)

The development of leadership outcome-indicators evaluating the contribution of clinical specialists and advanced practitioners to health care: a secondary analysis.

Science.gov (United States)

Elliott, Naomi; Begley, Cecily; Kleinpell, Ruth; Higgins, Agnes

2014-05-01

To report a secondary analysis of data collected from the case study phase of a national study of advanced practitioners and to develop leadership outcome-indicators appropriate for advanced practitioners. In many countries, advanced practitioners in nursing and midwifery have responsibility as leaders for health care development, but without having leadership outcome measures available they are unable to demonstrate the results of their activities. In Ireland, a sequential mixed method research study was used to develop a validated tool for the evaluation of clinical specialists and advanced practitioners. Despite strong evidence of leadership activities, few leadership-specific outcomes were generated from the primary analysis. Secondary analysis of a multiple case study data set. Data set comprised 23 case studies of advanced practitioner/clinical specialists from 13 sites across each region in Ireland from all divisions of the Nursing Board Register. Data were collected 2008-2010. Data sources included non-participant observation (n = 92 hours) of advanced practitioners in practice, interviews with clinicians (n = 21), patients (n = 20) and directors of nursing/midwifery (n = 13) and documents. Analysis focused on leadership outcome-indicator development in line with the National Health Service's Good Indicators Guide. The four categories of leadership outcomes for advanced practitioner developed were as follows: (i) capacity and capability building of multidisciplinary team; (ii) measure of esteem; (iii) new initiatives for clinical practice and healthcare delivery; and (iv) clinical practice based on evidence. The proposed set of leadership outcome-indicators derived from a secondary analysis captures the complexity of leadership in practice. They add to existing clinical outcomes measuring advanced practice. © 2013 John Wiley & Sons Ltd.

Posttraumatic hydrocephalus: a clinical, neuroradiologic, and neuropsychologic assessment of long-term outcome.

Science.gov (United States)

Mazzini, Letizia; Campini, Riccardo; Angelino, Elisabetta; Rognone, Felice; Pastore, Ilaria; Oliveri, Giuseppe

2003-11-01

To detect the clinical and radiologic characteristics of posttraumatic hydrocephalus (PTH), to define its prognostic value, and to assess the effects of shunt surgery. Correlational study on a prospective cohort. Brain injury rehabilitation center. One hundred forty patients with severe traumatic brain injury (TBI) referred to an inpatient intensive rehabilitation unit of primary care in a university-based system. Not applicable. The Glasgow Outcome Scale (GOS), Disability Rating Scale (DRS), FIM instrument, and Neurobehavioural Rating Scale (NRS), as well as single-photon emission computed tomography (SPECT) and magnetic resonance imaging. PTH was found in 45% of patients. Risk factors for PTH were as follows: age (PTBI. It influences functional and behavioral outcome and the appearance of posttraumatic epilepsy. The selection of patients for surgery can be defined principally on a clinical basis. SPECT may be helpful for differentiating ventricular enlargement due to cortical atrophy and hydrocephalus.

Twenty-Year Systematic Review of the Hip Pathology, Risk Factors, Treatment, and Clinical Outcomes in Artistic Athletes-Dancers, Figure Skaters, and Gymnasts.

Science.gov (United States)

Bolia, Ioanna; Utsunomiya, Hajime; Locks, Renato; Briggs, Karen; Philippon, Marc J

2018-01-01

To identify (1) the predominant level of evidence of the clinical studies regarding the hip pathology, risk factors, treatment, and clinical outcomes in artistic athletes (dancers, figure skaters, and gymnasts) (2) the most commonly reported hip pathology, risk factors, treatments, and clinical outcomes in dancers, figure skaters, and gymnasts. To conduct this systematic review PubMed, EMBASE, and Scopus databases were searched for relevant studies and pertinent data were collected from the eligible articles. Included were studies which reported hip injuries in artistic athletes, the risk factors, treatment, and/or the clinical outcomes. We excluded case reports or irrelevant studies. No meta-analysis was performed because of study heterogeneity. The methodical index for nonrandomized studies (MINORS) criteria were used for quality control. Thirty-eight studies were included in the analysis. The mean MINORS score was 13.6 ± 4.6 points indicating fair quality of evidence of the included articles. The predominant level of evidence was level IV. Chondrolabral pathology and muscle injuries were the most commonly reported pathologies. We found only 2 risk factor analysis studies; however, many studies reported risk correlation between artistic sports or imaging findings and hip pathology. Treatment strategies were reported in only 7 studies, clinical outcomes are significantly underreported. Chondrolabral pathology was the most commonly reported hip pathology in artistic athletes, however, prospective cohort studies are necessary to really understand these injuries and their associated risk factors. The lack of clinical outcomes is significant and future data collection is required to assess the effectiveness of the various treatments.

A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

Directory of Open Access Journals (Sweden)

Lipsky Benjamin A

2012-09-01

Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

Biocompatible Peritoneal Dialysis Fluids: Clinical Outcomes

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Yeoungjee Cho

2012-01-01

Full Text Available Peritoneal dialysis (PD is a preferred home dialysis modality and has a number of added advantages including improved initial patient survival and cost effectiveness over haemodialysis. Despite these benefits, uptake of PD remains relatively low, especially in developed countries. Wider implementation of PD is compromised by higher technique failure from infections (e.g., PD peritonitis and ultrafiltration failure. These are inevitable consequences of peritoneal injury, which is thought to result primarily from continuous exposure to PD fluids that are characterised by their “unphysiologic” composition. In order to overcome these barriers, a number of more biocompatible PD fluids, with neutral pH, low glucose degradation product content, and bicarbonate buffer have been manufactured over the past two decades. Several preclinical studies have demonstrated their benefit in terms of improvement in host cell defence, peritoneal membrane integrity, and cytokine profile. This paper aims to review randomised controlled trials assessing the use of biocompatible PD fluids and their effect on clinical outcomes.

Audit filters for improving processes of care and clinical outcomes in trauma systems.

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Evans, Christopher; Howes, Daniel; Pickett, William; Dagnone, Luigi

2009-10-07

Traumatic injuries represent a considerable public health burden with significant personal and societal costs. The care of the severely injured patient in a trauma system progresses along a continuum that includes numerous interventions being provided by a multidisciplinary group of healthcare personnel. Despite the recent emphasis on quality of care in medicine, there has been little research to direct trauma clinicians and administrators on how optimally to monitor and improve upon the quality of care delivered within a trauma system. Audit filters are one mechanism for improving quality of care and are defined as specific clinical processes or outcomes of care that, when they occur, represent unfavorable deviations from an established norm and which prompt review and feedback. Although audit filters are widely utilized for performance improvement in trauma systems they have not been subjected to systematic review of their effectiveness. To determine the effectiveness of using audit filters for improving processes of care and clinical outcomes in trauma systems. Our search strategy included an electronic search of the Cochrane Injuries Group Specialized Register, the Cochrane EPOC Group Specialized Register, CENTRAL (The Cochrane Library 2008, Issue 4), MEDLINE, PubMed, EMBASE, CINAHL, and ISI Web of Science: (SCI-EXPANDED and CPCI-S). We handsearched the Journal of Trauma, Injury, Annals of Emergency Medicine, Academic Emergency Medicine, and Injury Prevention. We searched two clinical trial registries: 1) The World Health Organization International Clinical Trials Registry Platform and, 2) Clinical Trials.gov. We also contacted content experts for further articles. The most recent electronic search was completed in December 2008 and the handsearch was completed up to February 2009. We searched for randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series studies that used audit filters as an

Clinical manifestations and outcome of tuberculous sclerokeratitis.

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Shoughy, Samir S; Jaroudi, Mahmoud O; Tabbara, Khalid F

2016-09-01

To study the clinical manifestations and outcome of patients with tuberculous sclerokeratitis treated with antituberculous therapy without concomitant use of systemic steroids. We reviewed retrospectively the medical records of eight consecutive patients with tuberculous sclerokeratitis. Patients were treated unsuccessfully with topical and/or systemic steroids. They underwent complete ophthalmic examination, systemic evaluation, laboratory investigations and imaging. Tuberculin skin test was done with purified protein derivative (PPD) on all patients. The diagnosis of tuberculous sclerokeratitis was made based on clinical findings of scleritis with adjacent peripheral corneal stromal keratitis, positive PPD test of 15 mm of induration or more, response to antituberculous treatment (ATT) within 4 weeks and exclusion of other causes of sclerokeratitis. Antituberculous drugs were given for a minimum of 6 months without concomitant use of corticosteroids. The outcome measure was resolution of the ocular surface inflammation of the sclera and cornea. Eight consecutive patients with a diagnosis of tuberculous sclerokeratitis were included. There were one male and seven female patients. The mean age was 29 years with an age range of 7-43 years. The involvement of the sclera was nodular in six patients and diffuse in two. The involvement of the cornea consisted of peripheral corneal stromal inflammation adjacent to the area of scleritis. Patients responded to antituberculous medications with complete resolution of the sclerokeratitis without topical or systemic anti-inflammatory agents. Antituberculous medications can lead to complete resolution of the sclerokeratitis without concomitant use of steroids, or other anti-inflammatory agents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Learning outcomes using video in supervision and peer feedback during clinical skills training

DEFF Research Database (Denmark)

Lauridsen, Henrik Hein; Toftgård, Rie Castella; Nørgaard, Cita

supervision of clinical skills (formative assessment). Demonstrations of these principles will be presented as video podcasts during the session. The learning outcomes of video supervision and peer-feedback were assessed in an online questionnaire survey. Results Results of the supervision showed large self......Objective New technology and learning principles were introduced in a clinical skills training laboratory (iLab). The intension was to move from apprenticeship to active learning principles including peer feedback and supervision using video. The objective of this study was to evaluate student...... learning outcomes in a manual skills training subject using video during feedback and supervision. Methods The iLab classroom was designed to fit four principles of teaching using video. Two of these principles were (a) group work using peer-feedback on videos produced by the students and, (b) video...

Cerebral amyloid angiopathy-related inflammation: imaging findings and clinical outcome

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Martucci, Matia [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Catholic University of Sacred Heart, ' ' A. Gemelli' ' University Hospital, Department of Radiological Sciences, Rome (Italy); Sarria, Silvana; Coscojuela, Pilar; Vert, Carla; Siurana, Sahyly; Auger, Cristina; Rovira, Alex [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Toledo, Manuel [Vall d' Hebron University Hospital, Epilepsy Unit, Neurology Department, Barcelona (Spain)

2014-04-15

We aim to investigate the clinical onset, computed tomography (CT) and magnetic resonance (MR) imaging findings, and follow-up of patients with cerebral amyloid angiopathy (CAA)-related inflammation, an uncommon but clinically striking presentation of CAA. We retrospectively reviewed the clinical manifestations, CT/MR imaging findings, and outcome of ten consecutive patients with CAA-related inflammation. In each patient, a brain CT study was performed at hospital admission, and brain MR imaging was carried out 2 to 4 days later. Clinical and radiologic follow-up findings were evaluated in all patients. The most common clinical onset was rapidly progressive cognitive decline, followed by focal neurological signs. Brain CT/MR showed unenhanced expansive subcortical lesions, corresponding to areas of vasogenic edema, associated with chronic lobar, cortical, or cortical-subcortical micro/macrohemorrhages. Clinical symptoms recovered in a few weeks under treatment in eight patients and spontaneously in the remaining two. MRI follow-up at 2 to 12 months after treatment showed resolution of the lesions. Three patients experienced symptomatic disease recurrence, with new lesions on CT/MR. In the absence of histological data, early recognition of the clinical symptoms and typical radiologic features of CAA-related inflammation is essential to enable timely establishment of proper treatment. (orig.)

Cerebral amyloid angiopathy-related inflammation: imaging findings and clinical outcome

International Nuclear Information System (INIS)

Martucci, Matia; Sarria, Silvana; Coscojuela, Pilar; Vert, Carla; Siurana, Sahyly; Auger, Cristina; Rovira, Alex; Toledo, Manuel

2014-01-01

We aim to investigate the clinical onset, computed tomography (CT) and magnetic resonance (MR) imaging findings, and follow-up of patients with cerebral amyloid angiopathy (CAA)-related inflammation, an uncommon but clinically striking presentation of CAA. We retrospectively reviewed the clinical manifestations, CT/MR imaging findings, and outcome of ten consecutive patients with CAA-related inflammation. In each patient, a brain CT study was performed at hospital admission, and brain MR imaging was carried out 2 to 4 days later. Clinical and radiologic follow-up findings were evaluated in all patients. The most common clinical onset was rapidly progressive cognitive decline, followed by focal neurological signs. Brain CT/MR showed unenhanced expansive subcortical lesions, corresponding to areas of vasogenic edema, associated with chronic lobar, cortical, or cortical-subcortical micro/macrohemorrhages. Clinical symptoms recovered in a few weeks under treatment in eight patients and spontaneously in the remaining two. MRI follow-up at 2 to 12 months after treatment showed resolution of the lesions. Three patients experienced symptomatic disease recurrence, with new lesions on CT/MR. In the absence of histological data, early recognition of the clinical symptoms and typical radiologic features of CAA-related inflammation is essential to enable timely establishment of proper treatment. (orig.)

Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

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de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

2018-05-01

Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

Helicobacter pylori iceA, clinical outcomes, and correlation with cagA: a meta-analysis.

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Shiota, Seiji; Watada, Masahide; Matsunari, Osamu; Iwatani, Shun; Suzuki, Rumiko; Yamaoka, Yoshio

2012-01-01

Although the iceA (induced by contact with epithelium) allelic types of Helicobacter pylori have been reported to be associated with peptic ulcer, the importance of iceA on clinical outcomes based on subsequent studies is controversial. The aim of this study was to estimate the magnitude of the risk for clinical outcomes associated with iceA. A literature search was performed using the PubMed and EMBASE databases for articles published through April 2011. Published case-control studies examining the relationship between iceA and clinical outcomes (gastritis, peptic ulcer, including gastric ulcer and duodenal ulcer, and gastric cancer) were included. Fifty studies with a total of 5,357 patients were identified in the search. Infection with iceA1-positive H. pylori increased the overall risk for peptic ulcer by 1.26-fold (95% confidence interval [CI], 1.09-1.45). However, the test for heterogeneity was significant among these studies. Sensitivity analysis showed that the presence of iceA1 was significantly associated with peptic ulcer (odds ratio [OR] = 1.25, 95% CI = 1.08-1.44). The presence of iceA2 was inversely associated with peptic ulcer (OR = 0.76, 95% CI = 0.65-0.89). The presence of iceA was not associated with gastric cancer. Most studies examined the cagA status; however, only 15 studies examined the correlation and only 2 showed a positive correlation between the presence of cagA and iceA1. Our meta-analysis confirmed the importance of the presence of iceA for peptic ulcer, although the significance was marginal.

Relationship between time to clinical response and outcomes among Pneumonia Outcomes Research Team (PORT) risk class III and IV hospitalized patients with community-acquired pneumonia who received ceftriaxone and azithromycin.

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Zasowski, Evan; Butterfield, Jill M; McNutt, Louise-Ann; Cohen, Jason; Cosler, Leon; Pai, Manjunath P; Gottwald, Joseph; Chen, Wen Zhen; Lodise, Thomas P

2014-07-01

Recent Food and Drug Administration (FDA) guidance endorses the use of an early clinical response endpoint as the primary outcome for community-acquired bacterial pneumonia (CABP) trials. While antibiotics will now be approved for CABP, in practice they will primarily be used to treat patients with community-acquired pneumonia (CAP). More importantly, it is unclear how achievement of the new FDA CABP early response endpoint translates into clinically applicable real-world outcomes for patients with CAP. To address this, a retrospective cohort study was conducted among adult patients who received ceftriaxone and azithromycin for CAP of Pneumonia Outcomes Research Team (PORT) risk class III and IV at an academic medical center. The clinical response was defined as clinical stability for 24 h with improvement in at least one pneumonia symptom and with no symptom worsening. A classification and regression tree (CART) was used to determine the delay in response time, measured in days, associated with the greatest risk of a prolonged hospital length of stay (LOS) and adverse outcomes (in-hospital mortality or 30-day CAP-related readmission). A total of 250 patients were included. On average, patients were discharged 2 days following the achievement of a clinical response. In the CART analysis, adverse clinical outcomes were higher among day 5 nonresponders than those who responded by day 5 (22.4% versus 6.9%, P = 0.001). The findings from this study indicate that time to clinical response, as defined by the recent FDA guidance, is a reasonable prognostic indicator of real-world effectiveness outcomes among hospitalized PORT risk class III and IV patients with CAP who received ceftriaxone and azithromycin. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Body Composition in Relation to Clinical Outcomes in Renal Cell Cancer: A Systematic Review and Meta-analysis.

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Vrieling, Alina; Kampman, Ellen; Knijnenburg, Nathalja C; Mulders, Peter F; Sedelaar, J P Michiel; Baracos, Vickie E; Kiemeney, Lambertus A

2016-12-04

Several studies suggest that body composition (ie, body proportions of muscle and fat defined by computed tomography) is associated with clinical outcomes of several cancer types, including renal cell cancer (RCC). To conduct a systematic review and meta-analysis of the evidence on body composition in relation to clinical outcomes in RCC. Literature was reviewed through October 2016 using PubMed and Embase. We included studies investigating computed tomography-measured cross-sectional areas of visceral adipose tissue (VAT), perinephric fat, subcutaneous adipose tissue (SAT), skeletal muscle index (SMI), and skeletal muscle radiodensity (SMD) in relation to perioperative outcomes, treatment toxicity, and survival in RCC patients. We included 28 studies with a total of 6608 patients. Binary classification of body composition was used in most studies. In metastatic RCC (mRCC) patients treated with antiangiogenic drugs, dose-limiting toxicity was more frequent in patients with low versus high SMI (four studies, risk difference = 16%, 95% confidence interval [CI]: 2-31%, p = 0.03, I 2 = 26%). Low versus high SMI (six studies, hazard ratio = 1.48, 95% CI: 1.08-2.03, p = 0.02, I 2 = 28%) and SMD (four studies, HR = 1.56, 95% CI: 1.20-2.03, p = 0.0008, I 2 = 0%) were associated with an increased risk of overall mortality in mRCC. Low versus high VAT and perinephric fat were not consistently associated with perioperative outcomes and survival. No associations for SAT were found. Low SMI is associated with increased dose-limiting toxicity, and low SMI and SMD are associated with increased overall mortality in mRCC. The association of VAT, perinephric fat, and SAT with clinical outcomes needs further investigation, also in localized RCC. We reviewed studies assessing the association of body composition with clinical outcomes in renal cell cancer. We demonstrated higher risk of dose-limiting toxicity and overall mortality for metastatic renal cell cancer patients with low

Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

Directory of Open Access Journals (Sweden)

Kristen Meldi Plasseraud

2016-01-01

Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

Added value of CT perfusion compared to CT angiography in predicting clinical outcomes of stroke patients treated with mechanical thrombectomy

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Tsogkas, Ioannis; Knauth, Michael; Schregel, Katharina; Behme, Daniel; Psychogios, Marios Nikos [University Medicine Goettingen, Department of Neuroradiology, Goettingen (Germany); Wasser, Katrin; Maier, Ilko; Liman, Jan [University Medicine Goettingen, Department of Neurology, Goettingen (Germany)

2016-11-15

CTP images analyzed with the Alberta stroke program early CT scale (ASPECTS) have been shown to be optimal predictors of clinical outcome. In this study we compared two biomarkers, the cerebral blood volume (CBV)-ASPECTS and the CTA-ASPECTS as predictors of clinical outcome after thrombectomy. Stroke patients with thrombosis of the M1 segment of the middle cerebral artery were included in our study. All patients underwent initial multimodal CT with CTP and CTA on a modern CT scanner. Treatment consisted of full dose intravenous tissue plasminogen activator, when applicable, and mechanical thrombectomy. Three neuroradiologists separately scored CTP and CTA images with the ASPECTS score. Sixty-five patients were included. Median baseline CBV-ASPECTS and CTA-ASPECTS for patients with favourable clinical outcome at follow-up were 8 [interquartile range (IQR) 8-9 and 7-9 respectively]. Patients with poor clinical outcome showed a median baseline CBV-ASPECTS of 6 (IQR 5-8, P < 0.0001) and a median baseline CTA-ASPECTS of 7 (IQR 7-8, P = 0.18). Using CBV-ASPECTS and CTA-ASPECTS raters predicted futile reperfusions in 96 % and 56 % of the cases, respectively. CBV-ASPECTS is a significant predictor of clinical outcome in patients with acute ischemic stroke treated with mechanical thrombectomy. (orig.)

Clinical, Pathological, and Surgical Outcomes for Adult Pineoblastomas.

Science.gov (United States)

Gener, Melissa A; Conger, Andrew R; Van Gompel, Jamie; Ariai, Mohammad S; Jentoft, Mark; Meyer, Fredric B; Cardinal, Jeremy S; Bonnin, José M; Cohen-Gadol, Aaron A

2015-12-01

Pineoblastomas are uncommon primitive neuroectodermal tumors that occur mostly in children; they are exceedingly rare in adults. Few published reports have compared the various aspects of these tumors between adults and children. The authors report a series of 12 pineoblastomas in adults from 2 institutions over 24 years. The clinical, radiologic, and pathologic features and clinical outcomes were compared with previously reported cases in children and adults. Patient age ranged from 24 to 81 years, and all but 1 patient exhibited symptoms of obstructive hydrocephalus. Three patients underwent gross total resection, and subtotal resection was performed in 3 patients. Diagnostic biopsy specimens were obtained in an additional 6 patients. Pathologically, the tumors had the classical morphologic and immunohistochemical features of pineoblastomas. Postoperatively, 10 patients received radiotherapy, and 5 patients received chemotherapy. Compared with previously reported cases, several differences were noted in clinical outcomes. Of the 12 patients, only 5 (42%) died of their disease (average length of survival, 118 months); 5 patients (42%) are alive with no evidence of disease (average length of follow-up, 92 months). One patient died of unrelated causes, and one was lost to follow-up. Patients with subtotal resections or diagnostic biopsies did not suffer a worse prognosis. Of the 9 patients with biopsy or subtotal resection, 4 are alive, 4 died of their disease, and 1 died of an unrelated hemorrhagic cerebral infarction. Although this series is small, the data suggest that pineoblastomas in adults have a less aggressive clinical course than in children. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

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Neehar D. Parikh

2015-01-01

Full Text Available Donation after cardiac death (DCD has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60 to those of donation after brain death (DBD liver recipients (n=669 during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001 and a trend toward lower rates of 5-year patient survival (P=0.064 when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC. Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05. While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

Impact of Preeclampsia on Clinical and Functional Outcomes in Women With Peripartum Cardiomyopathy.

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Lindley, Kathryn J; Conner, Shayna N; Cahill, Alison G; Novak, Eric; Mann, Douglas L

2017-06-01

Preeclampsia is a risk factor for the development of peripartum cardiomyopathy (PPCM), but it is unknown whether preeclampsia impacts clinical or left ventricular (LV) functional outcomes. This study sought to assess clinical and functional outcomes in women with PPCM complicated by preeclampsia. This retrospective cohort study included women diagnosed with PPCM delivering at Barnes-Jewish Hospital between 2004 to 2014. The primary outcome was one-year event-free survival rate for the combined end point of death and hospital readmission. The secondary outcome was recovery of LV ejection fraction. Seventeen of 39 women (44%) with PPCM had preeclampsia. The groups had similar mean LV ejection fraction at diagnosis (29.6 with versus 27.3 without preeclampsia; P =0.5). Women with preeclampsia had smaller mean LV end-diastolic diameters (5.2 versus 6.0 cm; P =0.001), greater relative wall thickness (0.41 versus 0.35 mm Hg; P =0.009), and lower incidence of eccentric remodeling (12% versus 48%; P =0.03). Clinical follow-up was available for 32 women; 5 died of cardiovascular complications within 1 year of diagnosis (4/15 with versus 1/17 without preeclampsia; P =0.16). In time to event analysis, patients with preeclampsia had worse event-free survival during 1-year follow-up ( P =0.047). Echocardiographic follow-up was available in 10 survivors with and 16 without preeclampsia. LV ejection fraction recovered in 80% of survivors with versus 25% without preeclampsia ( P =0.014). PPCM with concomitant preeclampsia is associated with increased morbidity and mortality and different patterns of LV remodeling and recovery of LV function when compared with patients with PPCM that is not complicated by preeclampsia. © 2017 American Heart Association, Inc.

The impact of anismus on the clinical outcome of rectocele repair.

Science.gov (United States)

van Dam, J H; Schouten, W R; Ginai, A Z; Huisman, W M; Hop, W C

1996-01-01

There are doubts as to whether rectocele repair (RR) is beneficial for patients with concomitant anismus. The aim of this prospective study was to evaluate the effect of anismus on the clinical outcome of RR. In 71 out of 75 patients who underwent RR evacuation proctography (EP) was performed. Electromyography (EMG) of the pelvic floor and balloon expulsion test (BET) were carried out in 61 and 35 patients respectively. On EP, measuring the central anorectal angle (CARA) and the posterior anorectal angle (PARA), signs of anismus were found in 34 and 28 percent of the patients respectively. EMG and BET revealed anismus in 39 and 71 percent of the patients respectively. These results showed poor agreement. RR was successful in 53 (71%) out of 75 patients (follow up 14-74 months). No differences were found in clinical outcome in patients with and without signs of anismus. In conclusion, RR is beneficial for patients with obstructed defecation, and signs of anismus do not appear to be a contraindication for RR.

Prevalence and clinical outcomes of hepatitis B virus infection in patients with aplastic anemia.

Science.gov (United States)

Zhao, Pan; Gao, Qing; He, Qiulian; Tan, Jing

2017-10-01

The association of HBV infection with other hematopoietic diseases has been discussed previously. However, the clinical significance and clinical outcomes of HBV infection in AA patients have not been clarified. In this study, we sought to investigate the prevalence and related events of HBV in patients with AA who received immunosuppressive therapy. We retrospectively analyzed 245 patients with acquired AA. The HBsAg positivity rate was 14.69% in this group of AA patients. No significant difference was observed in the severity of AA patients with HBV infection and in those without (P = 0.6358). HBV reactivation occurred in 4.76% of HBsAg-positive patients who received ATG/ALG + CsA treatment without anti-viral prophylaxis. HBV-infected patients who received CsA alone did not develop reactivation. Patients with HBV reactivation showed favorable clinical outcomes, with no HBV-related deaths. There was no significant difference in overall probability of survival in patients with different HBV infection status (P = 0.8617). Given the low rate of reactivation and favorable outcomes after reactivation in AA patients, close monitoring of HBV DNA, hepatic function and patient immune status may be a more effective approach than routine prophylaxis for AA patients with HBV infection undergoing ATG/ALG + CsA treatment. Further studies are warranted to clarify the optimal time to initiate anti-viral treatment.

Clinical Outcomes following median to radial nerve transfers

Science.gov (United States)

Ray, Wilson Z.; Mackinnon, Susan E.

2010-01-01

Purpose In this study the authors evaluate the clinical outcomes in patients with radial nerve palsy who underwent nerve transfers utilizing redundant fascicles of median nerve (innervating the flexor digitorum superficialis and flexor carpi radialis muscles) to the posterior interosseous nerve and the nerve to the extensor carpi radialis brevis. Methods A retrospective review of the clinical records of 19 patients with radial nerve injuries who underwent nerve transfer procedures using the median nerve as a donor nerve were included. All patients were evaluated using the Medical Research Council (MRC) grading system. Results The mean age of patients was 41 years (range 17 – 78 years). All patients received at least 12 months of follow-up (20.3 ± 5.8 months). Surgery was performed at a mean of 5.7 ± 1.9 months post-injury. Post-operative functional evaluation was graded according to the following scale: grades MRC 0/5 - MRC 2/5 were considered poor outcomes, while MRC of 3/5 was a fair result, MRC grade 4/5 was a good result, and grade 4+/5 was considered an excellent outcome. Seventeen patients (89%) had a complete radial nerve palsy while two patients (11%) had intact wrist extension but no finger or thumb extension. Post-operatively all patients except one had good to excellent recovery of wrist extension. Twelve patients recovered good to excellent finger and thumb extension, two patients had fair recovery, five patients had a poor recovery. Conclusions The radial nerve is a commonly injured nerve, causing significant morbidity in affected patients. The median nerve provides a reliable source of donor nerve fascicles for radial nerve reinnervation. This transfer was first performed in 1999 and evolved over the subsequent decade. The important nuances of both surgical technique and motor re-education critical for to the success of this transfer have been identified and are discussed. PMID:21168979

Bacterial meningitis in newborn and infant: correlation between organism, CT findings and clinical outcome