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.

PubMed

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.

Effects of Prophylactic Antiepileptic Drugs on Clinical Outcomes in Patients with a Good Clinical Grade Suffering from Aneurysmal Subarachnoid Hemorrhage

PubMed Central

Yoon, Seon Jin; Joo, Jin-Yang; Kim, Yong Bae; Hong, Chang-Ki

2015-01-01

Objective Routine use of prophylactic antiepileptic drugs (AED) has been debated. We retrospectively evaluated the effects of prophylactic AED on clinical outcomes in patients with a good clinical grade suffering from aneurysmal subarachnoid hemorrhage (aSAH). Materials and Methods Between September 2012 and December 2014, 84 patients who met the following criteria were included: (1) presence of a ruptured aneurysm; (2) Hunt-Hess grade 1, 2, or 3; and (3) without seizure presentation. Patients were divided into two groups; the AED group (n = 44) and the no AED group (n = 40). Clinical data and outcomes were compared between the two groups. Results Prophylactic AEDs were used more frequently in patients who underwent microsurgery (84.1%) compared to those who underwent endovascular surgery (15.9%, p < 0.001). Regardless of prophylactic AED use, seizure episodes were not observed during the six-month follow-up period. No statistical difference in clinical outcomes at discharge (p = 0.607) and after six months of follow-up (p = 0.178) were between the two groups. After six months, however, favorable outcomes in the no AED group tended to increase and poor outcomes tended to decrease. Conclusion No difference in the clinical outcomes and systemic complications at discharge and after six months of follow-up was observed between the two groups. However, favorable outcomes in the no AED group showed a slight increase after six months. These findings suggest that discontinuation of the current practice of using prophylactic AED might be recommended in patients with a good clinical grade. PMID:26526008

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

PubMed

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.

Acute Management of Hemostasis in Patients With Neurological Injury.

PubMed

Baharoglu, M Irem; Brand, Anneke; Koopman, Maria M; Vermeulen, Marinus; Roos, Yvo B W E M

2017-10-01

Neurological injuries can be divided into those with traumatic and nontraumatic causes. The largest groups are traumatic brain injury (TBI) and nontraumatic stroke. TBI patients may present with intracranial hemorrhages (contusions, or subdural or epidural hematomas). Strokes are ischemic or hemorrhagic. In all these disorders, thrombosis and hemostasis play a major role. Treatment aims to either cease bleeding and/or restore perfusion. We reviewed hemostatic and thrombolytic therapies in patients with neurological injuries by MEDLINE and EMBASE search using various key words for neurological disorders and hemostatic therapies restricted to English language and human adults. Review of articles fulfilling inclusion criteria and relevant references revealed that, in patients with ischemic stroke, intravenous thrombolytic therapy with recombinant tissue plasminogen activator within 4.5-5 hours after onset of symptoms improves clinical outcome. In contrast, there are no hemostatic therapies that are proven to improve clinical outcome of patients with hemorrhagic stroke or TBI. In patients with hemorrhagic stroke who use vitamin K antagonist or direct oral anticoagulants, there is evidence that specific reversal therapies improve hemostatic laboratory parameters but without an effect on clinical recovery. In patients with hemorrhagic stroke or TBI who use concomitant antiplatelet therapy, there is evidence for harm of platelet transfusion. In patients with aneurysmal subarachnoid hemorrhage, tranexamic acid was shown to reduce rebleeding rate without improving clinical outcome. The effects of tranexamic acid in patients with TBI are still under investigation. We conclude that, in patients with ischemic stroke, thrombolytic therapy improves outcome when given within 4.5-5 hours. In hemorrhagic stroke and TBI, most hemostatic therapies improved or corrected laboratory parameters but not clinical outcome. Currently, in several trials, the effects of tranexamic acid are being studied of which the results are eagerly awaited. Because improving clinical outcome should be the goal of new therapies, we encourage to use clinical outcome scales as the primary outcome measure in trials that investigate effects of hemostatic therapies in patients with neurological injury. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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.

Weighing Clinical Evidence Using Patient Preferences: An Application of Probabilistic Multi-Criteria Decision Analysis.

PubMed

Broekhuizen, Henk; IJzerman, Maarten J; Hauber, A Brett; Groothuis-Oudshoorn, Catharina G M

2017-03-01

The need for patient engagement has been recognized by regulatory agencies, but there is no consensus about how to operationalize this. One approach is the formal elicitation and use of patient preferences for weighing clinical outcomes. The aim of this study was to demonstrate how patient preferences can be used to weigh clinical outcomes when both preferences and clinical outcomes are uncertain by applying a probabilistic value-based multi-criteria decision analysis (MCDA) method. Probability distributions were used to model random variation and parameter uncertainty in preferences, and parameter uncertainty in clinical outcomes. The posterior value distributions and rank probabilities for each treatment were obtained using Monte-Carlo simulations. The probability of achieving the first rank is the probability that a treatment represents the highest value to patients. We illustrated our methodology for a simplified case on six HIV treatments. Preferences were modeled with normal distributions and clinical outcomes were modeled with beta distributions. The treatment value distributions showed the rank order of treatments according to patients and illustrate the remaining decision uncertainty. This study demonstrated how patient preference data can be used to weigh clinical evidence using MCDA. The model takes into account uncertainty in preferences and clinical outcomes. The model can support decision makers during the aggregation step of the MCDA process and provides a first step toward preference-based personalized medicine, yet requires further testing regarding its appropriate use in real-world settings.

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

PubMed

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

2016-03-01

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

Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains.

PubMed

Peyrani, P; Allen, M; Seligson, D; Roberts, C; Chen, A; Haque, N; Zervos, M; Wiemken, T; Harting, J; Christensen, D; Ramirez, R

2012-03-01

Methicillin-resistant Staphylococcus aureus (MRSA) USA-300 strains have emerged as an important cause of community-acquired infections. These strains have been recognized as an etiology of osteomyelitis but data on their incidence and outcomes are limited. We retrospectively studied the incidence and clinical outcomes of MRSA USA-300 osteomyelitis in patients at the University of Louisville Hospital and the Henry Ford Health System between January 2007 and March 2008. Pulsed-field gel electrophoresis was used to determine USA type. Clinical outcomes were defined as management success versus failure at 12 months. Chi-square tests, Fisher exact tests, and Mann-Whitney tests were used to compare patient characteristics on the basis of clinical outcomes and USA type. Of the 50 patients with MRSA osteomyelitis, 27 (54%) had the USA-300 strain. Clinical failure was identified in 22% (6/27) of the patients with MRSA USA-300 and in 30% (7/23) of the patients with MRSA non-USA-300 osteomyelitis (P = .509). Our results showed that MRSA USA-300 is a significant etiology of MRSA osteomyelitis. With current surgical and medical management, outcomes of patients with MRSA USA-300 osteomyelitis are similar to those of patients with MRSA non-USA-300 osteomyelitis.

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

PubMed Central

Malhotra, Aneil; Banning, Adrian P; Jenkinson, Crispin

2010-01-01

Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making. Design Systematic review. Data sources Medline and Embase. Study selection Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008. Results Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients. Conclusions Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This was largely explained by inappropriate use of composite outcomes and inadequate measurement of harms. PMID:21041324

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

PubMed Central

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

2015-01-01

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

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

PubMed

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 instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs. Copyright © 2017. Published by Elsevier Inc.

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

PubMed

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 < 0.001), suggesting clinically favorable outcomes. Preoperative psychological status of patients (anxiety, depression, and 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.

Neurointerventional Treatment in Acute Stroke. Whom to Treat? (Endovascular Treatment for Acute Stroke: Utility of THRIVE Score and HIAT Score for Patient Selection)

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

Fjetland, Lars, E-mail: lars.fjetland@lyse.net; Roy, Sumit, E-mail: sumit.roy@sus.no; Kurz, Kathinka D., E-mail: kathinka.dehli.kurz@sus.no

2013-10-15

Purpose: Intra-arterial therapy (IAT) is used increasingly as a treatment option for acute stroke caused by central large vessel occlusions. Despite high rates of recanalization, the clinical outcome is highly variable. The authors evaluated the Houston IAT (HIAT) and the totaled health risks in vascular events (THRIVE) score, two predicting scores designed to identify patients likely to benefit from IAT. Methods: Fifty-two patients treated at the Stavanger University Hospital with IAT from May 2009 to June 2012 were included in this study. We combined the scores in an additional analysis. We also performed an additional analysis according to high agemore » and evaluated the scores in respect of technical efficacy. Results: Fifty-two patients were evaluated by the THRIVE score and 51 by the HIAT score. We found a strong correlation between the level of predicted risk and the actual clinical outcome (THRIVE p = 0.002, HIAT p = 0.003). The correlations were limited to patients successfully recanalized and to patients <80 years. By combining the scores additional 14.3 % of the patients could be identified as poor candidates for IAT. Both scores were insufficient to identify patients with a good clinical outcome. Conclusions: Both scores showed a strong correlation to poor clinical outcome in patients <80 years. The specificity of the scores could be enhanced by combining them. Both scores were insufficient to identify patients with a good clinical outcome and showed no association to clinical outcome in patients aged {>=}80 years.« less

Wound care clinical pathway: a conceptual model.

PubMed

Barr, J E; Cuzzell, J

1996-08-01

A clinical pathway is a written sequence of clinical processes or events that guides a patient with a defined problem toward an expected outcome. Clinical pathways are tools to assist with the cost-effective management of clinical outcomes related to specific problems or disease processes. The primary obstacles to developing clinical pathways for wound care are the chronic natures of some wounds and the many variables that can delay healing. The pathway introduced in this article was modeled upon the three phases of tissue repair: inflammatory, proliferative, and maturation. This physiology-based model allows clinicians to identify and monitor outcomes based on observable and measurable clinical parameters. The pathway design, which also includes educational and behavioral outcomes, allows the clinician to individualize the expected timeframe for outcome achievement based on individual patient criteria and expert judgement. Integral to the pathway are the "4P's" which help standardize the clinical processes by wound type: Protocols, Policies, Procedures, and Patient education tools. Four categories into which variances are categorized based on the cause of the deviation from the norm are patient, process/system, practitioner, and planning/discharge. Additional research is warranted to support the value of this clinical pathway in the clinical arena.

A systematic review of evidence on the links between patient experience and clinical safety and effectiveness

PubMed Central

Doyle, Cathal; Lennox, Laura; Bell, Derek

2013-01-01

Objective To explore evidence on the links between patient experience and clinical safety and effectiveness outcomes. Design Systematic review. Setting A wide range of settings within primary and secondary care including hospitals and primary care centres. Participants A wide range of demographic groups and age groups. Primary and secondary outcome measures A broad range of patient safety and clinical effectiveness outcomes including mortality, physical symptoms, length of stay and adherence to treatment. Results This study, summarising evidence from 55 studies, indicates consistent positive associations between patient experience, patient safety and clinical effectiveness for a wide range of disease areas, settings, outcome measures and study designs. It demonstrates positive associations between patient experience and self-rated and objectively measured health outcomes; adherence to recommended clinical practice and medication; preventive care (such as health-promoting behaviour, use of screening services and immunisation); and resource use (such as hospitalisation, length of stay and primary-care visits). There is some evidence of positive associations between patient experience and measures of the technical quality of care and adverse events. Overall, it was more common to find positive associations between patient experience and patient safety and clinical effectiveness than no associations. Conclusions The data presented display that patient experience is positively associated with clinical effectiveness and patient safety, and support the case for the inclusion of patient experience as one of the central pillars of quality in healthcare. It supports the argument that the three dimensions of quality should be looked at as a group and not in isolation. Clinicians should resist sidelining patient experience as too subjective or mood-oriented, divorced from the ‘real’ clinical work of measuring safety and effectiveness. PMID:23293244

Clinical and economic outcomes in a population-based European cohort of 948 ulcerative colitis and Crohn's disease patients by Markov analysis.

PubMed

Odes, S; Vardi, H; Friger, M; Esser, D; Wolters, F; Moum, B; Waters, H; Elkjaer, M; Bernklev, T; Tsianos, E; O'Morain, C; Stockbrügger, R; Munkholm, P; Langholz, E

2010-04-01

Forecasting clinical and economic outcomes in ulcerative colitis (UC) and Crohn's disease (CD) patients is complex, but necessary. To determine: the frequency of treatment-classified clinical states; the probability of transition between states; and the economic outcomes. Newly diagnosed UC and CD patients, allocated into seven clinical states by medical and surgical treatments recorded in serial 3-month cycles, underwent Markov analysis. Over 10 years, 630 UC and 318 CD patients had 22,823 and 11,871 cycles. The most frequent clinical outcomes were medical/surgical remission (medication-free) and mild disease (on 5-aminosalicylates, antibiotics, topical corticosteroids), comprising 28% and 62% of UC cycles and 24% and 51% of CD cycles respectively. The probability of drug-response in patients receiving systemic corticosteroids/immunomodulators was 0.74 in UC, 0.66 in CD. Both diseases had similar likelihood of persistent drug-dependency or drug-refractoriness. Surgery was more probable in CD, 0.20, than UC, 0.08. In terms of economic outcomes, surgery was costlier in UC per cycle, but the outlay over 10 years was greater in CD. Drug-refractory UC and CD cases engendered high costs in the cohort. Most patients on 5-aminosalicylates, corticosteroids and immunomodulators had favourable clinical and economic outcomes over 10 years. Drug-refractory and surgical patients exhibited greater long-term expenses.

Stent Retriever Thrombectomy in Different Thrombus Locations of Anterior Cerebral Circulation

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

Protto, Sara; Sillanpää, Niko, E-mail: niko.sillanpaa@pshp.fi; Pienimäki, Juha-Pekka

BackgroundMechanical thrombectomy (MT) is a safe and efficient treatment for acute ischemic stroke in patients with proximal anterior occlusion and large penumbra. We evaluated the technical and clinical success of MT in relation to the location of the occlusion (internal carotid artery, M1 and M2 segments of the middle cerebral artery).MethodsWe prospectively reviewed 130 patients of whom 105 met the inclusion criteria. Baseline clinical, procedural and imaging variables, technical outcome (TICI, thrombolysis in cerebral infarction), 24 h imaging outcome and three-month clinical outcome (mRS, modified Rankin Scale) were recorded. Differences between the groups were studied with statistical tests according to themore » type of the variable.ResultsThere were 37, 46 and 22 patients in the internal carotid artery (ICA), M1 and M2 groups, respectively. TICI 2b or 3 was achieved in 92 cases (88 %) with a non-significant trend towards a better recanalization outcome in the ICA and M1 groups. Overall, 57 of the 105 patients (55 %) experienced favorable clinical outcome (mRS ≤ 2) with no significant differences between the groups. Excellent outcome (mRS ≤ 1) was seen in 40 patients (39 %) and there proportionally more patients with excellent outcome in the ICA and M1 groups (ICA: 44 %, M1: 41 %, M2: 23 % of patients, p = 0.22).ConclusionsThere were no statistically significant differences in the technical or clinical outcomes between the different sites of occlusion (ICA, M1 or M2). There was a non-significant trend towards achieving excellent clinical outcome (3-month mRS ≤ 1) more often and better recanalization results in the two more proximal locations.« less

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

PubMed

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 (p<0.003). Moreover, outcome groups differed significantly only on the Cartoon Predictions subtest (z-scores: poor outcome=-2.7 [SD=2.7]; good outcome=-0.7 [SD=1.8]; p=0.001) among the five subtests used. Overall, social 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.

Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review.

PubMed

Greenberg, Jacob K; Milner, Eric; Yarbrough, Chester K; Lipsey, Kim; Piccirillo, Jay F; Smyth, Matthew D; Park, Tae Sung; Limbrick, David D

2015-02-01

Chiari malformation Type I (CM-I) is a common and often debilitating neurological disease. Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes. To understand current approaches and lay a foundation for future research, the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. The authors searched PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov , and Cochrane databases to identify publications between January 2003 and August 2013 that met the following criteria: 1) reported clinical outcomes in patients treated for CM-I; 2) were original research articles; 3) included at least 10 patients or, if a comparative study, at least 5 patients per group; and 4) were restricted to patients with CM-I. Among the 74 papers meeting inclusion criteria, there was wide variation in the outcome methods used. However, all approaches were broadly grouped into 3 categories: 1) "gestalt" impression of overall symptomatic improvement (n=45 papers); 2) postoperative change in specific signs or symptoms (n=20); or 3) results of various standardized assessment scales (n=22). Among standardized scales, 11 general function measures were used, compared with 6 disease-specific tools. Only 3 papers used scales validated in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches, the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably, only 7 articles incorporated patient-response instruments when reporting outcome, and only 22 articles explicitly assessed quality of life. The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable, complicating efforts to analyze results across studies. Development, validation, and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients.

Clinical and Procedural Predictors of Outcomes From the Endovascular Treatment of Posterior Circulation Strokes.

PubMed

Mokin, Maxim; Sonig, Ashish; Sivakanthan, Sananthan; Ren, Zeguang; Elijovich, Lucas; Arthur, Adam; Goyal, Nitin; Kan, Peter; Duckworth, Edward; Veznedaroglu, Erol; Binning, Mandy J; Liebman, Kenneth M; Rao, Vikas; Turner, Raymond D; Turk, Aquilla S; Baxter, Blaise W; Dabus, Guilherme; Linfante, Italo; Snyder, Kenneth V; Levy, Elad I; Siddiqui, Adnan H

2016-03-01

Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization. © 2016 American Heart Association, Inc.

Satisfaction of care in a tertiary level diabetes clinic: correlations with diabetes knowledge, clinical outcome and health-related quality of life.

PubMed

Koves, Ildiko H; Boucher, Andrew; Ismail, Dunia; Donath, Susan; Cameron, Fergus J

2008-01-01

Patient satisfaction is regarded as an integral component of the quality of medical care. Therefore, as part of an ongoing process of outcome assessment, we analysed levels of satisfaction of care among patients and parents in our diabetes clinic and its relationship to short-term metabolic control outcome, diabetes knowledge and health-related quality of life (HRQOL). In 2004, parents and their children aged 5-18 years attending the Royal Children's Hospital (RCH) diabetes clinic completed questionnaires reporting their satisfaction with care provided, HRQOL and diabetes knowledge. Concurrent HbA(1c) levels were also recorded. The reporting profile was 83 patients, 24 fathers and 110 mothers. Generally, both patients and parents were satisfied with diabetes care provided at our tertiary centre. Satisfaction of care was not associated with the clinical outcome of metabolic control (measured by HbA(1c) levels), diabetes knowledge or HRQOL measures. Most patients and their parents in the RCH diabetes clinic appear generally satisfied with their diabetes care. The degree of satisfaction of care cannot be presumed according to clinical outcome, diabetes knowledge or HRQOL measures.

Improving the relevance and consistency of outcomes in comparative effectiveness research.

PubMed

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-03-01

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.

Improving the relevance and consistency of outcomes in comparative effectiveness research

PubMed Central

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-01-01

Policy makers have clearly indicated – through heavy investment in the Patient Centered Outcomes Research Institute – that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues. PMID:26930385

Outcome of endovascular treatment for acute basilar artery occlusion in the modern era: a single institution experience.

PubMed

Li, Chuanhui; Zhao, Wenbo; Wu, Chuanjie; Shang, Shuyi; Chen, Jian; Ren, Ming; Duan, Jiangang; Ma, Qingfeng; Li, Guilin; Zhang, Yunzhou; Zhang, Hongqi; Jiao, Liqun; Ji, Xunming

2018-06-01

The beneficial effect of endovascular treatment (EVT) for patients with acute basilar artery occlusion (ABAO) remains uncertain. The purpose of the present study was to evaluate clinical outcome of EVT for patients with ABAO and analyze prognostic factors of good outcome. From our prospectively established database, we reviewed all patients with ABAO receiving EVT during January 2014 to December 2016. Baseline characteristics and outcomes were evaluated. Favorable functional outcome was defined as modified Rankin Scale score of 0 to 3 assessed at 3-month follow-up. The association between clinical and procedural characteristics and functional outcome was assessed. Of the 68 patients included, 50 patients (73.5%) received mechanical thrombectomy with stent retriever device. Successful reperfusion (thrombolysis in cerebral infarction grades 2b-3) was achieved in 61 patients (89.7%). Overall favorable functional outcome was reached by 31 patients (45.6%). In univariate analysis, Glasgow Coma Scale sum score, baseline National Institutes of Health stroke scale score (NIHSS), and baseline glycemia level were identified predicting good clinical outcome. Multivariate analysis showed that lower NIHSS was the only independent risk factor of favorable functional outcome (OR 0.832; 95% CI, 0.715-0.968; p = 0.018). No difference of favorable outcomes was observed between the subgroups of time to EVT < 6 h and ≽ 6 h. Data in the present study suggests that EVT for ABAO patients should be reasonable within 24 h of symptom onset. The most important factor determining clinical outcome is initial stroke severity.

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

PubMed

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 waiting times were shorter in nurse led clinics. The other service delivery outcomes were not addressed. Clinical and health outcomes findings were that lower pain/discomfort levels were demonstrated in nurse led clinics but other clinical/health outcomes were not addressed. Financial outcomes findings were that nurse-led clinics were cost effective when compared with medical-led clinics. While all studies reported evidence of the effectiveness of nurse-led clinics in service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints, most of the data was self-reported and many of the outcomes of interest were not considered. The lack of experimental trials means that the level of evidence is low and further research is needed. There was also not enough detail in the financial outcomes from which clear conclusions of the cost benefit of nurse-led clinics could be drawn. Evidence from included studies indicated higher levels of patient satisfaction, cost benefits and lower levels of pain/discomfort in nurse-led clinics, which suggests that nurse-led ear, nose and throat clinics may be considered in the management of adult patients with ear, nose and throat complaints. Currently there is little evidence examining the effectiveness of nurse-led ear, nose and throat clinics. Areas to be addressed by future research should include: levels of patient education, booking queues, levels of self-treatment change in presentation to clinic episodes, reinfection rates, prevention and cure and representation of patients at clinics for same complaint.

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

PubMed

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.

Treatment outcomes of HIV-positive patients on first-line antiretroviral therapy in private versus public HIV clinics in Johannesburg, South Africa.

PubMed

Moyo, Faith; Chasela, Charles; Brennan, Alana T; Ebrahim, Osman; Sanne, Ian M; Long, Lawrence; Evans, Denise

2016-01-01

Despite the widely documented success of antiretroviral therapy (ART), stakeholders continue to face the challenges of poor HIV treatment outcomes. While many studies have investigated patient-level causes of poor treatment outcomes, data on the effect of health systems on ART outcomes are scarce. We compare treatment outcomes among patients receiving HIV care and treatment at a public and private HIV clinic in Johannesburg, South Africa. This was a retrospective cohort analysis of ART naïve adults (≥18.0 years), initiating ART at a public or private clinic in Johannesburg between July 01, 2007 and December 31, 2012. Cox proportional-hazards regression was used to identify baseline predictors of mortality and loss to follow-up (>3 months late for the last scheduled visit). Generalized estimating equations were used to determine predictors of failure to suppress viral load (≥400 copies/mL) while the Wilcoxon rank-sum test was used to compare the median absolute change in CD4 count from baseline to 12 months post-ART initiation. 12,865 patients initiated ART at the public clinic compared to 610 at the private clinic. The patients were similar in terms of sex and age at initiation. Compared to public clinic patients, private clinic patients initiated ART at higher median CD4 counts (159 vs 113 cells/mm(3)) and World Health Organization stage I/II (76.1% vs 58.5%). Adjusted hazard models showed that compared to public clinic patients, private clinic patients were less likely to die (adjusted hazard ratio [aHR] 0.50; 95% confidence interval [CI] 0.35-0.70) but were at increased risk of loss to follow-up (aHR 1.80; 95% CI 1.59-2.03). By 12 months post-ART initiation, private clinic patients were less likely to have a detectable viral load (adjusted relative risk 0.65; 95% CI 0.49-0.88) and recorded higher median CD4 change from baseline (184 cells/mm(3) interquartile range 101-300 vs 158 cells/mm(3) interquartile range 91-244), when compared to public clinic patients. We identified differences in treatment outcomes between the two HIV clinics. Findings suggest that the type of clinic at which ART patients initiate and receive treatment can have an impact on treatment outcomes. Further research is necessary to provide more conclusive results.

Clinical Outcome after Intra-Arterial Stroke Therapy in the Very Elderly: Why is it so Heterogeneous?

PubMed Central

Chandra, Ronil V.; Leslie-Mazwi, Thabele M.; Mehta, Brijesh P.; Yoo, Albert J.; Simonsen, Claus Z.

2014-01-01

Very elderly patients (i.e., ≥80 years) are disproportionally affected by acute ischemic stroke. They account for a third of hospital stroke admissions, but two-thirds of overall stroke-related morbidity and mortality. There is some evidence of clinical benefit in treating selected very elderly patients with intravenous thrombolysis (IVT). For very elderly patients ineligible or non-responsive to IVT, intra-arterial therapy (IAT) may have promise in improving clinical outcome. However, its unequivocal efficacy in the general population remains to be proven in randomized trials. Small cohort studies reveal that the rate of good clinical outcome for very elderly patients after IAT is highly variable, ranging from 0 to 28%. In addition, they experience higher rates of futile reperfusion than younger patients. Thus, it is imperative to understand the factors that impact on clinical outcome in very elderly patients after IAT. The aim of this review is to examine the factors that may be responsible for the heterogeneous clinical response of the very elderly to IAT. This will allow the reader to integrate the current available evidence to individualize intra-arterial stroke therapy in very elderly patients. Placing emphasis on pre-stroke independent living, smaller infarct core size, short procedure times, and avoiding general anesthesia where feasible, will help improve rates of good clinical outcome. PMID:24808887

Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

PubMed

D'Cruz, O'Neill

2015-12-01

Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

Meningitis With a Negative Cerebrospinal Fluid Gram Stain in Adults: Risk Classification for an Adverse Clinical Outcome

PubMed Central

Khoury, Nabil T.; Hossain, Md Monir; Wootton, Susan H.; Salazar, Lucrecia; Hasbun, Rodrigo

2012-01-01

Objective To derive and validate a risk score for an adverse clinical outcome in adults with meningitis and a negative cerebrospinal fluid (CSF) Gram stain. Patients and Methods We conducted a retrospective study of 567 adults from Houston, Texas, with meningitis evaluated between January 1, 2005, and January 1, 2010. The patients were divided into derivation (N=292) and validation (N=275) cohorts. An adverse clinical outcome was defined as a Glasgow Outcome Scale score of 4 or less. Results Of the 567 patients, 62 (11%) had an adverse clinical outcome. A predictive model was created using 3 baseline variables that were independently associated with an adverse clinical outcome (P<.05): age greater than 60 years, abnormal findings on neurologic examination (altered mental status, focal neurologic deficits, or seizures), and CSF glucose level of less than 2.4975 mmol/L (to convert CSF glucose to mmol/L, multiply by 0.05551). The model classified patients into 2 categories of risk for an adverse clinical outcome—derivation sample: low risk, 0.6% and high risk, 32.8%; P<.001; and validation sample: low risk, 0.5% and high risk, 21.1%; P<.001. Conclusion Adults with meningitis and a negative CSF Gram stain can be accurately stratified for the risk of an adverse clinical outcome using clinical variables available at presentation. PMID:23218086

A comparison between the clinical significance and growth mixture modelling early change methods at predicting negative outcomes.

PubMed

Flood, Nicola; Page, Andrew; Hooke, Geoff

2018-05-03

Routine outcome monitoring benefits treatment by identifying potential no change and deterioration. The present study compared two methods of identifying early change and their ability to predict negative outcomes on self-report symptom and wellbeing measures. 1467 voluntary day patients participated in a 10-day group Cognitive Behaviour Therapy (CBT) program and completed the symptom and wellbeing measures daily. Early change, as defined by (a) the clinical significance method and (b) longitudinal modelling, was compared on each measure. Early change, as defined by the simpler clinical significance method, was superior at predicting negative outcomes than longitudinal modelling. The longitudinal modelling method failed to detect a group of deteriorated patients, and agreement between the early change methods and the final unchanged outcome was higher for the clinical significance method. Therapists could use the clinical significance early change method during treatment to alert them of patients at risk for negative outcomes, which in turn could allow therapists to prevent those negative outcomes from occurring.

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

PubMed

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

2004-05-01

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

Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study

PubMed Central

Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira

2017-01-01

Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive value that should be considered in surgical decision-making. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. PMID:28060231

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

PubMed

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

2015-09-01

An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to describe the treatment's intended benefit as an effect on a clearly identified aspect of how a patient feels or functions. This aspect must have importance to the patient and be part of the patient's typical life. This meaningful health aspect can be measured directly or measured indirectly when it is impractical to evaluate it directly or when it is difficult to measure. For indirect measurement, a concept of interest (COI) can be identified. The COI must be related to how a patient feels or functions. Procedures are then developed to measure the COI. The relationship of these measurements with how a patient feels or functions in the intended setting and manner of use of the COA (the context of use) could then be defined. A COA has identifiable attributes or characteristics that affect the measurement properties of the COA when used in endpoints. One of these features is whether judgment can influence the measurement, and if so, whose judgment. This attribute defines four categories of COAs: patient reported outcomes, clinician reported outcomes, observer reported outcomes, and performance outcomes. A full description as well as explanation of other important COA features is included in this report. The information in this report should aid in the development, refinement, and standardization of COAs, and, ultimately, improve their measurement properties. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Manifesto: towards a clinically-oriented psychometrics.

PubMed

Vickers, Andrew J; Chen, Ling Y

2017-04-26

New technologies to collect patient - reported outcomes have substantially solved the challenge of integrating a questionnaire in a busy clinical practice. At Memorial Sloan Kettering, we have been collecting patient reported outcomes electronically for many years. Our experience confirms the predicted benefits of obtaining patient reported outcomes but has also raised serious concerns about whether instruments developed for the research setting are appropriate for routine clinical use. We summarize four principles for a clinically - relevant psychometrics. First, minimize patient burden: the use of a large number of items for a single domain may be of interest for research but additional items have little clinical utility. Secondly, use simplified language: patients who do not have good language skills are typically excluded from research studies but will nonetheless present in clinical practice. Third, avoid dumb questions: many questionnaire items are inappropriate when applied to a more general population. Fourth, what works for the group may not work for the individual: group level statistics used to validate survey instruments can obscure problems when applied to a subgroup of patients. There is a need for a clinically-oriented psychometrics to help design, test, and evaluate questionnaires that would be used in routine practice. Developing statistical methods to optimize questionnaires will be highly challenging but needed to bring the potential of patient reported outcomes into widespread clinical use.

Mother-infant home care drives quality in a managed care environment.

PubMed

Malnory, M

1997-04-01

Advocates of inpatient managed care employing clinical pathways are confident that this patient management strategy reduces cost while promoting equivalent patient outcomes. Other health care professionals are concerned that cost reductions place patients at higher risk for adverse health events. Research is needed to demonstrate the true impact of cost-containment strategies on clinical outcomes. The article describes a study in progress comparing patients conventionally managed by their physicians with similar patients whose overall management involved a nurse case manager. This study explores the issue of resource costs that can be linked to clinical and financial outcome measures.

Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial.

PubMed

Almario, Christopher V; Chey, William D; Khanna, Dinesh; Mosadeghi, Sasan; Ahmed, Shahzad; Afghani, Elham; Whitman, Cynthia; Fuller, Garth; Reid, Mark; Bolus, Roger; Dennis, Buddy; Encarnacion, Rey; Martinez, Bibiana; Soares, Jennifer; Modi, Rushaba; Agarwal, Nikhil; Lee, Aaron; Kubomoto, Scott; Sharma, Gobind; Bolus, Sally; Spiegel, Brennan M R

2016-11-01

The National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS) to allow efficient, online measurement of patient-reported outcomes (PROs), but it remains untested whether PROMIS improves outcomes. Here, we aimed to compare the impact of gastrointestinal (GI) PROMIS measures vs. usual care on patient outcomes. We performed a pragmatic clinical trial with an off-on study design alternating weekly between intervention (GI PROMIS) and control arms at one Veterans Affairs and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal 1 week before their visit; PROs were available for review by patients and their providers before and during the clinic visit. Usual care patients were managed according to customary practices. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems questionnaire. Secondary outcomes included provider interpersonal skills (Doctors' Interpersonal Skills Questionnaire (DISQ)) and shared decision-making (9-item Shared Decision Making Questionnaire (SDM-Q-9)). There were 217 and 154 patients in the GI PROMIS and control arms, respectively. Patient satisfaction was similar between groups (P>0.05). Intervention patients had similar assessments of their providers' interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, P=0.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, P=0.85) vs. This is the first controlled trial examining the impact of NIH PROMIS in clinical practice. One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making. Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption.

Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.

PubMed

van Vollenhoven, Ronald F; Bolce, Rebecca; Hambardzumyan, Karen; Saevarsdottir, Saedis; Forslind, Kristina; Petersson, Ingemar F; Sasso, Eric H; Hwang, C C; Segurado, Oscar G; Geborek, Pierre

2015-11-01

Rheumatoid arthritis (RA) clinical trials often exclude patients who have low C-reactive protein (CRP) levels, which slows enrollment into the trial. The purpose of this study was to determine whether high Multi-Biomarker Disease Activity (MBDA) scores (>44) in RA patients with low CRP levels (≤10 mg/liter) could be used as a complement to CRP levels >10 mg/liter to enhance patient recruitment without affecting clinical trial outcomes. We evaluated patients from the Swedish Pharmacotherapy (SWEFOT) trial, which did not include any selection criteria for CRP levels. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy in MTX-naive RA patients (n = 220) and after 3-10 months of add-on therapy in patients who were incomplete responders to MTX alone (MTX-IR) (n = 127). Radiographic outcomes were assessed at 1 year in all patients. Within each cohort, the outcomes were compared between patients with a CRP level of ≤10 mg/liter and an MBDA score of >44 at the start of the respective treatment interval versus those with a CRP level of >10 mg/liter. Patients with both a CRP level of ≤10 mg/liter and an MBDA score of >44 at baseline had clinical and radiographic outcomes that were comparable to those in patients with a CRP level of >10 mg/liter at baseline. This broadened definition of the inclusion criteria identified an additional 24% of patients in the MTX-naive cohort and 47% in the MTX-IR cohort. Patient recruitment into RA clinical trials may be substantially enhanced, without any decrease in clinical and radiographic outcomes, by using as an inclusion criterion "a CRP level of >10 mg/liter and/or an MBDA score of >44." © 2015 The Authors. Arthritis & Rheumatology is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

The clinical outcomes of oldest old patients with tuberculosis treated by regimens containing rifampicin, isoniazid, and pyrazinamide.

PubMed

Lin, Huang-Shen; Cheng, Chun-Wen; Lin, Ming-Shyan; Chou, Yen-Li; Chang, Pey-Jium; Lin, Jing-Chi; Ye, Jung-Jr

2016-01-01

To investigate the clinical characteristics, adverse drug reactions, and outcomes of the oldest old patients (aged ≥80 years) with tuberculosis (TB) treated with rifampicin, isoniazid, and pyrazinamide (RIP)-containing regimens. A retrospective chart review study. A 1,200-bed tertiary teaching hospital in southwest Taiwan. We conducted a retrospective observational study between January 1, 2005 and December 31, 2011. Seven hundred adult patients (aged ≥18 years) with TB treated with RIP-containing anti-TB regimens were reviewed, including 161 oldest old patients. Clinical outcomes included clinical responsiveness and microbiological eradication. Adverse outcomes included drug-induced hepatitis, and other symptoms included gastrointestinal upset (eg, abdominal pain, vomiting, diarrhea, or dyspepsia), skin rash, joint pain, and hyperuricemia. Compared with the non-oldest old adult patients, the oldest old patients more frequently had hepatitis (P=0.014), gastrointestinal upset (P=0.029), and unfavorable outcomes (P<0.001). In a multivariate analysis, hepatitis during treatment (adjusted odds ratio: 3.482, 95% confidence interval: 1.537-7.885; P<0.003) and oldest old age (adjusted odds ratio: 5.161, 95% confidence interval: 2.294-11.613; P<0.010) were independent risk factors for unfavorable outcomes. In the oldest old patients with hepatitis, rifampicin use was more common in the favorable outcome group than in the unfavorable outcome group (100% vs 37.5%; P=0.001). The oldest old age and hepatitis during RIP treatment were associated with unfavorable outcomes. For the oldest old patients with TB having hepatitis during treatment, rifampicin rechallenge and use might benefit the treatment outcome.

US-guided percutaneous cholecystostomy: features predicting culture-positive bile and clinical outcome.

PubMed

Sosna, Jacob; Kruskal, Jonathan B; Copel, Laurian; Goldberg, S Nahum; Kane, Robert A

2004-03-01

To assess sonographic and clinical features that might be used to predict infected bile and/or patient outcome from ultrasonography (US)-guided percutaneous cholecystostomy. Between February 1997 and August 2002 at one institution, 112 patients underwent US-guided percutaneous cholecystostomy (59 men, 53 women; average age, 69.3 years). All US images were scored on a defined semiquantitative scale according to preset parameters: (a) gallbladder distention, (b) sludge and/or stones, (c) wall appearance, (d) pericholecystic fluid, and (e) common bile duct size and/or choledocholithiasis. Separate and total scores were generated. Retrospective evaluation of (a) the bacteriologic growth of aspirated bile and its color and (b) clinical indices (fever, white blood cell count, bilirubin level, liver function test results) was conducted by reviewing medical records. For each patient, the clinical manifestation was classified into four groups: (a) localized right upper quadrant symptoms, (b) generalized abdominal symptoms, (c) unexplained sepsis, or (d) sepsis with other known infection. Logistic regression models, exact Wilcoxon-Mann-Whitney test, and the Kruskal-Wallis test were used. Forty-seven (44%) of 107 patients had infected bile. A logistic regression model showed that wall appearance, distention, bile color, and pericholecystic fluid were not individually significant predictors for culture-positive bile, leaving sludge and/or stones (P =.003, odds ratio = 1.647), common bile duct status (P =.02, odds ratio = 2.214), and total score (P =.007, odds ratio = 1.267). No US covariates or clinical indices predicted clinical outcome. Clinical manifestation was predictive of clinical outcome (P =.001) and aspirating culture-positive bile (P =.008); specifically, 30 (86%) of 35 patients with right upper quadrant symptoms had their condition improve, compared with one (7%) of 15 asymptomatic patients with other known causes of infection. US variables can be used to predict culture-positive bile but not patient outcome. Clinical manifestation is important because patients with right upper quadrant symptoms have the best clinical outcome. Copyright RSNA, 2004

Delusional Infestation: Perspectives from Scottish Dermatologists and a 10-year Case Series from a Single Centre.

PubMed

Wong, Yee Ling; Affleck, Andrew; Stewart, Alexander M

2018-04-16

Perceptions of the clinical management of delusional infestation (DI) were compared with clinical outcomes in this 10-year case series from a single centre in Dundee, UK. An online questionnaire (survey-monkey, a TM brand of online survey available for free for basic use) was sent to Scottish Dermatologists to gauge their opinions and confidence in the management of DI. Also, a retrospective review of medical case notes of patients seen by dermatologists in one institution was undertaken and clinical outcomes were reported by patients' general practitioners (GP). The survey showed that 61% of responding dermatologists encountered 1-5 cases of DI per year. Twenty-four percent respondees were 'confident' in managing patients with DI, 54% were 'somewhat confident'. Forty-seven patients (62% female, 70% single) were seen over the 10 years; 43% brought a self-collected specimen to clinic, 68% of patients had a psychiatric comorbidity, 23% of patients had primary DI and 11/47 (23%) were seen by a psychiatrist. Clinical outcomes as rated by patients' GPs were reasonable or good in 2/3 patients. A poor outcome was seen in 12 patients and associated with chronic pain in 50% (p < 0.01) and psychiatric comorbidity in 100% (p < 0.01). We conclude that good outcomes can be achieved in some patients with DI without psychiatric input and without psychoactive treatment.

The clinical outcomes of oldest old patients with tuberculosis treated by regimens containing rifampicin, isoniazid, and pyrazinamide

PubMed Central

Lin, Huang-Shen; Cheng, Chun-Wen; Lin, Ming-Shyan; Chou, Yen-Li; Chang, Pey-Jium; Lin, Jing-Chi; Ye, Jung-Jr

2016-01-01

Objectives To investigate the clinical characteristics, adverse drug reactions, and outcomes of the oldest old patients (aged ≥80 years) with tuberculosis (TB) treated with rifampicin, isoniazid, and pyrazinamide (RIP)-containing regimens. Design A retrospective chart review study. Setting A 1,200-bed tertiary teaching hospital in southwest Taiwan. Participants We conducted a retrospective observational study between January 1, 2005 and December 31, 2011. Seven hundred adult patients (aged ≥18 years) with TB treated with RIP-containing anti-TB regimens were reviewed, including 161 oldest old patients. Outcome measures Clinical outcomes included clinical responsiveness and microbiological eradication. Adverse outcomes included drug-induced hepatitis, and other symptoms included gastrointestinal upset (eg, abdominal pain, vomiting, diarrhea, or dyspepsia), skin rash, joint pain, and hyperuricemia. Results Compared with the non-oldest old adult patients, the oldest old patients more frequently had hepatitis (P=0.014), gastrointestinal upset (P=0.029), and unfavorable outcomes (P<0.001). In a multivariate analysis, hepatitis during treatment (adjusted odds ratio: 3.482, 95% confidence interval: 1.537–7.885; P<0.003) and oldest old age (adjusted odds ratio: 5.161, 95% confidence interval: 2.294–11.613; P<0.010) were independent risk factors for unfavorable outcomes. In the oldest old patients with hepatitis, rifampicin use was more common in the favorable outcome group than in the unfavorable outcome group (100% vs 37.5%; P=0.001). Conclusion The oldest old age and hepatitis during RIP treatment were associated with unfavorable outcomes. For the oldest old patients with TB having hepatitis during treatment, rifampicin rechallenge and use might benefit the treatment outcome. PMID:27042029

Patient-Doctor Contact Interval and Clinical Outcomes in Continuous Ambulatory Peritoneal Dialysis Patients.

PubMed

Yi, Chunyan; Guo, Qunying; Lin, Jianxiong; Li, Jianying; Yu, Xueqing; Yang, Xiao

2017-01-01

The optimal patient-doctor contact (PDC) interval remains unknown in peritoneal dialysis (PD) patients. The aim was to investigate the association between PDC interval and clinical outcomes in continuous ambulatory PD (CAPD) patients. In this retrospective cohort study, CAPD patients who resided in Guangzhou city between January 2006 and December 2012 were included. According to receiver operating characteristic curve analysis, all patients were classified as high (PDC interval ≤2 months) and low (PDC interval >2 months) PDC frequency groups. Biochemical data, clinical events, and clinical outcomes during the follow-up period were compared. Of 433 CAPD patients, the mean age was 51.3 ± 15.7 years, 54.3% of patients were male, and 29.1% with diabetes. The median vintage of PD was 45.8 (26.3-69.1) months. Patients with high PDC frequency (n = 233) had better patient-survival rates (99.6, 87.7, and 76.5% vs. 92.7, 76.5, and 58.7% at 1, 3, and 5 years; p < 0.001), lower peritonitis rate (0.17 vs. 0.23 episodes per patient-year; p < 0.001), and hospitalization rate (0.49 vs. 0.67 episodes per patient-year; p < 0.001) than those in the low PDC frequency group (n = 200). After adjustment for confounders, PDC interval of no more than 2 months was independently associated with better patient survival (hazard ratio 0.60, 95% CI 0.42-0.86, p = 0.006). A PDC interval of 2 months or less was associated with better clinical outcomes in CAPD patients. This indicates that a shorter PDC interval should be encouraged for them to achieve better clinical outcomes. © 2017 S. Karger AG, Basel.

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

PubMed

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

2016-04-01

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

Acute Kidney Injury in Critically Ill Patients with Sepsis: Clinical Characteristics and Outcomes.

PubMed

Zhi, De-Yuan; Lin, Jin; Zhuang, Hai-Zhou; Dong, Lei; Ji, Xiao-Jun; Guo, Dong-Cheng; Yang, Xiao-Wei; Liu, Shuai; Yue, Zu; Yu, Shu-Jing; Duan, Mei-Li

2018-04-25

The objectives of this study were to examine the clinical profile of critically ill patients with septic acute kidney injury (AKI) and to investigate clinical characteristics associated with the outcome of patients. Data from 582 critically ill patients were collected and retrospectively reviewed. Patients were divided into two groups: without AKI development and with AKI development. Baseline characteristics, laboratory, and other clinical data were compared between these two groups, and correlations between the characteristics and AKI development were examined. Patients with AKI development were further divided into two groups according to the survival outcome, and variables associated with the outcome were determined. AKI was developed in 54.12% (n = 315) of patients, and these patients had blood pressure, SOFA score, APACHE II score, GCS, and various blood chemistry and hematology characteristics significantly different from the patients without AKI. Demographic characteristics (e.g. age and weight) were comparable between the two groups of patients. Among the 315 patients with AKI, 136 of them died during the study period. Multivariate logistic regression analysis revealed that the outcome of patients was associated with lung infection, coagulation system dysfunction, staphylococcus aureus infection, and use of various treatments (epinephrine, norepinephrine, and the use of mechanical ventilation) after AKI development. AKI occurred in approximately half of the critically ill patients admitted to ICU. The site and type of infections, as well as the use of vasopressor agents, were associated with the outcome.

Trauma-associated lung injury differs clinically and biologically from acute lung injury due to other clinical disorders*

PubMed Central

Calfee, Carolyn S.; Eisner, Mark D.; Ware, Lorraine B.; Thompson, B. Taylor; Parsons, Polly E.; Wheeler, Arthur P.; Korpak, Anna; Matthay, Michael A.

2009-01-01

Objective Patients with trauma-associated acute lung injury have better outcomes than patients with other clinical risks for lung injury, but the mechanisms behind these improved outcomes are unclear. We sought to compare the clinical and biological features of patients with trauma-associated lung injury with those of patients with other risks for lung injury and to determine whether the improved outcomes of trauma patients reflect their baseline health status or less severe lung injury, or both. Design, Setting, and Patients Analysis of clinical and biological data from 1,451 patients enrolled in two large randomized, controlled trials of ventilator management in acute lung injury. Measurements and Main Results Compared with patients with other clinical risks for lung injury, trauma patients were younger and generally less acutely and chronically ill. Even after adjusting for these baseline differences, trauma patients had significantly lower plasma levels of intercellular adhesion molecule-1, von Willebrand factor antigen, surfactant protein-D, and soluble tumor necrosis factor receptor-1, which are biomarkers of lung epithelial and endothelial injury previously found to be prognostic in acute lung injury. In contrast, markers of acute inflammation, except for interleukin-6, and disordered coagulation were similar in trauma and nontrauma patients. Trauma-associated lung injury patients had a significantly lower odds of death at 90 days, even after adjusting for baseline clinical factors including age, gender, ethnicity, comorbidities, and severity of illness (odds ratio, 0.44; 95% confidence interval, 0.24 – 0.82; p = .01). Conclusions Patients with trauma-associated lung injury are less acutely and chronically ill than other lung injury patients; however, these baseline clinical differences do not adequately explain their improved outcomes. Instead, the better outcomes of the trauma population may be explained, in part, by less severe lung epithelial and endothelial injury. PMID:17944012

Overcoming barriers to implementing patient-reported outcomes in an electronic health record: a case report.

PubMed

Harle, Christopher A; Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried Of; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W

2016-01-01

In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Improvement of long-term outcomes in pancreatic cancer and its associated factors within the gemcitabine era: a collaborative retrospective multicenter clinical review of 1,082 patients.

PubMed

Kuroda, Taira; Kumagi, Teru; Yokota, Tomoyuki; Seike, Hirotaka; Nishiyama, Mari; Imai, Yusuke; Inada, Nobu; Shibata, Naozumi; Imamine, Satoshi; Okada, Shin-ichi; Koizumi, Mitsuhito; Yamanishi, Hirofumi; Azemoto, Nobuaki; Miyaike, Jiro; Tanaka, Yoshinori; Tatsukawa, Haruka; Utsunomiya, Hiroki; Ohno, Yoshinori; Miyake, Teruki; Hirooka, Masashi; Furukawa, Shinya; Abe, Masanori; Ikeda, Yoshiou; Matsuura, Bunzo; Hiasa, Yoichi; Onji, Morikazu

2013-08-31

Although the outcomes of pancreatic cancer have been improved by gemcitabine, the changes in its characteristics and long-term outcomes within the gemcitabine era remain unclear. This study was conducted to identify clinical characteristics of pancreatic cancer patients within the gemcitabine era. A retrospective chart review was performed at 10 centers for 1,248 consecutive patients who were ever considered to have a diagnosis of pancreatic cancer between 2001 and 2010. Data collected included demographics, diagnosis date, clinical stage, treatment, and outcome 1,082 patients met the inclusion criteria and were analyzed further. The chi-square test, Student's t-test, and Mann-Whitney U-test were used for statistical analysis. Outcomes were analyzed using the Kaplan-Meier method and Cox proportional hazards regression. Differences in survival analyses were determined using the log-rank test. The distribution of clinical stages was: I, 2.2% II, 3.4% III, 13% IVa, 27% and IVb, 55%. Chemotherapy alone was administered to 42% of patients and 17% underwent resection. The 1-, 3-, and 5-year survival rates were 39%, 13%, and 6.9%, respectively. The median survival time was 257 days, but differed considerably among treatments and clinical stages. Demographics, distribution of clinical stage, and cause of death did not differ between groups A (2001-2005, n=406) and B (2006-2010, n=676). However, group B included more patients who underwent chemotherapy (P<0.0001) and fewer treated with best supportive care (P=0.0004), mirroring improvements in this group's long-term outcomes (P=0.0063). Finally, factors associated with long-term outcomes derived from multivariate analysis were clinical stage (P<0.0001), location of the tumor (P=0.0294) and treatments (surgery, chemotherapy) (<0.0001). Long-term outcomes in pancreatic cancer has improved even within the gemcitabine era, suggesting the importance of offering chemotherapy to patients previously only considered for best supportive care. Most patients are still diagnosed at an advanced stage, making clinical strategy development for diagnosing pancreatic cancer at earlier stages essential.

The Clinical Presentation, Survival Outcomes, and Management of Patients With Renal Cell Carcinoma and Cardiac Metastasis Without Inferior Vena Cava Involvement: Results From a Pooled Clinical Trial Database and Systematic Review of Reported Cases.

PubMed

Viteri Malone, Mariuxi A; Ares, Gustavo Ruiz; De Velasco, Guillermo; Brandão, Raphael; Lin, Xun; Norton, Craig; Simantov, Ronit; Moslehi, Javid; Krajewski, Katherine M; Choueiri, Toni K; McKay, Rana R

2018-04-01

Cardiac metastases from renal cell carcinoma (RCC) are uncommon and there are limited data regarding the presentation and outcomes of this population. The objective of this study was to evaluate the characteristics and outcomes of patients with RCC with cardiac metastasis without inferior vena cava (IVC) involvement. We conducted a pooled retrospective analysis of metastatic RCC patients treated in 4 clinical trials. Additionally, we conducted a systematic review of cases reported in the literature from 1973 to 2015. Patients with cardiac metastases from RCC without IVC involvement were included. Patient and disease characteristics were described. Additionally, treatments, response to therapy, and survival outcomes were summarized. Of 1765 metastatic RCC patients in the clinical trials database, 10 had cardiac metastases without IVC involvement. All patients received treatment with targeted therapy. There was 1 observed partial response (10%) and 6 patients showed stable disease (60%). The median progression-free survival was 6.9 months. The systematic review of reported clinical cases included 39 patients. In these patients, the most common cardiac site of involvement was the right ventricle (51%; n = 20). Patients were treated with medical (28%; n = 11) and/or surgical treatment (49%; n = 19) depending on whether disease was isolated (n = 13) or multifocal (n = 26). To our knowledge, this is the first series to report on the presentation and outcomes of patients with cardiac metastasis without IVC involvement in RCC. We highlight that although the frequency of patients with cardiac metastases without IVC involvement is low, these patients have a unique clinical presentation and warrant special multidisciplinary management. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical outcomes and frontal plane two-dimensional biomechanics during the 30-second single leg stance test in patients before and after hip abductor tendon reconstructive surgery.

PubMed

Huxtable, Rose E; Ackland, Timothy R; Janes, Gregory C; Ebert, Jay R

2017-07-01

Hip abductor tendon tears are a common cause of Greater Trochanteric Pain Syndrome. Conservative treatments are often ineffective and surgical reconstruction may be recommended. This study investigated the improvement in clinical outcomes and frontal plane two-dimensional biomechanics during a 30-second single leg stance test, in patients undergoing reconstruction. We hypothesized that clinical scores and pertinent biomechanical variables would significantly improve post-surgery, and these outcomes would be significantly correlated. Twenty-one patients with symptomatic tendon tears underwent reconstruction. Patients were evaluated pre-surgery, and at 6 and 12months post-surgery, using patient-reported outcome measures, assessment of hip abductor strength and six-minute walk capacity. Frontal plane, two-dimensional, biomechanical variables including pelvis-on-femur angle, pelvic drop, trunk lean and lateral pelvic shift, were evaluated throughout a 30-second single leg stance test. ANOVA evaluated outcomes over time, while Pearson's correlations investigated associations between clinical scores, pain, functional and biomechanical outcome variables. While clinical and functional measures significantly improved (P<0.05) over time, no significant group differences (P>0.05) were observed in biomechanical variables from pre- to post-surgery. While five patients displayed a positive Trendelenburg sign pre-surgery, only one was positive post-surgery. Clinical outcomes and biomechanical variables during the single leg stance test were not correlated. Despite improvements in clinical and functional measures over time, biomechanical changes during a weight bearing single leg stance test were not significantly different following tendon repair. Follow up beyond 12months may be required, whereby symptomatic relief may precede functional and biomechanical improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Long-term behavioral outcomes after attendance at a secondary prevention clinic for cardiac patients.

PubMed

Worcester, Marian Una Christine; Stojcevski, Zlatko; Murphy, Barbara; Goble, Alan James

2003-01-01

Secondary prevention interventions, including hospital clinics, can help patients improve their risk factors and lifestyles after an acute cardiac event. This study aimed to investigate the long-term behavioral outcomes of attending and nonattending patients consecutively enrolled in a trial of a family-based clinic providing screening, advice, and support 3 months after hospital admission. The study also aimed to identify predictors of long-term smoking status, dietary habit, and physical activity. Semistructured interviews were conducted an average of 30 months after the acute cardiac event with 83 of the 103 nonattending patients and a random sample of 96 patients who had attended the clinic. Behavioral outcomes were investigated, and self-reported risk factors at the time of the acute illness were documented. The patients who had attended the clinic were significantly more likely than nonattenders to report positive dietary changes and, among former smokers, successful cessation of smoking. Furthermore, they reported being more physically active than nonattenders. Using logistic regression, clinic attendance was identified as a significant and independent predictor of all three outcomes. The results of this observational study suggest that attendance at a secondary prevention clinic facilitates maintenance of improved long-term health behaviors, although this finding is based on self-report. Factors possibly responsible for favorable outcomes include strong physician advice and support from a multidisciplinary team of health professionals. Furthermore, the timing of the intervention may have been appropriate for enrollment in a secondary prevention clinic.

Twice versus thrice weekly ECT in a clinical population: an evaluation of patient outcomes.

PubMed

Siskind, Dan; Charlson, Fiona; Saraf, Sudeep; Scheurer, Roman; Lie, David Charles

2012-10-30

Increasing demand on electroconvulsive therapy (ECT) services led to a recommendation that low risk patients be considered for twice weekly ECT rather than the usual thrice weekly. We evaluated whether practice changed and compared patient clinical outcomes for twice and thrice weekly ECT. Medical records for all patients receiving ECT in the 2-year study period (1/9/08 to 30/8/10) were reviewed to determine ECT protocol, diagnosis, admission duration and readmission rates. During the study period, 119 patients received 150 treatment courses. Patient outcomes were compared for twice weekly ECT and thrice weekly ECT protocols, as well as for 1 year before and after the recommendation (1/9/09). Twice weekly ECT courses increased (8-20) after the recommendation while thrice weekly ECT courses decreased (64-30). The recommendation had no significant effect on patient outcomes. Comparing twice and thrice weekly ECT, patient clinical outcomes were similar between the two groups, though non-affective twice weekly patients waited longer before starting ECT. In the context of resource constraints, psychiatrists can be influenced to examine and change their ECT prescribing practice. This bodes well for the implementation of evidence-based treatment into mental health services. Secondly, for adults, there appear to be no significant differences in clinical outcomes for twice versus thrice weekly ECT. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The prognostic value of sleep patterns in disorders of consciousness in the sub-acute phase.

PubMed

Arnaldi, Dario; Terzaghi, Michele; Cremascoli, Riccardo; De Carli, Fabrizio; Maggioni, Giorgio; Pistarini, Caterina; Nobili, Flavio; Moglia, Arrigo; Manni, Raffaele

2016-02-01

This study aimed to evaluate, through polysomnographic analysis, the prognostic value of sleep patterns, compared to other prognostic factors, in patients with disorders of consciousness (DOCs) in the sub-acute phase. Twenty-seven patients underwent 24-h polysomnography and clinical evaluation 3.5 ± 2 months after brain injury. Their clinical outcome was assessed 18.5 ± 9.9 months later. Polysomnographic recordings were evaluated using visual and quantitative indexes. A general linear model was applied to identify features able to predict clinical outcome. Clinical status at follow-up was analysed as a function of the baseline clinical status, the interval between brain injury and follow-up evaluation, patient age and gender, the aetiology of the injury, the lesion site, and visual and quantitative sleep indexes. A better clinical outcome was predicted by a visual index indicating the presence of sleep integrity (p=0.0006), a better baseline clinical status (p=0.014), and younger age (p=0.031). Addition of the quantitative sleep index strengthened the prediction. More structured sleep emerged as a valuable predictor of a positive clinical outcome in sub-acute DOC patients, even stronger than established predictors (e.g. age and baseline clinical condition). Both visual and quantitative sleep evaluation could be helpful in predicting clinical outcome in sub-acute DOCs. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Individual and Composite Study Endpoints: Separating the Wheat from the Chaff

PubMed Central

Goldberg, Robert; Gore, Joel M.; Barton, Bruce; Gurwitz, Jerry

2014-01-01

We provide an overview of the individual and combined clinical endpoints and patient reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. PMID:24486289

Mucosal Healing Is Associated With Improved Long-term Outcomes of Patients With Ulcerative Colitis: A Systematic Review and Meta-analysis.

PubMed

Shah, Shailja C; Colombel, Jean-Frederic; Sands, Bruce E; Narula, Neeraj

2016-09-01

The paradigm for treatment for ulcerative colitis (UC) is shifting from resolving symptoms toward objective measures such as mucosal healing (MH). However, it is unclear whether MH is associated with improved long-term outcomes. We performed a systematic review and meta-analysis to identify and analyze studies comparing long-term outcomes of patients with MH with those without MH. We performed a systematic search of 3 large databases to identify prospective studies of patients with active UC that included outcomes of patients found to have MH at the first endoscopic evaluation after initiation of UC therapy (MH1) compared with those without MH1. The primary outcome was clinical remission after at least 52 weeks. Secondary outcomes included proportions of patients who were free of colectomy or corticosteroids and rate of MH after at least 52 weeks. We analyzed 13 studies comprising 2073 patients with active UC. Patients with MH1 had pooled odds ratio of 4.50 for achieving long-term (after at least 52 weeks) clinical remission (95% confidence interval [CI], 2.12-9.52), 4.15 for remaining free of colectomy (95% CI, 2.53-6.81), 8.40 for achieving long-term MH (95% CI, 3.13-22.53), and 9.70 for achieving long-term corticosteroid-free clinical remission (95% CI, 0.94-99.67), compared with patients without MH1. We found no difference in outcomes if patients achieved MH1 while receiving biologic versus non-biologic therapy. In a meta-analysis, we associated MH with long-term clinical remission, avoidance of colectomy, and corticosteroid-free clinical remission. MH is therefore appropriate goal of UC therapy. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-04-01

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

Clinical characteristics and outcomes of Möbius syndrome in a children's hospital.

PubMed

Matsui, Kiyoshi; Kataoka, Ai; Yamamoto, Atsuko; Tanoue, Koji; Kurosawa, Kenji; Shibasaki, Jun; Ohyama, Makiko; Aida, Noriko

2014-12-01

Möbius syndrome is a congenital disorder with facial and abducens palsy. Although a few case series studies have examined comorbid conditions in Möbius syndrome, follow-up and outcome data are sparse. To examine the clinical characteristics and outcomes of Möbius syndrome. Clinical data were reviewed for 10 patients. Neonatal history, neurological examination, comorbid anomalies, medical home care, outcomes, and neuroimaging were summarized. The patients' mean age was 7.3 ± 6.2 years. On neurological examination, absent blink reflex, jaw ankylosis, absent gag reflex, and tongue atrophy were frequently observed. Poland anomaly and clubfoot were present in three and six patients, respectively. Specific therapies required for patients included medical home care (six patients), suction apparatus (six), tube feeding (five), gastrostomy (two), tracheostomy (three), oxygen therapy (three), and home ventilator (two). Punctate calcification in the brainstem was observed in four patients. Pontine and medulla hypoplasia were detected on the basis of anteroposterior diameter in four and seven patients, respectively. Two patients had congenital hydrocephalus with aqueductal stenosis. Global developmental delay occurred in five patients. Three patients died. The rate of both the use of home medical devices and death was high in our patients. Möbius syndrome is extremely diverse, not only in clinical manifestation, but also outcome. Early multidisciplinary intervention is important to ensure an optimal outcome. Aqueductal stenosis is an occasional comorbid anomaly resulting from midbrain abnormality. Copyright © 2014 Elsevier Inc. All rights reserved.

Effectiveness of structured, hospital-based, nurse-led atrial fibrillation clinics: a comparison between a real-world population and a clinical trial population.

PubMed

Qvist, Ina; Hendriks, Jeroen M L; Møller, Dorthe S; Albertsen, Andi E; Mogensen, Helle M; Oddershede, Gitte D; Odgaard, Annette; Mortensen, Leif Spange; Johnsen, Søren Paaske; Frost, Lars

2016-01-01

A previous randomised trial showed that structured, nurse-led atrial fibrillation (AF) care is superior to conventional AF care, although further research is needed to determine the outcomes of such care in a real-world setting. We compared the outcomes of patients in real-world, nurse-led, structured hospital AF clinics with the outcomes of a randomised trial of the efficacy of a nurse-led AF clinic, with respect to a composite outcome of cardiovascular-related hospitalisation and death. All patients were referred to the AF nurse specialist by cardiologists. The AF nurse specialist provided patient education, risk-factor control and stimulated empowerment and compliance. During follow-up, treatment was adjusted according to clinical guidelines. Patient education was repeated, and compliance with medical treatment was controlled. The study size was powered as a non-inferiority study. Outcome measures were adjudicated by the same principles in both cohorts. A total of 596 patients from the real world and 356 patients from a clinical trial were included in this study. No significant difference between groups with respect to age, type of AF or CHA2DS2VASc score was found. The composite primary end point occurred with an incidence rate of 8.0 (95% CI 6.1 to 10.4) per 100 person-years in the real-world population and 8.3 (95% CI 6.3 to 10.9) per 100 person-years in the clinical trial, with a crude HR of 0.83 (95% CI 0.56 to 1.23). Structured, nurse-led, hospital-based AF care appears to be effective, and patient outcomes in an actual, hospital-based, structured AF care are as least as good as those in trial settings.

The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

PubMed

Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

2016-01-01

The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

Clinical, operational and economic outcomes of point-of-care blood gas analysis in COPD patients.

PubMed

Oliver, Paloma; Buno, Antonio; Alvarez-Sala, Rodolfo; Fernandez-Calle, Pilar; Alcaide, Maria Jose; Casitas, Raquel; Garcia-Quero, Cristina; Madero, Rosario; Gomez-Rioja, Ruben; Iturzaeta, Jose Manuel

2015-04-01

Arterial blood gas analysis is relevant in chronic obstructive pulmonary disease (COPD) management. The aim of this study was to evaluate whether the use of a blood gas analyzer in pulmonology departments improves the clinical, operational and economic outcomes when compared with clinical laboratory measurements. It is an observational prospective study. 112 patients were selected. After specimen collection, the measurement was performed both in pulmonology office as point-of-care and in laboratory. We evaluated clinical outcomes (modification of the indication of long-term oxygen therapy (LTOT) according to results, changes in blood gas analysis results, relationship of the partial pressure of oxygen (PaO2) obtained in the medical visit and velocity of change of the PaO2, influence of total haemoglobin concentration and the change in PaO2), operational outcomes (turnaround time (TAT) from specimen collection to receiving the blood gas analysis report) and economic outcomes (overall cost per process of patient care). There were discrepancies in the indication of LTOT in 13.4% of patients. All parameters showed changes. PaO2 levels showed changes in 2 ways, though they frequently increase over time. The correlation was not good in the other two clinical outcomes. The median TATs in pulmonology office were 1 min versus 79 in laboratory, with 52 min for specimen preparation and transport and 17 min for TAT intralaboratory. The overall cost for the 112 patients in pulmonology office and laboratory was 16,769.89€ and 22,260.97€ respectively. The use of a blood gas analyzer in a pulmonology office improves clinical, operational and economic outcomes when compared with clinical laboratory. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

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.

PubMed

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.

Predicting Recovery Potential for Individual Stroke Patients Increases Rehabilitation Efficiency.

PubMed

Stinear, Cathy M; Byblow, Winston D; Ackerley, Suzanne J; Barber, P Alan; Smith, Marie-Claire

2017-04-01

Several clinical measures and biomarkers are associated with motor recovery after stroke, but none are used to guide rehabilitation for individual patients. The objective of this study was to evaluate the implementation of upper limb predictions in stroke rehabilitation, by combining clinical measures and biomarkers using the Predict Recovery Potential (PREP) algorithm. Predictions were provided for patients in the implementation group (n=110) and withheld from the comparison group (n=82). Predictions guided rehabilitation therapy focus for patients in the implementation group. The effects of predictive information on clinical practice (length of stay, therapist confidence, therapy content, and dose) were evaluated. Clinical outcomes (upper limb function, impairment and use, independence, and quality of life) were measured 3 and 6 months poststroke. The primary clinical practice outcome was inpatient length of stay. The primary clinical outcome was Action Research Arm Test score 3 months poststroke. Length of stay was 1 week shorter for the implementation group (11 days; 95% confidence interval, 9-13 days) than the comparison group (17 days; 95% confidence interval, 14-21 days; P =0.001), controlling for upper limb impairment, age, sex, and comorbidities. Therapists were more confident ( P =0.004) and modified therapy content according to predictions for the implementation group ( P <0.05). The algorithm correctly predicted the primary clinical outcome for 80% of patients in both groups. There were no adverse effects of algorithm implementation on patient outcomes at 3 or 6 months poststroke. PREP algorithm predictions modify therapy content and increase rehabilitation efficiency after stroke without compromising clinical outcome. URL: http://anzctr.org.au. Unique identifier: ACTRN12611000755932. © 2017 American Heart Association, Inc.

Outcomes among chronically ill adults in a medical home prototype.

PubMed

Liss, David T; Fishman, Paul A; Rutter, Carolyn M; Grembowski, David; Ross, Tyler R; Johnson, Eric A; Reid, Robert J

2013-10-01

To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Nonequivalent pretest-posttest control group design. PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care-sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses.

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

PubMed

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), P<0.01. Implementation of a physiotherapy-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 to achieve this with solely orthopaedic surgeon reviews, an issue that is only going to worsen with the increased demand for surgery. Physiotherapists have become involved in many advanced scope roles within public health care, and emerging research suggests that patients are highly satisfied with their care in these types of clinics. WHAT DOES THIS PAPER ADD?: Although it has been shown that patients are satisfied in physiotherapy-led advanced clinics, there is a paucity of evidence in the outcomes of patients attending these clinics. Implementation of a physiotherapy-led arthroplasty review clinic demonstrated that outcome measures in this patient cohort were not compromised and, following knee joint arthroplasty, may even be improved. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS?: The findings of this study indicate that joint review clinics involving physiotherapists acting in an advanced scope role are unlikely to compromise patient outcomes. The use of this role substitution on a broader scale can be recommended.

National data elements for the clinical management of acute coronary syndromes.

PubMed

Chew, Derek P B; Allan, Roger M; Aroney, Constantine N; Sheerin, Noella J

2005-05-02

Patients with acute coronary syndromes represent a clinically diverse group and their care remains heterogeneous. These patients account for a significant burden of morbidity and mortality in Australia. Optimal patient outcomes depend on rapid diagnosis, accurate risk stratification and the effective implementation of proven therapies, as advocated by clinical guidelines. The challenge is in effectively applying evidence in clinical practice. Objectivity and standardised quantification of clinical practice are essential in understanding the evidence-practice gap. Observational registries are key to understanding the link between evidence-based medicine, clinical practice and patient outcome. Data elements for monitoring clinical management of patients with acute coronary syndromes have been adapted from internationally accepted definitions and incorporated into the National Health Data Dictionary, the national standard for health data definitions in Australia. Widespread use of these data elements will assist in the local development of "quality-of-care" initiatives and performance indicators, facilitate collaboration in cardiovascular outcomes research, and aid in the development of electronic data collection methods.

Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review.

PubMed

Kim, Stephen; Losina, Elena; Solomon, Daniel H; Wright, John; Katz, Jeffrey N

2003-01-01

Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities. Copyright 2003, Elsevier Science (USA). All rights reserved.

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

PubMed

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 trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

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

PubMed

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

2017-02-01

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

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

PubMed

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.

A pharmacogenetics study to predict outcome in patients receiving anti-VEGF therapy in age related macular degeneration

PubMed Central

Kitchens, John W; Kassem, Nawal; Wood, William; Stone, Thomas W; Isernhagen, Rick; Wood, Edward; Hancock, Brad A; Radovich, Milan; Waymire, Josh; Li, Lang; Schneider, Bryan P

2013-01-01

Purpose To ascertain whether single nucleotide polymorphisms (SNPs) in the Vascular Endothelial Growth factor (VEGFA), Complement Factor H (CFH), and LOC387715 genes could predict outcome to anti-VEGF therapy for patients with age related macular degeneration (AMD). Methods Patients with “wet” AMD were identified by chart review. Baseline optical coherence tomography (OCT) and visual acuity (VA) data, and at least 6 months of clinical follow up after 3 initial monthly injections of bevacizumab or ranibizumab were required for inclusion. Based on OCT and VA, patients were categorized into two possible clinical outcomes: (a) responders and (b) non-responders. DNA was extracted from saliva and genotyped for candidate SNPs in the VEGFA, LOC387715, and CFH genes. Clinical outcomes were statistically compared to patient genotypes. Results 101 patients were recruited, and one eye from each patient was included in the analysis. 97% of samples were successfully genotyped for all SNPs. We found a statistically significant association between the LOC387715 A69S TT genotype and outcome based on OCT. Conclusion Genetic variation may be associated with outcome in patients receiving anti-VEGF therapy. PMID:24143065

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

PubMed

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.

Volume of hospital is important for the prognosis of high-risk patients with nonvariceal upper gastrointestinal bleeding (NVUGIB).

PubMed

Choi, Jin Woo; Jeon, Seong Woo; Kwon, Jung Gu; Lee, Dong Wook; Ha, Chang Yoon; Cho, Kwang Bum; Jang, Byung Ik; Park, Jung Bae; Park, Youn Sun

2017-08-01

Nonvariceal upper gastrointestinal bleeding (NVUGIB) is a potentially life-threatening hospital emergency requiring hemodynamic stabilization and resuscitation. This study is carried out to determine whether hospital volume can influence outcome in patients with NVUGIB. This is a retrospective study with a prospective cohort database (KCT 0000514. cris.nih.go.kr). Eight teaching hospitals were divided into two different groups: high-volume centers (HVC, ≥60 NVUGIB patients/year, four clinics) and low-volume centers (LVC, <60 NVUGIB patients/year, four clinics). Baseline characteristics of patients, risk stratification, and outcomes between hospitals of different volumes were compared. From February 2011 to December 2013, a total of 1584 NVUGIB patients enrolled in eight clinics were retrospectively reviewed. The main outcome measurements consisted of continuous bleeding after treatment, re-bleeding, necessity for surgical/other retreatments, and death within 30 days. Similar baseline characters for patients were observed in both groups. There was a significant difference in the incidence of poor outcome between the HVC and LVC groups (9.06 vs. 13.69%, P = 0.014). The incidence rate of poor outcome in high-risk patients (Rockall score ≥8) in HVC was lower than that in high-risk patients in LVC (16.07 vs. 26.92%, P = 0.048); however, there was no significant difference in poor outcome in the lower-risk patients in either group (8.72 vs. 10.42%, P = 0.370). Significant correlation between hospital volume and outcome in NVUGIB patients was observed. Referral to HVC for the management of high-risk NVUGIB patients should be considered in clinical practice.

[Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

PubMed

Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

2010-12-01

Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

Preference, Expectation, and Satisfaction in a Clinical Trial of Behavioral Interventions for Acute and Sub-Acute Low Back Pain (NCT00373867)

PubMed Central

George, Steven Z.; Robinson, Michael E.

2010-01-01

The equivalency of behavioral interventions has led to the consideration of whether patient related factors influence clinical trial outcomes. The primary purpose of this secondary analysis was to determine if treatment preference and patient expectation were predictors of trial outcomes and if selected patient satisfaction items were appropriate as outcome measures. Perceived effectiveness, treatment preference and patient expectation were assessed before random assignment, and patient satisfaction was assessed 6-months later. Patient preference was associated with perceived effectiveness for those with no treatment preference and those preferring graded exposure. Higher patient expectation was associated with higher perceived effectiveness ratings for all treatments in the clinical trial. Patients with no strong treatment preferences had larger 6-month improvements in pain intensity and disability, while patients with higher expectations had lower disability at baseline, 4-weeks, and 6-months. Patient satisfaction rates did not differ based on treatment received. Patient satisfaction was highest with treatment delivery, and much lower with treatment effect. Patient satisfaction was uniformly associated with expectations being met, but only satisfaction with treatment effect was associated with lower pain and disability scores. These data support assessment of treatment preference and patient expectation as predictors and patient satisfaction as an outcome measure in LBP clinical trials. PMID:20466596

Magnetic Resonance Imaging Assessment of Squamous Cell Carcinoma of the Anal Canal Before and After Chemoradiation: Can MRI Predict for Eventual Clinical Outcome?

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

Goh, Vicky, E-mail: vicky.goh@stricklandscanner.org.u; Gollub, Frank K.; Liaw, Jonathan

2010-11-01

Purpose: To describe the MRI appearances of squamous cell carcinoma of the anal canal before and after chemoradiation and to assess whether MRI features predict for clinical outcome. Methods and Materials: Thirty-five patients (15 male, 20 female; mean age 60.8 years) with histologically proven squamous cell cancer of the anal canal underwent MRI before and 6-8 weeks after definitive chemoradiation. Images were reviewed retrospectively by two radiologists in consensus blinded to clinical outcome: tumor size, signal intensity, extent, and TNM stage were recorded. Following treatment, patients were defined as responders by T and N downstaging and Response Evaluation Criteria inmore » Solid Tumors (RECIST). Final clinical outcome was determined by imaging and case note review: patients were divided into (1) disease-free and (2) with relapse and compared using appropriate univariate methods to identify imaging predictors; statistical significance was at 5%. Results: The majority of tumors were {<=}T2 (23/35; 65.7%) and N0 (21/35; 60%), mean size 3.75cm, and hyperintense (++ to +++, 24/35 patients; 68%). Following chemoradiation, there was a size reduction in all cases (mean 73.3%) and a reduction in signal intensity in 26/35 patients (74.2%). The majority of patients were classified as responders (26/35 (74.2%) patients by T and N downstaging; and 30/35 (85.7%) patients by RECIST). At a median follow-up of 33.5 months, 25 patients (71.4%) remained disease-free; 10 patients (28.6%) had locoregional or metastatic disease. Univariate analysis showed that no individual MRI features were predictive of eventual outcome. Conclusion: Early assessment of response by MRI at 6-8 weeks is unhelpful in predicting future clinical outcome.« less

Cost justification of clinical pharmacy services on a general surgery team: focus on diagnosis-related group cases.

PubMed

Bertch, K E; Hatoum, H T; Willett, M S; Witte, K W

1988-11-01

We used a novel approach to cost-justify clinical pharmacy services on a general surgery team in nine diagnosis-related group cases. The clinical pharmacist monitored nine patients longitudinally on a general surgery team from admission to discharge and intervened in their therapeutic management. Each recommendation was analyzed for rationale, acceptance, perceived impact on quality and/or cost of patient care, whether self-initiated or solicited, and impact on patient outcome. Types of recommendations and outcomes were categorized by process and outcome measurement criteria. Total cost avoidance per patient was calculated using costs of drug therapy, laboratory tests, and length of stay. Accounting for cost of clinical pharmacy services, net cost avoidance per patient was calculated. The clinical pharmacist made 101 recommendations on nine patients. Physicians accepted 82 percent of the recommendations; 77 percent of the recommendations were self-initiated and 23 percent were solicited. Recommendations had a perceived impact on cost, quality, or both at 13, 31, and 56 percent, respectively. Most recommendations (79 percent) brought patient therapy to a level of conformance with current standards of practice as documented in the medical literature. Recommendations that potentially preserved a major organ function by preventing drug-induced toxicity or the exacerbation of existing problems constituted 16 percent of the total. None of the accepted recommendations adversely affected patient outcome and 23 percent directly resulted in a measurable positive outcome in patient care. A total of four hospital days was potentially saved for two cases. Based on objective outcome criteria, a 1.9-day increase in therapeutic control was documented per patient.(ABSTRACT TRUNCATED AT 250 WORDS)

The Effect of Message Content and Clinical Outcome on Patients' Perception of Physician Compassion: A Randomized Controlled Trial.

PubMed

Tanco, Kimberson; Azhar, Ahsan; Rhondali, Wadih; Rodriguez-Nunez, Alfredo; Liu, Diane; Wu, Jimin; Baile, Walter; Bruera, Eduardo

2018-03-01

In a previous randomized crossover study, patients perceived a physician delivering a more optimistic message (MO) as more compassionate and professional. However, the impact of the clinical outcome of the patient on patient's perception of physician's level of compassion and professionalism has not been previously studied. Our aim was to determine if the reported clinical outcome modified the patient's perception of physician compassion, professionalism, impression, and preference for physician. One hundred twenty-eight advanced cancer patients in an outpatient Supportive Care Center were randomized to complete validated questionnaires about patients' perception of physician's level of compassion, professionalism, impression, and preference of physician for themselves and their family after watching scripted videos depicting a physician delivering an MO versus a less optimistic (LO) message followed by a clinical vignette depicting a worse outcome. Median age was 61 years and 55% were female. There was no difference in compassion score after the vignette in the MO and LO groups. However, there were significantly worse overall impression and professionalism scores in both the MO and LO groups after the vignette. In the MO group, preference for the physician for themselves and their family significantly decreased after the vignette. Seeing a worse clinical outcome did not change the patients' appraisal of an inappropriately optimistic physician. However, it reduced the overall impression of both physicians that conveyed an MO or an LO message and it also resulted in less likelihood of choosing the MO physician for themselves and their family. The study found that a patient's perception of a physician's compassion did not change after reading a vignette describing a negative clinical outcome, regardless of whether the physician had given a more or a less optimistic message to the patient. However, the results suggested that patients perceived worse professionalism and overall physician impression scores for both more and less optimistic physicians and lower likelihood to choose the more optimistic physician for themselves and their family. © AlphaMed Press 2017.

Benchmarking the perioperative process: II. Introducing anesthesia clinical pathways to improve processes and outcomes and to reduce nursing labor intensity in ambulatory orthopedic surgery.

PubMed

Williams, B A; DeRiso, B M; Engel, L B; Figallo, C M; Anders, J W; Sproul, K A; Ilkin, H; Harner, C D; Fu, F H; Nagarajan, N J; Evans, J H; Watkins, W D

1998-11-01

(1) To introduce anesthesia clinical pathways as a management tool to improve the quality of care; (2) to use the Procedural Times Glossary published by the Association of Anesthesia Clinical Directors (AACD) as a template for data collection and analysis; and (3) to determine the effects of anesthesia clinical pathways on surgical processes, outcomes, and costs in common ambulatory orthopedic surgery. Hospital database and patient chart review of consecutive patients undergoing anterior cruciate ligament reconstruction (ACLR) during academic years (AY) 1995-1996 and 1996-1997. Patient data from AY 1995-1996, during which no intraoperative anesthesia clinical pathways existed, served as historical controls. Data from AY 1996-1997, during which intraoperative anesthesia clinical pathways were used, served as the treatment group. Regional anesthesia options were routinely offered to patients in the clinical pathway. Ambulatory surgery center in a teaching hospital. The records of 503 ASA physical status I and II patients were reviewed. 1996-1997 patients underwent clinical pathway anesthesia care in which the intraoperative and postoperative anesthesia process was standardized with respect to symptom management, drugs, and equipment used. 1995-1996 patients did not have a standardized intraoperative and postoperative anesthetic course with respect to the management of common symptoms or to specific drugs and supplies used. Intervals described in the AACD Procedural Times Glossary, anesthesia drug and supply costs, and patient outcome variables (postoperative nursing interventions required and unexpected admissions), as influenced by the use of the anesthesia clinical pathway, were measured. Clinical pathway anesthesia care of ACLR in 1996-1997, which actively incorporated regional anesthesia options, reduced pharmacy and materials cost variability; slightly increased turnover time; improved intraoperative anesthesia and surgical efficiency, recovery times, and unexpected admission rates; and decreased the number of required nursing interventions for common postoperative symptoms. Clinical pathway patient management systems in anesthesia care are likely to produce useful outcome data of current practice patterns when compared with historical controls. This management tool may be useful in simultaneously containing costs and improving process efficiency and patient outcomes.

WE-G-9A-01: Radiation Oncology Outcomes Informatics

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

Mayo, C; Miller, R; Sloan, J

2014-06-15

The construction of databases and support software to enable routine and systematic aggregation, analysis and reporting of patient outcomes data is emerging as an important area. “How have results for our patients been affected by the improvements we have made in our practice and in the technologies we use?” To answer this type of fundamental question about the overall pattern of efficacy observed, it is necessary to systematically gather and analyze data on all patients treated within a clinic. Clinical trials answer, in great depth and detail, questions about outcomes for the subsets of patients enrolled in a given trial.more » However, routine aggregation and analysis of key treatment parameter data and outcomes information for all patients is necessary to recognize emergent patterns that would be of interest from a public health or practice perspective and could better inform design of clinical trials or the evolution of best practice principals. To address these questions, Radiation Oncology outcomes databases need to be constructed to enable combination essential data from a broad group of data types including: diagnosis and staging, dose volume histogram metrics, patient reported outcomes, toxicity metrics, performance status, treatment plan parameters, demographics, DICOM data and demographics. Developing viable solutions to automate aggregation and analysis of this data requires multidisciplinary efforts to define nomenclatures, modify clinical processes and develop software and database tools requires detailed understanding of both clinical and technical issues. This session will cover the developing area of Radiation Oncology Outcomes Informatics. Learning Objectives: Audience will be able to speak to the technical requirements (software, database, web services) which must be considered in designing an outcomes database. Audience will be able to understand the content and the role of patient reported outcomes as compared to traditional toxicity measures. Audience will be understand approaches, clinical process changes, consensus building efforts and standardizations which must be addressed to succeed in a multi-disciplinary effort to aggregate data for all patients. Audience will be able to discuss technical and process issues related to pooling data among institutions in the context of collaborative studies among the presenting institutions.« less

Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

PubMed

Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

2017-08-01

Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

Arterial phase CT for the detection of splenic injuries in blunt trauma: would it improve clinical outcomes?

PubMed

Corwin, Michael T; Fananapazir, Ghaneh; Lamba, Ramit; Salcedo, Edgardo S; Holmes, James F

2016-01-01

To determine if the addition of an arterial phase abdominal computed tomography (CT) improves clinical outcomes in patients with blunt splenic injuries. Retrospective review of patients who underwent CT of the abdomen revealing splenic injuries. Clinical management in these patients was determined. Fifty-one of three thousand five hundred twenty-five patients had splenic injuries. Twenty-five patients underwent nonsurgical management, and 3 failed. The theoretical additional arterial phase resulted in a 62% increase in mean effective dose compared to the portal venous phase alone. Routine use of arterial phase CT in blunt trauma patients may not be warranted as there is minimal improvement in outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

The degree of integration of non-dispensing pharmacists in primary care practice and the impact on health outcomes: A systematic review.

PubMed

Hazen, Ankie C M; de Bont, Antoinette A; Boelman, Lia; Zwart, Dorien L M; de Gier, Johan J; de Wit, Niek J; Bouvy, Marcel L

2018-03-01

A non-dispensing pharmacist conducts clinical pharmacy services aimed at optimizing patients individual pharmacotherapy. Embedding a non-dispensing pharmacist in primary care practice enables collaboration, probably enhancing patient care. The degree of integration of non-dispensing pharmacists into multidisciplinary health care teams varies strongly between settings. The degree of integration may be a determinant for its success. This study investigates how the degree of integration of a non-dispensing pharmacist impacts medication related health outcomes in primary care. In this literature review we searched two electronic databases and the reference list of published literature reviews for studies about clinical pharmacy services performed by non-dispensing pharmacists physically co-located in primary care practice. We assessed the degree of integration via key dimensions of integration based on the conceptual framework of Walshe and Smith. We included English language studies of any design that had a control group or baseline comparison published from 1966 to June 2016. Descriptive statistics were used to correlate the degree of integration to health outcomes. The analysis was stratified for disease-specific and patient-centered clinical pharmacy services. Eighty-nine health outcomes in 60 comparative studies contributed to the analysis. The accumulated evidence from these studies shows no impact of the degree of integration of non-dispensing pharmacists on health outcomes. For disease specific clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 75%, 63% and 59%. For patient-centered clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 55%, 57% and 70%. Full integration adds value to patient-centered clinical pharmacy services, but not to disease-specific clinical pharmacy services. To obtain maximum benefits of clinical pharmacy services for patients with multiple medications and comorbidities, full integration of non-dispensing pharmacists should be promoted. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Complications after Hypospadias Correction: Prognostic Factors and Impact on Final Clinical Outcome.

PubMed

Dokter, Elisabeth Maria; Mouës, Chantal M; Rooij, Iris A L M van; Biezen, Jan Jaap van der

2018-04-01

 The purpose of this study was to analyze the influence of patient and treatment characteristics on the occurrence of complications after hypospadias correction and the impact of complications on final clinical outcome.  The study cohort consisted of 205 hypospadias patients who had surgery in the Medical Centre Leeuwarden (1996-2011). Patient and treatment characteristics were hypospadias severity (preoperative meatal location and chordee), number of planned surgeries, reconstruction technique, operation year, and patient's age at the time of surgery. The final clinical outcome was measured with the Hypospadias Objective Scoring Evaluation (HOSE) (maximum score = 16) and compared between patients with and without complications.  Sixty-four patients (31%) had complications, most of which were fistulas ( n  = 40). An increased complication risk was seen in patients with severe hypospadias (preoperative proximal meatus or chordee), multistage reconstruction, reconstruction techniques other than Mathieu, and surgeries performed before 2005. Uncomplicated treatment resulted only in a marginally higher HOSE (15.7) compared with complicated treatment (15.4). Fistulas and multiple complications reduced clinical outcome more (15.3 and 14.9, respectively), while urinary tract infections, wound dehiscence, or prepuce related complications did not (16.0, 16.0, and 15.8, respectively).  The complication risk after hypospadias correction is influenced by hypospadias severity and type and year of reconstruction. Certain, but not all complications diminish final clinical outcome. Georg Thieme Verlag KG Stuttgart · New York.

Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned.

PubMed

Burns, Suzanne M; Earven, Sidenia; Fisher, Charles; Lewis, Rose; Merrell, Paul; Schubart, Jane R; Truwit, Jonathon D; Bleck, Thomas P

2003-12-01

To determine the effect of an institutional approach to the care of patients requiring mechanical ventilation for longer than three consecutive days in five adult intensive care units (ICU) on clinical and financial outcomes. A multidisciplinary team was selected from five adult ICUs to design the approach. Planning occurred from August 1999 to September 2000. The process was called outcomes management (OM) and included an evidence-based clinical pathway, protocols for weaning and sedation use, and the selection of four advanced practice nurses (called outcomes managers) to manage and monitor the program. The project was completed in a 550-bed mid-Atlantic academic medical center. The ICUs included the following: coronary care, medical ICU, neuroscience ICU, surgical trauma ICU, and thoracic cardiovascular ICU. The sample included 595 pre-OM patients and 510 post-OM patients mechanically ventilated for greater than three consecutive days. Full implementation of the OM approach occurred in March 2001. Retrospective baseline (18 months pre-OM) and prospective (12 months OM) clinical and financial data were compared. Statistically significant differences in clinical outcomes were demonstrated in the managed patients compared with those managed before the institutional approach. Outcomes include ventilator duration (median days declined from ten to nine; p =.0001), ICU length of stay (median days declined from 15 to 12; p =.0008), hospital length of stay (median days declined from 22 to 20; p =.0001), and mortality rate (declined from 38% to 31%, p =.02). More than 3,000,000 US dollars cost savings were realized in the OM group. This institutional approach to the care of patients ventilated >3 days improved all clinical and financial outcomes of interest. To date, few similar initiatives have demonstrated similar results. The approach and lessons learned in this process improvement project may be helpful to other institutions attempting to improve outcomes in this vulnerable population.

Uninstrumented Posterior Lumbar Interbody Fusion: Have Technological Advances in Stabilizing the Lumbar Spine Truly Improved Outcomes?

PubMed

Prolo, Laura M; Oklund, Sally A; Zawadzki, Nadine; Desai, Manisha; Prolo, Donald J

2018-04-06

Since the 1980s, numerous operations have replaced posterior lumbar interbody fusion (PLIF) with human bone. These operations often involve expensive implants and complex procedures. Escalating expenditures in lumbar fusion surgery warrant re-evaluation of classical PLIF with allogeneic ilium and without instrumentation. The purpose of this study was to determine the long-term fusion rate and clinical outcomes of PLIF with allogeneic bone (allo-PLIF). Between 1981 and 2006, 321 patients aged 12-80 years underwent 339 1-level or 2-level allo-PLIFs for degenerative instability and were followed for 1-28 years. Fusion status was determined by radiographs and as available, by computed tomography scans. Clinical outcome was assessed by the Economic/Functional Outcome Scale. Of the 321 patients, 308 were followed postoperatively (average 6.7 years) and 297 (96%) fused. Fusion rates were lower for patients with substance abuse (89%, P = 0.007). Clinical outcomes in 87% of patients were excellent (52%) or good (35%). Economic/Functional Outcome Scale scores after initial allo-PLIF on average increased 5.2 points. Successful fusion correlated with nearly a 2-point gain in outcome score (P = 0.001). A positive association between a patient characteristic and outcome was observed only with age 65 years and greater, whereas negative associations in clinical outcomes were observed with mental illness, substance abuse, heavy stress to the low back, or industrial injuries. The total complication rate was 7%. With 3 decades of follow-up, we found that successful clinical outcomes are highly correlated with solid fusion using only allogeneic iliac bone. Copyright © 2018 Elsevier Inc. All rights reserved.

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

PubMed Central

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

1998-01-01

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

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

PubMed

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 P<0.0001). On presentation, 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.

Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

PubMed

Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

2015-01-01

Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

National Databases for Neurosurgical Outcomes Research: Options, Strengths, and Limitations.

PubMed

Karhade, Aditya V; Larsen, Alexandra M G; Cote, David J; Dubois, Heloise M; Smith, Timothy R

2017-08-05

Quality improvement, value-based care delivery, and personalized patient care depend on robust clinical, financial, and demographic data streams of neurosurgical outcomes. The neurosurgical literature lacks a comprehensive review of large national databases. To assess the strengths and limitations of various resources for outcomes research in neurosurgery. A review of the literature was conducted to identify surgical outcomes studies using national data sets. The databases were assessed for the availability of patient demographics and clinical variables, longitudinal follow-up of patients, strengths, and limitations. The number of unique patients contained within each data set ranged from thousands (Quality Outcomes Database [QOD]) to hundreds of millions (MarketScan). Databases with both clinical and financial data included PearlDiver, Premier Healthcare Database, Vizient Clinical Data Base and Resource Manager, and the National Inpatient Sample. Outcomes collected by databases included patient-reported outcomes (QOD); 30-day morbidity, readmissions, and reoperations (National Surgical Quality Improvement Program); and disease incidence and disease-specific survival (Surveillance, Epidemiology, and End Results-Medicare). The strengths of large databases included large numbers of rare pathologies and multi-institutional nationally representative sampling; the limitations of these databases included variable data veracity, variable data completeness, and missing disease-specific variables. The improvement of existing large national databases and the establishment of new registries will be crucial to the future of neurosurgical outcomes research. Copyright © 2017 by the Congress of Neurological Surgeons

Impact of locus of control on clinical outcomes in renal dialysis.

PubMed

Dec, Elaine

2006-01-01

This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

Outcomes assessment of a pharmacist-directed seamless care program in an ambulatory oncology clinic.

PubMed

Edwards, Scott J; Abbott, Rick; Edwards, Jonathan; LeBlanc, Michael; Dranitsaris, George; Donnan, Jennifer; Laing, Kara; Whelan, Maria A; MacKinnon, Neil J

2014-02-01

The primary goal of seamless care is improved patient outcomes and improved standards of care for patients with cancer. The pharmacy service of the Newfoundland Cancer Treatment and Research Foundation conducted a randomized control study that measured clinical and humanistic outcomes of a pharmacist-directed seamless care program in an ambulatory oncology clinic. This article focuses on the intervention group, particularly the identification of drug-related problems (DRPs) and utilization of health care services as well the satisfaction of 3 types of health professionals with the services provided by the pharmacist-directed seamless care program. Overall, the seamless care pharmacist (SCP) identified an average of 3.7 DRPs per intervention patient; the most common DRP reported was a patient not receiving or taking a drug therapy for which there is an indication. The SCP identified more DRPs in patients receiving adjuvant treatment compared to those receiving palliative treatment. On average, family physicians, oncology nurses, and hospital pharmacists were satisfied with the SCP intervention indicating that they agreed the information collected and distributed by the SCP was useful to them. Pharmacist-directed seamless care services in an ambulatory oncology clinic have a significant impact on clinical outcomes and processes of patient care. The presence of a SCP can help identify and resolve DRPs experienced by patients in an outpatient oncology clinic, ensuring that patients are receiving the highest standard of care.

Cost analysis of non-invasive fractional flow reserve derived from coronary computed tomographic angiography in Japan.

PubMed

Kimura, Takeshi; Shiomi, Hiroki; Kuribayashi, Sachio; Isshiki, Takaaki; Kanazawa, Susumu; Ito, Hiroshi; Ikeda, Shunya; Forrest, Ben; Zarins, Christopher K; Hlatky, Mark A; Norgaard, Bjarne L

2015-01-01

Percutaneous coronary intervention (PCI) based on fractional flow reserve (FFRcath) measurement during invasive coronary angiography (CAG) results in improved patient outcome and reduced healthcare costs. FFR can now be computed non-invasively from standard coronary CT angiography (cCTA) scans (FFRCT). The purpose of this study is to determine the potential impact of non-invasive FFRCT on costs and clinical outcomes of patients with suspected coronary artery disease in Japan. Clinical data from 254 patients in the HeartFlowNXT trial, costs of goods and services in Japan, and clinical outcome data from the literature were used to estimate the costs and outcomes of 4 clinical pathways: (1) CAG-visual guided PCI, (2) CAG-FFRcath guided PCI, (3) cCTA followed by CAG-visual guided PCI, (4) cCTA-FFRCT guided PCI. The CAG-visual strategy demonstrated the highest projected cost ($10,360) and highest projected 1-year death/myocardial infarction rate (2.4 %). An assumed price for FFRCT of US $2,000 produced equivalent clinical outcomes (death/MI rate: 1.9 %) and healthcare costs ($7,222) for the cCTA-FFRCT strategy and the CAG-FFRcath guided PCI strategy. Use of the cCTA-FFRCT strategy to select patients for PCI would result in 32 % lower costs and 19 % fewer cardiac events at 1 year compared to the most commonly used CAG-visual strategy. Use of cCTA-FFRCT to select patients for CAG and PCI may reduce costs and improve clinical outcome in patients with suspected coronary artery disease in Japan.

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

PubMed

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 average of 5 emails (0-11) per patient were sent to the laboratory technicians to communicate the improvisation the CAD design of the dentures. An average of 3.3 denture adjustments were needed after insertion (0-10) during the 1-year period. For patient-centered outcomes, median ratings of all 14 participants indicated each of the 12 studied outcomes was favorable at the 1-year recall. Statistically significant improvements in patient ratings from baseline to 1 year were observed for the absence of denture sore spots and treatment time to make the dentures (P<.05). Minor complications related to loss of retention, excessive wear of teeth and the need for additional visits were observed in 5 participants. No other adverse clinical outcomes related to the CAD/CAM dentures were noted in the 14 evaluated participants, and all dentures were intact and in good condition at the 1-year follow-up. Clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated using a 2-visit protocol were evaluated favorably at a 1-year follow-up. However, the proportion of excellent and good ratings for overall satisfaction and assessment was higher for patients than clinicians. A considerable amount of the clinician's time and effort was devoted to aiding in the digital process for the fabrication of CAD/CAM dentures. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Effect of part-time practice on patient outcomes.

PubMed

Parkerton, Patricia H; Wagner, Edward H; Smith, Dean G; Straley, Hugh L

2003-09-01

Primary care physicians are spending fewer hours in direct patient care, yet it is not known whether reduced hours are associated with differences in patient outcomes. To determine whether patient outcomes vary with physicians' clinic hours. Cross-sectional retrospective design assessing primary care practices in 1998. All 25 outpatient-clinics of a single medical group in western Washington. One hundred ninety-four family practitioners and general internists, 80% of whom were part-time, who provided ambulatory primary care services to specified HMO patient panels. Physician appointment hours ranged from 10 to 35 per week (30% to 100% of full time). Twenty-three measures of individual primary care physician performance collected in an administrative database were aggregated into 4 outcome measures: cancer screening, diabetic management, patient satisfaction, and ambulatory costs. Multivariate regression on each of the 4 outcomes controlled for characteristics of physicians (administrative role, gender, seniority) and patient panels (size, case mix, age, gender). While the effects were small, part-time physicians had significantly higher rates for cancer screening (4% higher, P =.001), diabetic management (3% higher, P =.033), and for patient satisfaction (3% higher, P =.035). After controlling for potential confounders, there was no significant association with patient satisfaction (P =.212) or ambulatory costs (P =.323). Primary care physicians working fewer clinical hours were associated with higher quality performance than were physicians working longer hours, but with patient satisfaction and ambulatory costs similar to those of physicians working longer hours. The trend toward part-time clinical practice by primary care physicians may occur without harm to patient outcomes.

Cost-effectiveness analysis of a postoperative clinical care pathway in head and neck surgery with microvascular reconstruction.

PubMed

Dautremont, Jonathan F; Rudmik, Luke R; Yeung, Justin; Asante, Tiffany; Nakoneshny, Steve C; Hoy, Monica; Lui, Amanda; Chandarana, Shamir P; Matthews, Thomas W; Schrag, Christiaan; Dort, Joseph C

2013-12-19

The objective of this study is to evaluate the cost-effectiveness of a postoperative clinical care pathway for patients undergoing major head and neck oncologic surgery with microvascular reconstruction. This is a comparative trial of a prospective treatment group managed on a postoperative clinical care pathway and a historical group managed prior to pathway implementation. Effectiveness outcomes evaluated were total hospital days, return to OR, readmission to ICU and rate of pulmonary complications. Costing perspective was from the government payer. 118 patients were included in the study. All outcomes demonstrated that the postoperative pathway group was both more effective and less costly, and is therefore a dominant clinical intervention. The overall mean pre- and post-pathway costs are $22,733 and $16,564 per patient, respectively. The incremental cost reduction associated with the postoperative pathway was $6,169 per patient. Implementing the postoperative clinical care pathway in patients undergoing head and neck oncologic surgery with reconstruction resulted in improved clinical outcomes and reduced costs.

Cost effectiveness of high-sensitivity troponin compared to conventional troponin among patients presenting with undifferentiated chest pain: A trial based analysis.

PubMed

Kaambwa, Billingsley; Ratcliffe, Julie; Horsfall, Matthew; Astley, Carolyn; Karnon, Jonathan; Coates, Penelope; Arstall, Margaret; Zeitz, Christopher; Worthley, Matthew; Beltrame, John; Chew, Derek P

2017-07-01

Patients with low and intermediate risk chest pain features comprise the greatest proportion presenting to emergency services for evaluation of suspected acute coronary syndromes (ACS). The efficient and timely identification of patients with these features remains a major challenge within clinical practice. Troponin assays are increasingly being used for the determination of risk among patients presenting with chest pain potentially facilitating more appropriate care. To date, no economic evaluation comparing high-sensitivity troponin T (hs-TnT) reporting to standard troponin T (c-TnT) reporting in the routine management of suspected ACS and based on longer-term clinical outcomes has been conducted. An economic evaluation was conducted with 1937 participants randomized to either hs-TnT (n=973) or c-TnT (n=964) with 12month follow-up. The primary outcome measure was the number of cumulative combined outcomes of all-cause mortality and new or recurrent ACS avoided. Mean per participant Australian Medicare costs were higher in the hs-TnT arm compared to the c-TnT arm (by $1285/patient). Mean total adverse clinical outcomes avoided were higher in the hs-TnT arm (by 0.0120/patient) resulting in an incremental cost-effectiveness ratio (ICER) of $108,552/adverse clinical outcome avoided. An ICER of $49,030/adverse clinical outcome avoided was obtained when the analysis was restricted to patients below the threshold of normal Troponin testing (actual c-TnT levels <30ng/L). hs-TnT reporting leads to fewer adverse clinical events but at a high ICER. For the routine implementation of hs-TnT to be more cost-effective, substantial changes in clinical practice will be required. Australian New Zealand Clinical Trials Registry (ACTRN12614000189628). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365726. Copyright © 2017 Elsevier B.V. All rights reserved.

Does duration of symptoms affect clinical outcome after hip arthroscopy for labral tears? Analysis of prospectively collected outcomes with minimum 2-year follow-up

PubMed Central

Ni, Jake; Hohn, Eric A; Domb, Benjamin G

2017-01-01

Abstract Limited research exists on the possible association between duration of symptoms and clinical outcomes following hip arthroscopy for labral tears. The purpose of this study was to evaluate whether duration of symptoms affected clinical and patient-reported outcome (PRO) scores following hip arthroscopy for labral tears. From 2008 to 2011, data were collected prospectively on all patients undergoing primary hip arthroscopy for labral tears. Workers’ compensation cases, dysplasia cases and patients with previous ipsilateral hip surgeries were excluded. A total of 738 patients were identified with a minimum of 2-year follow-up, and clinical and PRO data were available for 680 patients. Uni- and multivariate analyses were performed to determine the relationship between duration of symptoms along with other variables and PROs. Overall, patients experienced significant improvements in all clinical and PRO scores. Results of univariate analysis revealed that all PROs were negatively associated with increasing Log10 months of symptoms as were pain and satisfaction scores. During multivariate analyses, increasing Log10 months of symptoms, age, body mass index and trauma were all negatively associated with PROs (P  < 0.05). Our study demonstrates that clinical and PRO scores were negatively associated with increasing duration of symptoms prior to hip arthroscopy for treatment of labral tears. Although this implies that delay in treatment may adversely affect outcome, conservative treatment remains the gold standard first line of treatment. Surgeons should incorporate this information into their treatment algorithm to maximize patient outcomes following treatment for labral tears. Level of evidence: Level IV, prospective case series. PMID:29250339

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

PubMed

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.

Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial.

PubMed

Griswold, David; Learman, Ken; Kolber, Morey J; O'Halloran, Bryan; Cleland, Joshua A

2018-03-01

Study Design Randomized clinical trial. Background The comparative effectiveness between nonthrust manipulation (NTM) and thrust manipulation (TM) for mechanical neck pain has been investigated, with inconsistent results. Objective To compare the clinical effectiveness of concordant cervical and thoracic NTM and TM for patients with mechanical neck pain. Methods The Neck Disability Index (NDI) was the primary outcome. Secondary outcomes included the Patient-Specific Functional Scale (PSFS), numeric pain-rating scale (NPRS), deep cervical flexion endurance (DCF), global rating of change (GROC), number of visits, and duration of care. The covariate was clinical equipoise for intervention. Outcomes were collected at baseline, visit 2, and discharge. Patients were randomly assigned to receive either NTM or TM directed at the cervical and thoracic spines. Techniques and dosages were selected pragmatically and applied to the most symptomatic level. Two-way mixed-model analyses of covariance were used to assess clinical outcomes at 3 time points. Analyses of covariance were used to assess between-group differences for the GROC, number of visits, and duration of care at discharge. Results One hundred three patients were included in the analyses (NTM, n = 55 and TM, n = 48). The between-group analyses revealed no differences in outcomes on the NDI (P = .67), PSFS (P = .26), NPRS (P = .25), DCF (P = .98), GROC (P = .77), number of visits (P = .21), and duration of care (P = .61) for patients with mechanical neck pain who received either NTM or TM. Conclusion NTM and TM produce equivalent outcomes for patients with mechanical neck pain. The trial was registered with ClinicalTrials.gov (NCT02619500). Level of Evidence Therapy, level 1b. J Orthop Sports Phys Ther 2018;48(3):137-145. Epub 6 Feb 2018. doi:10.2519/jospt.2018.7738.

Patients with lymphatic malformations who receive the immunostimulant OK-432 experience excellent long-term outcomes.

PubMed

Ghaffarpour, N; Petrini, B; Svensson, L A; Boman, K; Wester, T; Claesson, G

2015-11-01

Sclerotherapy is the primary treatment for lymphatic malformations. The aim of this study was to evaluate the long-term outcome in patients with lymphatic malformations treated with the immunostimulant OK-432 as a sclerosant. Between 1998 and 2013, we enrolled 131 of 138 eligible patients treated with OK-432 for lymphatic malformations in a retrospective study. The malformations were categorised according to the International Society for the Study of Vascular Anomalies. The outcome was assessed with a clinical examination and a questionnaire. The lymphatic malformations were localised to the head/neck (60%), the trunk (20%) and the extremities (6%) or involved with more than one region (14%). Patients with microcystic (10%), macrocystic (21%) and mixed lymphatic malformations (69%) underwent a median number of three, two and two injection treatments, respectively. The median age at the first injection was 3.4 years. Good or excellent clinical outcomes were seen in 70% of the patients. The number of injections, previous treatment and lesion localisation, but not time to follow-up and cyst size, predicted the clinical outcome. OK-432 treatment resulted in a successful outcome in 70% of patients with lymphatic malformations. The long-term outcome was comparable to the short-term outcome. ©2015 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy.

PubMed

Lee, Michael S; Shlofmitz, Evan; Lluri, Gentian; Shlofmitz, Richard A

2017-04-01

We evaluated the clinical outcomes of elderly patients who underwent orbital atherectomy for the treatment of severe coronary artery calcification (CAC) prior to stenting. Percutaneous coronary intervention (PCI) of severe CAC is associated with worse clinical outcomes including death, myocardial infarction (MI), and target vessel revascularization (TVR). The elderly represents a high-risk group of patients, often have more comorbid conditions, and have worse outcomes after PCI compared to younger patients. Clinical trials and a large multicenter registry have demonstrated the safety and efficacy of orbital atherectomy for the treatment of severe CAC. Clinical outcomes of elderly patients who undergo orbital atherectomy are unknown. Of the 458 patients, 229 were ≥75 years old (elderly) and 229 were <75 years old (younger). The primary endpoint was rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, MI, TVR, and stroke. The primary endpoint was similar in the elderly and younger groups (2.2% vs. 2.2%, P = 1), as were the individual endpoints of death (2.2% vs. 0.4%, P = 0.1), MI (0.9% vs. 1.3%, P = 0.65), TVR (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P = 0.32). The rates of angiographic complications and stent thrombosis were similarly low in both groups. The elderly represented a sizeable number of patients who underwent orbital atherectomy. It is a safe and effective treatment strategy for elderly patients with severe CAC as the clinical outcomes were similar to their younger counterparts. A randomized trial should further clarify the role of orbital atherectomy in these patients. © 2017, Wiley Periodicals, Inc.

The sFlt-1/PlGF ratio associates with prolongation and adverse outcome of pregnancy in women with (suspected) preeclampsia: analysis of a high-risk cohort.

PubMed

Saleh, Langeza; Verdonk, Koen; Jan Danser, A H; Steegers, Eric A P; Russcher, Henk; van den Meiracker, Anton H; Visser, Willy

2016-04-01

To evaluate the additive value of the sFlt-1/PlGF ratio for diagnosing preeclampsia (PE) and predicting prolongation of pregnancy and adverse outcome in a cohort of women with PE or at high risk of PE. Patients with suspected or confirmed clinical PE were recruited. At time of inclusion blood for measurement of sFlt-1and PlGF was taken. Values were determined after delivery. A cut-off ratio of ≥85 was defined as a positive test. A total of 107 patients were included. Of the patients, 62 (58%) met the clinical criteria of PE at time of blood sampling. In 10% of these patients (n=6) the ratio was <85 (false negative), whereas in 7% (n=3) of patients without clinical PE the ratio was ≥85 (false positive), resulting in positive and negative predictive values of 95% and 88% respectively. One patient with false positive ratio developed superimposed PE and 2 developed gestational hypertension, and adverse outcome occurred in all three. An adverse pregnancy outcome was only encountered in 1 of the 6 patients with a false negative ratio. Using a binary regression model with adjustment for gestational age <34 weeks, the adverse outcome risk was 11 times increased on the basis of clinical PE, and 30 times on the basis of an elevated ratio (P=0.036). The additive value of an increased ratio for diagnosing PE is limited since most patients with clinical PE also have a positive ratio. However, an elevated ratio is superior to the clinical diagnosis of PE for predicting an adverse pregnancy outcome. Furthermore, irrespective of clinical PE, a low ratio is inversely correlated with prolongation of pregnancy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.

PubMed

Soni-Jaiswal, Archana; Lakhani, Raj; Hopkins, Claire

2017-07-11

A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis. A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial. Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories. The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.

Integration of a Clinical Pharmacist into an Interdisciplinary Palliative Care Outpatient Clinic.

PubMed

DiScala, Sandra Lee; Onofrio, Sarah; Miller, Maura; Nazario, Mitchell; Silverman, Michael

2017-11-01

The primary objective of this quality improvement (QI) project was to determine if the Interdisciplinary Palliative Care Outpatient Clinic (IPCOC) at the West Palm Beach Veterans Affairs Medical Center offered improved symptom assessment and palliative care treatment outcomes. Secondary objectives were to identify, classify, and resolve medication problems and calculate the number of pharmacist recommendations accepted by prescribing providers. An IPCOC was created by selecting disciplines for a core group including a nurse practitioner, clinical pharmacist, social worker, chaplain, and physician. Consult referrals were recruited by providing educational sessions. The patient assessments were completed using the Edmonton Symptom Assessment System: (revised version; ESAS-R). The clinical pharmacist classified and resolved drug-related problems. The pharmacy resident telephoned veterans for completion of the "Patient Assessment: Overall Satisfaction with Outpatient Palliative Care Clinic." Seventeen consults were received, 6 patients were excluded, and 11 were seen in clinic. One (9%) of 11 patients met the outcomes measure of system assessment documentation in the past year. At completion, 11 (100%) of 11 patients met the outcomes data measure. The Patient Satisfaction Assessment revealed veterans strongly agree to recommend the IPCOC. The clinical pharmacist identified 20 drug-related problems, made 16 recommendations, had a 93.7% implementation rate, and facilitated implementation of medication changes. This QI project demonstrates that an IPCOC improved symptom assessment and palliative care outcomes in addition to resolution of medication prescribing issues in veterans with advanced cancer by integration of a clinical pharmacist into the core team.

[Embryo selection in IVF/ICSI cycles using time-lapse microscopy and the clinical outcomes].

PubMed

Chen, Minghao; Huang, Jun; Zhong, Ying; Quan, Song

2015-12-01

To compare the clinical outcomes of embryos selected using time-lapse microscopy and traditional morphological method in IVF/ICSI cycles and evaluate the clinical value of time-lapse microscopy in early embryo monitoring and selection. e retrospectively analyzed the clinical data of 139 IVF/ICSI cycles with embryo selection based on time-lapse monitoring (TLM group, n=68) and traditional morphological method (control group, n=71). The βHCG-positive rate, clinical pregnancy rate and embryo implantation rate were compared between the 2 groups. Subgroup analysis was performed in view of female patients age and the fertilization type. The βHCG-positive rate, clinical pregnancy rate and implantation rate were 66.2%, 61.8% and 47.1% in TLM group, significantly higher than those in the control group (47.9%, 43.7% and 30.3%, respectively; P<0.05). Compared with patients below 30 years of age, patients aged between 31 and 35 years benefited more from time-lapse monitoring with improved clinical outcomes. time-lapse monitoring significantly increased the βHCG-positive rate, clinical pregnancy rate and implantation rate for patients undergoing IVF cycles, but not for those undergoing ICSI or TESA cycles. Compared with those selected using traditional morphological method, the embryos selected with time-lapse microscopy have better clinical outcomes, especially in older patients (31-35 years of age) and in IVF cycles.

Outcomes Among Chronically Ill Adults in a Medical Home Prototype

PubMed Central

Liss, David T.; Fishman, Paul A.; Rutter, Carolyn M.; Grembowski, David; Ross, Tyler R.; Johnson, Eric A.; Reid, Robert J.

2014-01-01

Objectives To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Study Design Nonequivalent pretest-posttest control group design. Methods PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Results Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care–sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. Conclusions A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses. PMID:24304182

Clinical Practices and Outcomes in Elderly Hemodialysis Patients: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS)

PubMed Central

Tong, Lin; Tentori, Francesca; Akiba, Takashi; Karaboyas, Angelo; Gillespie, Brenda; Akizawa, Tadao; Pisoni, Ronald L.; Bommer, Juergen; Port, Friedrich K.

2011-01-01

Summary Background and objectives Demand for hemodialysis among elderly patients is increasing worldwide. Although clinical care of this high-risk group is complex and challenging, no guidelines exist to inform hemodialysis practices. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to assess dialysis practices and associated outcomes among elderly versus younger patients on chronic in-center hemodialysis in 12 countries. Design, setting, participants, & measurements Clinical characteristics, dialysis practices, and outcomes of elderly versus younger patients were compared among participants in four DOPPS regions in 2005 through 2007. Results Although participant mean age increased over time in all DOPPS countries, the percentage of elderly varied widely. Overall, comorbidities and malnutrition were more common in the elderly. Fistulae were used less frequently among elderly versus younger patients in Europe and North America but not in Australia, New Zealand, and Japan. No difference in treatment time was observed between elderly and younger patients after normalizing for body weight. In all regions, ultrafiltration rates were lower among elderly patients. Elderly patients reported poorer quality of life with respect to the physical but not mental component scores. Mortality risk was three- to sixfold higher in the elderly group, whereas causes of death overall were similar for elderly and younger patients. Conclusions Elderly patients represent a different proportion of DOPPS participants across countries, possibly reflecting differences in policies and clinical practices. In general, hemodialysis practices in the elderly reflected each region's clinical patterns, with some variation by age group depending upon the practice. PMID:21734085

MR imaging of the hippocampus in normal pressure hydrocephalus: correlations with cortical Alzheimer's disease confirmed by pathologic analysis.

PubMed

Savolainen, S; Laakso, M P; Paljärvi, L; Alafuzoff, I; Hurskainen, H; Partanen, K; Soininen, H; Vapalahti, M

2000-02-01

MR studies have shown hippocampal atrophy to be a sensitive diagnostic feature of Alzheimer's disease (AD). In this study, we measured the hippocampal volumes of patients with a clinical diagnosis of normal pressure hydrocephalus (NPH), a potentially reversible cause of dementia when shunted. Further, we examined the relationship between the hippocampal volumes and cortical AD pathologic findings, intracranial pressure, and clinical outcomes in cases of NPH. We measured hippocampal volumes from 37 patients with a clinical diagnosis of NPH (27 control volunteers and 24 patients with AD). The patients with NPH underwent biopsy, and their clinical outcomes were followed for a year. Compared with those for control volunteers, the findings for patients with NPH included a minor left-side decrease in the hippocampal volumes (P < .05). Compared with those for patients with AD, the findings for patients with NPH included significantly larger hippocampi on both sides. Although not statistically significant, trends toward larger volumes were observed in patients with NPH who had elevated intracranial pressure, who benefited from shunting, and who did not display cortical AD pathologic findings. Measurements of hippocampal volumes among patients with a clinical diagnosis of NPH have clear clinical implications, providing diagnostic discrimination from AD and possibly prediction of clinical outcome after shunting.

A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.

PubMed

Duffy, James M N; van 't Hooft, Janneke; Gale, Chris; Brown, Mark; Grobman, William; Fitzpatrick, Ray; Karumanchi, S Ananth; Lucas, Nuala; Magee, Laura; Mol, Ben; Stark, Michael; Thangaratinam, Shakila; Wilson, Mathew; von Dadelszen, Peter; Williamson, Paula; Khan, Khalid S; Ziebland, Sue; McManus, Richard J

2016-10-01

Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529. Copyright © 2016 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.

Medial medullary infarction: clinical, imaging, and outcome study in 86 consecutive patients.

PubMed

Kim, Jong S; Han, Young S

2009-10-01

Clinical-imaging correlation and long-term clinical outcomes remain to be investigated in medial medullary infarction (MMI). We studied clinical, MRI, and angiographic data of 86 consecutive MMI patients. The lesions were correlated with clinical findings, and long-term outcomes, divided into mild and severe (modified Rankin scale >3), were assessed by telephone interview. Central poststroke pain (CPSP) was defined as persistent pain with visual numeric scale > or = 4. The lesions were located mostly in the rostral medulla (rostral 76%, rostral+middle 16%), while ventro-dorsal lesion patterns include ventral (V, 20%), ventral+middle (VM, 33%), and ventral+middle+dorsal (VMD, 41%). Clinical manifestations included motor dysfunction in 78 patients (91%), sensory dysfunction in 59 (73%), and vertigo/dizziness in 51 (59%), each closely related to involvement of ventral, middle, and dorsal portions, respectively (P<0.001, each). Vertebral artery (VA) atherosclerotic disease relevant to the infarction occurred in 53 (62%) patients, mostly producing atheromatous branch occlusion (ABO). Small vessel disease (SVD) occurred in 24 (28%) patients. ABO was more closely related to VMD (versus V+VM) than was SVD (P=0.035). During follow-up (mean 71 months), 11 patients died, and recurrent strokes occurred in 11. Old age (P=0.001) and severe motor dysfunction at admission (P=0.001) were factors predicting poor prognosis. CPSP, occurring in 21 patients, was closely (P=0.013) related to poor clinical outcome. MMI usually presents with a rostral medullary lesion, with a good clinical ventro-dorsal imaging correlation, caused most frequently by ABO followed by SVD. A significant proportion of patients remain dependent or have CPSP.

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Sunitinib Possible Sex-Divergent Therapeutic Outcomes.

PubMed

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

2016-10-01

Sunitinib is a tyrosine kinase inhibitor used for the treatment of renal cell carcinoma and metastatic brain tumors. Preclinical pharmacokinetic studies have shown higher sunitinib hepatic and brain exposure in female mice and higher sunitinib kidney concentrations in male mice. We explored whether sex-divergent tissue pharmacokinetics may anticipate sex-divergent therapeutic and toxicology responses in male and female patients. The review of the available scientific literature identified case reports, case series reports, clinical trials, and other studies associating sex with sunitinib outcomes. The results suggest male patients may respond better to renal cell carcinoma treatment and female patients may have better brain tumor treatment outcomes but a higher incidence of adverse events. Although more high-quality evidence is needed, these results, as anticipated by the preclinical data, may indicate possible sunitinib sex-divergent therapeutic outcomes in patients. In addition, we propose the systematic analysis of sex-based outcomes in clinical trial reports and their inclusion and review in the ethics committees and review boards to prevent, amongst others, patient burden in upcoming clinical trials.

Establishing Maximal Medical Improvement After Arthroscopic Rotator Cuff Repair.

PubMed

Zuke, William A; Leroux, Timothy S; Gregory, Bonnie P; Black, Austin; Forsythe, Brian; Romeo, Anthony A; Verma, Nikhil N

2018-03-01

As health care transitions from a pay-for-service to a pay-for-performance infrastructure, the value of orthopaedic care must be defined accurately. Significant efforts have been made in defining quality and cost in arthroplasty; however, there remains a lag in ambulatory orthopaedic care. Two-year follow-up has been a general requirement for reporting outcomes after rotator cuff repair. However, this time requirement has not been established scientifically and is of increasing importance in the era of value-based health care. Given that arthroscopic rotator cuff repair is a common ambulatory orthopaedic procedure, the purpose of this study was to establish a time frame for maximal medical improvement (the state when improvement has stabilized) after arthroscopic rotator cuff repair. Systematic review. A systematic review of the literature was conducted, identifying studies reporting sequential patient-reported outcomes up to a minimum of 2 years after arthroscopic rotator cuff repair. The primary clinical outcome was patient-reported outcomes at 3-month, 6-month, 1-year, and 2-year follow-up. Secondary clinical outcomes included range of motion, strength, retears, and complications. Clinically significant improvement was determined between various time intervals by use of the minimal clinically important difference. The review included 19 studies including 1370 patients who underwent rotator cuff repair. Clinically significant improvement in patient-reported outcomes was seen up to 1 year after rotator cuff repair, but no clinical significance was noted from 1 year to 2 years. The majority of improvement in strength and range of motion was seen up to 6 months, but no clinically meaningful improvement was seen thereafter. All reported complications and the majority of retears occurred within 6 months after rotator cuff repair. After rotator cuff repair, a clinically significant improvement in patient-reported outcomes, range of motion, and strength was seen up to 1 year after surgery, but not beyond this. This information is important not only to establish appropriate patient expectations but also to determine a time frame for outcome collection after surgery to better define value in orthopaedic care.

Evaluation of outreach clinics held by specialists in general practice in England

PubMed Central

Bond, M.; Bowling, A.; Abery, A.; McClay, M.; Dickinson, E.

2000-01-01

OBJECTIVES—To measure the processes of care, health benefits and costs of outreach clinics held by hospital specialists in primary care settings.
DESIGN—The study was designed as a case-referent (comparative) study in which the features of 19 outreach clinics (cases) were compared with matched outpatient clinics (controls). The measuring instruments were self administered questionnaires. Patients were followed up at six months to reassess health status. The specialties included in the study were cardiology, ENT, general medicine, general surgery, gynaecology and rheumatology.
SETTING—Specialist outreach clinics in general practice in England, with matched outpatient clinic controls.
SUBJECTS—Consecutive patient attenders in the outreach and outpatient clinics, their specialists, the outreach patients' general practitioners, practice managers and trust accountants. Patients' response rate at baseline: 78% (1420).
MAIN OUTCOME MEASURES—Patient satisfaction, doctors' attitudes, processes and health outcomes, costs.
RESULTS—Outreach patients were more satisfied with the processes of their care than outpatients, their access to specialist care was better than that for outpatients and they were more likely to be discharged. Doctors reported that the main advantages of the outreach clinic were improved patient access to specialists and convenience for patients, in comparison with outpatients, and most GPs and specialists felt the outreach clinic was "worthwhile". At six month follow up, the health status of the outreach sample had significantly improved more than that of the outpatients on all eight sub-scales of the HSQ-12, but this was probably because of their better starting point at baseline. The impact of outreach on health outcomes was small. The NHS costs of outreach were significantly higher than outpatients. An increase in outreach clinic size would reduce cost per patient, but would lead to the loss of most of the clinics' benefits.
CONCLUSIONS—While the process of care was of higher quality in outreach than in outpatients, and the efficiency of care was also greater in the latter, the effect on patients' health outcomes was small. Responsiveness to patients' views and preferences is an essential component of good quality service provision. However, the greater cost of outreach raises the issue of whether improvements in the quality and efficiency of health care, without a substantial impact on health outcomes, is money well spent in a publicly funded health service. On the other hand, the real costs of outreach in comparison with outpatients clinics can probably only be truly estimated in a longitudinal study with a resource based costing model derived from documented patient attendances and treatment costs over time in relation to longer term outcome (for example, at a two year end point).


Keywords: outreach clinics; general practice PMID:10715749

Age at onset in patients with medically refractory temporal lobe epilepsy and mesial temporal sclerosis: impact on clinical manifestations and postsurgical outcome.

PubMed

Asadi-Pooya, Ali A; Sperling, Michael R

2015-08-01

To evaluate the demographic and clinical manifestations and postsurgical outcome of childhood-onset mesial temporal sclerosis and temporal lobe epilepsy (MTS-TLE) and establishing the potential differences as compared to the patients with adult-onset MTS-TLE. In this retrospective study all patients with a clinical diagnosis of medically refractory TLE due to mesial temporal sclerosis, who underwent epilepsy surgery at Jefferson comprehensive epilepsy center, were recruited. Patients were prospectively registered in a database from 1986 through 2014. Postsurgical outcome was classified into two groups; seizure-free or relapsed. Clinical manifestations and outcome were compared between patients with childhood-onset MTS-TLE (i.e., age at onset of the first afebrile habitual seizure below 10 years) and those with adult-onset MTS-TLE (i.e., age at onset of the first afebrile habitual seizure 20 years or above). One hundred and twelve patients had childhood-onset MTS-TLE and 76 had adult-onset MTS-TLE. Demographic, clinical, EEG and MRI characteristics of these two groups were similar. Postoperative outcome was not statistically different between these two groups of patients (P=0.9). Temporal lobe epilepsy due to mesial temporal sclerosis is a common cause of epilepsy that can start from early childhood to late adulthood. The etiology of MTS-TLE may be different in various age groups, but it seems that when mesial temporal sclerosis is the pathological substrate of TLE, clinical manifestations and response to surgical treatment of patients are very similar in patients with childhood-onset MTS-TLE compared to those with adult-onset disease. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Identifying Primary Care Pathways from Quality of Care to Outcomes and Satisfaction Using Structural Equation Modeling.

PubMed

Ricci-Cabello, Ignacio; Stevens, Sarah; Dalton, Andrew R H; Griffiths, Robert I; Campbell, John L; Valderas, Jose M

2018-02-01

To study the relationships between the different domains of quality of primary health care for the evaluation of health system performance and for informing policy decision making. A total of 137 quality indicators collected from 7,607 English practices between 2011 and 2012. Cross-sectional study at the practice level. Indicators were allocated to subdomains of processes of care ("quality assurance," "education and training," "medicine management," "access," "clinical management," and "patient-centered care"), health outcomes ("intermediate outcomes" and "patient-reported health status"), and patient satisfaction. The relationships between the subdomains were hypothesized in a conceptual model and subsequently tested using structural equation modeling. The model supported two independent paths. In the first path, "access" was associated with "patient-centered care" (β = 0.63), which in turn was strongly associated with "patient satisfaction" (β = 0.88). In the second path, "education and training" was associated with "clinical management" (β = 0.32), which in turn was associated with "intermediate outcomes" (β = 0.69). "Patient-reported health status" was weakly associated with "patient-centered care" (β = -0.05) and "patient satisfaction" (β = 0.09), and not associated with "clinical management" or "intermediate outcomes." This is the first empirical model to simultaneously provide evidence on the independence of intermediate health care outcomes, patient satisfaction, and health status. The explanatory paths via technical quality clinical management and patient centeredness offer specific opportunities for the development of quality improvement initiatives. © Health Research and Educational Trust.

Nursing Outcomes for Patients with Risk of Perioperative Positioning Injury.

PubMed

de Lima, Luciana Bjorklund; E Cardozo, Michelle Cardoso; Bernardes, Daniela de Souza; Rabelo-Silva, Eneida Rejane

2018-04-16

To select and refine the outcomes and indicators of Nursing Outcomes Classification for the diagnosis of risk for perioperative positioning injury. Validation study on expert consensus and refinement through pilot study. Eight outcomes and 35 indicators were selected in consensus. After clinical testing was performed, in which 10 patients were assessed at five different times. Eight outcomes and 33 indicators remained in the protocol. This study made it possible to select the most relevant outcomes and indicators to be measured for this diagnosis in clinical practice. Validation studies by consensus and clinical testing are important to promote the accuracy, creating opportunities to legitimize, and improve the concepts of taxonomies. © 2018 NANDA International, Inc.

Using an evidence-based approach to measure outcomes in clinical practice.

PubMed

MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

2009-02-01

Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

Clinical outcomes of a specialised inpatient unit for adults with mild to severe intellectual disability and mental illness.

PubMed

Lunsky, Y; White, S E; Palucka, A M; Weiss, J; Bockus, S; Gofine, T

2010-01-01

Limitations of general psychiatric services have led to the development of specialised psychiatric programmes for patients with intellectual disability (ID) and mental health needs. Few studies have examined treatment outcomes of specialised inpatient units, and no studies have explored how the effects of intervention may differ for individuals at varying levels of cognitive ability. The present study examined clinical outcomes of inpatients with mild ID in contrast to inpatients with moderate to severe ID within the same service. Thirty-three patients (17 with mild ID and 16 with moderate to severe ID) discharged between 2006 and 2008 from a specialised inpatient unit in Canada for adults with ID and mental illness were studied. In addition to examining change in scores on clinical measures, outcomes with regard to length of stay, diagnostic change, residential change and re-admission to hospital were explored. Both groups demonstrated clinical improvement from admission to discharge. However, only patients with mild ID demonstrated improvements on the Global Assessment of Functioning. This study is one of the first to consider outcomes of higher and lower functioning individuals with ID on a specialised inpatient unit. Results suggest that outcomes may be different for these groups, and some clinical measures may be more sensitive to changes in patients with more severe disabilities.

Discordance of physician clinical judgment vs. pneumonia severity index (PSI) score to admit patients with low risk community-acquired pneumonia: a prospective multicenter study.

PubMed

Marcos, Pedro J; Restrepo, Marcos I; González-Barcala, Francisco J; Soni, Nilam J; Vidal, Iria; Sanjuàn, Pilar; Llinares, Diego; Ferreira-Gonzalez, Lucía; Rábade, Carlos; Otero-González, Isabel; Marcos, Pedro; Verea-Hernando, Héctor

2017-06-01

The relationship between clinical judgment and the pneumonia severity index (PSI) score in deciding the site of care for patients with community-acquired pneumonia (CAP) has not been well investigated. The objective of the study was to determine the clinical factors that influence decision-making to hospitalize low-risk patients (PSI ≤2) with CAP. An observational, prospective, multicenter study of consecutive CAP patients was performed at five hospitals in Spain. Patients admitted with CAP and a PSI ≤2 were identified. Admitting physicians completed a patient-specific survey to identify the clinical factors influencing the decision to admit a patient. The reason for admission was categorized into 1 of 6 categories. We also assessed whether the reason for admission was associated with poorer clinical outcomes [intensive care unit (ICU) admission, 30-day mortality or readmission]. One hundred and fifty-five hospitalized patients were enrolled. Two or more reasons for admission were seen in 94 patients (60.6%), including abnormal clinical test results (60%), signs of clinical deterioration (43.2%), comorbid conditions (28.4%), psychosocial factors (28.4%), suspected H1N1 pneumonia (20.6%), and recent visit to the emergency department (ED) in the past 2 weeks (7.7%). Signs of clinical deterioration and abnormal clinical test results were associated with poorer clinical outcomes (P<0.005). Low-risk patients with CAP and a PSI ≤2 are admitted to the hospital for multiple reasons. Abnormal clinical test results and signs of clinical deterioration are two specific reasons for admission that are associated with poorer clinical outcomes in low risk CAP patients.

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

PubMed Central

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

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

PubMed

Evans, Scott R; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient's perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision.

Prognostic significance of electrophysiological tests for facial nerve outcome in vestibular schwannoma surgery.

PubMed

van Dinther, J J S; Van Rompaey, V; Somers, T; Zarowski, A; Offeciers, F E

2011-01-01

To assess the prognostic significance of pre-operative electrophysiological tests for facial nerve outcome in vestibular schwannoma surgery. Retrospective study design in a tertiary referral neurology unit. We studied a total of 123 patients with unilateral vestibular schwannoma who underwent microsurgical removal of the lesion. Nine patients were excluded because they had clinically abnormal pre-operative facial function. Pre-operative electrophysiological facial nerve function testing (EPhT) was performed. Short-term (1 month) and long-term (1 year) post-operative clinical facial nerve function were assessed. When pre-operative facial nerve function, evaluated by EPhT, was normal, the outcome from clinical follow-up at 1-month post-operatively was excellent in 78% (i.e. HB I-II) of patients, moderate in 11% (i.e. HB III-IV), and bad in 11% (i.e. HB V-VI). After 1 year, 86% had excellent outcomes, 13% had moderate outcomes, and 1% had bad outcomes. Of all patients with normal clinical facial nerve function, 22% had an abnormal EPhT result and 78% had a normal result. No statistically significant differences could be observed in short-term and long-term post-operative facial function between the groups. In this study, electrophysiological tests were not able to predict facial nerve outcome after vestibular schwannoma surgery. Tumour size remains the best pre-operative prognostic indicator of facial nerve function outcome, i.e. a better outcome in smaller lesions.

Cardiovascular Disease in Patients with End-Stage Renal Disease on Hemodialysis

PubMed Central

Aoki, Jiro; Ikari, Yuji

2017-01-01

Cardiovascular disease is a major concern for patients with end-stage renal disease (ESRD), especially those on hemodialysis. ESRD patients with coronary artery disease often do not have symptoms or present with atypical symptoms. Coronary lesions in ESRD patients are characterized by increased media thickness, infiltration and activation of macrophages, and marked calcification. Several studies showed worsened clinical outcomes after coronary revascularization, which were dependent on the severity of renal dysfunction. ESRD patients on hemodialysis have the most severe renal dysfunction; thus, the clinical outcomes are worse in these patients than in those with other types of renal dysfunction. Medications for primary or secondary cardiovascular prevention are also insufficient in ESRD patients. Efficacy of drug-eluting stents is inferior in ESRD patients, compared to the excellent outcomes observed in patients with normal renal function. Unsatisfactory outcomes with trials targeting cardiovascular disease in patients with ESRD emphasize a large potential to improve outcomes. Thus, optimal strategies for diagnosis, prevention, and management of cardiovascular disease should be modified in ESRD patients. PMID:29515692

Clinical and patient‐reported outcomes of Chinese patients undergoing haemodialysis in hospital or in the community: A 1‐year longitudinal study

PubMed Central

Wan, Eric YF; Choi, Edmond PH; Wong, Carlos KH; Chan, Anca KC; Chan, Karina HY; Li, Philip KT; Lam, Cindy LK

2016-01-01

Abstract Aim Little is known about the effect of haemodialysis (HD) setting on outcomes of patients with end stage renal disease (ESRD). The study aimed at comparing clinical outcomes and patient‐reported outcomes (PRO) of patients on community‐based (CBHD) and hospital‐based haemodialysis (HBHD). Methods A prospective cohort of Chinese ESRD patients receiving HBHD (n = 89) or CBHD (n = 117) in Hong Kong were followed up for 12 months. Subjects were assessed on clinical outcomes of dialysis adequacy (Kt/V) and blood haemoglobin and PRO of health‐related quality of life (SF‐12v2), general health condition (Global Rating Scale (GRS)) and confidence to cope with their illness (Patient Enablement Instrument (PEI)). Differences between groups were analyzed by independent t‐tests for the SF‐12v2, GRS and PEI scores. χ2 tests were used to analyze the difference in proportion of patients reaching the targets of Kt/V and blood haemoglobin and with GRS > 0 and PEI > 0. Multiple linear and logistic regressions were performed to assess the adjusted difference‐in‐difference estimation. Results The mean PEI and GRS scores of CBHD patients at 12 months were significantly higher than those of HBHD patients. CBHD patients had significantly greater improvement in self‐efficacy and were more likely to be enabled after 12 months than the HBHD patients. Conclusion The study showed similar clinical outcomes and PRO between CBHD and HBHD but CBHD was more effective than HBHD in promoting patient enablement over a 12‐month period. The results suggest added value for patients receiving CBHD and support the transfer of HD care from the hospital to the community. PMID:26616825

Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).

PubMed

Evans, Scott R; Rubin, Daniel; Follmann, Dean; Pennello, Gene; Huskins, W Charles; Powers, John H; Schoenfeld, David; Chuang-Stein, Christy; Cosgrove, Sara E; Fowler, Vance G; Lautenbach, Ebbing; Chambers, Henry F

2015-09-01

Clinical trials that compare strategies to optimize antibiotic use are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. The Antibacterial Resistance Leadership Group strives to overcome these challenges through innovative trial design. Response adjusted for duration of antibiotic risk (RADAR) is a novel methodology utilizing a superiority design and a 2-step process: (1) categorizing patients into an overall clinical outcome (based on benefits and harms), and (2) ranking patients with respect to a desirability of outcome ranking (DOOR). DOORs are constructed by assigning higher ranks to patients with (1) better overall clinical outcomes and (2) shorter durations of antibiotic use for similar overall clinical outcomes. DOOR distributions are compared between antibiotic use strategies. The probability that a randomly selected patient will have a better DOOR if assigned to the new strategy is estimated. DOOR/RADAR represents a new paradigm in assessing the risks and benefits of new strategies to optimize antibiotic use. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Framework to assess the effects of using patient-reported outcome measures in chronic care management.

PubMed

Santana, Maria-Jose; Feeny, David

2014-06-01

The inclusion of patient-reported outcome measures (PROMs) in the routine clinical care of chronically ill patients has the potential to add valuable information about the impact of the disease and its treatment and promotes effective patient self-management in which patients become more active participants in their own care. PROMs provide clinicians with timely information on patients' symptoms as well as functional and emotional status. PROMs are a useful tool for enhancing patient-clinician communication. We develop a conceptual framework describing the potential effects of the use of PROMs in chronic care management. The framework summarizes insights from the methods for evaluating the clinical effectiveness and methods for the health technology assessment of diagnostic technologies and results from the relevant studies. The framework describes potential effects, from proximal to distal, including communication (patient-clinician, patient-relative, clinician-clinician, and clinician-relative), engaging patients in shared clinical decision making, patient management (clinician management and patient self-management), and patient outcomes. Important potential effects also include enhancement in patient activation as well as improvements in clinician and patient satisfaction, and patient adherence to recommended treatment. Previous frameworks have described patient-physician communication, patient satisfaction, and health outcomes. Our framework adds unique domains, including patient engagement, patient activation, shared clinical decision making, and patient self-management. The framework can be used as a tool to guide the development of interventions to improve chronic care management through the use of PROMs.

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

PubMed Central

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. PMID:29243586

Patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review of patient reported outcomes and patient and clinician satisfaction

PubMed Central

2013-01-01

Background The cost to the NHS of missed or inappropriate hospital appointments is considerable. Alternative methods of appointment scheduling might be more flexible to patients’ needs without jeopardising health and service quality. The objective was to systematically review evidence of patient initiated clinics in secondary care on patient reported outcomes among patients with chronic/recurrent conditions. Methods Seven databases were searched from inception to June 2013. Hand searching of included studies references was also conducted. Studies comparing the effects of patient initiated clinics with traditional consultant led clinics in secondary care for patients with long term chronic or recurrent diseases on health related quality of life and/or patient satisfaction were included. Data was extracted by one reviewer and checked by a second. Results were synthesised narratively. Results Seven studies were included in the review, these covered a total of 1,655 participants across three conditions: breast cancer, inflammatory bowel disease and rheumatoid arthritis. Quality of reporting was variable. Results showed no significant differences between the intervention and control groups for psychological and health related quality of life outcomes indicating no evidence of harm. Some patients reported significantly more satisfaction using patient-initiated clinics than usual care (p < 0.001). Conclusions The results show potential for patient initiated clinics to result in greater patient and clinician satisfaction. The patient-consultant relationship appeared to play an important part in patient satisfaction and should be considered an important area of future research as should the presence or absence of a guidebook to aid self-management. Patient initiated clinics fit the models of care suggested by policy makers and so further research into long term outcomes for patients and service use in this area of practice is both relevant and timely. PMID:24289832

Using Data Augmentation to Facilitate Conduct of Phase I–II Clinical Trials with Delayed Outcomes

PubMed Central

Jin, Ick Hoon; Liu, Suyu; Thall, Peter F.; Yuan, Ying

2014-01-01

A practical impediment in adaptive clinical trials is that outcomes must be observed soon enough to apply decision rules to choose treatments for new patients. For example, if outcomes take up to six weeks to evaluate and the accrual rate is one patient per week, on average three new patients will be accrued while waiting to evaluate the outcomes of the previous three patients. The question is how to treat the new patients. This logistical problem persists throughout the trial. Various ad hoc practical solutions are used, none entirely satisfactory. We focus on this problem in phase I–II clinical trials that use binary toxicity and efficacy, defined in terms of event times, to choose doses adaptively for successive cohorts. We propose a general approach to this problem that treats late-onset outcomes as missing data, uses data augmentation to impute missing outcomes from posterior predictive distributions computed from partial follow-up times and complete outcome data, and applies the design’s decision rules using the completed data. We illustrate the method with two cancer trials conducted using a phase I–II design based on efficacy-toxicity trade-offs, including a computer stimulation study. PMID:25382884

Treatment, Outcomes, and Clinical Trial Participation in Elderly Patients With Metastatic Pancreas Adenocarcinoma

PubMed Central

Li, Daneng; Capanu, Marinela; Yu, Kenneth H.; Lowery, Maeve A.; Kelsen, David P.; O’Reilly, Eileen M.

2016-01-01

Studies on the treatment patterns and outcomes of elderly patients with metastatic pancreas cancer remain limited. Therefore, an analysis of systemic therapy use, clinical trial participation, and outcomes in elderly patients with metastatic pancreas cancer was performed at our institution. Elderly patients who received systemic therapy had a longer survival compared with those who did not. However, therapeutic clinical trial participation was low and should be encouraged Background Pancreas adenocarcinoma has a median age at diagnosis of 71 years. Limited studies have focused on the treatment of elderly patients with pancreas cancer. Patients and Methods An analysis of systemic therapy use, clinical trial participation, and overall outcomes of 237 patients with metastatic pancreas adenocarcinoma ≥ 75 years of age evaluated at Memorial Sloan-Kettering Cancer Center between 2005 and 2013 was undertaken. Results Median overall survival was 7 months for the entire study population. A total of 197 (83%) patients received systemic therapy, which was significantly associated with longer overall survival (P < .01). No significant difference was detected in survival between age groups 75 to 79, 80 to 84, and ≥ 85 years of age among those who received systemic therapy (P = .49). Seventy-seven (32%) patients participated in a clinical trial of whom 13 (5%) patients were enrolled in a therapeutic trial, including no patients aged ≥ 85 years. Multivariate analysis demonstrated that presence of liver metastases (P < .001), performance status (P < .001), and number of systemic agents (P < .001) were significantly associated with survival. Conclusion Receipt of systemic therapy was associated with longer survival in elderly patients ≥ 75 years of age with metastatic pancreas adenocarcinoma. Therapeutic clinical trial participation among these patients was low and future development of prognostic models for appropriate patient selection is warranted. PMID:26072442

Relationship between the duration of trimethoprim/sulfamethoxazole treatment and the clinical outcome of pulmonary nocardiosis.

PubMed

Tashiro, Hiroki; Takahashi, Koichiro; Kusaba, Koji; Tanaka, Masahide; Komiya, Kazutoshi; Nakamura, Tomomi; Aoki, Yosuke; Kimura, Shinya; Sueoka-Aragane, Naoko

2018-03-01

Despite treatment, pulmonary nocardiosis, which is a rare opportunistic disease caused by Nocardia species, has poor clinical outcomes including recurrence and death. Currently, the treatment regimen and duration for pulmonary nocardiosis are not fully understood. The present study aimed to clarify the factors related to the clinical outcome of pulmonary nocardiosis. The medical records of 24 patients with pulmonary nocardiosis were retrospectively reviewed. The patients were divided into two groups based on the outcomes within 2 years: patients with controlled disease (n = 14) and patients who developed recurrence or died (n = 10). Nocardia was identified by 16S ribosomal RNA sequencing in 17 patients (70.8%) and by conventional biochemical test in five patients (20.8%). The patients' characteristics, clinical findings, radiological features, and treatment history were not different between the two groups. Compared with patients who developed recurrence or died, those with controlled disease had significantly longer total duration of treatment with antibiotics, especially trimethoprim/sulfamethoxazole (67.5 ± 111.6 days vs. 9.0 ± 6.5 days; p = 0.01). Pancytopenia was the most frequent adverse effect of trimethoprim/sulfamethoxazole. Longer duration of trimethoprim/sulfamethoxazole treatment was significantly associated with better outcomes of pulmonary nocardiosis. In such cases, antibiotics, especially trimethoprim/sulfamethoxazole, should be administered for more than 3 months. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

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

PubMed

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.

Clinical Outcome After Mechanical Thrombectomy in Non-elderly Patients with Acute Ischemic Stroke in the Anterior Circulation: Primary Admission Versus Patients Referred from Remote Hospitals.

PubMed

Pfaff, J; Pham, M; Herweh, C; Wolf, M; Ringleb, P A; Schönenberger, S; Bendszus, M; Möhlenbruch, M

2017-06-01

Stroke networks have been installed to increase access to advanced stroke specific treatments like mechanical thrombectomy (MT). This concept often requires patients to be transferred to a comprehensive stroke center (CSC) offering MT. Do patient referral, transportation, and logistic effort translate into clinical outcomes comparable to patients admitted primarily to the CSC? We categorized 112 patients with acute ischemic stroke in the anterior circulation, who received MT at our institution, into primary admissions (A) and referrals from either local (B) or regional (C) hospitals, assessed the clinical outcome, and tested the impact of distance and delay of transportation from the referring remote hospital. The median time from symptom onset to initial CT was similar in all groups (p = 0,939). Patients who were transferred to the CSC had significantly increasing median time between initial CT and MT (in minutes (interquartile range [IQR]); A: 83 [68-120]; B: 174 [159-208]; C: 220 [181-235]; p < 0.001) and median time between onset to MT (in minutes [IQR]; A: 178 [150-210]; B: 274 [238-349]; C: 293 [256-329]; p < 0.001). After 90 days of MT there was no significant difference in clinical outcome (modified Rankin Scale ≤ 2) between primary admitted and referred patients (p = 0.502). Clinical outcome in patients who received MT after transfer from either local or regional remote hospitals was not significantly worse than in patients primarily admitted to the CSC. In the event of an acute ischemic stroke patients living in urban or rural areas should, despite a possible delay, have access to MT.

Does clinical supervision of healthcare professionals improve effectiveness of care and patient experience? A systematic review.

PubMed

Snowdon, David A; Leggat, Sandra G; Taylor, Nicholas F

2017-11-28

To ensure quality of care delivery clinical supervision has been implemented in health services. While clinical supervision of health professionals has been shown to improve patient safety, its effect on other dimensions of quality of care is unknown. The purpose of this systematic review is to determine whether clinical supervision of health professionals improves effectiveness of care and patient experience. Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Data were extracted on effectiveness of care (process of care and patient health outcomes) and patient experience. Seventeen studies across multiple health professions (medical (n = 4), nursing (n = 7), allied health (n = 2) and combination of nursing, medical and/or allied health (n = 4)) met the inclusion criteria. The clinical heterogeneity of the included studies precluded meta-analysis. Twelve of 14 studies investigating 38,483 episodes of care found that clinical supervision improved the process of care. This effect was most predominant in cardiopulmonary resuscitation and African health settings. Three of six studies investigating 1756 patients found that clinical supervision improved patient health outcomes, namely neurological recovery post cardiopulmonary resuscitation (n = 1) and psychological symptom severity (n = 2). None of three studies investigating 1856 patients found that clinical supervision had an effect on patient experience. Clinical supervision of health professionals is associated with effectiveness of care. The review found significant improvement in the process of care that may improve compliance with processes that are associated with enhanced patient health outcomes. While few studies found a direct effect on patient health outcomes, when provided to mental health professionals clinical supervision may be associated with a reduction in psychological symptoms of patients diagnosed with a mental illness. There was no association found between clinical supervision and the patient experience. CRD42015029643 .

The predictor of mortality outcome in adult patients with Ebola virus disease during the 2014-2015 outbreak in Guinea.

PubMed

Cherif, M S; Koonrungsesomboon, N; Diallo, M P; Le Gall, E; Kassé, D; Cherif, F; Koné, A; Diakité, M; Camara, F; Magassouba, N

2017-04-01

The purpose of this study was to examine the association of any demographic and clinical factors with mortality outcome among adult patients with Ebola virus disease (EVD) in Guinea. This retrospective observational study analyzed medical records of laboratory confirmed EVD adult patients during the 2014-2015 EVD outbreak in Guinea. The associations between any demographic or clinical variables and mortality outcome of EVD were assessed using univariate and multivariate logistic regression analyses. Of 2,310 EVD adult patients included for analysis, the overall case fatality rate was 68.1%. Univariate analyses identified factors possibly associated with mortality outcome, including patient age (p < 0.001), history of visiting or close contact with a suspected or confirmed EVD patient (p = 0.035), and seven clinical symptoms on admission, i.e., fever (p = 0.003), hiccups (p < 0.001), vomiting (p = 0.003), diarrhea (p < 0.001), cough (p = 0.001), sore throat (p = 0.016), and unexplained bleeding (p = 0.021). The multivariate analysis showed that patient age was independently associated with mortality outcome of EVD (OR = 1.06; 95%CI = 1.03-1.09; p < 0.001), while none the of clinical symptoms on admission were significantly associated with the mortality outcome. Our analysis indicates that older age was the only independent factor associated with death among EVD adult patients in Guinea. This suggests that older EVD patients should receive intensive medical care and be carefully monitored.

The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

PubMed Central

Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

2016-01-01

Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

Prevalence and clinical outcomes of hepatitis B virus infection in patients with aplastic anemia.

PubMed

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.

Relationship between total quality management, critical paths, and outcomes management.

PubMed

Lynn, P A

1996-09-01

Total quality management (TQM), clinical paths, and outcomes management are high-profile strategies in today's health care environment. Each strategy is distinct, yet there are interrelationships among them. TQM supports a customer-focused organizational culture, providing tools and techniques to identify and solve problems. Clinical paths are tools for enhancing patient care coordination and for identifying system-wide and patient population specific issues. Outcomes management is an integrated system for measuring the results in patient populations over time. There is a recent shift in outcomes measurement towards expanding both the nature of the outcomes examined and the timeframes in which they are studied.

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

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

Ohri, Nitin; Rapkin, Bruce D.; Guha, Chandan

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 228more » 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 outcomes.« less

Linking Nurses' Clinical Leadership to Patient Care Quality: The Role of Transformational Leadership and Workplace Empowerment.

PubMed

Boamah, Sheila

2018-03-01

Background While improving patient safety requires strong nursing leadership, there has been little empirical research that has examined the mechanisms by which leadership influences patient safety outcomes. Aim To test a model examining relationships among transformational leadership, structural empowerment, staff nurse clinical leadership, and nurse-assessed adverse patient outcomes. Methods A cross-sectional survey was conducted with a randomly selected sample of 378 registered nurses working in direct patient care in acute care hospitals across Ontario, Canada. Structural equation modeling was used to test the hypothesized model. Results The model had an acceptable fit, and all paths were significant. Transformational leadership was significantly associated with decreased adverse patient outcomes through structural empowerment and staff nurse clinical leadership. Discussion This study highlights the importance of transformational leadership in creating empowering practice environments that foster high-quality care. The findings indicate that a more complete understanding of what drives desired patient outcomes warrants the need to focus on how to empower nurses and foster clinical leadership practices at the point of care. Conclusion In planning safety strategies, managers must demonstrate transformational leadership behaviors in order to modify the work environment to create better defenses for averting adverse events.

Functional outcomes after bilateral arthroscopic rotator cuff repair.

PubMed

Aleem, Alexander W; Syed, Usman Ali M; Wascher, Jocelyn; Zoga, Adam C; Close, Koby; Abboud, Joseph A; Cohen, Steven B

2016-10-01

Arthroscopic repair of rotator cuff tears is a common procedure performed by orthopedic surgeons. There is a well-known incidence of up to 35% of bilateral rotator cuff tear disease in patients who have a known unilateral tear. The majority of the literature focuses on outcomes after unilateral surgery. The purpose of this study was to determine if there are clinical differences in shoulders of patients who underwent staged bilateral rotator cuff repairs during their lifetime. A retrospective review of all patients who underwent staged bilateral arthroscopic rotator cuff surgery at our institution was performed. All patients had at least 2 years of follow-up. Clinical outcome scores including the American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation, and Rowe measures were obtained. A subset of patients returned for clinical and ultrasound evaluation performed by an independent fellowship-trained musculoskeletal radiologist. Overall, 110 shoulders in 55 patients, representing 68% of all eligible patients, participated. No clinical or statistical difference was found in any outcome measure. ASES scores averaged 86.5 (36.7-100) in the dominant shoulder compared with 89.6 (23.3-100) in the nondominant shoulder (P = .42). Ultrasound was available on 34 shoulders and showed complete healing rate of 88%. The shoulders with retearing of the rotator cuff (12%) demonstrated clinically relevant lower ASES scores (72.5) compared with shoulders with confirmed healed repairs (86.2; P = .2). Patients who undergo staged bilateral rotator cuff repair can expect to have similarly good clinical outcomes regardless of hand dominance or chronologic incidence with excellent healing rates in both shoulders. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT).

PubMed

Sundseth, Jarle; Jacobsen, Eva Astrid; Kolstad, Frode; Sletteberg, Ruth O; Nygaard, Oystein P; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Fredriksli, Oddrun Anita; Myrseth, Erling; Zwart, John A

2016-07-01

Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

Risk-adjusted clinical outcomes in patients enrolled in a bloodless program

PubMed Central

Frank, Steven M.; Wick, Elizabeth C.; Dezern, Amy E.; Ness, Paul M.; Wasey, Jack O.; Pippa, Andrew C.; Dackiw, Elizabeth; Resar, Linda M.S.

2014-01-01

BACKGROUND Although clinical outcomes have been reported for patients who do not accept allogeneic blood transfusion (ABT), many previous studies lack a control group, fail to use risk adjustment, and focus exclusively on cardiac surgery. STUDY DESIGN AND METHODS We report a risk-adjusted, propensity score–matched, retrospective case-control study of clinical outcomes for inpatients who did not accept ABT (bloodless, n = 294) and those who did accept ABT (control, n = 1157). Multidisciplinary specialized care was rendered to the bloodless patients to conserve blood and optimize clinical outcomes. Differences in hemoglobin (Hb), mortality, five morbid outcomes, and hospital charges and costs were compared. Subgroups of medical and surgical patients were analyzed, and independent predictors of outcome were determined by multivariate analysis. RESULTS Overall, mortality was lower in the bloodless group (0.7%) than in the control group (2.7%; p = 0.046), primarily attributed to the surgical subgroup. After risk adjustment, bloodless care was not an independent predictor of the composite adverse outcome (death or any morbid event; p = 0.91; odds ratio, 1.02; 95% confidence interval, 0.68–1.53). Discharge Hb concentrations were similar in the bloodless (10.8 ± 2.7 g/dL) and control (10.9 ± 2.3 g/dL) groups (p = 0.42). Total and direct hospital costs were 12% (p = 0.02) and 18% (p = 0.02) less, respectively, in the bloodless patients, a difference attributed to the surgical subgroup. CONCLUSIONS Using appropriate blood conservation measures for patients who do not accept ABT results in similar or better outcomes and is associated with equivalent or lower costs. This specialized care may be beneficial even for those patients who accept ABT. PMID:24942198

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

PubMed

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 overall satisfaction with the anticoagulation treatment. The participants who were naïve to anticoagulation treatment reported a significantly greater satisfaction and better QoL than the experienced patients [58 (44) vs. 82 (59); P = 0·009]. These findings provide early evidence that the patients who were managed at a pharmacy-based anticoagulation clinic in an evolving healthcare system experienced optimal anticoagulation management. © 2016 John Wiley & Sons Ltd.

Anti-NMDA receptor encephalitis: clinical characteristics, predictors of outcome and the knowledge gap in southwest China.

PubMed

Wang, W; Li, J-M; Hu, F-Y; Wang, R; Hong, Z; He, L; Zhou, D

2016-03-01

The aim was to analyse the clinical profiles and outcomes of patients with anti- N-methyl-d-aspartate receptor (anti-NMDAR) encephalitis in China. A retrospective study of anti-NMDAR encephalitis in China was performed between June 2011 and June 2014. The clinical characteristics and predictors of poor outcome were determined. A total of 51 patients with a definitive diagnosis of anti-NMDAR encephalitis were included in this study. Four of them were surgically confirmed to have a neoplasm. Thirty-two patients, amongst whom 24 were female, presented with psychiatric disorder as the initial symptom, whereas 14 patients, of whom nine were male, presented with seizure as the initial symptom (P = 0.011). Twenty-nine patients (56.86%) were initially misdiagnosed with psychosis, viral encephalitis or other diseases, and 58.8% of the patients experienced at least one type of complication. It typically took 3 weeks before these patients were admitted to our hospital and another 2 weeks before the correct diagnosis was made. Forty-one patients (80%) reached a good outcome; 10 patients (20%) had a poor outcome. Older age, extended hospital stay, memory deficits, decreased consciousness, central hypoventilation, complications and abnormal cerebrospinal fluid results were associated with poor outcome (P < 0.05). Female patients more frequently initially present with psychiatric disorder but male patients more frequently initially present with seizure. Patients with anti-NMDAR encephalitis in China have a lower incidence of neoplasm. Nevertheless, this study reveals several challenges in treating anti-NMDAR encephalitis in China that may contribute to poor outcome. © 2015 EAN.

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation

PubMed Central

Evans, Scott R.; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient’s perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision. PMID:28435515

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?

PubMed

Hamaker, M E; Stauder, R; van Munster, B C

2014-03-01

Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population.

Clinical Course, Radiological Manifestations, and Outcome of Pneumocystis jirovecii Pneumonia in HIV Patients and Renal Transplant Recipients.

PubMed

Ebner, Lukas; Walti, Laura N; Rauch, Andri; Furrer, Hansjakob; Cusini, Alexia; Meyer, Andreas M J; Weiler, Stefan; Huynh-Do, Uyen; Heverhagen, Johannes; Arampatzis, Spyridon; Christe, Andreas

2016-01-01

Pneumocystis jirovecii pneumonia (PCP) is a frequent opportunistic infection in immunocompromised patients. In literature, presentation and outcome of PCP differs between patients with human immunodeficiency virus (HIV) infection and renal transplant recipients (RTRs). We conducted a cross-sectional study of patients with PCP based on the HIV and renal transplant registries at our institution. Radiological and clinical data from all confirmed PCP cases between 2005 and 2012 were compared. Forty patients were included: 16 with HIV and 24 RTRs. Radiologically, HIV patients had significantly more areas of diffuse lung affection (81% HIV vs. 25% RTR; p = 0.02), more ground glass nodules 5-10 mm (69% vs. 4%; p = <0.001) and enlarged hilar lymph nodes were found only in HIV patients (44%). Cough and dyspnea were the most common clinical signs (>80%) in both groups. Duration from illness onset to hospital presentation was longer in the HIV patients (median of 18 vs. 10 days (p = 0.02)), implying a less fulminant clinical course. Sixty percent of PCP cases in RTRs occurred >12 months after transplantation. Lengths of hospitalization, admission rates to the intensive care unit, and requirements for mechanical ventilation were similar. Outcome in both groups was favourable. While important differences in radiological presentation of PCP between HIV patients and RTRs were found, clinical presentation was similar. PCP only rarely presented with fulminant respiratory symptoms requiring ICU admission, with similar results and outcomes for HIV patients and RTRs. Early diagnosis and treatment is mandatory for clinical success.

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?†

PubMed Central

Hamaker, M. E.; Stauder, R.; van Munster, B. C.

2014-01-01

Background Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. Method The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Conclusion Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population. PMID:24458474

Clinical outcomes in a specialist male genital skin clinic: prospective follow-up of 600 patients.

PubMed

Shah, M

2017-10-01

It is important to assess outcomes for medical interventions in order to focus scarce resources on outcomes with a known positive benefit. An open, observational study was performed to assess the clinical outcomes of 600 male patients with a genital skin problem attending a specialist secondary care dermatology facility. Patients were mainly referred by general practitioners and genitourinary medicine physicians. Outcome was measured at 3 and 6 months, and was determined by clinical examination and assessment of patient symptoms. The mean age of the group was 45.3 years. The commonest diagnoses were lichen sclerosus (30.5%), balanitis (17.3%), eczema (12.8%), lichen planus (7.3%), psoriasis (7.2%) and benign lesions (5.5%). The commonest presenting symptoms were genital rash (43%), genital soreness, pain or burning (17.5%), and penile lesions (15.7%). Lichen sclerosus and all forms of balanitis were more common in uncircumcised patients, whereas lichen planus was more common in circumcised males. Short-term outcome was excellent, with 11.5% of patients being reassured and discharged on their first visit, and after 6 months 58% of all patients were clear and 12% had improved. Only 4.5% reported no improvement in symptoms. Diagnostic biopsy demonstrated malignant or premalignant lesions in nearly a fifth of those having a procedure. Close working with urological and genitourinary medicine colleagues is important to manage the various aspects of male health. © 2017 British Association of Dermatologists.

Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity.

PubMed

Smolen, Josef S; Strand, Vibeke; Koenig, Andrew S; Szumski, Annette; Kotak, Sameer; Jones, Thomas V

2016-05-21

Discordance between patient and physician ratings of rheumatoid arthritis (RA) severity occurs in clinical practice and correlates with pain scores and measurements of joint disease. However, information is lacking on whether discordance impacts patients' ability to work. We evaluated the discordance between patient and physician ratings of RA disease activity before and after treatment with etanercept and investigated the associations between discordance, clinical outcomes, and work productivity. In the PRESERVE clinical trial, patients with moderate RA received open-label etanercept 50 mg once weekly plus methotrexate for 36 weeks. Baseline and week-36 disease characteristics and clinical and work productivity outcomes were categorized according to week-36 concordance category, defined as positive discordance (patient global assessment - physician global assessment ≥2), negative discordance (patient global assessment - physician global assessment ≤ -2), and concordance (absolute difference between the two disease activity assessments = 0 or 1). Correlations between discordance, clinical outcomes, and predictors of discordance were determined. At baseline, 520/762 (68.2 %) patient and physician global assessment scores were concordant, 194 (25.5 %) were positively discordant, and 48 (6.3 %) were negatively discordant. After 36 weeks of therapy, 556/763 (72.9 %) scores were concordant, 189 (24.8 %) were positively discordant, and 18 (2.4 %) were negatively discordant. Patients with week-36 concordance had the best 36-week clinical and patient-reported outcomes, and overall, the greatest improvement between baseline and week 36. Baseline pain, swollen joint count, duration of morning stiffness, fatigue, and patient general health significantly correlated with week-36 discordance, p < 0.0001 to p < 0.05. Additionally, baseline pain, patient general health, and C-reactive protein were predictors of week-36 discordance (odds ratios 1.22, 1.02, and 0.98, respectively). For the employed patients, percent impairment while working and percent overall work impairment were highest (greatest impairment) at baseline and 36 weeks in the group with positive discordance. The percentage of patients with concordance increased after 36 weeks of treatment with etanercept, with concordant patients demonstrating the greatest improvement in clinical and patient-reported outcomes. Discordance correlated with several measures of disease activity and was associated with decreased work productivity. ClinicalTrials.gov identifier: NCT00565409 . Registered 28/11/2007.

Health literacy and patient outcomes in chronic kidney disease: a systematic review.

PubMed

Taylor, Dominic M; Fraser, Simon; Dudley, Chris; Oniscu, Gabriel C; Tomson, Charles; Ravanan, Rommel; Roderick, Paul

2017-11-20

Limited health literacy affects 25% of people with chronic kidney disease (CKD), and may reduce self-management skills resulting in poorer clinical outcomes. By disproportionately affecting people with low socio-economic status and non-white ethnicity, limited health literacy may promote health inequity. We performed a systematic review of quantitative studies of health literacy and clinical outcomes among adults with CKD. A total of 29 studies (13 articles; 16 conference abstracts) were included. One included non-USA patients. Of the 29 studies, 5 were cohort studies and 24 were cross-sectional. In all, 18 300 patients were studied: 4367 non-dialysis CKD; 13 202 dialysis; 390 transplant; 341 unspecified. Median study size was 127 [interquartile range (IQR) 92-238)], but 480 (IQR 260-2392) for cohort studies. Median proportion of non-white participants was 48% (IQR 17-70%). Six health literacy measures were used. Outcomes included patient attributes, care processes, clinical/laboratory parameters and 'hard' clinical outcomes. Limited health literacy was significantly, independently associated with hospitalizations, emergency department use, missed dialysis sessions, cardiovascular events and mortality (in cohort studies). Study quality was high (1 study), moderate (3 studies) and poor (25 studies), limited by sampling methods, variable adjustment for confounders and reduced methodological detail given in conference abstracts. There is limited robust evidence of the causal effects of health literacy on patient outcomes in CKD. Available evidence suggests associations with adverse clinical events, increased healthcare use and mortality. Prospective studies are required to determine the causal effects of health literacy on outcomes in CKD patients, and examine the relationships between socio-economic status, comorbidity, health literacy and CKD outcomes. Intervention development and evaluation will determine whether health literacy is a modifiable determinant of poor outcomes in CKD. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Systematization of Nursing Care in undergraduate training: the perspective of Complex Thinking.

PubMed

da Silva, Josilaine Porfírio; Garanhani, Mara Lucia; Peres, Aida Maris

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.

Analysis of long-term (median 10.5 years) outcomes in children presenting with traumatic brain injury and an initial Glasgow Coma Scale score of 3 or 4.

PubMed

Fulkerson, Daniel H; White, Ian K; Rees, Jacqueline M; Baumanis, Maraya M; Smith, Jodi L; Ackerman, Laurie L; Boaz, Joel C; Luerssen, Thomas G

2015-10-01

Patients with traumatic brain injury (TBI) with low presenting Glasgow Coma Scale (GCS) scores have very high morbidity and mortality rates. Neurosurgeons may be faced with difficult decisions in managing the most severely injured (GCS scores of 3 or 4) patients. The situation may be considered hopeless, with little chance of a functional recovery. Long-term data are limited regarding the clinical outcome of children with severe head injury. The authors evaluate predictor variables and the clinical outcomes at discharge, 1 year, and long term (median 10.5 years) in a cohort of children with TBI presenting with postresuscitation GCS scores of 3 and 4. A review of a prospectively collected trauma database was performed. Patients treated at Riley Hospital for Children (Indianapolis, Indiana) from 1988 to 2004 were reviewed. All children with initial GCS (modified for pediatric patients) scores of 3 or 4 were identified. Patients with a GCS score of 3 were compared with those with a GCS score of 4. The outcomes of all patients at the time of death or discharge and at 1-year and long-term follow-up were measured with a modified Glasgow Outcome Scale (GOS) that included a "normal" outcome. Long-term outcomes were evaluated by contacting surviving patients. Statistical "classification trees" were formed for survival and outcome, based on predictor variables. Sixty-seven patients with a GCS score of 3 or 4 were identified in a database of 1636 patients (4.1%). Three of the presenting factors differed between the GCS 3 patients (n = 44) and the GCS 4 patients (n = 23): presence of hypoxia, single seizure, and open basilar cisterns on CT scan. The clinical outcomes were statistically similar between the 2 groups. In total, 48 (71.6%) of 67 patients died, remained vegetative, or were severely disabled by 1 year. Eight patients (11.9%) were normal at 1 year. Ten of the 22 patients with long-term follow-up were either normal or had a GOS score of 5. Multiple clinical, historical, and radiological factors were analyzed for correlation with survival and clinical outcome. Classification trees were formed to stratify predictive factors. The pupillary response was the factor most predictive of both survival and outcome. Other factors that either positively or negatively correlated with survival included hypothermia, mechanism of injury (abuse), hypotension, major concurrent symptoms, and midline shift on CT scan. Other factors that either positively or negatively predicted long-term outcome included hypothermia, mechanism of injury, and the assessment of the fontanelle. In this cohort of 67 TBI patients with a presenting GCS score of 3 or 4, 56.6% died within 1 year. However, approximately 15% of patients had a good outcome at 10 or more years. Factors that correlated with survival and outcome included the pupillary response, hypothermia, and mechanism. The authors discuss factors that may help surgeons make critical decisions regarding their most serious pediatric trauma patients.

Impact of a Pharmacist-Managed Heart Failure Postdischarge (Bridge) Clinic for Veterans.

PubMed

Hale, Genevieve M; Hassan, Sonia L; Hummel, Scott L; Lewis, Carrie; Ratz, David; Brenner, Michael

2017-07-01

Hospitals that provide early postdischarge follow-up after heart failure (HF) hospitalization tend to have lower rates of readmission. However, HF postdischarge (bridge) clinics have not been extensively evaluated. To assess the impact of a pharmacist-managed HF bridge clinic in a veteran population. HF patients hospitalized from November 2010 to August 2013 were identified. Retrospective chart review was conducted of 122 HF patients seen at bridge clinic compared with 122 randomly selected HF patients not seen at this clinic (usual care). Primary end point was 90-day all-cause readmission and death. Secondary outcomes were 30-day all-cause readmission and death, time to first postdischarge follow-up, first all-cause readmission. Bridge clinic patients were at higher baseline risk of readmission and death; other characteristics were similar. 90-day death and all-cause readmission trended lower in bridge clinic patients (adjusted hazard ratio [HR] = 0.64; 95% CI = 0.40-1.02; P = 0.06). Time to first follow-up was shorter in bridge clinic patients (11 ± 6 vs 20 ± 23 days; P < 0.001); time to first all-cause readmission trended longer (40 ± 20 vs 33 ± 25days; P = 0.11). 30-day death and all-cause readmission was significantly lower in bridge clinic patients (adjusted HR = 0.44; 95% CI = 0.22-0.88; P = 0.02). In veteran patients hospitalized for HF, pharmacist-managed HF bridge clinic significantly reduced the time to initial follow-up compared with usual care. Improved short-term outcomes and trend toward improvement of longer-term outcomes in bridge clinic patients was shown.

Moderate clinical improvement after revision arthroplasty of the severely stiff knee.

PubMed

Heesterbeek, P J C; Goosen, J H M; Schimmel, J J P; Defoort, K C; van Hellemondt, G G; Wymenga, A B

2016-10-01

Revision of the severe stiff total knee arthroplasty (TKA) is challenging, and clinical outcome is inferior to other indications for revision. The purpose of the present study was to determine clinical outcome of TKA revision in patients with severe stiffness (range of motion (ROM) ≤ 70°) and evaluate a possible influence of accompanying findings, such as component malposition, aseptic loosening or instability. A prospective cohort of 40 patients with a preoperative ROM ≤ 70° and a minimum of 2-year follow-up after total system revision (Genesis or Legion stemmed condylar implant) was evaluated. ROM, Knee Society Scoring System (KSS) and visual analogue scale (VAS) pain scores were obtained preoperatively and at 2 years. Patient satisfaction and complication rate were assessed. Component malposition was most frequently reported as accompanying finding (n = 27). Comparisons between pre- and postoperative outcome (p < 0.05) and between different subgroups (component malposition, aseptic loosening, and instability) based on accompanying findings were made (no statistical comparison). ROM, KSS and VAS pain scores improved significantly (p < 0.001): median ROM at two years 85° (range 10-125) and median gain 25° (range -10 to +85). Median VAS satisfaction was 53.5 points (range 15-98). Seventeen patients reported at least one complication, including one re-revision. Six patients underwent manipulation under anaesthesia, and five were referred to the pain clinic. No clear differences between subgroups were observed. TKA revision in patients with severe stiffness resulted in a moderate but significant improved clinical outcome after 2 years. Accompanying abnormalities such as component malposition, aseptic loosening or instability did not influence clinical outcome. Realistic patient counselling on the moderate outcome and possible remaining limitations in daily life might help to improve patient satisfaction. Therapeutic studies-case series with no comparison group, Level IV.

Application of a simplified definition of diastolic function in severe sepsis and septic shock.

PubMed

Lanspa, Michael J; Gutsche, Andrea R; Wilson, Emily L; Olsen, Troy D; Hirshberg, Eliotte L; Knox, Daniel B; Brown, Samuel M; Grissom, Colin K

2016-08-04

Left ventricular diastolic dysfunction is common in patients with severe sepsis or septic shock, but the best approach to categorization is unknown. We assessed the association of common measures of diastolic function with clinical outcomes and tested the utility of a simplified definition of diastolic dysfunction against the American Society of Echocardiography (ASE) 2009 definition. In this prospective observational study, patients with severe sepsis or septic shock underwent transthoracic echocardiography within 24 h of onset of sepsis (median 4.3 h). We measured echocardiographic parameters of diastolic function and used random forest analysis to assess their association with clinical outcomes (28-day mortality and ICU-free days to day 28) and thereby suggest a simplified definition. We then compared patients categorized by the ASE 2009 definition and our simplified definition. We studied 167 patients. The ASE 2009 definition categorized only 35 % of patients. Random forest analysis demonstrated that the left atrial volume index and deceleration time, central to the ASE 2009 definition, were not associated with clinical outcomes. Our simplified definition used only e' and E/e', omitting the other measurements. The simplified definition categorized 87 % of patients. Patients categorized by either ASE 2009 or our novel definition had similar clinical outcomes. In both definitions, worsened diastolic function was associated with increased prevalence of ischemic heart disease, diabetes, and hypertension. A novel, simplified definition of diastolic dysfunction categorized more patients with sepsis than ASE 2009 definition. Patients categorized according to the simplified definition did not differ from patients categorized according to the ASE 2009 definition in respect to clinical outcome or comorbidities.

Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure.

PubMed

Youn, Jong-Chan; Lee, Hye Sun; Choi, Suk-Won; Han, Seong-Woo; Ryu, Kyu-Hyung; Shin, Eui-Cheol; Kang, Seok-Min

2016-01-01

Post-exercise heart rate recovery (HRR) is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF) has not been investigated. We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mean ejection fraction 28.9 ± 14.2%) during the pre-discharge period. The primary endpoint included cardiovascular (CV) events defined as CV mortality, cardiac transplantation, or rehospitalization due to HF aggravation. The CV events occurred in 30 (28.0%) patients (5 cardiovascular deaths and 7 cardiac transplantations) during the follow-up period (median 214 days, 11-812 days). When the patients with ADHF were grouped by HRR according to the Contal and O'Quigley's method, low HRR was shown to be associated with significantly higher levels of serum monokine-induced by gamma interferon (MIG) and poor clinical outcome. Multivariate Cox regression analysis revealed that low HRR was an independent predictor of CV events in both enter method and stepwise method. The addition of HRR to a model significantly increased predictability for CV events across the entire follow-up period. Impaired post-exercise HRR is associated with a pro-inflammatory response and independently predicts clinical outcome in patients with ADHF. These findings may explain the relationship between autonomic dysfunction and clinical outcome in terms of the inflammatory response in these patients.

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport® or Prograf® preparations of tacrolimus

PubMed Central

Connor, Andrew; Prowse, Andrew; Newell, Paul; Rowe, Peter A.

2013-01-01

Background The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®. Methods Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. Results A total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. Conclusions This is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure. PMID:27818747

Acute versus subacute community-acquired meningitis: Analysis of 611 patients.

PubMed

Sulaiman, Tarek; Salazar, Lucrecia; Hasbun, Rodrigo

2017-09-01

Community-acquired meningitis can be classified into acute and subacute presentations by the duration of illness of ≤ or >5 days, respectively. There are currently no studies comparing the clinical features, management decisions, etiologies, and outcomes between acute and subacute presentations.It is a retrospective study of adults with community-acquired meningitis hospitalized in Houston, TX between January 2005 and January 2010. An adverse clinical outcome was defined as a Glasgow Outcome Scale score of ≤4.A total of 611 patients were identified, of which 458 (75%) were acute and 153 subacute (25%). The most common etiologies were unknown in 418 (68.4%), viral in 94 (15.4%), bacterial in 47 (7.7%), fungal in 42 patients (6.9%), and other noninfectious etiologies in 6 (1%). Patients with subacute meningitis were more likely to be immunosuppressed or have comorbidities, had fungal etiologies, and had higher rates of hypoglycorrachia and abnormal neurological findings (P <.05). Patients with an acute presentation were more likely to be treated empirically with intravenous antibiotics and had higher cerebrospinal fluid pleocytosis and serum white blood cell counts (P <.05). On logistic regression, age >65 years and abnormal neurological findings were predictive of an adverse clinical outcome in both acute and subacute meningitis, whereas fever was also a significant prognostic factor in acute meningitis. (P <.05).Acute and subacute meningitis differ in regards to clinical presentations, etiologies, laboratory findings, and management decisions, but did not differ in rates of adverse clinical outcomes. Future studies including thoroughly investigated patients with new diagnostic molecular methods may show different results and outcomes.

Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research.

PubMed

Wu, Albert W; Kharrazi, Hadi; Boulware, L Ebony; Snyder, Claire F

2013-08-01

This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient centeredness and digitization. We pose the question, "What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?" We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; and the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. Copyright © 2013 Elsevier Inc. All rights reserved.

Healthcare provider perceptions of the role of interprofessional care in access to and outcomes of primary care in an underserved area.

PubMed

Wan, Shaowei; Teichman, Peter G; Latif, David; Boyd, Jennifer; Gupta, Rahul

2018-03-01

To meet the needs of an aging population who often have multiple chronic conditions, interprofessional care is increasingly adopted by patient-centred medical homes and Accountable Care Organisations to improve patient care coordination and decrease costs in the United States, especially in underserved areas with primary care workforce shortages. In this cross-sectional survey across multiple clinical settings in an underserved area, healthcare providers perceived overall outcomes associated with interprofessional care teams as positive. This included healthcare providers' beliefs that interprofessional care teams improved patient outcomes, increased clinic efficiency, and enhanced care coordination and patient follow-up. Teams with primary care physician available each day were perceived as better able to coordinate care and follow up with patients (p = .031), while teams that included clinical pharmacists were perceived as preventing medication-associated problems (p < .0001). Healthcare providers perceived the interprofessional care model as a useful strategy to improve various outcomes across different clinical settings in the context of a shortage of primary care physicians.

Diabetes Does Not Influence Selected Clinical Outcomes in Critically Ill Burn Patients

DTIC Science & Technology

2011-01-01

18464942] 46. Gornik I, Gornik O, Gasparovic V. HbA1c is outcome predictor in diabetic patients with sepsis. Diabetes Research and Clinical Practice...of Surgery. 2009; 96(11):1358–1364. [PubMed: 19847870] 50. O’Sullivan CJ, Hynes N, Mahendran B, et al. Haemoglobin A1c ( HbA1C ) in non-diabetic and...diabetic vascular patients. Is HbA1C an independent risk factor and predictor of adverse outcome? European Journal of Vascular and Endovascular Surgery

Lumbar Disc Replacement for Junctional Decompensation After Fusion Surgery: Clinical and Radiological Outcome at an Average Follow-Up of 33 Months

PubMed Central

Sliwa, Karen; Weinberg, Ian R.; Sweet, Barry MBE; de Villiers, Malan; Candy, Geoffrey P.

2007-01-01

Background Failed fusion surgery remains difficult to treat. Few published data on disc replacement surgery after failed fusion procedures exist. Our objective was to evaluate outcomes of junctional lumbar disc replacement after previous fusion surgery and to correlate outcome with radiological changes to parameters of sagittal balance. Methods Out of a single-center prospective registry of 290 patients with 404 lumbar disc replacements, 27 patients had had a previous lumbar fusion operation on 1 to 4 lumbar segments and had completed a mean follow- up of 33 months (range: 18–56). We correlated the clinical outcome measures (patient satisfaction, 10-point pain score, and Oswestry Disability Index [ODI] score) to parameters of spinal sagittal alignment (sacral tilt, pelvic tilt, pelvic incidence, and lumbar lordosis). Results Postoperative hospital stay averaged 3.3 days (range: 2–8). Previously-employed patients went back to their jobs with a mean of 32 days (range: 21–42) after the procedure. At the latest follow-up, 1 of the patients considered the outcome to be poor, 3 fair, 8 good, and 15 excellent. Twenty-four patients “would undergo the operation again.” Average pain score decreased from 9.1 ± 1.0 (SD) to 3.2 ± 2.1 (P < .01). Average ODI decreased from 50.2 ± 9.9 preoperatively to 21.7 ± 14.2 (P ≤ .01). We found the change in pelvic tilt to be an independent predictor of better clinical outcome by multivariate analysis (P < .05). Conclusions In patients with junctional failure adjacent to a previous posterolateral fusion, disc replacement at the junctional level(s), compared with osteotomy and fusion surgery, offers the advantage of maintaining segmental mobility and correcting the flat-back deformity through a single approach with less operative time and blood loss. Early- to intermediate-term results are promising. The influence of changes in spinal sagittal alignment on clinical outcome needs to be addressed in future research. Clinical Relevance This is the first study on “junctional disc replacement patients” correlating clinical outcome to changes in spinal/pelvic alignment. PMID:25802584

Low Cerebral Blood Volume Identifies Poor Outcome in Stent Retriever Thrombectomy

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

Protto, Sara, E-mail: sara.protto@pshp.fi; Pienimäki, Juha-Pekka; Seppänen, Janne

BackgroundMechanical thrombectomy (MT) is an efficient treatment of acute stroke caused by large-vessel occlusion. We evaluated the factors predicting poor clinical outcome (3-month modified Rankin Scale, mRS >2) although MT performed with modern stent retrievers.MethodsWe prospectively collected the clinical and imaging data of 105 consecutive anterior circulation stroke patients who underwent MT after multimodal CT imaging. Patients with occlusion of the internal carotid artery and/or middle cerebral artery up to the M2 segment were included. We recorded baseline clinical, procedural and imaging variables, technical outcome, 24-h imaging outcome and the clinical outcome. Differences between the groups were studied with appropriatemore » statistical tests and binary logistic regression analysis.ResultsLow cerebral blood volume Alberta stroke program early CT score (CBV-ASPECTS) was associated with poor clinical outcome (median 7 vs. 9, p = 0.01). Lower collateral score (CS) significantly predicted poor outcome in regression modelling with CS = 0 increasing the odds of poor outcome 4.4-fold compared to CS = 3 (95% CI 1.27–15.5, p = 0.02). Lower CBV-ASPECTS significantly predicted poor clinical outcome among those with moderate or severe stroke (OR 0.82, 95% CI 0.68–1, p = 0.05) or poor collateral circulation (CS 0–1, OR 0.66, 95% CI 0.48–0.90, p = 0.009) but not among those with mild strokes or good collaterals.ConclusionsCBV-ASPECTS estimating infarct core is a significant predictor of poor clinical outcome among anterior circulation stroke patients treated with MT, especially in the setting of poor collateral circulation and/or moderate or severe stroke.« less

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Soluble intercellular adhesion molecule-1 and clinical outcomes in patients with acute lung injury

PubMed Central

Eisner, Mark D.; Parsons, Polly E.; Thompson, B. Taylor; Conner, Edward R.; Matthay, Michael A.; Ware, Lorraine B.

2009-01-01

Objective To determine if levels of soluble intercellular adhesion molecule-1 (sICAM-1), a marker of alveolar epithelial and endothelial injury, differ in patients with hydrostatic pulmonary edema and acute lung injury (ALI) and are associated with clinical outcomes in patients with ALI. Design, setting, and participants Measurement of sICAM-1 levels in (1) plasma and edema fluid from 67 patients with either hydrostatic pulmonary edema or ALI enrolled in an observational, prospective single center study, and (2) in plasma from 778 patients with ALI enrolled in a large multi-center randomized controlled trial of ventilator strategy. Results In the single-center study, levels of sICAM-1 were significantly higher in both edema fluid and plasma (median 938 and 545 ng/ml, respectively) from ALI patients compared to hydrostatic edema patients (median 384 and 177 ng/ml, P < 0.03 for both comparisons). In the multi-center study, higher plasma sICAM-1 levels were associated with poor clinical outcomes in both unadjusted and multivariable models. Subjects with ALI whose plasma sICAM-1 levels increased over the first 3 days of the study had a higher risk of death, after adjusting for other important predictors of outcome (odds ratio 1.48; 95% CI 1.03–2.12, P = 0.03). Conclusions Both plasma and edema fluid levels of sICAM-1 are higher in patients with ALI than in patients with hydrostatic pulmonary edema. Higher plasma sICAM-1 levels and increasing sICAM-1 levels over time are associated with poor clinical outcomes in ALI. Measurement of sICAM-1 levels may be useful for identifying patients at highest risk of poor outcomes from ALI. PMID:18670758

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

PubMed

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 (<20 ng/ml) and 31 (32%) had vitamin D insufficiency (<30 ng/ml, ≥20 mg/ml). Patients with vitamin D deficiency were similar with regard to age, gender, and comorbidities compared to patients with vitamin D levels ≥20. Univariate analysis revealed that patients with vitamin D deficiency had significantly worse FAOS with regard to symptoms (P = 0.017) and quality of life (P = 0.040) domains than patients with vitamin D levels ≥20. Multivariate regression analysis suggested that vitamin D deficiency was a factor in inferior FAOS with regard to symptoms, activities of daily living, and quality of life. In our group of patients with operative treated 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.

Community-Acquired Meningitis in Older Adults: Clinical Features, Etiology, and Prognostic Factors

PubMed Central

Wang, Amy Y.; Machicado, Jorge D.; Khoury, Nabil T.; Wootton, Susan H.; Salazar, Lucrecia; Hasbun, Rodrigo

2014-01-01

Background Bacterial meningitis in older adults is a well-studied and serious disease, but few studies have investigated the epidemiology and outcomes of community-acquired meningitis in older adults. Methods We conducted a retrospective study of 619 adults in Houston, Texas, with community-acquired meningitis hospitalized between January 1, 2005, and January 1, 2010. Patients were categorized as older if age ≥65 (N=54) and younger if age 18–64 (N=565). An adverse clinical outcome was defined as a Glasgow Outcome Scale score of 4 or less. Results Older patients consisted of 8.7% (54/619) of the total cohort and had higher rates of comorbidities, abnormal neurological and laboratory findings, abnormalities on computed tomography and magnetic resonance imaging of the head and adverse clinical outcomes (ACO) (p<0.05). The majority of patients (65.8%) had meningitis of unknown etiology. Bacterial meningitis was an infrequent cause (7.4%). Of the known causes, bacterial meningitis and West Nile virus were more common in older patients. In contrast, younger patients more frequently had cryptococcal and viral meningitis. On logistic regression, female gender was predictive of a poor outcome in the older patients, whereas abnormal neurologic exam, fever, and CSF glucose <45mg/dLwere significant poor prognostic factors in younger patients (p<0.05). Conclusion Most cases of community-acquired meningitis are of unknown origin. Older patients are more likely to have bacterial meningitis and West Nile virus infection when a cause can be identified. They also have more neurologic abnormalities, laboratory and imaging abnormalities, as well as adverse clinical outcomes. PMID:25370434

First BNCT treatment of a skin melanoma in Argentina: dosimetric analysis and clinical outcome.

PubMed

González, S J; Bonomi, M R; Santa Cruz, G A; Blaumann, H R; Calzetta Larrieu, O A; Menéndez, P; Jiménez Rebagliati, R; Longhino, J; Feld, D B; Dagrosa, M A; Argerich, C; Castiglia, S G; Batistoni, D A; Liberman, S J; Roth, B M C

2004-11-01

A Phase I/II protocol for treating cutaneuos melanomas with BNCT was designed in Argentina by the Comisión Nacional de Energía Atómica and the medical center Instituto Roffo. The first of a cohort of thirty planned patients was treated on October 9, 2003. This article depicts the protocol-based procedure and describes the first clinical case, treatment regime and planning, patient irradiation, retrospective dosimetric analysis and clinical outcome. Considering the low acute skin toxicity and the complete response in 21 of the 25 subcutaneous melanoma nodules treated, a second irradiation was performed in a different location of the extremity of the same patient. The corresponding clinical outcome is still under evaluation.

The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia.

PubMed

Joshi, Kruti; Mao, Lian; Biondi, David M; Millet, Robert

2018-01-29

Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of "real-world" patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual. This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12. A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort. Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes. Clinical Trial Registry: NCT01181960 . Registered 12 August 2010.

Clinical Features, Etiology, and Outcomes of Community-Acquired Pneumonia in Patients With Diabetes Mellitus

PubMed Central

Di Yacovo, Silvana; Garcia-Vidal, Carolina; Viasus, Diego; Adamuz, Jordi; Oriol, Isabel; Gili, Francesca; Vilarrasa, Núria; García-Somoza, M. Dolors; Dorca, Jordi; Carratalà, Jordi

2013-01-01

Abstract We performed an observational analysis of a prospective cohort of immunocompetent hospitalized adults with community-acquired pneumonia (CAP) to determine the epidemiology, clinical features, and outcomes of pneumonia in patients with diabetes mellitus (DM). We also analyzed the risk factors for mortality and the impact of statins and other cardiovascular drugs on outcomes. Of 2407 CAP episodes, 516 (21.4%) occurred in patients with DM; 483 (97%) had type 2 diabetes, 197 (40%) were on insulin treatment, and 119 (23.9%) had end-organ damage related to DM. Patients with DM had different clinical features compared to the other patients. They were less likely to have acute onset, cough, purulent sputum, and pleural chest pain. No differences in etiology were found between study groups. Patients with DM had more inhospital acute metabolic complications, although the case-fatality rate was similar between the groups. Independent risk factors for mortality in patients with DM were advanced age, bacteremia, septic shock, and gram-negative pneumonia. Patients with end-organ damage related to DM had more inhospital cardiac events and a higher early case-fatality rate than did the overall population. The use of statins and other cardiovascular drugs was not associated with better CAP outcomes in patients with DM. In conclusion, CAP in patients with DM presents different clinical features compared to the features of patients without DM. PMID:23263718

Features and Effects of Information Technology-Based Interventions to Improve Self-Management in Chronic Kidney Disease Patients: a Systematic Review of the Literature.

PubMed

Jeddi, Fateme Rangraz; Nabovati, Ehsan; Amirazodi, Shahrzad

2017-09-18

Slowing down the progression of chronic kidney disease (CKD) and its adverse health outcomes requires the patient's self-management and attention to treatment recommendations. Information technology (IT)-based interventions are increasingly being used to support self-management in patients with chronic diseases such as CKD. We conducted a systematic review of randomized controlled trials (RCTs) to assess the features and effects of IT-based interventions on self-management outcomes of CKD patients. A comprehensive search was conducted in Medline, Scopus, and the Cochrane Library to identify relevant papers that were published until May 2016. RCT Studies that assessed at least one automated IT tool in patients with CKD stages 1 to 5, and reported at least one self-management outcome were included. Studies were appraised for quality using the Cochrane Risk of Bias assessment tool. Out of 12,215 papers retrieved, eight study met the inclusion criteria. Interventions were delivered via smartphones/personal digital assistants (PDAs) (three studies), wearable devices (three studies), computerized systems (one study), and multiple component (one study). The studies assessed 15 outcomes, including eight clinical outcomes and seven process of care outcomes. In 12 (80%) of the 15 outcomes, the studies had revealed the effects of the interventions as statistically significant positive. These positive effects were observed in 75% of the clinical outcomes and 86% of the process of care outcomes. The evidence indicates the potential of IT-based interventions (i.e. smartphones/PDAs, wearable devices, and computerized systems) in self-management outcomes (clinical and process of care outcomes) of CKD patients.

Caring for Depression in Older Home Health Patients.

PubMed

Bruce, Martha L

2015-11-01

Depression is common in older home health patients and increases their risk of adverse outcomes. Depression screening is required by Medicare's Outcome and Assessment Information Set. The Depression Care for Patients at Home (CAREPATH) was developed as a feasible strategy for home health nurses to manage depression in their patients. The protocol builds on nurses' existing clinical skills and is designed to fit within routine home visits. Major components include ongoing clinical assessment, care coordination, medication management, education, and goal setting. In a randomized trial, Depression CAREPATH patients had greater improvement in depressive symptoms compared to usual care. The difference between groups was significant at 3 months, growing larger and more clinically meaningful over 1 year. The intervention had no impact on patient length of stay, number of home visits, or duration of visits. Thus, nurses can play a pivotal role in the long-term course and outcomes of patients with depression. Copyright 2015, SLACK Incorporated.

Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia.

PubMed

Bond, Bryan M; Kinslow, Christopher

2015-06-01

The primary purpose of this case report is to outline the diagnosis, intervention and clinical outcome of a patient presenting with occipital neuralgia. Upon initial presentation, the patient described a four-year history of stabbing neck pain and headaches. After providing informed consent, the patient underwent a total of four dry needling (DN) sessions over a two-week duration. During each of the treatment sessions, needles were inserted into the trapezii and suboccipital muscles. Post-intervention, the patient reported a 32-point change in her neck disability index score along with a 28-point change in her headache disability index score. Thus, it appears that subsequent four sessions of DN over two weeks, our patient experienced meaningful improvement in her neck pain and headaches. To the best of our knowledge, this is the first case report describing DN to successfully improve clinical outcomes in a patient diagnosed with occipital neuralgia.

Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia

PubMed Central

Bond, Bryan M.; Kinslow, Christopher

2015-01-01

The primary purpose of this case report is to outline the diagnosis, intervention and clinical outcome of a patient presenting with occipital neuralgia. Upon initial presentation, the patient described a four-year history of stabbing neck pain and headaches. After providing informed consent, the patient underwent a total of four dry needling (DN) sessions over a two-week duration. During each of the treatment sessions, needles were inserted into the trapezii and suboccipital muscles. Post-intervention, the patient reported a 32-point change in her neck disability index score along with a 28-point change in her headache disability index score. Thus, it appears that subsequent four sessions of DN over two weeks, our patient experienced meaningful improvement in her neck pain and headaches. To the best of our knowledge, this is the first case report describing DN to successfully improve clinical outcomes in a patient diagnosed with occipital neuralgia. PMID:26136602

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2017-01-01

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

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

PubMed

Kluetz, Paul G; O'Connor, Daniel J; Soltys, Katherine

2018-05-01

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents.

PubMed

Win, Htut K; Caldera, Angel E; Maresh, Kelly; Lopez, John; Rihal, Charanjit S; Parikh, Manish A; Granada, Juan F; Marulkar, Sachin; Nassif, Deborah; Cohen, David J; Kleiman, Neal S

2007-05-09

Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear. To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features. From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents. The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated. Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05). Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.

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

PubMed

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.

Posterior reversible encephalopathy syndrome in Korean patients with systemic lupus erythematosus: risk factors and clinical outcome.

PubMed

Jung, S M; Moon, S-J; Kwok, S-K; Ju, J H; Park, K-S; Park, S-H; Kim, H-Y

2013-08-01

Posterior reversible encephalopathy syndrome (PRES) is an uncommon neurologic condition associated with systemic lupus erythematosus (SLE). This study aimed to demonstrate the risk factors and clinical outcome of PRES in patients with SLE. Fifteen patients with SLE were diagnosed with PRES by characteristic clinical manifestations and magnetic resonance imaging (MRI) features from 2000 to 2012. Clinical profiles and outcomes were assessed for this study population. Additionally, 48 SLE patients with neurologic symptoms who underwent brain MRI were included for comparative analyses. The median age and duration of SLE in patients with PRES was 27 and 6.1 years, respectively. Comparison between patients with and without PRES revealed significant differences in the presentation of hypertension and seizure, lupus nephritis with renal insufficiency, treatment with high-dose steroid and cyclophosphamide, recent transfusion, and lupus activity measured by SLE disease activity index. Renal failure was the single independent factor with a high odds ratio of 129.250 by multivariate analysis. Of 15 patients, four experienced relapse and two died of sepsis during hospitalization. Our results suggest that lupus nephritis with renal dysfunction and other related clinical conditions can precede the occurrence of PRES in patients with SLE. It is important to perform early brain imaging for a timely diagnosis of PRES when clinically suspected.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

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.

PubMed

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 July 2016.

Clinical features and outcome of typhoid fever and invasive non-typhoidal salmonellosis in a tertiary hospital in Belgium: analysis and review of the literature.

PubMed

Yombi, J C; Martins, L; Vandercam, B; Rodriguez-Villalobos, H; Robert, A

2015-08-01

Typhoid fever (TF) occurs rarely in industrialized countries because of advances in health care and improvement of drinking water. Conversely, non-typhoid salmonellosis (NTS) remains widespread, because of food contamination or asymptomatic carriage. Non-typhoid salmonellosis can be severe when becoming invasive non-typhoid salmonellosis (iNTS). Although established prognostic indicators of the two pathologies are different, direct comparisons between iNTS and TF in the literature remain scarce. The purpose of this study was to analyse and compare demographic, clinical features and outcome of hospitalized patients with TF and iNTS. Demographic, clinical features and outcome were retrospectively analysed in a series of patients hospitalized between 2007 and 2012. A total of 33 patients were enrolled, including 13 with established TF and 20 with iNTS. No differences between TF and iNTS patients were observed in incidence of fever, abdominal cramps, diarrhoea, headache, nausea and vomiting and duration of antibiotic therapy (≤ 7 days in both groups). Although the clinical outcome of TF patients was identical to that of iNTS patients, including incidence of complications, length of hospitalization and mortality (1/13 (7.7%) vs 2/20 (10%), P = 0.43), comorbidities were less frequent in the TF group than in the iNTS group (2/13 vs 15/20, P = 0.003). The clinical profile and outcome of TF patients are similar to those with iNTS. Although comorbidities are more often associated with iNTS, the results of our study suggest that clinical management of these two diseases should remain similar.

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

PubMed

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

2017-05-01

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

Co-colonisation with Aspergillus fumigatus and Pseudomonas aeruginosa is associated with poorer health in cystic fibrosis patients: an Irish registry analysis.

PubMed

Reece, Emma; Segurado, Ricardo; Jackson, Abaigeal; McClean, Siobhán; Renwick, Julie; Greally, Peter

2017-04-21

Pulmonary infection is the main cause of death in cystic fibrosis (CF). Aspergillus fumigatus (AF) and Pseudomonas aeruginosa (PA) are the most prevalent fungal and bacterial pathogens isolated from the CF airway, respectively. Our aim was to determine the effect of different colonisation profiles of AF and PA on the clinical status of patients with CF. A retrospective analysis of data from the Cystic Fibrosis Registry of Ireland from 2013 was performed to determine the effect of intermittent and persistent colonisation with AF or PA or co-colonisation with both microorganisms on clinical outcome measures in patients with CF. Key outcomes measured included forced expiratory volume in one second (FEV 1 ), number of hospitalisations, respiratory exacerbations and antimicrobials prescribed, and complications of CF, including CF related diabetes (CFRD) and allergic bronchopulmonary aspergillosis (ABPA). The prevalence of AF and PA colonisation were 11% (5% persistent, 6% intermittent) and 31% (19% persistent, 12% intermittent) in the Irish CF population, respectively. Co-colonisation with both pathogens was associated with a 13.8% reduction in FEV 1 (p = 0.016), higher levels of exacerbations (p = 0.042), hospitalisations (p = 0.023) and antimicrobial usage (p = 0.014) compared to non-colonised patients and these clinical outcomes were comparable to those persistently colonised with PA. Intermittent and persistent AF colonisation were not associated with poorer clinical outcomes or ABPA. Patients with persistent PA had a higher prevalence of CFRD diagnosis (p = 0.012). CF patients co-colonised with AF and PA had poor clinical outcomes comparable to patients persistently colonised with PA, emphasising the clinical significance of co-colonisation with these microorganisms.

Rotator cuff surgery in patients with rheumatoid arthritis: clinical outcome comparable to age, sex and tear size matched non-rheumatoid patients.

PubMed

Lim, S J; Sun, J-H; Kekatpure, A L; Chun, J-M; Jeon, I-H

2017-09-01

Aims This study aimed to compare the clinical outcomes of rotator cuff repair in patients with rheumatoid arthritis with those of patients who have no known history of the disease. We hypothesised that the functional outcomes are comparable between patients and without rheumatoid arthritis and may be affected by the level of disease activity, as assessed from C-reactive protein (CRP) level and history of systemic steroid intake. Patients and methods We conducted a retrospective review of the institutional surgical database from May 1995 to April 2012. Twenty-nine patients with rheumatoid arthritis who had rotator cuff repair were enrolled as the study group. Age, sex, and tear size matched patients with no disease who were selected as the control group. The mean duration of follow-up was 46 months (range 24-92 months). Clinical outcomes were assessed with the American Shoulder and Elbow Surgeons (ASES) questionnaire, Constant score and visual analogue scale (VAS). All data were recorded preoperatively and at regular postoperative follow-up visits. CRP was measured preoperatively as the disease activity marker for rheumatoid arthritis. Medication history was thoroughly reviewed in the study group. Results In patients with rheumatoid arthritis, all shoulder functional scores improved after surgery (ASES 56.1-78.1, Constant 50.8-70.5 and VAS 5.2-2.5; P < 0.001). The functional outcome of surgery in patients with rheumatoid arthritis was comparable to that of the control group (difference with control: ASES 78.1 vs. 85.5, P = 0.093; Constant 70.5 vs. 75.9, P = 0.366; VAS 2.5 vs. 1.8, P = 0.108). Patients with rheumatoid arthritis who had an elevated CRP level (> 1 mg/dl) showed inferior clinical outcomes than those with normal CRP levels. Patients with a history of systemic steroid intake showed inferior functional outcomes than those who had not taken steroids. Conclusions Surgical intervention for rotator cuff tear in patients with rheumatoid arthritis improved the shoulder functional outcome comparable to that in matched patients without rheumatoid arthritis. Elevated preoperative CRP level and history of systemic steroid intake portend inferior functional outcome in patients with rheumatoid arthritis.

Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms

PubMed Central

Kasper, Siegfried; Dienel, Angelika

2017-01-01

Purpose This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated with Rhodiola rosea. The reported capacity of R. rosea to strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment with R. rosea dry extract in this target group. Methods The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mg R. rosea extract (WS® 1375, Rosalin) was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales. Results The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to the end of the study. The incidence of adverse events was low with 0.015 events per observation day. Discussion The trial reported here was the first to investigate clinical outcomes in patients suffering from burnout symptoms when treated with R. rosea. During administration of the study drug over the course of 12 weeks, a wide range of outcome measures associated with the syndrome clearly improved. Conclusion The results presented provide an encouraging basis for clinical trials further investigating the clinical outcomes of R. rosea extract in patients with the burnout syndrome. PMID:28367055

Ulysses: the effectiveness of a multidisciplinary cognitive behavioural pain management programme-an 8-year review.

PubMed

Fullen, B M; Blake, C; Horan, S; Kelley, V; Spencer, O; Power, C K

2014-06-01

To characterise a cohort of patients with chronic pain registered to the Ulysses cognitive behavioural pain management programme (CBT-PMP) and to evaluate the effectiveness of the CBT-PMP 6 months post-discharge. A review of patients referred to the Ulysses CBT-PMP from 2002 to 2010 was undertaken. The profile of patients was established. Domains measured included pain, physical and psychological function. Relationships between these factors were explored. Clinically significant changes in outcome measures were established at the 6-month follow-up. In total 553 patients registered to the CBT-PMP, pre-post data were available for 91 % of patients and 52 % at 6 months. The majority of patients were female and aged between 40 and 50 years. Most patients had significant psychological morbidity (76 % depression, 84.5 % anxiety), moderate reports of pain [numerical rating scale, mean (SD) 6.0 (2.2)], and low levels of functional activity. At 6 months follow-up, statistically significant positive findings for physical and psychological outcome measures are supplemented by results showing their clinical significance. With regard to psychological function, a clinically significant change (depending on outcome measure) was shown between 1 in 2 and 1 in 10 patients. Improvements in physical function were lower with rates of 1 in 4 to 1 in 14 reporting significant gains. The effectiveness of the Ulysses CBT-PMP is established with measures of clinically significant change for physical and psychological outcomes contributing to the evidence for this novel approach of analysis. Future research determining benchmarks for CBT-PMP outcomes will assist clinicians in monitoring and enhancing patient's progress in clinical practice.

Utilizing Clinical Pharmacy Specialists to Address Access to Care Barriers in the Veteran Population for the Management of Diabetes.

PubMed

Edwards, Krystal L; Hadley, Ryan L; Baby, Nidhu; Yeary, Julianne C; Chastain, Lisa M; Brown, Crystal D

2017-08-01

To show that clinical pharmacy specialists (CPSs) can be utilized in remote facilities to provide appropriate diabetes outcomes along with potential cost savings. A retrospective cohort chart review conducted at the Veterans Affairs North Texas Healthcare System (VANTHCS) evaluated outcomes in patients with type 2 diabetes mellitus referred to CPSs at Fort Worth Outpatient Clinic (FWOPC) or the endocrinologist-managed specialty clinic at the Dallas VA Medical Center (DVAMC). The primary outcome was percentage of patients reaching hemoglobin A1c (HbA1c) goal of <8%. Secondary outcomes were percentage of patients reaching HbA1c <7%, time to reach HbA1c goals of <8% and <7%, and cost savings. There was no statistically significant difference in the number of patients reaching HbA1c goal <8% in the FWOPC (65.3%) compared to the DVAMC (55.8%). Secondary end points comparing FWOPC and DVAMC found no difference in patients reaching HbA1c <7% (20.8% vs 19.2%) and time to reach HbA1c goal of <8% (4.5 vs 6 months) and <7% (8.5 vs 7.5 months). Cost-saving analysis demonstrated a composite of US$350 292 could be saved by the VANTHCS facility if patients continued to be referred to CPS. CPSs can be utilized in diabetes management to provide similar health outcomes as the endocrinologist-managed clinic and to potentially allow for facility cost savings.

Impact of a Clinical Pharmacy Specialist in an Emergency Department for Seniors.

PubMed

Shaw, Paul B; Delate, Thomas; Lyman, Alfred; Adams, Jody; Kreutz, Heather; Sanchez, Julia K; Dowd, Mary Beth; Gozansky, Wendolyn

2016-02-01

This study assesses outcomes associated with the implementation of an emergency department (ED) for seniors in which a clinical pharmacy specialist, with specialized geriatric training that included medication management training, is a key member of the ED care team. This was a retrospective cohort analysis of patients aged 65 years or older who presented at an ED between November 1, 2012, and May 31, 2013. Three groups of seniors were assessed: treated by the clinical pharmacy specialist in the ED for seniors, treated in the ED for seniors but not by the clinical pharmacy specialist, and not treated in the ED for seniors. Outcomes included rates of an ED return visit, mortality and hospital admissions, and follow-up total health care costs. Multivariable regression modeling was used to adjust for any potential confounders in the associations between groups and outcomes. A total of 4,103 patients were included, with 872 (21%) treated in the ED for seniors and 342 (39%) of these treated by the clinical pharmacy specialist. Groups were well matched overall in patient characteristics. Patients who received medication review and management by the clinical pharmacy specialist did not experience a reduction in ED return visits, mortality, cost of follow-up care, or hospital admissions compared with the other groups. Of the patients treated by the clinical pharmacy specialist, 154 (45.0%) were identified as having at least 1 medication-related problem. Although at least 1 medication-related problem was identified in almost half of patients treated by the clinical pharmacy specialist in the ED for seniors, incorporation of a clinical pharmacy specialist into the ED staff did not improve clinical outcomes. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

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

PubMed Central

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

2014-01-01

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

Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

PubMed

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

2013-10-01

Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary.

An analysis of clinical outcomes and costs of a long term acute care hospital.

PubMed

Votto, John J; Scalise, Paul J; Barton, Randall W; Vogel, Cristine A

2011-01-01

Compare clinical outcomes and costs in a study group of long-term acute care hospital (LTCH) patients with a control group of LTCH-eligible patients in an acute care hospital. LTCHs were created to provide post-acute care services not available at other post-acute settings. This is based on the premise that these patients would otherwise have stayed at acute care hospitals as high-cost outliers. The LTCH hospital is intended to deliver care to patients more efficiently, however, there are little documented clinical and financial data regarding the comparative clinical outcomes and costs for patients. Retrospective medical and billing record review of patients from the following groups: (1) LTCH study comprising patients admitted directly from an acute care hospital to the study LTCH and discharged from the LTCH from September 2004 through August 2006; (2) a control group of LTCH-eligible, medically complex patients treated and discharged from an acute care hospital in FY 2002. The control group was selected from approximately 500 patients who had at least one of the ten most common principle diagnosis DRGs of the study LTCH with >30-day length of stay at the referring hospital and met NALTH admitting guidelines. Discharge disposition is an important outcome measure of the quality of care of medically complex patients. The in-hospital mortality rate trended lower and home discharge was 3 times higher for the LTCH study group than for the control group. As a possible result, SNF discharge of LTCH patients was approximately half that of the control group. Both mean patient cost per day and mean total cost per patient were significantly higher in the control group than in the LTCH study group. The patients in the LTCH study group had both better clinical outcomes and lower cost of care than the control group.

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

PubMed

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

2012-07-01

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

A survivorship care plan for breast cancer survivors: extended results of a randomized clinical trial.

PubMed

Boekhout, Annelies H; Maunsell, Elizabeth; Pond, Gregory R; Julian, Jim A; Coyle, Doug; Levine, Mark N; Grunfeld, Eva

2015-12-01

Prevailing wisdom suggests that implementation of a survivorship care plan (SCP) will address deficits in survivorship care planning and delivery for cancer patients. Here, we present 24-month results of a randomized clinical trial on health service and patient-reported outcomes among breast cancer patients transferred to their primary care physician for follow-up care. The 24-month assessments represent the long-term benefit and sustainability of the implantation of a SCP. In all, 408 patients with early-stage breast cancer were randomized to the SCP or control group. Patient self-completed questionnaires, supplemented with telephone interviews, during the 24-month study period assessed health service and patient-reported outcomes. The primary outcome was cancer-specific distress. Secondary outcomes included health-related quality of life, patient satisfaction, continuity and coordination of care, and health service outcomes such as adherence to guidelines. Over the course of 24 months, there were no differences between both groups in health service and patient-reported outcomes. Women from Quebec compared to those from Western Canada (p < 0.001), women within 2 years of completion of primary treatment compared to a longer period (p = 0.013), and those with a higher SF-36 mental component score compared to a lower score (p = 0.044) were positively associated with adherence to guidelines. The implementation of a SCP in the transition of survivorship care from cancer center to primary care did not contribute to improved health service or patient-reported outcomes in this study population. Therefore, additional research is needed before widespread implementation of a SCP in clinical practice. The transition of survivorship care from cancer center to the primary care setting showed no negative effect on health service and patient-reported outcomes.

Time to rethink the role of the library in educating doctors: driving information literacy in the clinical environment.

PubMed

Simons, Mary R; Morgan, Michael Kerin; Davidson, Andrew Stewart

2012-10-01

Can information literacy (IL) be embedded into the curriculum and clinical environment to facilitate patient care and lifelong learning? The Australian School of Advanced Medicine (ASAM) provides competence-based programs incorporating patient-centred care and lifelong learning. ASAM librarians use outcomes-based educational theory to embed and assess IL into ASAM's educational and clinical environments. A competence-based IL program was developed where learning outcomes were linked to current patients and assessed with checklists. Weekly case presentations included clinicians' literature search strategies, results, and conclusions. Librarians provided support to clinicians' literature searches and assessed their presentations using a checklist. Outcome data showed clinicians' searching skills improved over time; however, advanced MEDLINE searching remained challenging for some. Recommendations are provided. IL learning that takes place in context using measurable outcomes is more meaningful, is enduring, and likely contributes to patient care. Competence-based assessment drives learning in this environment.

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

PubMed

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

2014-01-01

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

Patient-centered Medical Home Capability and Clinical Performance in HRSA-supported Health Centers

PubMed Central

Shi, Leiyu; Lock, Diana C.; Lee, De-Chih; Lebrun-Harris, Lydie A.; Chin, Marshall H.; Chidambaran, Preeta; Nocon, Robert S.; Zhu, Jinsheng; Sripipatana, Alek

2015-01-01

Objectives To evaluate the relationship between Patient-centered Medical Home (PCMH) model adoption in health centers (HCs) and clinical performance measures and to determine if adoption of PCMH characteristics is associated with better clinical performance. Research Design Data came from the Health Resources and Services Administration’s 2009 Uniform Data System and the 2009 Commonwealth Fund National Survey of Federally Qualified Health Centers. Clinical performance measures included 2 process measures (childhood immunization and cervical cancer screening) and 2 outcome measures (hypertension control and diabetes control). Total and subscale PCMH scores were regressed on the clinical performance measures, adjusting for patient, provider, financial, and institutional characteristics. Results The findings showed different directional relationships, with some PCMH domains (care management, test/referral tracking, quality improvement, and external coordination) showing little or no effect on outcome measures of interest, 1 domain (access/communication) associated with improved outcomes, and 1 domain (patient tracking/registry) associated with worse outcomes. Conclusions This study is among the first to examine the association between PCMH transformation and clinical performance in HCs, providing an understanding of the impact of PCMH adoption within safety-net settings. The mixed results highlight the importance of examining relationships between specific PCMH domains and specific clinical quality measures, in addition to analyzing overall PCMH scores which could yield distorted findings. PMID:25793267

Use of patient-reported outcome measures in foot and ankle research.

PubMed

Hunt, Kenneth J; Hurwit, Daniel

2013-08-21

In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will emerge as widely used and clinically meaningful. These data support the need for a paradigm shift toward the consistent use of valid and reliable outcome measures for foot and ankle clinical research.

A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model.

PubMed

McEwan, Phil; Bennett Wilton, Hayley; Ong, Albert C M; Ørskov, Bjarne; Sandford, Richard; Scolari, Francesco; Cabrera, Maria-Cristina V; Walz, Gerd; O'Reilly, Karl; Robinson, Paul

2018-02-13

Autosomal dominant polycystic kidney disease (ADPKD) is the leading inheritable cause of end-stage renal disease (ESRD); however, the natural course of disease progression is heterogeneous between patients. This study aimed to develop a natural history model of ADPKD that predicted progression rates and long-term outcomes in patients with differing baseline characteristics. The ADPKD Outcomes Model (ADPKD-OM) was developed using available patient-level data from the placebo arm of the Tolvaptan Efficacy and Safety in Management of ADPKD and its Outcomes Study (TEMPO 3:4; ClinicalTrials.gov identifier NCT00428948). Multivariable regression equations estimating annual rates of ADPKD progression, in terms of total kidney volume (TKV) and estimated glomerular filtration rate, formed the basis of the lifetime patient-level simulation model. Outputs of the ADPKD-OM were compared against external data sources to validate model accuracy and generalisability to other ADPKD patient populations, then used to predict long-term outcomes in a cohort matched to the overall TEMPO 3:4 study population. A cohort with baseline patient characteristics consistent with TEMPO 3:4 was predicted to reach ESRD at a mean age of 52 years. Most patients (85%) were predicted to reach ESRD by the age of 65 years, with many progressing to ESRD earlier in life (18, 36 and 56% by the age of 45, 50 and 55 years, respectively). Consistent with previous research and clinical opinion, analyses supported the selection of baseline TKV as a prognostic factor for ADPKD progression, and demonstrated its value as a strong predictor of future ESRD risk. Validation exercises and illustrative analyses confirmed the ability of the ADPKD-OM to accurately predict disease progression towards ESRD across a range of clinically-relevant patient profiles. The ADPKD-OM represents a robust tool to predict natural disease progression and long-term outcomes in ADPKD patients, based on readily available and/or measurable clinical characteristics. In conjunction with clinical judgement, it has the potential to support decision-making in research and clinical practice.

Texas Medication Algorithm Project, phase 3 (TMAP-3): clinical results for patients with a history of mania.

PubMed

Suppes, Trisha; Rush, A John; Dennehy, Ellen B; Crismon, M Lynn; Kashner, T Michael; Toprac, Marcia G; Carmody, Thomas J; Brown, E Sherwood; Biggs, Melanie M; Shores-Wilson, Kathy; Witte, Bradley P; Trivedi, Madhukar H; Miller, Alexander L; Altshuler, Kenneth Z; Shon, Steven P

2003-04-01

The Texas Medication Algorithm Project (TMAP) assessed the clinical and economic impact of algorithm-driven treatment (ALGO) as compared with treatment-as-usual (TAU) in patients served in public mental health centers. This report presents clinical outcomes in patients with a history of mania (BD), including bipolar I and schizoaffective disorder, bipolar type, during 12 months of treatment beginning March 1998 and ending with the final active patient visit in April 2000. Patients were diagnosed with bipolar I disorder or schizoaffective disorder, bipolar type, according to DSM-IV criteria. ALGO was comprised of a medication algorithm and manual to guide treatment decisions. Physicians and clinical coordinators received training and expert consultation throughout the project. ALGO also provided a disorder-specific patient and family education package. TAU clinics had no exposure to the medication algorithms. Quarterly outcome evaluations were obtained by independent raters. Hierarchical linear modeling, based on a declining effects model, was used to assess clinical outcome of ALGO versus TAU. ALGO and TAU patients showed significant initial decreases in symptoms (p =.03 and p <.001, respectively) measured by the 24-item Brief Psychiatric Rating Scale (BPRS-24) at the 3-month assessment interval, with significantly greater effects for the ALGO group. Limited catch-up by TAU was observed over the remaining 3 quarters. Differences were also observed in measures of mania and psychosis but not in depression, side-effect burden, or functioning. For patients with a history of mania, relative to TAU, the ALGO intervention package was associated with greater initial and sustained improvement on the primary clinical outcome measure, the BPRS-24, and the secondary outcome measure, the Clinician-Administered Rating Scale for Mania (CARS-M). Further research is planned to clarify which elements of the ALGO package contributed to this between-group difference.

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

PubMed

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

2018-01-01

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

Effect of sports modification on clinical outcome in children and adolescent athletes with symptomatic lumbar spondylolysis.

PubMed

El Rassi, Georges; Takemitsu, Masakazu; Glutting, Joseph; Shah, Suken A

2013-12-01

This cohort study aimed to report the compliance of young athletes with nonoperative treatment and to clarify the role of sports modification on clinical outcome of symptomatic spondylolysis. This study included patients with a chief complaint of low back pain participating in regular sports activity, having spondylolysis, and being treated and followed up between 1990 and 2002 in the authors' hospital. One hundred thirty-two athletes were included in this study: 78 males and 54 females. The mean age of the patients was 13 yrs (range, 7-18 yrs). Only 56 patients (42.4%) were compliant to nonoperative treatment. Eighty-six patients (65%) stopped all sports activities for at least 3 mos, and 46 patients (35%) stopped exercising for a variable period of less than 3 mos. The grading of clinical outcome after nonoperative treatment was as follows: excellent in 48 patients (36.4%), good in 74 patients (56.1), fair in 6 patients (4.5%), and poor in 4 patients (3%). The patients who stopped sports for at least 3 mos were 16.39 times more likely to have an excellent result than those who did not stop sports. Bony healing on radiographs did not correlate with clinical outcome. Timely cessation of sports activity for 3 mos is considered an effective method of nonoperative treatment for young athletes with symptomatic lumbar spondylolysis.

Bevacizumab as a treatment for hereditary hemorrhagic telangiectasia in children: a case report

PubMed Central

Ospina, Fabio E; Echeverri, Alex; Posso-Osorio, Iván; Jaimes, Lina; Gutierrez, Jaiber

2017-01-01

Abstract Case description: Five-year-old female patient with hereditary hemorrhagic telangiectasia. Clinical Findings: Deterioration of cardiopulmonary function with higher oxygen requirements secondary to pulmonary arteriovenous shunts, epistaxis. Treatment and Outcome: The patient was treated with the monoclonal antibody bevacizumab, which inhibits the vascular endothelial growth factor, with good clinical outcome. Clinical Relevance: Hereditary hemorrhagic telangiectasia is an autosomal dominant disorder characterized by arteriovenous malformations in different organs, making its clinical presentations varied. Systemic therapeutic options for a generalized disease are limited. The monoclonal antibody bevacizumab, seems to be a good option in this disorder. Although reported as successful in adult population, its use in pediatric population has not yet been reported. Here we report the use of bevacizumab in a 5-year-old female patient with hereditary hemorrhagic telangiectasia, showing clinical benefits and good outcome. PMID:29021642

The Relationship Between Serum Neuron-Specific Enolase Levels and Severity of Bleeding and Functional Outcomes in Patients With Nontraumatic Subarachnoid Hemorrhage.

PubMed

Tawk, Rabih G; Grewal, Sanjeet S; Heckman, Michael G; Rawal, Bhupendra; Miller, David A; Edmonston, Drucilla; Ferguson, Jennifer L; Navarro, Ramon; Ng, Lauren; Brown, Benjamin L; Meschia, James F; Freeman, William D

2016-04-01

The value of neuron-specific enolase (NSE) in predicting clinical outcomes has been investigated in a variety of neurological disorders. To investigate the associations of serum NSE with severity of bleeding and functional outcomes in patients with subarachnoid hemorrhage (SAH). We retrospectively reviewed the records of patients with SAH from June 2008 to June 2012. The severity of SAH bleeding at admission was measured radiographically with the Fisher scale and clinically with the Glasgow Coma Scale, Hunt and Hess grade, and World Federation of Neurologic Surgeons scale. Outcomes were assessed with the modified Rankin Scale at discharge. We identified 309 patients with nontraumatic SAH, and 71 had NSE testing. Median age was 54 years (range, 23-87 years), and 44% were male. In multivariable analysis, increased NSE was associated with a poorer Hunt and Hess grade (P = .003), World Federation of Neurologic Surgeons scale score (P < .001), and Glasgow Coma Scale score (P = .003) and worse outcomes (modified Rankin Scale at discharge; P = .001). There was no significant association between NSE level and Fisher grade (P = .81) in multivariable analysis. We found a significant association between higher NSE levels and poorer clinical presentations and worse outcomes. Although it is still early for any relevant clinical conclusions, our results suggest that NSE holds promise as a tool for screening patients at increased risk of poor outcomes after SAH.

Minimally invasive decompression surgery for lumbar spinal stenosis with degenerative scoliosis: Predictive factors of radiographic and clinical outcomes.

PubMed

Minamide, Akihito; Yoshida, Munehito; Iwahashi, Hiroki; Simpson, Andrew K; Yamada, Hiroshi; Hashizume, Hiroshi; Nakagawa, Yukihiro; Iwasaki, Hiroshi; Tsutsui, Shunji; Kagotani, Ryohei; Sonekatsu, Mayumi; Sasaki, Takahide; Shinto, Kazunori; Deguchi, Tsuyoshi

2017-05-01

There is ongoing controversy regarding the most appropriate surgical treatment for lumbar spinal stenosis (LSS) with concurrent degenerative lumbar scoliosis (DLS): decompression alone, decompression with limited spinal fusion, or long spinal fusion for deformity correction. The coexistence of degenerative stenosis and deformity is a common scenario; Nonetheless, selecting the appropriate surgical intervention requires thorough understanding of the patients clinical symptomatology as well as radiographic parameters. Minimally invasive (MIS) decompression surgery was performed for LSS patients with DLS. The aims of this study were (1) to investigate the clinical outcomes of MIS decompression surgery in LSS patients with DLS, and (2) to identify the predictive factors for both radiographic and clinical outcomes after MIS surgery. 438 consecutive patients were enrolled in this study. Inclusion criteria was evidence of LSS and DLS with coronal curvature measuring greater than 10°. The Japanese Orthopaedic Association (JOA) score, JOA recovery rate, low back pain (LBP), and radiographic features were evaluated preoperatively and at over 2 years postoperatively. Of the 438 patients, 122 were included in final analysis, with a mean follow-up of 2.4 years. The JOA recovery rate was 47.6%. LBP was significantly improved at final follow-up. Cobb angle was maintained for 2 years postoperatively (p = 0.159). Clinical outcomes in foraminal stenosis patients were significantly related to sex, preoperative high Cobb angle and progression of scoliosis (p = 0.008). In the severe scoliosis patients, the JOA recovery was 44%, and was significantly depended on progression of scoliosis (Cobb angle: preoperation 29.6°, 2-years follow-up 36.9°) and mismatch between the pelvic incidence (PI) and the lumbar lordosis (LL) (preoperative PI-LL 35.5 ± 21.2°) (p = 0.028). This study investigated clinical outcomes of MIS decompression surgery in LSS patients with DLS. The predictive risk factors of clinical outcomes were severe scoliosis, foramina stenosis, progressive scoliosis and large mismatch of PI-LL. Copyright © 2016 The Japanese Orthopaedic Association. All rights reserved.

Patient-reported outcomes in borderline personality disorder.

PubMed

Hasler, Gregor; Hopwood, Christopher J; Jacob, Gitta A; Brändle, Laura S; Schulte-Vels, Thomas

2014-06-01

Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes.

[Clinical outcomes and economic analysis of two ovulation induction protocols in patients undergoing repeated IVF/ICSI cycles].

PubMed

Chen, Xiao; Geng, Ling; Li, Hong

2014-04-01

To compare the clinical outcomes and cost-effectiveness of luteal phase down-regulation with gonadotrophin-releasing hormone (GnRH) agonist protocol and GnRH antagonist protocol in patients undergoing repeated in vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI) cycles. A retrospective analysis of clinical outcomes and costs was conducted among 198 patients undergoing repeated IVF-ICSI cycles, including 109 receiving luteal phase down-regulation with GnRH agonist protocol (group A) and 89 receiving GnRH antagonist protocol (group B). The numbers of oocytes retrieved and good embryos, clinical pregnancy rate, abortion rate, the live birth rate, mean total cost, and the cost-effective ratio were compared between the two groups. In patients undergoing repeated IVF-ICSI cycles, the two protocols produced no significant differences in the number of good embryos, clinical pregnancy rate, abortion rate, or twin pregnancy rate. Compared with group B, group A had better clinical outcomes though this difference was not statistically significant. The number of retrieved oocytes was significantly greater and live birth rate significantly higher in group A than in group B (9.13=4.98 vs 7.11=4.74, and 20.2% vs 9.0%, respectively). Compared with group B, group A had higher mean total cost per cycle but lower costs for each oocyte retrieved (2729.11 vs 3038.60 RMB yuan), each good embryo (8867.19 vs 9644.85 RMB yuan), each clinical pregnancy (77598.06 vs 96139.85 RMB yuan). For patients undergoing repeated IVF/ICSI cycle, luteal phase down-regulation with GnRH agonist protocol produces good clinical outcomes with also good cost-effectiveness in spite an unsatisfactory ovarian reserve.

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

PubMed

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 < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

Clinical and functional outcomes of patients who experience partial response to citalopram: secondary analysis of STAR*D.

PubMed

Dennehy, Ellen B; Marangell, Lauren B; Martinez, James; Balasubramani, G K; Wisniewski, Stephen R

2014-05-01

We analyzed the public STAR*D database to better characterize the baseline clinical characteristics and functional outcomes of patients with major depressive disorder (MDD) who experienced partial response in order to better understand the burden associated with this outcome. Patients (n=2,876) received treatment with citalopram. The last available Quick Inventory of Depressive Symptoms (QIDS-SR) from the 12-week treatment period was used to assign subjects to one of three groups: remitters QIDS-SR≤5; non-responders QIDS-SR >5 and <25% reduction from baseline; and partial responders QIDS-SR >5 and ≥25% reduction from baseline. Baseline sociodemographic and clinical characteristics were compared across groups, as well as functional outcomes at Level 1 exit. RESULTS. Of the 2,876 patients, 943 patients (33%) were classified as remitters, 1069 (37%) as partial responders, and 854 (30%) as non-responders. The groups differed on a number of pre-treatment course of illness variables and comorbidities. In addition, remitters, partial responders, and non-responders all separated on posttreatment quality of life and functional outcomes at Level 1 exit. Partial responders demonstrated significant functional impairment at Level 1 exit, differing significantly from the patients who remitted on quality of life, mental and physical functioning, and social and work-related impairment. Adjusted outcomes showed similar differences. Differences in baseline rates of suicidality, comorbidity, and atypical presentations of depression were also observed between outcome groups. Given the substantial clinical and economic burden associated with functional impairment in depression, the need to fully treat partially responding patients to achieve depression remission and restoration of functioning is highlighted by this work.

Systematization of Nursing Care in undergraduate training: the perspective of Complex Thinking 1

PubMed Central

da Silva, Josilaine Porfírio; Garanhani, Mara Lucia; Peres, Aida Maris

2015-01-01

AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806632

Conceptual framework for outcomes research studies of hepatitis C: an analytical review

PubMed Central

Sbarigia, Urbano; Denee, Tom R; Turner, Norris G; Wan, George J; Morrison, Alan; Kaufman, Anna S; Rice, Gary; Dusheiko, Geoffrey M

2016-01-01

Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments. PMID:27313473

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol.

PubMed

Gagnier, Joel J; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Buchbinder, Rachelle

2017-07-20

The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders. The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

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

PubMed

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.

Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: A pilot study

PubMed Central

Prasad, Kameshwar; Mohanty, Sujata; Bhatia, Rohit; Srivastava, M.V.P.; Garg, Ajay; Srivastava, Achal; Goyal, Vinay; Tripathi, Manjari; Kumar, Amit; Bal, Chandrashekar; Vij, Aarti; Mishra, Nalini Kant

2012-01-01

Background & objectives: Bone marrow mononuclear cell therapy has emerged as one of the option for the treatment of Stroke. Several preclinical studies have shown that the treatment with mononuclear cell (MNCs) can reduce the infarct size and improve the functional outcome. We evaluated the feasibility, safety and clinical outcome of administering bone marrow mononuclear cell (MNCs) intravenously to patients with subacute ischaemic stroke. Methods: In a non-randomized phase-I clinical study, 11 consecutive, eligible and consenting patients, aged 30-70 yr with ischaemic stroke involving anterior circulation within 7 to 30 days of onset of stroke were included. Bone marrow was aspirated from iliac crest and the harvested mononuclear cells were infused into antecubital vein. Outcomes measured for safety included immediate reactions after cell infusion and evidence of tumour formation at one year in whole body PET scan. Patients were followed at week 1, 4-6, 24 and 52 to determine clinical progress using National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), MRI, EEG and PET. Feasibility outcomes included target-dose feasibility. Favourable clinical outcome was defined as mRS score of 2 or less or BI score of 75 to 100 at six months after stem cell therapy. Results: Between September 2006 and April 2007, 11 patients were infused with bone-marrow mononuclear cells (mean 80 million with CD-34+ mean 0.92 million). Protocol was target-dose feasible in 9 patients (82%). FDG-PET scan at 24 and 52 wk in nine patients did not reveal evidence of tumour formation. Seven patients had favourable clinical outcome. Interpretation & conclusions: Intravenous bone marrow mononuclear cell therapy appears feasible and safe in patients with subacute ischaemic stroke. Further, a randomized controlled trial to examine its efficacy is being conducted. PMID:22960888

Rockall score in predicting outcomes of elderly patients with acute upper gastrointestinal bleeding

PubMed Central

Wang, Chang-Yuan; Qin, Jian; Wang, Jing; Sun, Chang-Yi; Cao, Tao; Zhu, Dan-Dan

2013-01-01

AIM: To validate the clinical Rockall score in predicting outcomes (rebleeding, surgery and mortality) in elderly patients with acute upper gastrointestinal bleeding (AUGIB). METHODS: A retrospective analysis was undertaken in 341 patients admitted to the emergency room and Intensive Care Unit of Xuanwu Hospital of Capital Medical University with non-variceal upper gastrointestinal bleeding. The Rockall scores were calculated, and the association between clinical Rockall scores and patient outcomes (rebleeding, surgery and mortality) was assessed. Based on the Rockall scores, patients were divided into three risk categories: low risk ≤ 3, moderate risk 3-4, high risk ≥ 4, and the percentages of rebleeding/death/surgery in each risk category were compared. The area under the receiver operating characteristic (ROC) curve was calculated to assess the validity of the Rockall system in predicting rebleeding, surgery and mortality of patients with AUGIB. RESULTS: A positive linear correlation between clinical Rockall scores and patient outcomes in terms of rebleeding, surgery and mortality was observed (r = 0.962, 0.955 and 0.946, respectively, P = 0.001). High clinical Rockall scores > 3 were associated with adverse outcomes (rebleeding, surgery and death). There was a significant correlation between high Rockall scores and the occurrence of rebleeding, surgery and mortality in the entire patient population (χ2 = 49.29, 23.10 and 27.64, respectively, P = 0.001). For rebleeding, the area under the ROC curve was 0.788 (95%CI: 0.726-0.849, P = 0.001); For surgery, the area under the ROC curve was 0.752 (95%CI: 0.679-0.825, P = 0.001) and for mortality, the area under the ROC curve was 0.787 (95%CI: 0.716-0.859, P = 0.001). CONCLUSION: The Rockall score is clinically useful, rapid and accurate in predicting rebleeding, surgery and mortality outcomes in elderly patients with AUGIB. PMID:23801840

A comparative study of tuberculosis patients initiated on ART and receiving different models of TB-HIV care.

PubMed

Schulz, S A; Draper, H R; Naidoo, P

2013-12-01

Although health policy in South Africa calls for the integration of services, the effectiveness of different models of integration on patient outcomes has not been well demonstrated. To evaluate the outcomes of coinfected patients starting antiretroviral treatment (ART) in a tuberculosis (TB) hospital who received different models of ongoing care. This cohort study compared outcomes for 271 coinfected patients who started ART in a TB hospital in the Western Cape. After discharge, one group of patients received anti-tuberculosis treatment and ART from different providers, in the same or in different clinics (vertical care). The other group received anti-tuberculosis treatment and ART at the same visit from the same service provider (integrated care). Demographic and clinical data and TB and ART outcomes were compared. The vertical care model had more unfavourable outcomes for anti-tuberculosis treatment (28.7% vs. 5.9%, P < 0.001) and ART (30.1% vs. 7.4%, P < 0.001) than the integrated care model. The vertical care model showed no difference whether services were provided by two service providers in the same or in geographically separate primary health care clinics. Patient outcomes were better when TB and HIV care was received from the same service provider at the same visit.

Patient-specific evolution of renal function in chronic heart failure patients dynamically predicts clinical outcome in the Bio-SHiFT study.

PubMed

Brankovic, Milos; Akkerhuis, K Martijn; van Boven, Nick; Anroedh, Sharda; Constantinescu, Alina; Caliskan, Kadir; Manintveld, Olivier; Cornel, Jan Hein; Baart, Sara; Rizopoulos, Dimitris; Hillege, Hans; Boersma, Eric; Umans, Victor; Kardys, Isabella

2018-04-01

Renal dysfunction is an important component of chronic heart failure (CHF), but its single assessment does not sufficiently reflect clinically silent progression of CHF prior to adverse clinical outcome. Therefore, we aimed to investigate temporal evolutions of glomerular and tubular markers in 263 stable patients with CHF, and to determine if their patient-specific evolutions during this clinically silent period can dynamically predict clinical outcome. We determined the risk of clinical outcome (composite endpoint of Heart Failure hospitalization, cardiac death, Left Ventricular Assist Device placement, and heart transplantation) in relation to marker levels, slopes and areas under their trajectories. In each patient, the trajectories were estimated using repeatedly measured glomerular markers: creatinine/estimated glomerular filtration rate (eGFR), cystatin C (CysC), and tubular markers: urinary N-acetyl-beta-D-glucosaminidase (NAG) and kidney injury molecule (KIM)-1, plasma and urinary neutrophil gelatinase-associated lipocalin (NGAL). During 2.2 years of follow-up, we collected on average 8 urine and 9 plasma samples per patient. All glomerular markers predicted the endpoint (univariable hazard ratio [95% confidence interval] per 20% increase: creatinine: 1.18[1.07-1.31], CysC: 2.41[1.81-3.41], and per 20% eGFR decrease: 1.13[1.05-1.23]). Tubular markers, NAG, and KIM-1 also predicted the endpoint (NAG: 1.06[1.01-1.11] and KIM-1: 1.08[1.04-1.11]). Larger slopes were the strongest predictors (creatinine: 1.57[1.39-1.84], CysC: 1.76[1.52-2.09], eGFR: 1.59[1.37-1.90], NAG: 1.26[1.11-1.44], and KIM-1: 1.64[1.38-2.05]). Associations persisted after multivariable adjustment for clinical characteristics. Thus, during clinically silent progression of CHF, glomerular and tubular functions deteriorate, but not simultaneously. Hence, patient-specific evolutions of these renal markers dynamically predict clinical outcome in patients with CHF. Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Clinical Outcomes in a Large Cohort of Musculoskeletal Patients Undergoing Chiropractic Care in the United Kingdom: A Comparison of Self- and National Health Service-Referred Routes.

PubMed

Field, Jonathan R; Newell, Dave

2016-01-01

An innovative commissioning pathway has recently been introduced in the United Kingdom allowing chiropractic organizations to provide state-funded chiropractic care to patients through referral from National Health Service (NHS) primary care physicians. The purpose of this study was to examine the outcomes of NHS and private patient groups presenting with musculoskeletal conditions to chiropractors under the Any Qualified Provider scheme and compare the clinical outcomes of these patients with those presenting privately. A prospective cohort design monitoring patient outcomes comparing self-referring and NHS-referred patients undergoing chiropractic care was used. The primary outcome was the change in Bournemouth Questionnaire scores. Within- and between-group analyses were performed to explore differences between outcomes with additional analysis of subgroups as categorized by the STarT back tool. A total of 8222 patients filled in baseline questionnaires. Of these, NHS patients (41%) had more adverse health measures at baseline and went on to receive more treatment. Using percent change in Bournemouth Questionnaire scores categorized at minimal clinical change cutoffs and adjusting for baseline differences, patients with low back and neck pain presenting privately are more likely to report improvement within 2 weeks and to have slightly better outcomes at 90 days. However, these patients were more likely to be attending consultations beyond 30 days. This study supports the contention that chiropractic services as provided in United Kingdom are appropriate for both private and NHS-referred patient groups and should be considered when general medical physicians make decisions concerning referral routes and pain pathways for patients with musculoskeletal conditions. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

FRAIL-HF, a study to evaluate the clinical complexity of heart failure in nondependent older patients: rationale, methods and baseline characteristics.

PubMed

Vidán, María T; Sánchez, Elísabet; Fernández-Avilés, Francisco; Serra-Rexach, José A; Ortiz, Javier; Bueno, Héctor

2014-12-01

The clinical scenario of heart failure (HF) in older hospitalized patients is complex and influenced by acute and chronic comorbidities, coexistent geriatric syndromes, the patient's ability for self-care after discharge, and degree of social support. The impact of all these factors on clinical outcomes or disability evolution is not sufficiently known. FRAIL-HF is a prospective observational cohort study designed to evaluate clinical outcomes (mortality and readmission), functional evolution, quality of life, and use of social resources at 1, 3, 6, and 12 months after admission in nondependent elderly patients hospitalized for HF. Clinical features, medical treatment, self-care ability, and health literacy were prospectively evaluated and a comprehensive geriatric assessment with special focus on frailty was systematically performed in hospital to assess interactions and relationships with postdischarge outcomes. Between May 2009 and May 2011, 450 consecutive patients with a mean age of 80 ± 6 years were enrolled. Comorbidity was high (mean Charlson index, 3.4 ± 2.9). Despite being nondependent, 118 (26%) had minor disability for basic activities of daily living, only 76 (16.2%) had no difficulty in walking 400 meters, and 340 (75.5%) were living alone or with another elderly person. In addition, 316 patients (70.2%) fulfilled frailty criteria. Even nondependent older patients hospitalized for HF show a high prevalence of clinical and nonclinical factors that may influence prognosis and are usually not considered in routine clinical practice. The results of FRAIL-HF will provide important information about the relationship between these factors and different postdischarge clinical, functional, and quality-of-life outcomes. © 2014 Wiley Periodicals, Inc.

Effect of invasive EEG monitoring on cognitive outcome after left temporal lobe epilepsy surgery.

PubMed

Busch, Robyn M; Love, Thomas E; Jehi, Lara E; Ferguson, Lisa; Yardi, Ruta; Najm, Imad; Bingaman, William; Gonzalez-Martinez, Jorge

2015-10-27

The objective of this cohort study was to compare neuropsychological outcomes following left temporal lobe resection (TLR) in patients with epilepsy who had or had not undergone prior invasive monitoring. Data were obtained from an institutional review board-approved, neuropsychology registry for patients who underwent epilepsy surgery at Cleveland Clinic between 1997 and 2013. A total of 176 patients (45 with and 131 without invasive EEG) met inclusion criteria. Primary outcome measures were verbal memory and language scores. Other cognitive outcomes were also examined. Outcomes were assessed using difference in scores from before to after surgery and by presence/absence of clinically meaningful decline using reliable change indices (RCIs). Effect of invasive EEG on cognitive outcomes was estimated using weighting and propensity score adjustment to account for differences in baseline characteristics. Linear and logistic regression models compared surgical groups on all cognitive outcomes. Patients with invasive monitoring showed greater declines in confrontation naming; however, when RCIs were used to assess clinically meaningful change, there was no significant treatment effect on naming performance. No difference in verbal memory was observed, regardless of how the outcome was measured. In secondary outcomes, patients with invasive monitoring showed greater declines in working memory, which were no longer apparent using RCIs to define change. There were no outcome differences on other cognitive measures. Results suggest that invasive EEG monitoring conducted prior to left TLR is not associated with greater cognitive morbidity than left TLR alone. This information is important when counseling patients regarding cognitive risks associated with this elective surgery. © 2015 American Academy of Neurology.

Molsidomine for the prevention of vasospasm-related delayed ischemic neurological deficits and delayed brain infarction and the improvement of clinical outcome after subarachnoid hemorrhage: a single-center clinical observational study.

PubMed

Ehlert, Angelika; Schmidt, Christoph; Wölfer, Johannes; Manthei, Gerd; Jacobs, Andreas H; Brüning, Roland; Heindel, Walter; Ringelstein, E Bernd; Stummer, Walter; Pluta, Ryszard M; Hesselmann, Volker

2016-01-01

OBJECT Delayed ischemic neurological deficits (DINDs) and cerebral vasospasm (CVS) are responsible fora poor outcome in patients with aneurysmal subarachnoid hemorrhage (SAH), most likely because of a decreased availability of nitric oxide (NO) in the cerebral microcirculation. In this study, the authors examined the effects of treatment with the NO donor molsidomine with regard to decreasing the incidence of spasm-related delayed brain infarctions and improving clinical outcome in patients with SAH. METHODS Seventy-four patients with spontaneous aneurysmal SAH were included in this post hoc analysis. Twenty-nine patients with SAH and proven CVS received molsidomine in addition to oral or intravenous nimodipine. Control groups consisted of 25 SAH patients with proven vasospasm and 20 SAH patients without. These patients received nimodipine therapy alone. Cranial computed tomography (CCT) before and after treatment was analyzed for CVS-related infarcts. A modified National Institutes of Health Stroke Scale (mNIHSS) and the modified Rankin Scale (mRS) were used to assess outcomes at a 3-month clinical follow-up. RESULTS Four of the 29 (13.8%) patients receiving molsidomine plus nimodipine and 22 of the 45 (48%) patients receiving nimodipine therapy alone developed vasospasm-associated brain infarcts (p < 0.01). Follow-up revealed a median mNIHSS score of 3.0 and a median mRS score of 2.5 in the molsidomine group compared with scores of 11.5 and 5.0, respectively, in the nimodipine group with CVS (p < 0.001). One patient in the molsidomine treatment group died, and 12 patients in the standard care group died (p < 0.01). CONCLUSIONS In this post hoc analysis, patients with CVS who were treated with intravenous molsidomine had a significant improvement in clinical outcome and less cerebral infarction. Molsidomine offers a promising therapeutic option in patients with severe SAH and CVS and should be assessed in a prospective study.

Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome.

PubMed

Pillai, Sekhar C; Hacohen, Yael; Tantsis, Esther; Prelog, Kristina; Merheb, Vera; Kesson, Alison; Barnes, Elizabeth; Gill, Deepak; Webster, Richard; Menezes, Manoj; Ardern-Holmes, Simone; Gupta, Sachin; Procopis, Peter; Troedson, Christopher; Antony, Jayne; Ouvrier, Robert A; Polfrit, Yann; Davies, Nicholas W S; Waters, Patrick; Lang, Bethan; Lim, Ming J; Brilot, Fabienne; Vincent, Angela; Dale, Russell C

2015-04-01

Pediatric encephalitis has a wide range of etiologies, clinical presentations, and outcomes. This study seeks to classify and characterize infectious, immune-mediated/autoantibody-associated and unknown forms of encephalitis, including relative frequencies, clinical and radiologic phenotypes, and long-term outcome. By using consensus definitions and a retrospective single-center cohort of 164 Australian children, we performed clinical and radiologic phenotyping blinded to etiology and outcomes, and we tested archived acute sera for autoantibodies to N-methyl-D-aspartate receptor, voltage-gated potassium channel complex, and other neuronal antigens. Through telephone interviews, we defined outcomes by using the Liverpool Outcome Score (for encephalitis). An infectious encephalitis occurred in 30%, infection-associated encephalopathy in 8%, immune-mediated/autoantibody-associated encephalitis in 34%, and unknown encephalitis in 28%. In descending order of frequency, the larger subgroups were acute disseminated encephalomyelitis (21%), enterovirus (12%), Mycoplasma pneumoniae (7%), N-methyl-D-aspartate receptor antibody (6%), herpes simplex virus (5%), and voltage-gated potassium channel complex antibody (4%). Movement disorders, psychiatric symptoms, agitation, speech dysfunction, cerebrospinal fluid oligoclonal bands, MRI limbic encephalitis, and clinical relapse were more common in patients with autoantibodies. An abnormal outcome occurred in 49% of patients after a median follow-up of 5.8 years. Herpes simplex virus and unknown forms had the worst outcomes. According to our multivariate analysis, an abnormal outcome was more common in patients with status epilepticus, magnetic resonance diffusion restriction, and ICU admission. We have defined clinical and radiologic phenotypes of infectious and immune-mediated/autoantibody-associated encephalitis. In this resource-rich cohort, immune-mediated/autoantibody-associated etiologies are common, and the recognition and treatment of these entities should be a clinical priority. Copyright © 2015 by the American Academy of Pediatrics.

Ultraearly assessed reperfusion status after middle cerebral artery recanalization predicting clinical outcome.

PubMed

Gölitz, P; Muehlen, I; Gerner, S T; Knossalla, F; Doerfler, A

2018-06-01

Mechanical thrombectomy has high evidence in stroke therapy; however, successful recanalization guarantees not a favorable clinical outcome. We aimed to quantitatively assess the reperfusion status ultraearly after successful middle cerebral artery (MCA) recanalization to identify flow parameters that potentially allow predicting clinical outcome. Sixty-seven stroke patients with acute MCA occlusion, undergoing recanalization, were enrolled. Using parametric color coding, a post-processing algorithm, pre-, and post-interventional digital subtraction angiography series were evaluated concerning the following parameters: pre- and post-procedural cortical relative time to peak (rTTP) of MCA territory, reperfusion time, and index. Functional long-term outcome was assessed by the 90-day modified Rankin Scale score (mRS; favorable: 0-2). Cortical rTTP was significantly shorter before (3.33 ± 1.36 seconds; P = .03) and after intervention (2.05 ± 0.70 seconds; P = .003) in patients with favorable clinical outcome. Additionally, age (P = .005) and initial National Institutes of Health Stroke Scale score (P = .02) were significantly different between the patients, whereas reperfusion index and time as well as initially estimated infarct size were not. In multivariate analysis, only post-procedural rTTP (P = .005) was independently associated with favorable clinical outcome. 2.29 seconds for post-procedural rTTP might be a threshold to predict favorable clinical outcome. Ultraearly quantitative assessment of reperfusion status after successful MCA recanalization reveals post-procedural cortical rTTP as possible independent prognostic value in predicting favorable clinical outcome, even determining a threshold value might be possible. In consequence, focusing stroke therapy on microcirculatory patency could be valuable to improve outcome. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinically meaningful parameters of progression and long-term outcome of Parkinson disease: An international consensus statement.

PubMed

Puschmann, Andreas; Brighina, Laura; Markopoulou, Katerina; Aasly, Jan; Chung, Sun Ju; Frigerio, Roberta; Hadjigeorgiou, Georgios; Kõks, Sulev; Krüger, Rejko; Siuda, Joanna; Wider, Christian; Zesiewicz, Theresa A; Maraganore, Demetrius M

2015-07-01

Parkinson disease (PD) is associated with a clinical course of variable duration, severity, and a combination of motor and non-motor features. Recent PD research has focused primarily on etiology rather than clinical progression and long-term outcomes. For the PD patient, caregivers, and clinicians, information on expected clinical progression and long-term outcomes is of great importance. Today, it remains largely unknown what factors influence long-term clinical progression and outcomes in PD; recent data indicate that the factors that increase the risk to develop PD differ, at least partly, from those that accelerate clinical progression and lead to worse outcomes. Prospective studies will be required to identify factors that influence progression and outcome. We suggest that data for such studies is collected during routine office visits in order to guarantee high external validity of such research. We report here the results of a consensus meeting of international movement disorder experts from the Genetic Epidemiology of Parkinson's Disease (GEO-PD) consortium, who convened to define which long-term outcomes are of interest to patients, caregivers and clinicians, and what is presently known about environmental or genetic factors influencing clinical progression or long-term outcomes in PD. We propose a panel of rating scales that collects a significant amount of phenotypic information, can be performed in the routine office visit and allows international standardization. Research into the progression and long-term outcomes of PD aims at providing individual prognostic information early, adapting treatment choices, and taking specific measures to provide care optimized to the individual patient's needs. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

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 in middle cerebral artery trunk occlusions versus secondary division occlusions after mechanical thrombectomy: pooled analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials.

PubMed

Shi, Zhong-Song; Loh, Yince; Walker, Gary; Duckwiler, Gary R

2010-05-01

The benefit of endovascular revascularization of patients with acute ischemic stroke with middle cerebral artery (MCA) secondary division (M2) occlusions as compared with MCA trunk (M1) occlusions is not known. In this analysis, we compared revascularization status and clinical outcomes in patients with angiographically confirmed MCA M1 versus isolated M2 occlusions treated with mechanical thrombectomy using the Merci Retriever devices. We retrospectively analyzed the pooled data of patients with MCA strokes from the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials. Patient data were dichotomized into 2 groups: MCA M1 occlusions and isolated M2 occlusions. Baseline characteristics, revascularization rates, hemorrhage rates, complications, outcomes, and mortality were evaluated for both groups. Of 178 patients with MCA occlusion treated in the MERCI and Multi MERCI trials, 84.3% had M1 lesions and 15.7% had isolated M2 lesions. Patients with isolated M2 occlusions were revascularized at a higher rate, required a lower mean number of passes, and were associated with a trend toward shorter mean procedure time than patients with M1 occlusions. No statistically significant differences were found between M2 and M1 groups for symptomatic hemorrhage, clinically significant procedural adverse events, favorable 90-day outcome, or 90-day mortality, although in all instances, the M2 outcomes were numerically better than those in M1 subjects. In multivariate analysis, final revascularization was the strongest independent predictor of good outcome at 90 days. Patients with both MCA M1 occlusions and isolated M2 occlusions can achieve a relatively high rate of revascularization and favorable clinical outcomes after mechanical thrombectomy. In fact, patients with isolated M2 occlusions had a higher rate of revascularization, required fewer passes, and had no increased complications compared with patients with M1 occlusions.

Clinical Profile and Outcome of Postthymectomy versus Non-Thymectomy Myasthenia Gravis Patients in the Philippine General Hospital: A 6-Year Retrospective Study.

PubMed

De Roxas, Ranhel C; Bagnas, Marjorie Anne C; Baldonado, Jobelle Joyce Anne R; Rivera, Jonathan P; Roxas, Artemio A

2016-01-01

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by the production of abnormal autoantibodies directed against the receptors present in the neuromuscular junction. It has been the standard practice to offer thymectomy in all generalized myasthenia gravis patients despite the lack of robust evidence. The objectives of this study are to describe the clinical profile and differentiate the clinical outcomes of thymectomy versus non-thymectomy and thymomatous versus non-thymomatous myasthenia gravis patients in the Philippine General Hospital. Between 2009 and 2014, a total of 69 postthymectomy and 16 non-thymectomy patient records were successfully retrieved. The demographic characteristics, surgical approach, and histopathologic results were obtained. The clinical outcome after 6 months or 1 year-follow-up was also determined and grouped according to the following: (1) complete remission, (2) pharmacological remission, (3) no clinical change, (4) worsening symptoms, and (5) mortality. Majority of the patients were females (68.0%) with a mean age of 39.8 years and a mean duration of myasthenic symptoms of 21 months. Using the Myasthenia Gravis Foundation of America classification, 54.1% of patients fell under Class II and 48.2% of them presented with generalized weakness. In this study, 60.8% of postthymectomy myasthenia gravis patients had either complete remission or pharmacologic remission compared with 12.5% among non-thymectomy patients (p-value <0.001). No significant difference in the clinical outcome was found between thymomatous and non-thymomatous myasthenia gravis after thymectomy (p-value = 0.29). This study showed that both thymomatous and non-thymomatous myasthenia gravis patients who underwent thymectomy had a higher incidence of complete stable remission and pharmacologic remission as compared with myasthenia gravis patients who did not undergo thymectomy.

Use of plate fixation without coracoclavicular ligament augmentation for unstable distal clavicle fractures.

PubMed

Shin, Sang-Jin; Ko, Young-Won; Lee, Juyeob; Park, Min-Gyue

2016-06-01

The purpose of this study was to evaluate the clinical and radiologic outcomes of unstable distal clavicle fractures treated with anatomic plate fixation without coracoclavicular ligament augmentation and to compare the outcome of Neer type IIA with that of type IIB. Twenty-five patients with unstable distal clavicle fractures who underwent anatomic plate fixation without coracoclavicular ligament augmentation were enrolled prospectively, including 9 patients of Neer type IIA and 16 patients of Neer type IIB. Clinical outcomes were evaluated using Constant and University of California-Los Angeles (UCLA) scores. Coracoclavicular distance was measured on plain radiographs. Bone union was achieved in all patients. Satisfactory clinical and radiologic outcomes were obtained regardless of fracture type. After operation, the mean coracoclavicular distance on the injured side was increased by 10% compared with the uninjured side. However, between the patients who showed an increased coracoclavicular distance >10% (Constant score, 89.4 ± 3.7; UCLA score, 32.6 ± 3) and the patients with increased coracoclavicular distance <10% of the uninjured side (Constant score, 88.7 ± 3.6; UCLA score, 31.9 ± 3), there was no statistically significant difference in clinical outcomes of Constant score (P = .934) and UCLA score (P = .598). In unstable distal clavicle fractures, precontoured anatomic plate fixation without coracoclavicular ligament augmentation showed satisfactory clinical outcomes and high union rates even with a small lateral fragment. Patients who had increased coracoclavicular distance also demonstrated satisfactory shoulder functional outcomes regardless of the fracture type. Therefore, anatomic plate fixation without additional coracoclavicular ligament augmentation can be considered one of the treatment options for unstable distal clavicle fracture. Level IV; Case Series; Treatment Study. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Joint ultrasound baseline abnormalities predict a specific long-term clinical outcome in systemic lupus erythematosus patients.

PubMed

Corzo, P; Salman-Monte, T C; Torrente-Segarra, V; Polino, L; Mojal, S; Carbonell-Abelló, J

2017-06-01

Objective To describe long-term clinical and serological outcome in all systemic lupus erythematosus (SLE) domains in SLE patients with hand arthralgia (HA) and joint ultrasound (JUS) inflammatory abnormalities, and to compare them with asymptomatic SLE patients with normal JUS. Methods SLE patients with HA who presented JUS inflammatory abnormalities ('cases') and SLE patients without HA who did not exhibit JUS abnormalities at baseline ('controls') were included. All SLE clinical and serological domain involvement data were collected. End follow-up clinical activity and damage scores (systemic lupus erythematosus disease activity index (SLEDAI), Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR)) were recorded. JUS inflammatory abnormalities were defined based on the Proceedings of the Seventh International Consensus Conference on Outcome Measures in Rheumatology Clinical Trials (OMERACT-7) definitions. Statistical analyses were carried out to compare 'cases' and 'controls'. Results A total of 35 patients were recruited. The 'cases', n = 18/35, had a higher incidence of musculoskeletal involvement (arthralgia and/or arthritis) through the follow-up period (38.9% vs 0%, p = 0.008) and received more hydroxychloroquine (61.1% vs 25.0%, p = 0.034) and methotrexate (27.8% vs 0%, p = 0.046) compared to 'controls', n = 17/35. Other comparisons did not reveal any statistical differences. Conclusions We found SLE patients with arthralgia who presented JUS inflammatory abnormalities received more hydroxychloroquine and methotrexate, mainly due to persistent musculoskeletal involvement over time. JUS appears to be a useful technique for predicting worse musculoskeletal outcome in SLE patients.

The Long-Term Clinical Outcomes Following Autogenous Bone Grafting for Large-Volume Defects of the Knee

PubMed Central

Delano, Mark; Spector, Myron; Pittsley, Andrew; Gottschalk, Alexander

2014-01-01

Objective: We report the long-term clinical outcomes of patients who underwent autogenous bone grafting of large-volume osteochondral defects of the knee due to osteochondritis dessicans (OCD) and osteonecrosis (ON). This is the companion report to one previous published on the biological response. We hypothesized that these grafts would integrate with host bone and the articular surface would form fibrocartilage providing an enduring clinical benefit. Design: Three groups (patients/knees) were studied: OCD without a fragment (n = 12/13), OCD with a partial fragment (n = 14/16), and ON (n = 25/26). Twenty-five of 52 patients were available for clinical follow-up between 12 and 21 years. Electronic medical records provided comparison clinical information. In addition, there were plain film radiographs, MRIs, plus repeat arthroscopy and biopsy on 14 patients. Results: Autogenous bone grafts integrated with the host bone. MRI showed soft tissue covering all the grafts at long-term follow-up. Biopsy showed initial surface fibrocartilage that subsequently converted to fibrocartilage and hyaline cartilage at 20 years. OCD patients had better clinical outcomes than ON patients. No OCD patients were asymptomatic at anytime following surgery. Half of the ON patients came to total knee replacement within 10 years. Conclusions: Autogenous bone grafting provides an alternative biological matrix to fill large-volume defects in the knee as a singular solution integrating with host bone and providing an enduring articular cartilage surface. The procedure is best suited for those with OCD. The treatment for large-volume articular defects by this method remains salvage in nature and palliative in outcome. PMID:26069688

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

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

PubMed

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.

Impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior: a systematic literature review.

PubMed

Nguyen, Elaine; Weeda, Erin R; Sobieraj, Diana M; Bookhart, Brahim K; Piech, Catherine Tak; Coleman, Craig I

2016-07-01

To evaluate current knowledge of the impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior. The literature was searched (Medline and Web of Science, January 2000-November 2015) to identify United States' studies evaluating ≥25 patients and measuring the impact of non-medical switching of drugs (switching to a chemically distinct but similar medication for reasons other than lack of clinical efficacy/response, side effects or poor adherence) on ≥1 clinical, economic, resource utilization or medication-taking behavior outcome. The direction of association between non-medical switching and outcomes was classified as negative or positive if a statistically significant worsening or improvement was reported, or neutral if no significant difference was observed. Twenty-nine studies contributed 96 outcomes (60.4% clinical; 21.9% resource utilization; 13.5% economic; 4.2% medication-taking behavior) within six disease categories (cardio-metabolic, immune-mediated, acid suppression, psychiatric, hormone replacement therapy and pain). The direction of association was more frequently negative (33.3%) or neutral (55.2%) than it was positive (11.5%). Stratified by outcome type, non-medical switching was negatively associated with clinical, economic, healthcare utilization and medication-taking behavior outcomes in 20.7%, 69.2%, 38.1% and 75.0% of cases, respectively; and positively in only 4.8%-17.2% of outcomes subgroups. Of 32 outcomes in patients demonstrating stable/well controlled disease, 68.8% and 31.3% had a negative and neutral direction of association. In patients without demonstrated disease stability, outcomes were negatively, neutrally and positively impacted by non-medical switching in 15.6%, 67.2% and 17.2% of 64 outcomes. Our inability to evaluate specific disease state categories and studies/outcomes received equal weight regardless of sample size or magnitude of effect. Non-medical switching was more often associated with negative or neutral effects than positive effects on an array of important outcomes. Among patients with stable/well controlled disease, non-medical switching was associated with mostly negative effects.

Resident Cosmetic Clinic: Practice Patterns, Safety, and Outcomes at an Academic Plastic Surgery Institution.

PubMed

Qureshi, Ali A; Parikh, Rajiv P; Myckatyn, Terence M; Tenenbaum, Marissa M

2016-10-01

Comprehensive aesthetic surgery education is an integral part of plastic surgery residency training. Recently, the ACGME increased minimum requirements for aesthetic procedures in residency. To expand aesthetic education and prepare residents for independent practice, our institution has supported a resident cosmetic clinic for over 25 years. To evaluate the safety of procedures performed through a resident clinic by comparing outcomes to benchmarked national aesthetic surgery outcomes and to provide a model for resident clinics in academic plastic surgery institutions. We identified a consecutive cohort of patients who underwent procedures through our resident cosmetic clinic between 2010 and 2015. Major complications, as defined by CosmetAssure database, were recorded and compared to published aesthetic surgery complication rates from the CosmetAssure database for outcomes benchmarking. Fisher's exact test was used to compare sample proportions. Two hundred and seventy-one new patients were evaluated and 112 patients (41.3%) booked surgery for 175 different aesthetic procedures. There were 55 breast, 19 head and neck, and 101 trunk or extremity aesthetic procedures performed. The median number of preoperative and postoperative visits was 2 and 4 respectively with a mean follow-up time of 35 weeks. There were 3 major complications (2 hematomas and 1 infection requiring IV antibiotics) with an overall complication rate of 1.7% compared to 2.0% for patients in the CosmetAssure database (P = .45). Surgical outcomes for procedures performed through a resident cosmetic clinic are comparable to national outcomes for aesthetic surgery procedures, suggesting this experience can enhance comprehensive aesthetic surgery education without compromising patient safety or quality of care. 4 Risk. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Surgical Treatment of Rotator Cuff Tears After 65 Years of Age: A Systematic Review.

PubMed

Silva, Bruno Mota; Cartucho, António; Sarmento, Marco; Moura, Nuno

2017-04-28

The objective of this study was to analyze current evidence regarding surgical management of rotator cuff tears in patients of 65 years of age and above. Our hypothesis was that surgical repair of rotator cuff tears, in patients older than 65 years, conveys good outcome scores. We have not found a similar systematic review in current literature. Medline®, PubMed, Scopus, and the Cochrane Register of Controlled Trials were searched from January 1999 unto December 2015 for studies, regardless of language, including the words 'rotator cuff' and '65 years' or '70 years'. Inclusion criteria were studies (level I to IV) that reported clinical outcomes in patients older than 65 years, having undertaken surgical repair of a symptomatic rotator cuff tears. Arthroscopic, mini open and open techniques were included. Exclusion criteria were: studies with patients younger than 65 years, studies that did not use validated outcome evaluation scores as primary assessment tools and those with follow up under one year. This work followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - PRISMA guidelines. Data abstracted included patient demographics, tear pattern, surgical procedures, clinical and repair results. Outcome scores were converted to percentages, allowing comparison of data between studies. After deep analysis, 14 studies met the inclusion criteria: 11 level IV studies, 1 level III study and 2 level II studies. Seven studies found statistically significant outcome improvements between pre and postoperative evaluations. All studies reported good or excellent surgical outcomes. Better results would probably be achieved if all studies had rigorous and homogeneous patient selection criteria, but the fact is, that even though this was not the case, the clinical scores remained favorable, and with statistically significant outcome improvement in all studies with prospectively collected data. Based on current literature, rotator cuff repair in patients older than 65 years imparts favorable improvement in clinical outcome scores and overall patient satisfaction.

Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.

PubMed

Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M

2015-02-01

There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.

Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

PubMed

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.

Magnetic resonance imaging in follow-up assessment of sciatica.

PubMed

el Barzouhi, Abdelilah; Vleggeert-Lankamp, Carmen L A M; Lycklama à Nijeholt, Geert J; Van der Kallen, Bas F; van den Hout, Wilbert B; Jacobs, Wilco C H; Koes, Bart W; Peul, Wilco C

2013-03-14

Magnetic resonance imaging (MRI) is frequently performed during follow-up in patients with known lumbar-disk herniation and persistent symptoms of sciatica. The association between findings on MRI and clinical outcome is controversial. We studied 283 patients in a randomized trial comparing surgery and prolonged conservative care for sciatica and lumbar-disk herniation. Patients underwent MRI at baseline and after 1 year. We used a 4-point scale to assess disk herniation on MRI, ranging from 1 for "definitely present" to 4 for "definitely absent." A favorable clinical outcome was defined as complete or nearly complete disappearance of symptoms at 1 year. We compared proportions of patients with a favorable outcome among those with a definite absence of disk herniation and those with a definite, probable, or possible presence of disk herniation at 1 year. The area under the receiver-operating-characteristic (ROC) curve was used to assess the prognostic accuracy of the 4-point scores regarding a favorable or unfavorable outcome, with 1 indicating perfect discriminatory value and 0.5 or less indicating no discriminatory value. At 1 year, 84% of the patients reported having a favorable outcome. Disk herniation was visible in 35% with a favorable outcome and in 33% with an unfavorable outcome (P=0.70). A favorable outcome was reported in 85% of patients with disk herniation and 83% without disk herniation (P=0.70). MRI assessment of disk herniation did not distinguish between patients with a favorable outcome and those with an unfavorable outcome (area under ROC curve, 0.48). MRI performed at 1-year follow-up in patients who had been treated for sciatica and lumbar-disk herniation did not distinguish between those with a favorable outcome and those with an unfavorable outcome. (Funded by the Netherlands Organization for Health Research and Development and the Hoelen Foundation; Controlled Clinical Trials number, ISRCTN26872154.).

Liver transplantation for fulminant hepatitis at Stanford University.

PubMed

Lu, Amy; Monge, Humberto; Drazan, Kenneth; Millan, Maria; Esquivel, Carlos O

2002-01-01

To review the clinical characteristics and outcomes of 26 patients evaluated for liver transplantation for fulminant hepatic failure at Stanford University and Lucile Packard Children's Hospital in an attempt to identify risk factors and prognostic predictors of survival. A retrospective review of the records of 26 consecutive patients who were evaluated for possible liver transplantation for acute liver failure from May 1, 1995, to January 1, 2000. Pretransplant patient demographics and clinical characteristics were collected, and the data were analyzed by univariate and multivariate analysis. Clinical assessment of encephalopathy did not predict outcome. Patients with abnormal computed tomography (CT) of the brain had a twofold increase in mortality compared with those patients with normal studies (p = 0.03). Patients requiring mechanical ventilation and continuous venovenous hemofiltration (CVVH) also had a poor prognosis. Predictors of poor outcome after fulminant hepatic failure include abnormal CT scan, mechanical ventilation, and requirement for hemofiltration.

Medical students as health educators at a student-run free clinic: improving the clinical outcomes of diabetic patients.

PubMed

Gorrindo, Phillip; Peltz, Alon; Ladner, Travis R; Reddy, India; Miller, Bonnie M; Miller, Robert F; Fowler, Michael J

2014-04-01

Student-run free clinics (SRFCs) provide service-learning opportunities for medical students and care to underserved patients. Few published studies, however, support that they provide high-quality care. In this study, the authors examined the clinical impact of a medical student health educator program for diabetic patients at an SRFC. In 2012, the authors retrospectively reviewed the electronic medical records of diabetic patients who established care at Shade Tree Clinic in Nashville, Tennessee, between 2008 and 2011. They compared clinical outcomes at initial presentation to the clinic and 12 months later. They analyzed the relationship between the number of patient-student interactions (touchpoints) and change in hemoglobin A1c values between these two time points and compared the quality of care provided to best-practice benchmarks (process and outcomes measures). The authors studied data from 45 patients. Mean hemoglobin A1c values improved significantly from 9.6 to 7.9, after a mean of 12.5 ± 1.5 months (P < .0001). A trend emerged between increased number of touchpoints and improvement in A1c values (r = 0.06, P = .10). A high percentage of patients were screened during clinic visits, whereas a low to moderate percentage met benchmarks for A1c, LDL, and blood pressure levels. These findings demonstrate that a medical student health educator program at an SRFC can provide high-quality diabetes care and facilitate clinical improvement one year after enrollment, despite inherent difficulties in caring for underserved patients. Future studies should examine the educational and clinical value of care provided at SRFCs.

Plasma 8-iso-Prostaglandin F2α concentrations and outcomes after acute intracerebral hemorrhage.

PubMed

Du, Quan; Yu, Wen-Hua; Dong, Xiao-Qiao; Yang, Ding-Bo; Shen, Yong-Feng; Wang, Hao; Jiang, Li; Du, Yuan-Feng; Zhang, Zu-Yong; Zhu, Qiang; Che, Zhi-Hao; Liu, Qun-Jie

2014-11-01

Higher plasma 8-iso-Prostaglandin F2α concentrations have been associated with poor outcome of severe traumatic brain injury. We further investigated the relationships between plasma 8-iso-Prostaglandin F2α concentrations and clinical outcomes in patients with acute intracerebral hemorrhage. Plasma 8-iso-Prostaglandin F2α concentrations of 128 consecutive patients and 128 sex- and gender-matched healthy subjects were measured by enzyme-linked immunosorbent assay. We assessed their relationships with disease severity and clinical outcomes including 1-week mortality, 6-month mortality and unfavorable outcome (modified Rankin Scale score>2). Plasma 8-iso-Prostaglandin F2α concentrations were substantially higher in patients than in healthy controls. Plasma 8-iso-Prostaglandin F2α concentrations were positively associated with National Institutes of Health Stroke Scale (NIHSS) scores and hematoma volume using a multivariate linear regression. It emerged as an independent predictor for clinical outcomes of patients using a forward stepwise logistic regression. ROC curves identified the predictive values of plasma 8-iso-Prostaglandin F2α concentrations, and found its predictive value was similar to NIHSS scores and hematoma volumes. However, it just numerically added the predictive values of NIHSS score and hematoma volume. Increased plasma 8-iso-Prostaglandin F2α concentrations are associated with disease severity and clinical outcome after acute intracerebral hemorrhage. Copyright © 2014 Elsevier B.V. All rights reserved.

PatientViewpoint: a website for patient-reported outcomes assessment.

PubMed

Snyder, Claire F; Jensen, Roxanne; Courtin, S Orion; Wu, Albert W

2009-09-01

To develop a prototype website to collect patient-reported outcomes in outpatient clinical oncology and link the data with the electronic medical record (EMR). A multidisciplinary Research Network, including experts in outcomes research, clinical oncology, nursing, social work, information technology, EMRs, behavioral science, decision science, clinical trials, law, and a cancer survivor, was formed to design the prototype website. The Research Network developed the initial website specifications, elicited feedback from patients (n = 20) and clinicians (n = 7), constructed the website, and conducted usability testing (n = 10). Clinicians reported that the website could improve clinical practice if it was not burdensome and were most interested in tracking change over time. Patients were interested in using the website because of the potential to facilitate communication with their clinicians. Patients emphasized the importance of short and simple surveys and a user-friendly interface. The PatientView-oint website was designed to meet these specifications. Usability testing suggested that patients had few problems accessing and using the site. Preliminary reports from clinicians and patients suggest that a website to collect PROs and link them with the EMR could help improve the quality of cancer care. Further pilot-testing will evaluate the use, usefulness, and acceptability of PatientViewpoint.

The characteristics of patients with mycobacterium tuberculosis blood stream infections in Beijing, China: a retrospective study.

PubMed

Liu, Xiaoqing; Bian, Sainan; Zhang, Yueqiu; Zhang, Lifan; Yang, Qiwen; Wang, Peng; Xu, Yingchun; Shi, Xiaochun; Zhang, Yao; Chemaly, Roy F

2016-12-12

Published information regarding the clinical characteristics, laboratory findings, and outcomes of patients with Mycobacterium tuberculosis (MTB) blood stream infection (BSI) is limited. We aimed in this study to evaluate the clinical characteristics, laboratory evaluation, and outcomes of patients with MTB BSI. All patients diagnosed with MTB BSI at Peking Union Medical College Hospital between January 2008 and May 2014 were identified by examining the electronic database listing results of all blood cultures. Data on demographics, clinical characteristics, laboratory manifestations, management, and outcomes were abstracted from medical records. Six thousand nine hundred seventy-four patients had mycobacterial blood cultures during the study period. Of 48 patients (0.7%) with MTB BSI, 26 patients (54%) were considered to be immunocompromised (refers to a person who has a significantly impaired immune system). This was due to human immunodeficiency virus (HIV) infection (n = 2 of 48 tested), receiving steroids (n = 17, including 16 with rheumatic diseases and one with myasthenia gravis), malignancy (n = 3), diabetes mellitus (n = 3), and renal transplantation (n = 1). The main clinical manifestations were fever (100%, with a median of 40 °C), weight loss (48%) and cough with sputum production (46%). Most patients had one or more organs involved (81%). The median time from onset of fever to diagnosis was 8 weeks (IQR 5 ~ 14). Six patients died within 1 week after diagnosis. Of the 17 patients completing treatment, 14 patients (82%) recovered without major complications and they had a shorter time interval between onsets of symptoms to treatment compared to those died of TB. In this group of patients with MTB BSI, fever and multiple organs involvement were common, the outcome was poor and timely diagnosis and treatment might favor outcome.

Should We Pursue Patients Who Fail to Attend Colorectal Clinics? A 9-Year Study

PubMed Central

John, SKP; Jones, OM; Fay, H; Howell, RD; Fozard, JBJ

2007-01-01

INTRODUCTION No uniform protocol exists on how to deal with patients who fail to attend colorectal clinics. Our aim was to identify whether the tendency to ‘failure to attend’ (FTA) in the colorectal clinic was associated with FTA in other clinics and also whether FTA patients have serious pathology. PATIENTS AND METHODS This was a retrospective study of a prospectively recorded list of FTA patients, in colorectal urgent or two-week wait clinics from 1996–2004. RESULTS A total of 151 patients, who failed to attend their first appointment, were included in the study. Of these, 61 (40.4%) were colorectal referrals, 76 (50.3%) were general surgical referrals, and for 14 (9.3%) case notes were not available. There were 59 FTA episodes in 61 colorectal patients associated with 59 FTA episodes in other clinics (Pearson correlation: r = 0.411; P = 0.01, two-tailed, SPSS v.12). Of 58 colorectal outcomes, five (8.6%) colorectal cancers (CRC) were diagnosed, 23 (39.6%) were persistent non-attendees, 16 (27.5%) had benign colorectal pathology, two (3.4%) benign non-colorectal outcomes and 12 (20.6%) normal outcomes. CONCLUSIONS Tendency to FTA is habitual. Care needs to be exercised in the management of FTAs to avoid delayed presentation of colorectal cancer. PMID:17688719

Rupture during coiling of intracranial aneurysms: Predictors and clinical outcome.

PubMed

Kocur, Damian; Przybyłko, Nikodem; Bażowski, Piotr; Baron, Jan

2018-02-01

The intraprocedural aneurysm rupture (IPR) is one of the most feared adverse effect associated with the coil embolization therapy. The aim of the study was to identify predisposing factors for IPR, as well as to define patient groups with worse clinical outcome following IPR. From February 2008 to March 2015, 273 consecutive patients were treated at our institution via endovascular coil embolization. Patient medical records were reviewed with emphasis on procedure description, potential risk factors and clinical outcomes related to IPR. The IPR occurred in 14 (5.13%) cases. Multivariate logistic regression models were used to determine independent predictors of IPR. Clinical outcome was analyzed using the Glasgow Outcome Scale (GOS). Multivariate analysis showed that aneurysm location at posterior communicating artery is an independent risk factor for IPR (p = 0.035; OR 3.5; 95%CI 1.09-11.26). The frequencies of favorable disability (GOS 4-5), severe disability (GOS 2-3), and mortality (GOS 1) between patients with IPR and without IPR were significantly different in the general study population (p < 0.001, p < 0.001 and p = 0.023, respectively) and in patients with previously unruptured aneurysms (p < 0.001, p = 0.006 and p = 0.003, respectively) but not in patients with previously ruptured aneurysms (p = 0.187, p = 0.089 and p = 1.0, respectively). Posterior communicating artery aneurysm location is an independent predictor for IPR. IPR is associated with a significant clinical deterioration in a subgroup of patients with previously unruptured aneurysms, but not in patients with ruptured aneurysms. Copyright © 2018 Elsevier B.V. All rights reserved.

Triple antithrombotic therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

PubMed

Kang, Dong Oh; Yu, Cheol Woong; Kim, Hee Dong; Cho, Jae Young; Joo, Hyung Joon; Choi, Rak Kyong; Park, Jin Sik; Lee, Hyun Jong; Kim, Je Sang; Park, Jae Hyung; Hong, Soon Jun; Lim, Do-Sun

2015-08-01

The optimal antithrombotic regimen in patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation for complex coronary artery disease is unclear. We compared the net clinical outcomes of triple antithrombotic therapy (TAT; aspirin, thienopyridine, and warfarin) and dual antiplatelet therapy (DAPT; aspirin and thienopyridine) in AF patients who had undergone DES implantation. A total of 367 patients were enrolled and analyzed retrospectively; 131 patients (35.7%) received TAT and 236 patients (64.3%) received DAPT. DAPT and warfarin were maintained for a minimum of 12 and 24 months, respectively. The primary endpoint was the 2-year net clinical outcomes, a composite of major bleeding and major adverse cardiac and cerebral events (MACCE). Propensity score-matching analysis was carried out in 99 patient pairs. The 2-year net clinical outcomes of the TAT group were worse than those of the DAPT group (34.3 vs. 21.1%, P=0.006), which was mainly due to the higher incidence of major bleeding (16.7 vs. 4.6%, P<0.001), without any significant increase in MACCE (22.1 vs. 17.7%, P=0.313). In the multivariate analysis, TAT was an independent predictor of worse net clinical outcomes (odds ratio 1.63, 95% confidence interval 1.06-2.50) and major bleeding (odds ratio 3.54, 95% confidence interval 1.65-7.58). After propensity score matching, the TAT group still had worse net clinical outcomes and a higher incidence of major bleeding compared with the DAPT group. In AF patients undergoing DES implantation, prolonged administration of TAT may be harmful due to the substantial increase in the risk for major bleeding without any reduction in MACCE.

The Value of the SYNTAX Score II in Predicting Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Ryan, Nicola; Nombela-Franco, Luis; Jiménez-Quevedo, Pilar; Biagioni, Corina; Salinas, Pablo; Aldazábal, Andrés; Cerrato, Enrico; Gonzalo, Nieves; Del Trigo, María; Núñez-Gil, Iván; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-11-27

The predictive value of the SYNTAX score (SS) for clinical outcomes after transcatheter aortic valve implantation (TAVI) is very limited and could potentially be improved by the combination of anatomic and clinical variables, the SS-II. We aimed to evaluate the value of the SS-II in predicting outcomes in patients undergoing TAVI. A total of 402 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI were included. Preprocedural TAVI angiograms were reviewed and the SS-I and SS-II were calculated using the SS algorithms. Patients were stratified in 3 groups according to SS-II tertiles. The coprimary endpoints were all-cause death and major adverse cardiovascular events (MACE), a composite of all-cause death, cerebrovascular event, or myocardial infarction at 1 year. Increased SS-II was associated with higher 30-day mortality (P=.036) and major bleeding (P=.015). The 1-year risk of death and MACE was higher among patients in the 3rd SS-II tertile (HR, 2.60; P=.002 and HR, 2.66; P<.001) and was similar among patients in the 2nd tertile (HR, 1.27; P=.507 and HR, 1.05; P=.895) compared with patients in the 1st tertile. The highest SS-II tertile was an independent predictor of long-term mortality (P=.046) and MACE (P=.001). The SS-II seems more suited to predict clinical outcomes in patients undergoing TAVI than the SS-I. Increased SS-II was associated with poorer clinical outcomes at 1 and 4 years post-TAVI, independently of the presence of coronary artery disease. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Measure Once, Cut Twice – Adding Patient-Reported Outcome Measures to the Electronic Health Record for Comparative Effectiveness Research

PubMed Central

Wu, Albert W.; Kharrazi, Hadi; Boulware, L. Ebony; Snyder, Claire F.

2013-01-01

Objective This paper presents the current state of patient-reported outcome measures, and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Study Design and Setting Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient-centeredness and digitization. We pose the question: “What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?” Results We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. Conclusion The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other e-health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. PMID:23849145

Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

PubMed

Blakeley, Jaishri O; Coons, Stephen Joel; Corboy, John R; Kline Leidy, Nancy; Mendoza, Tito R; Wefel, Jeffrey S

2016-03-01

The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed. Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Is cancer history really an exclusion criterion for clinical trial of lung cancer? Influence of gastrointestinal tract cancer history on the outcomes of lung cancer surgery.

PubMed

Aokage, Keiju; Okada, Morihito; Suzuki, Kenji; Nomura, Shogo; Suzuki, Shigeki; Tsubokawa, Norifumi; Mimae, Takahiro; Hattori, Aritoshi; Hishida, Tomoyuki; Yoshida, Junji; Tsuboi, Masahiro

2017-02-15

Exclusion of patients with a history of other cancer treatment except in situ situation has been considered to be inevitable for clinical trials investigating survival outcome. However, there have been few reports confirming these influences on surgical outcome of lung cancer patients ever. Multi-institutional, individual data from patients with non–small cell lung cancer resected between 2000 and 2013 were collected. The patients were divided into two groups: those with a history of gastrointestinal tract cancer (GI group) and those without any history (non-GI group). We compared the outcomes with well-matched groups using propensity scoring to minimize bias related to the nonrandomness. The influence of gastrointestinal tract cancer stage, disease-free interval, and treatment method for gastrointestinal tract cancer on the surgical outcome of non–small cell lung cancer was examined. We analyzed 196 patients in the GI group and 3732 in the non-GI group. In unmatched cohort, multivariate analyses showed that a history of gastrointestinal tract cancer did not affect overall survival or recurrence-free survival. Independent predictors of poor prognosis included older age, male sex, high carcinoembryonic antigen levels and advanced clinical stage of non–small cell lung cancer. The two groups in the matched cohort demonstrated equivalent overall survival and recurrence-free survival, even in patients with clinical stage I. Gastrointestinal tract cancer stage, disease-free interval and treatment method for gastrointestinal tract cancer were not associated with outcomes. History of early gastrointestinal tract cancer completely resected is not always necessary for exclusion criteria in clinical trial of lung cancer.

Psychiatric outcomes after pediatric sports-related concussion.

PubMed

Ellis, Michael J; Ritchie, Lesley J; Koltek, Mark; Hosain, Shahid; Cordingley, Dean; Chu, Stephanie; Selci, Erin; Leiter, Jeff; Russell, Kelly

2015-12-01

The objectives of this study were twofold: (1) to examine the prevalence of emotional symptoms among children and adolescents with a sports-related concussion (SRC) who were referred to a multidisciplinary pediatric concussion program and (2) to examine the prevalence, clinical features, risk factors, and management of postinjury psychiatric outcomes among those in this clinical population. The authors conducted a retrospective chart review of all patients with SRC referred to a multidisciplinary pediatric concussion program between September 2013 and October 2014. Clinical assessments carried out by a single neurosurgeon included clinical history, physical examination, and Post-Concussion Symptom Scale (PCSS) scoring. Postinjury psychiatric outcomes were defined as a subjective worsening of symptoms of a preinjury psychiatric disorder or new and isolated suicidal ideation or diagnosis of a novel psychiatric disorder (NPD). An NPD was defined as a newly diagnosed psychiatric disorder that occurred in a patient with or without a lifetime preinjury psychiatric disorder after a concussion. Clinical resources, therapeutic interventions, and clinical and return-to-play outcomes are summarized. One hundred seventy-four patients (mean age 14.2 years, 61.5% male) were included in the study. At least 1 emotional symptom was reported in 49.4% of the patients, and the median emotional PCSS subscore was 4 (interquartile range 1-8) among those who reported at least 1 emotional symptom. Overall, 20 (11.5%) of the patients met the study criteria for a postinjury psychiatric outcome, including 14 patients with an NPD, 2 patients with isolated suicidal ideation, and 4 patients with worsening symptoms of a preinjury psychiatric disorder. Female sex, a higher initial PCSS score, a higher emotional PCSS subscore, presence of a preinjury psychiatric history, and presence of a family history of psychiatric illness were significantly associated with postinjury psychiatric outcomes. Interventions for patients with postinjury psychiatric outcomes included pharmacological therapy alone in 2 patients (10%), cognitive behavioral therapy alone in 4 (20%), multimodal therapy in 9 (45%), and no treatment in 5 (25%). Overall, 5 (25%) of the patients with postinjury psychiatric disorders were medically cleared to return to full sports participation, whereas 5 (25%) were lost to follow-up and 9 (45%) remained in treatment by the multidisciplinary concussion program at the end of the study period. One patient who was asymptomatic at the time of initial consultation committed suicide. Emotional symptoms were commonly reported among pediatric patients with SRC referred to a multidisciplinary pediatric concussion program. In some cases, these symptoms contributed to the development of an NPD, isolated suicidal ideation, and worsening symptoms of a preexisting psychiatric disorder. Future research is needed to clarify the prevalence, pathophysiology, risk factors, and evidence-based management of postinjury psychiatric outcomes after pediatric SRC. Successful management of these patients requires prompt recognition and multidisciplinary care by experts with clinical training and experience in concussion and psychiatry.

Clinical characteristics and outcomes of septic bursitis.

PubMed

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.

Effectiveness of Collaborative Care for Depression in Public-Sector Primary Care Clinics Serving Latinos.

PubMed

Lagomasino, Isabel T; Dwight-Johnson, Megan; Green, Jennifer M; Tang, Lingqi; Zhang, Lily; Duan, Naihua; Miranda, Jeanne

2017-04-01

Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics. A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks. Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (p<.001 for all). Intervention patients also had significantly improved quality-of-care indicators, including the proportion of patients receiving either psychotherapy or antidepressant medication (77% versus 21%, p<.001). Collaborative care for depression can greatly improve care and outcomes in public-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

Influence of age on the pattern and outcome of external beam radiotherapy for clinically localized prostate cancer.

PubMed

Ogawa, Kazuhiko; Nakamura, Katsumasa; Onishi, Hiroshi; Koizumi, Masahiko; Sasaki, Tomonari; Araya, Masayuki; Miyabe, Yuuki; Otani, Yuuki; Teshima, Teruki

2006-01-01

The influence of age on the patterns and outcomes of external beam radiotherapy for clinically localized prostate cancer patients was examined. The Japanese Patterns of Care Study surveys were used to compare the processes and outcomes of radical external beam radiotherapy in 140 elderly patients (>75 years old) and 304 younger patients (<75 years old). Although the Karnofsky performance status was significantly different between elderly and younger patients, there were no significant differences in disease characteristics such as pretreatment PSA level, differentiation, Gleason combined score and clinical T stage. There were also no significant differences in the treatment characteristics such as CT-based treatment planning, conformal therapy, total radiation doses (both a median of 66.0 Gy) and hormonal therapy usage. Moreover, no significant differences in overall survival, biochemical relapse-free survival and late toxicity rates were observed between elderly and younger patients. Age did not influence the disease characteristics, patterns of external beam radiotherapy, survival and late toxicities for clinically localized prostate cancer patients. Therefore, radiotherapy could represent an important treatment modality for elderly patients as well as for younger ones.

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

ERIC Educational Resources Information Center

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

2009-01-01

The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…

Iron and clinical outcomes in dialysis and non-dialysis-dependent chronic kidney disease patients.

PubMed

Kovesdy, Csaba P

2009-03-01

Abnormal iron homeostasis plays an important role in the anemia of chronic kidney disease (CKD). Although iron overload was the main complication seen in the pre-erythropoiesis-stimulating agent era, relative iron deficiency is much more common today in patients with CKD. Maintaining certain "desirable" levels of commonly used markers of iron stores (such as transferrin saturation ratio and serum ferritin) have become the goal of iron management in clinical practice, yet it is unclear whether achievement and maintenance of these "desirable" levels translates into improved clinical outcomes. This review examines issues related to iron and long-term clinical outcomes from an epidemiologic perspective, with the goal to determine what an ideal therapeutic approach should be in clinical practice and what future research is required to clarify important practical questions. Particular attention is devoted to patients with non-dialysis-dependent CKD because the management of iron homeostasis in this group of patients poses additional intriguing questions.

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

PubMed

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.

Long-term clinical outcomes in patients diagnosed with severe digital ischemia.

PubMed

Keo, Hong H; Umer, Melika; Baumgartner, Iris; Willenberg, Torsten; Gretener, Silvia B

2011-02-18

To investigate the aetiology and long-term clinical outcomes of patients diagnosed with digital ischemia. Data of 36 consecutive patients presenting with digital ischemia were collected in July 2000 to June 2001 from a vascular referral centre. Demographic data, aetiology, medication and treatment were abstracted from the medical records. Clinical outcomes were assessed at 5 year follow-up including ulcer healing, digital amputation and mortality. Of the 36 patients, 69.4% were male and the mean age was 55±14 years. In 15 patients (41.7%) a systemic disease was present and of those 53.3% was due to connective tissue disease. Twelve patients (33.3%) had hypothenar hammer syndrome and in 8 patients (22.2%) no apparent cause was found. Whereas 13 patients (36.1%) presented with rest pain or trophic lesions at baseline, no patients presented with these symptoms at follow-up. At follow-up, 18 (62.1%) patients had symptoms on provocation and 5 patients (4 patients with systemic disease and 1 with no apparent cause) had died. Digital amputation was performed in one patient at initial presentation and no digital amputation was performed at follow-up. No ulcer reoccurred and no workers' insurance compensation was applied. Of those with hypothenar hammer syndrome, 80.0% had symptoms on provocation at follow-up. Among patients with digital ischemia, systemic disease and hypothenar hammer syndrome were the most frequent aetiologies. In patients with hypothenar hammer syndrome the clinical outcome was remarkably benign, although symptoms may persist with provocation, whereas patients with systemic disease have a high mortality rate.

Prognostic factors of arthroscopic pull-out repair for a posterior root tear of the medial meniscus.

PubMed

Moon, Hong-Kyo; Koh, Yong-Gon; Kim, Yong-Chan; Park, Young-Sik; Jo, Seung-Bae; Kwon, Sae-Kwang

2012-05-01

Repair of a posterior root tear of the medial meniscus (MRT) decreases peak contact pressure by restoring hoop tension and is expected to prevent progression to osteoarthritis. The purposes of this study were (1) to report the clinical and magnetic resonance imaging (MRI) results of arthroscopic pull-out repair of the MRT and (2) to identify prognostic factors of poor outcome. Case series; Level of evidence, 4. Fifty-one patients (47 women, 4 men) who underwent arthroscopic pull-out repair of the MRT by a single surgeon were enrolled. Mean follow-up after surgery was 33 months (range, 24-44 months). To identify factors affecting final outcome, patient-specific factors, such as gender, age, body mass index, meniscus extrusion, extrusion increase, subchondral edema, degree of varus alignment (<5° or >5°), and cartilage status in the medial compartment (Outerbridge grade 1 or 2 lesion vs grade 3 or 4 lesion), were investigated. Final clinical outcomes were determined using a visual analog scale (VAS) for pain and patient satisfaction scores, American Knee Society (AKS) scores, and Lysholm scores, and MRI outcomes were determined by evaluating meniscus extrusion and articular cartilage status. Multiple regression analysis was performed to identify variables that independently affected clinical and MRI-determined outcomes. All clinical outcome measures significantly improved after surgery. Patients with Outerbridge grade 3 or 4 chondral lesions had poorer results than those with grade 1 or 2 lesions in terms of AKS function and Lysholm scores. Patients with varus alignment of >5° had poorer results than those with varus alignment of <5° in terms of VAS satisfaction, AKS function, and Lysholm scores. Mean meniscus extrusion increased from 3.6 mm preoperatively to 5.0 mm postoperatively. Chondral lesions progressed in 3 (9.7%) of 31 patients. Preoperative meniscus extrusion was found to be positively correlated with final extrusion. At a mean follow-up of 33 months after pull-out repair, extrusion of the meniscus was found to have progressed. Nevertheless, this technique provided patients with a clinical benefit. Outerbridge grade 3 or 4 chondral lesions and varus alignment of >5° were found to independently predict an inferior clinical outcome.

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

PubMed

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.

Elevated Baseline C-Reactive Protein as a Predictor of Outcome After Aneurysmal Subarachnoid Hemorrhage: Data From the Simvastatin in Aneurysmal Subarachnoid Hemorrhage (STASH) Trial.

PubMed

Turner, Carole L; Budohoski, Karol; Smith, Christopher; Hutchinson, Peter J; Kirkpatrick, Peter J; Murray, G D

2015-11-01

There remains a proportion of patients with unfavorable outcomes after aneurysmal subarachnoid hemorrhage, of particular relevance in those who present with a good clinical grade. A forewarning of those at risk provides an opportunity towards more intensive monitoring, investigation, and prophylactic treatment prior to the clinical manifestation of advancing cerebral injury. To assess whether biochemical markers sampled in the first days after the initial hemorrhage can predict poor outcome. All patients recruited to the multicenter Simvastatin in Aneurysmal Hemorrhage Trial (STASH) were included. Baseline biochemical profiles were taken between time of ictus and day 4 post ictus. The t-test compared outcomes, and a backwards stepwise binary logistic regression was used to determine the factors providing independent prediction of an unfavorable outcome. Baseline biochemical data were obtained in approximately 91% of cases from 803 patients. On admission, 73% of patients were good grade (World Federation of Neurological Surgeons grades 1 or 2); however, 84% had a Fisher grade 3 or 4 on computed tomographic scan. For patients presenting with good grade on admission, higher levels of C-reactive protein, glucose, and white blood cells and lower levels of hematocrit, albumin, and hemoglobin were associated with poor outcome at discharge. C-reactive protein was found to be an independent predictor of outcome for patients presenting in good grade. Early recording of C-reactive protein may prove useful in detecting those good grade patients who are at greater risk of clinical deterioration and poor outcome.

[Clinical evaluation of open and close treatment in pediatric condylar fractures].

PubMed

Han, Jing; Li, Zhi; Zhou, Haihua; Yang, Rongtao; Xiong, Guizhong; Li, Zubing

2014-08-01

To evaluate the long-term clinical and radiographic outcomes of open and close treatment of condylar fractures of mandible in children. A total of 78 cases (105 mandibular condylar fractures) were included in this study. All patients (younger than 12 years at the time of injury were followed up for at least 3 years. According to the classification of the condylar fractures, open or close treatment was chosen. Clinical outcomes were classified as favorable or unfavorable depending on the mouth opening, pattern of mouth opening, occlusion, facial symmetry. Condylar remodeling was defined as complete, moderate, or poor based on the radiographic findings. Depending on the classification, 14 sides of type I, 48 sides of type II and 43 sides of type III were included in this study. Open treatment was chosen in 51 sides and close treatment was chosen in 54 sides. Most of the patients acquired satisfactory clinical outcomes. Better radiologic remodeling of the condylar process was found in the patients treated by open treatment. Favorable long-term clinical outcomes were obtained in both open and close treatment of mandibular condylar fractures. A better morphological remodeling of condylar process was found in patients with open treatment.

Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS' ESRD CPM Project.

PubMed

Neu, Alicia M; Frankenfield, Diane L

2009-07-01

Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes.

Risk Factors for Postoperative Respiratory Mortality and Morbidity in Patients Undergoing Coronary Artery Bypass Grafting

PubMed Central

Rajaei, Samira; Dabbagh, Ali

2012-01-01

ABSTRACT Nowadays, coronary artery bypass grafting (CABG) is considered to be one of the most common surgical procedures. This procedure has been the main topic in many clinical research studies, which have assessed the effect of the procedure on patients’ outcomes. Like other surgical procedures, this procedure is also accompanied by a number of unwanted complications, including those of the respiratory system. Since the respiratory system plays an integral role in defining the clinical outcome of patients, improvements in studies that can assess and predict clinical outcomes of the respiratory system, assume greater importance. There are a number of predictive models which can assess patients in the preoperative period and introduce a number of risk factors, which could be considered as prognostic factors for patients undergoing CABG. The respiratory system is among the clinical systems that are assessed in many prediction scoring systems. This review assesses the main studies which have evaluated the possible risk factors for postoperative respiratory mortality and morbidity, in patients undergoing CABG. PMID:24223339

The impact of extubation failure in patients with good-grade subarachnoid hemorrhage.

PubMed

Wojak, Jann F; Ditz, Claudia; Abusamha, Abdulkareem; Smith, Emma; Gliemroth, Jan; Tronnier, Volker; Küchler, Jan

2018-06-13

The aim of this study was to analyze the clinical impact of extubation failure (EF) in with good grade subarachnoid hemorrhage (SAH), in which a good clinical course is usually expected. We reviewed the clinical data from 141 patients with SAH and i. initial Hunt & Hess grade 1-3 ii. induction of general anesthesia for intervention and iii. the presence of data about the functional outcome. Patients were divided into three groups: 1. Primary tracheotomized patients (PT), 2. Patients with successful extubation (ES) and 3. Patients with EF (reintubation within 48 h). EF occurred with a rate of 0.12. The leading cause of EF was respiratory insufficiency (n=7), followed by impaired consciousness (n=5). Multivariate logistic regression did not show any neurological predictor of EF. Patients with ES showed an excellent outcome after 6 months (favorable outcome: 95.7 %), whereas the outcome of EF and PT patients was significantly (p<0.05) poorer. The case fatality rate was non-significantly higher in the EF group (0.15 vs 0.03). Hospitalization was significantly reduced for patients with ES, while the occurrence of symptomatic cerebral vasospasms and vasospastic cerebral infarction was similar between Patients with EF, ES or PT. We showed that EF is a frequent condition in good grade SAH, but is not predictable using common neurological parameters. Regarding the functional outcome, we were able to show that the result of an extubation trial clearly delineates the patients in two distinct groups, in which ES predicts an excellent outcome. Copyright © 2018 Elsevier Inc. All rights reserved.

Improving patient outcomes to targeted therapies in melanoma.

PubMed

Eroglu, Zeynep; Smalley, Keiran S M; Sondak, Vernon K

2016-06-01

The arrival of targeted therapies has led to significant improvements in clinical outcomes for patients with BRAFV600 mutated advanced melanoma over the past five years. In several clinical trials, BRAF and MEK inhibitors have shown improvement in progression free and overall survival, along with much higher tumor response rates in comparison to chemotherapy, with the combination of these drugs superior to monotherapy. These agents are also being tested in earlier-stage patients, in addition to alternative dosing regimens and in combinations with other therapeutics. Efforts are also ongoing to expand the success found with targeted therapies to other subtypes of melanoma, including NRAS and c-kit mutated melanomas, uveal melanomas, and BRAF/NRAS wild type melanomas. Expert Commentary: We aim to provide an overview of clinical outcomes with targeted therapies in melanoma patients.

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

PubMed

Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

2010-10-01

Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

Clinical Presentation and Outcome of Patients With Optic Pathway Glioma.

PubMed

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 impact of continuous versus intermittent vital signs monitoring in hospitals: A systematic review and narrative synthesis.

PubMed

Downey, C L; Chapman, S; Randell, R; Brown, J M; Jayne, D G

2018-08-01

Continuous vital signs monitoring on general hospital wards may allow earlier detection of patient deterioration and improve patient outcomes. This systematic review will assess if continuous monitoring is practical outside of the critical care setting, and whether it confers any clinical benefit to patients. MEDLINE ® , MEDLINE ® In-Process, EMBASE, CINAHL and The Cochrane Library were searched for articles that evaluated the clinical or non-clinical outcomes of continuous vital signs monitoring in adults outside of the critical care setting. The protocol was registered with PROSPERO (CRD42017058098). Twenty-four studies met the inclusion criteria and reported outcomes on a total of 40,274 patients and 59 ward staff in nine countries. The majority of studies showed benefits in terms of critical care use and length of hospital stay. Larger studies were more likely to demonstrate clinical benefit, particularly critical care use and length of hospital stay. Three studies showed cost-effectiveness. Barriers to implementation included nursing and patient satisfaction and the burden of false alerts. Continuous vital signs monitoring outside the critical care setting is feasible and may provide a benefit in terms of improved patient outcomes and cost efficiency. Large, well-controlled studies in high-risk populations are required to evaluate the clinical benefit of continuous monitoring systems. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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 important. Given high rates of high-risk behaviors in these youth, regular mental health follow-up to assess safety is important. Additional evidence-based treatments for pediatric bipolar disorder are needed.

Long-term neuromuscular outcomes of west nile virus infection: A clinical and electromyographic evaluation of patients with a history of infection.

PubMed

Athar, Parveen; Hasbun, Rodrigo; Nolan, Melissa S; Salazar, Lucrecia; Woods, Steven P; Sheikh, Kazim; Murray, Kristy O

2018-01-01

Neuromuscular clinical manifestations during acute West Nile virus (WNV) infection are well documented; however, long-term neurologic outcomes still require investigation. We conducted a long-term follow-up study in patients with history of WNV infection. Of the 117 patients who participated in neurologic and neurocognitive evaluations, 30 were referred for neuromuscular and electrodiagnostic evaluation based on abnormal findings. We found that 33% of these patients (10 of 30) showed abnormalities on nerve conduction and/or needle electromyography due to primary or secondary outcomes of WNV infection. Most common electrodiagnostic findings and causes of long-term disability were related to anterior horn cell poliomyelitis (WNV poliomyelitis). Electrical data on these patient populations were similar to those observed in chronic poliomyelitis. With more than 16,000 cases of WNV neuroinvasive disease reported across the USA since 1999, understanding clinical outcomes from infection will provide a resource for physicians managing long-term care of these patients. Muscle Nerve 57: 77-82, 2018. © 2017 Wiley Periodicals, Inc.

Long-term outcome of patients with distal ulcerative colitis and inflammation of the appendiceal orifice.

PubMed

Naves, Juan E; Lorenzo-Zúñiga, Vicente; Marín, Laura; Mañosa, Míriam; Oller, Blanca; Moreno, Vicente; Zabana, Yamile; Boix, Jaume; Cabré, Eduard; Domènech, Eugeni

2011-12-01

Skip inflammation of the appendiceal orifice has been described in distal UC (UC-IAO) but long-term clinical outcomes are poorly established. Our aim was to evaluate the long-term clinical outcomes of UC-IAO as compared to classic distal UC. Patients with UC-IAO were identified from the local IBD database. Disease outcome and therapeutic requirements during follow-up were accurately collected, and compared with a control group of patients with distal UC without peri-appendiceal involvement matched by disease extent (proctitis/distal), smoking habit, and date and age at diagnosis. Fourteen UC patients were found to have UC-IAO, most of them with initial extent of UC limited to the rectum. All patients were initially managed with mesalazine administered orally (28.5%), topically (28.5%), or in combination (43%). After a median follow-up of 78 months (interquartile range--IQR 45-123) most UC-IAO patients were successfully managed with oral and/or topical aminosalicylates. Only one of them developed proximal disease progression. As compared to controls, no differences in clinical outcomes or therapeutic requirements were found. Patients with UC-IAO tend to present a mild course, with a low probability to develop proximal progression of disease extent or to require immunosuppressive therapy or colectomy.

Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

PubMed Central

Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

2016-01-01

Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

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

PubMed Central

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

2017-01-01

Background 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. Methods 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. Results 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. Conclusion 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. PMID:28727832

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

PubMed

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.

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

PubMed

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

2016-03-01

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

Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study.

PubMed

Reilly-Harrington, Noreen A; Sylvia, Louisa G; Rabideau, Dustin J; Gold, Alexandra K; Deckersbach, Thilo; Bowden, Charles L; Bobo, William V; Singh, Vivek; Calabrese, Joseph R; Shelton, Richard C; Friedman, Edward S; Thase, Michael E; Kamali, Masoud; Tohen, Mauricio; McInnis, Melvin G; McElroy, Susan L; Ketter, Terence A; Kocsis, James H; Kinrys, Gustavo; Nierenberg, Andrew A

2016-11-15

Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure. Copyright © 2016 Elsevier B.V. All rights reserved.

Incorporating PROMIS Symptom Measures into Primary Care Practice-a Randomized Clinical Trial.

PubMed

Kroenke, Kurt; Talib, Tasneem L; Stump, Timothy E; Kean, Jacob; Haggstrom, David A; DeChant, Paige; Lake, Kittie R; Stout, Madison; Monahan, Patrick O

2018-04-05

Symptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated. To assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes. Randomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system. Primary care patients who screened positive for at least one SPADE symptom. After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians. The primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction. Most patients (84%) had multiple clinically significant (T-score ≥ 55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P = 0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic. Simple feedback of symptom scores to primary care clinicians in the absence of additional systems support or incentives is not superior to usual care in improving symptom outcomes. clinicaltrials.gov identifier: NCT02383862.

Inflammation-driven malnutrition: a new screening tool predicts outcome in Crohn's disease.

PubMed

Jansen, Irene; Prager, Matthias; Valentini, Luzia; Büning, Carsten

2016-09-01

Malnutrition is a frequent feature in Crohn's disease (CD), affects patient outcome and must be recognised. For chronic inflammatory diseases, recent guidelines recommend the development of combined malnutrition and inflammation risk scores. We aimed to design and evaluate a new screening tool that combines both malnutrition and inflammation parameters that might help predict clinical outcome. In a prospective cohort study, we examined fifty-five patients with CD in remission (Crohn's disease activity index (CDAI) <200) at 0 and 6 months. We assessed disease activity (CDAI, Harvey-Bradshaw index), inflammation (C-reactive protein (CRP), faecal calprotectin (FC)), malnutrition (BMI, subjective global assessment (SGA), serum albumin, handgrip strength), body composition (bioelectrical impedance analysis) and administered the newly developed 'Malnutrition Inflammation Risk Tool' (MIRT; containing BMI, unintentional weight loss over 3 months and CRP). All parameters were evaluated regarding their ability to predict disease outcome prospectively at 6 months. At baseline, more than one-third of patients showed elevated inflammatory markers despite clinical remission (36·4 % CRP ≥5 mg/l, 41·5 % FC ≥100 µg/g). Prevalence of malnutrition at baseline according to BMI, SGA and serum albumin was 2-16 %. At 6 months, MIRT significantly predicted outcome in numerous nutritional and clinical parameters (SGA, CD-related flares, hospitalisations and surgeries). In contrast, SGA, handgrip strength, BMI, albumin and body composition had no influence on the clinical course. The newly developed MIRT was found to reliably predict clinical outcome in CD patients. This screening tool might be used to facilitate clinical decision making, including treatment of both inflammation and malnutrition in order to prevent complications.

Acute Liver Failure in Children: The First 348 Patients in The Pediatric Acute Liver Failure Study Group

PubMed Central

Squires, Robert H.; Shneider, Benjamin L.; Bucuvalas, John; Alonso, Estella; Sokol, Ronald J.; Narkewicz, Michael R.; Dhawan, Anil; Rosenthal, Philip; Rodriguez-Baez, Norberto; Murray, Karen F.; Horslen, Simon; Martin, Martin G.; Lopez, M. James; Soriano, Humberto; McGuire, Brendan M.; Jonas, Maureen M.; Yazigi, Nada; Shepherd, Ross W.; Schwarz, Kathleen; Lobritto, Steven; Thomas, Daniel W.; Lavine, Joel E.; Karpen, Saul; Ng, Vicky; Kelly, Deirdre; Simonds, Nancy; Hynan, Linda S.

2008-01-01

Objectives To determine short-term outcome for children with acute liver failure (ALF) as it relates to etiology, clinical status, patient demographics and to determine prognostic factors. Study design A prospective, multi-center case study collecting demographic, clinical, laboratory and short-term outcome data on children from birth to 18 years with ALF. Patients without encephalopathy were included if the prothrombin time and INR remained ≥ 20 seconds and/or >2, respectively, despite vitamin K. Primary outcome measures three weeks after study entry were death, death after transplant, alive with native liver, alive with transplanted organ. Results The etiology of ALF in 348 children included acute acetaminophen toxicity (14%), metabolic disease (10%), autoimmune liver disease (6%), non-APAP drug-related hepatotoxicity (5%), infections (6%), other diagnosed conditions (10%); 49% were indeterminate. Outcome varied between patient sub-groups; 20% with non-acetaminophen ALF died or underwent liver transplantation and never developed clinical encephalopathy. Conclusions Etiologies of ALF in children differ from adults. Clinical encephalopathy may not be present in children. The high percentage of indeterminate cases provides an opportunity for investigation. PMID:16737880

Remission as perceived by people with schizophrenia, family members and psychiatrists.

PubMed

Karow, A; Naber, D; Lambert, M; Moritz, S

2012-08-01

Studies indicate that patient-rated outcomes and symptomatic remission as defined by the remission in schizophrenia working group rely on different assumptions. The aim of this observational study was to assess symptomatic remission by patients with schizophrenia, family members and psychiatrists and to compare their assessments with standardized criteria and clinical measures. One hundred and thirty-one patients with schizophrenia (DSM-IV), family members and psychiatrists assessed remission within the European Group on Functional Outcomes and Remission in Schizophrenia (EGOFORS) project. Symptoms (Positive and Negative Syndrome Scale [PANSS]), functional outcome (Functional Recovery Scale in Schizophrenia [FROGS]), subjective well-being (SWN-K) and demographic characteristics were investigated. Remission assessed by psychiatrists showed the best accordance with standardized remission (80%), followed by remission assessed by family members (52%) and patients (43%). Only in 18%, patients, relatives and psychiatrists agreed in their assessments. Good subjective well-being was most important for remission estimated by patients, good subjective well-being and symptom reduction by family members, and finally better symptom scores, well-being and functioning by psychiatrists. Self- and expert-rated clinical outcomes differ markedly, with a preference on the patients' side for subjective outcome. Symptomatic remission as assessed by the standardized criteria plays a secondary role for patients and relatives in daily clinical practice. A more thorough consideration of patients' and caregivers' perspectives should supplement the experts' assessment. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

What Makes Patient Navigation Most Effective: Defining Useful Tasks and Networks.

PubMed

Gunn, Christine; Battaglia, Tracy A; Parker, Victoria A; Clark, Jack A; Paskett, Electra D; Calhoun, Elizabeth; Snyder, Frederick R; Bergling, Emily; Freund, Karen M

2017-01-01

Given the momentum in adopting patient navigation into cancer care, there is a need to understand the contribution of specific navigator activities to improved clinical outcomes. A mixed-methods study combined direct observations of patient navigators within the Patient Navigation Research Program and outcome data from the trial. We correlated the frequency of navigator tasks with the outcome of rate of diagnostic resolution within 365 days among patients who received the intervention relative to controls. A focused content analysis examined those tasks with the strongest correlations between navigator tasks and patient outcomes. Navigating directly with specific patients (r = 0.679), working with clinical providers to facilitate patient care (r = 0.643), and performing tasks not directly related to their diagnostic evaluation for patients were positively associated with more timely diagnosis (r = 0.714). Using medical records for non-navigation tasks had a negative association (r = -0.643). Content analysis revealed service provision directed at specific patients improved care while systems-focused activities did not.

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

PubMed

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%; p<0.001). Using a logistic regression model, palpable pedal pulse and use of a total contact cast were associated with better wound healing. 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.

Uncovering precision phenotype-biomarker associations in traumatic brain injury using topological data analysis

PubMed Central

Nielson, Jessica L.; Cooper, Shelly R.; Sorani, Marco D.; Inoue, Tomoo; Yuh, Esther L.; Mukherjee, Pratik; Petrossian, Tanya C.; Lum, Pek Y.; Lingsma, Hester F.; Gordon, Wayne A.; Okonkwo, David O.; Manley, Geoffrey T.

2017-01-01

Background Traumatic brain injury (TBI) is a complex disorder that is traditionally stratified based on clinical signs and symptoms. Recent imaging and molecular biomarker innovations provide unprecedented opportunities for improved TBI precision medicine, incorporating patho-anatomical and molecular mechanisms. Complete integration of these diverse data for TBI diagnosis and patient stratification remains an unmet challenge. Methods and findings The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot multicenter study enrolled 586 acute TBI patients and collected diverse common data elements (TBI-CDEs) across the study population, including imaging, genetics, and clinical outcomes. We then applied topology-based data-driven discovery to identify natural subgroups of patients, based on the TBI-CDEs collected. Our hypothesis was two-fold: 1) A machine learning tool known as topological data analysis (TDA) would reveal data-driven patterns in patient outcomes to identify candidate biomarkers of recovery, and 2) TDA-identified biomarkers would significantly predict patient outcome recovery after TBI using more traditional methods of univariate statistical tests. TDA algorithms organized and mapped the data of TBI patients in multidimensional space, identifying a subset of mild TBI patients with a specific multivariate phenotype associated with unfavorable outcome at 3 and 6 months after injury. Further analyses revealed that this patient subset had high rates of post-traumatic stress disorder (PTSD), and enrichment in several distinct genetic polymorphisms associated with cellular responses to stress and DNA damage (PARP1), and in striatal dopamine processing (ANKK1, COMT, DRD2). Conclusions TDA identified a unique diagnostic subgroup of patients with unfavorable outcome after mild TBI that were significantly predicted by the presence of specific genetic polymorphisms. Machine learning methods such as TDA may provide a robust method for patient stratification and treatment planning targeting identified biomarkers in future clinical trials in TBI patients. Trial Registration ClinicalTrials.gov Identifier NCT01565551 PMID:28257413

Clinical outcome after reconstruction of the medial patellofemoral ligament in paediatric patients with recurrent patella instability.

PubMed

Lind, Martin; Enderlein, Ditte; Nielsen, Torsten; Christiansen, Svend Erik; Faunø, Peter

2016-03-01

Medial patellofemoral ligament (MPFL) reconstruction has recently been broadly accepted as primary surgical treatment in adults. Reconstruction techniques with osseous fixation in femur cannot be used for patients with open growth plates. Operative treatment of patella instability in children therefore is a challenge and requires alternative MPFL reconstruction techniques. Limited knowledge exists concerning outcome after MPFL reconstruction in children and adolescents. This study present clinical outcome in a consecutive single clinic series of children treated with paediatric MPFL reconstruction using a soft tissue femoral fixation technique. Twenty-four MPFL reconstructions in 20 operated children aged 8-16 were included in the study. Indication for surgery was two or more patella dislocations. MPFL reconstruction was performed by looping the released gracilis tendon around the adductor magnus tendon insertion and through drill holes in the proximal medial patella edge. Clinical outcome was evaluated by Kujala score and NRS pain score preoperatively, at 1-year follow-up and final follow-up at 39 months. Outcome was compared with a cohort of 179 adult patients with recurrent patella instability operated with an adult MPFL reconstruction technique. Kujala score improved from 61 (13) to 81 (16). NRS pain score improved from 3.0 (3.1) to 1.5 (1.3) in activity. Four patients (20%) experienced redislocation within the first postoperative year compared with 5% in an adult patient population. Five patients (25%) experienced subluxations. One patient with a redislocation was re-operated with adult MPFL reconstruction technique. Cartilage injury was seen in six patients. There are clinical relevant improvements in knee function and pain after MPFL reconstruction in paediatric patients. Patella stability after MPFL reconstruction using femoral soft tissue graft fixation in paediatric patients was inferior to MPFL reconstruction using bony femoral fixation in adult patients. Case-Control study, Level III.

Bivalirudin therapy is associated with improved clinical and economic outcomes in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: results from an observational database.

PubMed

Pinto, Duane S; Ogbonnaya, Augustina; Sherman, Steven A; Tung, Patricia; Normand, Sharon-Lise T

2012-01-01

Randomized trials show improved outcomes among acute coronary syndrome patients treated with bivalirudin. The objective of this analysis was to compare clinical and economic outcomes in ST-elevation myocardial infarction (STEMI) patients encountered in routine clinical practice undergoing primary percutaneous coronary intervention (PPCI), treated with bivalirudin or heparin+GP IIb/IIIa receptor inhibitor (heparin+GPI). STEMI admissions from January 1, 2004 through March 31, 2008 among patients receiving PPCI and bivalirudin or heparin+GPI in the Premier hospital database were identified. The probability of receiving bivalirudin was estimated using individual and hospital variables; using propensity scores, each bivalirudin patient was matched to 3 heparin+GPI treated patients. The primary outcome was in-hospital death. Rates of bleeding, transfusion, length of stay, and in-hospital cost were secondary outcomes. There were 59,917 STEMI PPCIs receiving bivalirudin (n=6735) or heparin+GPI (n=53,182). Seventy-nine percent of bivalirudin patients matched, resulting in 21,316 STEMI PPCIs for analysis. Compared with heparin+GPI patients, bivalirudin patients had fewer deaths (3.2% versus 4.0%; P=0.011) and less inpatient bleeding (clinically apparent bleeding [6.9% versus 10.5%, P<0.0001], clinically apparent bleeding with transfusion [1.6% versus 3.0%, P<0.0001], and transfusion [5.9% versus 7.6%, P<0.0001]). Patients receiving bivalirudin had shorter average length of stay (mean 4.3 versus 4.5 days; P<0.0001), with lower in-hospital cost (mean $18,640 versus $19,967 [median $14,462 versus $16,003], P<0.0001). This large "real-world" retrospective analysis demonstrates that bivalirudin therapy compared with heparin+GPI is associated with a lower rate of inpatient death, inpatient bleeding, and decreased overall in-hospital cost in STEMI patients undergoing PPCI.

No evidence of disease activity in patients receiving fingolimod at private or academic centers in clinical practice: a retrospective analysis of the multiple sclerosis, clinical, and magnetic resonance imaging outcomes in the USA (MS-MRIUS) study.

PubMed

Zivadinov, Robert; Khan, Nasreen; Korn, Jonathan R; Lathi, Ellen; Silversteen, Jason; Calkwood, Jonathan; Kolodny, Scott; Silva, Diego; Medin, Jennie; Weinstock-Guttman, Bianca

2018-04-12

The impact of multiple sclerosis (MS) center type on outcomes has not been investigated. This study aimed to evaluate baseline characteristics and clinical and magnetic resonance imaging (MRI) outcomes in patients with MS receiving fingolimod over 16 months' follow-up at private or academic centers in the USA. Clinical and MRI data collected in clinical practice from patients initiating fingolimod were stratified by center type and retrospectively analyzed. No evidence of disease activity (NEDA-3) was defined as patients with no new/enlarged T2/gadolinium-enhancing lesions, no relapses, and no disability progression (Expanded Disability Status Scale scores). Data were collected for 398 patients from 25 private centers and 192 patients from eight academic centers. Patients were older (median age = 43 vs 41 years; p = .0047) and had a numerically shorter median disease duration (7.0 vs 8.5 years; p = .0985) at private vs academic centers. Annualized relapse rate (ARR) was higher in patients at private than academic centers in the pre-index (0.40 vs 0.29; p = .0127) and post-index (0.16 vs 0.08; p = .0334) periods. The opposite was true for T2 lesion volume in the pre-index (2.86 vs 5.23 mL; p = .0002) and post-index (2.86 vs 5.11 mL; p = .0016) periods; other MRI outcomes were similar between center types. After initiating fingolimod, ARRs were reduced, disability and most MRI outcomes remained stable, and a similar proportion of patients achieved NEDA-3 at private and academic centers (64.1% vs 56.1%; p = .0659). Patient characteristics differ between private and academic centers. Over 55% of patients achieved NEDA-3 during fingolimod treatment at both center types.

Patient-reported outcomes in borderline personality disorder

PubMed Central

Hasler, Gregor; Hopwood, Christopher J.; Jacob, Gitta A.; Brändle, Laura S.; Schulte-Vels, Thomas

2014-01-01

Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes. PMID:25152662

The impact of depression and antidepressant usage on primary biliary cholangitis clinical outcomes

PubMed Central

Kaplan, Gilaad G.; Almishri, Wagdi; Vallerand, Isabelle; Frolkis, Alexandra D.; Patten, Scott; Swain, Mark G.

2018-01-01

Background Depression is prevalent in primary biliary cholangitis (PBC) patients. Our aims were to examine the effects of depression and antidepressants on hepatic outcomes of PBC patients. Methods We used the UK Health Improvement Network database to identify PBC patients between 1974 and 2007. Our primary outcome was one of three clinical events: decompensated cirrhosis, liver transplantation and death. We assessed depression and each class of antidepressant medication in adjusted multivariate Cox proportional hazards models to identify independent predictors of outcomes. In a sensitivity analysis, the study population was restricted to PBC patients using ursodeoxycholic acid (UDCA). Results We identified 1,177 PBC patients during our study period. In our cohort, 86 patients (7.3%) had a depression diagnosis prior to PBC diagnosis, while 79 patients (6.7%) had a depression diagnosis after PBC diagnosis. Ten-year incidence of mortality, decompensated cirrhosis, and liver transplantation were 13.4%, 6.6%, and 2.0%, respectively. In our adjusted models, depression status was not a predictor of poor outcomes. After studying all classes of antidepressants, using the atypical antidepressant mirtazapine after PBC diagnosis was significantly protective (Adjusted HR 0.23: 95% CI 0.07–0.72) against poor liver outcomes (decompensation, liver transplant, mortality), which remained statistically significant in patients using UCDA (HR 0.21: 95% CI 0.05–0.83). Conclusions In our study, depression was not associated with poor clinical outcomes. However, using the antidepressant mirtazapine was associated with decreased mortality, decompensated cirrhosis and liver transplantation in PBC patients. These findings support further assessment of mirtazapine as a potential treatment for PBC patients. PMID:29617396

Polyurethane on titanium unconstrained disc arthroplasty versus anterior discectomy and fusion for the treatment of cervical disc disease: a review of level I-II randomized clinical trials including clinical outcomes.

PubMed

Aragonés, María; Hevia, Eduardo; Barrios, Carlos

2015-12-01

To contrast the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) with a single cervical disc arthroplasty design, the polyurethane on titanium unconstrained cervical disc (PTUCD). This is a systematic review of randomized clinical trials (RCT) with evidence level I-II reporting clinical outcomes. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of 51 studies found were entered in the study. RTCs were searched from the earliest available records in 2005 to November 2014. Out of a total of 1101 patients, 562 were randomly assigned into the PTUCD arthroplasty group and 539 into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing arthroplasty had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with PTUCD arthroplasty had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level was slightly higher in patients with ACDF, showing no statistically significant difference. According to this review, PTUCD arthroplasty showed a global superiority to ACDF in clinical outcomes. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and PTUCD arthroplasty.

Treatment of Anxiety in Patients with Coronary Heart Disease: Rationale and Design of the UNWIND Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Feger, Bryan J.; Smith, Patrick J.; Watkins, Lana L.; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M.; Ashworth, Megan; Mabe, Stephanie K.; Babyak, Michael A.; Kraus, William E.; Hinderliter, Alan; Sherwood, Andrew

2016-01-01

Background Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. Methods The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70–85% VO2peak), escitalopram (5–20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. Conclusions The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. PMID:27264220

Cytokines as a predictor of clinical response following hip arthroscopy: minimum 2-year follow-up.

PubMed

Shapiro, Lauren M; Safran, Marc R; Maloney, William J; Goodman, Stuart B; Huddleston, James I; Bellino, Michael J; Scuderi, Gaetano J; Abrams, Geoffrey D

2016-08-01

Hip arthroscopy in patients with osteoarthritis has been shown to have suboptimal outcomes. Elevated cytokine concentrations in hip synovial fluid have previously been shown to be associated with cartilage pathology. The purpose of this study was to determine whether a relationship exists between hip synovial fluid cytokine concentration and clinical outcomes at a minimum of 2 years following hip arthroscopy. Seventeen patients without radiographic evidence of osteoarthritis had synovial fluid aspirated at time of portal establishment during hip arthroscopy. Analytes included fibronectin-aggrecan complex as well as a multiplex cytokine array. Patients completed the modified Harris Hip Score, Western Ontario and McMaster Universities Arthritis Index and the International Hip Outcomes Tool pre-operatively and at a minimum of 2 years following surgery. Pre and post-operative scores were compared with a paired t-test, and the association between cytokine values and clinical outcome scores was performed with Pearson's correlation coefficient with an alpha value of 0.05 set as significant. Sixteen of seventeen patients completed 2-year follow-up questionnaires (94%). There was a significant increase in pre-operative to post-operative score for each clinical outcome measure. No statistically significant correlation was seen between any of the intra-operative cytokine values and either the 2-year follow-up scores or the change from pre-operative to final follow-up outcome values. No statistically significant associations were seen between hip synovial fluid cytokine concentrations and 2-year follow-up clinical outcome assessment scores for those undergoing hip arthroscopy.

Outcome measures in coeliac disease trials: the Tampere recommendations.

PubMed

Ludvigsson, Jonas F; Ciacci, Carolina; Green, Peter Hr; Kaukinen, Katri; Korponay-Szabo, Ilma R; Kurppa, Kalle; Murray, Joseph A; Lundin, Knut Erik Aslaksen; Maki, Markku J; Popp, Alina; Reilly, Norelle R; Rodriguez-Herrera, Alfonso; Sanders, David S; Schuppan, Detlef; Sleet, Sarah; Taavela, Juha; Voorhees, Kristin; Walker, Marjorie M; Leffler, Daniel A

2018-02-13

A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

How to influence patient oral hygiene behavior effectively.

PubMed

Clarkson, J E; Young, L; Ramsay, C R; Bonner, B C; Bonetti, D

2009-10-01

Considerable resources are expended in dealing with dental disease easily prevented with better oral hygiene. The study hypothesis was that an evidence-based intervention, framed with psychological theory, would improve patients' oral hygiene behavior. The impact of trial methodology on trial outcomes was also explored by the conducting of two independent trials, one randomized by patient and one by dentist. The study included 87 dental practices and 778 patients (Patient RCT = 37 dentists/300 patients; Cluster RCT = 50 dentists/478 patients). Controlled for baseline differences, pooled results showed that patients who experienced the intervention had better behavioral (timing, duration, method), cognitive (confidence, planning), and clinical (plaque, gingival bleeding) outcomes. However, clinical outcomes were significantly better only in the Cluster RCT, suggesting that the impact of trial design on results needs to be further explored.

Calcium supplementation improves clinical outcome in intensive care unit patients: a propensity score matched analysis of a large clinical database MIMIC-II.

PubMed

Zhang, Zhongheng; Chen, Kun; Ni, Hongying

2015-01-01

Observational studies have linked hypocalcemia with adverse clinical outcome in critically ill patients. However, calcium supplementation has never been formally investigated for its beneficial effect in critically ill patients. To investigate whether calcium supplementation can improve 28-day survival in adult critically ill patients. Secondary analysis of a large clinical database consisting over 30,000 critical ill patients was performed. Multivariable analysis was performed to examine the independent association of calcium supplementation and 28-day morality. Furthermore, propensity score matching technique was employed to investigate the role of calcium supplementation in improving survival. none. Primary outcome was the 28-day mortality. 90-day mortality was used as secondary outcome. A total of 32,551 adult patients, including 28,062 survivors and 4489 non-survivors (28-day mortality rate: 13.8 %) were included. Calcium supplementation was independently associated with improved 28-day mortality after adjusting for confounding variables (hazard ratio: 0.51; 95 % CI 0.47-0.56). Propensity score matching was performed and the after-matching cohort showed well balanced covariates. The results showed that calcium supplementation was associated with improved 28- and 90-day mortality (p < 0.05 for both Log-rank test). In adult critically ill patients, calcium supplementation during their ICU stay improved 28-day survival. This finding supports the use of calcium supplementation in critically ill patients.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

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

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

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

PubMed Central

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

2014-01-01

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

Comparison of clinical outcomes in diabetic and non-diabetic burns patients in a national burns referral centre in southeast Asia: A 3-year retrospective review.

PubMed

Low, Zhao-Kai; Ng, Wai-Yee; Fook-Chong, Stephanie; Tan, Bien-Keem; Chong, Si-Jack; Hwee, Jolie; Tay, Sook-Muay

2017-03-01

Diabetic burns patients may be at risk of worse clinical outcomes. This study aims to further investigate the impact of diabetes mellitus on clinical outcomes in burns patients in Singapore. A 3-year retrospective review was performed at the Singapore General Hospital Burns Centre (2011-2013). Pure inhalational burns were excluded. Diabetic (N=53) and non-diabetic (N=533) patients were compared, and the impact of diabetes on clinical outcomes, adjusting for confounders, was investigated using multivariate logistic regression. The diabetic group had a significantly higher incidence of wound infection and severe renal impairment, as well as a longer length of stay, higher number of operations and higher rate of unplanned readmission. ICU admission was significantly associated with hyperglycaemia (OR 5.44 [2.61-11.35], p<0.001) and a higher total body surface area of burn (OR per 1% TBSA 1.07 [1.05-1.09], p<0.001). Unplanned readmission was significantly associated with wound infection (OR 4.29 [1.70-10.83], p=0.002), and mortality associated with a higher TBSA (OR per 1% TBSA 1.1 [1.07-1.14], p<0.001). After adjusting for confounders, diabetes mellitus was not significantly associated with unplanned readmission or mortality. Diabetic burns patients have an increased risk of worse clinical outcomes, including wound infections, renal impairment and longer length of stay. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Empirically and Clinically Useful Decision Making in Psychotherapy: Differential Predictions with Treatment Response Models

ERIC Educational Resources Information Center

Lutz, Wolfgang; Saunders, Stephen M.; Leon, Scott C.; Martinovich, Zoran; Kosfelder, Joachim; Schulte, Dietmar; Grawe, Klaus; Tholen, Sven

2006-01-01

In the delivery of clinical services, outcomes monitoring (i.e., repeated assessments of a patient's response to treatment) can be used to support clinical decision making (i.e., recurrent revisions of outcome expectations on the basis of that response). Outcomes monitoring can be particularly useful in the context of established practice research…

The taxonomy statistic uncovers novel clinical patterns in a population of ischemic stroke patients.

PubMed

Tukiendorf, Andrzej; Kaźmierski, Radosław; Michalak, Sławomir

2013-01-01

In this paper, we describe a simple taxonomic approach for clinical data mining elaborated by Marczewski and Steinhaus (M-S), whose performance equals the advanced statistical methodology known as the expectation-maximization (E-M) algorithm. We tested these two methods on a cohort of ischemic stroke patients. The comparison of both methods revealed strong agreement. Direct agreement between M-S and E-M classifications reached 83%, while Cohen's coefficient of agreement was κ = 0.766(P < 0.0001). The statistical analysis conducted and the outcomes obtained in this paper revealed novel clinical patterns in ischemic stroke patients. The aim of the study was to evaluate the clinical usefulness of Marczewski-Steinhaus' taxonomic approach as a tool for the detection of novel patterns of data in ischemic stroke patients and the prediction of disease outcome. In terms of the identification of fairly frequent types of stroke patients using their age, National Institutes of Health Stroke Scale (NIHSS), and diabetes mellitus (DM) status, when dealing with rough characteristics of patients, four particular types of patients are recognized, which cannot be identified by means of routine clinical methods. Following the obtained taxonomical outcomes, the strong correlation between the health status at moment of admission to emergency department (ED) and the subsequent recovery of patients is established. Moreover, popularization and simplification of the ideas of advanced mathematicians may provide an unconventional explorative platform for clinical problems.

Secondary patella resurfacing in painful non-resurfaced total knee arthroplasties : A study of survival and clinical outcome from the Norwegian Arthroplasty Register (1994-2011).

PubMed

Leta, Tesfaye H; Lygre, Stein Håkon L; Skredderstuen, Arne; Hallan, Geir; Gjertsen, Jan-Erik; Rokne, Berit; Furnes, Ove

2016-04-01

In Norway, 19 % of revisions of non-resurfaced total knee arthroplasties done for knee pain between 1994 and 2011 were Secondary Patella Resurfacing (SPR). It is, however, unclear whether SPR actually resolves the pain. The aim was to investigate prostheses survival and clinical outcomes following SPR. A total of 308 knees (301 patients) with SPR were used to assess implant survival, and a sub-cohort (n = 114 out of 301 patients) with Patient Reported Outcome Measures (PROMs) data were used to assess the clinical outcomes. The EuroQol (EQ-5D), the Knee Injury and Osteoarthritis Outcome Score, and Visual Analogue Scales on satisfaction and pain were used to collect PROM data. Outcomes were analysed by Kaplan-Meier, Cox regression, and multiple linear regression. The five- and ten-year Kaplan-Meier survival percentages were 91 % and 87 %, respectively. Overall, 35 knees were re-revised at a median follow-up of eight years and pain alone (10 knees) was the main cause of re-revision. Younger patients (<60 years) had nearly nine times higher risk of re-revision compared to older patients (>70 years) (RR = 8.6; p < 0.001). Mean EQ-5D index score had improved from 0.41 (SD 0.21) preoperative to 0.56 (SD 0.25) postoperative following SPR. A total of 63 % of patients with PROM data were satisfied with the outcomes of SPR. The long-term prostheses survival following SPR was satisfactory, although not as good as for primary knee replacement. Patients' health related quality of life improved significantly following SPR. Still, more than a third of patients with PROMs data were dissatisfied with the outcomes of the SPR procedure.

Course of cannabis use and clinical outcome in patients with non-affective psychosis: a 3-year follow-up study.

PubMed

van der Meer, F J; Velthorst, E

2015-07-01

Prospective studies on the relationship between course of cannabis use and clinical outcome in patients with non-affective psychotic disorders are inconclusive. The current study examined whether (1) persistent, recently started, discontinued and non-cannabis-using patients with a psychotic disorder differed with regard to illness outcome at 3-year follow-up, and (2) whether timing of cannabis discontinuation was associated with course of clinical outcome. This 3-year follow-up study was part of a multi-center study in the Netherlands and Belgium (Genetic Risk and Outcome of Psychosis; GROUP). We used mixed-model analyses to investigate the association between pattern of cannabis use and symptoms, global functioning and psychotic relapse. In our sample of 678 patients, we found persistent users to have more positive and general symptoms, worse global functioning and more psychotic relapses compared with non-users and discontinued users [Positive and Negative Syndrome Scale (PANSS) positive, p < 0.001; PANSS general, p < 0.001; Global Assessment of Functioning (GAF) symptoms, p = 0.017; GAF disability, p < 0.001; relapses, p = 0.038]. Patients who started using cannabis after study onset were characterized by worse functioning at baseline and showed an increase in general symptoms (including depression and anxiety) at the 3-year follow-up (p = 0.005). Timing of cannabis discontinuation was not associated with clinical outcome. These findings suggest that cannabis use in patients with a psychotic disorder has a long-lasting negative effect on illness outcome, particularly when persistent. Treatment should focus on discouraging cannabis use.

Comparative analysis of arthroscopic debridement in osseous versus soft tissue anterior ankle impingement.

PubMed

Devgan, Ashish; Rohilla, Rajesh; Tanwar, Milind; Jain, Aditya; Siwach, Karan; Devgan, Radika

2016-01-01

Arthroscopic debridement has been a gold standard procedure for anterior ankle impingement, both in cases of osseous and soft tissue impingement. There is sparse literature on comparative outcome with respect to functional results between the two types of impingement post-arthroscopic debridement. Our study included 14 patients diagnosed as cases of anterior ankle impingement on the basis of clinical and radiological examination. They were segregated into two groups (on the basis of cause of impingement (osseous versus soft tissue)). Both groups were treated by arthroscopic debridement. Primary outcome was patient satisfaction, which was assessed by Likert scale and clinical outcomes were measured using AOFAS ankle-hind foot scale, VAS score, range of motion and time to return to pre-injury activity level in both groups. Mean follow-up was of 15 months where eleven patients reported an excellent recovery, two patients had good recovery while one patient reported poor outcome. Mean AOFAS ankle hind foot scale improved from 50.5 preoperatively to 85.71 postoperatively (statistically significant; p value - 0.0001). Mean Likert scale value post-operative was 4.21. VAS score showed significant improvement in patients of both the groups. Range of motion was slightly better in soft tissue impingement type with a relatively shorter time to return to sports or preinjury activity level as compared to osseous impingement group. The patients in both the groups had comparable outcomes with no statistically significant difference with regard to patient satisfaction and clinical outcome.

Histopathologic grading of medulloblastomas: a Pediatric Oncology Group study.

PubMed

Eberhart, Charles G; Kepner, James L; Goldthwaite, Patricia T; Kun, Larry E; Duffner, Patricia K; Friedman, Henry S; Strother, Douglas R; Burger, Peter C

2002-01-15

Medulloblastomas are small cell embryonal tumors of the cerebellum found predominantly in children, only slightly more than half of whom survive. Predicting favorable outcome has been difficult, and improved stratification clearly is required to avoid both undertreatment and overtreatment. Patients currently are staged clinically, but no pathologic staging system is in use. Two rare subtypes at extreme ends of the histologic spectrum, i.e., medulloblastomas with extensive nodularity and large cell/anaplastic medulloblastomas, are associated with better and worse clinical outcomes, respectively. However, there is little data about correlations between histologic features and clinical outcome for most patients with medulloblastomas that fall between these histologic extremes of nodularity and anaplasia. Therefore, the authors evaluated the clinical effects of increasing anaplasia and nodularity in a large group of children with medulloblastomas, hypothesizing that increasing nodularity would predict better clinical outcomes and that increasing anaplasia would presage less favorable results. Medulloblastomas from 330 Pediatric Oncology Group patients were evaluated histologically with respect to extent of nodularity, presence of desmoplasia, grade of anaplasia, and extent of anaplasia. Pathologic and clinical data were then compared using Kaplan-Meier and log-rank analyses. Increasing grade of anaplasia and extent of anaplasia were associated strongly with progressively worse clinical outcomes (P < 0.0001 for both). Significant anaplasia (moderate or severe) was identified in 24% of medulloblastoma specimens. Neither increasing degrees of nodularity nor desmoplasia were associated significantly with longer survival. Moderate anaplasia and severe anaplasia were associated with aggressive clinical behavior in patients with medulloblastomas and were detected in a significant number of specimens (24%). Pathologic grading of medulloblastomas with respect to anaplasia may be of clinical utility.

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

PubMed

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

2016-04-01

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

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

PubMed

González-Ortega, Itxaso; Echeburúa, Enrique; García-Alocén, Adriana; Vega, Patricia; González-Pinto, Ana

2016-07-29

The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.

Thrombolytic-Related Asymptomatic Hemorrhagic Transformation Does Not Deteriorate Clinical Outcome: Data from TIMS in China

PubMed Central

Jia, Weihua; Liao, Xiaoling; Pan, Yuesong; Wang, Yilong; Cui, Tao; Zhou, Lichun; Wang, Yongjun

2015-01-01

Objective It has been unclear whether thrombolytic-related asymptomatic hemorrhagic transformation (AHT) affects the clinical outcome. To answer this question, we examined whether thrombolytic-related AHT affect short-term and long-term clinical outcome. Methods All data were collected from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) registry. The patients were diagnosed as having AHT group and non- hemorrhagic transformation (HT) group based on clinical and imaging data. The patients with symptomatic hemorrhagic transformation were excluded from this study. Thrombolytic-related AHT was defined according to European-Australasian Acute Stroke Study (ECASS) II criteria. 90-day functional outcome, 7-day National Institutes of Health Stroke Scale (NIHSS) score, 7-day and 90-day mortalities were compared between two groups. Logistic regression analysis was used to evaluate the effects of AHT on a short-term and long-term clinical outcome. Results 904 of all 1440 patients in TIMS-China registry were enrolled. 89 (9.6%) patients presented with AHT after thrombolysis within 24-36h. These patients with AHT were more likely to be elder age, cardioembolic subtype, and to have higher National Institutes of Health Stroke Scale score before thrombolysis than patients without AHT. No significant difference was found on the odds of 7-day (95% CI:0.692 (0.218–2.195), (P = 0.532) or 90-day mortalities (95% CI:0.548 (0.237–1.268), P = 0.160) and modified Rankin Score(0–1) at 90-day (95% CI:0.798 (0.460–1.386), P = 0.423) or modified Rankin Score(0–2) at 90-day (95% CI:0.732 (0.429–1.253), P = 0.116) or modified Rankin Score(5–6) at 90-day (95% CI:0.375 (0.169–1.830), P = 0.116) between two groups. Conclusions Thrombolytic-related AHT does not deteriorate short-term and long-term clinical outcome. PMID:26619008

Thrombolytic-Related Asymptomatic Hemorrhagic Transformation Does Not Deteriorate Clinical Outcome: Data from TIMS in China.

PubMed

Jia, Weihua; Liao, Xiaoling; Pan, Yuesong; Wang, Yilong; Cui, Tao; Zhou, Lichun; Wang, Yongjun

2015-01-01

It has been unclear whether thrombolytic-related asymptomatic hemorrhagic transformation (AHT) affects the clinical outcome. To answer this question, we examined whether thrombolytic-related AHT affect short-term and long-term clinical outcome. All data were collected from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) registry. The patients were diagnosed as having AHT group and non- hemorrhagic transformation (HT) group based on clinical and imaging data. The patients with symptomatic hemorrhagic transformation were excluded from this study. Thrombolytic-related AHT was defined according to European-Australasian Acute Stroke Study (ECASS) II criteria. 90-day functional outcome, 7-day National Institutes of Health Stroke Scale (NIHSS) score, 7-day and 90-day mortalities were compared between two groups. Logistic regression analysis was used to evaluate the effects of AHT on a short-term and long-term clinical outcome. 904 of all 1440 patients in TIMS-China registry were enrolled. 89 (9.6%) patients presented with AHT after thrombolysis within 24-36 h. These patients with AHT were more likely to be elder age, cardioembolic subtype, and to have higher National Institutes of Health Stroke Scale score before thrombolysis than patients without AHT. No significant difference was found on the odds of 7-day (95% CI:0.692 (0.218-2.195), (P = 0.532) or 90-day mortalities (95% CI:0.548 (0.237-1.268), P = 0.160) and modified Rankin Score(0-1) at 90-day (95% CI:0.798 (0.460-1.386), P = 0.423) or modified Rankin Score(0-2) at 90-day (95% CI:0.732 (0.429-1.253), P = 0.116) or modified Rankin Score(5-6) at 90-day (95% CI:0.375 (0.169-1.830), P = 0.116) between two groups. Thrombolytic-related AHT does not deteriorate short-term and long-term clinical outcome.

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

PubMed

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.

Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures.

PubMed

van Bekkum, Marlies L; van Munster, Barbara C; Thunnissen, Peter L M; Smorenburg, Carolien H; Hamaker, Marije E

2015-01-01

The elderly comprise the majority of patients newly diagnosed with cancer. Despite this, little evidence-based data are available on the care of the growing number of older patients with cancer. The objective of the current study was to evaluate the characteristics and outcome measures of current clinical trials on palliative chemotherapy in elderly patients. Fourteen international clinical trials registries were searched using the terms "cancer" and "elderly" to identify clinical palliative chemotherapy trials designed specifically for patients aged 70+ years. From the trial protocol, data were extracted on trial characteristics and outcome measures. Of 127 trials, 81% formulated one or more stringent criteria with respect to organ function; 32% excluded patients with WHO performance status (PS) 2 and 83% with PS3. Functional outcomes, health care utilisation, cognitive function after treatment, and quality of life were reported in 6%, 3%, 6%, and 31% of trials, respectively. In only 16% of trials on palliative cancer treatment, a geriatric assessment was performed at baseline. Although recent years have seen a growing evidence base regarding fit older patients, our study suggests a lack of representative cohorts of older patients and patient-centred outcome measures in current palliative treatment trials for the elderly. Research addressing alternative outcome measures, including quality of life and impact of therapy on general functioning, cognition, and preservation of independence, and incorporation of a geriatric assessment are needed to provide elderly patients with cancer and their treating physicians with realistic information about palliative chemotherapy. Copyright © 2014 Elsevier Inc. All rights reserved.

'What will I be like' after my diagnosis of head and neck cancer?

PubMed

Rogers, S N; Hogg, E S; Cheung, W K A; Lai, L K L; Jassal, P; Lowe, D; Kanatas, A

2015-09-01

Consequences of treating head and neck cancer are reflected in health-related quality of life (HRQOL) patient-reported outcomes. HRQOL is an important outcome alongside survival and recurrence. However, relatively little HRQOL information is in a format that patients and oncology teams can easily interpret as a guide to likely outcomes following curative treatment. The study aim was to collate University of Washington Quality of Life (UW-QOL) questionnaires collected 1995-2012 at the Regional Head and Neck Surgical Unit with a view of summarizing key clinical-demographic influences on HRQOL outcomes at 2 years following diagnosis. Patients completing UW-QOL questionnaires at 9-60 months had their record closest to 2 years selected for cross-sectional analyses, while all questionnaires were analyzed to assess temporal trends. 65 % (1,134) of survivors to 9 months had a UW-QOL record in the cross-sectional analysis (median 23 months). Overall 1,349 completed 5,573 UW-QOL questionnaires. Various associations were seen, notably late overall clinical staging and treatment adversely associated with UW-QOL physical functioning domains. Logistic regression was used to better understand the predictive factors of UW-QOL outcome and determined the final formatting of tables for results. These tables provide important reference data about UW-QOL outcome at 2 years relevant to patients at the outset of their cancer journey. The increasing amount of HRQOL data allows for quite detailed subgroup analysis, which can help give patients and the clinical team a better understanding of likely long-term HRQOL outcomes. How this is best utilized in clinical care needs further evaluation.

Brainstem encephalitis: etiologies, treatment, and predictors of outcome

PubMed Central

Tan, Ik Lin; Mowry, Ellen M.; Steele, Sonya U.; Pardo, Carlos A.; McArthur, Justin C.; Nath, Avindra

2016-01-01

Brainstem encephalitis (BE) is an uncommon condition. We sought to characterize clinical presentations, etiologies, response to treatment, and predictors of outcome. We performed a retrospective review of non–HIV infected patients diagnosed with BE at Johns Hopkins Hospital (January 1997–April 2010). We characterized clinical and paraclinical features, and used regression models to assess associations with poor outcome. BE was diagnosed in 81 patients. An etiology was identified in 58 of 81 (71.6 %) of cases, most of which were confirmed or probable inflammatory/autoimmune conditions. Of the remaining 23 cases in which a specific diagnosis remained undefined, clinical presentation, CSF, neuroimaging studies, and outcomes were similar to the inflammatory/autoimmune group. Brain biopsy identified a specific diagnosis in 7 of 14 patients (50 %). Fifteen patients (18.5 %) either died or had a poor outcome. In multivariate logistic regression models, a higher CSF protein (per 5 mg/dl, OR = 1.11, 95 % CI: 1.03–1.20), a higher CSF glucose (per 5 mg/dl, OR = 1.36, 95 % CI: 1.09–1.70), and higher serum glucose (per 5 mg/dl, OR = 1.27, 95 % CI: 1.06–1.52) were independently associated with increased odds of poor outcome. Inflammatory and non-infectious conditions accounted for most cases of BE. Higher CSF protein and glucose were independently associated with poor outcome. In immunocompetent patients with BE of undefined etiology despite extensive investigation, a trial of immunosuppressive treatment may be warranted, though deterioration clinically or on magnetic resonance imaging should prompt a brain biopsy. PMID:23749332

A Multidisciplinary Sepsis Program Enabled by a Two-Stage Clinical Decision Support System: Factors That Influence Patient Outcomes.

PubMed

Amland, Robert C; Haley, James M; Lyons, Jason J

2016-11-01

Sepsis is an inflammatory response triggered by infection, with risk of in-hospital mortality fueled by disease progression. Early recognition and intervention by multidisciplinary sepsis programs may reverse the inflammatory response among at-risk patient populations, potentially improving outcomes. This retrospective study of a sepsis program enabled by a 2-stage sepsis Clinical Decision Support (CDS) system sought to evaluate the program's impact, identify early indicators that may influence outcomes, and uncover opportunities for quality improvement. Data encompassed 16 527 adult hospitalizations from 2014 and 2015. Of 2108 non-intensive care unit patients screened-in by sepsis CDS, 97% patients were stratified by 177 providers. Risk of adverse outcome improved 30% from baseline to year end, with gains materializing and stabilizing at month 7 after sepsis program go-live. Early indicators likely to influence outcomes include patient age, recent hospitalization, electrolyte abnormalities, hypovolemic shock, hypoxemia, patient location when sepsis CDS activated, and specific alert patterns. © The Author(s) 2015.

Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

PubMed

Aaron, Shawn D; Vandemheen, Katherine L; Freitag, Andreas; Pedder, Linda; Cameron, William; Lavoie, Annick; Paterson, Nigel; Wilcox, Pearce; Rabin, Harvey; Tullis, Elizabeth; Morrison, Nancy; Ratjen, Felix

2012-01-01

Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF). We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life. Over the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. ClinicalTrials.gov NCT00528190.

Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

PubMed

Hróbjartsson, A; Gøtzsche, P C

2001-05-24

Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos.

Differences in clinical presentation and pregnancy outcomes in antepartum preeclampsia and new-onset postpartum preeclampsia: Are these the same disorder?

PubMed

Vilchez, Gustavo; Hoyos, Luis R; Leon-Peters, Jocelyn; Lagos, Moraima; Argoti, Pedro

2016-11-01

New-onset postpartum preeclampsia is a poorly defined condition that accounts for a significant percentage of eclampsia cases. It is unclear whether new-onset postpartum preeclampsia is a different disorder from or belongs to the same spectrum of classic antepartum preeclampsia. The objective of this study was to compare the clinical presentation and pregnancy outcomes of antepartum preeclampsia and new-onset postpartum preeclampsia. A retrospective study including 92 patients with antepartum preeclampsia and 92 patients with new-onset postpartum preeclampsia was performed. Clinical presentation and pregnancy outcomes were compared. Chi-square test was used to analyze categorical variables, and independent t -test and Mann-Whitney U -test for numerical variables. P -values of <0.05 were used to indicate statistical signifi cance. Patients with antepartum preeclampsia and new-onset postpartum preeclampsia differ significantly in profile, symptoms at presentation, laboratory markers and pregnancy outcomes. New-onset postpartum preeclampsia has a distinct patient profile and clinical presentation than antepartum preeclampsia, suggesting they may represent different disorders. Characterization of a patient profile with increased risk of developing this condition will help clinicians to identify patients at risk and provide early and targeted interventions to decrease the morbidity associated with this condition.

International collaboration including patients is essential to develop new therapies for patients with myositis.

PubMed

Lundberg, Ingrid E; Vencovsky, Jiri

2017-05-01

To discuss the needs for international collaborations between investigators in different disciplines working with myositis and with patients with myositis. Recent advances in detection of several myositis-specific autoantibodies that are associated with distinct clinical phenotypes, will enable studies in new well defined clinically homogenous subgroups of myositis This is likely to lead to development of new information on molecular pathogenesis that might be different in different myositis subgroups. Subgrouping patients according to autoantibody profile may also be important to assess outcome, to identify prognostic biomarkers and in clinical trials. As these are rare disorders international collaboration is essential to enrol large enough cohorts of the subgroups. To facilitate such collaboration we have developed a web-based international myositis register, www.euromyositis.eu, which includes validated outcome measures and patient reported outcome measures. This register is to support research but also to support decision-making in the clinic. We welcome investigators to join the Euromyositis register. Myositis is a heterogeneous disorder with varying treatment response and outcome. There is a high unmet need for new therapies which can only be achieved by increased knowledge on molecular disease mechanisms. Subgrouping patients according to autoantibody profile may be a new way forward to get a better understanding on disease mechanisms and to develop novel therapies.

Patient-reported outcomes in drug development for hematology.

PubMed

Acquadro, Catherine; Regnault, Antoine

2015-01-01

Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs. © 2015 by The American Society of Hematology. All rights reserved.

Heart-fatty acid-binding and tau proteins relate to brain injury severity and long-term outcome in subarachnoid haemorrhage patients.

PubMed

Zanier, E R; Zoerle, T; Fiorini, M; Longhi, L; Cracco, L; Bersano, A; Branca, V; Benedetti, M D; De Simoni, M G; Monaco, S; Stocchetti, N

2013-09-01

Vasospasm and other secondary neurological insults may follow subarachnoid haemorrhage (SAH). Biomarkers have the potential to stratify patient risk and perhaps serve as an early warning sign of delayed ischaemic injury. Serial cerebrospinal fluid (CSF) samples were collected from 38 consecutive patients with aneurysmal SAH admitted to the neurosurgical intensive care unit. We measured heart-fatty acid-binding protein (H-FABP) and tau protein (τ) levels in the CSF to evaluate their association with brain damage, and their potential as predictors of the long-term outcome. H-FABP and τ were analysed in relation to acute clinical status, assessed by the World Federation of Neurological Surgeons (WFNS) scale, radiological findings, clinical vasospasm, and 6-month outcome. H-FABP and τ increased after SAH. H-FABP and τ were higher in patients in poor clinical status on admission (WFNS 4-5) compared with milder patients (WFNS 1-3). Elevated H-FABP and τ levels were also observed in patients with early cerebral ischaemia, defined as a CT scan hypodense lesion visible within the first 3 days after SAH. After the acute phase, H-FABP, and τ showed a delayed increase with the occurrence of clinical vasospasm. Finally, patients with the unfavourable outcome (death, vegetative state, or severe disability) had higher peak levels of both proteins compared with patients with good recovery or moderate disability. H-FABP and τ show promise as biomarkers of brain injury after SAH. They may help to identify the occurrence of vasospasm and predict the long-term outcome.

Distinct Clinical Features and Outcomes in Motor Neuron Disease Associated with Behavioural Variant Frontotemporal Dementia.

PubMed

Cortés-Vicente, Elena; Turon-Sans, Janina; Gelpi, Ellen; Clarimón, Jordi; Borrego-Écija, Sergi; Dols-Icardo, Oriol; Illán-Gala, Ignacio; Lleó, Alberto; Illa, Isabel; Blesa, Rafael; Al-Chalabi, Ammar; Rojas-García, Ricard

2018-06-08

To determine the motor phenotype and outcome in a clinically ascertained group of patients with motor neuron disease (MND) and frontotemporal dementia (FTD). This is an observational retrospective clinical study of patients fulfilling the clinical criteria for MND-FTD. A contemporary series of patients with amyotrophic lateral sclerosis (ALS) without dementia were included for comparison. Demographic, clinical, genetic, and neuropathological data were collected. A descriptive and comparative data analysis was performed. We identified 22 patients with MND-FTD. Selective distal upper limb muscle weakness and atrophy with non-significant lower limb weakness during follow-up was the most frequent motor pattern, present in 18 patients - in 15 of them associated with severe dysphagia. Aspiration pneumonia was the most common cause of death (12/19; 63%) despite gastrostomy. One-third of the patients did not develop upper motor neuron dysfunction. When compared to classic ALS without dementia (n = 162), these features were significantly different. A neuro-pathological examination was performed on 7 patients, and it confirmed the presence of MND with TDP43 protein aggregates in all patients. The MND-FTD patients frequently displayed a distinctive motor pattern characterized by weakness and atrophy in distal upper limb muscles and dysphagia, with no or little spreading to other regions. These features may help to define specific subgroups of patients, which is important with regard to clinical management, outcome, and research. © 2018 S. Karger AG, Basel.

Differences in clinical ocular outcomes between exogenous and endogenous endophthalmitis caused by Sporothrix: a systematic review of published literature.

PubMed

Ramírez Soto, Max Carlos

2017-09-28

Sporotrichosis is an implantation mycosis caused by Sporothrix species prevalent worldwide, which occasionally can also result in intraocular infection presenting as an exogenous or endogenous infection (disseminated sporotrichosis). Knowledge in its clinical recognition and management is limited. To systematically review and analyse data from published literature with a view to comparing clinical outcomes between exogenous and endogenous endophthalmitis caused by Sporothrix . Case reports of intraocular sporotrichosis, published from 1960 to 2016, were retrieved from MEDLINE, Embase, Cochrane, LILACS and SciELO databases. The entire data set was divided into two patient groups: (1) exogenous endophthalmitis and (2) endogenous endophthalmitis. Primary outcomes were differences in ocular findings and clinical ocular outcomes between the two groups. From 16 publications retrieved, a total of 8 eyes of 8 patients with exogenous endophthalmitis and 13 eyes of 10 patients with endogenous endophthalmitis were identified. Compared with exogenous endophthalmitis, endogenous endophthalmitis was more common in patients infected with HIV (p=0.001) and those from hyperendemic areas (p=0.036). Anterior uveitis (p=0.015) and posterior uveitis (p=0.04) were more common in the exogenous and endogenous endophthalmitis groups, respectively. The majority of patients with endogenous endophthalmitis had partial or full clinical resolution of ocular lesions with systemic amphotericin B alone or in combination with an oral antifungal, whereas patients with exogenous endophthalmitis had poor outcomes with irreversible vision loss, enucleation and evisceration. Anterior uveitis is more common in exogenous endophthalmitis with worse overall outcomes and complications, compared with endogenous endophthalmitis where posterior uveitis is the most common clinical manifestation, especially in patients infected with HIV and those from hyperendemic areas. Sporothrix infection should be included in the differential diagnosis for ocular inflammation, regardless of the presence or absence of autoimmune comorbidities and whether the patient resides in an endemic area or not. Ophthalmologists should consider intravitreal and systemic antifungal therapy for exogenous and endogenous endophthalmitis caused by Sporothrix . © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Relationship between patient-reported outcomes and clinical outcomes in metastatic castration-resistant prostate cancer: post hoc analysis of COU-AA-301 and COU-AA-302.

PubMed

Cella, D; Traina, S; Li, T; Johnson, K; Ho, K F; Molina, A; Shore, N D

2018-02-01

Patient-reported outcomes (PROs) are used to assess benefit-risk in drug development. The relationship between PROs and clinical outcomes is not well understood. We aim to elucidate the relationships between changes in PRO measures and clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC). We investigated relationships between changes in self-reported fatigue, pain, functional well-being (FWB), physical well-being (PWB) and prostate cancer-specific symptoms with overall survival (OS) and radiographic progression-free survival (rPFS) after 6 and 12 months of treatment in COU-AA-301 (N = 1195) or COU-AA-302 (N = 1088). Eligible COU-AA-301 patients had progressed after docetaxel and had Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2. Eligible COU-AA-302 patients had no prior chemotherapy and ECOG PS 0 or 1. Patients were treated with abiraterone acetate (1000 mg/day) plus prednisone (10 mg/day) or prednisone alone daily. Association between self-reported fatigue, pain and functional status, and OS and/or rPFS, using pooled data regardless of treatment, was assessed. Cox proportional hazard regression modeled time to death or radiographic progression. In COU-AA-301 patients, PRO improvements were associated with longer OS and longer time to radiographic progression versus worsening or stable PROs (P < 0.0001). In multivariate models, all except pain intensity remained associated with OS. Pain intensity, PWB and FWB improvements remained associated with rPFS. In COU-AA-302 patients, worsening PROs were associated with higher likelihood of radiographic progression (P ≤ 0.025) compared with improved or stable PROs. In multivariate models, worsening PWB remained associated with worse rPFS. The 12-month analysis confirmed the 6-month results. PROs are significantly associated with clinically relevant time-to-event efficacy outcomes in clinical trials and may complement and help predict traditional clinical practice methods for monitoring patients for disease progression. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

One year clinical outcomes in patients with insulin-treated diabetes mellitus and non-insulin-treated diabetes mellitus compared to non-diabetics after deployment of the bio-engineered COMBO stent.

PubMed

Kalkman, Deborah N; Woudstra, Pier; den Heijer, Peter; Menown, Ian B A; Erglis, Andrejs; Suryapranata, Harry; Arkenbout, Karin E; Iñiguez, Andrés; van 't Hof, Arnoud W J; Muller, Philippe; Tijssen, Jan G; de Winter, Robbert J

2017-01-01

The COMBO stent is a novel sirolimus-eluting stent with a luminal anti-CD34+ antibody layer to promote vessel healing. No data is currently available on clinical outcomes after treatment with this novel bio-engineered device in diabetic patients. We evaluate clinical outcomes at twelve months after COMBO stent placement in patients without diabetes mellitus (non-DM), patients with non-insulin-treated diabetes mellitus (nITDM) and patients with insulin-treated diabetes mellitus (ITDM). This study is a pre-specified subgroup analysis of the 1000 patient all-comers REMEDEE Registry. The primary endpoint is target lesion failure (TLF), which is a combined endpoint consisting of cardiac death, target vessel-myocardial infarction (tv-MI) and target lesion revascularization (TLR) at twelve months follow-up. Kaplan Meier method is used with log rank to compare outcomes between groups. This subgroup analysis includes 807 non-DM, 117 nITDM and 67 ITDM. Kaplan-Meier estimates for TLF at twelve months are 4.4% in non-DM, 6.8% in nITDM and 20.3% in ITDM, p<0.001 (non-DM vs nITDM p=0.244, non-DM vs ITDM p<0.001). This study gives the first insight into the impact of insulin-treated diabetes mellitus on clinical outcome of patients treated with the novel COMBO stent. At one year after COMBO stent placement significantly higher rates of target lesion failure are seen in patients with ITDM compared to patients with nITDM and patients without DM. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Differential Impact of Net Atrioventricular Compliance on Clinical Outcomes in Patients with Mitral Stenosis According to Cardiac Rhythm.

PubMed

Cho, In-Jeong; Chang, Hyuk-Jae; Lee, Soo Yeon; Shim, Chi Young; Hong, Geu-Ru; Chung, Namsik

2017-06-01

Net atrioventricular compliance (Cn), a parameter for the net compliance of the left atrium and left ventricle, is known to be a useful predictor of outcomes in patients with mitral stenosis (MS). The present study aimed to evaluate whether the impact of Cn on symptom status and clinical outcomes, as well as its contribution toward systolic pulmonary artery pressure (SPAP), differed according to cardiac rhythm. We retrospectively reviewed patients (N = 308) with rheumatic pure MS. Doppler-derived Cn was calculated using planimetered mitral valve area and E-wave downslope of transmitral flow. The primary endpoint was defined as a composite of all-cause death, percutaneous mitral valvotomy, surgical mitral valve replacement, admission for heart failure, and stroke. Overall, there were 178 patients (58%) with sinus rhythm (SR) and 130 patients (42%) with atrial fibrillation (AF). In multivariable linear regression analysis, there was a significant independent association between Cn and SPAP in patients with SR (P = .014), but not in those with AF (P = .112). During a median follow-up of 38 months, 130 patients (27%) experienced the study endpoint. In multivariable Cox regression, high Cn was associated with a more favorable prognosis in patients with SR (hazard ratio = 0.83; 95% CI, 0.69-0.99; P = .038). Conversely, high Cn was not found to offset the burden of adverse clinical outcomes in those with AF (hazard ratio = 1.18; 95% CI, 0.99-1.40; P = .071). Cn appears to be associated with SPAP and clinical outcomes in MS patients with SR. The predictive role of Cn in patients with AF requires further clarification. Copyright © 2017 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.

Outcome definitions and clinical predictors influence pharmacogenetic associations between HTR3A gene polymorphisms and response to clozapine in patients with schizophrenia.

PubMed

Rajkumar, A P; Poonkuzhali, B; Kuruvilla, A; Srivastava, A; Jacob, M; Jacob, K S

2012-12-01

Pharmacogenetics of schizophrenia has not yet delivered anticipated clinical dividends. Clinical heterogeneity of schizophrenia contributes to the poor replication of the findings of pharmacogenetic association studies. Functionally important HTR3A gene single-nucleotide polymorphisms (SNPs) were reported to be associated with response to clozapine. The aim of this study was to investigate how the association between HTR3A gene SNP and response to clozapine is influenced by various clinical predictors and by differing outcome definitions in patients with treatment-resistant schizophrenia (TRS). We recruited 101 consecutive patients with TRS, on stable doses of clozapine, and evaluated their HTR3A gene SNP (rs1062613 and rs2276302), psychopathology, and serum clozapine levels. We assessed their socio-demographic and clinical profiles, premorbid adjustment, traumatic events, cognition, and disability using standard assessment schedules. We evaluated their response to clozapine, by employing six differing outcome definitions. We employed appropriate multivariate statistics to calculate allelic and genotypic association, accounting for the effects of various clinical variables. T allele of rs1062613 and G allele of rs2276302 were significantly associated with good clinical response to clozapine (p = 0.02). However, varying outcome definitions make these associations inconsistent. rs1062613 and rs2276302 could explain only 13.8 % variability in the responses to clozapine, while combined clinical predictors and HTR3A pharmacogenetic association model could explain 38 % variability. We demonstrated that the results of pharmacogenetic studies in schizophrenia depend heavily on their outcome definitions and that combined clinical and pharmacogenetic models have better predictive values. Future pharmacogenetic studies should employ multiple outcome definitions and should evaluate associated clinical variables.

The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial.

PubMed

Williams, Aled L; Phillips, Ceri J; Watkins, Alan; Rushton, Alison B

2014-10-25

Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes, few studies have been conducted. Within musculoskeletal physiotherapy, the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed, but the impact of this mentoring on patient outcomes remains unknown. The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy. A stepped wedge cluster randomised controlled trial (CRCT) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service (NHS) organization. Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods. Patients will be blinded to whether their physiotherapist has received the intervention. The primary outcome measure will be the Patient-Specific Functional Scale; secondary outcome measures will include the EQ-5D, patient activation, patient satisfaction and physiotherapist performance. Sample size considerations used published methods describing stepped wedge designs, conventional values of 0.80 for statistical power and 0.05 for statistical significance, and pragmatic groupings of 12 participating physiotherapists in three clusters. Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0, 10 patients are required to complete outcome measures per physiotherapist, at time period 1 (prior to intervention roll-out) and at each of time periods 2, 3 and 4, giving a sample size of 480 patients. To account for the potential loss to follow-up of 33%, 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control. Consecutive, consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline, discharge and 12 months post-baseline. The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters. Assigned 31 July 2012: ISRCTN79599220.

The Impact of Personality Traits on the Outcome of Total Knee Arthroplasty.

PubMed

Giurea, A; Fraberger, G; Kolbitsch, P; Lass, R; Schneider, E; Kubista, B; Windhager, R

2016-01-01

Ten to twenty percent of patients with total knee arthroplasty (TKA) are dissatisfied with their clinical outcome. Aim of this study was to investigate the impact of personality traits on the subjective outcome of TKA. We investigated 80 patients with 86 computer navigated TKAs. We asked for patients satisfaction and divided patients into two groups (satisfied or dissatisfied). 12 personality traits were tested by the Freiburg Personality Inventory (FPI-R). Postoperative examination included Knee Society Score (KSS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the Visual Analogue Scale (VAS). Radiologic investigation was done in all patients. 84% of our patients were satisfied, while 16% were not satisfied. The FPI-R showed statistical significant influence of four personality traits on patient satisfaction: life satisfaction (p = 0.006), performance orientation (p = 0.015), somatic distress (p = 0.001), and emotional stability (p = 0.002). All clinical scores (VAS, WOMAC, and KSS) showed significantly better results in the satisfied patient. Radiological examination showed optimal alignment of all TKAs. There were no complications requiring revision surgery. The results of our study show that personality traits may influence patients satisfaction and clinical outcome after TKA. Therefore patients personality traits may be a useful predictive factor for postoperative satisfaction after TKA.

The Impact of Personality Traits on the Outcome of Total Knee Arthroplasty

PubMed Central

Giurea, A.; Fraberger, G.; Kolbitsch, P.; Lass, R.; Schneider, E.; Kubista, B.; Windhager, R.

2016-01-01

Ten to twenty percent of patients with total knee arthroplasty (TKA) are dissatisfied with their clinical outcome. Aim of this study was to investigate the impact of personality traits on the subjective outcome of TKA. We investigated 80 patients with 86 computer navigated TKAs. We asked for patients satisfaction and divided patients into two groups (satisfied or dissatisfied). 12 personality traits were tested by the Freiburg Personality Inventory (FPI-R). Postoperative examination included Knee Society Score (KSS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the Visual Analogue Scale (VAS). Radiologic investigation was done in all patients. 84% of our patients were satisfied, while 16% were not satisfied. The FPI-R showed statistical significant influence of four personality traits on patient satisfaction: life satisfaction (p = 0.006), performance orientation (p = 0.015), somatic distress (p = 0.001), and emotional stability (p = 0.002). All clinical scores (VAS, WOMAC, and KSS) showed significantly better results in the satisfied patient. Radiological examination showed optimal alignment of all TKAs. There were no complications requiring revision surgery. The results of our study show that personality traits may influence patients satisfaction and clinical outcome after TKA. Therefore patients personality traits may be a useful predictive factor for postoperative satisfaction after TKA. PMID:26989686

Effectiveness of nurse-led cardiac clinics in adult patients with a diagnosis of coronary heart disease.

PubMed

Page, Tamara; Lockwood, Craig; Conroy-Hiller, Tiffany

2005-02-01

Background  Coronary heart disease is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. Consumers with established coronary heart disease are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established coronary heart disease. Improved management of cardiac risk factors by providing education and referrals as required has been suggested as one way of maintaining quality care in patients with established coronary heart disease. There is a need to ascertain whether or not nurse-led clinics would be an effective adjunct for patients with coronary heart disease to supplement general practitioner advice and care. Objectives  The objective of this review was to present the best available evidence related to nurse-led cardiac clinics. Inclusion criteria  This review considered any randomised controlled trials that evaluated cardiac nurse-led clinics. In the absence of randomised controlled trials, other research designs such as non-randomised controlled trials and before and after studies were considered for inclusion. Participants were adults (18 years and older) with new or existing coronary heart disease. The interventions of interest to the review included education, assessment, consultation, referral and administrative structures. Outcomes measured included adverse event rates, readmissions, admissions, clinical and cost effectiveness, consumer satisfaction and compliance with therapy. Results  Based on the search terms used, 80 papers were initially identified and reviewed for inclusion; full reports of 24 of these papers were retrieved. There were no papers included that addressed cost effectiveness or adverse events; and none addressed the outcome of referrals. A critical appraisal of the 24 remaining papers identified a total of six randomised controlled trials that met the inclusion criteria. Two studies addressed nurse-led clinics for patients diagnosed with angina, one looked at medication administration and the other looked at educational plans. A further four studies compared secondary preventative care with a nurse-led clinic and general practitioner clinic. One specifically compared usual care versus shared care introduced by nurses for patients awaiting coronary artery bypass grafting. Of the remaining three studies, two have been combined in the results section, as they are an interim report and a final report of the same study. Because of inconsistencies in reporting styles and outcome measurements, meta-analysis could not be performed on all outcomes. However, a narrative summary of each study and comparisons of specific outcomes assessed from within each study has been developed. Although not all outcomes obtained statistical significance, nurse-led clinics were at least as effective as general practitioner clinics for most outcomes. Recommendations  The following recommendations are made: • The use of nurse-led clinics is recommended for patients with coronary heart disease (Level II). • Utilise nurse-led clinics to increase clinic attendance and follow-up rates (Level II). • Nurse-led clinics are recommended for patients who require lifestyle changes to decrease their risk of adverse outcomes associated with coronary heart disease (Level II).

Association of stroke clinical outcomes with coexistence of hyperglycemia and biomarkers of inflammation.

PubMed

Zhou, Jingwen; Wu, Jiahui; Zhang, Jintao; Xu, Tan; Zhang, Huan; Zhang, Yonghong; Zhang, Shaoyan

2015-06-01

To investigate the association of short-term clinical outcomes with coexistence of hyperglycemia and elevated biomarkers of inflammation among acute ischemic stroke (AIS) patients. We performed a retrospective study of 2675 patients diagnosed with AIS from January 2006 to December 2008. The study outcomes were defined as neurologic deficiency (National Institutes of Health Stroke Scale score ≥5) at discharge or death during hospitalization. Compared with normoglycemia and without any elevated biomarkers, patients with hyperglycemia, elevated white blood cell (WBC) count, elevated neutrophils ratio (NEUR), and elevated erythrocyte sedimentation rate (ESR) had higher rates of study outcomes (all P < .05). Furthermore, patients with coexistence of hyperglycemia with any of elevated WBC count, NEUR, or ESR were more likely to have study outcomes (all P < .05). Compared with subjects with normoglycaemia and without any elevated biomarker, multivariate adjusted odds ratios (95% confidence interval) of study outcomes associated with hyperglycemia, elevated WBC count, elevated NEUR, elevated ESR, coexistences of hyperglycemia with elevated WBC count, elevated NEUR, and elevated ESR were 1.492 (1.139-1.955), 1.404 (1.048-1.881), 1.897 (1.411-2.551), 2.184 (1.339-3.564), 1.963 (1.337-2.883), 2.544(1.715- 3.775), and 2.687 (1.347-5.363), respectively. This study indicated that hyperglycemia and elevated biomarkers of inflammation were associated with short-term clinical outcomes, and individuals with coexistence of hyperglycemia and elevated biomarkers of inflammation had higher risk of poor clinical outcomes among AIS patients. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Symptoms of depression and anxiety predict treatment response and long-term physical health outcomes in rheumatoid arthritis: secondary analysis of a randomized controlled trial

PubMed Central

Norton, Sam; Scott, David L.; Steer, Sophia; Hotopf, Matthew

2016-01-01

Objective. The aim of this analysis is to examine the longitudinal impact of symptoms of depression/anxiety on treatment response, long-term disease activity and physical disability in RA. Methods. Secondary analysis of clinical trial data was performed. Data were collected at baseline and at 6-monthly intervals for 2 years. The EuroQoL (EQ-5DTM) indicated depression/anxiety symptom severity. Our primary outcomes of interest were (i) DAS-28 and (ii) physical disability measured via the HAQ. Secondary outcomes were: tender and swollen joint counts, patient global assessment, ESR and odds of reaching clinical remission. Multilevel models were used to assess the impact of baseline and persistent depression/anxiety on outcomes over 2 years. Results. Data from 379 patients were included. After adjusting for covariates, baseline depression/anxiety symptoms were associated with increased DAS-28 outcomes and increased tender joint counts. Persistent depression/anxiety symptoms were associated with increased DAS-28 scores, HAQ scores, tender joint counts and patient global assessment of disease activity, and reduced odds of reaching clinical remission. Patients with symptoms of depression/anxiety at baseline also showed a 50% reduction in prednisolone treatment effect, in comparison with patients with no symptoms of depression/anxiety at baseline. Conclusion. Baseline and persistent symptoms of depression/anxiety are associated with poorer health outcomes over time, as well as reduced treatment response. Mental health should be routinely measured both in clinical practice and in research, and managed alongside rheumatological disease to optimize health outcomes. Further research is required to examine whether treatment of mental disorders can improve rheumatological outcomes. PMID:26350486

Symptoms of depression and anxiety predict treatment response and long-term physical health outcomes in rheumatoid arthritis: secondary analysis of a randomized controlled trial.

PubMed

Matcham, Faith; Norton, Sam; Scott, David L; Steer, Sophia; Hotopf, Matthew

2016-02-01

The aim of this analysis is to examine the longitudinal impact of symptoms of depression/anxiety on treatment response, long-term disease activity and physical disability in RA. Secondary analysis of clinical trial data was performed. Data were collected at baseline and at 6-monthly intervals for 2 years. The EuroQoL (EQ-5D(TM)) indicated depression/anxiety symptom severity. Our primary outcomes of interest were (i) DAS-28 and (ii) physical disability measured via the HAQ. Secondary outcomes were: tender and swollen joint counts, patient global assessment, ESR and odds of reaching clinical remission. Multilevel models were used to assess the impact of baseline and persistent depression/anxiety on outcomes over 2 years. Data from 379 patients were included. After adjusting for covariates, baseline depression/anxiety symptoms were associated with increased DAS-28 outcomes and increased tender joint counts. Persistent depression/anxiety symptoms were associated with increased DAS-28 scores, HAQ scores, tender joint counts and patient global assessment of disease activity, and reduced odds of reaching clinical remission. Patients with symptoms of depression/anxiety at baseline also showed a 50% reduction in prednisolone treatment effect, in comparison with patients with no symptoms of depression/anxiety at baseline. Baseline and persistent symptoms of depression/anxiety are associated with poorer health outcomes over time, as well as reduced treatment response. Mental health should be routinely measured both in clinical practice and in research, and managed alongside rheumatological disease to optimize health outcomes. Further research is required to examine whether treatment of mental disorders can improve rheumatological outcomes. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

Efficacy and Clinical Outcomes of Transcatheter Arterial Embolization for Gastrointestinal Bleeding from Gastrointestinal Stromal Tumor.

PubMed

Koo, Hyun Jung; Shin, Ji Hoon; Shin, Sooyoung; Yoon, Hyun-Ki; Ko, Gi-Young; Gwon, Dong Il

2015-09-01

To evaluate the efficacy and clinical outcomes of transcatheter arterial embolization (TAE) for gastrointestinal (GI) bleeding from gastrointestinal stromal tumor (GIST). TAE was performed in 20 referred patients (male:female = 13:7; median age, 56.3 y) for GI bleeding from GISTs. The locations of GISTs were assessed using contrast-enhanced computed tomography (CT) and catheter angiography. The technical and clinical success of TAE and clinical outcomes including procedure-related complications, recurrent bleeding, 30-day and overall mortality, and cumulative survival were evaluated. The sites of GIST-related bleeding or tumor staining were the jejunum (n = 9), stomach (n = 5), ileum (n = 3), duodenum (n = 2), and jejunum and colon (n = 1). Angiography showed bleeding from GIST in 5 patients, and tumor staining was noted in only 15 patients. TAE was performed for patients with and without contrast medium extravasation on angiography. Technical and clinical success rates of TAE were 95% (19 of 20 patients) and 90% (18 of 20 patients), respectively. Recurrent bleeding was noted in 1 patient. There were no procedure-related complications. In 15 patients, surgical resection of the tumors was performed after TAE. The 30-day and overall mortality rates were 10% (2 of 20 patients) and 30% (6 of 20 patients), respectively. TAE is a safe and effective method for controlling GI bleeding from the GIST. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

Treatment outcomes of intracranial dural arteriovenous fistulas of the transverse and sigmoid sinuses from a single institute in Asia.

PubMed

Cho, Won-Sang; Han, Jung Ho; Kang, Hyun-Seung; Kim, Jeong Eun; Kwon, O-Ki; Oh, Chang Wan; Han, Moon Hee; Chung, Young Seob

2013-07-01

Intracranial dural arteriovenous fistulas (DAVFs) of the transverse and sigmoid sinuses (TSS) are rare in Asian populations. This study sought to evaluate the treatment outcomes of intracranial TSS DAVFs at a single Asian institute. Between 1989 and 2007, 122 patients presented to the Seoul National University Hospital with intracranial DAVFs; we performed a retrospective analysis of the 38 patients (31.1%) with TSS DAVFs. The common clinical presentations were headache (44.7%), tinnitus (39.5%), and intracranial hemorrhage (26.3%), and 71.1% had Borden type II or III lesions. Two patients were conservatively managed, two underwent surgery, and 34 were treated endovascularly with transarterial embolization (TAE), transvenous embolization (TVE), or both. The complete occlusion rate immediately after treatment was 50%. Of the 31 patients (81.6%) who underwent follow-up angiography, initial complete occlusion was achieved in 51.6%, and, at the last follow-up, the complete occlusion rate was 64.5%, with the surgery and TVE groups achieving 100% occlusion. The clinical cure rate was 34.2%, and 86.8% of patients had a favorable clinical outcome. However, all patients in both the surgery and TVE groups achieved a favorable clinical outcome. Four (26.7%) of 15 lesions with initially partial embolization showed delayed occlusion. Five patients (13.2%) exhibited clinical or angiographic signs of recurrence, and five patients had permanent complications. TSS DAVFs were less common than cavernous sinus DAVFs, unlike in Western countries, but the angiographic and clinical characteristics of TSS DAVFs were similar to those in Western countries. TSS DAVFs were successfully managed with different modalities, but both surgery and TVE were superior to conservative management or TAE. Copyright © 2012 Elsevier Ltd. All rights reserved.

Growth hormone receptor exon 3 isoforms may have no importance in the clinical setting of multiethnic Brazilian acromegaly patients.

PubMed

de Oliveira Machado, Evelyn; Lima, Carlos Henrique Azeredo; Ogino, Liana Lumi; Kasuki, Leandro; Gadelha, Mônica R

2016-08-01

Acromegaly is associated with significant morbidity and increased mortality, but has a variable severity phenotype. The presence of the exon 3-deleted isoform of the growth hormone receptor (d3-GHR) may influence the disease phenotype and treatment outcomes, including the frequency of biochemical discordance after medical treatment. The objective of this study was to analyze the influence of the d3-GHR isoform on clinical and biochemical characteristics and in the treatment outcomes of Brazilian multiethnic acromegaly patients. We retrospectively analyzed our acromegaly outpatient clinic databank and collected demographic, clinical, biochemical and treatment outcome data from those patients who agreed to participate in the study. A blood sample was collected from all patients, the DNA was extracted and the GHR isoforms were evaluated by PCR, with the full length (fl)-GHR represented by a 935-bp fragment and the d3-GHR represented by a 532-bp fragment. A total of 121 patients were included. Fifty-six patients (46.3 %) were full-length homozygous (fl/fl), 48 (39.7 %) were heterozygous (fl/d3) and 17 (14.0 %) were d3-GHR homozygous (d3/d3). There was no difference between patients homozygous for the fl isoform and those harboring at least one d3-GHR allele in the demographic, clinical and biochemical data or in the treatment outcomes, including somatostatin receptor ligands (SRL) monotherapy, combination therapy with SRL and cabergoline and pegvisomant treatment. There was also no difference between the groups for the frequency of GH and IGF-I discordance after medical treatment. GHR exon 3 genotyping appears to have no clinical significance, at least in Brazilian acromegaly patients.

Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients WIth coroNary heart Disease (UNWIND) randomized clinical trial.

PubMed

Blumenthal, James A; Feger, Bryan J; Smith, Patrick J; Watkins, Lana L; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M; Ashworth, Megan; Mabe, Stephanie K; Babyak, Michael A; Kraus, William E; Hinderliter, Alan; Sherwood, Andrew

2016-06-01

Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70%-85% VO2peak), escitalopram (5-20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of Clinical and Radiographic Outcomes for Posterior Fossa Decompression with and without Duraplasty for Treatment of Pediatric Chiari I Malformation: A Prospective Study.

PubMed

Jiang, Enze; Sha, Shifu; Yuan, XinXin; Zhu, WeiGuo; Jiang, Jian; Ni, Hongbin; Liu, Zhen; Qiu, Yong; Zhu, Zezhang

2018-02-01

The aim of this study was to prospectively compare the radiographic and clinical outcomes between the posterior fossa decompression (PFD) and PFD with duraplasty (PFDD) procedures in adolescent patients with Chiari malformation type I (CMI). Ninety adolescent patients with CMI were randomly assigned to undergo either PFDD or PFD. In both groups, a dissection from the occipital bone was performed. The dura was not opened in the PFD group, and the outer layer of dura was resected. However, in the PFDD group, the dura mater was opened and expanded. Data were analyzed for clinical outcome, complications, and syrinx resolution. The age, gender, and preoperative neurologic status were similar between the 2 groups. Compared with the PFD group, patients undergoing PFDD had significantly longer operation time, longer postoperative drainage time, and higher drainage volume. At the latest follow-up, no statistically significant difference was found between the 2 groups in terms of syrinx resolution. The clinical outcomes were similar in the PFDD and PFD group. Compared with the PFD group, patients in the PFDD group had a higher incidence of cerebrospinal fluid leak. Compared with the more aggressive decompression with duraplasty, PFD without duraplasty produces comparable radiologic and clinical outcomes and is associated with a lower risk of complications. Copyright © 2017 Elsevier Inc. All rights reserved.

Leigh Syndrome in Childhood: Neurologic Progression and Functional Outcome.

PubMed

Lee, Jin Sook; Kim, Hunmin; Lim, Byung Chan; Hwang, Hee; Choi, Jieun; Kim, Ki Joong; Hwang, Yong Seung; Chae, Jong Hee

2016-04-01

Few studies have analyzed the clinical course and functional outcome in Leigh syndrome (LS). The aim of this study was to determine the clinical, radiological, biochemical, and genetic features of patients with LS, and identify prognostic indicators of the disease progression and neurological outcome. Thirty-nine patients who had been diagnosed with LS at the Seoul National University Children's Hospital were included. Their medical records, neuroimaging findings, and histological/biochemical findings of skeletal muscle specimens were reviewed. Targeted sequencing of mitochondrial DNA was performed based on mitochondrial respiratory chain (MRC) enzyme defects. Isolated complex I deficiency was the most frequently observed MRC defect (in 42% of 38 investigated patients). Mitochondrial DNA mutations were identified in 11 patients, of which 81.8% were MT-ND genes. The clinical outcome varied widely, from independent daily activity to severe disability. Poor functional outcomes and neurological deterioration were significantly associated with early onset (before an age of 1 year) and the presence of other lesions additional to basal ganglia involvement in the initial neuroimaging. The neurological severity and outcome of LS may vary widely and be better than those predicted based on previous studies. We suggest that age at onset and initial neuroimaging findings are prognostic indicators in LS.

Impact of perioperative myocardial infarction on angiographic and clinical outcomes following coronary artery bypass grafting (from PRoject of Ex-vivo Vein graft ENgineering via Transfection [PREVENT] IV).

PubMed

Yau, James M; Alexander, John H; Hafley, Gail; Mahaffey, Kenneth W; Mack, Michael J; Kouchoukos, Nicholas; Goyal, Abhinav; Peterson, Eric D; Gibson, C Michael; Califf, Robert M; Harrington, Robert A; Ferguson, T Bruce

2008-09-01

Myocardial infarction (MI) after coronary artery bypass grafting (CABG) is associated with significant morbidity and mortality. Frequency, management, mechanisms, and angiographic and clinical outcomes associated with perioperative MI remain poorly understood. PREVENT IV was a multicenter, randomized, placebo-controlled trial of edifoligide in 3,014 patients undergoing CABG. Angiographic and 2-year clinical follow-up were complete for 1,920 and 2,956 patients, respectively. Perioperative MI was defined as creatinine kinase-MB increase >or=10 times the upper limit of normal or >or=5 times the upper limit of normal with new 30-ms Q waves within 24 hours of surgery. Baseline characteristics, in-hospital management, and angiographic and clinical outcomes of patients with and without perioperative MI were compared. Perioperative MI occurred in 294 patients (9.8%). Patients with perioperative MI had longer surgery (250 vs 230 minutes; p <0.001), more on-pump surgery (83% vs 78%; p = 0.048), and worse target-artery quality (p <0.001). Patients with perioperative MI more frequently underwent angiography within 30 days of enrollment (1.7% vs 0.6%; p = 0.021). One-year angiographic vein graft failure occurred in 62.4% of patients with and 43.8% of patients without perioperative MI (p <0.001). Two-year composite clinical outcome (death, MI, or revascularization) was worse in patients with perioperative MI before (19.4% vs 15.2%; p = 0.039) and after (hazard ratio 1.33, 95% confidence interval 1.00 to 1.76, p = 0.046) adjusting for differences in significant predictors. In conclusion, perioperative MI was relatively common, was associated with worse outcomes, and mechanisms other than vein graft failure accounted for a substantial proportion of these MIs. Further research is needed into the prevention and treatment of perioperative MI in patients undergoing CABG.

Are dental researchers asking patient-important questions? A scoping review.

PubMed

Fleming, Padhraig S; Koletsi, Despina; O'Brien, Kevin; Tsichlaki, Aliki; Pandis, Nikolaos

2016-06-01

There is an increasing recognition that research outcomes should resonate with patients rather than fixating on technical aspects of interventions. We aimed to assess the nature of outcomes within a representative subset of clinical trials published in leading dental journals. Randomized controlled trials published over a 3-year period up to December 31st, 2015 were identified in eight leading general and specialty dental journals: Journal of Dental Research, Journal of Dentistry, American Journal of Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, International Journal of Prosthodontics, Journal of Endodontics, International Journal of Oral and Maxillofacial Surgery and Journal of Clinical Periodontology. The number and nature of outcomes considered within these trials were assessed. Overall 220 RCTs involving 409 outcomes (257 primary and 152 secondary) were identified. Measures of disease activity were most commonly assessed as both primary (n=91, 35%) and secondary outcomes (n=59, 39%). Quality of life and functional measures were rarely considered as primary outcome domains. Overall, 182 (44%) outcomes were primarily clinician-focused, 140 (34%) were patient-centered, while 22% (n=87) were both patient- and clinician- focused. There is an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of core outcome sets representing the minimum set of data that should be obtained within a dental clinical trial would assist in addressing this issue. There is an acceptance that research outcomes should ultimately be of relevance and benefit to patients rather than focusing on technical aspects of interventions. This study points to an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of agreed dental core outcome sets would help to remedy this. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effectiveness of clinical networks in improving quality of care and patient outcomes: a systematic review of quantitative and qualitative studies.

PubMed

Brown, Bernadette Bea; Patel, Cyra; McInnes, Elizabeth; Mays, Nicholas; Young, Jane; Haines, Mary

2016-08-08

Reorganisation of healthcare services into networks of clinical experts is increasing as a strategy to promote the uptake of evidence based practice and to improve patient care. This is reflected in significant financial investment in clinical networks. However, there is still some question as to whether clinical networks are effective vehicles for quality improvement. The aim of this systematic review was to ascertain the effectiveness of clinical networks and identify how successful networks improve quality of care and patient outcomes. A systematic search was undertaken in accordance with the PRISMA approach in Medline, Embase, CINAHL and PubMed for relevant papers between 1 January 1996 and 30 September 2014. Established protocols were used separately to examine and assess the evidence from quantitative and qualitative primary studies and then integrate findings. A total of 22 eligible studies (9 quantitative; 13 qualitative) were included. Of the quantitative studies, seven focused on improving quality of care and two focused on improving patient outcomes. Quantitative studies were limited by a lack of rigorous experimental design. The evidence indicates that clinical networks can be effective vehicles for quality improvement in service delivery and patient outcomes across a range of clinical disciplines. However, there was variability in the networks' ability to make meaningful network- or system-wide change in more complex processes such as those requiring intensive professional education or more comprehensive redesign of care pathways. Findings from qualitative studies indicated networks that had a positive impact on quality of care and patients outcomes were those that had adequate resources, credible leadership and efficient management coupled with effective communication strategies and collaborative trusting relationships. There is evidence that clinical networks can improve the delivery of healthcare though there are few high quality quantitative studies of their effectiveness. Our findings can provide policymakers with some insight into how to successfully plan and implement clinical networks by ensuring strong clinical leadership, an inclusive organisational culture, adequate resourcing and localised decision-making authority.

The effect of measuring serum doxycycline concentrations on clinical outcomes during treatment of chronic Q fever.

PubMed

van Roeden, S E; Bleeker-Rovers, C P; Kampschreur, L M; de Regt, M J A; Vermeulen Windsant, A; Hoepelman, A I M; Wever, P C; Oosterheert, J J

2018-04-01

First choice treatment for chronic Q fever is doxycycline plus hydroxychloroquine. Serum doxycycline concentration (SDC) >5 μg/mL has been associated with a favourable serological response, but the effect on clinical outcomes is unknown. To assess the effect of measuring SDC during treatment of chronic Q fever on clinical outcomes. We performed a retrospective cohort study, to assess the effect of measuring SDC on clinical outcomes in patients treated with doxycycline and hydroxychloroquine for chronic Q fever. Primary outcome was the first disease-related event (new complication or chronic Q fever-related mortality); secondary outcomes were all-cause mortality and PCR-positivity. Multivariable analysis was performed with a Cox proportional hazards model, with shared-frailty terms for different hospitals included. We included 201 patients (mean age 68 years, 83% male): in 167 patients (83%) SDC was measured, 34 patients (17%) were treated without SDC measurement. First SDC was >5 μg/mL in 106 patients (63%), all with 200 mg doxycycline daily. In patients with SDC measured, dosage was adjusted in 41% (n = 68), concerning an increase in 64 patients. Mean SDC was 4.1 μg/mL before dosage increase, and 5.9 μg/mL afterwards. SDC measurement was associated with a lower risk for disease-related events (HR 0.51, 95% CI 0.26-0.97, P = 0.04), but not with all-cause mortality or PCR-positivity. SDC measurement decreases the risk for disease-related events, potentially through more optimal dosing or improved compliance. We recommend measurement of SDC and striving for SDC >5 μg/mL and <10 μg/mL during treatment of chronic Q fever.

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment.

PubMed

Kofoed, Sarah; Breen, Sibilah; Gough, Karla; Aranda, Sanchia

2012-03-05

In Australia, the incidence of cancer diagnoses is rising along with an aging population. Cancer treatments, such as chemotherapy, are increasingly being provided in the ambulatory care setting. Cancer treatments are commonly associated with distressing and serious side-effects and patients often struggle to manage these themselves without specialized real-time support. Unlike chronic disease populations, few systems for the remote real-time monitoring of cancer patients have been reported. However, several prototype systems have been developed and have received favorable reports. This review aimed to identify and detail systems that reported statistical analyses of changes in patient clinical outcomes, health care system usage or health economic analyses. Five papers were identified that met these criteria. There was wide variation in the design of the monitoring systems in terms of data input method, clinician alerting and response, groups of patients targeted and clinical outcomes measured. The majority of studies had significant methodological weaknesses. These included no control group comparisons, small sample sizes, poor documentation of clinical interventions or measures of adherence to the monitoring systems. In spite of the limitations, promising results emerged in terms of improved clinical outcomes (e.g. pain, depression, fatigue). Health care system usage was assessed in two papers with inconsistent results. No studies included health economic analyses. The diversity in systems described, outcomes measured and methodological issues all limited between-study comparisons. Given the acceptability of remote monitoring and the promising outcomes from the few studies analyzing patient or health care system outcomes, future research is needed to rigorously trial these systems to enable greater patient support and safety in the ambulatory setting.

A novel thyroid function index associated with opposite therapeutic outcomes in advanced hepatocellular carcinoma patients receiving chemotherapy or sorafenib.

PubMed

Chu, Yu-De; Lin, Kwang-Huei; Huang, Ya-Hui; Lin, Chen-Chun; Hung, Chien-Fu; Yeh, Ta-Sen; Lee, Wei-Chen; Yeh, Chau-Ting

2018-05-21

A sustained proportion of advanced hepatocellular carcinoma (HCC) patients worldwide received either chemotherapy or sorafenib. However, to date, effective and convenient biomarkers to predict their therapeutic outcomes remained elusive. Hypothyroidism was associated with favorable anticancer treatment outcomes in several advanced cancers. Here, we aimed to investigate the potential of using thyroid-stimulating hormone (TSH) and free T4 (FT4) levels as biomarkers to predict clinical outcomes in HCC patients receiving chemotherapy or sorafenib. Total 123 advanced HCC patients at Barcelona Clinical Liver Cancer Stage C were included. They were separated into two cohorts, one treated by sorafenib (n = 62) and the other by chemotherapy (n = 61). Clinical data including TSH and FT4 were retrieved and correlated with treatment outcomes. Because of restriction in local insurance policy, the baseline liver function reserve was better in patients receiving sorafenib. Therefore, the two cohorts were analyzed separately. The results showed that a higher (> median) TSH × FT4 value was independently associated with favorable time-to-tumor progression (P = 0.006) and overall survival (P = 0.002) if chemotherapy was provided; whereas it was associated with unfavorable time-to-tumor progression (P = 0.017) and overall survival (P = 0.001) if sorafenib was administrated. These opposite associations remained valid when patients with Child-Pugh class A liver function from either cohort were included for analysis. A novel thyroid function index, TSH × FT4, significantly predicted opposite clinical outcomes in advanced HCC patients receiving sorafenib or chemotherapy treatment. © 2018 John Wiley & Sons Australia, Ltd.

Impact of high lipoprotein(a) levels on in-stent restenosis and long-term clinical outcomes of angina pectoris patients undergoing percutaneous coronary intervention with drug-eluting stents in Asian population.

PubMed

Park, Sang-Ho; Rha, Seung-Woon; Choi, Byoung-Geol; Park, Ji-Young; Jeon, Ung; Seo, Hong-Seog; Kim, Eung-Ju; Na, Jin-Oh; Choi, Cheol-Ung; Kim, Jin-Won; Lim, Hong-Euy; Park, Chang-Gyu; Oh, Dong-Joo

2015-06-01

Lipoprotein(a) (Lp(a)) is known to be associated with cardiovascular complications and atherothrombotic properties in general populations. However, it has not been examined whether Lp(a) levels are able to predict adverse cardiovascular outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 595 consecutive patients with angina pectoris who underwent elective PCI with DES were enrolled from 2004 to 2010. The patients were divided into two groups according to the levels of Lp(a): Lp(a) < 50 mg/dL (n = 485 patients), and Lp(a) ≥ 50 mg/dL (n = 111 patients). The 6-9-month angiographic outcomes and 3-year cumulative major clinical outcomes were compared between the two groups. Binary restenosis occurred in 26 of 133 lesions (19.8%) in the high Lp(a) group and 43 of 550 lesions (7.9%) in the low Lp(a) group (P = 0.001). In multivariate analysis, the reference vessel diameter, low density lipoprotein cholesterol, total lesion length, and Lp(a) ≥ 50 mg/dL were predictors of binary restenosis. In the Cox proportional hazards regression analysis, Lp(a) > 50 mg/dL was significantly associated with the 3-year adverse clinical outcomes including any myocardial infarction, revascularization (target lesion revascularization (TLR) and target vessel revascularization (TVR)), TLR-major adverse cardiac events (MACEs), TVR-MACE, and All-MACEs. In our study, high Lp(a) level ≥ 50 mg/dL in angina pectoris patients undergoing elective PCI with DES was significantly associated with binary restenosis and 3-year adverse clinical outcomes in an Asian population. © 2015 Wiley Publishing Asia Pty Ltd.

The prognostic value of standardized reference values for speckle-tracking global longitudinal strain in hypertrophic cardiomyopathy.

PubMed

Hartlage, Gregory R; Kim, Jonathan H; Strickland, Patrick T; Cheng, Alan C; Ghasemzadeh, Nima; Pernetz, Maria A; Clements, Stephen D; Williams, B Robinson

2015-03-01

Speckle-tracking left ventricular global longitudinal strain (GLS) assessment may provide substantial prognostic information for hypertrophic cardiomyopathy (HCM) patients. Reference values for GLS have been recently published. We aimed to evaluate the prognostic value of standardized reference values for GLS in HCM patients. An analysis of HCM clinic patients who underwent GLS was performed. GLS was defined as normal (more negative or equal to -16%) and abnormal (less negative than -16%) based on recently published reference values. Patients were followed for a composite of events including heart failure hospitalization, sustained ventricular arrhythmia, and all-cause death. The power of GLS to predict outcomes was assessed relative to traditional clinical and echocardiographic variables present in HCM. 79 HCM patients were followed for a median of 22 months (interquartile range 9-30 months) after imaging. During follow-up, 15 patients (19%) met the primary outcome. Abnormal GLS was the only echocardiographic variable independently predictive of the primary outcome [multivariate Hazard ratio 5.05 (95% confidence interval 1.09-23.4, p = 0.038)]. When combined with traditional clinical variables, abnormal GLS remained independently predictive of the primary outcome [multivariate Hazard ratio 5.31 (95 % confidence interval 1.18-24, p = 0.030)]. In a model including the strongest clinical and echocardiographic predictors of the primary outcome, abnormal GLS demonstrated significant incremental benefit for risk stratification [net reclassification improvement 0.75 (95 % confidence interval 0.21-1.23, p < 0.0001)]. Abnormal GLS is an independent predictor of adverse outcomes in HCM patients. Standardized use of GLS may provide significant incremental value over traditional variables for risk stratification.

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment

PubMed Central

Kofoed, Sarah; Breen, Sibilah; Gough, Karla; Aranda, Sanchia

2012-01-01

In Australia, the incidence of cancer diagnoses is rising along with an aging population. Cancer treatments, such as chemotherapy, are increasingly being provided in the ambulatory care setting. Cancer treatments are commonly associated with distressing and serious side-effects and patients often struggle to manage these themselves without specialized real-time support. Unlike chronic disease populations, few systems for the remote real-time monitoring of cancer patients have been reported. However, several prototype systems have been developed and have received favorable reports. This review aimed to identify and detail systems that reported statistical analyses of changes in patient clinical outcomes, health care system usage or health economic analyses. Five papers were identified that met these criteria. There was wide variation in the design of the monitoring systems in terms of data input method, clinician alerting and response, groups of patients targeted and clinical outcomes measured. The majority of studies had significant methodological weaknesses. These included no control group comparisons, small sample sizes, poor documentation of clinical interventions or measures of adherence to the monitoring systems. In spite of the limitations, promising results emerged in terms of improved clinical outcomes (e.g. pain, depression, fatigue). Health care system usage was assessed in two papers with inconsistent results. No studies included health economic analyses. The diversity in systems described, outcomes measured and methodological issues all limited between-study comparisons. Given the acceptability of remote monitoring and the promising outcomes from the few studies analyzing patient or health care system outcomes, future research is needed to rigorously trial these systems to enable greater patient support and safety in the ambulatory setting. PMID:25992209

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

PubMed

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.

Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

PubMed Central

Valencia, Marcelo; Fresán, Ana; Barak, Yoram; Juárez, Francisco; Escamilla, Raul; Saracco, Ricardo

2015-01-01

Background New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome. Objective The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission. Methods A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI) Scale. Results Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the patients achieved our predefined functional remission outcome. The logistic regression model included five predictive variables for functional remission: (1) being employed, (2) use of atypical antipsychotics, (3) lower number of medications, (4) lower negative symptom severity, and (5) lower excitement symptom severity. Conclusion The study demonstrated that symptomatic remission, psychosocial remission, and functioning could be achievable goals for a considerable number of patients. The outcome of functional remission was achieved by a minority of patients, less than 15%. New approaches should include multidimensional measures to assess functional outcome in schizophrenia research. PMID:26396518

Outcome of shunting in idiopathic normal-pressure hydrocephalus and the value of outcome assessment in shunted patients.

PubMed

Klinge, Petra; Marmarou, Anthony; Bergsneider, Marvin; Relkin, Norman; Black, Peter McL

2005-09-01

To develop guidelines for assessing shunt outcome in patients with idiopathic normal-pressure hydrocephalus (INPH). To date, the literature available on this topic has been marked by disparate definitions of clinical improvement, varying postoperative follow-up protocols and periods, and substantial differences in the postoperative management. Because specific criteria for defining clinical improvement are seldom reported, conclusions drawn about shunt outcome may be subjective. A MEDLINE search back to 1966 was undertaken using the query NPH, normal-pressure hydrocephalus, shunting, shunt treatment, shunt response, outcome, and clinical outcome. The criteria for selection were studies that included INPH from 1966 to the present in which the outcome of INPH was reported in patient groups of 20 or more. To date, there is no standard for outcome assessment of shunt treatment in INPH. The variable improvement rates reported are not only because of different criteria for selection of patients but also because of different postoperative assessment procedures and follow-up intervals. Studies that have established fixed protocols for follow-up have shown that short- and long-term periods after shunting are determined by many factors. Whereas short-term results were more likely to be influenced by shunt-associated risks, long-term results were independent of factors inherent to the shunt procedure and shunt complications, i.e., death and morbidity related to concomitant cerebrovascular and vascular diseases. Studies have shown that beyond 1 year after surgery, these factors definitely influence the clinical effect of shunting, making the 1-year postshunt period a potential determinant of the shunt outcome. Guidelines for outcome assessment were developed on the basis of the available evidence and consensus of expert opinion.

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

PubMed

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

2018-02-01

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

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

PubMed Central

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

2013-01-01

Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. Conclusions In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary PMID:24115912

Patient assessment of diabetes care in a pay-for-performance program.

PubMed

Chiu, Herng-Chia; Hsieh, Hui-Min; Lin, Yi-Chieh; Kuo, Shou-Jen; Kao, Hao-Yun; Yeh, Shu-Chuan Jennifer; Chang, Wen-Hsin; Hsiao, Pi-Jung; Chen, Yao-Shen; Lin, Shoei-Loong; Lo, Gin-Ho; Ker, Chen-Guo; Hung, Yu-Han; Cheng, Hsien-An; Chou, Tiang-Hong; Chou, Sze-Yuan; Wang, Jao-Hsien; Wang, Chien-Fu

2016-04-01

Few studies address quality of care in pay-for-performance (P4P) programs from the perspective of patients' perceptions. This study aimed to examine and compare the patient assessment of diabetes chronic care as perceived by diabetic patients enrolled and not enrolled in a P4P program from the patients' self-reported perspectives. A cross-sectional study with case and comparison group design. A large-scale survey was conducted from February to November 2013 in 18 healthcare institutions in Taiwan. A total of 1458 P4P (n = 1037) and non-P4P (n = 421) diabetic patients participated in this large survey. The Chinese version of the Patient Assessment of Chronic Illness Care (PACIC) instrument was used and patients' clinical outcome data (e.g. HbA1c, LDL) were collected. None. Five subscales from the PACIC were measured, including patient activation, delivery system design/system support, goal setting/tailoring, problem solving/contextual and follow-up/coordination. Patient clinical outcomes were also measured. Multiple linear regression and logistic regression models were used and controlled for patient demographic and health institution characteristics statistically. After adjusting for covariates, P4P patients had higher overall scores on the PACIC and five subscales than non-P4P patients. P4P patients also had better clinical processes of care (e.g. HbA1c test) and intermediate outcomes. Patients who participated in the program likely received better patient-centered care given the original Chronic Care Model. Better perceptions of diabetic care assessment also better clinical outcomes. The PACIC instrument can be used for the patient assessment of chronic care in a P4P program. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Predictors of clinical outcome following lumbar disc surgery: the value of historical, physical examination, and muscle function variables.

PubMed

Hebert, Jeffrey J; Fritz, Julie M; Koppenhaver, Shane L; Thackeray, Anne; Kjaer, Per

2016-01-01

Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. We recruited 55 adult patients 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, and leg and low back pain (LBP) intensity at 10 weeks. Linear regression models were used to identify univariate and multivariate predictors of outcome. Univariate predictors of better outcome varied depending on the outcome measure. Clinical history predictors included a greater proportion of leg pain to LBP, pain medication use, greater time to surgery, and no history of previous physical or injection therapy. Physical examination predictors were a positive straight or cross straight leg raise test, diminished lower extremity strength, sensation or reflexes, and the presence of postural abnormality or pain peripheralization. Preoperative pain peripheralization remained a significant predictor of improved disability (p = 0.04) and LBP (p = 0.02) after accounting for information from the clinical history. Preoperative lumbar multifidus function was not associated with clinical outcome. 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 implementation.

Clinical Application of Genome and Exome Sequencing as a Diagnostic Tool for Pediatric Patients: a Scoping Review of the Literature.

PubMed

Smith, Hadley Stevens; Swint, J Michael; Lalani, Seema R; Yamal, Jose-Miguel; de Oliveira Otto, Marcia C; Castellanos, Stephan; Taylor, Amy; Lee, Brendan H; Russell, Heidi V

2018-05-14

Availability of clinical genomic sequencing (CGS) has generated questions about the value of genome and exome sequencing as a diagnostic tool. Analysis of reported CGS application can inform uptake and direct further research. This scoping literature review aims to synthesize evidence on the clinical and economic impact of CGS. PubMed, Embase, and Cochrane were searched for peer-reviewed articles published between 2009 and 2017 on diagnostic CGS for infant and pediatric patients. Articles were classified according to sample size and whether economic evaluation was a primary research objective. Data on patient characteristics, clinical setting, and outcomes were extracted and narratively synthesized. Of 171 included articles, 131 were case reports, 40 were aggregate analyses, and 4 had a primary economic evaluation aim. Diagnostic yield was the only consistently reported outcome. Median diagnostic yield in aggregate analyses was 33.2% but varied by broad clinical categories and test type. Reported CGS use has rapidly increased and spans diverse clinical settings and patient phenotypes. Economic evaluations support the cost-saving potential of diagnostic CGS. Multidisciplinary implementation research, including more robust outcome measurement and economic evaluation, is needed to demonstrate clinical utility and cost-effectiveness of CGS.

Missing data on body mass index in a breast cancer register: how is it associated with patient characteristics and clinical outcomes?

PubMed

Tin Tin, Sandar; Elwood, J Mark; Lawrenson, Ross; Campbell, Ian

2017-03-03

To assess the completeness of data on body mass index (BMI) in a regional breast cancer register, and its association with patient characteristics and clinical outcomes. This analysis used the data from the Waikato Breast Cancer Register and involved all women who were diagnosed with primary breast cancer in the Waikato District Health Board Region between January 2000 and June 2014. Patients with recorded BMI were compared with those with missing data in terms of demographics, disease factors and treatment factors. Cox regression modelling was performed, and hazards of specific outcomes associated with missing data on BMI were assessed. Of the 3,536 patients included in this analysis, 27.4% had missing data on BMI. Missing data was more frequent in older patients, rural dwellers, patients with comorbidities, screen detected patients, patients with early stage or low grade cancer and hormone receptor positive patients, but was minimal in patients who received chemotherapy. Patients with missing data were less likely to experience loco-regional recurrence (although not significant), metastasis and breast cancer specific mortality, but more likely to experience death from other causes even after demographic, disease and treatment factors were adjusted. Height or weight or both were not recorded for more than one quarter of the patients. Missing data was differential by specific patient characteristics and clinical outcomes.

Outcome of transforaminal lumbar interbody fusion in spondylolisthesis-A clinico-radiological correlation.

PubMed

Balasubramanian, Vijay Anand; Douraiswami, Balaji; Subramani, Suresh

2018-06-01

Lumbar spondylolisthesis is a common cause of morbidity in middle aged individuals. Spinal fusion with instrumentation has become the gold standard for lumbar segmental instability. Studies which correlate the improvement in radiology postoperatively with functional outcome show contrasting reports. This study is aimed at finding the correlation between clinical and radiological outcomes after surgery with transforaminal lumbar interbody fusion. A retrospective study in 35 patients who underwent transforaminal lumbar interbody fusion in a period of 1 year was done. Preoperative pain (VAS Score), functional ability (ODI), radiological parameters (slip angle, slip grade, disc height, foraminal height, lumbar lordosis) were compared with postoperative recordings at the last followup. Functional improvement (Macnab's criteria) and fusion (Lee's fusion criteria) were assessed. Statistical analysis was done with student's paired t -test and Pearson's correlation coefficient. VAS score, ODI improved from 8 to 2 and 70 to 15 respectively. Slip angle improved from 23°to 5° on an average. 80% patients showed fusion and 85% showed good clinical outcome at 1 year followup. Analyzing with Pearson correlation coefficient showed no significant relation between pain scores and radiological parameters. But there was statistically significant relation between radiological fusion and the final clinical outcome. TLIF produces spinal fusion in most individuals. Strong spinal fusion is essential for good clinical outcome in spondylolisthesis patients who undergo TLIF. Reduction in slip is not necessary for all patients with listhesis.

Can data extraction from general practitioners' electronic records be used to predict clinical outcomes for patients with type 2 diabetes?

PubMed

Staff, Michael

2012-01-01

The review of clinical data extraction from electronic records is increasingly being used as a tool to assist general practitioners (GPs) manage their patients in Australia. Type 2 diabetes (T2DM) is a chronic condition cared for primarily in the general practice setting that lends itself to the application of tools in this area. To assess the feasibility of extracting data from a general practice medical record software package to predict clinically significant outcomes for patients with T2DM. A pilot study was conducted involving two large practices where routinely collected clinical data were extracted and inputted into the United Kingdom Prospective Diabetes Study Outcomes Model to predict life expectancy. An initial assessment of the completeness of data available was performed and then for those patients aged between 45 and 64 years with adequate data life expectancies estimated. A total of 1019 patients were identified as current patients with T2DM. There were sufficient data available on 40% of patients from one practice and 49% from the other to provide inputs into the UKPDS Outcomes Model. Predicted life expectancy was similar across the practices with women having longer life expectancies than men. Improved compliance with current management guidelines for glycaemic, lipid and blood pressure control was demonstrated to increase life expectancy between 1.0 and 2.4 years dependent on gender and age group. This pilot demonstrated that clinical data extraction from electronic records is feasible although there are several limitations chiefly caused by the incompleteness of data for patients with T2DM.

Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database

PubMed Central

Koeks, Zaïda; Bladen, Catherine L.; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E.; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I.; Roy, Anna J.; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C.; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C.; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A. Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V.; Martin, Ann S.; Peay, Holly L.; Kirschner, Jan; Flanigan, Kevin M.; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J.; Lochmüller, Hanns

2017-01-01

Background: Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. Objective: To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. Methods: In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Results: Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. Conclusions: This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field. PMID:29125504

Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database.

PubMed

Koeks, Zaïda; Bladen, Catherine L; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I; Roy, Anna J; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V; Martin, Ann S; Peay, Holly L; Kirschner, Jan; Flanigan, Kevin M; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J; Lochmüller, Hanns

2017-01-01

Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field.

Integrating cost information with health management support system: an enhanced methodology to assess health care quality drivers.

PubMed

Kohli, R; Tan, J K; Piontek, F A; Ziege, D E; Groot, H

1999-08-01

Changes in health care delivery, reimbursement schemes, and organizational structure have required health organizations to manage the costs of providing patient care while maintaining high levels of clinical and patient satisfaction outcomes. Today, cost information, clinical outcomes, and patient satisfaction results must become more fully integrated if strategic competitiveness and benefits are to be realized in health management decision making, especially in multi-entity organizational settings. Unfortunately, traditional administrative and financial systems are not well equipped to cater to such information needs. This article presents a framework for the acquisition, generation, analysis, and reporting of cost information with clinical outcomes and patient satisfaction in the context of evolving health management and decision-support system technology. More specifically, the article focuses on an enhanced costing methodology for determining and producing improved, integrated cost-outcomes information. Implementation issues and areas for future research in cost-information management and decision-support domains are also discussed.

Time to rethink the role of the library in educating doctors: driving information literacy in the clinical environment

PubMed Central

Simons, Mary R.; Morgan, Michael Kerin; Davidson, Andrew Stewart

2012-01-01

Question: Can information literacy (IL) be embedded into the curriculum and clinical environment to facilitate patient care and lifelong learning? Setting: The Australian School of Advanced Medicine (ASAM) provides competence-based programs incorporating patient-centred care and lifelong learning. ASAM librarians use outcomes-based educational theory to embed and assess IL into ASAM's educational and clinical environments. Methods: A competence-based IL program was developed where learning outcomes were linked to current patients and assessed with checklists. Weekly case presentations included clinicians' literature search strategies, results, and conclusions. Librarians provided support to clinicians' literature searches and assessed their presentations using a checklist. Main Results: Outcome data showed clinicians' searching skills improved over time; however, advanced MEDLINE searching remained challenging for some. Recommendations are provided. Conclusion: IL learning that takes place in context using measurable outcomes is more meaningful, is enduring, and likely contributes to patient care. Competence-based assessment drives learning in this environment. PMID:23133329

Comparison between AMS 700™ CX and Coloplast™ Titan inflatable penile prosthesis for Peyronie's disease treatment and remodeling: clinical outcomes and patient satisfaction.

PubMed

Chung, Eric; Solomon, Matthew; DeYoung, Ling; Brock, Gerald B

2013-11-01

The implantation of inflatable penile prosthesis (IPP) with simultaneous manual penile remodeling allows for men to undergo a single procedure aimed at correcting both the penile deformity/curvature and erectile dysfunction (ED). To evaluate the clinical outcomes and patient satisfaction in men with Peyronie's disease (PD) and ED who underwent AMS 700™ CX and the newer Coloplast™ Titan inflatable penile prosthesis (IPP) implant. Patient demographics, type of IPP, clinical outcomes, post-implant sexual characteristics, and overall patient satisfaction. A single-center retrospective review of clinical database and prospective telephone survey were conducted in all men with PD who underwent IPP between January 2006 and November 2010. A total of 138 patients with an average age of 57.7 (32 to 80) underwent AMS 700 CX (88 patients) and Coloplast Titans (50 patients) IPP implantation during the 5-year period. The majority of patients (91%) had only one IPP implantation. The IPP clinical outcomes include eight (6%) revision surgery for device malfunction and three (2%) device explantation for prosthesis infection. While there was no statistically significance in device survival between the two devices, the trend favored AMS 700 CX over Titan (5-year Kaplan-Meier estimates of mechanical survival were 91% vs. 87%, P>0.05) and both IPPs provided similar penile straightening without the need for revision surgery. Most men (79%) reported great satisfaction following CX or Titan implants with greater than two thirds of men reported greater self-confidence and 82% of patients would undergo the same operation again. AMS 700™ CX and Coloplast™ Titan IPP implantation and penile remodeling appeared to provide permanent penile straightening and high patient satisfaction without an increase risk of revision surgery. © 2012 International Society for Sexual Medicine.

Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures

PubMed Central

Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.

2013-01-01

Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562

Adverse impact of marijuana use on clinical outcomes among psychiatry patients with depression and alcohol use disorder.

PubMed

Bahorik, Amber L; Campbell, Cynthia I; Sterling, Stacy A; Leibowitz, Amy; Travis, Adam; Weisner, Constance M; Satre, Derek D

2018-01-01

This study examined whether marijuana use was associated with clinically problematic outcomes for patients with depression and alcohol use disorder (AUD). The sample consisted of 307 psychiatry outpatients with mild to severe depression and past 30-day hazardous drinking/drug use, who participated in a trial of substance use treatment. Participants were assessed for AUD based on DSM-IV criteria. Measures of marijuana use, depression symptoms, and functional status related to mental health were collected at baseline, 3, and 6 months. Differences in these outcomes were analyzed among patients with and without AUD using growth models, adjusting for treatment effects. Marijuana was examined as both an outcome (patterns of use) and a predictor (impact on depression and functioning). Forty percent used marijuana and about half the sample met AUD criteria. Fewer patients with AUD used marijuana than those without AUD at baseline. Over 6 months, the proportion of patients with AUD using marijuana increased compared to those without AUD. Patients with AUD using marijuana had greater depressive symptoms and worse functioning than those without AUD. These findings indicate that marijuana use is clinically problematic for psychiatry outpatients with depression and AUD. Addressing marijuana in the context of psychiatry treatment may help improve outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Outcomes of videotape instruction in clinic waiting area.

PubMed

Oermann, Marilyn H; Webb, Sue A; Ashare, Jo Ann

2003-01-01

The purpose of our study was to examine the effectiveness of general health-promotion teaching for patients in the waiting room of a clinic, using focused videotape instruction. An experimental design was used. Subjects were patients (N = 215) in the waiting rooms of clinics in a university medical center in the Midwest. Patients were randomly assigned to two groups: focused videotape instruction in the clinic (n = 106) and control (no instruction in the clinic waiting area) (n = 109). The outcome measures included patient learning about a health education topic and patient satisfaction with overall care, explanations by the provider, and education received during the clinic visit. There was a significant gain in knowledge for patients who viewed the videotape in the waiting room (t = 5.43, df = 213, p < .0001), and they were more satisfied with their education compared with the control group (t = 4.73, df = 213, p < .0001). This study supports focused video instruction as an effective and efficient teaching intervention for disseminating health information in the waiting area.

A matched cohort comparison of clinical outcomes following microsurgical resection or stereotactic radiosurgery for patients with small- and medium-sized vestibular schwannomas.

PubMed

Golfinos, John G; Hill, Travis C; Rokosh, Rae; Choudhry, Osamah; Shinseki, Matthew; Mansouri, Alireza; Friedmann, David R; Thomas Roland, J; Kondziolka, Douglas

2016-12-01

OBJECTIVE A randomized trial that compares clinical outcomes following microsurgery (MS) or stereotactic radiosurgery (SRS) for patients with small- and medium-sized vestibular schwannomas (VSs) is impractical, but would have important implications for clinical decision making. A matched cohort analysis was conducted to evaluate clinical outcomes in patients treated with MS or SRS. METHODS The records of 399 VS patients who were cared for by 2 neurosurgeons and 1 neurotologist between 2001 and 2014 were evaluated. From this data set, 3 retrospective matched cohorts were created to compare hearing preservation (21 matched pairs), facial nerve preservation (83 matched pairs), intervention-free survival, and complication rates (85 matched pairs) between cases managed with SRS and patients managed with MS. Cases were matched for age at surgery (± 10 years) and lesion size (± 0.1 cm). To compare hearing outcomes, cases were additionally matched for preoperative Class A hearing according to the American Academy of Otolaryngology-Head and Neck Surgery guidelines. To compare facial nerve (i.e., cranial nerve [CN] VII) outcomes, cases were additionally matched for preoperative House-Brackmann (HB) score. Investigators who were not involved with patient care reviewed the clinical and imaging records. The reported outcomes were as assessed at the time of the last follow-up, unless otherwise stated. RESULTS The preservation of preoperative Class A hearing status was achieved in 14.3% of MS cases compared with 42.9% of SRS cases (OR 4.5; p < 0.05) after an average follow-up interval of 43.7 months and 30.3 months, respectively. Serviceable hearing was preserved in 42.8% of MS cases compared with 85.7% of SRS cases (OR 8.0; p < 0.01). The rates of postoperative CN VII dysfunction were low for both groups, although significantly higher in the MS group (HB III-IV 11% vs 0% for SRS; OR 21.3; p < 0.01) at a median follow-up interval of 35.7 and 19.0 months for MS and SRS, respectively. There was no difference in the need for subsequent intervention (2 MS patients and 2 SRS patients). CONCLUSIONS At this high-volume center, VS resection or radiosurgery for tumors ≤ 2.8 cm in diameter was associated with low overall morbidity. The need for subsequent intervention was the same in both groups. SRS was associated with improved hearing and facial preservation rates and reduced morbidity, but with a shorter average follow-up period. Facial function was excellent in both groups. Since patients were not randomly selected for surgery, different clinical outcomes may be of different value to individual patients. Both anticipated medical outcomes and patient goals remain the drivers of treatment decisions.

Antiplatelet agents and/or anticoagulants are not associated with worse outcome following nonvariceal upper gastrointestinal bleeding.

PubMed

Teles-Sampaio, Elvira; Maia, Luís; Salgueiro, Paulo; Marcos-Pinto, Ricardo; Dinis-Ribeiro, Mário; Pedroto, Isabel

2016-11-01

Nonvariceal upper gastrointestinal bleeding emerges as a major complication of using antiplatelet agents and/or anticoagulants and represents a clinical challenge in patients undergoing these therapies. To characterize patients with nonvariceal upper gastrointestinal bleeding related to antithrombotics and their management, and to determine clinical predictors of adverse outcomes. Retrospective cohort of adults who underwent upper gastrointestinal endoscopy after nonvariceal upper gastrointestinal bleeding from 2010 to 2012. The outcomes were compared between patients exposed and not exposed to antithrombotics. Five hundred and forty-eight patients with nonvariceal upper gastrointestinal bleeding (67% men; mean age 66.5 ± 16.4 years) were included, of which 43% received antithrombotics. Most patients had comorbidities. Peptic ulcer was the main diagnosis and endoscopic therapy was performed in 46% of cases. The 30-day mortality rate was 7.7% (n = 42), and 36% were bleeding-related. The recurrence rate was 9% and 14% of patients with initial endoscopic treatment needed endoscopic retreatment. There were no significant differences between the exposed and non-exposed groups in most outcomes. Co-morbidities, hemodynamic instability, high Rockall score, low hemoglobin (7.76 ± 2.72 g/dL) and higher international normalized ratio (1.63 ± 1.13) were associated significantly with mortality in a univariate analysis. Adverse outcomes were not associated with antithrombotic use. The management of nonvariceal upper gastrointestinal bleeding constitutes a challenge to clinical performance optimization and clinical cooperation.

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

PubMed

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.

Clinical and radiological features of Marchiafava–Bignami disease

PubMed Central

Dong, Xiaoyu; Bai, Chaobo; Nao, Jianfei

2018-01-01

Abstract Marchiafava–Bignami disease (MBD) is a rare neurological disease usually associated with chronic alcoholism and characterized by demyelination and necrosis. Our aims were to describe the clinicoradiological features and identify factors that may affect the prognosis of patients with MBD. We examined clinical manifestations, laboratory results, and neuroradiological features of 9 patients with MBD. The patients were classified into 2 subgroups (favorable and poor outcome subgroups) based on the Modified Oxford Handicap Scale (MOSH). In addition, we compared the clinical and neuroimaging features between the 2 subgroups. Nine adult male patients (age of onset range 37–62 years, with a mean age of 47.00 ± 14.50 years) were included in this study. According to MOSH, 4 patients were placed in the poor outcome subgroup (MOHS ≥ 3), 5 patients were placed in the favorable outcome subgroup (MOHS ≤ 2). Relatively high score of MAST-C (≥6) (P = .008), extracallosal lesions (P = .048), GCS (P = .026), cerebral lobe impairment (P = .048) was significantly more common in the poor outcome subgroup. Clinical manifestations of MBD are variable and lack specificity. Early diagnosis by relatively specific performance of bisymmetric lesions in corpus callosum of diffusion-weighted imaging (DWI) may affect the prognosis. The prognosis of patients with severe disturbance of consciousness, heavy alcohol consumption, extracallosal lesions, cerebral lobe impairment is probably unfavorable. PMID:29384842

[Clinical and biological prognostic factors in relapsed acute myeloid leukemia patients].

PubMed

Yébenes-Ramírez, Manuel; Serrano, Josefina; Martínez-Losada, Carmen; Sánchez-García, Joaquín

2016-09-02

Acute myeloid leukemia (AML) is the most frequent type of acute leukemia in adults. Despite recent advances in the characterization of pathogenesis of AML, the cure rates are under 40%, being leukemia relapse the most common cause of treatment failure. Leukaemia relapse occurs due to clonal evolution or clonal escape. In this study, we aimed to analyze the clinical and biological factors influencing outcomes in patients with AML relapse. We included a total of 75 AML patients who experienced leukaemia relapse after achieving complete remission. We performed complete immunophenotyping and conventional karyotyping in bone marrow aspirates obtained at diagnosis and at leukemia relapse. Overall survival (OS) of the series was 3.7%±2.3, leukaemia progression being the most common cause of death. Patients relapsing before 12 months and those with adverse cytogenetic-molecular risk had statistically significant worse outcomes. A percentage of 52.5 of patients showed phenotypic changes and 50% cytogenetic changes at relapse. We did not find significant clinical factors predicting clonal evolution. The presence of clonal evolution at relapse did not have a significant impact on outcome. Patients with relapsed AML have a dismal prognosis, especially those with early relapse and adverse cytogenetic-molecular risk. Clonal evolution with phenotypic and cytogenetic changes occurred in half of the patients without predictive clinical factors or impact on outcome. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial.

PubMed

Torino, Claudia; Manfredini, Fabio; Bolignano, Davide; Aucella, Filippo; Baggetta, Rossella; Barillà, Antonio; Battaglia, Yuri; Bertoli, Silvio; Bonanno, Graziella; Castellino, Pietro; Ciurlino, Daniele; Cupisti, Adamasco; D'Arrigo, Graziella; De Paola, Luciano; Fabrizi, Fabrizio; Fatuzzo, Pasquale; Fuiano, Giorgio; Lombardi, Luigi; Lucisano, Gaetano; Messa, Piergiorgio; Rapanà, Renato; Rapisarda, Francesco; Rastelli, Stefania; Rocca-Rey, Lisa; Summaria, Chiara; Zuccalà, Alessandro; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine; Mallamaci, Francesca

2014-01-01

Scarce physical activity predicts shorter survival in dialysis patients. However, the relationship between physical (motor) fitness and clinical outcomes has never been tested in these patients. We tested the predictive power of an established metric of motor fitness, the Six-Minute Walking Test (6MWT), for death, cardiovascular events and hospitalization in 296 dialysis patients who took part in the trial EXCITE (ClinicalTrials.gov Identifier: NCT01255969). During follow up 69 patients died, 90 had fatal and non-fatal cardiovascular events, 159 were hospitalized and 182 patients had the composite outcome. In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of 20 walked metres during the 6MWT was associated to a 6% reduction of the risk for the composite end-point (P=0.001) and a similar relationship existed between the 6MWT, mortality (P<0.001) and hospitalizations (P=0.03). A similar trend was observed for cardiovascular events but this relationship did not reach statistical significance (P=0.09). Poor physical performance predicts a high risk of mortality, cardiovascular events and hospitalizations in dialysis patients. Future studies, including phase-2 EXCITE, will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population. © 2014 S. Karger AG, Basel.

Patient's perceptions of chronic kidney disease and their association with psychosocial and clinical outcomes: a narrative review

PubMed Central

Clarke, Amy L.; Yates, Thomas; Smith, Alice C.; Chilcot, Joseph

2016-01-01

Patients with chronic kidney disease (CKD) form organized beliefs regarding their illness and treatment. These perceptions influence the coping strategies employed by an individual to manage his/her illness and may act as a predictor for his/her willingness to engage in self-management behaviours. While illness perceptions have been identified as predictors of non-adherence, depression and mortality in dialysis patients, there is a paucity of research in CKD patients not requiring renal replacement therapy. This narrative review synthesizes the existing literature regarding the role of illness perceptions and associated clinical and psychosocial outcomes in non-dialysis CKD patients. Studies were identified following database searches of AMED, BNI, CINAHL, EMBASE, Health Business Elite, HMIC, Medline, PsycINFO and Google Scholar in January 2016. Despite the small evidence base, existing studies indicate that negative illness perceptions are associated with disease progression and a number of psychosocial outcomes in non-dialysis CKD patients. Evidence from other clinical populations suggests that illness perceptions are modifiable through psychological intervention, which may be most effective if delivered early before beliefs have the chance to become more established. Therefore, targeting illness perceptions in the earlier stages of CKD may be optimal. Further studies are now required to ascertain the mechanisms through which illness perceptions predict psychosocial and clinical outcomes in CKD patients and to ultimately test the efficacy of illness perception–based interventions. PMID:27274839

Patient's perceptions of chronic kidney disease and their association with psychosocial and clinical outcomes: a narrative review.

PubMed

Clarke, Amy L; Yates, Thomas; Smith, Alice C; Chilcot, Joseph

2016-06-01

Patients with chronic kidney disease (CKD) form organized beliefs regarding their illness and treatment. These perceptions influence the coping strategies employed by an individual to manage his/her illness and may act as a predictor for his/her willingness to engage in self-management behaviours. While illness perceptions have been identified as predictors of non-adherence, depression and mortality in dialysis patients, there is a paucity of research in CKD patients not requiring renal replacement therapy. This narrative review synthesizes the existing literature regarding the role of illness perceptions and associated clinical and psychosocial outcomes in non-dialysis CKD patients. Studies were identified following database searches of AMED, BNI, CINAHL, EMBASE, Health Business Elite, HMIC, Medline, PsycINFO and Google Scholar in January 2016. Despite the small evidence base, existing studies indicate that negative illness perceptions are associated with disease progression and a number of psychosocial outcomes in non-dialysis CKD patients. Evidence from other clinical populations suggests that illness perceptions are modifiable through psychological intervention, which may be most effective if delivered early before beliefs have the chance to become more established. Therefore, targeting illness perceptions in the earlier stages of CKD may be optimal. Further studies are now required to ascertain the mechanisms through which illness perceptions predict psychosocial and clinical outcomes in CKD patients and to ultimately test the efficacy of illness perception-based interventions.

Clinical and economic impact of non-adherence to antidepressants in major depressive disorder: A systematic review.

PubMed

Ho, Siew Ching; Chong, Huey Yi; Chaiyakunapruk, Nathorn; Tangiisuran, Balamurugan; Jacob, Sabrina Anne

2016-03-15

Medication non-adherence is one of the major challenges in treating patients with depression. This systematic review aims to determine the clinical and economic outcomes of non-adherence in depression. A systematic search was performed across the following databases: PubMed, EMBASE, DARE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews; from database inception to March 31, 2015. Studies must report on the association between adherence and outcomes, and English full texts needed to be available. The quality of each study was assessed using the Newcastle-Ottawa scale. A total of 11 articles were included, with eight reporting on clinical outcomes, two reporting on economic outcomes, and one reporting on both. The majority of studies were retrospective cohort studies. The mean quality of all included studies was 7, with a range from 3 to 9. Results clearly indicate that patients who were non-adherent were more likely to experience increased risks of relapse and/or recurrence, emergency department visits, and hospitalization rates; increased severity of depression, and a decrease in response and remission rates. The worsening of clinical outcomes in patients who were non-adherent subsequently translated to an increase in healthcare utilization and charges. No standardized adherence measurement tools were used, and few studies looked at the economic impact of non-adherence in depression. There is a strong association between non-adherence to antidepressants and a worsening of patients' clinical and economic outcomes. Cost-effective interventions should be directed to this group of patients to improve medication adherence. Copyright © 2015 Elsevier B.V. All rights reserved.

Linking Cultural Competence to Functional Life Outcomes in Mental Health Care Settings.

PubMed

Michalopoulou, Georgia; Falzarano, Pamela; Butkus, Michael; Zeman, Lori; Vershave, Judy; Arfken, Cynthia

2014-01-01

Minorities in the United States have well-documented health disparities. Cultural barriers and biases by health care providers may contribute to lower quality of services which may contribute to these disparities. However, evidence linking cultural competency and health outcomes is lacking. This study, part of an ongoing quality improvement effort, tested the mediation hypothesis that patients' perception of provider cultural competency indirectly influences patients' health outcomes through process of care. Data were from patient satisfaction surveys collected in seven mental health clinics (n=94 minority patients). Consistent with our hypothesis, patients' perception of clinicians' cultural competency was indirectly associated with patients' self-reported improvements in social interactions, improvements in performance at work or school, and improvements in managing life problems through the patients' experience of respect, trust, and communication with the clinician. These findings indicate that process of care characteristics during the clinical encounter influence patients' perceptions of clinicians' cultural competency and affect functional outcomes. © 2013 National Medical Association. Published by Elsevier Inc. All rights reserved.

Quantitative risk stratification in Markov chains with limiting conditional distributions.

PubMed

Chan, David C; Pollett, Philip K; Weinstein, Milton C

2009-01-01

Many clinical decisions require patient risk stratification. The authors introduce the concept of limiting conditional distributions, which describe the equilibrium proportion of surviving patients occupying each disease state in a Markov chain with death. Such distributions can quantitatively describe risk stratification. The authors first establish conditions for the existence of a positive limiting conditional distribution in a general Markov chain and describe a framework for risk stratification using the limiting conditional distribution. They then apply their framework to a clinical example of a treatment indicated for high-risk patients, first to infer the risk of patients selected for treatment in clinical trials and then to predict the outcomes of expanding treatment to other populations of risk. For the general chain, a positive limiting conditional distribution exists only if patients in the earliest state have the lowest combined risk of progression or death. The authors show that in their general framework, outcomes and population risk are interchangeable. For the clinical example, they estimate that previous clinical trials have selected the upper quintile of patient risk for this treatment, but they also show that expanded treatment would weakly dominate this degree of targeted treatment, and universal treatment may be cost-effective. Limiting conditional distributions exist in most Markov models of progressive diseases and are well suited to represent risk stratification quantitatively. This framework can characterize patient risk in clinical trials and predict outcomes for other populations of risk.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

PubMed

Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

2017-07-01

Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

Understanding reasons for and outcomes of patients lost to follow-up in antiretroviral therapy programs in Africa through a sampling-based approach.

PubMed

Geng, Elvin H; Bangsberg, David R; Musinguzi, Nicolas; Emenyonu, Nneka; Bwana, Mwebesa Bosco; Yiannoutsos, Constantin T; Glidden, David V; Deeks, Steven G; Martin, Jeffrey N

2010-03-01

Losses to follow-up after initiation of antiretroviral therapy (ART) are common in Africa and are a considerable obstacle to understanding the effectiveness of nascent treatment programs. We sought to characterize, through a sampling-based approach, reasons for and outcomes of patients who become lost to follow-up. Cohort study. We searched for and interviewed a representative sample of lost patients or close informants in the community to determine reasons for and outcomes among lost patients. Three thousand six hundred twenty-eight HIV-infected adults initiated ART between January 1, 2004 and September 30, 2007 in Mbarara, Uganda. Eight hundred twenty-nine became lost to follow-up (cumulative incidence at 1, 2, and 3 years of 16%, 30%, and 39%). We sought a representative sample of 128 lost patients in the community and ascertained vital status in 111 (87%). Top reasons for loss included lack of transportation or money and work/child care responsibilities. Among the 111 lost patients who had their vital status ascertained through tracking, 32 deaths occurred (cumulative 1-year incidence 36%); mortality was highest shortly after the last clinic visit. Lower pre-ART CD4 T-cell count, older age, low blood pressure, and a central nervous system syndrome at the last clinic visit predicted deaths. Of patients directly interviewed, 83% were in care at another clinic and 71% were still using ART. Sociostructural factors are the primary reasons for loss to follow-up. Outcomes among the lost are heterogeneous: both deaths and transfers to other clinics were common. Tracking a sample of lost patients is an efficient means for programs to understand site-specific reasons for and outcomes among patients lost to follow-up.

Predicting dire outcomes of patients with community acquired pneumonia.

PubMed

Cooper, Gregory F; Abraham, Vijoy; Aliferis, Constantin F; Aronis, John M; Buchanan, Bruce G; Caruana, Richard; Fine, Michael J; Janosky, Janine E; Livingston, Gary; Mitchell, Tom; Monti, Stefano; Spirtes, Peter

2005-10-01

Community-acquired pneumonia (CAP) is an important clinical condition with regard to patient mortality, patient morbidity, and healthcare resource utilization. The assessment of the likely clinical course of a CAP patient can significantly influence decision making about whether to treat the patient as an inpatient or as an outpatient. That decision can in turn influence resource utilization, as well as patient well being. Predicting dire outcomes, such as mortality or severe clinical complications, is a particularly important component in assessing the clinical course of patients. We used a training set of 1601 CAP patient cases to construct 11 statistical and machine-learning models that predict dire outcomes. We evaluated the resulting models on 686 additional CAP-patient cases. The primary goal was not to compare these learning algorithms as a study end point; rather, it was to develop the best model possible to predict dire outcomes. A special version of an artificial neural network (NN) model predicted dire outcomes the best. Using the 686 test cases, we estimated the expected healthcare quality and cost impact of applying the NN model in practice. The particular, quantitative results of this analysis are based on a number of assumptions that we make explicit; they will require further study and validation. Nonetheless, the general implication of the analysis seems robust, namely, that even small improvements in predictive performance for prevalent and costly diseases, such as CAP, are likely to result in significant improvements in the quality and efficiency of healthcare delivery. Therefore, seeking models with the highest possible level of predictive performance is important. Consequently, seeking ever better machine-learning and statistical modeling methods is of great practical significance.

Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).

PubMed

Simpson, Eric L; Gadkari, Abhijit; Worm, Margitta; Soong, Weily; Blauvelt, Andrew; Eckert, Laurent; Wu, Richard; Ardeleanu, Marius; Graham, Neil M H; Pirozzi, Gianluca; Sutherland, E Rand; Mastey, Vera

2016-09-01

Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P < .0001 all doses, except 100 mg every 4 weeks P < .05); improved sleep and health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P < .05 all doses, except 100 mg every 4 weeks); and reduced anxiety and depression symptoms (P < .05 all doses). Dupilumab's effects appeared early and achieved clinically relevant improvements without significant safety concerns. There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points. Dupilumab produced early and sustained patient-reported and clinically relevant improvements in sleep, mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-09-01

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

Do ictal EEG characteristics predict treatment outcomes in schizophrenic patients undergoing electroconvulsive therapy?

PubMed

Simsek, Gulnihal Gokce; Zincir, Selma; Gulec, Huseyin; Eksioglu, Sevgin; Semiz, Umit Basar; Kurtulmus, Yasemin Sipka

2015-08-01

The aim of this study is to investigate the relationship between features of electroencephalography (EEG), including seizure time, energy threshold level and post-ictal suppression time, and clinical variables, including treatment outcomes and side-effects, among schizophrenia inpatients undergoing electroconvulsive therapy (ECT). This is a naturalistic follow-up study on schizophrenia patients, diagnosed using DSM-IV-TR criteria, treated by a psychosis inpatient service. All participants completed the Brief Psychiatric Rating Scale (BPRS), the Global Assessment of Functioning (GAF) scale, the Frontal Assessment Battery (FAB) and a Data Collection Form. Assessments were made before treatment, during ECT and after treatment. Statistically significant improvements in both clinical and cognitive outcome were noted after ECT in all patients. Predictors of improvement were sought by evaluating electrophysiological variables measured at three time points (after the third, fifth and seventh ECT sessions). Logistic regression analysis showed that clinical outcome/improvement did not differ by seizure duration, threshold energy level or post-ictal suppression time. We found that ictal EEG parameters measured at several ECT sessions did not predict clinical recovery/outcomes. This may be because our centre defensively engages in "very specific patient selection" when ECT is contemplated. ECT does not cause short-term cognitive functional impairment and indeed improves cognition, because symptoms of the schizophrenic episode are alleviated.

Cardiac surgical outcomes improvement led by a physician champion working with a nurse clinical coordinator.

PubMed

Stanford, John R; Swaney-Berghoff, Laurie; Recht, Kimberly

2012-01-01

Cardiac surgical outcomes improvement in a community hospital was driven by a physician champion working with a nurse clinical coordinator. Specific system improvements implemented were (1) nurse checklists of vital signs, cardiovascular function parameters, and life support appliance operation; (2) use of the EuroSCORE system of preoperative patient risk assessment; (3) monthly morbidity and mortality conferences; and (4) daily patient progress tracking. The hospital received 1 star (bottom 12% of hospitals for quality outcomes) from the Society of Thoracic Surgeons Adult Cardiac Database in 2006 prior to program inception, 2 stars (middle 76% of hospitals for quality outcomes) in 2007 and 2008, and 3 stars (top 12% of hospitals) in 2009. The physician and nurse together combined a strategy for clinical improvement with the cultural practices at the hospital to ensure that system improvements approved at the strategic level were implemented at the point of care. Both strategy and culture must be addressed to ensure patient outcomes improvement.

The Defect in Autophagy Induction by Clinical Isolates of Mycobacterium Tuberculosis Is Correlated with Poor Tuberculosis Outcomes.

PubMed

Li, Furong; Gao, Bo; Xu, Wei; Chen, Ling; Xiong, Sidong

2016-01-01

Tuberculosis (TB) represents a major global health problem. The prognosis of clinically active tuberculosis depends on the complex interactions between Mycobacterium tuberculosis (Mtb) and its host. In recent years, autophagy receives particular attention for its role in host defense against intracellular pathogens, including Mtb. In present study, we aim to investigate the relationship of autophagy induction by clinical isolates of Mtb with the clinical outcomes in patients with TB. We collected 185 clinical isolates of Mtb, and determined the effect of these Mtb isolates on autophagy induction in macrophages. It was found that most of clinical isolates of Mtb were able to induce autophagosome formation in macrophages, however, the autophagy-inducing ability varied significantly among different isolates. Of importance, our results revealed that patients infected by Mtb with poor autophagy-inducing ability displayed more severe radiographic extent of disease (p<0.001), and were more likely to have unfavorable treatment outcomes (p<0.001). No significant association was observed between the extent of Mtb-induced autophagy with some socio-demographic characteristics (such as gender, age and tobacco consumption), and some laboratory tests (such as hemoglobin, leukocyte count and erythrocyte sedimentation rate). Furthermore, results from logistic regression analysis demonstrated that the defect in autophagy induction by clinical isolates of Mtb was an independent risk factor for far-advanced radiographic disease (aOR 4.710 [1.93-11.50]) and unfavorable treatment outcomes (aOR 8.309 [2.22-28.97]) in TB. These data indicated that the defect in autophagy induction by Mtb isolates increased the risk of poor clinical outcomes in TB patients, and detection of clinical isolates-induced autophagosome formation might help evaluate the TB outcomes.

A Lyme borreliosis diagnosis probability score - no relation with antibiotic treatment response.

PubMed

Briciu, Violeta T; Flonta, Mirela; Leucuţa, Daniel; Cârstina, Dumitru; Ţăţulescu, Doina F; Lupşe, Mihaela

2017-05-01

(1) To describe epidemiological and clinical data of patients that present with the suspicion of Lyme borreliosis (LB); (2) to evaluate a previous published score that classifies patients on the probability of having LB, following-up patients' clinical outcome after antibiotherapy. Inclusion criteria: patients with clinical manifestations compatible with LB and Borrelia (B.) burgdorferi positive serology, hospitalized in a Romanian hospital between January 2011 and October 2012. erythema migrans (EM) or suspicion of Lyme neuroborreliosis (LNB) with lumbar puncture performed for diagnosis. A questionnaire was completed for each patient regarding associated diseases, tick bites or EM history and clinical signs/symptoms at admission, end of treatment and 3 months later. Two-tier testing (TTT) used an ELISA followed by a Western Blot kit. The patients were classified in groups, using the LB probability score and were evaluated in a multidisciplinary team. Antibiotherapy followed guidelines' recommendations. Sixty-four patients were included, presenting diverse associated comorbidities. Fifty-seven patients presented positive TTT, seven presenting either ELISA or Western Blot test positive. No differences in outcome were found between the groups of patients classified as very probable, probable and little probable LB. Instead, a better post-treatment outcome was described in patients with positive TTT. The patients investigated for the suspicion of LB present diverse clinical manifestations and comorbidities that complicate differential diagnosis. The LB diagnosis probability score used in our patients did not correlate with the antibiotic treatment response, suggesting that the probability score does not bring any benefit in diagnosis.

Diffusion-weighted imaging score of the brain stem: A predictor of outcome in acute basilar artery occlusion treated with the Solitaire FR device.

PubMed

Mourand, I; Machi, P; Nogué, E; Arquizan, C; Costalat, V; Picot, M-C; Bonafé, A; Milhaud, D

2014-06-01

The prognosis for ischemic stroke due to acute basilar artery occlusion is very poor: Early recanalization remains the main factor that can improve outcomes. The baseline extent of brain stem ischemic damage can also influence outcomes. We evaluated the validity of an easy-to-use DWI score to predict clinical outcome in patients with acute basilar artery occlusion treated by mechanical thrombectomy. We analyzed the baseline clinical and DWI parameters of 31 patients with acute basilar artery occlusion, treated within 24 hours of symptom onset by using a Solitaire FR device. The DWI score of the brain stem was assessed with a 12-point semiquantitative score that separately considered each side of the medulla, pons, and midbrain. Clinical outcome was assessed at 180 days by using the mRS. According to receiver operating characteristic analyses, the cutoff score determined the optimal positive predictive value for outcome. The Spearman rank correlation coefficient assessed the correlation between the DWI brain stem score and baseline characteristics. Successful recanalization (Thrombolysis in Cerebral Infarction 3-2b) was achieved in 23 patients (74%). A favorable outcome (mRS ≤ 2) was observed in 11 patients (35%). An optimal DWI brain stem score of <3 predicted a favorable outcome. The probability of a very poor outcome (mRS ≥ 5) if the DWI brain stem score was ≥5 reached 80% (positive predictive value) and 100% if this score was ≥6. Interobserver reliability of the DWI brain stem score was excellent, with an intraclass correlation coefficient of 0.97 (95% CI, 0.96-0.99). The DWI brain stem score was significantly associated with baseline tetraplegia (P = .001) and coma (P = .005). In patients with acute basilar artery occlusion treated by mechanical thrombectomy, the baseline DWI brain lesion score seems to predict clinical outcome. © 2014 by American Journal of Neuroradiology.

Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools.

PubMed

Tafazal, Suhayl I; Sell, Philip J

2006-11-01

Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient's progress and the effect of various treatments. The clinical importance of a score change is not so clear. Although previous studies have looked at the minimum clinically important score change, the degree of score change varies considerably. Our study is a prospective cohort study of 193 patients undergoing discectomy, decompression and fusion procedures with minimum 2-year follow-up. We have used three standard outcome measures in common usage, the oswestry disability index (ODI), the low back outcome score (LBOS) and the visual analogue score (VAS). We have defined each of these scores according to a global measure of outcome graded by the patient as excellent, good, fair or poor. We have also graded patient perception and classified excellent and good as success and fair and poor as failure. Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success. We have also found that different surgical disorders have very different minimal clinically important differences as perceived by patient perception. We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success, for a decompression the change in ODI needed to class it as a success would be 16 points, whereas for a fusion the change in the ODI would be only 13 points. We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the standard outcome measures used in spinal surgery.

Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms

PubMed Central

Eustace, J; Brophy, D; Gibney, R; Bresnihan, B; FitzGerald, O

1997-01-01

OBJECTIVE—To study the effect of accuracy on the clinical outcome of local steroid injections to the shoulder.
METHODS—37 patients with shoulder symptoms of at least two months' duration received local injections of a mixture of triamcinolone and radiographic contrast material using a standardised technique. Radiographs of the joint were taken immediately afterwards. Details of the patients' symptoms (assessed by visual analogue scales) and range of movement at the joint were obtained before and two weeks after the injection. At follow up the patients were also assessed by means of a five point global rating scale of maximum and current benefit.
RESULTS—14 of the 38 procedures (37%) were judged to be accurately placed: four of the 14 attempted subacromial injections (29%) and 10 of the 24 attempted glenohumeral injections (42%). There were significant differences in relation to outcome between the accurately placed and the inaccurately placed groups.
CONCLUSIONS—Accuracy of steroid placement by injection in patients with shoulder symptoms may significantly affect the clinical outcome.

 PMID:9059143

Treatment of anemia with darbepoetin alfa in systolic heart failure.

PubMed

Swedberg, Karl; Young, James B; Anand, Inder S; Cheng, Sunfa; Desai, Akshay S; Diaz, Rafael; Maggioni, Aldo P; McMurray, John J V; O'Connor, Christopher; Pfeffer, Marc A; Solomon, Scott D; Sun, Yan; Tendera, Michal; van Veldhuisen, Dirk J

2013-03-28

Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with systolic heart failure and anemia. In this randomized, double-blind trial, we assigned 2278 patients with systolic heart failure and mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g per deciliter) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure. The primary outcome occurred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90 to 1.13; P=0.87). There was no significant between-group difference in any of the secondary outcomes. The neutral effect of darbepoetin alfa was consistent across all prespecified subgroups. Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (P=0.23). Thromboembolic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the placebo group (P=0.01). Cancer-related adverse events were similar in the two study groups. Treatment with darbepoetin alfa did not improve clinical outcomes in patients with systolic heart failure and mild-to-moderate anemia. Our findings do not support the use of darbepoetin alfa in these patients. (Funded by Amgen; RED-HF ClinicalTrials.gov number, NCT00358215.).

Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry.

PubMed

Chioncel, Ovidiu; Mebazaa, Alexandre; Harjola, Veli-Pekka; Coats, Andrew J; Piepoli, Massimo Francesco; Crespo-Leiro, Maria G; Laroche, Cecile; Seferovic, Petar M; Anker, Stefan D; Ferrari, Roberto; Ruschitzka, Frank; Lopez-Fernandez, Silvia; Miani, Daniela; Filippatos, Gerasimos; Maggioni, Aldo P

2017-10-01

To identify differences in clinical epidemiology, in-hospital management and 1-year outcomes among patients hospitalized for acute heart failure (AHF) and enrolled in the European Society of Cardiology Heart Failure Long-Term (ESC-HF-LT) Registry, stratified by clinical profile at admission. The ESC-HF-LT Registry is a prospective, observational study collecting hospitalization and 1-year follow-up data from 6629 AHF patients. Among AHF patients enrolled in the registry, 13.2% presented with pulmonary oedema (PO), 2.9% with cardiogenic shock (CS), 61.1% with decompensated heart failure (DHF), 4.8% with hypertensive heart failure (HT-HF), 3.5% with right heart failure (RHF) and 14.4% with AHF and associated acute coronary syndromes (ACS-HF). The 1-year mortality rate was 28.1% in PO, 54.0% in CS, 27.2% in DHF, 12.8% in HT-HF, 34.0% in RHF and 20.6% in ACS-HF patients. When patients were classified by systolic blood pressure (SBP) at initial presentation, 1-year mortality was 34.8% in patients with SBP <85 mmHg, 29.0% in those with SBP 85-110 mmHg, 21.2% in patients with SBP 110-140 mmHg and 17.4% in those with SBP >140 mmHg. These differences tended to diminish in the months post-discharge, and 1-year mortality for the patients who survived at least 6 months post-discharge did not vary significantly by either clinical profile or SBP classification. Rates of adverse outcomes in AHF remain high, and substantial differences have been found when patients were stratified by clinical profile or SBP. However, patients who survived at least 6 months post-discharge represent a more homogeneous group and their 1-year outcome is less influenced by clinical profile or SBP at admission. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

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

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Chiren, Sarah G; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Cartee, Todd V; Maher, Ian A; Alam, Murad; Sobanko, Joseph F

2017-07-12

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

Inpatient versus Outpatient Management of TIA or Minor Stroke: Clinical Outcome.

PubMed

Majidi, Shahram; Leon Guerrero, Christopher R; Burger, Kathleen M; Rothrock, John F

2017-06-01

The management of patients with acute transient ischemic attack (TIA) or minor stroke is highly variable. Whether hospitalization of such patients significantly improves short-term clinical outcome is unknown. We assessed the short-term clinical outcome associated with inpatient versus outpatient management of patients with TIA or minor stroke. We evaluated a consecutive series of patients with acute TIA or minor ischemic stroke (NIH Stroke Scale score ≤ 3) presenting to a single emergency department (ED). We randomized patients to either hospital-based or outpatient-based management. All patients underwent interview and examination 7-10 days following the index event. This study included 100 patients, 41 with TIA and 59 with minor stroke. Nineteen (46%) of the TIA patients and 29 (49%) of the minor stroke patients randomized to hospital management, and the remaining 22 TIA patients and 30 minor stroke patients randomized to outpatient-based management. In the patients with a minor stroke, neurologic worsening occurred in 6 out of 29 (21%) in the inpatient arm compared with 3 out of 30 (10%) in the outpatient arm ( p = 0.3). In none of these cases was acute interventional therapy or need for urgent admission considered medically appropriate. In the patients with a TIA, recurrence of a TIA occurred in 2 out of 19 (11%) in the inpatient arm compared with 2 out of 22 (9%) in the outpatient arm ( p = 1). None of the patients with a TIA randomized to the inpatient arm experienced a stroke compared with 1 out of 22 in the outpatient arm ( p = 1). There were no deaths in either group. Routine hospitalization of all patients with TIA or minor ischemic stroke may not positively affect short-term clinical outcome.

Inpatient versus Outpatient Management of TIA or Minor Stroke: Clinical Outcome

PubMed Central

Majidi, Shahram; Leon Guerrero, Christopher R.; Burger, Kathleen M.; Rothrock, John F.

2017-01-01

Background The management of patients with acute transient ischemic attack (TIA) or minor stroke is highly variable. Whether hospitalization of such patients significantly improves short-term clinical outcome is unknown. We assessed the short-term clinical outcome associated with inpatient versus outpatient management of patients with TIA or minor stroke. Methods We evaluated a consecutive series of patients with acute TIA or minor ischemic stroke (NIH Stroke Scale score ≤ 3) presenting to a single emergency department (ED). We randomized patients to either hospital-based or outpatient-based management. All patients underwent interview and examination 7–10 days following the index event. Results This study included 100 patients, 41 with TIA and 59 with minor stroke. Nineteen (46%) of the TIA patients and 29 (49%) of the minor stroke patients randomized to hospital management, and the remaining 22 TIA patients and 30 minor stroke patients randomized to outpatient-based management. In the patients with a minor stroke, neurologic worsening occurred in 6 out of 29 (21%) in the inpatient arm compared with 3 out of 30 (10%) in the outpatient arm (p = 0.3). In none of these cases was acute interventional therapy or need for urgent admission considered medically appropriate. In the patients with a TIA, recurrence of a TIA occurred in 2 out of 19 (11%) in the inpatient arm compared with 2 out of 22 (9%) in the outpatient arm (p = 1). None of the patients with a TIA randomized to the inpatient arm experienced a stroke compared with 1 out of 22 in the outpatient arm (p = 1). There were no deaths in either group. Conclusion Routine hospitalization of all patients with TIA or minor ischemic stroke may not positively affect short-term clinical outcome. PMID:28702120

Impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization.

PubMed

Matzke, Gary R; Moczygemba, Leticia R; Williams, Karen J; Czar, Michael J; Lee, William T

2018-05-22

The impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization is described. Six hospitals from the Carilion Clinic health system in southwest Virginia, along with 22 patient-centered medical home (PCMH) practices affiliated with Carilion Clinic, participated in this project. Eligibility criteria included documented diagnosis of 2 or more of the 7 targeted chronic conditions (congestive heart failure, hypertension, hyperlipidemia, diabetes mellitus, asthma, chronic obstructive pulmonary disease, and depression), prescriptions for 4 or more medications, and having a primary care physician in the Carilion Clinic health system. A total of 2,480 evaluable patients were included in both the collaborative care group and the usual care group. The primary clinical outcomes measured were the absolute change in values associated with diabetes mellitus, hypertension, and hyperlipidemia management from baseline within and between the collaborative care and usual care groups. Significant improvements ( p < 0.01) in glycosylated hemoglobin, blood pressure, low-density-lipoprotein cholesterol, and total cholesterol were observed in the collaborative care group compared with the usual care group. Hospitalizations declined significantly in the collaborative care group (23.4%), yielding an estimated cost savings of $2,619 per patient. The return on investment (net savings divided by program cost) was 504%. Inclusion of clinical pharmacists in this physician-pharmacist collaborative care-based PCMH model was associated with significant improvements in patients' medication-related clinical health outcomes and a reduction in hospitalizations. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Anterior cervical corpectomy: review and comparison of results using titanium mesh cages and carbon fibre reinforced polymer cages.

PubMed

Kabir, Syed M R; Alabi, J; Rezajooi, Kia; Casey, Adrian T H

2010-10-01

Different types of cages have recently become available for reconstruction following anterior cervical corpectomy. We review the results using titanium mesh cages (TMC) and stackable CFRP (carbon fibre reinforced polymer) cages. Forty-two patients who underwent anterior cervical corpectomy between November 2001 and September 2008 were retrospectively reviewed. Pathologies included cervical spondylotic myelopathy (CSM), cervical radiculopathy, OPLL (ossified posterior longitudinal ligament), metastasis/primary bone tumour, rheumatoid arthritis and deformity correction. All patients were evaluated clinically and radiologically. Outcome was assessed on the basis of the Odom's criteria, neck disability index (NDI) and myelopathy disability index (MDI). Mean age was 60 years and mean follow-up was 1½ years. Majority of the patients had single-level corpectomy. Twenty-three patients had TMC cages while 19 patients had CFRP cages. The mean subsidence noted with TMC cage was 1.91 mm, while with the stackable CFRP cage it was 0.5 mm. This difference was statistically significant (p < 0.05). However, there was no statistically significant correlation noted between subsidence and clinical outcome (p > 0.05) or between subsidence and post-operative sagittal alignment (p > 0.05) in either of the groups. Three patients had significant subsidence (> 3 mm), one of whom was symptomatic. There were no hardware-related complications. On the basis of the Odom's criterion, 9 patients (21.4%) had an excellent outcome, 14 patients (33.3%) had a good outcome, 9 patients (21.4%) had a fair outcome and 5 patients (11.9%) had a poor outcome, i.e. symptoms and signs unchanged or exacerbated. Mean post-operative NDI was 26.27% and mean post-operative MDI was 19.31%. Fusion was noted in all 42 cases. Both TMC and stackable CFRP cages provide solid anterior column reconstruction with good outcome following anterior cervical corpectomy. However, more subsidence is noted with TMC cages though this might not significantly alter the clinical outcome unless the subsidence is significant (>3 mm).

Insulin-like growth factor 1 as a predictor of ischemic stroke outcome in the elderly.

PubMed

Denti, Licia; Annoni, Valentina; Cattadori, Evelina; Salvagnini, Maria Angela; Visioli, Sandra; Merli, Maria Francesca; Corradi, Francesco; Ceresini, Graziano; Valenti, Giorgio; Hoffman, Andrew R; Ceda, Gian Paolo

2004-09-01

To examine whether serum insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3) concentrations, determined early after the onset of stroke, are predictive of clinical outcome in elderly patients. The sample comprised 85 patients (mean [+/- SD] age, 83 +/- 7.4 years; range, 67 to 99 years; 34% male) who were admitted with acute stroke to a geriatric ward between January 1998 and June 2000, and 88 control patients who were similar in age and sex. Clinical and laboratory assessments, computed tomographic scan of the head, carotid ultrasonography, and electrocardiography were employed to define the clinical and etiologic stroke subtype. Fasting blood samples were collected within 24 hours of admission for IGF-I and IGFBP-3 measurement. Univariate and multiple logistic regression analyses, with adjustment for other related clinical covariates, were used to assess the relation of IGF-I and IGFBP-3 to poor outcome, defined as severe disability (Barthel index <60/100) or death, at 1 month (or at discharge), 3 months, and 6 months. Mean (+/- SD) IGF-1 levels were lower in patients with stroke than in controls (69 +/- 45 ng/mL vs. 102 +/- 67 ng/mL, P adjusted for age = 0.001). The mean IGF-1/IGFBP-3 molar ratio was also lower in stroke patients (0.12 +/- 0.07 vs. 0.19 +/- 0.09, P adjusted for age <0.0001). However, there was no relation of hormone levels to either the clinical subtype of stroke or the extent of neurologic impairment. IGF-1 levels were inversely related to poor outcome (mainly death) at 3 and 6 months, independent of other clinical covariates that were highly predictive of outcome, such as age and stroke scale score on admission (hazard ratio for death at 6 months for each 20-ng/mL increase = 0.7; 95% confidence interval: 0.5 to 0.9). An independent association of the molar ratio with death at 3 and 6 months was also found. Low levels of circulating IGF-1 may predict the clinical outcome of stroke in elderly patients.

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

PubMed

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 determine IBD activity. Further studies are needed to determine their accuracy and whether they can be used effectively in routine practice, clinical trials, telemedicine systems, and value-based healthcare programs. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Connectivity Predicts Deep Brain Stimulation Outcome in Parkinson Disease

PubMed Central

Horn, Andreas; Reich, Martin; Vorwerk, Johannes; Li, Ningfei; Wenzel, Gregor; Fang, Qianqian; Schmitz-Hübsch, Tanja; Nickl, Robert; Kupsch, Andreas; Volkmann, Jens; Kühn, Andrea A.; Fox, Michael D.

2018-01-01

Objective The benefit of deep brain stimulation (DBS) for Parkinson disease (PD) may depend on connectivity between the stimulation site and other brain regions, but which regions and whether connectivity can predict outcome in patients remain unknown. Here, we identify the structural and functional connectivity profile of effective DBS to the subthalamic nucleus (STN) and test its ability to predict outcome in an independent cohort. Methods A training dataset of 51 PD patients with STN DBS was combined with publicly available human connectome data (diffusion tractography and resting state functional connectivity) to identify connections reliably associated with clinical improvement (motor score of the Unified Parkinson Disease Rating Scale [UPDRS]). This connectivity profile was then used to predict outcome in an independent cohort of 44 patients from a different center. Results In the training dataset, connectivity between the DBS electrode and a distributed network of brain regions correlated with clinical response including structural connectivity to supplementary motor area and functional anticorrelation to primary motor cortex (p<0.001). This same connectivity profile predicted response in an independent patient cohort (p<0.01). Structural and functional connectivity were independent predictors of clinical improvement (p<0.001) and estimated response in individual patients with an average error of 15% UPDRS improvement. Results were similar using connectome data from normal subjects or a connectome age, sex, and disease matched to our DBS patients. Interpretation Effective STN DBS for PD is associated with a specific connectivity profile that can predict clinical outcome across independent cohorts. This prediction does not require specialized imaging in PD patients themselves. PMID:28586141

Outcomes of a Clinic-Based, Surveillance-Informed Intervention to Relink Patients to HIV Care

PubMed Central

Bove, Joanna; Golden, Matthew R.; Dhanireddy, Shireesha; Harrington, Robert D.; Dombrowski, Julia C.

2015-01-01

Background Improving patient retention in HIV care is crucial to improving the HIV care continuum. We instituted and evaluated a relinkage program that uses clinical data to identify potentially out-of-care patients, matches those data to public health surveillance, and employs a linkage specialist (LS) to coordinate care relinkage. Methods The intervention began November 1, 2012 in the largest HIV clinic in Washington State. We evaluated program outcomes and compared patient outcomes in the year following initiation of the intervention to a historical control cohort of patients. Cox proportional hazard ratios were used to compare time to relinkage to care between cohorts, and regression models using generalized estimated equations were preformed to examine secondary outcomes of relinkage to care, engagement in care, and viral suppression. Results 753 patients were identified as “out of care” on 11/1/12. Matching with surveillance data and initial LS investigations found that 596 (79%) of these patients had moved, transferred care or were incarcerated. Of the 157 remaining patients: 40 (25%) relinked to care before LS contact, and the LS successfully contacted 38 (24%). A total of 116 (15%) patients in the intervention cohort relinked to care and 24 (20%) were contacted by the LS. Compared to the historical cohort, the time to relinkage was shorter among patients in the intervention cohort [adjusted HR=1.7 (1.2-2.3)] and a greater proportion relinked [15% vs. 10%]. Conclusions This clinic-based, surveillance-informed relinkage intervention showed statistically significant but modest effectiveness in returning out-of-care patients to HIV care compared to historical controls. PMID:26068720

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.

PubMed

Goldstein, Judith E; Jackson, Mary Lou; Fox, Sandra M; Deremeik, James T; Massof, Robert W

2015-07-01

To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients' psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the population was observed in overall visual ability. Age (P = .006) was an independent predictor of changes in overall visual ability, and logMAR visual acuity (P = .002) was predictive of changes in visual information processing. Forty-four to fifty percent of patients presenting for outpatient LVR show clinically meaningful differences in overall visual ability after LVR, and the average effect sizes in overall visual ability are large, close to 1 SD.

Radiographic changes and clinical outcomes associated with an adjustable diaphyseal press-fit humeral stem in primary reverse shoulder arthroplasty.

PubMed

Harmsen, Samuel M; Norris, Tom R

2017-09-01

Press-fit humeral fixation in reverse shoulder arthroplasty (RSA) has become increasingly popular; however, radiographic analysis of these stems is limited. We aimed to evaluate the radiographic and clinical outcomes of an adjustable diaphyseal press-fit humeral stem in primary RSA. We conducted a retrospective review of 232 primary RSAs in 219 patients performed by a single surgeon using this system. Radiographic outcomes were evaluated in patients with at least 2 years of radiographic follow-up. Standardized postoperative digital radiographs were analyzed for loosening, osteolysis, and stress shielding. Clinical outcomes in patients who also had complete clinical data sets were evaluated at the most recent follow-up. Radiographic evidence of loosening was identified in 1 RSA (0.4%) associated with deep infection. Aseptic loosening was not observed. No stems were identified as being at high risk for loosening. Internal stress shielding was observed proximal to the coated diaphyseal component in 226 shoulders (97.4%). This finding was often visible at 3 months (92.7%) and predictably progressed on subsequent radiographs. Progression beyond the 2-year period was rarely seen (4.4%). No external stress shielding or osteolysis was observed. Thirty-six complications occurred in 33 patients (15.1%). At an average follow-up of 36.6 months, significant improvements were identified in all measured clinical outcomes (P < .001). Predictable fixation is achieved using an adjustable diaphyseal press-fit humeral system in primary RSA. Internal stress shielding is commonly observed but does not appear to compromise quality of fixation or clinical outcomes. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures.

PubMed

Morel, Thomas; Cano, Stefan J

2017-11-02

Our ability to evaluate outcomes which genuinely reflect patients' unmet needs, hopes and concerns is of pivotal importance. However, much current clinical research and practice falls short of this objective by selecting outcome measures which do not capture patient value to the fullest. In this Opinion, we discuss Patient-Centered Outcomes Measures (PCOMs), which have the potential to systematically incorporate patient perspectives to measure those outcomes that matter most to patients. We argue for greater multi-stakeholder collaboration to develop PCOMs, with rare disease patients and families at the center. Beyond advancing the science of patient input, PCOMs are powerful tools to translate care or observed treatment benefit into an 'interpretable' measure of patient benefit, and thereby help demonstrate clinical effectiveness. We propose mixed methods psychometric research as the best route to deliver fit-for-purpose PCOMs in rare diseases, as this methodology brings together qualitative and quantitative research methods in tandem with the explicit aim to efficiently utilise data from small samples. And, whether one opts to develop a brand-new PCOM or to select or adapt an existing outcome measure for use in a rare disease, the anchors remain the same: patients, their daily experience of the rare disease, their preferences, core concepts and values. Ultimately, existing value frameworks, registries, and outcomes-based contracts largely fall short of consistently measuring the full range of outcomes that matter to patients. We argue that greater use of PCOMs in rare diseases would enable a fast track to Patient-Centered Care.

Outcomes of endovascular reconstruction of the inferior vena cava with self-expanding nitinol stents.

PubMed

Sebastian, Tim; Dopheide, Jörn F; Engelberger, Rolf P; Spirk, David; Kucher, Nils

2018-05-01

Occlusion of the inferior vena cava (IVC) often causes venous claudication, leg swelling, or skin changes. We hypothesized that the outcome of nitinol stents for endovascular reconstruction of the IVC is similar to the outcome reported for steel alloy stents. From the prospective Bern Venous Stent Registry, we investigated technical success, patency rates, and clinical outcome in consecutive patients with endovascular IVC reconstruction. During routine follow-up visits, stent patency was assessed by duplex ultrasound. Clinical outcomes were evaluated using the Bozkaya score, Villalta score, and revised Venous Clinical Severity Score. Of the 62 patients (mean age, 46 ± 18 years), 33 (53%) patients were treated for the post-thrombotic syndrome, 17 (27%) for acute thrombosis, and 12 (19%) for nonthrombotic IVC occlusion. Technical success was achieved in 61 (98%) patients, with a mean of 4.5 ± 1.9 stents (iliac kissing stents in 84%). During follow-up (mean, 21 months), 22 (36%) underwent endovascular reintervention for symptomatic stent stenosis (13 [21%] with complete stent occlusion). Primary, primary assisted, and secondary patency rates at 24 months were 57% (95% confidence interval [CI], 50%-73%), 76% (95% CI, 65%-86%), and 87% (95% CI, 80%-95%), respectively. None developed new ulcers, and all eight patients with venous ulcers at baseline had complete healing. Twenty-nine (48%) patients showed significant clinical improvement, and another 26 (43%) were free from any symptoms or signs of venous hypertension. Patients with post-thrombotic venographic changes of the femoral veins at baseline or a history of thrombosis were more likely to lose primary patency compared with patients with normal leg inflow veins and no history of thrombosis (19 [48%] vs 3 [16%]; P = .02). The clinical outcome of endovascular reconstruction of the IVC with nitinol stents was favorable. However, approximately one-third of the patients required reintervention to maintain stent patency, most likely because of the impaired venous inflow. Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

The effect of missing KIR ligands, activating KIR genotype and haplotype on the outcome of T-cell-replete hematopoietic stem cell transplantation from HLA-identical siblings in Thai patients.

PubMed

Khanuntong, S; Kuptawintu, P; Upaisilpsathaporn, K; Poolchareon, A; Bunworasate, U; Hirankarn, N

2016-06-01

This study was a retrospective analysis of Thai patients undergoing T-replete hematopoietic stem cell transplant from human leukocyte antigen (HLA)-identical sibling donors. We investigated 66 patients, including 40 patients with acute myeloid leukemia (AML), 12 patients with acute lymphoblastic leukemia and 14 patients with chronic myeloid leukemia. Killer cell immunoglobulin-like receptor (KIR) genes and HLA ligands were typed by polymerase chain reaction-sequence specific oligonucleotide probes. We analyzed the effect of the number of missing KIR ligands (Bw4, C1 and C2) on clinical outcomes. A beneficial effect of missing KIR ligand was not observed in both univariate and multivariate analysis. When we analyzed the effect of specific missing KIR ligand on clinical outcomes, there was a trend that patients with missing A11 ligand had lower relapse rate (P = 0.076). Therefore, we also conducted the analysis by including the group with missing KIR ligands of Bw4, C1, C2 and A11. Patients with two or more than two missing KIR ligands had a trend for better clinical outcome including reduced relapse (P = 055) and statistically significant in terms of reduced acute graft-vs-host disease (aGVHD) rate (P = 0.013). In multivariate analysis, patients with two or more than two missing KIR ligands had a statistically significant better clinical outcome in terms of reduced aGVHD rate (HR = 0.155, 95%CI = 0.040-0.605, P = 0.007). The association between clinical outcome with KIR haplotypes, centromeric B haplotype and activating KIR was not observed here. Although the sample size in this study is rather limited, these data can later be subjected to meta-analysis to help reach the conclusion of the usefulness of this additional promising KIR genotyping in various hematopoietic stem cell transplantation types. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical long-term outcome of septal myectomy for obstructive hypertrophic cardiomyopathy in infants.

PubMed

Schleihauf, Julia; Cleuziou, Julie; Pabst von Ohain, Jelena; Meierhofer, Christian; Stern, Heiko; Shehu, Nerejda; Mkrtchyan, Naira; Kaltenecker, Emanuel; Kühn, Andreas; Nagdyman, Nicole; Hager, Alfred; Seidel, Heide; Lange, Rüdiger; Ewert, Peter; Wolf, Cordula M

2018-03-01

Surgical septal myectomy is performed to relieve left ventricular outflow tract narrowing in severe drug-refractory obstructive hypertrophic cardiomyopathy. The objective of this study was to assess the perioperative and long-term clinical outcome of this procedure performed during infancy. Clinical, transthoracic echocardiographic, electrocardiographic, 24-h Holter, cardiopulmonary exercise test and genetic data were extracted by medical record review. A subset of patients underwent additional prospective detailed clinical evaluation including cardiac magnetic resonance imaging with contrast. Surgery was performed in 23 paediatric patients between 1978 and 2015 at the German Heart Centre Munich. Twelve patients had undergone surgery during infancy (≤ 1 year) (Group A), 11 between 1 and 18 years of age (Group B). The underlying genetic diagnosis was Noonan syndrome spectrum and non-syndromic hypertrophic cardiomyopathy. As compared to Group B, patients in Group A showed more concomitant cardiac procedures and received more homologous transfusions. One perioperative death occurred in Group A, and none in Group B. Two patients in Group A but no patient in Group B required redo septal myectomy. The long-term clinical outcome was similar between the 2 groups. One patient in Group B required cardioverter-defibrillator/pacemaker implantation for higher degree atrioventricular block and none in Group A. There was no evidence of differences in myocardial fibrosis between groups on long-term follow-up magnetic resonance imaging. Surgical septal myectomy can be performed safely during infancy with favourable perioperative and long-term clinical outcome but with a trend towards a higher reoperation rate later in life. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Outcome in Chronic Subdural Hematoma After Subdural vs. Subgaleal Drain.

PubMed

Ishfaq, Asim

2017-07-01

To compare the outcome after surgery for chronic subdural hematoma when the drain is placed in subdural space or subgaleal space. Quasi experimental study. Combined Military Hospital, Lahore, from July 2015 to June 2016. Patients with chronic subdural hematoma of both genders and age, ranging between 55 to 85 years, were included. Patients on antiplatelet/anticoagulant therapy and acute on chronic subdural hematoma were excluded. Patients were divided in two equal groups each depending on whether drain was placed in subgaleal space (Group 1), and subdual space (Group 2), (n=31 patients each). Patients were positioned flat in bed after surgery. Clinical and radiological parameters and clinical outcome were compared between the two groups. Statistical test with significance of p <0.05 was utilized using Statistical Package of Social Sciences (SPSS version 17). Median age of the 62 patients was 72 ±12.5 years. Headache was the most common symptom reported in both groups, (n=47,75.8%) patients. Median thickness of hematoma was 15 ±6.5 mm. Patients with subdural drain placement had more complications such as pneumocephalus 11 (35.4%) vs. 6 (19.3%), and intracerebral hemorrhage 4 (12.9%) vs. 2 (6.4%). Clinical outcome was good in both groups 27 (87%) in Group 1 and 28 (90%) in Group 2. Patients of both groups had good outcome after surgery. Complications like pneumocephalus and intracerebral hemorrhage were more common in subdural location of drain, though not reaching statistically significance level to favor one technique over another.

Comparison of Multiple Chronic Obstructive Pulmonary Disease (COPD) Indices in Chinese COPD Patients.

PubMed

Zhang, Jinsong; Miller, Anastasia; Li, Yongxia; Lan, Qinqin; Zhang, Ning; Chai, Yanling; Hai, Bing

2018-04-01

Chronic obstructive pulmonary disease (COPD) is a serious chronic condition with a global impact. Symptoms of COPD include progressive dyspnea, breathlessness, cough, and sputum production, which have a considerable impact on the lives of patients. In addition to the human cost of living with COPD and the resulting death, COPD entails a huge economic burden on the Chinese population, with patients spending up to one-third of the average family income on COPD management in some regions is clinically beneficial to adopt preventable measures via prudent COPD care utilization, monetary costs, and hospitalizations. Toward this end, this study compared the relative effectiveness of six indices in predicting patient healthcare utilization, cost of care, and patient health outcome. The six assessment systems evaluated included the three multidimensional Body mass index, Obstruction, Dyspnea, Exercise capacity index, Dyspnea, Obstruction, Smoking, Exacerbation (DOSE) index, and COPD Assessment Test index, or the unidimensional measures that best predict the future of patient healthcare utilization, cost of care, and patient health outcome among Chinese COPD patients. Multiple linear regression models were created for each healthcare utilization, cost, and outcome including a single COPD index and the same group of demographic variables for each of the outcomes. We conclude that the DOSE index facilitates the prediction of patient healthcare utilization, disease expenditure, and negative clinical outcomes. Our study indicates that the DOSE index has a potential role beyond clinical predictions. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

Clinical course and prognosis of musculoskeletal pain in patients referred for physiotherapy: does pain site matter?

PubMed

de Vos Andersen, Nils-Bo; Kent, Peter; Hjort, Jakob; Christiansen, David Høyrup

2017-03-29

Danish patients with musculoskeletal disorders are commonly referred for primary care physiotherapy treatment but little is known about their general health status, pain diagnoses, clinical course and prognosis. The objectives of this study were to 1) describe the clinical course of patients with musculoskeletal disorders referred to physiotherapy, 2) identify predictors associated with a satisfactory outcome, and 3) determine the influence of the primary pain site diagnosis relative to those predictors. This was a prospective cohort study of patients (n = 2,706) newly referred because of musculoskeletal pain to 30 physiotherapy practices from January 2012 to May 2012. Data were collected via a web-based questionnaire 1-2 days prior to the first physiotherapy consultation and at 6 weeks, 3 and 6 months, from clinical records (including primary musculoskeletal symptom diagnosis based on the ICPC-2 classification system), and from national registry data. The main outcome was the Patient Acceptable Symptom State. Potential predictors were analysed using backwards step-wise selection during longitudinal Generalised Estimating Equation regression modelling. To assess the influence of pain site on these associations, primary pain site diagnosis was added to the model. Of the patients included, 66% were female and the mean age was 48 (SD 15). The percentage of patients reporting their symptoms as acceptable was 32% at 6 weeks, 43% at 3 months and 52% at 6 months. A higher probability of satisfactory outcome was associated with place of residence, being retired, no compensation claim, less frequent pain, shorter duration of pain, lower levels of disability and fear avoidance, better mental health and being a non-smoker. Primary pain site diagnosis had little influence on these associations, and was not predictive of a satisfactory outcome. Only half of the patients rated their symptoms as acceptable at 6 months. Although satisfactory outcome was difficult to predict at an individual patient level, there were a number of prognostic factors that were associated with this outcome. These factors should be considered when developing generic prediction tools to assess the probability of satisfactory outcome in musculoskeletal physiotherapy patients, because the site of pain did not affect that prognostic association.

Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB.

PubMed

Lee, Wonyong; Choi, Chong-Hyuk; Choi, Yun-Rak; Lim, Kyung-Han; Chun, Yong-Min

2017-07-01

The purpose of this study was to investigate clinical and radiologic outcomes of clavicle hook plate fixation for distal-third clavicle fracture (Neer type II) and to compare the clinical and radiologic outcomes and complications between Neer type IIA and type IIB. We retrospectively reviewed 35 patients who underwent open reduction and internal fixation with AO hook locking compression plate (LCP) for distal clavicle fracture, including 13 patients with Neer type IIA and 22 patients with type IIB. Visual analog scale pain score, shoulder scores (subjective shoulder value, University of California-Los Angeles shoulder score, American Shoulder and Elbow Surgeons score), and active range of motion were evaluated to determine clinical outcome. Coracoclavicular distance was measured, and that of the injured side at last follow-up was compared with that of the uninjured side to evaluate radiologic outcomes. AO hook LCP fixation for distal-third clavicle fracture (Neer type II) produced satisfactory radiologic outcomes, including high union rates (100%) and coracoclavicular distance maintenance, as well as satisfactory clinical outcomes, including visual analog scale score for pain, shoulder scores (subjective shoulder value, University of California-Los Angeles shoulder score, American Shoulder and Elbow Surgeons score), and active range of motion. There were no significant differences between Neer type IIA and type IIB. With regard to complications, 22.9% of patients experienced shoulder stiffness and 17.1% had subacromial erosion; however, there were no significant differences between the 2 groups. The AO hook LCP is a suitable choice for Neer type IIA and type IIB distal-third clavicle fracture fixation. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Immediate Clinical and Echocardiographic Outcome of Percutaneous Transvenous Mitral Commissurotomy for Patients of Mitral Stenosis with Atrial Fibrillation.

PubMed

Rahman, M T; Rahman, M M; Islam, M M; Khan, M R; Haque, S A; Chowdhury, A W; Majumder, A S; Rahman, A; Islam, Q I

2015-07-01

Rheumatic fever and rheumatic heart disease continue to be the major health problem in all developing countries including Bangladesh. Rheumatic mitral stenosis is a very common problem in our population having an incidence of 54 percent among rheumatic heart disease with a female preponderance of 2:1. Percutaneous balloon mitral commissurotomy is appealing because the mechanism of valve dilation closely parallels the mechanism of surgical mitral commissurotomy. The technique of balloon mitral commissurotomy has evolved rapidly, with improvements in balloons, guide wires, and the application of double-balloon techniques. There is controversy that whether the presence of AF has a direct negative effect on the immediate or long-term outcome after PTMC in mitral stenosis patients. The purpose of this study was to see the effect of atrial fibrillation (AF) on the immediate clinical and echocardiographic outcome of patients undergoing Percutaneous Transvenous Mitral Commissurotomy (PTMC). The immediate procedural and in-hospital clinical outcome after PTMC of 264 patients with AF were prospectively collected and compared with those of 288 patients in normal sinus rhythm (NSR) with mitral stenosis admitted in National Institute of Cardiovascular Diseases, Dhaka and Al-Helal Heart Institute, Mirpur, Dhaka, Bangladesh. Patients with AF were older than patients with normal sinus rhythm (53 ± 11 vs. 33 ± 12 years; p<0.0001) and presented more frequently with New York Heart Association (NYHA) class III-IV (78.3% vs. 58.5%; p<0.0001), echocardiographic score >8 (38.9% vs. 22.7%; p<0.0001), calcified valves under fluoroscopy (22.2% vs.12.4%, p<0.0001) and with history of previous surgical commissurotomy (21.7% vs. 10.5%; p<0.0001). In patients with AF, PTMC resulted in worse outcomes, as reflected in a smaller post-PTMC mitral valve area (1.6±0.4 vs. 2.1 ± 0.8 cm²; p<0.0001). Patients with atrial fibrillation have a worse immediate clinical and echocardiographic outcome after PTMC.

Impact of patient position on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials.

PubMed

Alexiou, Vangelis G; Ierodiakonou, Vrettos; Dimopoulos, George; Falagas, Matthew E

2009-12-01

The aim of this study is to summarize the effect of position (prone and semirecumbent 45 degrees ) of mechanically ventilated patients on the incidence of ventilator-associated pneumonia (VAP) and other outcomes. A systematic search for randomized control trials (RCTs) was done. We estimated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using fixed effects model or random effects model, where appropriate. For continuous variables, we calculated the estimation of weighted mean differences. We analyzed data extracted from 3 RCTs studying the semirecumbent 45 degrees and 4 RCTs studying the prone position with a total of 337 and 1018 patients, respectively. The odds of developing clinically diagnosed VAP were significantly lower among patients in the semirecumbent 45 degrees position compared to patients in the supine position (OR = 0.47; 95% CI, 0.27-0.82; 337 patients). The comparison of prone vs supine position group showed a moderate trend toward better outcomes regarding the incidence of clinically diagnosed VAP among patients in the prone position (OR = 0.80; 95% CI, 0.60-1.08; 1018 patients). The subanalysis regarding the incidence of microbiologically documented VAP, the length of intensive care unit stay, and the duration of mechanical ventilation showed that patients in the semirecumbent 45 degrees position have a moderate trend toward better clinical outcomes. This meta-analysis provides additional evidence that the usual practice of back-rest elevation of 15 degrees to 30 degrees is not sufficient to prevent VAP in mechanically ventilated patients. Patients positioned semirecumbently 45 degrees have significantly lower incidence of clinically diagnosed VAP compared to patients positioned supinely. On the other hand, the incidence of clinically diagnosed VAP among patients positioned pronely does not differ significantly from the incidence of clinically diagnosed VAP among patients positioned supinely.

Clinical presentation, imaging findings, and prognosis of spinal dural arteriovenous fistula.

PubMed

Lee, Jookyung; Lim, Young-Min; Suh, Dae Chul; Rhim, Seung Chul; Kim, Sang Joon; Kim, Kwang-Kuk

2016-04-01

Spinal dural arteriovenous fistula (SDAVF) is a relatively common acquired vascular malformation of the spinal cord. Assessment of a SDAVF is often difficult because of non-specific findings on non-invasive imaging modalities. Diagnosis of a SDAVF is often delayed, and some patients receive unnecessary treatment and treatment delays, often resulting in a poor outcome. The aim of this study was to characterize the clinical presentation, typical imaging findings, and long-term outcome of SDAVF. Forty patients (13 women, 27 men; mean age 58.18 ± standard deviation 14.75 years) who were treated at our hospital from June 1992 to March 2014 were retrospectively reviewed. We investigated the baseline characteristics, clinical presentation, imaging findings, treatment modalities, and outcome of the patients. The most common clinical presentation was a sensory symptom (80%), followed by motor weakness (70%), and sphincter dysfunction (62.5%). Roughly one-third (32.5%) of patients had a stepwise progression of fluctuating weakness and sensory symptoms, but the most common presentation was chronic progressive myelopathic symptoms (47.5%). Thirty-four patients (85%) had T2 signal change on the spinal cord MRI, indicative of cord edema. Thirty-eight patients had typical perimedullary vessel flow voids on T2-weighted MRI. Twenty-eight patients were treated with endovascular embolization, five patients underwent surgery, and four patients underwent both. Clinical outcome was determined by severity of initial deficit (p=0.008), extent of cord edema (p=0.010), treatment failure (p=0.004), and a residual fistula (p=0.017). SDAVF causes a treatable myelopathy, so early diagnosis and intervention is essential. Copyright © 2015 Elsevier Ltd. All rights reserved.

Long-term outcomes of open radical retropubic prostatectomy for clinically localized prostate cancer in the prostate-specific antigen era.

PubMed

Dorin, Ryan P; Daneshmand, Siamak; Lassoff, Mark A; Cai, Jie; Skinner, Donald G; Lieskovsky, Gary

2012-03-01

To determine long-term oncological outcomes and complication rates for patients with clinically organ confined prostate adenocarcinoma (PCa) treated with open radical retropubic prostatectomy and pelvic lymph node dissection (RRP/PLND) in the prostate-specific antigen (PSA) era. Outcomes data were obtained from a prospectively maintained prostate cancer database. Patients with cT1/cT2 PCa undergoing RRP/PLND without neoadjuvant therapy between July 1988 and June 2008 were included. Kaplan-Meier and Cox proportional regression models were used to evaluate factors influencing biochemical recurrence, clinical recurrence, and overall survival (OS). A total of 2487 patients met inclusion criteria, and median follow-up was 7.2 years (range 1-21 years). Of the patients, 49.7% were low risk, 33.2% intermediate risk, and 16.1% high risk by D'Amico criteria, and 6% were LN+. The 10-year biochemical recurrence-free survival (BCRFS) for low-, intermediate-, and high-risk patients was 92%, 83%, and 76%, respectively (P < .001), and 10 year OS was 91%, 83%, and 74%, respectively (P < .001). BCRFS at 10 years was 76% and 88% for patients with positive and negative margins, respectively (P < .001). Of the 2487 patients, 11% developed BCR, and 3.7% experienced CR, with 9 local recurrences. The overall complication rate was 2.3%, and the cancer specific mortality rate was 2%. D'Amico risk group, margin status, and LN status are significantly correlated with outcomes in patients undergoing RRP/PLND for clinically localized PCa. Local recurrence and death from prostate cancer are rare in patients undergoing open RRP/PLND for clinically organ confined disease in the PSA era. Copyright © 2012 Elsevier Inc. All rights reserved.

The effect of CD34+ cell telomere length and hTERT expression on the outcome of autologous CD34+ cell transplantation in patients with chronic heart failure.

PubMed

Rozman, Jasmina-Ziva; Perme, Maja Pohar; Jez, Mojca; Malicev, Elvira; Krasna, Metka; Novakovic, Srdjan; Vrtovec, Bojan; Rozman, Primoz

2017-09-01

Age-related telomere attrition in stem/progenitor cells may diminish their functional capacity and thereby impair the outcome of cell-based therapies. The aim of the present study was to investigate the effect of CD34 + cell telomere length and hTERT expression on the clinical outcome of autologous CD34 + cell transplantation. We studied 43 patients with cardiomyopathy. Their peripheral blood CD34 + cells were mobilized with granulocyte colony-stimulating factor, enriched by immunoselection and delivered transendocardially. Relative telomere length and expression levels of hTERT were measured using a real-time PCR assay. Immunoselected CD34 + cells had longer telomere length compared to leukocytes in leukapheresis products (p=0.001). In multivariate analysis, CD34 + cell telomere length was not associated with the clinical outcome (b=3.306, p=0.540). While hTERT expression was undetectable in all leukapheresis products, 94.4% of the CD34 + enriched cell products expressed hTERT. Higher CD34 + hTERT expression was associated with a better clinical outcome on univariate analysis (b=87.911, p=0.047). Our findings demonstrate that CD34 + cell telomere length may not influence the clinical outcome in cardiomyopathy patients treated with autologous CD34 + cell transplantation. Larger studies are needed to validate the impact of the CD34 + hTERT expression on the clinical outcome of autologous CD34 + cell transplantation. Copyright © 2017 Elsevier B.V. All rights reserved.

Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials.

PubMed

Savarese, Gianluigi; Paolillo, Stefania; Costanzo, Pierluigi; D'Amore, Carmen; Cecere, Milena; Losco, Teresa; Musella, Francesca; Gargiulo, Paola; Marciano, Caterina; Perrone-Filardi, Pasquale

2012-09-25

The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH). 6MWD is used as an endpoint to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown. Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes. Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio [OR]: 0.429; 95% confidence interval [CI]: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected. In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Histological Disease Activity as a Predictor of Clinical Relapse Among Patients With Ulcerative Colitis: Systematic Review and Meta-Analysis.

PubMed

Park, Sunhee; Abdi, Tsion; Gentry, Mark; Laine, Loren

2016-12-01

Endoscopic remission in ulcerative colitis (UC) is associated with improved clinical outcomes. We assessed whether histological remission predicts clinical outcomes, estimated the magnitude of effect, and determined whether histological remission provides additional prognostic utility beyond clinical or endoscopic remission. Bibliographic databases were searched for studies in inflammatory bowel disease providing baseline histological status and relation to an outcome of clinical relapse or exacerbation. Our primary analysis compared the proportion of patients with study-defined histological remission vs. the proportion with histological activity who developed clinical relapse/exacerbation. Additional analyses compared the proportion with relapse/exacerbation for the presence vs. absence of different histological features and for histological remission vs. endoscopic remission and clinical remission. A fixed-effect model was used for meta-analysis, with a random-effects model if statistical heterogeneity was present. Fifteen studies met inclusion criteria. The major methodological shortcoming was lack of blinding of the assessor of clinical relapse/exacerbation to baseline histological status in 13 of the 15 studies. Relapse/exacerbation was less frequent with baseline histological remission vs. histological activity (relative risk (RR)=0.48, 95% confidence interval (CI) 0.39-0.60) and vs. baseline clinical and endoscopic remission (RR=0.81, 95% CI 0.70-0.94). Relapse/exacerbation was also less common in the absence vs. presence of specific histological features: neutrophils in epithelium (RR=0.32, 95% CI 0.23-0.45), neutrophils in lamina propria (RR=0.43, 95% CI 0.32-0.59), crypt abscesses (RR=0.38, 95% CI 0.27-0.54), eosinophils in the lamina propria (RR=0.43, 95% CI 0.21-0.91), and chronic inflammatory cell infiltrate (RR=0.28, 95% CI 0.10-0.75). Histological remission was present in 964 (71%) of the 1360 patients with combined endoscopic and clinical remission at baseline. UC patients with histological remission have a significant 52% RR reduction in clinical relapse/exacerbation compared with those with histological activity. Histological remission is also superior to endoscopic and clinical remission in predicting clinical outcomes. As ~30% of patients with endoscopic and clinical remission still have histological activity, addition of histological status as an end point in clinical trials or practice has the potential to improve clinical outcomes.

Clinical outcomes of temporary shunting for infants with cerebral pseudomeningocele.

PubMed

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.

The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients

PubMed Central

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

2016-01-01

Abstract Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients. HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization. A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan–Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21–2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00–1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12–2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08–2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables. Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients. PMID:27175661

Impact of sagittal spinopelvic alignment on clinical outcomes after decompression surgery for lumbar spinal canal stenosis without coronal imbalance.

PubMed

Hikata, Tomohiro; Watanabe, Kota; Fujita, Nobuyuki; Iwanami, Akio; Hosogane, Naobumi; Ishii, Ken; Nakamura, Masaya; Toyama, Yoshiaki; Matsumoto, Morio

2015-10-01

The object of this study was to investigate correlations between sagittal spinopelvic alignment and improvements in clinical and quality-of-life (QOL) outcomes after lumbar decompression surgery for lumbar spinal canal stenosis (LCS) without coronal imbalance. The authors retrospectively reviewed data from consecutive patients treated for LCS with decompression surgery in the period from 2009 through 2011. They examined correlations between preoperative or postoperative sagittal vertical axis (SVA) and radiological parameters, clinical outcomes, and health-related (HR)QOL scores in patients divided according to SVA. Clinical outcomes were assessed according to Japanese Orthopaedic Association (JOA) and visual analog scale (VAS) scores. Health-related QOL was evaluated using the Roland-Morris Disability Questionnaire (RMDQ) and the JOA Back Pain Evaluation Questionnaire (JOABPEQ). One hundred nine patients were eligible for inclusion in the study. Compared to patients with normal sagittal alignment prior to surgery (Group A: SVA < 50 mm), those with preoperative sagittal imbalance (Group B: SVA ≥ 50 mm) had significantly smaller lumbar lordosis and thoracic kyphosis angles and larger pelvic tilt. In Group B, there was a significant decrease in postoperative SVA compared with the preoperative SVA (76.3 ± 29.7 mm vs. 54.3 ± 39.8 mm, p = 0.004). The patients in Group B with severe preoperative sagittal imbalance (SVA > 80 mm) had residual sagittal imbalance after surgery (82.8 ± 41.6 mm). There were no significant differences in clinical and HRQOL outcomes between Groups A and B. Compared to patients with normal postoperative SVA (Group C: SVA < 50 mm), patients with a postoperative SVA ≥ 50 mm (Group D) had significantly lower JOABPEQ scores, both preoperative and postoperative, for walking ability (preop: 36.6 ± 26.3 vs. 22.7 ± 26.0, p = 0.038, respectively; postop: 71.1 ± 30.4 vs. 42.5 ± 29.6, p < 0.001) and social functioning (preop: 38.7 ± 18.5 vs. 30.2 ± 16.7, p = 0.045; postop: 67.0 ± 25.8 vs. 49.6 ± 20.0, p = 0.001), as well as significantly higher postoperative RMDQ (4.9 ± 5.2 vs. 7.9 ± 5.7, p = 0.015) and VAS scores for low-back pain (2.68 ± 2.69 vs. 3.94 ± 2.59, p = 0.039). Preoperative sagittal balance was not significantly correlated with clinical or HRQOL outcomes after decompression surgery in LCS patients without coronal imbalance. Decompression surgery improved the SVA value in patients with preoperative sagittal imbalance; however, the patients with severe preoperative sagittal imbalance (SVA > 80 mm) had residual imbalance after decompression surgery. Both clinical and HRQOL outcomes were negatively affected by postoperative residual sagittal imbalance.

Medical Students as Health Educators at a Student-Run Free Clinic: Improving the Clinical Outcomes of Diabetic Patients

PubMed Central

Peltz, Alon; Ladner, Travis R.; Reddy, India; Miller, Bonnie M.; Miller, Robert F.; Fowler, Michael J.

2014-01-01

Purpose Student-run free clinics (SRFCs) provide service–learning opportunities for medical students and care to underserved patients. Few published studies, however, support that they provide high-quality care. In this study, the authors examined the clinical impact of a medical student health educator program for diabetic patients at an SRFC. Method In 2012, the authors retrospectively reviewed the electronic medical records of diabetic patients who established care at Shade Tree Clinic in Nashville, Tennessee, between 2008 and 2011. They compared clinical outcomes at initial presentation to the clinic and 12 months later. They analyzed the relationship between the number of patient–student interactions (touchpoints) and change in hemoglobin A1c values between these two time points and compared the quality of care provided to best-practice benchmarks (process and outcomes measures). Results The authors studied data from 45 patients. Mean hemoglobin A1c values improved significantly from 9.6 to 7.9, after a mean of 12.5 ± 1.5 months (P < .0001). A trend emerged between increased number of touchpoints and improvement in A1c values (r2 = 0.06, P = .10). A high percentage of patients were screened during clinic visits, whereas a low to moderate percentage met benchmarks for A1c, LDL, and blood pressure levels. Conclusions These findings demonstrate that a medical student health educator program at an SRFC can provide high-quality diabetes care and facilitate clinical improvement one year after enrollment, despite inherent difficulties in caring for underserved patients. Future studies should examine the educational and clinical value of care provided at SRFCs. PMID:24556762

An assessment of HIV treatment outcomes among utilizers of semi-mobile clinics in rural Kenya.

PubMed

Gorman, Sara E; Martinez, Jose M; Olson, Jennifer

2015-01-01

HIV/AIDS is a major cause of morbidity and mortality in Africa, and rates of retention in treatment are low. Some research has shown that mobile clinics are effective in connecting people in rural areas with health care. We compared HIV outcomes between HIV-positive patients who chose to access treatment from a regional hospital to those who chose care in one of four semi-mobile clinics closer to where they live. The subjects for this analysis were HIV-positive residents in West Pokot accessing care at one of four semi-mobile sites (Kabichbich, Chepareria, Kacheliba, and Sigor) or at the regional hospital in Kapenguria. We examined four outcome variables between the two groups: (1) retention in HIV treatment, (2) change in CD4 count, (3) adherence to ARVs, and (4) deaths. The patients who chose semi-mobile clinic care were less well educated, poorer, and sicker than those who chose to continue care in the regional hospital. There were no statistically significant differences between the groups in any of the four outcome measures. Although the population of patients attending semi-mobile clinics was on average poorer and sicker than those attending the hospital, their outcomes were similar. Care at the semi-mobile clinics did not result in significantly different outcomes from care in the district hospital. This program showed that semi-mobile clinics are a viable alternative to hospital care for very ill, isolated populations, but further measures must be taken to improve retention and adherence in these settings.

Bilateral medial medullary infarction: a systematic review.

PubMed

Pongmoragot, Jitphapa; Parthasarathy, Sujatha; Selchen, Daniel; Saposnik, Gustavo

2013-08-01

Bilateral infarction of the medial medulla (MMI) is rare. Limited information is available on clinical characteristics, etiology, and prognosis. High-resolution neuroimaging has a major role in elucidating the underlying stroke mechanism. The aim of this systematic review was to analyze the clinical presentations, stroke mechanisms, and outcomes in patients with bilateral MMI. We performed a systematic review of the literature from 1992-2011 that reported on clinical presentations, stroke mechanism, and/or outcomes in patients with magnetic resonance imaging-proven bilateral MMI. Medline, EMBASE, and Web of Science Scholars Portal were searched without language restriction. Two reviewers independently assessed identified studies to determine eligibility, validity, and quality. The primary outcome was inpatient mortality; a secondary outcome was case fatality at 12 months. We identified 138 articles from Medline, EMBASE, and Scholars Portal including the MeSH terms "brainstem infarction," "medulla," and "bilateral." Twenty-nine articles met our inclusion criteria, including a total of 38 cases with bilateral MMI, and included in our study. These 38 patients had a mean age of 62.2 years and were predominately male (74.2%). The most common clinical presentations were motor weakness in 78.4%, dysarthria in 48.6%, and hypoglossal palsy in 40.5%. The most common vascular pathology was vertebral artery atherosclerosis, in 38.5%. The clinical outcome was poor (mortality, 23.8%; dependency, 61.9%). Bilateral medial medullary infarction is a rare stroke syndrome. Clinical presentations were mostly rostral medullary lesions. Large-artery atherosclerosis and branch disease were the most common stroke mechanisms. The clinical outcome was usually poor. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Patient outcomes using Wii-enhanced rehabilitation after total knee replacement - the TKR-POWER study.

PubMed

Negus, J J; Cawthorne, D P; Chen, J S; Scholes, C J; Parker, D A; March, L M

2015-01-01

Home-based rehabilitation following total knee replacement surgery can be as effective as clinic-based or in-patient rehabilitation. The use of the Nintendo Wii has been postulated as a novel rehabilitation tool that adds an additional focus on balance and proprioception into the recovery protocol. The aim of the proposed clinical trial is to investigate the effectiveness of this novel rehabilitation tool, used at home for three months after total knee replacement surgery and to assess any lasting improvements in functional outcome at one year. This will be a randomised controlled trial of 128 patients undergoing primary total knee replacement. The participants will be recruited preoperatively from three surgeons at a single centre. There will be no change to the usual care provided until 6 weeks after the operation. Then participants will be randomised to either the Wii-Fit group or usual rehabilitative care group. Outcomes will be assessed preoperatively, a 6-week post surgery baseline and then at 18 weeks, 6 months and 1 year. The primary outcome is the change in self-reported WOMAC total score from week 6 to 18 weeks. Secondary outcomes include objective measures of strength, function and satisfaction scores. The results of this clinical trial will be directly relevant for implementation into clinical practice. If beneficial, this affordable technology could be used by many patients to rehabilitate at home. Not only could it optimize the outcomes from their total knee replacement surgery but decrease the need for clinic-based or outpatient therapy for the majority. (ACTRN12611000291987). Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical and radiological outcomes of surgical treatment for symptomatic arachnoid cysts in adults.

PubMed

Wang, Yongqian; Wang, Fei; Yu, Mingkun; Wang, Weiping

2015-09-01

We retrospectively analyzed 63 patients (31 males and 32 females) with arachnoid cysts managed over a 15 year period at our institution. Surgical indications and modalities for the treatment of intracranial arachnoid cysts are controversial, although endoscopic fenestration is often recommended as a standard procedure. In our cohort, clinical postoperative results and radiological assessments based on the presenting symptoms, cyst location, cyst volume and surgical modalities were recorded. The most common symptoms included headaches (66.7%), dizziness (46%) and seizures (36.5%). Cyst wall excision with microsurgical craniotomy was carried out in 28 patients (44.4%), cyst fenestration in 16 (25.4%), cystoperitoneal or ventriculoperitoneal shunting in 15 (23.8%) and endoscopic fenestration in four patients (6.3%). A satisfactory clinical outcome was achieved in 51 patients (80.9%) and cyst reduction was achieved in 49 (77.8%), at the last follow-up. Clinical improvement correlated significantly with volume reduction in patients with suprasellar and infratentorial cysts (r=0.495; p=0.022) while a similar result was not found after surgery in patients with frontal and temporal cysts. Surgical complications were not correlated with surgical modalities, occurring in only seven patients (11.1%). The various surgical modalities did not influence outcomes. Patients with nonspecific symptoms such as headache may obtain favourable outcomes from surgical treatment with no severe complications, although, intracranial hypertension and neurological deficits are more definite surgical indications for arachnoid cysts. Copyright © 2015 Elsevier Ltd. All rights reserved.

GRP78 promoter polymorphism rs391957 as potential predictor for clinical outcome in gastric and colorectal cancer patients

PubMed Central

Winder, T.; Bohanes, P.; Zhang, W.; Yang, D.; Power, D. G.; Ning, Y.; Gerger, A.; Wilson, P. M.; Tang, L. H.; Shah, M.; Lee, A. S.; Lenz, H.-J.

2011-01-01

Background: Recently, the analysis of gastric and colorectal tumor specimens determined that 78-kiloDalton glucose-regulated protein (GRP78), an endoplasmic reticulum chaperone, up-regulation serves as an efficient mechanism protecting cells against apoptosis and can confer drug resistance. We tested whether functional polymorphisms within the GRP78 gene are related to clinical outcome in gastric and colorectal cancer (CRC) patients. Patients and methods: Blood samples of 234 stage II/III CRC patients at the University of Southern California (USC) and formalin-fixed paraffin-embedded tissues of 137 patients with localized gastric adenocarcinoma (GA) at USC and Memorial Sloan-Kettering Cancer Centers were obtained. GRP78 polymorphisms analyzed on germline DNA were correlated with clinical outcome using univariate and multivariate analyses. Results: GA patients with the combined GRP78 rs391957 C/T and T/T genotype were at higher risk for tumor recurrence and death [hazard ratio (HR) 2.61; P < 0.001 and HR 3.17; P < 0.001, respectively], than those with C/C. These findings were subsequently tested in a CRC cohort where patients with the homozygous T/T genotype were at highest risk for tumor recurrence (HR 2.61; P = 0.015). The results remained significant after adjusting for clinicopathologic determinants. Conclusion: These data provide the first evidence that the GRP78 rs391957 polymorphism can predict clinical outcome in localized GA and locally advanced CRC patients. PMID:21382870

Collaborative depression care among Latino patients in diabetes disease management, Los Angeles, 2011-2013.

PubMed

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen; Wu, Shinyi

2014-08-28

The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes-Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system.

Collaborative Depression Care Among Latino Patients in Diabetes Disease Management, Los Angeles, 2011–2013

PubMed Central

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen

2014-01-01

Introduction The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes–Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. Methods A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Results Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Conclusion Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system. PMID:25167093

Collaborative learning using nursing student dyads in the clinical setting.

PubMed

Austria, Mary Jean; Baraki, Katie; Doig, Alexa K

2013-05-04

Formal pairing of student nurses to work collaboratively on one patient assignment is a strategy for improving the quality and efficiency of clinical instruction while better utilizing the limited resources at clinical agencies. The aim of this qualitative study was to explore the student nurse and patient experiences of collaborative learning when peer dyads are used in clinical nursing education. Interviews were conducted with 11 students and 9 patients. Students described the process of collaborative learning as information sharing, cross-checking when making clinical decisions, and group processing when assessing the outcomes of nursing interventions. Positive outcomes reported by students and patients included reduced student anxiety, increased confidence and task efficiency. Students' primary concern was reduced opportunity to perform hands-on skills which had to be negotiated within each dyad. Meeting the present and future challenges of educating nurses will require innovative models of clinical instruction such as collaborative learning using student peer dyads.

Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.

Impact of delirium on clinical outcome in critically ill patients: a meta-analysis.

PubMed

Zhang, Zhongheng; Pan, Lifei; Ni, Hongying

2013-01-01

Delirium is prevalent in the intensive care unit (ICU) and has been associated with negative clinical outcomes. However, a quantitative and systematic assessment of published studies has not been conducted. Meta-analysis of clinical observational studies was performed to investigate the association between delirium and clinical outcomes. Relevant studies were identified by investigators from databases including Medline, Embase, OVID and EBSCO from inception to May 2012. Studies that reported the association of delirium with clinical outcomes in critical care setting were included. Data were extracted independently by reviewers and summary effects were obtained using random effects model. Of the 16 studies included, 14 studies involving 5891 patients reported data on mortality, and delirious patients had higher mortality rate than non-delirious patients (odds ratio [OR]: 3.22; 95% confidence interval [CI]: 2.30-4.52). Delirious patients had higher rate of complications (OR: 6.5; 95% CI: 2.7-15.6), and were more likely to be discharged to skilled placement (OR: 2.59; 95% CI: 1.59-4.21). Furthermore, patients with delirium had longer length of stay in both ICU (weighted mean difference [WMD]: 7.32 days; 95% CI: 4.63-10.01) and hospital (WMD: 6.53 days; 95% CI: 3.03-10.03), and they spent more time on mechanical ventilation (WMD: 7.22 days; 95% CI: 5.15-9.29). Delirium in critically ill patients is associated with higher mortality rate, more complications, longer duration of mechanical ventilation, and longer length of stay in ICU and hospital. Copyright © 2013 Elsevier Inc. All rights reserved.

Patterns and Predictors of Change in Outcome Measures in Clinical Trials in Scleroderma An Individual Patient Meta-Analysis of 629 Subjects with Diffuse Scleroderma

PubMed Central

Merkel, PA; Silliman, NP; Clements, PJ; Denton, CP; Furst, DE; Mayes, MD; Pope, JE; Polisson, RP; Streisand, JB; Seibold, JR

2012-01-01

Purpose To examine the range and responsiveness to change of clinical outcome measures and study the predictors of clinical response for patients with diffuse cutaneous systemic sclerosis (dcSSc) in the context of clinical trials. Methods Data from 629 patients with dcSSc who participated in 7 multicenter clinical therapeutic trials were combined. Trials used common outcome measures: modified Rodnan skin score (MRSS), the Health Assessment Questionnaire (HAQ), Patient Global Assessment (PtGA), pulmonary function tests (FVC, DLCO), and oral aperture (OAp). Results The combined database included 629 patients: 82% women; mean age = 46.5 ± 11.8 years (range 15–82) with disease duration (months): mean: 19.4 ± 15.9, median = 47.0, range 1.0–144.0. Outcomes tended to improve during trials for patients with more severe disease at study entry and worsen for patients with less severe disease at entry. There were weak negative correlations between baseline values and change over 6 months for MRSS (r = −0.17; p<.0001), HAQ (r = −0.15; p= .002), and PtGA (r = −0.44; p<.0001). Baseline FVC and OAp did not predict change in 6 months. Baseline DLCO values were positively correlated with change in DLCO at 6 months (r= −0.32; p<.0001). Disease duration was mildly negatively predictive of change in MRSS at 6 months (r = −0.27; p<.0001) and substantial bidirectional variation in change in MRSS and HAQ was seen over the spectrum of disease duration. 63% of patients with “early” disease (<18 months) had a decline in MRSS and 37% had an increase in MRSS. 81% of patients with late disease (≥ 18 months) had a decline in MRSS and 19% had an increase in MRSS. 53% of patients with early disease had a decline in HAQ and 47% had an increase in HAQ. 51% of patients with late disease had a decline in HAQ and 49% had an increase in HAQ. Multivariate mixed models did not demonstrate that any baseline variables were strongly predictive of subsequent outcome. These results did not differ when comparing trials of early vs. late disease or trial “completers” vs. “non-completers”. Conclusions Among patients with dcSSc enrolled in clinical trials, standard outcome measures tend to improve for patients with more severe disease at study entry and worsen for patients with less severe disease at entry. Overall, MRSS scores improve during observation periods while HAQ and lung function are mostly static, although there are wide variations in individual changes in these measures. None of these variables, including disease duration, reliably identify groups of subjects whose MRSS will predictably increase or decrease in the course of a clinical trial. These findings have important implications for clinical trial design in scleroderma. PMID:22328195

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

PubMed

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.

Predictors of Long-Term Outcomes of Percutaneous Mitral Valvuloplasty in Patients with Rheumatic Mitral Stenosis.

PubMed

Kim, Darae; Chung, Hyemoon; Nam, Jong Ho; Park, Dong Hyuk; Shim, Chi Young; Kim, Jung Sun; Chang, Hyuk Jae; Hong, Geu Ru; Ha, Jong Won

2018-03-01

We determined factors associated with long-term outcomes of patients who underwent successful percutaneous mitral balloon valvuloplasty (PMV). Between August 1980 and May 2013, 1187 patients underwent PMV at Severance Hospital, Seoul, Korea. A total of 742 patients who underwent regular clinic visits for more than 10 years were retrospectively analyzed. The endpoints consisted of repeated PMV, mitral valve (MV) surgery, and cardiovascular-related death. The optimal result, defined as a post-PMV mitral valve area (MVA) >1.5 cm² and mitral regurgitation ≤Grade II, was obtained in 631 (85%) patients. Over a mean follow up duration of 214±50 months, 54 (7.3%) patients underwent repeat PMV, 4 (0.5%) underwent trido-PMV, and 248 (33.4%) underwent MV surgery. A total of 33 patients (4.4%) had stroke, and 35 (4.7%) patients died from cardiovascular-related reasons. In a multivariate analysis, echocardiographic score [p=0.003, hazard ratio=1.56, 95% confidence interval (CI): 1.01-2.41] and post-MVA cut-off (p<0.001, relative risk=0.39, 95% CI: 0.37-0.69) were the only significant predictors of long-term clinical outcomes after adjusting for confounding variables. A post-MVA cut-off value of 1.76 cm² showed satisfactory predictive power for poor long-term clinical outcomes. In this long-term follow up study (up to 20 years), an echocardiographic score >8 and post-MVA ≤1.76 cm² were independent predictors of poor long-term clinical outcomes after PMV, including MV reintervention, stroke, and cardiovascular-related death. © Copyright: Yonsei University College of Medicine 2018

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

PubMed

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 <20 degrees is a constant phenomenon in 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 idiopathic SMAS.

Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review.

PubMed

Mann, Bikaramjit S; Barnieh, Lianne; Tang, Karen; Campbell, David J T; Clement, Fiona; Hemmelgarn, Brenda; Tonelli, Marcello; Lorenzetti, Diane; Manns, Braden J

2014-01-01

Prescription drugs are used in people with hypertension, diabetes, and cardiovascular disease to manage their illness. Patient cost sharing strategies such as copayments and deductibles are often employed to lower expenditures for prescription drug insurance plans, but the impact on health outcomes in these patients is unclear. To determine the association between drug insurance and patient cost sharing strategies on medication adherence, clinical and economic outcomes in those with chronic diseases (defined herein as diabetes, hypertension, hypercholesterolemia, coronary artery disease, and cerebrovascular disease). Studies were included if they examined various cost sharing strategies including copayments, coinsurance, fixed copayments, deductibles and maximum out-of-pocket expenditures. Value-based insurance design and reference based pricing studies were excluded. Two reviewers independently identified original intervention studies (randomized controlled trials, interrupted time series, and controlled before-after designs). MEDLINE, EMBASE, Cochrane Library, CINAHL, and relevant reference lists were searched until March 2013. Two reviewers independently assessed studies for inclusion, quality, and extracted data. Eleven studies, assessing the impact of seven policy changes, were included: 2 separate reports of one randomized controlled trial, 4 interrupted time series, and 5 controlled before-after studies. Outcomes included medication adherence, clinical events (myocardial infarction, stroke, death), quality of life, healthcare utilization, or cost. The heterogeneity among the studies precluded meta-analysis. Few studies reported the impact of cost sharing strategies on mortality, clinical and economic outcomes. The association between patient copayments and medication adherence varied across studies, ranging from no difference to significantly lower adherence, depending on the amount of the copayment. Lowering cost sharing in patients with chronic diseases may improve adherence, but the impact on clinical and economic outcomes is uncertain.

The evolving field of prognostication and risk stratification in MDS: Recent developments and future directions.

PubMed

Lee, Eun-Ju; Podoltsev, Nikolai; Gore, Steven D; Zeidan, Amer M

2016-01-01

The clinical course of patients with myelodysplastic syndromes (MDS) is characterized by wide variability reflecting the underlying genetic and biological heterogeneity of the disease. Accurate prediction of outcomes for individual patients is an integral part of the evidence-based risk/benefit calculations that are necessary for tailoring the aggressiveness of therapeutic interventions. While several prognostication tools have been developed and validated for risk stratification, each of these systems has limitations. The recent progress in genomic sequencing techniques has led to discoveries of recurrent molecular mutations in MDS patients with independent impact on relevant clinical outcomes. Reliable assays of these mutations have already entered the clinic and efforts are currently ongoing to formally incorporate mutational analysis into the existing clinicopathologic risk stratification tools. Additionally, mutational analysis holds promise for going beyond prognostication to therapeutic selection and individualized treatment-specific prediction of outcomes; abilities that would revolutionize MDS patient care. Despite these exciting developments, the best way of incorporating molecular testing for use in prognostication and prediction of outcomes in clinical practice remains undefined and further research is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

CYP2C19 genetic variation and individualized clopidogrel prescription in a cardiology clinic.

PubMed

Mirabbasi, Seyed Abbas; Khalighi, Koroush; Wu, Yin; Walker, Stanley; Khalighi, Bahar; Fan, Wuqiang; Kodali, Archana; Cheng, Gang

2017-07-01

Background : Clopidogrel (Plavix) is an antiplatelet medication that is routinely used in patients with cardiovascular disease. Cytochrome P2C19 enzymes play a major role in its metabolism, which determines its varied therapeutic level and its effectiveness. Objectives : To customize clopidogrel therapy and evaluate its efficacy by using CYP2C19 genotypic and phenotypic information to improve clinical outcomes in patients. Methods : A total of 465 patients with underlying cardiovascular disease were selected from our out-patient cardiology clinic. DNA sequences of CYP2C19 were analyzed in 465 patients. Results : Of 465 patients, 183 were wild-type homozygous (*1/*1) and 18.8% gain-of function and 19.8% loss-of-function alleles in our patient population The following changes were made: 1) Switching to prasugrel in patients whose genotype noted them to be "Slow metabolizers. This medication adjustment improved clinical outcomes in this patient group. 2) Discontinuing or lowering clopidogrel doses in patients whose genotypes noted them to be "Fast or ultra-fast metabolizes" to decrease bleeding risk. For those who were not on clopidogrel but carried abnormal allele(s), "clopidogrel caution" was documented. These individuals were followed up for 3 years and there has not been any cardiac clinical symptoms, cardiac death or excessive bleeding reported. Conclusions : Given the varied effectiveness of clopidogrel due to its metabolism by CYP2C19 enzyme, and the relatively high frequency of both gain-of-function (18.8%) and loss-of-function (19.8%) alleles in our patient population, we believe that genotyping CYP2C19 is clinically important in order to improve patient outcomes and minimize patient risk.

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

PubMed

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.

The usefulness of chief complaints to predict severity, ventilator dependence, treatment option, and short-term outcome of patients with Guillain-Barré syndrome: a retrospective study.

PubMed

Wang, Ying; Shang, Pei; Xin, Meiying; Bai, Jing; Zhou, Chunkui; Zhang, Hong-Liang

2017-11-21

It remains an urgent need for early recognition of disease severity, treatment option and outcome of Guillain-Barré syndrome (GBS). The chief complaint may be quickly obtained in clinic and is one of the candidates for early predictors. However, studies on the chief complaint are still lacking in GBS. The aim of the study is to describe the components of chief complaints of GBS patients, and to explore association between chief complaints and disease severity/treatment option/outcome of GBS, so as to aid the early prediction of the disease course and to assist the clinicians to prescribe an optimal early treatment. A total of 523 GBS patients admitted to the First Hospital of Jilin University from 2003 to 2013 were enrolled for retrospective analysis. The data of chief complaints, clinical manifestations, and treatment options, etc. were collected. The clinical severity was evaluated by the Medical Research Council sum score and the Hughes Functional Grading Scale. The prognosis at 6 month after discharge was described by modified Erasmus GBS outcome score. The clinic GBS severity evaluation scale (CGSES), a newly established model in our study, was used to explore the role of chief complaints to predict intravenous immunoglobulin (IVIg). The major components of the chief complaints of GBS patients were weakness, numbness, pain, cranial nerve involvement, dyspnea, ataxia and autonomic dysfunction. Chief complaint of weakness was a predictor of severe disease course and poor short-term outcome, while chief complaint of numbness and cranial nerve involvement were promising predictors. Cranial nerve involvement was the predictor of ventilator dependence. The percentages of 366 GBS patients, who need IVIg treatment at nadir with CGSES ranging from 1 to 4, were 50.00, 67.34, 80.61, and 90.67%, respectively. Chief complaints are clinic predictors of disease severity, ventilator dependence and short-term outcome. IVIg treatment during hospitalisation could be predicted in clinic using CGSES score.

The Factors Associated with Outcomes in Surgically Managed Ruptured Cerebral Aneurysm.

PubMed

Chee, Lai Chuang; Siregar, Johari Adnan; Ghani, Abdul Rahman Izani; Idris, Zamzuri; Rahman Mohd, Noor Azman A

2018-02-01

Ruptured cerebral aneurysm is a life-threatening condition that requires urgent medical attention. In Malaysia, a prospective study by the Umum Sarawak Hospital, Neurosurgical Center, in the year 2000-2002 revealed an average of two cases of intracranial aneurysms per month with an operative mortality of 20% and management mortality of 25%. Failure to diagnose, delay in admission to a neurosurgical centre, and lack of facilities could have led to the poor surgical outcome in these patients. The purpose of this study is to identify the factors that significantly predict the outcome of patients undergoing a surgical clipping of ruptured aneurysm in the local population. A single center retrospective study with a review of medical records was performed involving 105 patients, who were surgically treated for ruptured intracranial aneurysms in the Sultanah Aminah Hospital, in Johor Bahru, from July 2011 to January 2016. Information collected was the patient demographic data, Glasgow Coma Scale (GCS) prior to surgery, World Federation of Neurosurgical Societies Scale (WFNS), subarachnoid hemorrhage (SAH) grading system, and timing between SAH ictus and surgery. A good clinical grade was defined as WFNS grade I-III, whereas, WFNS grades IV and V were considered to be poor grades. The outcomes at discharge and six months post surgery were assessed using the modified Rankin's Scale (mRS). The mRS scores of 0 to 2 were grouped into the "favourable" category and mRS scores of 3 to 6 were grouped into the "unfavourable" category. Only cases of proven ruptured aneurysmal SAH involving anterior circulation that underwent surgical clipping were included in the study. The data collected was analysed using the Statistical Package for Social Sciences (SPSS). Univariate and multivariate analyses were performed and a P -value of < 0.05 was considered to be statistically significant. A total of 105 patients were included. The group was comprised of 42.9% male and 57.1% female patients. The mean GCS of the patients subjected to surgical clipping was 13, with the majority falling into the good clinical grade (78.1%). The mean timing of the surgery after SAH was 5.3 days and this was further categorised into early (day one to day three, 45.3%), intermediate (day four to day ten, 56.2%), and late (after day ten, 9.5%). The total favourable outcome achieved at discharge was 59.0% as compared to 41.0% of the unfavourable outcome, with an overall mortality rate of 10.5%. At the six-month post surgery review ( n = 94), the patients with a favourable outcome constituted 71.3% as compared to 28.7% with an unfavourable outcome. The mortality, six months post surgery was 3.2%. On a univariate analysis of early surgical clipping, patients with a better GCS and good clinical grade had a significantly better outcome at discharge. Based on the univariate study, six months post surgery, the timing of the surgery and the clinical grade remained significant predictors of the outcome. On the basis of the multivariate analysis, male patients of younger age, with a good clinical grade, were associated with favourable outcomes, both at discharge and six months post surgery. In this study, we concluded that younger male patients with a good clinical grade were associated with a favourable outcome both at discharge and six months post surgery. We did not find the timing of the surgery, size of the aneurysm or duration of surgery to be associated with a patient's surgical outcome. Increasing age was not associated with the surgical outcome in a longer term of patient's follow up.

Anticoagulant therapy and outcomes in patients with prior or acute heart failure and acute coronary syndromes: Insights from the APixaban for PRevention of Acute ISchemic Events 2 trial.

PubMed

Cornel, Jan H; Lopes, Renato D; James, Stefan; Stevens, Susanna R; Neely, Megan L; Liaw, Danny; Miller, Julie; Mohan, Puneet; Amerena, John; Raev, Dimitar; Huo, Yong; Urina-Triana, Miguel; Gallegos Cazorla, Alex; Vinereanu, Dragos; Fridrich, Viliam; Harrington, Robert A; Wallentin, Lars; Alexander, John H

2015-04-01

Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome (ACS) and either a history of or acute heart failure (HF) are largely unknown. We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations. High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily. Median follow-up was 8 (4-12) months. The primary outcome was cardiovascular death, myocardial infarction, or stroke. The main safety outcome was thrombolysis in myocardial infarction major bleeding. Heart failure was reported in 2,995 patients (41%), either as prior HF (2,076 [28%]) or acute HF (2,028 [27%]). Patients with HF had a very high baseline risk and were more often managed medically. Heart failure was associated with a higher rate of the primary outcome (prior HF: adjusted hazard ratio [HR] 1.73, 95% CI 1.42-2.10, P < .0001, acute HF: adjusted HR 1.65, 95% CI 1.35-2.01, P < .0001) and cardiovascular death (prior HF: HR 2.54, 95% CI 1.82-3.54, acute HF: adjusted HR 2.52, 95% CI 1.82-3.50). Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding (prior HF: adjusted HR 1.22, 95% CI 0.65-2.27, P = .54, acute HF: adjusted HR 1.78, 95% CI 1.03-3.08, P = .04). There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF; however, among patients with acute HF, there were numerically fewer events with apixaban than placebo (14.8 vs 19.3, HR 0.76, 95% CI 0.57-1.01, interaction P = .13), a trend that was not seen in patients with prior HF or no HF. In high-risk patients post-ACS, both prior and acute HFs are associated with an increased risk of subsequent clinical events. Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF; however, there was a tendency toward fewer clinical events with apixaban in patients with acute HF. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving patient outlook in rheumatoid arthritis: experience with abatacept.

PubMed

Coughlin, Mary

2008-10-01

To examine the importance of improving patient outlook in rheumatoid arthritis (RA) and to discuss the role of the nurse practitioner (NP) who, through the assessment of patient-reported outcomes and in acting as an advocate for the patient with the wider healthcare team, has a crucial part to play in managing the overall well-being of the patient. This article will draw on the clinical experience to date with abatacept, a first-in-class therapy that has been approved for the treatment of RA in patients with an inadequate response to either traditional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, or biological DMARDs, such as tumor necrosis factor-alpha antagonists. A comprehensive literature search was performed using the National Library of Medicine (MEDLINE), EMBASE, and BIOSIS databases (restricted to articles posted between January 2000 and February 2007) with the search terms CTLA-4Ig, abatacept, and primary clinical trial publications in patients with RA. The clinical data are summarized in this review along with safety data presented in the prescribing information. Recent changes in the approach to RA treatment, particularly the advent of biological therapies, have impacted the role of the NP. The role of the NP is integral to the management of RA and in maximizing patient outcomes, through educating patients to make informed choices regarding their treatment, ensuring the safe administration of therapies and monitoring response to therapy, and in acting as an advocate for the patient within the wider healthcare team. The use of more patient-centered measures of response are gaining increasing importance both in clinical trials and in clinical practice, and as such the NP has an important role in ensuring that both the physical and the psychological needs of patients are met. Clinical trials to date have shown that abatacept provides significant and clinically meaningful improvements in patient-reported outcomes, as well as demonstrating significant clinical benefits and a consistent safety profile, thus representing a valuable treatment option within the RA treatment armamentarium.

Blood DNA methylation biomarkers predict clinical reactivity in food-sensitized infants.

PubMed

Martino, David; Dang, Thanh; Sexton-Oates, Alexandra; Prescott, Susan; Tang, Mimi L K; Dharmage, Shyamali; Gurrin, Lyle; Koplin, Jennifer; Ponsonby, Anne-Louise; Allen, Katrina J; Saffery, Richard

2015-05-01

The diagnosis of food allergy (FA) can be challenging because approximately half of food-sensitized patients are asymptomatic. Current diagnostic tests are excellent makers of sensitization but poor predictors of clinical reactivity. Thus oral food challenges (OFCs) are required to determine a patient's risk of reactivity. We sought to discover genomic biomarkers of clinical FA with utility for predicting food challenge outcomes. Genome-wide DNA methylation (DNAm) profiling was performed on blood mononuclear cells from volunteers who had undergone objective OFCs, concurrent skin prick tests, and specific IgE tests. Fifty-eight food-sensitized patients (aged 11-15 months) were assessed, half of whom were clinically reactive. Thirteen nonallergic control subjects were also assessed. Reproducibility was assessed in an additional 48 samples by using methylation data from an independent population of patients with clinical FA. Using a supervised learning approach, we discovered a DNAm signature of 96 CpG sites that predict clinical outcomes. Diagnostic scores were derived from these 96 methylation sites, and cutoffs were determined in a sensitivity analysis. Methylation biomarkers outperformed allergen-specific IgE and skin prick tests for predicting OFC outcomes. FA status was correctly predicted in the replication cohort with an accuracy of 79.2%. DNAm biomarkers with clinical utility for predicting food challenge outcomes are readily detectable in blood. The development of this technology in detailed follow-up studies will yield highly innovative diagnostic assays. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Korean guidelines for the diagnosis and management of dry eye: development and validation of clinical efficacy.

PubMed

Hyon, Joon Young; Kim, Hyo-Myung; Lee, Doh; Chung, Eui-Sang; Song, Jong-Suk; Choi, Chul Young; Lee, Jungbok

2014-06-01

To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 ± 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

The Effects of an 8-Week Stabilization Exercise Program on Lumbar Multifidus Muscle Thickness and Activation as Measured With Ultrasound Imaging in Patients With Low Back Pain: An Exploratory Study.

PubMed

Larivière, Christian; Gagnon, Dany H; Henry, Sharon M; Preuss, Richard; Dumas, Jean-Pierre

2018-05-01

Lumbar stabilization exercise programs (LSEP) produce positive effects on clinical outcomes, but the underlying mechanisms remain relatively unexplored. Psychological and neuromuscular mechanisms can be involved, such as a better activation of the lumbar multifidus, which represents one possibility. To determine the following: (1) the effect of an LSEP on lumbar multifidus muscle thickness and activation, as measured with rehabilitative ultrasound imaging (RUSI), in patients with low back pain (LBP); (2) the correlation between RUSI measures and any change in clinical outcomes following the LSEP; and (3) the reliability of RUSI measures in control subjects over 8 weeks. One-arm clinical trial with healthy subjects as a control group; reliability study. LSEP delivered in a clinical setting; outcomes measured in a laboratory setting. A total of 34 patients with nonacute LBP and 28 healthy control subjects. Outcomes were measured before and after an 8-week LSEP in patients with LBP, and at the same time interval (without treatment, to assess reliability) in control subjects. Pain numeric rating scale, Oswestry Disability Index (function), as well as RUSI measures for the lumbar multifidus (LM) muscles at 3 vertebral levels (L5-S1, L4-5, and L3-4) during rest (static) and dynamic contractions (percent thickness change). Patients did not show systematic changes in RUSI measures relative to controls, even though RUSI impairments were observed at baseline (dynamic measure at L5-S1) and even though patients had significant improvements in pain and disability. Correlational analyses with these clinical outcomes suggested that patients had reduced muscle thickness at baseline that was associated with a greater reduction in disability following LSEP; however, LM activation measured at baseline showed the opposite. Static RUSI measures showed excellent reliability at the L4-5 and L3-4 levels, whereas dynamic measures were not reliable. Patients showed less muscle activation than controls at baseline (L5-S1 level), but the LSEP did not normalize this impairment. The links between RUSI measures and the change in clinical outcomes during LSEP should be further explored. This clinical trial has been recorded in the International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ID: ISRCTN94152969). II. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Metabolomics-Based Discovery of Small Molecule Biomarkers in Serum Associated with Dengue Virus Infections and Disease Outcomes

PubMed Central

Voge, Natalia V.; Perera, Rushika; Mahapatra, Sebabrata; Gresh, Lionel; Balmaseda, Angel; Loroño-Pino, María A.; Hopf-Jannasch, Amber S.; Belisle, John T.; Harris, Eva; Blair, Carol D.; Beaty, Barry J.

2016-01-01

Background Epidemic dengue fever (DF) and dengue hemorrhagic fever/dengue shock syndrome (DHF/DSS) are overwhelming public health capacity for diagnosis and clinical care of dengue patients throughout the tropical and subtropical world. The ability to predict severe dengue disease outcomes (DHF/DSS) using acute phase clinical specimens would be of enormous value to physicians and health care workers for appropriate triaging of patients for clinical management. Advances in the field of metabolomics and analytic software provide new opportunities to identify host small molecule biomarkers (SMBs) in acute phase clinical specimens that differentiate dengue disease outcomes. Methodology/Principal Findings Exploratory metabolomic studies were conducted to characterize the serum metabolome of patients who experienced different dengue disease outcomes. Serum samples from dengue patients from Nicaragua and Mexico were retrospectively obtained, and hydrophilic interaction liquid chromatography (HILIC)-mass spectrometry (MS) identified small molecule metabolites that were associated with and statistically differentiated DHF/DSS, DF, and non-dengue (ND) diagnosis groups. In the Nicaraguan samples, 191 metabolites differentiated DF from ND outcomes and 83 differentiated DHF/DSS and DF outcomes. In the Mexican samples, 306 metabolites differentiated DF from ND and 37 differentiated DHF/DSS and DF outcomes. The structural identities of 13 metabolites were confirmed using tandem mass spectrometry (MS/MS). Metabolomic analysis of serum samples from patients diagnosed as DF who progressed to DHF/DSS identified 65 metabolites that predicted dengue disease outcomes. Differential perturbation of the serum metabolome was demonstrated following infection with different DENV serotypes and following primary and secondary DENV infections. Conclusions/Significance These results provide proof-of-concept that a metabolomics approach can be used to identify metabolites or SMBs in serum specimens that are associated with distinct DENV infections and disease outcomes. The differentiating metabolites also provide insights into metabolic pathways and pathogenic and immunologic mechanisms associated with dengue disease severity. PMID:26913918

Implementation and outcomes of an active defaulter tracing system for HIV, prevention of mother to child transmission of HIV (PMTCT), and TB patients in Kibera, Nairobi, Kenya.

PubMed

Thomson, Kerry A; Cheti, Erastus O; Reid, Tony

2011-06-01

Retention of patients in long term care and adherence to treatment regimens are a constant challenge for HIV, prevention of mother to child transmission of HIV (PMTCT), and TB programmes in sub-Saharan Africa. This study describes the implementation and outcomes of an active defaulter tracing system used to reduce loss to follow-up (LTFU) among HIV, PMTCT, TB, and HIV/TB co-infected patients receiving treatment at three Médecins Sans Frontières clinics in the informal settlement of Kibera, Nairobi, Kenya. Patients are routinely contacted by a social worker via telephone, in-person visit, or both very soon after they miss an appointment. Patient outcomes identified through 1066 tracing activities conducted between 1 April 2008 and 31 March 2009 included: 59.4% returned to the clinic, 9.0% unable to return to clinic, 6.3% died, 4.7% refused to return to clinic, 4.5% went to a different clinic, and 0.8% were hospitalized. Fifteen percent of patients identified for tracing could not be contacted. LTFU among all HIV patients decreased from 21.2% in 2006 to 11.5% in 2009. An active defaulter tracing system is feasible in a resource poor setting, solicits feedback from patients, retains a mobile population of patients in care, and reduces LTFU among HIV, PMTCT, and TB patients. Copyright © 2011 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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.

Association Between Nutritional Status, Inflammatory Condition, and Prognostic Indexes with Postoperative Complications and Clinical Outcome of Patients with Gastrointestinal Neoplasia.

PubMed

Costa, Milena Damasceno de Souza; Vieira de Melo, Camila Yandara Sousa; Amorim, Ana Carolina Ribeiro de; Cipriano Torres, Dilênia de Oliveira; Dos Santos, Ana Célia Oliveira

2016-10-01

The aim of this study is to describe and relate nutritional and inflammatory status and prognostic indexes with postoperative complications and clinical outcome of patients with gastrointestinal malignancies. Twenty-nine patients were evaluated; nutritional assessment was carried out by subjective and objective parameters; albumin, pre-albumin, C-reactive protein (CRP), and alpha-1-acid glycoprotein (AGP) were determined. To assess prognosis, the Glasgow scale, the Prognostic Inflammatory Nutritional Index (PINI), and CRP/albumin ratio were used; the clinical outcomes considered were hospital discharge and death. A high Subjective Global Assessment (SGA) score was associated with the occurrence of postoperative complications: 73% of the patients with postoperative complications had the highest SGA score, but only 6% of those without postoperative complications had the highest SGA score (P < 0.001). Greater occurrence of death was observed in patients with a high SGA score, low serum albumin, increased CRP, PINI > 1, and Glasgow score 2. There was a positive correlation between weight loss percentage with serum CRP levels (P = 0.002), CRP/albumin (P = 0.002), PINI (P = 0.002), and Glasgow score (P = 0.000). This study provides evidence that the assessment of the nutritional status and the use of prognostic indexes are good tools for predicting postoperative complications and clinical outcome in patients with gastrointestinal neoplasia.

Waist-hip ratio and 1-year clinical outcome in patients with non-ST-elevation myocardial infarctions.

PubMed

Lee, Hye Won; Hong, Taek Jong; Hong, Ju Young; Choi, Jong Hyun; Kim, Bo Won; Ahn, Jinhee; Park, Jin Sup; Oh, Jun-Hyok; Choi, Jung Hyun; Lee, Han Cheol; Cha, Kwang Soo

2016-08-01

Obesity is a well-known cardiovascular disease risk factor. We evaluated the relationship between the waist-hip ratio (WHR), as a surrogate marker of central obesity, and clinical outcomes in patients with non-ST-segment elevation myocardial infarctions (NSTEMIs) undergoing percutaneous coronary interventions (PCIs). Between 2008 and 2010, NSTEMI patients who underwent PCI and who had available anthropometric data were divided into three groups according to their WHR tertile range. Clinical outcomes in the groups were analyzed. Increasing incidences of hypertension and diabetes mellitus were associated with increasing WHR. As the WHR increased, a disintegration of patient metabolic patterns was documented in laboratory findings. There was no difference in the 1-year mortality rates between the three groups. However, increasing 1-year major adverse cardiovascular event rates were documented as the WHR increased (13, 14.7, and 19.4% in tertile groups 1-3, respectively; P=0.005). After adjusting for confounding variables, the highest tertile group was associated with increased 1-year mortality and major adverse cardiovascular event rates compared with the lowest tertile group. These differences arose from the female subgroup, suggesting that the magnitude of the central obesity effect might be greater in female than in male patients. Central obesity, represented by WHR, was associated with poor clinical outcomes in NSTEMI patients undergoing PCI, particularly among women.

Capsular Management in Hip Arthroscopy: An Anatomic, Biomechanical, and Technical Review

PubMed Central

Kuhns, Benjamin D.; Weber, Alexander E.; Levy, David M.; Bedi, Asheesh; Mather, Richard C.; Salata, Michael J.; Nho, Shane J.

2016-01-01

Hip arthroscopy has become an increasingly utilized surgical technique for the treatment of the young, active patients with hip pain. The clinical outcomes of hip arthroscopy in this patient population have been largely successful; however, there is increasing interest in the contribution of hip capsule in postoperative clinical and functional outcomes. The structure and function of the normal hip capsule will be reviewed. Capsular contributions to hip stability will be discussed in the setting of hip arthroscopy with an emphasis on diagnosis-based considerations. Lastly, clinical outcomes following hip arthroscopy will be discussed as they relate to capsular management. PMID:26973840

Long-term outcome of vertebral artery origin stenosis in patients with acute ischemic stroke

PubMed Central

2013-01-01

Background Vertebral artery origin (VAO) stenosis is occasionally observed in patients who have acute ischemic stroke. We investigated the long-term outcomes and clinical significance of VAO stenosis in patients with acute ischemic stroke. Methods We performed a prospective observational study using a single stroke center registry to investigate the risk of recurrent stroke and vascular outcomes in patients with acute ischemic stroke and VAO stenosis. To relate the clinical significance of VAO stenosis to the vascular territory of the index stroke, patients were classified into an asymptomatic VAO stenosis group and a symptomatic VAO stenosis group. Results Of the 774 patients who had acute ischemic stroke, 149 (19.3%) of them had more than 50% stenosis of the VAO. During 309 patient-years of follow-up (mean, 2.3 years), there were 7 ischemic strokes, 6 hemorrhagic strokes, and 2 unknown strokes. The annual event rates were 0.97% for posterior circulation ischemic stroke, 4.86% for all stroke, and 6.80% for the composite cardiovascular outcome. The annual event rate for ischemic stroke in the posterior circulation was significantly higher in patients who had symptomatic VAO stenosis than in patients who had asymptomatic stenosis (1.88% vs. 0%, p = 0.046). In a multivariate analysis, the hazard ratio, per one point increase of the Essen Stroke Risk Score (ESRS) for the composite cardiovascular outcome, was 1.46 (95% CI, 1.02-2.08, p = 0.036). Conclusions Long-term outcomes of more than 50% stenosis of the VAO in patients with acute ischemic stroke were generally favorable. Additionally, ESRS was a predictor for the composite cardiovascular outcome. Asymptomatic VAO stenosis may not be a specific risk factor for recurrent ischemic stroke in the posterior circulation. However, VAO stenosis may require more clinical attention as a potential source of recurrent stroke when VAO stenosis is observed in patients who have concurrent ischemic stroke in the posterior circulation. PMID:24215371

Clinical outcome and surgical strategies for late post-traumatic kyphosis after failed thoracolumbar fracture operation

PubMed Central

Li, Suyun; Li, Zhi; Hua, Wenbin; Wang, Kun; Li, Shuai; Zhang, Yunkun; Ye, Zhewei; Shao, Zengwu; Wu, Xinghuo; Yang, Cao

2017-01-01

Abstract Rationale: Thoracic-lumbar vertebral fracture is very common in clinic, and late post-traumatic kyphosis is the main cause closely related to the patients’ life quality, which has evocated extensive concern for the surgical treatment of the disease. This study aimed to analyze the clinical outcomes and surgical strategies for late post-traumatic kyphosis after failed thoracolumbar fracture operation. Patient concerns: All patients presented back pain with kyphotic apex vertebrae between T12 and L3. According to Frankel classification grading system, among them, 3 patients were classified as grade D, with the ability to live independently. Diagnoses: A systematic review of 12 case series of post-traumatic kyphosis after failed thoracolumbar fracture operation was involved. Interventions: Wedge osteotomy was performed as indicated—posterior closing osteotomy correction in 5 patients and anterior open-posterior close correction in 7 patients.Postoperatively, thoracolumbar x-rays were obtained to evaluate the correction of kyphotic deformity, visual analog scales (VAS) and Frankel grading system were used for access the clinical outcomes. Outcomes: All the patients were followed up, with the average period of 38.5 months (range 24–56 months). The Kyphotic Cobb angle was improved from preoperative (28.65 ± 11.41) to postoperative (1.14 ± 2.79), with the correction rate of 96.02%. There was 1 case of intraoperative dural tear, without complications such as death, neurological injury, and wound infection. According to Frankel grading system, no patient suffered deteriorated neurological symptoms after surgery, and 2 patients (2/3) experienced significant relief after surgery. The main VAS score of back pain was improved from preoperative (4.41 ± 1.08) to postoperative (1.5 ± 0.91) at final follow-up, with an improvement rate of 65.89%. Lessons: Surgical treatment of late post-traumatic kyphosis after failed thoracolumbar fracture operation can obtain good radiologic and clinical outcomes by kyphosis correction, decompression, and posterior stability. PMID:29245233

Clinical experience and two-year follow-up with a one-piece viscoelastic cervical total disc replacement.

PubMed

Chin, Kingsley Richard; Lubinski, Jacob Ryan; Zimmers, Kari Bracher; Sands, Barry Eugene; Pencle, Fabio

2017-12-01

The purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe. Thirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions. Thirty patients had the Freedom ® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male [20] and female [19] subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would "definitely" choose to have the same treatment for their neck/arm condition and another 11% responding that they would "probably" choose to have the same treatment. The FCD performs as expected in patients with single-level and two-level degenerative disc disease.

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

PubMed

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

2007-02-01

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

Impact of EML4-ALK Variant on Resistance Mechanisms and Clinical Outcomes in ALK-Positive Lung Cancer.

PubMed

Lin, Jessica J; Zhu, Viola W; Yoda, Satoshi; Yeap, Beow Y; Schrock, Alexa B; Dagogo-Jack, Ibiayi; Jessop, Nicholas A; Jiang, Ginger Y; Le, Long P; Gowen, Kyle; Stephens, Philip J; Ross, Jeffrey S; Ali, Siraj M; Miller, Vincent A; Johnson, Melissa L; Lovly, Christine M; Hata, Aaron N; Gainor, Justin F; Iafrate, Anthony J; Shaw, Alice T; Ou, Sai-Hong Ignatius

2018-04-20

Purpose Advanced anaplastic lymphoma kinase ( ALK) fusion-positive non-small-cell lung cancers (NSCLCs) are effectively treated with ALK tyrosine kinase inhibitors (TKIs). However, clinical outcomes in these patients vary, and the benefit of TKIs is limited as a result of acquired resistance. Emerging data suggest that the ALK fusion variant may affect clinical outcome, but the molecular basis for this association is unknown. Patients and Methods We identified 129 patients with ALK-positive NSCLC with known ALK variants. ALK resistance mutations and clinical outcomes on ALK TKIs were retrospectively evaluated according to ALK variant. A Foundation Medicine data set of 577 patients with ALK-positive NSCLC was also examined. Results The most frequent ALK variants were EML4-ALK variant 1 in 55 patients (43%) and variant 3 in 51 patients (40%). We analyzed 77 tumor biopsy specimens from patients with variants 1 and 3 who had progressed on an ALK TKI. ALK resistance mutations were significantly more common in variant 3 than in variant 1 (57% v 30%; P = .023). In particular, ALK G1202R was more common in variant 3 than in variant 1 (32% v 0%; P < .001). Analysis of the Foundation Medicine database revealed similar associations of variant 3 with ALK resistance mutation and with G1202R ( P = .010 and .015, respectively). Among patients treated with the third-generation ALK TKI lorlatinib, variant 3 was associated with a significantly longer progression-free survival than variant 1 (hazard ratio, 0.31; 95% CI, 0.12 to 0.79; P = .011). Conclusion Specific ALK variants may be associated with the development of ALK resistance mutations, particularly G1202R, and provide a molecular link between variant and clinical outcome. ALK variant thus represents a potentially important factor in the selection of next-generation ALK inhibitors.

Effect of Baseline Exercise Capacity on Outcomes in Patients With Stable Coronary Heart Disease (A Post Hoc Analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Trial)

PubMed Central

Padala, Santosh K.; Sidhu, Mandeep S.; Hartigan, Pamela M.; Maron, David J.; Teo, Koon K.; Spertus, John A.; John Mancini, G.B.; Sedlis, Steven P.; Chaitman, Bernard R.; Heller, Gary V.; Weintraub, William S.; Boden, William E.

2017-01-01

The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. Published by Elsevier Inc. (Am J Cardiol 2015;116:1509–1515) PMID:26410604

Quality of Anticoagulation Control in Preventing Adverse Events in Heart Failure Patients in Sinus Rhythm: A Warfarin Aspirin Reduced Cardiac Ejection Fraction Trial (WARCEF) Substudy

PubMed Central

Homma, Shunichi; Thompson, John L.P.; Qian, Min; Ye, Siqin; Di Tullio, Marco R.; Lip, Gregory Y.H.; Mann, Douglas L.; Sacco, Ralph L.; Levin, Bruce; Pullicino, Patrick M.; Freudenberger, Ronald S.; Teerlink, John R.; Graham, Susan; Mohr, J.P.; Labovitz, Arthur J.; Buchsbaum, Richard; Estol, Conrado J.; Lok, Dirk J.; Ponikowski, Piotr; Anker, Stefan D.

2015-01-01

Background The aim of this study is to examine the relationship between time in therapeutic range (TTR) and clinical outcomes in heart failure (HF) patients in sinus rhythm (SR) treated with warfarin. Methods and Results We used data from the Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Trial (WARCEF) to assess the relationship of TTR with the WARCEF primary outcome (ischemic stroke, intracerebral hemorrhage, or death); with death alone; ischemic stroke alone; major hemorrhage alone; and net clinical benefit (primary outcome and major hemorrhage combined). Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR, low TTR, and aspirin patients, with TTR being treated as a time-dependent covariate. 2,217 patients were included in the analyses, among whom 1,067 were randomized to warfarin and 1,150 were randomized to aspirin. The median (IQR) follow-up duration was 3.6 (2.0–5.0) years. Mean (±SD) age was 61±11.3 years, with 80% being men. The mean (±SD) TTR was 57% (±28.5%). Increasing TTR was significantly associated with reduction in primary outcome (adjusted p<0.001), death alone (adjusted p=0.001), and improved net clinical benefit (adjusted p<0.001). A similar trend was observed for the other two outcomes but significance was not reached (adjusted p=0.082 for ischemic stroke, adjusted p=0.109 for major hemorrhage). Conclusions In HF patients in SR, increasing TTR is associated with better outcome and improved net clinical benefit. Patients in whom good quality anticoagulation can be achieved may benefit from the use of anticoagulants. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00041938. PMID:25850425

Volume and functional outcome of intracerebral hemorrhage according to oral anticoagulant type

PubMed Central

Wilson, Duncan; Charidimou, Andreas; Shakeshaft, Clare; Ambler, Gareth; White, Mark; Cohen, Hannah; Yousry, Tarek; Al-Shahi Salman, Rustam; Lip, Gregory Y.H.; Brown, Martin M.; Jäger, Hans Rolf

2016-01-01

Objective: To compare intracerebral hemorrhage (ICH) volume and clinical outcome of non–vitamin K oral anticoagulants (NOAC)–associated ICH to warfarin-associated ICH. Methods: In this multicenter cross-sectional observational study of patients with anticoagulant-associated ICH, consecutive patients with NOAC-ICH were compared to those with warfarin-ICH selected from a population of 344 patients with anticoagulant-associated ICH. ICH volume was measured by an observer blinded to clinical details. Outcome measures were ICH volume and clinical outcome adjusted for confounding factors. Results: We compared 11 patients with NOAC-ICH to 52 patients with warfarin-ICH. The median ICH volume was 2.4 mL (interquartile range [IQR] 0.3–5.4 mL) for NOAC-ICH vs 8.9 mL (IQR 4.0–21.3 mL) for warfarin-ICH (p = 0.0028). In univariate linear regression, use of warfarin (difference in cube root volume 1.61; 95% confidence interval [CI] 0.69 to 2.53) and lobar ICH location (compared with nonlobar ICH; difference in cube root volume 1.52; 95% CI 2.20 to 0.85) were associated with larger ICH volumes. In multivariable linear regression adjusting for confounding factors (sex, hypertension, previous ischemic stroke, white matter disease burden, and premorbid modified Rankin Scale score [mRS]), warfarin use remained independently associated with larger ICH (cube root) volumes (coefficient 0.64; 95% CI 0.24 to 1.25; p = 0.042). Ordered logistic regression showed an increased odds of a worse clinical outcome (as measured by discharge mRS) in warfarin-ICH compared with NOAC-ICH: odds ratio 4.46 (95% CI 1.10 to 18.14; p = 0.037). Conclusions: In this small prospective observational study, patients with NOAC-associated ICH had smaller ICH volumes and better clinical outcomes compared with warfarin-associated ICH. PMID:26718576

Volume and functional outcome of intracerebral hemorrhage according to oral anticoagulant type.

PubMed

Wilson, Duncan; Charidimou, Andreas; Shakeshaft, Clare; Ambler, Gareth; White, Mark; Cohen, Hannah; Yousry, Tarek; Al-Shahi Salman, Rustam; Lip, Gregory Y H; Brown, Martin M; Jäger, Hans Rolf; Werring, David J

2016-01-26

To compare intracerebral hemorrhage (ICH) volume and clinical outcome of non-vitamin K oral anticoagulants (NOAC)-associated ICH to warfarin-associated ICH. In this multicenter cross-sectional observational study of patients with anticoagulant-associated ICH, consecutive patients with NOAC-ICH were compared to those with warfarin-ICH selected from a population of 344 patients with anticoagulant-associated ICH. ICH volume was measured by an observer blinded to clinical details. Outcome measures were ICH volume and clinical outcome adjusted for confounding factors. We compared 11 patients with NOAC-ICH to 52 patients with warfarin-ICH. The median ICH volume was 2.4 mL (interquartile range [IQR] 0.3-5.4 mL) for NOAC-ICH vs 8.9 mL (IQR 4.0-21.3 mL) for warfarin-ICH (p = 0.0028). In univariate linear regression, use of warfarin (difference in cube root volume 1.61; 95% confidence interval [CI] 0.69 to 2.53) and lobar ICH location (compared with nonlobar ICH; difference in cube root volume 1.52; 95% CI 2.20 to 0.85) were associated with larger ICH volumes. In multivariable linear regression adjusting for confounding factors (sex, hypertension, previous ischemic stroke, white matter disease burden, and premorbid modified Rankin Scale score [mRS]), warfarin use remained independently associated with larger ICH (cube root) volumes (coefficient 0.64; 95% CI 0.24 to 1.25; p = 0.042). Ordered logistic regression showed an increased odds of a worse clinical outcome (as measured by discharge mRS) in warfarin-ICH compared with NOAC-ICH: odds ratio 4.46 (95% CI 1.10 to 18.14; p = 0.037). In this small prospective observational study, patients with NOAC-associated ICH had smaller ICH volumes and better clinical outcomes compared with warfarin-associated ICH. © 2015 American Academy of Neurology.

Early antihypertensive treatment and clinical outcomes in acute ischemic stroke: subgroup analysis by baseline blood pressure.

PubMed

He, William J; Zhong, Chongke; Xu, Tan; Wang, Dali; Sun, Yingxian; Bu, Xiaoqing; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Zhang, Jintao; Geng, Deqin; Zhang, Jianhui; Li, Dong; Li, Yongqiu; Yuan, Xiaodong; Zhang, Yonghong; Kelly, Tanika N

2018-06-01

We studied the effect of early antihypertensive treatment on death, major disability, and vascular events among patients with acute ischemic stroke according to their baseline SBP. We randomly assigned 4071 acute ischemic stroke patients with SBP between 140 and less than 220 mmHg to receive antihypertensive treatment or to discontinue all antihypertensive medications during hospitalization. A composite primary outcome of death and major disability and secondary outcomes were compared between treatment and control stratified by baseline SBP levels of less than 160, 160-179, and at least 180 mmHg. At 24 h after randomization, differences in SBP reductions were 8.8, 8.6 and 7.8 mmHg between the antihypertensive treatment and control groups among patients with baseline SBP less than 160, 160-179, and at least 180 mmHg, respectively (P < 0.001 among subgroups). At day 14 or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups among subgroups. However, there was a significant interaction between antihypertensive treatment and baseline SBP subgroups on death (P = 0.02): odds ratio (95% CI) of 2.42 (0.74-7.89) in patients with baseline SBP less than 60 mmHg and 0.34 (0.11-1.09) in those with baseline SBP at least 180 mmHg. At the 3-month follow-up, the primary and secondary clinical outcomes were not significantly different between the treatment and control groups by baseline SBP levels. Early antihypertensive treatment had a neutral effect on clinical outcomes among acute ischemic stroke patients with various baseline SBP levels. Future clinical trials are warranted to test BP-lowering effects in acute ischemic stroke patients by baseline SBP levels. ClinicalTrials.gov Identifier: NCT01840072.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

PubMed

Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

2018-01-29

Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

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

PubMed

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.

Decompressive craniectomy in severe traumatic brain injury: prognostic factors and complications

PubMed Central

Grille, Pedro; Tommasino, Nicolas

2015-01-01

Objective To analyze the clinical characteristics, complications and factors associated with the prognosis of severe traumatic brain injury among patients who undergo a decompressive craniectomy. Methods Retrospective study of patients seen in an intensive care unit with severe traumatic brain injury in whom a decompressive craniectomy was performed between the years 2003 and 2012. Patients were followed until their discharge from the intensive care unit. Their clinical-tomographic characteristics, complications, and factors associated with prognosis (univariate and multivariate analysis) were analyzed. Results A total of 64 patients were studied. Primary and lateral decompressive craniectomies were performed for the majority of patients. A high incidence of complications was found (78% neurological and 52% nonneurological). A total of 42 patients (66%) presented poor outcomes, and 22 (34%) had good neurological outcomes. Of the patients who survived, 61% had good neurological outcomes. In the univariate analysis, the factors significantly associated with poor neurological outcome were postdecompressive craniectomy intracranial hypertension, greater severity and worse neurological state at admission. In the multivariate analysis, only postcraniectomy intracranial hypertension was significantly associated with a poor outcome. Conclusion This study involved a very severe and difficult to manage group of patients with high morbimortality. Intracranial hypertension was a main factor of poor outcome in this population. PMID:26340150

Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome.

PubMed

Bracey, A W; Radovancevic, R; Riggs, S A; Houston, S; Cozart, H; Vaughn, W K; Radovancevic, B; McAllister, H A; Cooley, D A

1999-10-01

There is controversy regarding the application of transfusion triggers in cardiac surgery. The goal of this study was to determine if lowering the hemoglobin threshold for red cell (RBC) transfusion to 8 g per dL after coronary artery bypass graft surgery would reduce blood use without adversely affecting patient outcome. Consecutive patients (n = 428) undergoing elective primary coronary artery bypass graft surgery were randomly assigned to two groups: study patients (n = 212) received RBC transfusions in the postoperative period if the Hb level was < 8 g per dL or if predetermined clinical conditions required RBC support, and control patients (n = 216) were treated according to individual physician's orders (hemoglobin levels < 9 g/dL as the institutional guideline). Multiple demographic, procedure-related, transfusion, laboratory, and outcome data were analyzed. Questionnaires were administered for patient self-assessment of fatigue and anemia. Preoperative and operative clinical characteristics, as well as the intraoperative transfusion rate, were similar for both groups. There was a significant difference between the postoperative RBC transfusion rates in study (0.9 +/- 1.5 RBC units) and control (1.4 +/- 1.8 RBC units) groups (p = 0.005). There was no difference in clinical outcome, including morbidity and mortality rates, in the two groups; group scores for self-assessment of fatigue and anemia were also similar. A lower Hb threshold of 8 g per dL does not adversely affect patient outcome. Moreover, RBC resources can be saved without increased risk to the patient.

Photodynamic therapy in the management of actinic keratosis: Retrospective evaluation of outcome.

PubMed

Jerjes, Waseem; Hamdoon, Zaid; Abdulkareem, Ali A; Hopper, Colin

2017-03-01

Photodynamic therapy (PDT) is a minimally invasive intervention used in the management of tissue disorders. In this retrospective study, a total of 62 patients with actinic keratosis (AKs) were treated with surface illumination PDT. Comparisons with the clinical features, rate of recurrence as well as malignant transformation and overall outcome were made. The medical records of 62 consecutive patients who presented with suspicious skin lesions and diagnosed with AKs were examined. These patients with 178 AKs lesions were treated with surface illumination methyl aminolevulinate-photodynamic therapy (MAL-PDT). The 16% strength cream (MAL) was applied topically 3h prior to tissue illumination. A single-channel 628nm diode laser was used for illumination and light was delivered at 100J/cm 2 per site. These patients were followed-up for a mean of 7.4 years. Eight recurrences were reported after the first round of MAL-PDT, and two recurrences after the second round. Malignant transformation to squamous cell carcinoma (SCC) was noted in 2 patients only. The 3-year outcome resulted in 60 patients with complete response (CR), and this was maintained at the final outcome (last clinic review). Assessment of lesional outcome vs. response showed that 175/178 treated lesions had complete response (CR) at 3-year follow-up, which increased to 176/178 lesions at the last clinic follow-up. MAL-PDT offers an effective treatment for AKs lesions with excellent cosmetic outcome. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-01-01

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

The effectiveness of holistic diabetic management between Siriraj Continuity of Care clinic and medical out-patient department.

PubMed

Chalermsri, Chalobol; Paisansudhi, Supalerg; Kantachuvesiri, Pitchaporn; Pramyothin, Pornpoj; Washirasaksiri, Chaiwat; Srivanichakorn, Weerachai; Nopmaneejumruslers, Cherdchai; Chouriyagune, Charoen; Pandejpong, Denla; Phisalprapa, Pochamana

2014-03-01

Diabetes mellitus is one of the most common diseases in the Thai population, and it is well known that diabetic complications could be prevented with appropriate management. Despite published guidelines, most Thai patients with diabetes do not achieve treatment goals. Siriraj Continuity of Care clinic (CC clinic) was recently established in order to provide training for medical students and internal medicine residents. It is possible that the training component in the CC clinic may contribute to better overall outcomes in type 2 diabetes mellitus (type 2 DM) patients when compared with usual care at the medical out-patient department (OPD). To compare the effectiveness of diabetic management in type 2 diabetes mellitus patients who attended the CC clinic and the medical OPD. Retrospective chart review was performed in type 2 diabetes mellitus patients who were treated at either clinic at Siriraj Hospital in 2007-2011. Baseline demographics, treatment strategies and outcomes, and participation in an appropriate health maintenance program were assessed in both groups. Seven hundred and fifty seven medical records were reviewed, including 383 patients in the CC clinic group and 374 in the OPD group. Mean HbA1c was significantly lower in the CC clinic group compared with the OPD group (7.3 +/- 0.9% and 7.8 +/- 1.3%, respectively, < 0.001). The number of patients who achieved goal HbA1c of less than 7% in CC clinic group was 123 (32.1%) compared with 91 (24.3%) in the OPD group (p = 0.039). More patients were screened for diabetic complications in the CC clinic group compared with the OPD group, including screening for diabetic neuropathy (57.4% vs. 2.1%, p < 0.001), diabetic retinopathy (56.7% vs. 36.6%, p < 0.001), and diabetic nephropathy (80.9% vs. 36.9%, p < 0.001). Patients in the CC clinic group had a higher rate of age-appropriate cancer screening than those in the OPD group (54.2% vs. 13.3%, p < 0.001 for breast cancer; 24.0% vs. 0.9%, p < 0.001 for cervical cancer; and 23.0% vs. 7.4%, p < 0.001 for colon cancer). Moreover, significantly more patients in the CC clinic group received recommended immunization (influenza, diphtheria tetanus and pneumococcal vaccine) compared with the control group (p < or = 0.001). Diabetic patients treated at the CC clinic had better clinical outcomes and healthcare maintenance compared with those who received usual care at the medical OPD. Continuity of care and integrated training component may have contributed to the improved outcomes.

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PubMed

van Tol, R R; Melenhorst, J; Dirksen, C D; Stassen, L P S; Breukink, S O

2017-07-01

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

Beyond the Storm: Comparison of Clinical Factors, Arrhythmogenic Substrate, and Catheter Ablation Outcomes in Structural Heart Disease Patients With versus Those Without a History of Ventricular Tachycardia Storm.

PubMed

Kumar, Saurabh; Fujii, Akira; Kapur, Sunil; Romero, Jorge; Mehta, Nishaki K; Tanigawa, Shinichi; Epstein, Laurence M; Koplan, Bruce A; Michaud, Gregory F; John, Roy M; Stevenson, William G; Tedrow, Usha B

2017-01-01

Catheter ablation can be lifesaving in ventricular tachycardia (VT) storm, but the underlying substrate in patients with storm is not well characterized. We sought to compare the clinical factors, substrate, and outcomes differences in patients with sustained monomorphic VT who present for catheter ablation with VT storm versus those with a nonstorm presentation. Consecutive ischemic (ICM; n = 554) or nonischemic cardiomyopathy patients (NICM; n = 369) with a storm versus nonstorm presentation were studied (ICM storm 186; NICM storm 101). In ICM, storm compared with nonstorm patients had significantly lower left ventricular (LV) ejection fraction (EF), greater number of antiarrhythmic drug (AAD) failures, slower VTs, greater number of scarred LV segments, higher incidence of anterior, septal, and apical endocardial LV scar (all P < 0.05). However, outcomes in follow-up were similar (12-month ventricular arrhythmia [VA]-free survival: 51% vs. 52%, P = 0.6; survival free of death/transplant 75% vs. 87%, P = 0.7). In addition to the above differences, NICM storm patients were also older; however, the extent and distribution of scar was similar except for a higher incidence of lateral endocardial scar in storm patients (P = 0.05). VA-free survival (36% vs. 47%, P = 0.004) and survival free of death/transplant, however, were worse in NICM storm than nonstorm patients (72% vs. 88%, P = 0.001). NICM storm patients had worse VA-free survival than ICM storm patients. There are differences in clinical factors and scar patterns in patients undergoing VT ablation who present with VT storm versus those with a nonstorm presentation. Clinical outcomes are worse in NICM storm patients. © 2016 Wiley Periodicals, Inc.