Idiopathic Pulmonary Fibrosis: Clinically Meaningful Primary Endpoints in Phase 3 Clinical Trials

PubMed Central

Collard, Harold R.; Anstrom, Kevin J.; Flaherty, Kevin R.; Fleming, Thomas R.; King, Talmadge E.; Martinez, Fernando J.; Brown, Kevin K.

2012-01-01

Definitive evidence of clinical efficacy in a Phase 3 trial is best shown by a beneficial impact on a clinically meaningful endpoint—that is, an endpoint that directly measures how a patient feels (symptoms), functions (the ability to perform activities in daily life), or survives. In idiopathic pulmonary fibrosis (IPF), we believe the endpoints that best meet these criteria are all-cause mortality and all-cause nonelective hospitalization. There are no validated measures of symptoms or broader constructs such as health status or funtional status in IPF. A surrogate endpoint is defined as an indirect measure that is intended to substitute for a clinically meaningful endpoint. Surrogate endpoints can be appropriate outcome measures if validated. However, validation requires substantial evidence that the effect of an intervention on a clinically meaningful endpoint is reliably predicted by the effect of an intervention on the surrogate endpoint. For patients with IPF, there are currently no validated surrogate endpoints. PMID:22505745

Physicians' perspective on the clinical meaningfulness of inflammatory bowel disease trial results: an International Organization for the Study of Inflammatory Bowel Disease (IOIBD) survey.

PubMed

Olivera, P; Sandborn, W J; Panés, J; Baumann, C; D'Haens, G; Vermeire, S; Danese, S; Peyrin-Biroulet, L

2018-03-01

Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated. To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results. We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials. Forty-six IOIBD members responded to the survey (52.3%). In biologic-naïve ulcerative colitis (UC) and Crohn's disease (CD) patients, most of the participants considered a 15% difference with placebo for clinical remission and endoscopic remission to be clinically relevant. In head-to-head trials, most of participants considerer a 10% difference between groups for clinical remission and endoscopic remission to be clinically relevant. Half of respondents considered 10% to be an adequate margin in non-inferiority trials. In bioequivalence studies, most of the participants considered adequate a ± 5% difference between a biosimilar and the originator for pharmacokinetic parameters, efficacy, safety and immunogenicity. Regarding safety, the difference between two drugs considered clinically relevant varied from 1% to 5%, depending on the type of adverse event. This is the first survey exploring how physicians perceive IBD trial results, providing an estimation of the magnitude of the difference between treatment arms that may directly influence clinical practice. © 2018 John Wiley & Sons Ltd.

Quality of Life and Toxicity From Passively Scattered and Spot-Scanning Proton Beam Therapy for Localized Prostate Cancer

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

Pugh, Thomas J.; Munsell, Mark F.; Choi, Seungtaek

Purpose: To report quality of life (QOL)/toxicity in men treated with proton beam therapy for localized prostate cancer and to compare outcomes between passively scattered proton therapy (PSPT) and spot-scanning proton therapy (SSPT). Methods and Materials: Men with localized prostate cancer enrolled on a prospective QOL protocol with a minimum of 2 years' follow-up were reviewed. Comparative groups were defined by technique (PSPT vs SSPT). Patients completed Expanded Prostate Cancer Index Composite questionnaires at baseline and every 3-6 months after proton beam therapy. Clinically meaningful differences in QOL were defined as ≥0.5 × baseline standard deviation. The cumulative incidence ofmore » modified Radiation Therapy Oncology Group grade ≥2 gastrointestinal (GI) or genitourinary (GU) toxicity and argon plasma coagulation were determined by the Kaplan-Meier method. Results: A total of 226 men received PSPT, and 65 received SSPT. Both PSPT and SSPT resulted in statistically significant changes in sexual, urinary, and bowel Expanded Prostate Cancer Index Composite summary scores. Only bowel summary, function, and bother resulted in clinically meaningful decrements beyond treatment completion. The decrement in bowel QOL persisted through 24-month follow-up. Cumulative grade ≥2 GU and GI toxicity at 24 months were 13.4% and 9.6%, respectively. There was 1 grade 3 GI toxicity (PSPT group) and no other grade ≥3 GI or GU toxicity. Argon plasma coagulation application was infrequent (PSPT 4.4% vs SSPT 1.5%; P=.21). No statistically significant differences were appreciated between PSPT and SSPT regarding toxicity or QOL. Conclusion: Both PSPT and SSPT confer low rates of grade ≥2 GI or GU toxicity, with preservation of meaningful sexual and urinary QOL at 24 months. A modest, yet clinically meaningful, decrement in bowel QOL was seen throughout follow-up. No toxicity or QOL differences between PSPT and SSPT were identified. Long-term comparative results in a larger patient cohort are warranted.« less

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.

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

PubMed

Berliner, Jonathan L; Brodke, Dane J; Chan, Vanessa; SooHoo, Nelson F; Bozic, Kevin J

2017-01-01

Despite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery. The purpose of this study was to determine if an association exists between preoperative PROM scores and patients' likelihood of experiencing a clinically meaningful change in function 1 year after TKA. A retrospective study design was used to evaluate preoperative and 1-year postoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) scores from 562 patients who underwent primary unilateral TKA. This cohort represented 75% of the 750 patients who underwent surgery during that time period; a total of 188 others (25%) either did not complete PROM scores at the designated times or were lost to follow-up. Minimum clinically important differences (MCIDs) were calculated for each PROM using a distribution-based method and were used to define meaningful clinical improvement. MCID values for KOOS and SF12v2 physical component summary (PCS) scores were calculated to be 10 and 5, respectively. A receiver operating characteristic analysis was used to determine threshold values for preoperative KOOS and SF12v2 PCS scores and their respective predictive abilities. Threshold values defined the point after which the likelihood of clinically meaningful improvement began to diminish. Multivariate regression was used to control for the effect of preoperative mental and emotional health, patient attributes quantified by SF12v2 mental component summary (MCS) scores, on patients' likelihood of experiencing meaningful improvement in function after surgery. Threshold values for preoperative KOOS and SF12v2 PCS scores were a maximum of 58 (area under the curve [AUC], 0.76; p < 0.001) and 34 (AUC, 0.65; p < 0.001), respectively. Patients scoring above these thresholds, indicating better preoperative function, were less likely to experience a clinically meaningful improvement in function after TKA. When accounting for mental and emotional health with a multivariate analysis, the predictive ability of both KOOS and SF12v2 PCS threshold values improved (AUCs increased to 0.80 and 0.71, respectively). Better preoperative mental and emotional health, as reflected by a higher MCS score, resulted in higher threshold values for KOOS and SF12v2 PCS. We identified preoperative PROM threshold values that are associated with clinically meaningful improvements in functional outcome after TKA. Patients with preoperative KOOS or SF12v2 PCS scores above the defined threshold values have a diminishing probability of experiencing clinically meaningful improvement after TKA. Patients with worse baseline mental and emotional health (as defined by SF12v2 MCS score) have a lower probability of experiencing clinically important levels of functional improvement after surgery. The results of this study are directly applicable to patient-centered informed decision-making tools and may be used to facilitate discussions with patients regarding the expected benefit after TKA. Level III, prognostic study.

Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example.

PubMed

Dodick, David W; Turkel, Catherine C; DeGryse, Ronald E; Diener, Hans-Christoph; Lipton, Richard B; Aurora, Sheena K; Nolan, Marissa E; Silberstein, Stephen D

2015-02-01

In addition to headache, persons with chronic migraine (CM) experience multiple symptoms, both ictal and interictal, that may contribute to their suffering. Translating clinical trial results into practice requires assessment of the results' clinical meaningfulness. When examining treatment benefit in this disabled patient population, multiple headache-symptom measures should be considered to fully reflect clinical relevance. Currently, only onabotulinumtoxinA is approved specifically for headache prophylaxis in adults with CM. Topiramate is the only other therapeutic agent with double-blind, placebo-controlled evidence in this population. Herein we evaluate the clinical meaningfulness of onabotulinumtoxinA and topiramate as headache prophylaxis in CM by comparing primary endpoints from the placebo-controlled, double-blind phase of the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program and the topiramate clinical trial (frequency of headache days [primary endpoint in PREEMPT; secondary in topiramate trial] and migraine/migrainous days [primary in topiramate trial, or "migraine/probable-migraine days"; secondary in PREEMPT]). Additionally, outcome measures such as responder rates, health-related quality of life, discontinuation rates, safety, and tolerability profiles are important clinical considerations. The clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate. These data support these treatments as meaningful headache prophylaxis in adults with CM. CM is a chronic pain condition. We sought to determine the clinical relevance of recent trials in this disabled population. Clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate, and support use of these treatments as meaningful headache prophylaxis in CM. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

Biosimilars: Here and Now.

PubMed

Lemery, Steven J; Esteva, Francisco J; Weise, Martina

2016-01-01

Congress passed the Biologics Price Competition and Innovation Act (BPCI Act) as part of the Affordable Care Act on March 23, 2010. The BPCI Act authorized an approval pathway for biosimilar and interchangeable products. It defines biosimilarity to mean "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product." The biosimilar pathway has the potential to facilitate access to biologic products through increased competition, in the same manner as biosimilars have done for almost 10 years in Europe. The goal of a biosimilar program is not to independently establish safety and effectiveness for each condition of use. Rather, the goal is to demonstrate biosimilarity through an extensive analytical characterization and a targeted clinical program designed to assess for clinically meaningful differences, if they exist. The regulatory approaches in both the United States and Europe involve a totality-of-the-evidence approach to demonstrate biosimilarity. Importantly, the biosimilar pathway allows for extrapolation of data across indications so that a sponsor, with adequate scientific justification, need not conduct clinical studies in each intended condition of use. Without extrapolation, development may not be feasible for many products, and patients and resources could be diverted from clinical studies of newer agents for cancer.

Does the choice of antibiotic affect outcome in strep throat?

PubMed

Santos, Cynthia; Alerhand, Stephen; Koyfman, Alex

2015-05-01

There is insufficient evidence to show clinically meaningful differences between antibiotics for group A beta hemolytic streptococci tonsillopharyngitis. Penicillin or amoxicillin is recommended as first choice, given the absence of resistance and low cost.

A patent extension proposal to end the underrepresentation of women in clinical trials and secure meaningful drug guidance for women.

PubMed

Hathaway, Cynthia

2012-01-01

Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard to how drugs work in the human body, testing of drugs in men alone can both deny women the full benefit of a drug and cause them to suffer from increased adverse side effects. Attempts to reform drug development law and agency practices to resolve this problem have met with only partial success. Proposed herein is a patent term extension and for studies in women, modeled upon the pediatric patent term extension, but with several key differences intended to reduce the cost to the public and fund auxiliary programs to address off-patent medicines as well. Such an extension would incentivize this research and provide meaningful guidance to women and their physicians.

Influence of contouring and hardness of foot orthoses on ratings of perceived comfort.

PubMed

Mills, Kathryn; Blanch, Peter; Vicenzino, Bill

2011-08-01

Comfort is a vital component of orthosis therapy. The purpose of this study was to examine what features of orthoses (design or hardness) influence the perception of comfort by using previously established footwear comfort measures: 100-mm visual analog scale (VAS) and ranking scale. Twenty subjects were consecutively allocated to two experiments consisting of five sessions of repeated measures. Comfort measures were taken from four prefabricated orthosis in each session using the VAS (experiment 1) and ranking scale (experiment 2). Subjects in experiment 1 were also asked to rate each orthosis relative to their shoe using a criterion scale. Measures were taken in both walking and jogging. A soft-flat orthosis was found to be significantly more comfortable than all contoured orthoses, including one of the same hardness using both the VAS and ranking scale. Using the VAS, differences between the soft-flat and contoured orthoses were also found to be clinically meaningful for dimensions of overall comfort and arch cushioning (>10.2 mm). Perceived comfort of orthoses significantly differed between walking and jogging on the VAS but was not clinically meaningful. Comparisons between the VAS and criterion scale detected a VAS difference of 11.34 mm between orthoses judged as comfortable as my shoe and slightly more comfortable than my shoe. There was a VAS difference of 17.49 mm between orthoses judged as comfortable as my shoe and slightly less comfortable than my shoe. Healthy subjects prioritize contouring over hardness when judging the comfort of orthoses. Clinically meaningful changes were required to change or enhance the comfort of orthoses standardized in material type and fabrication.

FDA's Approach to Regulating Biosimilars.

PubMed

Lemery, Steven J; Ricci, M Stacey; Keegan, Patricia; McKee, Amy E; Pazdur, Richard

2017-04-15

The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency. The foundation of a biosimilar development program is an analytic similarity assessment that directly compares the structural/physiochemical and functional properties of the proposed biosimilar with the reference product. Data from clinical studies, which include an assessment of immunogenicity and pharmacokinetics/pharmacodynamics, are used to assess for clinically meaningful differences and not to independently establish the safety and effectiveness of the biosimilar. Like all products that the FDA regulates, the FDA requires that biosimilar products meet the agency's rigorous standards of safety and efficacy for approval. That means patients and health care professionals are able to rely upon the safety and effectiveness of biosimilar products in the same manner as for the reference product. Clin Cancer Res; 23(8); 1882-5. ©2016 AACR . ©2016 American Association for Cancer Research.

Are Changes in Leg Power Responsible for Clinically Meaningful Improvements in Mobility Among Older Adults?

PubMed Central

Bean, Jonathan F.; Kiely, Dan K.; LaRose, Sharon; Goldstein, Richard; Frontera, Walter R.; Leveille, Suzanne G.

2010-01-01

Objectives Mobility as measured by the Short Physical Performance Battery (SPPB) or habitual Gait Speed (GS) is predictive of mortality and disability among older adults. Clinically meaningful changes of these measures have been identified. Among physiologic attributes commonly targeted in rehabilitation, we sought to identify those attributes in which changes led to clinically meaningful differences (CMD) in the mobility outcomes. Participants Community-dwelling, mobility-limited older adults (n=116) participating in a 16-week randomized controlled trial (RCT) of two modes of exercise Setting Outpatient rehabilitation centers Design Secondary analysis of data collected for a RCT of exercise using binary outcomes defined by recording a large CMD (SPPB=1 unit; GS=.1m/s). Iterative models were performed to evaluate possible confounding between physiologic variables and relevant covariates. Measures Physiologic measures included leg power, leg strength, balance as measured by the Performance Oriented Mobility Assessment (POMA), rate pressure product (RPP) at the maximal stage of an exercise tolerance test. Outcomes included GS and SPPB. Leg power and leg strength were measured using computerized pneumatic strength training equipment and recorded in Watts and Newtons respectively. Results Participants were 68% female, had a mean age of 75.2 years, with a mean of 5.5 chronic conditions and a baseline mean SPPB score of 8.7. After controlling for age, site, group assignment, and baseline outcome values, leg power was the only attribute in which changes were significantly associated with a large CMD in SPPB (OR 1.48, 95% CI 1.09, 2.02) and GS (OR1.31, 95% CI 1.01, 1.70). Conclusion Improvements in leg power, independent of strength, appear to make an important contribution towards clinically meaningful improvements in both SPPB and GS. PMID:21143443

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

PubMed

Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

2016-01-01

The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The journey of primary care practices to meaningful use: a Colorado Beacon Consortium study.

PubMed

Fernald, Douglas H; Wearner, Robyn; Dickinson, W Perry

2013-01-01

The Health Information Technology for Economic and Clinical Health Act of 2009 provides for incentive payments through Medicare and Medicaid for clinicians who implement electronic health records (EHRs) and use this technology meaningfully to improve patient care. There are few comprehensive descriptions of how primary care practices achieve the meaningful use of clinical data, including the formal stage 1 meaningful use requirements. Evaluation of the Colorado Beacon Consortium project included iterative qualitative analysis of practice narratives, provider and staff interviews, and separate focus groups with quality improvement (QI) advisors and staff from the regional health information exchange (HIE). Most practices described significant realignment of practice priorities and aims, which often required substantial education and training of physicians and staff. Re-engineering office processes, data collection protocols, EHRs, staff roles, and practice culture comprised the primary effort and commitment to attest to stage 1 meaningful use and subsequent meaningful use of clinical data. While realizing important benefits, practices bore a significant burden in learning the true capabilities of their EHRs with little effective support from vendors. Attestation was an important initial milestone in the process, but practices faced substantial ongoing work to use their data meaningfully for patient care and QI. Key resources were instrumental to these practices: local technical EHR expertise; collaborative learning mechanisms; and regular contact and support from QI advisors. Meeting the stage 1 requirements for incentives under Medicare and Medicaid meaningful use criteria is the first waypoint in a longer journey by primary care practices to the meaningful use of electronic data to continuously improve the care and health of their patients. The intensive re-engineering effort for stage 1 yielded practice changes consistent with larger practice aims and goals. While many of these practices are now poised to use data meaningfully, faster progress will likely come with continued local QI and technical support and planned community-wide learning.

Parental Functioning in Families of Children with ADHD: Evidence for Behavioral Parent Training and Importance of Clinically Meaningful Change

ERIC Educational Resources Information Center

Gerdes, Alyson C.; Haack, Lauren M.; Schneider, Brian W.

2012-01-01

Objective/Method: Statistically significant and clinically meaningful effects of behavioral parent training on parental functioning were examined for 20 children with ADHD and their parents who had successfully completed a psychosocial treatment for ADHD. Results/Conclusion: Findings suggest that behavioral parent training resulted in…

Effectiveness of functional electrical stimulation on walking speed, functional walking category, and clinically meaningful changes for people with multiple sclerosis.

PubMed

Street, Tamsyn; Taylor, Paul; Swain, Ian

2015-04-01

To determine the effectiveness of functional electrical stimulation (FES) on drop foot in patients with multiple sclerosis (MS), using data from standard clinical practice. Case series with a consecutive sample of FES users collected between 2008 and 2013. Specialist FES center at a district general hospital. Patients with MS who have drop foot (N=187) (117 women, 70 men; mean age, 55y [range, 27-80y]; mean duration since diagnosis, 11.7y [range, 1-56y]). A total of 166 patients were still using FES after 20 weeks, with 153 patients completing the follow-up measures. FES of the common peroneal nerve (178 unilateral, 9 bilateral FES users). Clinically meaningful changes (ie, >.05m/s and >0.1m/s) and functional walking category derived from 10-m walking speed. An increase in walking speed was found to be highly significant (P<.001), both initially where a minimum clinically meaningful change was observed (.07m/s) and after 20 weeks with a substantial clinically meaningful change (.11m/s). After 20 weeks, treatment responders displayed a 27% average improvement in their walking speed. No significant training effect was found. Overall functional walking category was maintained or improved in 95% of treatment responders. FES of the dorsiflexors is a well-accepted intervention that enables clinically meaningful changes in walking speed, leading to a preserved or an increased functional walking category. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

PubMed

Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

2017-01-01

The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P < 0.001]. Among the 226 RCTs for which the ESMO-MCBS could be applied, 31% (70/226) were designed to detect an effect size that could meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs. © The Author 2016. 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.

Measuring use of electronic health record functionality using system audit information.

PubMed

Bowes, Watson A

2010-01-01

Meaningful and efficient methods for measuring Electronic Health Record (EHR) adoption and functional usage patterns have recently become important for hospitals, clinics, and health care networks in the United State due to recent government initiatives to increase EHR use. To date, surveys have been the method of choice to measure EHR adoption. This paper describes another method for measuring EHR adoption which capitalizes on audit logs, which are often common components of modern EHRs. An Audit Data Mart is described which identified EHR functionality within 836 Departments, within 22 Hospitals and 170 clinics at Intermountain Healthcare, a large integrated delivery system. The Audit Data Mart successfully identified important and differing EHR functional usage patterns. These patterns were useful in strategic planning, tracking EHR implementations, and will likely be utilized to assist in documentation of "Meaningful Use" of EHR functionality.

Construct validation of the hybrid model of posttraumatic stress disorder: Distinctiveness of the new symptom clusters.

PubMed

Silverstein, Madison W; Dieujuste, Nathalie; Kramer, Lindsay B; Lee, Daniel J; Weathers, Frank W

2018-03-01

Despite the factor analytic support for the seven-factor hybrid model (Armour et al., 2015) of posttraumatic stress disorder (PTSD), little research has examined the degree to which newly established symptom clusters (i.e., negative affect, anhedonia, dysphoric arousal, anxious arousal, externalizing behavior) functionally and meaningfully differ in their associations with other clinical phenomena. The aim of the current study was to examine the degree to which newly established PTSD symptom clusters differentially relate to co-occurring psychopathology and related clinical phenomena through Wald testing using latent variable modeling. Participants were 535 trauma-exposed undergraduates who completed the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers et al., 2013) and Personality Assessment Inventory (PAI; Morey, 1991). As expected and in line with results from previous studies, significant heterogeneity emerged for dysphoric arousal, anxious arousal, and externalizing behavior. However, there was less evidence for the distinctiveness of negative affect and anhedonia. Results indicate that only some of the newly established symptom clusters significantly differ in their associations with related clinical phenomena and that the hybrid model might not provide a meaningful framework for understanding which PTSD symptoms relate to associated features. Limitations include a non-clinical sample and reliance on retrospective self-report assessment measures. Copyright © 2017 Elsevier Ltd. All rights reserved.

Determining the Minimal Clinically Important Difference for Six-Minute Walk Distance in Fibromyalgia

PubMed Central

Kaleth, Anthony S.; Slaven, James E.; Ang, Dennis C.

2016-01-01

Objective To estimate the minimal clinically important difference (MCID) for 6-minute walk distance (6MWD) in patients with fibromyalgia (FM). Design Data from a recently completed trial that included 187 patients who completed the 6-minute walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 weeks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain (SF36-PF) as clinical anchors. Results The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (p<0.001). The anchor-based MCID’s for the 6MWD were 156 m and 167 m for the FIQ and SF36-PF, respectively. These MCID’s correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-PF (10 point increase). Conclusion The MCID for 6MWD in patients with FM was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with FM. PMID:27003201

Determining the Minimal Clinically Important Difference for 6-Minute Walk Distance in Fibromyalgia.

PubMed

Kaleth, Anthony S; Slaven, James E; Ang, Dennis C

2016-10-01

The aim of this study was to estimate the minimal clinically important difference (MCID) for 6-min walk distance (6MWD) in patients with fibromyalgia. Data from a recently completed trial that included 187 patients who completed the 6-min walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 wks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain as clinical anchors. The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (P < 0.001). The anchor-based MCIDs for the 6MWD were 156 and 167 m for the FIQ and SF36-physical function domain, respectively. These MCIDs correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-physical function domain (10-point increase). The MCID for 6MWD in patients with fibromyalgia was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with fibromyalgia.

What does meaningful look like? A qualitative study of patient engagement at the Pan-Canadian Oncology Drug Review: perspectives of reviewers and payers.

PubMed

Rozmovits, Linda; Mai, Helen; Chambers, Alexandra; Chan, Kelvin

2018-04-01

Objectives While there is wide support for patient engagement in health technology assessment, determining what constitutes meaningful (as opposed to tokenistic) engagement is complex. This paper explores reviewer and payer perceptions of what constitutes meaningful patient engagement in the Pan-Canadian Oncology Drug Review process. Methods Qualitative interview study comprising 24 semi-structured telephone interviews. A qualitative descriptive approach, employing the technique of constant comparison, was used to produce a thematic analysis. Results Submissions from patient advocacy groups were seen as meaningful when they provided information unavailable from other sources. This included information not collected in clinical trials, information relevant to clinical trade-offs and information about aspects of lived experience such as geographic differences and patient and carer priorities. In contrast, patient submissions that relied on emotional appeals or lacked transparency about their own methods were seen as detracting from the meaningfulness of patient engagement by conflating health technology assessment with other functions of patient advocacy groups such as fundraising or public awareness campaigns, and by failing to provide credible information relevant to deliberations. Conclusions This study suggests that misalignment of stakeholder expectations remains an issue even for a well-regarded health technology assessment process that has promoted patient engagement since its inception. Support for the technical capacity of patient groups to participate in health technology assessment is necessary but not sufficient to address this issue fully. There is a fundamental tension between the evidence-based nature of health technology assessment and the experientially oriented culture of patient advocacy. Divergent notions of what constitutes evidence and how it should be used must also be addressed.

Community-based medical education: is success a result of meaningful personal learning experiences?

PubMed

Kelly, Len; Walters, Lucie; Rosenthal, David

2014-01-01

Community-based medical education (CBME) is the delivery of medical education in a specific social context. Learners become a part of social and medical communities where their learning occurs. Longitudinal integrated clerkships (LICs) are year-long community-based placements where the curriculum and clinical experience is typically delivered by primary care physicians. These programs have proven to be robust learning environments, where learners develop strong communication skills and excellent clinical reasoning. To date, no learning model has been offered to describe CBME. The characteristics of CBME are explored by the authors who suggest that the social and professional context provided in small communities enhances medical education. The authors postulate that meaningfulness is engendered by the authentic context, which develops over time. These relationships with preceptors, patients and the community provide meaningfulness, which in turn enhances learning. The authors develop a novel learning model. They propose that the context-rich environment of CBME allows for meaningful relationships and experiences for students and that such meaningfulness enhances learning.

Patient-level clinically meaningful improvements in activities of daily living and pain after total hip arthroplasty: data from a large US institutional registry.

PubMed

Singh, Jasvinder A; Lewallen, David G

2013-06-01

To characterize patient-level clinically meaningful improvements in pain and limitation of key activities of daily living (ADLs) after primary or revision total hip arthroplasty (THA). We analysed prospectively collected data from the Mayo Clinic Total Joint Registry to study clinically meaningful improvements in index hip pain severity and limitation in seven key ADLs (walking, climbing stairs, putting on shoes/socks, picking up objects, getting in/out of car, rising from a chair and sitting), from preoperative to 2- and 5-year post-THA. The primary THA cohort consisted of 6168 responders preoperatively, 5707 at 2 years and 3289 at 5 years postoperatively. The revision THA cohort consisted of 2063 responders preoperatively, 2682 at 2 years and 1627 at 5 years postoperatively. In the primary THA cohort, clinically meaningful pain reduction to mild or no hip pain at 2 years was reported by 94% with moderate and 91% with severe preoperative pain; respective proportions were 91% and 89% at 5-year follow-up. For revision THA, respective proportions were 84% and 77% at 2 years and 80% and 78% at 5 years. In the primary THA cohort, up to 4% with moderate and 17% with severe preoperative ADL limitation reported severe limitation in the respective activity 2 years post-primary THA; at 5 years, the respective proportions were up to 7% and 20%. Respective proportions for revision THA were up to 10% and 26% at 2 years and 13% and 30% at 5 years. These comprehensive data for patient-level clinically meaningful improvements in pain and seven key ADLs can help patients set realistic goals for improvement after THA.

Failure of Ivermectin per Rectum to Achieve Clinically Meaningful Serum Levels in Two Cases of Strongyloides Hyperinfection

PubMed Central

Bogoch, Isaac I.; Khan, Kamran; Abrams, Howard; Nott, Caroline; Leung, Elizabeth; Fleckenstein, Lawrence; Keystone, Jay S.

2015-01-01

Two cases of Strongyloides hyperinfection are presented. Ivermectin was initially administered orally and per rectum pending the availability of subcutaneous (SC) preparations. In neither case did rectal suppositories of ivermectin achieve clinically meaningful serum values. Clinicians should use SC preparations of ivermectin as early as possible in Strongyloides hyperinfection and dissemination. PMID:25918215

"Meaningful use" of EHR in dental school clinics: how to benefit from the U.S. HITECH Act's financial and quality improvement incentives.

PubMed

Kalenderian, Elsbeth; Walji, Muhammad; Ramoni, Rachel B

2013-04-01

Through the 2009 HITECH (Health Information Technology for Economic and Clinical Health) Act, the U.S. government committed $27 billion to incentivize the adoption and "meaningful use" of certified electronic health records (EHRs) by providers, including dentists. Given their patient profiles, dental school clinics are in a position to benefit from this time-delimited commitment to support the adoption and use of certified EHR technology under the Medicaid-based incentive. The benefits are not merely financial: rather, the meaningful use objectives and clinical quality measures can drive quality improvement initiatives within dental practices and help develop a community of medical and dental professionals focused on quality. This article describes how dentists can qualify as eligible providers and the set of activities that must be undertaken and attested to in order to obtain this incentive. Two case studies describe the approaches that can be used to meet the Medicaid threshold necessary to be eligible for the incentive. Dentists can and have successfully applied for meaningful use incentive payments. Given the diverse set of patients who are treated at dental schools, these dental practices are among those most likely to benefit from the incentive programs.

Mirror Therapy and Task-Oriented Training for People With a Paretic Upper Extremity.

PubMed

Bondoc, Salvador; Booth, Julie; Budde, Grace; Caruso, Katelyn; DeSousa, Michelle; Earl, Brittany; Hammerton, Kaitlynn; Humphreys, Jill

This study investigates the effect of mirror therapy and task-oriented training on the paretic upper extremity function and occupational performance of people with stroke. This study used a repeated-measures, case-series design in which 4 participants completed a 4-wk intervention consisting of mirror therapy and task-specific training. The intervention was conducted 2×/wk in the clinic and 4×/wk at home. All participants displayed clinically meaningful improvements in self-identified goals at the end of the intervention and at follow-up. Three participants showed clinically meaningful changes in motor function. Although only 1 participant improved in his reported amount of use, all participants showed clinically meaningful improvements in perceived movement quality at varying points of assessment. Mirror therapy, when used as priming for task-oriented training, can produce clinical improvements in upper extremity function and occupational performance in people with hemiparesis. Copyright © 2018 by the American Occupational Therapy Association, Inc.

Meaningful change and responsiveness in common physical performance measures in older adults.

PubMed

Perera, Subashan; Mody, Samir H; Woodman, Richard C; Studenski, Stephanie A

2006-05-01

To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness. Secondary data analyses using distribution- and anchor-based methods to determine meaningful change. Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors. Older adults with mobility disabilities in a strength training trial (n=100), subacute stroke survivors in an intervention trial (n=100), and a prospective cohort of community-dwelling older people (n=492). Gait speed, Short Physical Performance Battery (SPPB), 6-minute-walk distance (6MWD), and self-reported mobility. Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed, 0.27 to 0.55 points for SPPB, and 19 to 22 m for 6MWD. Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed, 0.99 to 1.34 points for SPPB, and 47 to 49 m for 6MWD. Based on responsiveness indices, per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change. Best initial estimates of small meaningful change are near 0.05 m/s for gait speed, 0.5 points for SPPB, and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed, 1.0 point for SPPB, and 50 m for 6MWD. For clinical use, substantial change in these measures and small change in gait speed and 6MWD, but not SPPB, are detectable. For research use, these measures yield feasible sample sizes for detecting meaningful change.

Juvenile-Onset OCD: Clinical Features in Children, Adolescents and Adults

PubMed Central

Mancebo, Maria C.; Garcia, Abbe M.; Pinto, Anthony; Freeman, Jennifer B.; Przeworski, Amy; Stout, Robert; Kane, Joshua S.; Eisen, Jane L.; Rasmussen, Steven A.

2009-01-01

Objective To examine clinical correlates of juvenile-onset OCD across the lifespan. Method Intake data collected from 257 consecutive participants with a juvenile-onset of OCD (20 children, 44 adolescents, and 193 adults) in a naturalistic study of the clinical course of OCD were examined. Participants and parents of juvenile participants completed a structured diagnostic interview, rater-administered severity measures, and self-report questionnaires. Results Children and adolescents (i.e. juveniles) shared similar features with the exception of age at onset and OCD symptom expression. Clinically meaningful differences between juvenile and adult participants were also found. Compared to adults, juveniles were more likely to be male, recall an earlier age at OCD onset, and have different lifetime comorbidity patterns. Conclusion Juvenile-onset OCD symptom expression is remarkably similar across the lifespan. However, findings also suggest clinically meaningful differences between juveniles and adults. Future work using a prospective design will improve our understanding of course patterns of juvenile-onset OCD. Significant Outcomes •Children were less likely than either adolescent or adults to report aggressive obsessions and mental rituals. •Males were overrepresented in the juvenile sample but gender was equally distributed in the adult sample •Compared to lifetime comorbidity patterns of adults, juveniles showed elevated rates of ADHD and lower rates of mood, substance use and eating disorders Limitations •The cross-sectional design with retrospective recall regarding course prior to study entry limits conclusions about the course of OCD. •The adult sample is limited to adults whose symptoms persisted into adulthood and therefore results cannot be generalized to all individuals with a juvenile-onset. •The small number of very young children (under age 10) may have limited power to detect differences among children and adolescents. PMID:18699949

Quality of Life Analysis of a Radiation Dose-Escalation Study of Patients With Non-Small-Cell Lung Cancer: A Secondary Analysis of the Radiation Therapy Oncology Group 0617 Randomized Clinical Trial.

PubMed

Movsas, Benjamin; Hu, Chen; Sloan, Jeffrey; Bradley, Jeffrey; Komaki, Ritsuko; Masters, Gregory; Kavadi, Vivek; Narayan, Samir; Michalski, Jeff; Johnson, Douglas W; Koprowski, Christopher; Curran, Walter J; Garces, Yolanda I; Gaur, Rakesh; Wynn, Raymond B; Schallenkamp, John; Gelblum, Daphna Y; MacRae, Robert M; Paulus, Rebecca; Choy, Hak

2016-03-01

A recent randomized radiation dose-escalation trial in unresectable stage III non-small-cell lung cancer (NSCLC) (Radiation Therapy Oncology Group [RTOG] 0617) showed a lower survival rate in the high-dose radiation therapy (RT) arm (74 Gy) than in the low-dose arm (60 Gy) with concurrent chemotherapy. The primary QOL hypothesis predicted a clinically meaningful decline in quality of life (QOL) via the Functional Assessment of Cancer Therapy (FACT)-Lung Cancer Subscale (LCS) in the high-dose RT arm at 3 months. The RTOG 0617 trial was a randomized phase 3 study (conducted from November 2007 to November 2011) in stage III NSCLC using a 2 × 2 factorial design and stratified by histology, positron emission tomography staging, performance status, and irradiation technique (3-dimensional conformal RT [3D-CRT] vs intensity-modulated RT [IMRT]). A total of 185 institutions in the United States and Canada took part. Of 424 eligible patients with stage III NSCLC randomized, 360 (85%) consented to QOL evaluation, of whom 313 (88%) completed baseline QOL assessments. Treatment with 74-Gy vs 60-Gy RT with concurrent and consolidation carboplatin/paclitaxel with or without cetuximab. The QOL data were collected prospectively via FACT Trial Outcome Index (FACT-TOI), calculated as the sum of the following measures: Physical Well Being (PWB), Functional Well Being (FWB), and the LCS. Data are presented at baseline and 3 and 12 months via minimal clinically meaningful changes of 2 points or more for PWB, FWB, and LCS or 5 points or more for TOI. Of the 313 patients who completed baseline QOL assessments, 219 patients (70%) completed the 3-month QOL assessments, and 137 of the living patients (57%) completed the 12-month assessment. Patient demographics and baseline QOL scores were comparable between the 74-Gy and 60-Gy arms. Significantly more patients in the 74-Gy arm than in the 60-Gy arm had clinically meaningful decline in FACT-LCS at 3 months (45% vs 30%; P = .02). At 12 months, fewer patients who received IMRT (vs 3D-CRT) had clinically meaningful decline in FACT-LCS (21% vs 46%; P = .003). Baseline FACT-TOI was associated with overall survival in multivariate analysis. Despite few differences in clinician-reported toxic effects between treatment arms, QOL analysis demonstrated a clinically meaningful decline in QOL in the 74-Gy arm at 3 months, confirming the primary QOL hypothesis. Baseline QOL was an independent prognostic factor for survival. clinicaltrials.gov Identifier: NCT00533949.

Further statistics in dentistry. Part 4: Clinical trials 2.

PubMed

Petrie, A; Bulman, J S; Osborn, J F

2002-11-23

The principles which underlie a well-designed clinical trial were introduced in a previous paper. The trial should be controlled (to ensure that the appropriate comparisons are made), randomised (to avoid allocation bias) and, preferably, blinded (to obviate assessment bias). However, taken in isolation, these concepts will not necessarily ensure that meaningful conclusions can be drawn from the study. It is essential that the sample size is large enough to enable the effects of interest to be estimated precisely, and to detect any real treatment differences.

Meaningful relief with flurbiprofen 8.75 mg spray in patients with sore throat due to upper respiratory tract infection.

PubMed

de Looze, Ferdinandus; Russo, Marc; Bloch, Mark; Montgomery, Barney; Shephard, Adrian; DeVito, Robert

2018-03-01

Evaluate the efficacy of flurbiprofen 8.75 mg spray for sore throat relief. Randomized, double-blind study in adults with sore throat due to upper respiratory tract infection who took flurbiprofen (n = 249) or placebo spray (n = 256). Pain relief was assessed using the Sore Throat Relief Rating Scale. Flurbiprofen spray provided significantly greater relief versus placebo from 20 min to 6 h (p < 0.0001; maximum difference: 75 min). Sore throat severity was reduced ≥-2.2 on the Sore Throat Scale from 75 min to 6 h, indicating meaningful relief. Significantly more patients taking flurbiprofen spray reported ≥30 min of 'at least moderate' relief versus placebo over 6 h (p < 0.0001). Most adverse events were mild. Flurbiprofen spray provides rapid, long-lasting and clinically meaningful relief from sore throat (ANZCTR: ACTRN12612000457842).

Event segmentation improves event memory up to one month later.

PubMed

Flores, Shaney; Bailey, Heather R; Eisenberg, Michelle L; Zacks, Jeffrey M

2017-08-01

When people observe everyday activity, they spontaneously parse it into discrete meaningful events. Individuals who segment activity in a more normative fashion show better subsequent memory for the events. If segmenting events effectively leads to better memory, does asking people to attend to segmentation improve subsequent memory? To answer this question, participants viewed movies of naturalistic activity with instructions to remember the activity for a later test, and in some conditions additionally pressed a button to segment the movies into meaningful events or performed a control condition that required button-pressing but not attending to segmentation. In 5 experiments, memory for the movies was assessed at intervals ranging from immediately following viewing to 1 month later. Performing the event segmentation task led to superior memory at delays ranging from 10 min to 1 month. Further, individual differences in segmentation ability predicted individual differences in memory performance for up to a month following encoding. This study provides the first evidence that manipulating event segmentation affects memory over long delays and that individual differences in event segmentation are related to differences in memory over long delays. These effects suggest that attending to how an activity breaks down into meaningful events contributes to memory formation. Instructing people to more effectively segment events may serve as a potential intervention to alleviate everyday memory complaints in aging and clinical populations. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.

PubMed

Singh, Jasvinder A; Hossain, Alomgir; Tanjong Ghogomu, Elizabeth; Mudano, Amy S; Maxwell, Lara J; Buchbinder, Rachelle; Lopez-Olivo, Maria Angeles; Suarez-Almazor, Maria E; Tugwell, Peter; Wells, George A

2017-03-10

Biologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics. To compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (placebo or methotrexate (MTX)/other DMARDs) in people with RA, previously unsuccessfully treated with biologics. On 22 June 2015 we searched for randomized controlled trials (RCTs) in CENTRAL, MEDLINE, and Embase; and trials registries (WHO trials register, Clinicaltrials.gov). We carried out article selection, data extraction, and risk of bias and GRADE assessments in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparison (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We have also presented results in absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB). Outcomes measured included four benefits (ACR50, function measured by Health Assessment Questionnaire (HAQ) score, remission defined as DAS < 1.6 or DAS28 < 2.6, slowing of radiographic progression) and three harms (withdrawals due to adverse events, serious adverse events, and cancer). This update includes nine new RCTs for a total of 12 RCTs that included 3364 participants. The comparator was placebo only in three RCTs (548 participants), MTX or other traditional DMARD in six RCTs (2468 participants), and another biologic in three RCTs (348 participants). Data were available for four tumor necrosis factor (TNF)-biologics: (certolizumab pegol (1 study; 37 participants), etanercept (3 studies; 348 participants), golimumab (1 study; 461 participants), infliximab (1 study; 27 participants)), three non-TNF biologics (abatacept (3 studies; 632 participants), rituximab (2 studies; 1019 participants), and tocilizumab (2 studies; 589 participants)); there was only one study for tofacitinib (399 participants). The majority of the trials (10/12) lasted less than 12 months.We judged 33% of the studies at low risk of bias for allocation sequence generation, allocation concealment and blinding, 25% had low risk of bias for attrition, 92% were at unclear risk for selective reporting; and 92% had low risk of bias for major baseline imbalance. We downgraded the quality of the evidence for most outcomes to moderate or low due to study limitations, heterogeneity, or rarity of direct comparator trials. Biologic monotherapy versus placeboCompared to placebo, biologics were associated with clinically meaningful and statistically significant improvement in RA as demonstrated by higher ACR50 and RA remission rates. RR was 4.10 for ACR50 (95% CI 1.97 to 8.55; moderate-quality evidence); absolute benefit RD 14% (95% CI 6% to 21%); and NNTB = 8 (95% CI 4 to 23). RR for RA remission was 13.51 (95% CI 1.85 to 98.45, one study available; moderate-quality evidence); absolute benefit RD 9% (95% CI 5% to 13%); and NNTB = 11 (95% CI 3 to 136). Results for withdrawals due to adverse events and serious adverse events did not show any statistically significant or clinically meaningful differences. There were no studies available for analysis for function measured by HAQ, radiographic progression, or cancer outcomes. There were not enough data for any of the outcomes to look at subgroups. Biologic + MTX versus active comparator (MTX/other traditional DMARDs)Compared to MTX/other traditional DMARDs, biologic + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50, function measured by HAQ, and RA remission rates in direct comparisons. RR for ACR50 was 4.07 (95% CI 2.76 to 5.99; high-quality evidence); absolute benefit RD 16% (10% to 21%); NNTB = 7 (95% CI 5 to 11). HAQ scores showed an improvement with a mean difference (MD) of 0.29 (95% CI 0.21 to 0.36; high-quality evidence); absolute benefit RD 9.7% improvement (95% CI 7% to 12%); and NNTB = 5 (95% CI 4 to 7). Remission rates showed an improved RR of 20.73 (95% CI 4.13 to 104.16; moderate-quality evidence); absolute benefit RD 10% (95% CI 8% to 13%); and NNTB = 17 (95% CI 4 to 96), among the biologic + MTX group compared to MTX/other DMARDs. There were no studies for radiographic progression. Results were not clinically meaningful or statistically significantly different for withdrawals due to adverse events or serious adverse events, and were inconclusive for cancer. Tofacitinib monotherapy versus placeboThere were no published data. Tofacitinib + MTX versus active comparator (MTX)In one study, compared to MTX, tofacitinib + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50 (RR 3.24; 95% CI 1.78 to 5.89; absolute benefit RD 19% (95% CI 12% to 26%); NNTB = 6 (95% CI 3 to 14); moderate-quality evidence), and function measured by HAQ, MD 0.27 improvement (95% CI 0.14 to 0.39); absolute benefit RD 9% (95% CI 4.7% to 13%), NNTB = 5 (95% CI 4 to 10); high-quality evidence). RA remission rates were not statistically significantly different but the observed difference may be clinically meaningful (RR 15.44 (95% CI 0.93 to 256.1; high-quality evidence); absolute benefit RD 6% (95% CI 3% to 9%); NNTB could not be calculated. There were no studies for radiographic progression. There were no statistically significant or clinically meaningful differences for withdrawals due to adverse events and serious adverse events, and results were inconclusive for cancer. Biologic (with or without MTX) or tofacitinib (with MTX) use was associated with clinically meaningful and statistically significant benefits (ACR50, HAQ, remission) compared to placebo or an active comparator (MTX/other traditional DMARDs) among people with RA previously unsuccessfully treated with biologics.No studies examined radiographic progression. Results were not clinically meaningful or statistically significant for withdrawals due to adverse events and serious adverse events, and were inconclusive for cancer.

Real-World Massage Therapy Produces Meaningful Effectiveness Signal for Primary Care Patients with Chronic Low Back Pain: Results of a Repeated Measures Cohort Study.

PubMed

Elder, William G; Munk, Niki; Love, Margaret M; Bruckner, Geza G; Stewart, Kathryn E; Pearce, Kevin

2017-07-01

While efficacy of massage and other nonpharmacological treatments for chronic low back pain is established, stakeholders have called for pragmatic studies of effectiveness in "real-world" primary health care. The Kentucky Pain Research and Outcomes Study evaluated massage impact on pain, disability, and health-related quality of life for primary care patients with chronic low back pain. We report effectiveness and feasibility results, and make comparisons with established minimal clinically important differences. Primary care providers referred eligible patients for 10 massage sessions with community practicing licensed massage therapists. Oswestry Disability Index and SF-36v2 measures obtained at baseline and postintervention at 12 and 24 weeks were analyzed with mixed linear models and Tukey's tests. Additional analyses examined clinically significant improvement and predictive patient characteristics. Of 104 enrolled patients, 85 and 76 completed 12 and 24 weeks of data collection, respectively. Group means improved at 12 weeks for all outcomes and at 24 weeks for SF-36v2's Physical Component Summary and Bodily Pain Domain. Of those with clinically improved disability at 12 weeks, 75% were still clinically improved at 24 weeks ( P  < 0.01). For SF-36v2 Physical and Mental Component Summaries, 55.4% and 43.4%, respectively, showed clinically meaningful improvement at 12 weeks, 46.1% and 30.3% at 24 weeks. For Bodily Pain Domain, 49.4% were clinically improved at 12 weeks, 40% at 24 weeks. Adults older than age 49 years had better pain and disability outcomes than younger adults. Results provide a meaningful signal of massage effect for primary care patients with chronic low back pain and call for further research in practice settings using pragmatic designs with control groups. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Progress in defining clinically meaningful changes for clinical trials in nonrenal manifestations of SLE disease activity.

PubMed

Choi, Chan-Bum; Liang, Matthew H; Bae, Sang-Cheol

2016-01-06

Since the 2002 Dusseldorf meeting, one new agent, Benlysta, has been approved by the US Food and Drug Administration for systemic lupus erythematosus. Experiences from the field in conducting trials of all the agents tested during this period have provided valuable practical insights. There has been incremental progress in defining the minimal clinically important difference (MCID) of key disease manifestations and the view is largely that of the health care providers and not that of the person suffering the disease. This basic methodological work on the MCID should improve the efficiency and the clinical relevance of future trials and their design.

Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials.

PubMed

Saad, F; Ivanescu, C; Phung, D; Loriot, Y; Abhyankar, S; Beer, T M; Tombal, B; Holmstrom, S

2017-03-01

We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments. First SREs caused HRQoL deterioration in both trials. Spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine FACT-P domains in PREVAIL and all three in AFFIRM (mean (95% confidence interval (CI)) change in FACT-P total score -16.95 (-26.47, -7.44) and -9.69 (-16.10, -3.27), respectively). In PREVAIL, first SREs caused clinically meaningful declines in EQ-5D utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% CI) change -0.24 (-0.39, -0.08)). In AFFIRM, FACT-P and FACT-General total scores showed clinically meaningful declines after radiation/surgery to bone. SREs were associated with clinically meaningful functional declines in the daily lives of patients with mCRPC. Spinal cord compression had the largest impact on HRQoL.

Increased Trunk Extension Endurance is Associated with Meaningful Improvement in Balance among Older Adults with Mobility Problems

PubMed Central

Suri, Pradeep; Kiely, Dan K.; Leveille, Suzanne G.; Frontera, Walter R.; Bean, Jonathan. F.

2011-01-01

Objective To determine if trunk extension endurance changes with training are associated with clinically meaningful improvements in balance among mobility-limited older adults. Design Longitudinal data from a randomized clinical trial. Setting Outpatient rehabilitation research center. Participants Community-dwelling older adults (N=64; mean age 75.9 y) with mobility limitations as defined by a score of 4 to 10 on the Short Physical Performance Battery. Interventions 16 weeks of progressive resistance training. Main Outcome Measures Outcomes were the Berg Balance Scale (BBS) and the Unipedal Stance Test (UST). Predictors included leg strength, leg power, trunk extension endurance and the product of heart rate and blood pressure (RPP) at the final stage of an exercise tolerance test. We performed an analysis of data from participants who completed 16 weeks of training using binary outcomes defined by a clinically meaningful change from baseline to completion of the intervention (CMC) (BBS= 4 units; UST= 5 seconds). The association of predictor variables with balance outcomes was examined separately and together in multivariate adjusted logistic regression models. Results Trunk extension endurance in seconds (1.04 [1.00– 1.09]) was independently associated with CMC on the BBS. Trunk extension endurance (1.02 [1.00– 1.03]) was independently associated with CMC on the UST. Other physical attributes were not associated with meaningful change in balance. Conclusions Improvements in trunk extension endurance were independently associated with clinically meaningful changes in balance in older adults. Leg strength, leg power, and RPP were not associated with CMC in balance. Poor trunk extension endurance may be a rehabilitative impairment worthy of further study as a modifiable factor linked to balance among older adults. PMID:21636073

Interchangeability and reliability of macular perfusion parameter measurements using optical coherence tomography angiography

PubMed Central

Dong, Jing; Jia, Ya-ding; Wu, Qiang; Zhang, Suhua; Jia, Yali; Huang, David; Wang, Xiaogang

2018-01-01

Aim The aim of the study was to investigate the interchangeability and reliability of macular perfusion measurements using optical coherence tomography angiography. Methods A prospective cross-sectional observational study. Healthy adult Chinese subjects were recruited. Macular perfusion parameters were automatically analysed by software included in a spectral-domain optical coherence tomography system. The vessel density (VD) of the whole, parafovea, superior-hemi, inferior-hemi, fovea, temporal, superior, nasal and inferior quadrants as well as the foveal avascular zone (FAZ) and choroidal capillary VD (CCVD) were quantified. Results A total of 51 eyes in 27 subjects were included (8 men and 19 women, mean age 24±4 years). Significant differences in VD of all quadrants (all p<0.001) was detected between the 3×3 mm and 6×6 mm macular scan size. The biggest difference of VD between the two scan size was 5.14±4.03, which was not clinically meaningful. No statistically significant differences were found in FAZ or CCVD between the two different scan sizes. The mean intraclass correlation coefficient (ICC) between two measurements from the inter-rater of 20 eyes was from 0.560 to 0.893 for VD and 0.845 for FAZ. The mean ICC between two measurements from the intrarater of 20 eyes was from 0.497 to 0.870 for VD and 0.780 for FAZ. Conclusions FAZ and CCVD are interchangeable between the 3×3 mm and 6×6 mm macular scan sizes. The VD differences between the two different scan sizes are not clinically meaningful. The macular perfusion parameters presented good but not perfect reliability, which should be acknowledged in clinical practice. PMID:28336674

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials

PubMed Central

Zabetian, Azadeh; Ferket, Bart S.; Zhou, Jing; Testani, Jeffrey M.; Garg, Amit X.; Parikh, Chirag R.

2016-01-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short–term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between–group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo–controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. PMID:26712525

The use of a responder analysis to identify clinically meaningful differences in chronic urticaria patients following placebo- controlled treatment with rupatadine 10 and 20 mg.

PubMed

Giménez-Arnau, A; Izquierdo, I; Maurer, M

2009-09-01

According to the EAACI/GA(2)LEN/EDF guidelines for urticaria management, modern non-sedating H1-antihistamines are the first-line symptomatic treatment for chronic urticaria. Two previous randomized clinical trials demonstrated rupatadine efficacy and safety in chronic urticaria treatment. However, a responder analysis to identify clinically meaningful differences in patients with chronic urticaria has not yet been performed. This analysis includes the pooled data from two randomized, double-blind, placebo-controlled, multicentre studies in which chronic urticaria patients were treated with rupatadine at different doses. Responder rates were defined as the percentage of patients after 4 weeks of treatment who exhibited a reduction of symptoms by at least 50% or 75% as compared to baseline. The variables analysed were as follows: Mean Pruritus Score (MPS), Mean Number of Wheals (MNW), and Mean Urticaria Activity Score (UAS). A total of 538 patients were included. This responder analysis, using different response levels, shows that the efficacy of rupatadine 10 mg and 20 mg is significantly better as compared to placebo in the treatment of chronic urticaria patients. Notably, treatment with rupatadine 20 mg daily resulted in a higher percentage of patients with response of 75% symptom reduction or better than rupatadine 10 mg. Our results support the use of higher than standard doses of non sedating antihistamines in chronic urticaria. We strongly recommend performing and reporting responder analyses for established and new drugs used by patients with chronic urticaria.

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.

Clinical Importance of Steps Taken per Day among Persons with Multiple Sclerosis

PubMed Central

Motl, Robert W.; Pilutti, Lara A.; Learmonth, Yvonne C.; Goldman, Myla D.; Brown, Ted

2013-01-01

Background The number of steps taken per day (steps/day) provides a reliable and valid outcome of free-living walking behavior in persons with multiple sclerosis (MS). Objective This study examined the clinical meaningfulness of steps/day using the minimal clinically important difference (MCID) value across stages representing the developing impact of MS. Methods This study was a secondary analysis of de-identified data from 15 investigations totaling 786 persons with MS and 157 healthy controls. All participants provided demographic information and wore an accelerometer or pedometer during the waking hours of a 7-day period. Those with MS further provided real-life, health, and clinical information and completed the Multiple Sclerosis Walking Scale-12 (MSWS-12) and Patient Determined Disease Steps (PDDS) scale. MCID estimates were based on regression analyses and analysis of variance for between group differences. Results The mean MCID from self-report scales that capture subtle changes in ambulation (1-point change in PDSS scores and 10-point change in MSWS-12 scores) was 779 steps/day (14% of mean score for MS sample); the mean MCID for clinical/health outcomes (MS type, duration, weight status) was 1,455 steps/day (26% of mean score for MS sample); real-life anchors (unemployment, divorce, assistive device use) resulted in a mean MCID of 2,580 steps/day (45% of mean score for MS sample); and the MCID for the cumulative impact of MS (MS vs. control) was 2,747 steps/day (48% of mean score for MS sample). Conclusion The change in motion sensor output of ∼800 steps/day appears to represent a lower-bound estimate of clinically meaningful change in free-living walking behavior in interventions of MS. PMID:24023843

Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) - Report from OMERACT CTD-ILD Working Group.

PubMed

Khanna, Dinesh; Mittoo, Shikha; Aggarwal, Rohit; Proudman, Susanna M; Dalbeth, Nicola; Matteson, Eric L; Brown, Kevin; Flaherty, Kevin; Wells, Athol U; Seibold, James R; Strand, Vibeke

2015-11-01

Interstitial lung disease (ILD) is common in connective tissue disease (CTD) and is the leading cause of mortality. Investigators have used certain outcome measures in randomized controlled trials (RCT) in CTD-ILD, but the lack of a systematically developed, CTD-specific index that captures all measures relevant and meaningful to patients with CTD-ILD has left a large and conspicuous gap in CTD-ILD research. The CTD-ILD working group, under the aegis of the Outcome Measures in Rheumatology (OMERACT) initiative, has completed a consensus group exercise to reach harmony on core domains and items for inclusion in RCT in CTD-ILD. During the OMERACT 12 meeting, consensus was sought on domains and core items for inclusion in RCT. In addition, consensus was pursued on a definition of response in RCT. Consensus was defined as ≥ 75% agreement among the participants. OMERACT 12 participants endorsed the domains with minimal modifications. Clinically meaningful progression for CTD-ILD was proposed as ≥ 10% relative decline in forced vital capacity (FVC) or ≥ 5% to < 10% relative decline in FVC and ≥ 15% relative decline in DLCO. There is consensus on domains for inclusion in RCT in CTD-ILD and on a definition of clinically meaningful progression. Data-driven approaches to validate these results in different cohorts and RCT are needed.

When meaning matters more: Media preferences across the adult life span.

PubMed

Mares, Marie-Louise; Bartsch, Anne; Bonus, James Alex

2016-08-01

Two studies considered age differences in the roles of emotion and meaningfulness in adults' media preferences. Socioemotional Selectivity Theory (SST) suggests that with increasing age, positive emotions become more meaningful, and emotional meaningfulness matters more for situation selection. Other developmental descriptions suggest that negative affect may be meaningful and interesting in youth. In Study 1, United States 18-86 year olds read descriptions of TV programs that varied in levels of warmth, funniness, sadness, and fright; in Study 2, United States and German 18-82 year olds watched film trailers that varied in levels of gore and meaningfulness. Participants rated their anticipated emotions, anticipated meaningfulness of the content, and their viewing interest. Consistent with SST, in both studies, anticipated meaningfulness was a stronger predictor of viewing interest for older adults relative to younger adults, and the indirect path (Emotion → Meaning → Interest) was stronger for older relative to younger adults. In Study 1, warmth (but not funniness) was more predictive of meaningfulness for older relative to younger adults; sadness and fear were not more predictive of meaningfulness for younger adults. In Study 2, there were age differences in the effects of fright on interest, in part via effects on anticipated fun and suspense (but not arousal). Overall, the results provide limited evidence that positive or negative emotions are more meaningful or interesting at different ages. However, they support the argument that emotional meaningfulness matters more to older than to younger adults. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Pharmacokinetic properties of IB1001, an investigational recombinant factor IX, in patients with haemophilia B: repeat pharmacokinetic evaluation and sialylation analysis.

PubMed

Martinowitz, U; Shapiro, A; Quon, D V; Escobar, M; Kempton, C; Collins, P W; Chowdary, P; Makris, M; Mannucci, P M; Morfini, M; Valentino, L A; Gomperts, E; Lee, M

2012-11-01

IB1001 trenacog alfa is an investigational recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with haemophilia B. To compare the pharmacokinetics (PK) of IB1001 with nonacog alfa in individuals with haemophilia B and to assess the relationship between sialylation and PK of IB1001 (NCT00768287). A randomized, double-blind, non-inferiority, cross-over study conducted in participants aged ≥ 12 years weighing ≥ 40 kg, with severe or moderately severe haemophilia B (FIX activity ≤ 2 IU dL (-1) ). PK parameters were derived using observed FIX concentration levels and actual PK sampling times, and repeated in a subset of participants who had received IB1001 prophylaxis for 4-18 months. A retrospective analysis was conducted in subgroups according to the sialylation levels of IB1001 (50.8, 57.8-59.0%, or 71.7%). In the 32 adolescent and adult males evaluated, there were no clinically meaningful differences in PK parameters between those receiving IB1001 75 IU kg(-1) or nonacog alfa. The lower limit of the one-sided 95% confidence interval for the ratio of AUC(0-t) and AUC(0-∞) (IB1001/nonacog alfa) was 0.90, establishing non-inferiority. Terminal phase half-lives were similar (29.7 ± 18.2 h for IB1001 and 33.4 ± 21.2 h for nonacog alfa). The PK results were stable for up to 18 months of IB1001 exposure; the impact of sialylation levels was not clinically meaningful. There were no clinically meaningful PK differences between IB1001 and nonacog alfa. IB1001 was well tolerated and without safety concerns. The non-inferiority of IB1001 to nonacog alfa supports IB1001 becoming a useful alternative recombinant agent for the management of haemophilia B. © 2012 Blackwell Publishing Ltd.

Categorizing Drugs and Drug-Taking: A More Meaningful Approach.

ERIC Educational Resources Information Center

Gold, Robert S.; Duncan, David F.

This document reviews various definitions of the nature and classification of drugs. Difficulties with existing categorizations which use such bases as clinical utility, molecular structure, effects on the central nervous system, legality, and hazard potential are disucssed. A more meaningful categorization based on the availability and sources of…

Semi-spontaneous oral text production: measurements in clinical practice.

PubMed

Lind, Marianne; Kristoffersen, Kristian Emil; Moen, Inger; Simonsen, Hanne Gram

2009-12-01

Functionally relevant assessment of the language production of speakers with aphasia should include assessment of connected speech production. Despite the ecological validity of everyday conversations, more controlled and monological types of texts may be easier to obtain and analyse in clinical practice. This article discusses some simple measurements for the analysis of semi-spontaneous oral text production by speakers with aphasia. Specifically, the measurements are related to the production of verbs and nouns, and the realization of different sentence types. The proposed measurements should be clinically relevant, easily applicable, and linguistically meaningful. The measurements have been applied to oral descriptions of the 'Cookie Theft' picture by eight monolingual Norwegian speakers, four with an anomic type of aphasia and four without any type of language impairment. Despite individual differences in both the clinical and the non-clinical group, most of the measurements seem to distinguish between speakers with and without aphasia.

Toxicogenomics and clinical toxicology: an example of the connection between basic and applied sciences.

PubMed

Ferrer-Dufol, Ana; Menao-Guillen, Sebastian

2009-04-10

The relationship between basic research and its potential clinical applications is often a difficult subject. Clinical toxicology has always been very dependent on experimental research whose usefulness has been impaired by the existence of huge differences in the toxicity expression of different substances, inter- and intra-species which make it difficult to predict clinical effects in humans. The new methods in molecular biology developed in the last decades are furnishing very useful tools to study some of the more relevant molecules implied in toxicokinetic and toxicodynamic processes. We aim to show some meaningful examples of how recent research developments with genes and proteins have clear applications to understand significant clinical matters, such as inter-individual variations in susceptibility to chemicals, and other phenomena related to the way some substances act to induce variations in the expression and functionality of these targets.

Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

PubMed Central

Blackwell, K.; Semiglazov, V.; Krasnozhon, D.; Davidenko, I.; Nelyubina, L.; Nakov, R.; Stiegler, G.; Singh, P.; Schwebig, A.; Kramer, S.; Harbeck, N.

2015-01-01

Background Biosimilars of filgrastim are in widespread clinical use in Europe. This phase III study compares biosimilar filgrastim (EP2006), with the US-licensed reference product, Neupogen®, in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC). Patients and methods A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomized 1:1:1:1 into four arms. Two arms received only one product (nonalternating), biosimilar or reference, and two arms (alternating) received alternating treatments during each cycle (biosimilar then reference or vice versa). The primary end point was duration of severe neutropenia (DSN) during cycle 1. Results The baseline characteristics were balanced between the four treatment arms. Noninferiority of biosimilar versus the reference was demonstrated: DSN (days) in cycle 1 was 1.17 ± 1.11 (biosimilar, N = 101) and 1.20 ± 1.02 (reference, N = 103), 97.5% confidence interval lower boundary for the difference was −0.26 days (above the predefined limit of −1 day). No clinically meaningful differences were observed regarding any other efficacy parameter: incidence of febrile neutropenia (FN); hospitalization due to FN; incidence of infections; depth and time of absolute neutrophil count (ANC) nadir and time to ANC recovery during cycle 1 and across all cycles. The pattern and frequency of adverse events were similar across all treatments. Conclusion This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia. Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment. Study number NCT01519700. PMID:26122726

Simulating Expert Clinical Comprehension: Adapting Latent Semantic Analysis to Accurately Extract Clinical Concepts from Psychiatric Narrative

PubMed Central

Cohen, Trevor; Blatter, Brett; Patel, Vimla

2008-01-01

Cognitive studies reveal that less-than-expert clinicians are less able to recognize meaningful patterns of data in clinical narratives. Accordingly, psychiatric residents early in training fail to attend to information that is relevant to diagnosis and the assessment of dangerousness. This manuscript presents cognitively motivated methodology for the simulation of expert ability to organize relevant findings supporting intermediate diagnostic hypotheses. Latent Semantic Analysis is used to generate a semantic space from which meaningful associations between psychiatric terms are derived. Diagnostically meaningful clusters are modeled as geometric structures within this space and compared to elements of psychiatric narrative text using semantic distance measures. A learning algorithm is defined that alters components of these geometric structures in response to labeled training data. Extraction and classification of relevant text segments is evaluated against expert annotation, with system-rater agreement approximating rater-rater agreement. A range of biomedical informatics applications for these methods are suggested. PMID:18455483

The Interrelationship of Common Clinical Movement Screens: Establishing Population-Specific Norms in a Large Cohort of Military Applicants.

PubMed

de la Motte, Sarah J; Gribbin, Timothy C; Lisman, Peter; Beutler, Anthony I; Deuster, Patricia

2016-11-01

 Musculoskeletal injuries (MSK-Is) are a leading cause of missed duty time and morbidity in the military. Modifiable risk factors for MSK-Is, such as inadequate core stability, poor movement patterns, and dynamic balance deficits, have not been identified in military applicants on entering service.  To establish normative functional movement data using a series of screens in military applicants entering basic training and explore relationships among several movement tests.  Cross-sectional study.  Military Entrance Processing Station.  A total of 1714 (1434 male, 280 female) military applicants entering the US Army (n = 546), Navy (n = 414), Air Force (n = 229), or Marine Corps (n = 525).  We conducted the Functional Movement Screen (FMS), Y-Balance Test (YBT), overhead squat (OHS), and Landing Error Scoring System (LESS). Movements were assessed using the scoring convention for each screen.  The FMS, YBT, OHS, and LESS scores and associations among the movement screens as well as clinical meaningfulness.  A total of 1037 of the 1714 enrolled applicants were screened on the day they left for basic training. Normative means for this population were established: FMS = 14.7 ± 1.8, YBT anterior-reach difference = 3.1 ± 3.0 cm, mean YBT composite differences = 8.0 ± 6.8 cm, mean YBT composite percentage = 90.9% ± 8.3%, OHS errors = 5.0 ± 2.8, and LESS score = 5.7 ± 2.1. Backward regression results revealed that the YBT composite percentage was related to the FMS and OHS scores in males and to the FMS and LESS results in females. However, clinically meaningful relationships between the tests varied for both males and females.  Sex-normative values for the FMS, YBT, OHS, and LESS screens were established for US military applicants, and some of the assessments overlapped. Overall, males performed better on the OHS and LESS and achieved a greater YBT composite percentage than females. The regression results revealed movement screen performance relationships that varied by sex and clinical meaningfulness. In future studies, we will determine if performance on any of the screens is associated with MSK-Is in basic trainees.

Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population

PubMed Central

Delgado-Herrera, Leticia; Lasch, Kathryn; Zeiher, Bernhardt; Lembo, Anthony J.; Drossman, Douglas A.; Banderas, Benjamin; Rosa, Kathleen; Lademacher, Christopher; Arbuckle, Rob

2017-01-01

Background: To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. Methods: Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ClinicalTrials.gov identifier: NCT01494233]. Results: A total of 434 patients were included in the analyses. Significant differences were found among severity groups (p < 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S (p < 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items −0.13 to −0.86 [standard deviation (SD) 0.79–1.39]. Similarly, for patients who reported being ‘slightly improved’ (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from −0.45 to −1.55 (SD 0.69–1.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests. Conclusions: These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population. PMID:28932269

Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials

PubMed Central

Saad, F; Ivanescu, C; Phung, D; Loriot, Y; Abhyankar, S; Beer, T M; Tombal, B; Holmstrom, S

2017-01-01

Background: We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. Methods: Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments. Results: First SREs caused HRQoL deterioration in both trials. Spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine FACT-P domains in PREVAIL and all three in AFFIRM (mean (95% confidence interval (CI)) change in FACT-P total score –16.95 (–26.47, –7.44) and –9.69 (–16.10, –3.27), respectively). In PREVAIL, first SREs caused clinically meaningful declines in EQ-5D utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% CI) change –0.24 (–0.39, –0.08)). In AFFIRM, FACT-P and FACT-General total scores showed clinically meaningful declines after radiation/surgery to bone. Conclusions: SREs were associated with clinically meaningful functional declines in the daily lives of patients with mCRPC. Spinal cord compression had the largest impact on HRQoL. PMID:28045115

Cultural differences define diagnosis and genomic medicine practice: implications for undiagnosed diseases program in China.

PubMed

Duan, Xiaohong; Markello, Thomas; Adams, David; Toro, Camilo; Tifft, Cynthia; Gahl, William A; Boerkoel, Cornelius F

2013-09-01

Despite the current acceleration and increasing leadership of Chinese genetics research, genetics and its clinical application have largely been imported to China from the Occident. Neither genetics nor the scientific reductionism underpinning its clinical application is integral to the traditional Chinese worldview. Given that disease concepts and their incumbent diagnoses are historically derived and culturally meaningful, we hypothesize that the cultural expectations of genetic diagnoses and medical genetics practice differ between the Occident and China. Specifically, we suggest that an undiagnosed diseases program in China will differ from the recently established Undiagnosed Diseases Program at the United States National Institutes of Health; a culturally sensitive concept will integrate traditional Chinese understanding of disease with the scientific reductionism of Occidental medicine.

Hospital Characteristics Related to the Intention to Apply for Meaningful Use Incentive Payments

PubMed Central

Diana, Mark L; Kazley, Abby Swanson; Ford, Eric W; Menachemi, Nir

2012-01-01

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 provides incentives for hospitals to fully adopt and use electronic health records (EHRs). We used data from the 2009 American Hospital Association (AHA) Annual Survey Information Technology Supplement and the Centers for Medicare and Medicaid Services (CMS) 2008 Hospital Cost Reports to examine how various hospital characteristics are associated with the intention to pursue meaningful use incentives. Overall, 86 percent of hospitals indicated an intent to pursue HITECH incentives. However, hospitals that already have an EHR system, are larger, and are located in urban areas are more likely to indicate an intention to pursue incentives. Despite a high interest in HITECH incentives, certain hospital characteristics, including current EHR use, increase the proclivity for some hospitals to pursue meaningful use. Given these differences, there is the potential for the HITECH Act to inadvertently increase the digital divide between hospitals with certain characteristics and their counterparts without those characteristics. Policy makers should consider ways to alleviate barriers, especially for nonusers of EHRs, to realize the maximum benefits of the HITECH Act. PMID:22737100

Only complementary voices tell the truth: a reevaluation of validity in multi-informant approaches of child and adolescent clinical assessments.

PubMed

Kaurin, Aleksandra; Egloff, Boris; Stringaris, Argyris; Wessa, Michèle

2016-08-01

Multi-informant approaches are thought to be key to clinical assessment. Classical theories of psychological measurements assume that only convergence among different informants' reports allows for an estimate of the true nature and causes of clinical presentations. However, the integration of multiple accounts is fraught with problems because findings in child and adolescent psychiatry do not conform to the fundamental expectation of convergence. Indeed, reports provided by different sources (self, parents, teachers, peers) share little variance. Moreover, in some cases informant divergence may be meaningful and not error variance. In this review, we give an overview of conceptual and theoretical foundations of valid multi-informant assessment and discuss why our common concepts of validity need revaluation.

Development and Validation of a Photonumeric Scale for Assessment of Chin Retrusion.

PubMed

Sykes, Jonathan M; Carruthers, Alastair; Hardas, Bhushan; Murphy, Diane K; Jones, Derek; Carruthers, Jean; Donofrio, Lisa; Creutz, Lela; Marx, Ann; Dill, Sara

2016-10-01

A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. A difference of ≥1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

PubMed

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

Does Pre-Cooling With Whole-Body Immersion Affect Thermal Sensation or Perceived Exertion?: A Critically-Appraised Topic.

PubMed

Wohlfert, Timothy M; Miller, Kevin C

2018-02-21

Clinical Scenario: Exertional heat stroke (EHS) is a potentially deadly heat illness and poses a significant health risk to athletes; EHS survival rates are near 100% if properly recognized and treated. 1 Whole body cold water immersion (CWI) is the most effective method of lowering body core temperature. 2 Precooling (PC) with CWI before exercise may prevent severe hyperthermia and/or EHS by increasing the body's overall heat-storage capacity. 3 However, PC may also alter athletes' perception of how hot they feel or how hard they are exercising. Consequently, they may be unable to accurately perceive their body core temperature or how hard they are working which may predispose them to severe hyperthermia or EHS. Does PC with whole-body CWI affect thermal sensation (TS) or rating of perceived exertion (RPE) during exercise in the heat? In four studies, 4-7 RPE during exercise ranged from 12 ± 2 to 20 ± 3 with no clinically meaningful differences between PC and control trials. Thermal sensation scores ranged from 2 ± 1 to 8 ± 0.5 in control trials and from 2 ± 1 to 7.5 ± 0.5 during PC trials. Clinical Bottom Line: Precooling did not cause clinically-meaningful differences in RPE or TS during exercise. It is unlikely PC would predispose athletes to EHS by altering perceptions of exercise intensity or body core temperature. Strength of Recommendation: None of the reviewed studies 4-7 (all level 2 studies with PEDro scores ≥5) suggest PC with CWI influences RPE or TS in exercising males.

Differences in depression, anxiety, and quality of life between women with and without breast pain prior to breast cancer surgery.

PubMed

Kyranou, Maria; Paul, Steven M; Dunn, Laura B; Puntillo, Kathleen; Aouizerat, Bradley E; Abrams, Gary; Hamolsky, Deborah; West, Claudia; Neuhaus, John; Cooper, Bruce; Miaskowski, Christine

2013-04-01

Little is known about the relationships between pain, anxiety, and depression in women prior to breast cancer surgery. The purpose of this study was to evaluate for differences in anxiety, depression, and quality of life (QOL) in women who did and did not report the occurrence of breast pain prior to breast cancer surgery. We hypothesized that women with pain would report higher levels of anxiety and depression as well as poorer QOL than women without pain. A total of 390 women completed self-report measures of pain, anxiety depression, and QOL prior to surgery. Women with preoperative breast pain (28%) were significantly younger, had a lower functional status score, were more likely to be Non-white and to have gone through menopause. Over 37% of the sample reported clinically meaningful levels of depressive symptoms. Almost 70% of the sample reported clinically meaningful levels of anxiety. Patients with preoperative breast pain reported significantly higher depression scores and significantly lower physical well-being scores. No between group differences were found for patients' ratings of state and trait anxiety or total QOL scores. Our a priori hypotheses were only partially supported. Findings from this study suggest that, regardless of pain status, anxiety and depression are common problems in women prior to breast cancer surgery. Copyright © 2012 Elsevier Ltd. All rights reserved.

Trauma-focused cognitive behavioral therapy a clinical trial to increase self-efficacy in abused the primary school children.

PubMed

Farina, Vahid; Salemi, Safora; Tatari, Faezeh; Abdoli, Nasrin; Jouybari, Touraj Ahmadi; Alikhani, Mostafa; Basanj, Behrad; Zakiei, Ali

2018-01-01

Child abuse and violence toward children has become a complex phenomenon in nowadays societies leaving hurt children with numerous complications such as lowered self-efficacy. Hence, this study was conducted to assess the effect of trauma-focused cognitive behavioral therapy (TF-CBT) in physically abused children self-efficacy. This study was a randomized clinical trial. From this statistical population of all abused children aged 9-12 in Kermanshah in 2016-2017, 40 were divided into intervention and control groups randomly. Tools used in this study were Maurice self-efficacy questionnaire and child abuse questionnaire. Data analysis was done using Chi-square test, paired t -test, and independent t -test. It was revealed that the mean difference between two groups was not meaningful before intervention. After TF-CBT in intervention group, self-efficacy mean scores of social (17.95 vs. 24.20) and emotional (15.05 vs. 19.05) domains showed meaningful differences, whereas academic self-efficacy mean score did not change significantly (14.10 vs. 14.65) ( P < 0.086). In control group, social (16.20 vs. 15.55), emotional (13.90 vs. 14.35), and academic (13.40 vs. 13.90) mean self-efficacy scores were not of significant difference ( P > 0.001). TF-CBT can be used as an appropriate therapy intervention to improve social and emotional self-efficacy in abused children.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study.

PubMed

Judge, A; Batra, R N; Thomas, G E; Beard, D; Javaid, M K; Murray, D W; Dieppe, P A; Dreinhoefer, K E; Peter-Guenther, K; Field, R; Cooper, C; Arden, N K

2014-03-01

To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery. Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (EPOS) (n = 1431); EUROHIP (n = 1327); Elective Orthopaedic Centre (n = 2832); and St. Helier (n = 787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27-1.28), P-value 0.001. Compared to people of normal BMI (20-25), those in the obese class II (BMI 35-40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Are changes in leg power responsible for clinically meaningful improvements in mobility in older adults?

PubMed

Bean, Jonathan F; Kiely, Dan K; LaRose, Sharon; Goldstein, Richard; Frontera, Walter R; Leveille, Suzanne G

2010-12-01

From among physiological attributes commonly targeted in rehabilitation, to identify those in which changes led to clinically meaningful differences (CMDs) in mobility outcomes. Secondary analysis of data collected for a randomized controlled trial of exercise using binary outcomes defined by recording a large CMD (Short Physical Performance Battery (SPPB)=1 unit; gait speed (GS)=0.1 m/s). Iterative models were performed to evaluate possible confounding between physiological variables and relevant covariates. Outpatient rehabilitation centers. Community-dwelling mobility-limited older adults (n=116) participating in a 16-week randomized controlled trial of two modes of exercise. Physiological measures included leg power, leg strength, balance as measured according to the Performance-Oriented Mobility Assessment (POMA), and rate pressure product at the maximal stage of an exercise tolerance test. Outcomes included GS and SPPB. Leg power and leg strength were measured using computerized pneumatic strength training equipment and recorded in Watts and Newtons, respectively. Participants were 68% female, had a mean age of 75.2, a mean of 5.5 chronic conditions, and a baseline mean SPPB score of 8.7. After controlling for age, site, group assignment, and baseline outcome values, leg power was the only attribute in which changes were significantly associated with a large CMD in SPPB (odds ratio (OR)=1.48, 95% confidence interval (CI)=1.09-2.02) and GS (OR=1.31, 95% CI=1.01-1.70). Improvements in leg power, independent of strength, appear to make an important contribution to clinically meaningful improvements in SPPB and GS. © 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

PubMed Central

Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

2014-01-01

Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

Correspondence between Psychometric and Clinical High Risk for Psychosis in an Undergraduate Population

PubMed Central

Cicero, David C.; Martin, Elizabeth A.; Becker, Theresa M.; Docherty, Anna; Kerns, John G.

2014-01-01

Despite the common use of either psychometric or clinical methods for identifying individuals at risk for psychosis, previous research has not examined the correspondence and extent of convergence of these two approaches. Undergraduates (n = 160), selected from a larger pool, completed three self-report schizotypy scales, the Magical Ideation Scale, the Perceptual Aberration Scale, and the Revised Social Anhedonia Scale, and were administered the Structured Interview for Prodromal Syndromes (SIPS). First, high correlations were observed for self-report and interview-rated psychotic like experiences (rs between .48 and .61, p < .001). Second, 77 percent of individuals identified as having a risk for psychosis with the self-report measures reported at least one clinically meaningful psychotic-like experience on the SIPS. Third, receiver operating characteristic curve analyses showed that the self-report scales can be used to identify which participants report clinically meaningful positive symptoms. These results suggest that mostly white undergraduate participants identified as at risk with the psychometric schizotypy approach report clinically meaningful psychotic-like experiences in an interview format and that the schizotypy scales are moderately to strongly correlated with interview-rated psychotic-like experiences. The results of the current research provide a baseline for comparing research between these two approaches. PMID:24708081

Statistical Primer on Biosimilar Clinical Development.

PubMed

Isakov, Leah; Jin, Bo; Jacobs, Ira Allen

A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.

Predicting Manual Therapy Treatment Success in Patients With Chronic Ankle Instability: Improving Self-Reported Function.

PubMed

Wikstrom, Erik A; McKeon, Patrick O

2017-04-01

  Therapeutic modalities that stimulate sensory receptors around the foot-ankle complex improve chronic ankle instability (CAI)-associated impairments. However, not all patients have equal responses to these modalities. Identifying predictors of treatment success could improve clinician efficiency when treating patients with CAI.   To conduct a response analysis on existing data to identify predictors of improved self-reported function in patients with CAI.   Secondary analysis of a randomized controlled clinical trial.   Sports medicine research laboratories.   Fifty-nine patients with CAI, which was defined in accordance with the International Ankle Consortium recommendations.   Participants were randomized into 3 treatment groups (plantar massage [PM], ankle-joint mobilization [AJM], or calf stretching [CS]) that received six 5-minute treatments over 2 weeks.   Treatment success, defined as a patient exceeding the minimally clinically important difference of the Foot and Ankle Ability Measure-Sport (FAAM-S).   Patients with ≤5 recurrent sprains and ≤82.73% on the Foot and Ankle Ability Measure had a 98% probability of having a meaningful FAAM-S improvement after AJM. As well, ≥5 balance errors demonstrated 98% probability of meaningful FAAM-S improvements from AJM. Patients <22 years old and with ≤9.9 cm of dorsiflexion had a 99% probability of a meaningful FAAM-S improvement after PM. Also, those who made ≥2 single-limb-stance errors had a 98% probability of a meaningful FAAM-S improvement from PM. Patients with ≤53.1% on the FAAM-S had an 83% probability of a meaningful FAAM-S improvement after CS.   Each sensory-targeted ankle-rehabilitation strategy resulted in a unique combination of predictors of success for patients with CAI. Specific indicators of success with AJM were deficits in self-reported function, single-limb balance, and <5 previous sprains. Age, weight-bearing-dorsiflexion restrictions, and single-limb balance deficits identified patients with CAI who will respond well to PM. Assessing self-reported sport-related function can identify CAI patients who will respond positively to CS.

Long-term stability of cognitive behavioral therapy effects for panic disorder with agoraphobia: a two-year follow-up study.

PubMed

Gloster, Andrew T; Hauke, Christina; Höfler, Michael; Einsle, Franziska; Fydrich, Thomas; Hamm, Alfons; Sthröhle, Andreas; Wittchen, Hans-Ulrich

2013-12-01

Cognitive-behavioral therapy (CBT) aims to help patients establish new behaviors that will be maintained and adapted to the demands of new situations. The long-term outcomes are therefore crucial in testing the durability of CBT. A two-year follow-up assessment was undertaken on a subsample of n = 146 PD/AG patients from a multicenter randomized controlled trial. Treatment consisted of two variations of CBT: exposure in situ in the presence of the therapist (T+) or on their own following therapist preparation (T-). Both variations of CBT had high response rates and, overall, maintained the level of symptomatology observed at post-treatment with high levels of clinical significance. Effect sizes 24 months following treatment were somewhat lower than at the 6-month follow up. Once patients reached responder status, they generally tended to remain responders at subsequent assessments. Differences were observed for patients that obtained additional treatment during the follow-up period. Expert opinion and subjective appraisal of treatment outcome differed. No robust baseline predictors of 2-year outcome were observed. Most patients maintain clinically meaningful changes two years following treatment across multiple outcome measures. Approximately 1/3 of patients continued to experience meaningful residual problems. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical decision support: effectiveness in improving quality processes and clinical outcomes and factors that may influence success.

PubMed

Murphy, Elizabeth V

2014-06-01

The use of electronic health records has skyrocketed following the 2009 HITECH Act, which provides financial incentives to health care providers for the "meaningful use" of electronic medical record systems. An important component of the "Meaningful Use" legislation is the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study.

Cost-effectiveness of achieving clinical improvement with a dissonance-based eating disorder prevention program.

PubMed

Akers, Laura; Rohde, Paul; Stice, Eric; Butryn, Meghan L; Shaw, Heather

2017-01-01

Using data from an effectiveness trial delivered by college clinicians, we examined the cost-effectiveness of the dissonance-based Body Project program for reducing eating disorder symptoms in women with body dissatisfaction. The outcome of interest was individual-level change; 14.9% of Body Project participants attained clinically meaningful improvement vs. 6.7% of controls. Delivering the intervention costs approximately $70 (2012 U.S. dollars) per person. Incremental cost-effectiveness was $838 for each additional at-risk person reducing eating disorder symptomology to a clinically meaningful degree. These analyses demonstrate the economic value of the Body Project for college-age women with symptoms below the eating disorder diagnosis threshold.

Evaluation of group versus individual physiotherapy following lower limb intra-muscular Botulinum Toxin-Type A injections for ambulant children with cerebral palsy: A single-blind randomized comparison trial.

PubMed

Thomas, Rachel E; Johnston, Leanne M; Sakzewski, Leanne; Kentish, Megan J; Boyd, Roslyn N

2016-01-01

This study aimed to evaluate efficacy of group (GRP) versus individual (IND) physiotherapy rehabilitation following lower limb intramuscular injections of Botulinum Toxin-Type A (BoNT-A) for ambulant children with cerebral palsy (CP). Following lower limb BoNT-A injections, 34 children were randomly allocated to GRP (n=17; mean age 7y8m SD 2.0; 13 males; Gross Motor Function Classification System (GMFCS) I=5, II=8, III=4) or IND physiotherapy (n=17; mean age 8y7m SD 2.0; 11 males; GMFCS I=9, II=5, III=3). Primary outcomes were the Canadian Occupational Performance Measure (COPM) and Edinburgh Visual Gait Score (EVGS) assessed at baseline, 10 and 26 weeks post intervention. There were no baseline differences between groups. GRP intervention had greater, but not clinically meaningful, improvement in COPM satisfaction (estimated mean difference EMD 1.7, 95% CI 0.4-3.1; p<0.01) at 26 weeks. Both groups demonstrated clinically significant improvements in COPM performance and satisfaction, but minimal change in quality of gait (EVGS). Six hours of direct physiotherapy (either GRP or IND) with an additional indirect dose (median 16 episodes) of individualized home programme activities following lower limb BoNT-A injections, however, was inadequate to drive clinically meaningful changes in lower limb motor outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Developing a system to track meaningful outcome measures in head and neck cancer treatment.

PubMed

Walters, Ronald S; Albright, Heidi W; Weber, Randal S; Feeley, Thomas W; Hanna, Ehab Y; Cantor, Scott B; Lewis, Carol M; Burke, Thomas W

2014-02-01

The health care industry, including consumers, providers, and payers of health care, recognize the importance of developing meaningful, patient-centered measures. This article describes our experience using an existing electronic medical record largely based on free text formats without structured documentation, in conjunction with tumor registry abstraction techniques, to obtain and analyze data for use in clinical improvement and public reporting. We performed a retrospective analysis of 2467 previously untreated patients treated with curative intent who presented with laryngeal, pharyngeal, or oral cavity cancer in order to develop a system to monitor and report meaningful outcome metrics of head and neck cancer treatment. Patients treated between 1995 and 2006 were analyzed for the primary outcomes of survival at 1 and 2 years, the ability to speak at 1 year posttreatment, and the ability to swallow at 1 year posttreatment. We encountered significant limitations in clinical documentation because of the lack of standardization of meaningful measures, as well limitations with data abstraction using a retrospective approach to reporting measures. Almost 5000 person-hours were required for data abstraction, quality review, and reporting, at a cost of approximately $134,000. Our multidisciplinary teams document extensive patient information; however, data is not stored in easily accessible formats for measurement, comparison, and reporting. We recommend identifying measures meaningful to patients, providers, and payers to be documented throughout the patients' entire treatment cycle, and significant investment in the improvements to electronic medical records and tumor registry reporting in order to provide meaningful quality measures for the future. Copyright © 2013 Wiley Periodicals, Inc.

Personalized intensification of insulin therapy in type 2 diabetes - does a basal-bolus regimen suit all patients?

PubMed

Giugliano, D; Sieradzki, J; Stefanski, A; Gentilella, R

2016-08-01

Many patients with type 2 diabetes mellitus (T2DM) require insulin therapy. If basal insulin fails to achieve glycemic control, insulin intensification is one possible treatment intensification strategy. We summarized clinical data from randomized clinical trials designed to compare the efficacy and safety of basal-bolus and premixed insulin intensification regimens. We defined a between-group difference of ≥0.3% in end-of-study glycated hemoglobin (HbA1c) as clinically meaningful. A PubMed database search supplemented by author-identified papers yielded 15 trials which met selection criteria: randomized design, patients with T2DM receiving basal-bolus (bolus injection ≤3 times/day) vs. premixed (≤3 injections/day) insulin regimens, primary/major endpoint(s) HbA1c- and/or hypoglycemia-related, and trial duration ≥12 weeks. Glycemic control improved with both basal-bolus and premixed insulin regimens with - in most cases - acceptable levels of weight gain and hypoglycemia. A clinically meaningful difference between regimens in glycemic control was recorded in only four comparisons, all of which favored basal-bolus therapy. The incidence of hypoglycemia was significantly different between regimens in only three comparisons, one of which favored premixed insulin and two basal-bolus therapy. Of the four trials that reported a significant difference between regimens in bodyweight change, two favored basal-bolus therapy and two favored premixed insulin. Thus, on a population level, neither basal-bolus therapy nor premixed insulin showed a consistent advantage in terms of glycemic control, hypoglycemic risk, or bodyweight gain. It is therefore recommended that clinicians should adopt an individualized approach to insulin intensification - taking into account the benefits and risks of each treatment approach and the attitude and preferences of each patient - in the knowledge that both basal-bolus and premixed regimens may be successful.

Quality clinical placements: The perspectives of undergraduate nursing students and their supervising nurses.

PubMed

Ford, Karen; Courtney-Pratt, Helen; Marlow, Annette; Cooper, John; Williams, Danielle; Mason, Ron

2016-02-01

Clinical placement for students of nursing is a central component of tertiary nursing programs but continues to be a complex and multifaceted experience for all stakeholders. This paper presents findings from a longitudinal 3-year study across multiple sites within the Australian context investigating the quality of clinical placements. A study using cross-sectional survey. Acute care, aged care and subacute health care facilities. A total of 1121 Tasmanian undergraduate nursing students and 932 supervising ward nurses. Survey data were collected at completion of practicum from participating undergraduate students and supervising ward nurses across the domains of "welcome and belonging," "competence and confidence: reflections on learning," and "support for learning." In addition, free text comments were sought to further inform understandings of what constitutes quality clinical placements. Overwhelmingly quantitative data demonstrate high-quality clinical placements are provided. Analysis of free text responses indicates further attention to the intersect between the student and the supervising ward nurse is required, including the differing expectations that each holds for the other. While meaningful interpersonal interactions are pivotal for learning, these seemingly concentrated on the relationship between student and their supervisor-the patient/client was not seen to be present. Meaningful learning occurs within an environment that facilitates mutual respect and shared expectations. The role the patient has in student learning was not made obvious in the results and therefore requires further investigation. Copyright © 2015 Elsevier Ltd. All rights reserved.

A systematic review comparing sex differences in cognitive function in schizophrenia and in rodent models for schizophrenia, implications for improved therapeutic strategies.

PubMed

Leger, Marianne; Neill, Joanna C

2016-09-01

Sex is often overlooked in animal and human research. Cognitive impairment associated with schizophrenia (CIAS) remains an unmet clinical need, as current antipsychotic medication does not provide clinically meaningful improvements. One explanation could be lack of appreciation of gender differences in CIAS. Animal models play a critical role in drug development and improved translation to the clinic is an on-going process. Our systematic review aims to evaluate how well the animal studies translate into clinical findings. Supporting clinical results, our review highlights a male working memory advantage and a female advantage for visual memory and social cognition in rodent models for schizophrenia. Not investigated in animals, a female advantage for attention and speed of processing has been found in schizophrenia patients. Sex differences in reasoning and problem solving are poorly investigated in both human and animal studies. Overall, our review provides evidence of good translation from the animal models into the clinic when sexual dimorphism is assessed. Enhanced understanding of these sex differences will improve the management of CIAS. Copyright © 2016 Elsevier Ltd. All rights reserved.

How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

PubMed

Naci, Huseyin; Ioannidis, John P A

2015-01-01

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

A Qualitative Exploration of a Clinical Ethicist's Role and Contributions During Family Meetings.

PubMed

Bruce, Courtenay R; Bibler, Trevor M; Pena, Adam M; Kusin, Betsy

2016-12-01

Despite the interpersonal nature of family meetings and the frequency in which they occur, the clinical ethics literature is devoid of any rich descriptions of what clinical ethicists should actually be doing during family meetings. Here, we propose a framework for describing and understanding "transitioning" facilitation skills based on a retrospective review of our internal documentation of 100 consecutive cases (June 01, 2013-December 31, 2014) wherein a clinical ethicist facilitated at least one family meeting. The internal documents were analyzed using qualitative methodologies, i.e., "codes", to identify emergent themes. We identified four different transitioning strategies clinical ethicists use to reach a meaningful resolution. These transitioning strategies serve as a jumping-off point for additional analyses, future research, evaluating clinical ethics consultation, and overall performance improvement of a consultation service.

Food Environment and Weight Change: Does Residential Mobility Matter?

PubMed Central

Laraia, Barbara A.; Downing, Janelle M.; Zhang, Y. Tara; Dow, William H.; Kelly, Maggi; Blanchard, Samuel D.; Adler, Nancy; Schillinger, Dean; Moffet, Howard; Warton, E. Margaret; Karter, Andrew J.

2017-01-01

Abstract Associations between neighborhood food environment and adult body mass index (BMI; weight (kg)/height (m)2) derived using cross-sectional or longitudinal random-effects models may be biased due to unmeasured confounding and measurement and methodological limitations. In this study, we assessed the within-individual association between change in food environment from 2006 to 2011 and change in BMI among adults with type 2 diabetes using clinical data from the Kaiser Permanente Diabetes Registry collected from 2007 to 2011. Healthy food environment was measured using the kernel density of healthful food venues. Fixed-effects models with a 1-year-lagged BMI were estimated. Separate models were fitted for persons who moved and those who did not. Sensitivity analysis using different lag times and kernel density bandwidths were tested to establish the consistency of findings. On average, patients lost 1 pound (0.45 kg) for each standard-deviation improvement in their food environment. This relationship held for persons who remained in the same location throughout the 5-year study period but not among persons who moved. Proximity to food venues that promote nutritious foods alone may not translate into clinically meaningful diet-related health changes. Community-level policies for improving the food environment need multifaceted strategies to invoke clinically meaningful change in BMI among adult patients with diabetes. PMID:28387785

The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

PubMed

Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

2017-02-01

The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Meta-analysis of first-line therapies with maintenance regimens for advanced non-small-cell lung cancer (NSCLC) in molecularly and clinically selected populations.

PubMed

Tan, Pui San; Bilger, Marcel; de Lima Lopes, Gilberto; Acharyya, Sanchalika; Haaland, Benjamin

2017-08-01

Evidence has suggested survival benefits of maintenance for advanced NSCLC patients not progressing after first-line chemotherapy. Additionally, particular first-line targeted therapies have shown survival improvements in selected populations. Optimal first-line and maintenance therapies remain unclear. Here, currently available evidence was synthesized to elucidate optimal first-line and maintenance therapy within patient groups. Literature was searched for randomized trials evaluating first-line and maintenance regimens in advanced NSCLC patients. Bayesian network meta-analysis was performed within molecularly and clinically selected groups. The primary outcome was combined clinically meaningful OS and PFS benefits. A total of 87 records on 56 trials evaluating first-line treatments with maintenance were included. Results showed combined clinically meaningful OS and PFS benefits with particular first-line with maintenance treatments, (1) first-line intercalated chemotherapy+erlotinib, maintenance erlotinib in patients with EGFR mutations, (2) first-line afatinib, maintenance afatinib in patients with EGFR deletion 19, (3) first-line chemotherapy + bevacizumab, maintenance bevacizumab in EGFR wild-type patients, (4) chemotherapy+conatumumab, maintenance conatumumab in patients with squamous histology, (5) chemotherapy+cetuximab, maintenance cetuximab or chemotherapy + necitumumab, maintenance necitumumab in EGFR FISH-positive patients with squamous histology, and (6) first-line chemotherapy+bevacizumab, maintenance bevacizumab or first-line sequential chemotherapy+gefitinib, maintenance gefitinib in patients clinically enriched for EGFR mutations with nonsquamous histology. No treatment showed combined clinically meaningful OS and PFS benefits in patients with EGFR L858R or nonsquamous histology. Particular first-line with maintenance treatments show meaningful OS and PFS benefits in patients selected by EGFR mutation or histology. Further research is needed to achieve effective therapy for patients with EGFR mutation L858R or nonsquamous histology. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Impacts of EHR Certification and Meaningful Use Implementation on an Integrated Delivery Network.

PubMed

Bowes, Watson A

2014-01-01

Three years ago Intermountain Healthcare made the decision to participate in the Medicare and Medicaid Electronic Heath Record (EHR) Incentive Program which required that hospitals and providers use a certified EHR in a meaningful way. At that time, the barriers to enhance our home grown system, and change clinician workflows were numerous and large. This paper describes the time and effort required to enhance our legacy systems in order to pass certification, including filling 47 gaps in (EHR) functionality. We also describe the processes and resources that resulted in successful changes to many clinical workflows required by clinicians to meet meaningful use requirements. In 2011 we set meaningful use targets of 75% of employed physicians and 75% of our hospitals to meet Stage 1 of meaningful use by 2013. By the end of 2013, 87% of 696 employed eligible professionals and 100% of 22 Intermountain hospitals had successfully attested for Stage 1. This paper describes documented and perceived costs to Intermountain including time, effort, resources, postponement of other projects, as well as documented and perceived benefits of attainment of meaningful use.

Patient participation in ERS guidelines and research projects: the EMBARC experience

PubMed Central

Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-01-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. Educational aims To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects. PMID:28894480

Patient participation in ERS guidelines and research projects: the EMBARC experience.

PubMed

Chalmers, James D; Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-09-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities.To understand the barriers and potential solutions to these barriers from a physician's perspective, in order to ensure meaningful patient involvement in clinical projects.To understand the barriers and potential solutions from a patient's perspective, in order to meaningfully involve patients in clinical projects.

Artificial intelligence in medicine.

PubMed Central

Ramesh, A. N.; Kambhampati, C.; Monson, J. R. T.; Drew, P. J.

2004-01-01

INTRODUCTION: Artificial intelligence is a branch of computer science capable of analysing complex medical data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical scenarios. METHODS: Medline and internet searches were carried out using the keywords 'artificial intelligence' and 'neural networks (computer)'. Further references were obtained by cross-referencing from key articles. An overview of different artificial intelligent techniques is presented in this paper along with the review of important clinical applications. RESULTS: The proficiency of artificial intelligent techniques has been explored in almost every field of medicine. Artificial neural network was the most commonly used analytical tool whilst other artificial intelligent techniques such as fuzzy expert systems, evolutionary computation and hybrid intelligent systems have all been used in different clinical settings. DISCUSSION: Artificial intelligence techniques have the potential to be applied in almost every field of medicine. There is need for further clinical trials which are appropriately designed before these emergent techniques find application in the real clinical setting. PMID:15333167

Artificial intelligence in medicine.

PubMed

Ramesh, A N; Kambhampati, C; Monson, J R T; Drew, P J

2004-09-01

Artificial intelligence is a branch of computer science capable of analysing complex medical data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical scenarios. Medline and internet searches were carried out using the keywords 'artificial intelligence' and 'neural networks (computer)'. Further references were obtained by cross-referencing from key articles. An overview of different artificial intelligent techniques is presented in this paper along with the review of important clinical applications. The proficiency of artificial intelligent techniques has been explored in almost every field of medicine. Artificial neural network was the most commonly used analytical tool whilst other artificial intelligent techniques such as fuzzy expert systems, evolutionary computation and hybrid intelligent systems have all been used in different clinical settings. Artificial intelligence techniques have the potential to be applied in almost every field of medicine. There is need for further clinical trials which are appropriately designed before these emergent techniques find application in the real clinical setting.

Clinical Decision Support: Effectiveness in Improving Quality Processes and Clinical Outcomes and Factors That May Influence Success

PubMed Central

Murphy, Elizabeth V.

2014-01-01

The use of electronic health records has skyrocketed following the 2009 HITECH Act, which provides financial incentives to health care providers for the “meaningful use” of electronic medical record systems. An important component of the “Meaningful Use” legislation is the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study. PMID:24910564

Determining the longitudinal validity and meaningful differences in HRQL of the PedsQL™ Sickle Cell Disease Module.

PubMed

Panepinto, Julie A; Paul Scott, J; Badaki-Makun, Oluwakemi; Darbari, Deepika S; Chumpitazi, Corrie E; Airewele, Gladstone E; Ellison, Angela M; Smith-Whitley, Kim; Mahajan, Prashant; Sarnaik, Sharada A; Charles Casper, T; Cook, Larry J; Leonard, Julie; Hulbert, Monica L; Powell, Elizabeth C; Liem, Robert I; Hickey, Robert; Krishnamurti, Lakshmanan; Hillery, Cheryl A; Brousseau, David C

2017-06-12

Detecting change in health status over time and ascertaining meaningful changes are critical elements when using health-related quality of life (HRQL) instruments to measure patient-centered outcomes. The PedsQL™ Sickle Cell Disease module, a disease specific HRQL instrument, has previously been shown to be valid and reliable. Our objectives were to determine the longitudinal validity of the PedsQL™ Sickle Cell Disease module and the change in HRQL that is meaningful to patients. An ancillary study was conducted utilizing a multi-center prospective trial design. Children ages 4-21 years with sickle cell disease admitted to the hospital for an acute painful vaso-oclusive crisis were eligible. Children completed HRQL assessments at three time points (in the Emergency Department, one week post-discharge, and at return to baseline (One to three months post-discharge). The primary outcome was change in HRQL score. Both distribution (effect size, standard error of measurement (SEM)) and anchor (global change assessment) based methods were used to determine the longitudinal validity and meaningful change in HRQL. Changes in HRQL meaningful to patients were identified by anchoring the change scores to the patient's perception of global improvement in pain. Moderate effect sizes (0.20-0.80) were determined for all domains except the Communication I and Cognitive Fatigue domains. The value of 1 SEM varied from 3.8-14.6 across all domains. Over 50% of patients improved by at least 1 SEM in Total HRQL score. A HRQL change score of 7-10 in the pain domains represented minimal perceived improvement in HRQL and a HRQL change score of 18 or greater represented moderate to large improvement. The PedsQL™ Sickle Cell Disease Module is responsive to changes in HRQL in patients experiencing acute painful vaso-occlusive crises. The study data establish longitudinal validity and meaningful change parameters for the PedsQL™ Sickle Cell Disease Module. ClinicalTrials.gov (study identifier: NCT01197417 ). Date of registration: 08/30/2010.

Anchoring the Panic Disorder Severity Scale

ERIC Educational Resources Information Center

Keough, Meghan E.; Porter, Eliora; Kredlow, M. Alexandra; Worthington, John J.; Hoge, Elizabeth A.; Pollack, Mark H.; Shear, M. Katherine; Simon, Naomi M.

2012-01-01

The Panic Disorder Severity Scale (PDSS) is a clinician-administered measure of panic disorder symptom severity widely used in clinical research. This investigation sought to provide clinically meaningful anchor points for the PDSS both in terms of clinical severity as measured by the Clinical Global Impression-Severity Scale (CGI-S) and to extend…

Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture

PubMed Central

Carruthers, Alastair; Hardas, Bhushan; Murphy, Diane K.; Carruthers, Jean; Jones, Derek; Sykes, Jonathan M.; Creutz, Lela; Marx, Ann; Dill, Sara

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96–1.23] for clinically different image pairs and 0.53 [0.38–0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness. PMID:27661744

Clinical Pharmacokinetics and Pharmacodynamics of Saxagliptin, a Dipeptidyl Peptidase-4 Inhibitor.

PubMed

Boulton, David W

2017-01-01

Saxagliptin is an orally active, highly potent, selective and competitive dipeptidyl peptidase (DPP)-4 inhibitor used in the treatment of type 2 diabetes mellitus at doses of 2.5 or 5 mg once daily. DPP-4 is responsible for degrading the intestinally derived hormones glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP). Inhibition of DPP-4 increases intact plasma GLP-1 and GIP concentrations, augmenting glucose-dependent insulin secretion. Both saxagliptin and its major active metabolite, 5-hydroxy saxagliptin, demonstrate high degrees of selectivity for DPP-4 compared with other DPP enzymes. Saxagliptin is orally absorbed and can be administered with or without food. The half-life of plasma DPP-4 inhibition with saxagliptin 5 mg is ~27 h, which supports a once-daily dosing regimen. Saxagliptin is metabolized by cytochrome P450 (CYP) 3A4/5 and is eliminated by a combination of renal and hepatic clearance. No clinically meaningful differences in saxagliptin or 5-hydroxy saxagliptin pharmacokinetics have been detected in patients with hepatic impairment. No clinically meaningful differences in saxagliptin or 5-hydroxy saxagliptin pharmacokinetics have been detected in patients with mild renal impairment, whereas dose reduction is recommended in patients with moderate or severe renal impairment because of greater systemic exposure [the area under the plasma concentration-time curve (AUC)] to saxagliptin total active moieties. Clinically relevant drug-drug interactions have not been detected; however, limiting the dose to 2.5 mg once daily is recommended in the USA when saxagliptin is coadministered with strong CYP inhibitors, because of increased saxagliptin exposure. In summary, saxagliptin has a predictable pharmacokinetic and pharmacodynamic profile.

Evaluation of the measurement model and clinically important differences for menopause-specific quality of life associated with bazedoxifene/conjugated estrogens.

PubMed

Bushmakin, Andrew G; Abraham, Lucy; Pinkerton, JoAnn V; Cappelleri, Joseph C; Mirkin, Sebastian

2014-08-01

This study aims to confirm the factor structure of the Menopause-Specific Quality of Life (MENQOL) questionnaire by using confirmatory factor analysis (CFA) and to determine whether improvements in menopause-specific health-related quality of life (HRQOL) observed with bazedoxifene (BZA)/conjugated estrogens (CE) relative to placebo are clinically meaningful. Postmenopausal women with seven or more moderate to severe hot flushes per day (or ≥50 per wk) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire, respectively. The structure of the MENQOL questionnaire was evaluated using CFA. To estimate clinically important differences (CIDs) in HRQOL, we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors. The CFA model fits the MENQOL data (Bentler's comparative fit index >0.9). CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score. Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID, as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo. CFA confirms the factor structure of the MENQOL questionnaire. Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms.

Evaluating meaningful learning using concept mapping in dental hygiene education: a pilot study.

PubMed

Canasi, Dina M; Amyot, Cynthia; Tira, Daniel

2014-02-01

Concept mapping, as a teaching strategy, has been shown to promote critical thinking and problem solving in educational settings. Dental clinicians must distinguish between critical and irrelevant characteristics in the delivery of care, thus necessitating reasoning skills to do so. One of the aims of the American Dental Education Association Commission on Change and Innovation (ADEA-CCI) is to identify deficiencies in curriculum which were meant to improve critical thinking and problem solving skills necessary in clinical practice. The purpose of this study was to compare 2 teaching strategies, traditional lecture and lecture supported by concept mapping exercises within collaborative working groups, to determine if there is a beneficial effect on meaningful learning. For this pilot study, the study population consisted of students from 2 geographically separated associate level dental hygiene programs in the southeastern U.S. A quasi-experimental control group pre- and post-test design was used. The degree of meaningful learning achieved by both programs was assessed by comparing pre- and post-test results. Both programs experienced a significant degree of meaningful learning from pre- to post-test. However, there was no statistically significant difference between the programs on the post-test. These results were in direct contrast to research in other disciplines on concept mapping and its effect on promoting meaningful learning. Further investigation into the study's outcome was obtained through a follow-up focus group. In spite of careful attention to methodology in the development of this research project, the focus group illuminated methodological failings that potentially impacted the outcome of the study. Recommendations are underscored for future conduct of educational research of this kind.

Preliminary efficacy of service dogs as a complementary treatment for posttraumatic stress disorder in military members and veterans.

PubMed

O'Haire, Marguerite E; Rodriguez, Kerri E

2018-02-01

Psychiatric service dogs are an emerging complementary treatment for military members and veterans with posttraumatic stress disorder (PTSD). Yet despite anecdotal accounts of their value, there is a lack of empirical research on their efficacy. The current proof-of-concept study assessed the effects of this practice. A nonrandomized efficacy trial was conducted with 141 post-9/11 military members and veterans with PTSD to compare usual care alone (n = 66) with usual care plus a trained service dog (n = 75). The primary outcome was longitudinal change on The PTSD Checklist (PCL; Weathers, Litz, Herman, Huska, & Keane, 1993), including data points from a cross-sectional assessment and a longitudinal record review. Secondary outcomes included cross-sectional differences in depression, quality of life, and social and work functioning. Mixed-model analyses revealed clinically significant reductions in PTSD symptoms from baseline following the receipt of a service dog, but not while receiving usual care alone. Though clinically meaningful, average reductions were not below the diagnostic cutoff on the PCL. Regression analyses revealed significant differences with medium to large effect sizes among those with service dogs compared with those on the waitlist, including lower depression, higher quality of life, and higher social functioning. There were no differences in employment status, but there was lower absenteeism because of health among those who were employed. The addition of trained service dogs to usual care may confer clinically meaningful improvements in PTSD symptomology for military members and veterans with PTSD, though it does not appear to be associated with a loss of diagnosis. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Time-to-first-event versus recurrent-event analysis: points to consider for selecting a meaningful analysis strategy in clinical trials with composite endpoints.

PubMed

Rauch, Geraldine; Kieser, Meinhard; Binder, Harald; Bayes-Genis, Antoni; Jahn-Eimermacher, Antje

2018-05-01

Composite endpoints combining several event types of clinical interest often define the primary efficacy outcome in cardiologic trials. They are commonly evaluated as time-to-first-event, thereby following the recommendations of regulatory agencies. However, to assess the patient's full disease burden and to identify preventive factors or interventions, subsequent events following the first one should be considered as well. This is especially important in cohort studies and RCTs with a long follow-up leading to a higher number of observed events per patients. So far, there exist no recommendations which approach should be preferred. Recently, the Cardiovascular Round Table of the European Society of Cardiology indicated the need to investigate "how to interpret results if recurrent-event analysis results differ […] from time-to-first-event analysis" (Anker et al., Eur J Heart Fail 18:482-489, 2016). This work addresses this topic by means of a systematic simulation study. This paper compares two common analysis strategies for composite endpoints differing with respect to the incorporation of recurrent events for typical data scenarios motivated by a clinical trial. We show that the treatment effects estimated from a time-to-first-event analysis (Cox model) and a recurrent-event analysis (Andersen-Gill model) can systematically differ, particularly in cardiovascular trials. Moreover, we provide guidance on how to interpret these results and recommend points to consider for the choice of a meaningful analysis strategy. When planning trials with a composite endpoint, researchers, and regulatory agencies should be aware that the model choice affects the estimated treatment effect and its interpretation.

Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.

PubMed

Brantingham, James W; Parkin-Smith, Gregory; Cassa, Tammy Kay; Globe, Gary A; Globe, Denise; Pollard, Henry; deLuca, Katie; Jensen, Muffit; Mayer, Stephan; Korporaal, Charmaine

2012-02-01

To determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA). Parallel-group randomized trial with 3-month follow-up. Two chiropractic outpatient teaching clinics. Convenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively. Participants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period. Western Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes. Total dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively). There were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Chamomile (Matricaria recutita) may provide antidepressant activity in anxious, depressed humans: an exploratory study.

PubMed

Amsterdam, Jay D; Shults, Justine; Soeller, Irene; Mao, Jun James; Rockwell, Kenneth; Newberg, Andrew B

2012-01-01

Anxiety and depression are the most commonly reported psychiatric conditions and frequently occur as comorbid disorders. While the advent of conventional drug therapies has simplified treatment, a large segment of the population goes untreated or declines conventional therapy for financial, cultural, or personal reasons. Therefore, the identification of inexpensive and effective alternative therapies for anxiety and depression is of relevance to public health. The current study explores data from a 2009 clinical chamomile trial in humans to determine if chamomile provides clinically meaningful antidepressant activity versus a placebo. In the 2009 randomized, double-blind, placebo-controlled study, the research team examined the antianxiety and antidepressant action of oral chamomile (Matricaria recutita) extract in participants with symptoms of comorbid anxiety and depression. In the 2009 study, all of participants' evaluations took place at the Depression Research Unit at the University of Pennsylvania. The study drew participants from patients at the Department of Family Medicine and Community Health's primary care clinic at the University of Pennsylvania, Philadelphia. Of the 57 participants in the 2009 trial, 19 had anxiety with comorbid depression; 16 had anxiety with a past history of depression; and 22 had anxiety with no current or past depression. The intervention and placebo groups in the 2009 trial received identically appearing 220-mg capsules containing either pharmaceutical-grade chamomile extract standardized to a content of 1.2% apigenin or a placebo (ie, lactose monohydrate NF), respectively. In the current study, the research team used generalized estimating equations analysis to identify clinically meaningful changes over time in scores from the Hamilton Depression Rating (HAM-D) questionnaire among treatment groups. In the current study, the research team observed a significantly greater reduction over time in total HAM-D scores for chamomile vs placebo in all participants (P < .05). The team also observed a clinically meaningful but nonsignificant trend for a greater reduction in total HAM-D scores for chamomile vs placebo in participants with current comorbid depression (P = .062). When the team examined the HAM-D core mood item scores, it observed a significantly greater reduction over time for chamomile vs placebo in all participants (P < .05) and a clinically meaningful but nonsignificant trend for a greater reduction over time for chamomile vs placebo in participants without current or past depression (P = .06). Chamomile may provide clinically meaningful antidepressant activity that occurs in addition to its previously observed anxiolytic activity.

Meaningful use: a roadmap for the advancement of health information exchange

PubMed Central

2013-01-01

Frankel and colleagues have compared Israel and the U.S.’s experiences with health information exchange (HIE). They highlight the importance of institutional factors in fostering HIE development, notably the influence of local structures, experience and incentives. Historically, information infrastructure in the U.S. has been limited due to lack of standards, fragmented institutions and competition. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorized billions of dollars for the adoption and “Meaningful Use” of electronic health records. HITECH programs and Meaningful Use incentives target the advancement of HIE through 1) building blocks, 2) local support and 3) payment incentives. Meaningful Use requirements create a roadmap to broader electronic exchange of health information among providers and with patients. Ultimately, successful HIE in the U.S. will depend on whether Meaningful Use can address institutional needs within local markets. This is a commentary on http://www.ijhpr.org/content/2/1/722 PMID:23880399

A Mixed-Methods Study of the Recovery Concept, "A Meaningful Day," in Community Mental Health Services for Individuals with Serious Mental Illnesses.

PubMed

Myers, Neely A L; Smith, Kelly; Pope, Alicia; Alolayan, Yazeed; Broussard, Beth; Haynes, Nora; Compton, Michael T

2016-10-01

The recovery concept encompasses overcoming or managing one's illness, being physically and emotionally healthy, and finding meaningful purpose through work, school, or volunteering, which connects one to others in mutually fulfilling ways. Using a mixed-methods approach, we studied the emphasis on "a meaningful day" in the new Opening Doors to Recovery (ODR) program in southeast Georgia. Among 100 participants, we measured the meaningful day construct using three quantitative items at baseline (hospital discharge) and at 4-, 8-, and 12-month follow-up, finding statistically significant linear trends over time for all three measures. Complementary qualitative interviews with 30 individuals (ODR participants, family members, and ODR's Community Navigation Specialists and program leaders) revealed themes pertaining to companionship, productivity, achieving stability, and autonomy, as well as the concern about insufficient resources. The concept of "a meaningful day" can be a focus of clinical attention and measured as a person-centered outcome for clients served by recovery-oriented community mental health services.

Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

PubMed

Kemp, Robert; Prasad, Vinay

2017-07-21

Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak. Attempts to validate surrogates are rarely undertaken. When this is done, validation relies on only a fraction of available data, and often concludes that the surrogate is poor. Post-marketing studies, designed to ensure drugs have meaningful benefits, are often not performed. Alternatively, if a drug fails to improve quality of life or overall survival, market authorization is rarely revoked. We suggest this reliance on surrogates, and the imprecision surrounding their acceptable use, means that numerous drugs are now approved based on small yet statistically significant increases in surrogates of questionable reliability. In turn, this means the benefits of many approved drugs are uncertain. This is an unacceptable situation for patients and professionals, as prior experience has shown that such uncertainty can be associated with significant harm. The use of surrogate outcomes should be limited to situations where a surrogate has demonstrated robust ability to predict meaningful benefits, or where cases are dire, rare or with few treatment options. In both cases, surrogates must be used only when continuing studies examining hard endpoints have been fully recruited.

Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care.

PubMed

Kolotkin, Ronette L; Corey-Lisle, Patricia K; Crosby, Ross D; Kan, Hong J; McQuade, Robert D

2008-12-01

This is a secondary analysis of clinical trial data collected in 12 European countries. We examined changes in weight and weight-related quality of life among community patients with schizophrenia treated with aripiprazole (ARI) versus standard of care (SOC), consisting of other marketed atypical antipsychotics (olanzapine, quetiapine, and risperidone). Five-hundred and fifty-five patients whose clinical symptoms were not optimally controlled and/or experienced tolerability problems with current medication were randomized to ARI (10-30 mg/day) or SOC. Weight and weight-related quality of life (using the IWQOL-Lite) were assessed at baseline, and weeks 8, 18 and 26. Random regression analysis across all time points using all available data was used to compare groups on changes in weight and IWQOL-Lite. Meaningful change from baseline was also assessed. Participants were 59.7% male, with a mean age of 38.5 years (SD 10.9) and mean baseline body mass index of 27.2 (SD 5.1). ARI participants lost an average of 1.7% of baseline weight in comparison to a gain of 2.1% by SOC participants (p<0.0001) at 26 weeks. ARI participants experienced significantly greater increases in physical function, self-esteem, sexual life, and IWQOL-Lite total score. At 26 weeks, 20.7% of ARI participants experienced meaningful improvements in IWQOL-Lite score, versus 13.5% of SOC participants. A clinically meaningful change in weight was also associated with a meaningful change in quality of life (p<0.001). A potential limitation of this study was its funding by a pharmaceutical company. Compared to standard of care, patients with schizophrenia treated with aripiprazole experienced decreased weight and improved weight-related quality of life over 26 weeks. These changes were both statistically and clinically significant.

Clinical development of CT-P10 and other biosimilar cancer therapeutics.

PubMed

Kim, Won Seog; Coiffier, Bertrand; Kwon, Hyuk-Chan; Kim, SuYeon

2017-05-01

Biosimilars are highly similar versions of approved biologic drugs that may confer equivalent efficacy at a reduced cost. Patents for several biological cancer therapeutics are past or approaching expiry, presenting an opportunity to increase affordability and global accessibility of key drugs through the development of biosimilars. To receive approval, a biosimilar must show no clinically meaningful differences from the reference product in terms of efficacy or safety. The first monoclonal antibody biosimilar cancer therapeutic to gain approval was CT-P10, a biosimilar of rituximab. Here, we review the oncology clinical development program for CT-P10, providing insights into the rationale for, and design of, CT-P10 clinical trials in patients with cancer. Trials of biosimilar cancer therapeutics in development are also discussed.

The Interrelationship of Common Clinical Movement Screens: Establishing Population-Specific Norms in a Large Cohort of Military Applicants

PubMed Central

de la Motte, Sarah J.; Gribbin, Timothy C.; Lisman, Peter; Beutler, Anthony I.; Deuster, Patricia

2016-01-01

Context: Musculoskeletal injuries (MSK-Is) are a leading cause of missed duty time and morbidity in the military. Modifiable risk factors for MSK-Is, such as inadequate core stability, poor movement patterns, and dynamic balance deficits, have not been identified in military applicants on entering service. Objective: To establish normative functional movement data using a series of screens in military applicants entering basic training and explore relationships among several movement tests. Design: Cross-sectional study. Setting: Military Entrance Processing Station. Patients or Other Participants: A total of 1714 (1434 male, 280 female) military applicants entering the US Army (n = 546), Navy (n = 414), Air Force (n = 229), or Marine Corps (n = 525). Intervention(s): We conducted the Functional Movement Screen (FMS), Y-Balance Test (YBT), overhead squat (OHS), and Landing Error Scoring System (LESS). Movements were assessed using the scoring convention for each screen. Main Outcome Measure(s): The FMS, YBT, OHS, and LESS scores and associations among the movement screens as well as clinical meaningfulness. Results: A total of 1037 of the 1714 enrolled applicants were screened on the day they left for basic training. Normative means for this population were established: FMS = 14.7 ± 1.8, YBT anterior-reach difference = 3.1 ± 3.0 cm, mean YBT composite differences = 8.0 ± 6.8 cm, mean YBT composite percentage = 90.9% ± 8.3%, OHS errors = 5.0 ± 2.8, and LESS score = 5.7 ± 2.1. Backward regression results revealed that the YBT composite percentage was related to the FMS and OHS scores in males and to the FMS and LESS results in females. However, clinically meaningful relationships between the tests varied for both males and females. Conclusions: Sex-normative values for the FMS, YBT, OHS, and LESS screens were established for US military applicants, and some of the assessments overlapped. Overall, males performed better on the OHS and LESS and achieved a greater YBT composite percentage than females. The regression results revealed movement screen performance relationships that varied by sex and clinical meaningfulness. In future studies, we will determine if performance on any of the screens is associated with MSK-Is in basic trainees. PMID:27831746

Manifest Content in the Dreams of Clinical Populations.

ERIC Educational Resources Information Center

Mellen, Ronald R.; And Others

1993-01-01

Reviews relevant literature to examine relationships between dream content and diagnosis of clinical populations. Although many clinical populations remain unexamined in terms of meaningful characterizations of their dream life, relationship between manifest content and differential diagnosis is noted and generalizations are offered for different…

Cortical visual prostheses: from microstimulation to functional percept

NASA Astrophysics Data System (ADS)

Najarpour Foroushani, Armin; Pack, Christopher C.; Sawan, Mohamad

2018-04-01

Cortical visual prostheses are intended to restore vision by targeted electrical stimulation of the visual cortex. The perception of spots of light, called phosphenes, resulting from microstimulation of the visual pathway, suggests the possibility of creating meaningful percept made of phosphenes. However, to date electrical stimulation of V1 has still not resulted in perception of phosphenated images that goes beyond punctate spots of light. In this review, we summarize the clinical and experimental progress that has been made in generating phosphenes and modulating their associated perceptual characteristics in human and macaque primary visual cortex (V1). We focus specifically on the effects of different microstimulation parameters on perception and we analyse key challenges facing the generation of meaningful artificial percepts. Finally, we propose solutions to these challenges based on the application of supervised learning of population codes for spatial stimulation of visual cortex.

Steps to Health employee weight management randomized control trial: short-term follow-up results.

PubMed

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2015-02-01

To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

A note on sample size calculation for mean comparisons based on noncentral t-statistics.

PubMed

Chow, Shein-Chung; Shao, Jun; Wang, Hansheng

2002-11-01

One-sample and two-sample t-tests are commonly used in analyzing data from clinical trials in comparing mean responses from two drug products. During the planning stage of a clinical study, a crucial step is the sample size calculation, i.e., the determination of the number of subjects (patients) needed to achieve a desired power (e.g., 80%) for detecting a clinically meaningful difference in the mean drug responses. Based on noncentral t-distributions, we derive some sample size calculation formulas for testing equality, testing therapeutic noninferiority/superiority, and testing therapeutic equivalence, under the popular one-sample design, two-sample parallel design, and two-sample crossover design. Useful tables are constructed and some examples are given for illustration.

Normal, Problematic and Compulsive Consumption of Sexually Explicit Media: Clinical Findings using the Compulsive Pornography Consumption (CPC) Scale among Men who have Sex with Men

PubMed Central

Rosser, B. R. Simon; Noor, Syed WB; Iantaffi, Alex

2015-01-01

To assess problematic sexually explicit media (SEM) consumption, and to identify clinically meaningful cut-off points, we examined clinical correlates using the new Compulsive Pornography Consumption (CPC) scale among 1165 participating MSM. Building on scale practices in measuring compulsive sexual behavior, two cut-off points were identified. While most (76-80%) MSM do not report compulsive symptoms, about 16-20% report levels of problematic SEM consumption, including 7% with extreme scores consistent with DSM criteria for compulsive disorders. Demographic, sexual, and HIV risk differences were identified between the three groups. Researchers and clinicians are encouraged to consider using the CPC scale for comprehensive assessment of compulsive sexual behavior. PMID:26167109

Is the Meaningful Use Venous Thromboembolism VTE-6 Measure Meaningful? A Retrospective Analysis of One Hospital's VTE-6 Cases.

PubMed

Farrow, Norma E; Lau, Brandyn D; JohnBull, Eric A; Hobson, Deborah B; Kraus, Peggy S; Taffe, Elizabeth R; Shaffer, Dauryne L; Popoola, Victor O; Streiff, Michael B; Pronovost, Peter J; Haut, Elliott R

2016-09-01

Venous thromboembolism (VTE) is a common, often deadly cause of preventable harm for hospitalized patients. The Centers for Medicare & Medicaid Services Meaningful Use VTE-6 measure automatically captures data documented in a Meaningful Use-certified electronic health record (EHR) to identify patients with potentially preventable VTE, defined as those who developed radiologically confirmed, in-hospital VTE and did not receive prophylaxis between admission and the day prior to the diagnostic test order date. The validity of the Meaningful Use VTE-6 measure was assessed by reviewing the quality of VTE prophylaxis provided to patients identified by the measure. A retrospective chart review was performed on all patients identified by VTE-6 during the first year of Meaningful Use Stage 1. The following information was abstracted from the Meaningful Use-certified EHR: patient demographics, clinical data, VTE prophylaxis prescribed and administered, and diagnostic testing. These data were then analyzed to assess prevention efforts prior to each VTE event and identify potential targets for improvement. Fifteen patients were identified as having sustained potentially preventable VTE by the Meaningful Use VTE-6 measure. Nine (60%) of the 15 patients identified were false positives and did not meet the rationale of the measure. For only 6 (40%) of the 15 patients was VTE considered to be truly potentially preventable; those patients provided targets for quality improvement measures. The majority of patients identified by the Meaningful Use VTE-6 algorithm did not suffer truly potentially preventable VTE. Misclassification of VTE as "potentially preventable" hinders efforts to target true opportunities for quality improvement.

The deficit syndrome of schizophrenia: towards heterogeneity.

PubMed

Thibaut, F; Petit, M

1997-01-01

Since the turn of the century, psychiatrists have been concerned with both the unity and diversity of schizophrenia. From these early descriptions until now, many authors have attempted to delineate clinically meaningful subtypes within this disorder. In this connection, negative/positive subtyping has generated great interest. Carpenter and his team have emphasized the origin of the negative symptoms observed. They have proposed that primary enduring negative symptoms should be distinguished from transient negative symptoms resulting from treatment, depression or social deprivation and should be termed deficit symptoms. The validity of this subtyping is supported by clinical, biochemical or electrophysiological studies showing differences between deficit and nondeficit patients.

Relation of intelligence to ego functioning in an adult psychiatric population.

PubMed

Allen, J G; Coyne, L; David, E

1986-01-01

Wechsler Adult Intelligence Scale-Revised (WAIS-R) IQs and clinical ratings of 10 ego functions in a diagnostically heterogeneous sample of 60 adult psychiatric inpatients were correlated. With severity of pathology statistically controlled, higher intelligence was associated with more adequate ego functioning in several spheres: primary autonomous functions, thought processes, object relations, and mastery-competence. There were also some clinically meaningful differences between the Verbal and Performance IQs in the pattern of correlations. Extending Hartmann's original views, the authors employ an ethological framework to conceptualize intelligence in relation to the ego's role in adaptation, emphasizing that intelligence is an important-albeit neglected-aspect of ego functioning.

Chamomile (Matricaria recutita) May Have Antidepressant Activity in Anxious Depressed Humans - An Exploratory Study

PubMed Central

Amsterdam, Jay D.; Shults, Justine; Soeller, Irene; Mao, Jun James; Rockwell, Kenneth; Newberg, Andrew B.

2013-01-01

Objective As part of a randomized, double-blind, placebo-controlled study, we examined the antidepressant action of oral chamomile (Matricaria recutita) extract in subjects with co-morbid anxiety and depression symptoms. We hypothesized that chamomile may demonstrate a clinically meaningful antidepressant activity versus placebo. Methods 57 subjects received either chamomile extract or placebo therapy. Nineteen subjects had anxiety with co-morbid depression, 16 had anxiety with past history of depression, and 22 had anxiety with no current or past depression. Generalized estimating equations analysis was used to identify clinically meaningful changes over time in Hamilton Depression Rating (HAM-D) rating outcome measures among treatment groups. Results We observed a significantly greater reduction in mean total HAM-D scores (p<0.05) and HAM-D core depression item score (p<0.05) for chamomile versus placebo in all subjects, and a non-significant trend for a greater reduction in HAM-D core depression score for chamomile versus placebo in subjects with anxiety with current co-morbid depression (p=0.062). Conclusion Chamomile may have clinically meaningful antidepressant activity that occurs in addition to its previously observed anxiolytic activity. PMID:22894890

Psychometric properties of the Numeric Pain Rating Scale and Neck Disability Index in patients with cervicogenic headache.

PubMed

Young, Ian A; Dunning, James; Butts, Raymond; Cleland, Joshua A; Fernández-de-Las-Peñas, César

2018-01-01

Background Self-reported disability and pain intensity are commonly used outcomes in patients with cervicogenic headaches. However, there is a paucity of psychometric evidence to support the use of these self-report outcomes for individuals treated with cervicogenic headaches. Therefore, it is unknown if these measures are reliable, responsive, or result in meaningful clinically important changes in this patient population. Methods A secondary analysis of a randomized clinical trial (n = 110) examining the effects of spinal manipulative therapy with and without exercise in patients with cervicogenic headaches. Reliability, construct validity, responsiveness and thresholds for minimal detectable change and clinically important difference values were calculated for the Neck Disability Index and Numeric Pain Rating Scale. Results The Neck Disability Index exhibited excellent reliability (ICC = 0.92; [95 % CI: 0.46-0.97]), while the Numeric Pain Rating Scale exhibited moderate reliability (ICC = 0.72; [95 % CI: 0.08-0.90]) in the short term. Both instruments also exhibited adequate responsiveness (area under the curve; range = 0.78-0.93) and construct validity ( p < 0.001) in this headache population. Conclusions Both instruments seem well suited as short-term self-report measures for patients with cervicogenic headaches. Clinicians and researchers should expect at least a 2.5-point reduction on the numeric pain rating scale and a 5.5-point reduction on the neck disability index after 4 weeks of intervention to be considered clinically meaningful.

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

PubMed

Visco, Anthony G; Fraser, Matthew O; Newgreen, Donald; Oelke, Matthias; Cardozo, Linda

2016-02-01

The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. © 2016 Wiley Periodicals, Inc.

Reproducibility of isometric shoulder protraction and retraction strength measurements in normal subjects and individuals with winged scapula.

PubMed

Oh, Jae-Seop; Kang, Min-Hyeok; Dvir, Zeevi

2016-11-01

The strength of the shoulder protractors and retractors may be compromised in individuals with winged scapula (IwWS). However, no standard approach to measuring the strength of these muscles has been described. The aim of this study was to study the intra-rater and inter-rater reproducibility of a fixed-base isometric dynamometer and to describe cutoff scores for clinically meaningful change for protraction and retraction isometric strength. Twice during a week, 20 normal subjects and 20 IwWS were tested by 2 independent raters. IwWS were significantly weaker (P < .001) than control subjects in their protraction and retraction isometric strength. Excellent intra-rater and inter-rater correlations were obtained in most combinations, leading to low cutoff scores for meaningful change expressed in terms of the smallest real difference. When it is properly used, the technique described in this paper is recommended as an effective clinical tool for the quantitative assessment of protraction and retraction isometric strength, both for status determination and for monitoring of change in IwWS during and after rehabilitation. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Art therapy for people with psychosis: a narrative review of the literature.

PubMed

Attard, Angelica; Larkin, Michael

2016-11-01

Art therapy enables individuals to use art to creatively express themselves and communicate differently with themselves, others, and their reality. The National Institute for Health and Clinical Excellence guidelines for psychosis and schizophrenia suggest that arts therapies, which include art therapy, are considered to improve negative symptoms of psychosis. We examined the effectiveness of art therapy for people with psychosis and explored whether art therapy is a meaningful and acceptable intervention in this Review. Seven electronic databases were searched for empirical papers that concerned the use of art therapy for adults with psychosis that were published from 2007 onwards. The search identified 18 papers. High-quality quantitative articles provided inconclusive evidence for the effectiveness of art therapy in adults with psychosis. However, high-quality qualitative articles indicated that therapists and clients considered art therapy to be a beneficial, meaningful, and acceptable intervention, although this conclusion was based on a small number of studies. In this Review, we discuss the theoretical, clinical, and methodological issues in light of the development of more robust research, which is needed to corroborate individuals' experiences and guide evidence-based practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

Meaningful improvement in gait speed in hip fracture recovery.

PubMed

Alley, Dawn E; Hicks, Gregory E; Shardell, Michelle; Hawkes, William; Miller, Ram; Craik, Rebecca L; Mangione, Kathleen K; Orwig, Denise; Hochberg, Marc; Resnick, Barbara; Magaziner, Jay

2011-09-01

To estimate meaningful improvements in gait speed observed during recovery from hip fracture and to evaluate the sensitivity and specificity of gait speed changes in detecting change in self-reported mobility. Secondary longitudinal data analysis from two randomized controlled trials Twelve hospitals in the Baltimore, Maryland, area. Two hundred seventeen women admitted with hip fracture. Usual gait speed and self-reported mobility (ability to walk 1 block and climb 1 flight of stairs) measured 2 and 12 months after fracture. Effect size-based estimates of meaningful differences were 0.03 for small differences and 0.09 for substantial differences. Depending on the anchor (stairs vs walking) and method (mean difference vs regression), anchor-based estimates ranged from 0.10 to 0.17 m/s for small meaningful improvements and 0.17 to 0.26 m/s for substantial meaningful improvement. Optimal gait speed cutpoints yielded low sensitivity (0.39-0.62) and specificity (0.57-0.76) for improvements in self-reported mobility. Results from this sample of women recovering from hip fracture provide only limited support for the 0.10-m/s cut point for substantial meaningful change previously identified in community-dwelling older adults experiencing declines in walking abilities. Anchor-based estimates and cut points derived from receiver operating characteristic curve analysis suggest that greater improvements in gait speed may be required for substantial perceived mobility improvement in female hip fracture patients. Furthermore, gait speed change performed poorly in discriminating change in self-reported mobility. Estimates of meaningful change in gait speed may differ based on the direction of change (improvement vs decline) or between patient populations. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Meaningful Improvement in Gait Speed in Hip Fracture Recovery

PubMed Central

Alley, Dawn E.; Hicks, Gregory E.; Shardell, Michelle; Hawkes, William; Miller, Ram; Craik, Rebecca L.; Mangione, Kathleen K.; Orwig, Denise; Hochberg, Marc; Resnick, Barbara; Magaziner, Jay

2011-01-01

OBJECTIVES To estimate meaningful improvements in gait speed observed during recovery from hip fracture and to evaluate the sensitivity and specificity of gait speed changes in detecting change in self-reported mobility. DESIGN Secondary longitudinal data analysis from two randomized controlled trials SETTING Twelve hospitals in the Baltimore, Maryland, area. PARTICIPANTS Two hundred seventeen women admitted with hip fracture. MEASUREMENTS Usual gait speed and self-reported mobility (ability to walk 1 block and climb 1 flight of stairs) measured 2 and 12 months after fracture. RESULTS Effect size–based estimates of meaningful differences were 0.03 for small differences and 0.09 for substantial differences. Depending on the anchor (stairs vs walking) and method (mean difference vs regression), anchor-based estimates ranged from 0.10 to 0.17 m/s for small meaningful improvements and 0.17 to 0.26 m/s for substantial meaningful improvement. Optimal gait speed cut-points yielded low sensitivity (0.39–0.62) and specificity (0.57–0.76) for improvements in self-reported mobility. CONCLUSION Results from this sample of women recovering from hip fracture provide only limited support for the 0.10-m/s cut point for substantial meaningful change previously identified in community-dwelling older adults experiencing declines in walking abilities. Anchor-based estimates and cut points derived from receiver operating characteristic curve analysis suggest that greater improvements in gait speed may be required for substantial perceived mobility improvement in female hip fracture patients. Furthermore, gait speed change performed poorly in discriminating change in self-reported mobility. Estimates of meaningful change in gait speed may differ based on the direction of change (improvement vs decline) or between patient populations. PMID:21883109

Sex differences in sub-clinical psychosis--results from a community study over 30 years.

PubMed

Rössler, Wulf; Hengartner, Michael P; Ajdacic-Gross, Vladeta; Haker, Helene; Angst, Jules

2012-08-01

Sex differences in schizophrenia have long been reported. They are found within almost all aspects of the disease, from incidence and prevalence, age of onset, symptomatology, and course to its psycho-social outcome. Many sex-related hypotheses have been developed about the biology, psychology, or sociology of that disease. A further approach to study sex differences would be to examine such differences in sub-clinical psychotic states as well. If factors related to full-blown psychosis were equally meaningful over the entire psychosis continuum, we should expect that "true" sex differences could also be identified in sub-clinical psychosis. Here, we studied sex differences in sub-clinical psychosis within a community cohort in Zurich, Switzerland. This population was followed for over 30 years and included males and females between the ages of 20/21 and 49/50. We applied two different measures of sub-clinical psychosis representing schizotypal signs and schizophrenia nuclear symptoms. Using cross-sectional and longitudinal analyses, we found no significant sex differences in sub-clinical psychosis over time with respect to age of onset, symptomatology, course, or psycho-social outcome. Thus it appears that sex differences in psychosis manifest themselves at the high end of the continuum (full-blown schizophrenia) rather than within the sub-threshold range. Possibly males and females have separate thresholds for certain symptoms because they are differently vulnerable or exposed to various risk factors. Copyright © 2012. Published by Elsevier B.V.

Second-line outcomes in metastatic colorectal cancer--raising the bar for the high jump rather than the doing the limbo.

PubMed

Noonan, Anne Mary; Bekaii-Saab, Tanios

2015-02-01

Metastatic colorectal cancer is a significant burden to patients and healthcare systems worldwide. While outcomes have improved in the past 20 years, gains in survival in the second-line setting have been achieved at a significant monetary cost. The American Society of Clinical Oncology recently published guidelines on the definition of a clinically meaningful outcome as the measure of success of a therapy. We reviewed the FDA labels for drugs used in the second-line treatment of metastatic colorectal cancer and found that outcomes fell short of American Society of Clinical Oncology's definition of clinically meaningful. There was also variation in the methods used to determine cost-effectiveness and value of outcomes. We discuss these observations and the challenges associated with justifying payment for expensive drugs that often only achieve marginal benefits.

Researching asthma across the ages: insights from the National Heart, Lung, and Blood Institute's Asthma Network.

PubMed

Cabana, Michael D; Kunselman, Susan J; Nyenhuis, Sharmilee M; Wechsler, Michael E

2014-01-01

Clinical asthma studies across different age groups (ie, cross-age studies) can potentially offer insight into the similarities, differences, and relationships between childhood and adult asthma. The National Institutes of Health's Asthma Research Network (AsthmaNet) is unique and innovative in that it has merged pediatric and adult asthma research into a single clinical research network. This combination enhances scientific exchange between pediatric and adult asthma investigators and encourages the application of cross-age studies that involve participants from multiple age groups who are generally not studied together. The experience from AsthmaNet in the development of cross-age protocols highlights some of the issues in the evaluation of cross-age research in asthma. The aim of this review is to summarize these challenges, including the selection of parallel cross-age clinical interventions, identification of appropriate controls, measurement of meaningful clinical outcomes, and various ethical and logistic issues. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Evaluation and applications of the clinically significant change method with the Violence Risk Scale-Sexual Offender version: implications for risk-change communication.

PubMed

Olver, Mark E; Beggs Christofferson, Sarah M; Wong, Stephen C P

2015-02-01

We examined the use of the clinically significant change (CSC) method with the Violence Risk Scale-Sexual Offender version (VRS-SO), and its implications for risk communication, in a combined sample of 945 treated sexual offenders from three international settings, followed up for a minimum 5 years post-release. The reliable change (RC) index was used to identify thresholds of clinically meaningful change and to create four CSC groups (already okay, recovered, improved, unchanged) based on VRS-SO dynamic scores and amount of change made. Outcome analyses demonstrated important CSC-group differences in 5-year rates of sexual and violent recidivism. However, when baseline risk was controlled via Cox regression survival analysis, the pattern and magnitude of CSC-group differences in sexual and violent recidivism changed to suggest that observed variation in recidivism base rates could be at least partly explained by pre-existing group differences in risk level. Implications for communication of risk-change information and applications to clinical practice are discussed. Copyright © 2015 John Wiley & Sons, Ltd.

Do aggression and rule-breaking have different interpersonal correlates? A study of antisocial behavior subtypes, negative affect, and hostile perceptions of others.

PubMed

Burt, S Alexandra; Mikolajewski, Amy J; Larson, Christine L

2009-01-01

There is mounting evidence that physical aggression and nonaggressive, rule-breaking delinquency constitute two separable though correlated subtypes of antisocial behavior. Even so, it remains unclear whether these behavioral subtypes have meaningfully different interpersonal correlates, particularly as they are subsumed within the same broad domain of antisocial behavior. To evaluate this, we examined whether hostile perceptions of others (assessed via exposure to a series of neutral unknown faces) were linked to level and type of antisocial behavior aggression vs. rule-breaking, and moreover, whether this association persisted even when also considering the common association with negative affect (as manipulated via written recollection of one's best and worst life experiences). Analyses revealed that aggression, but not rule-breaking, was uniquely tied to hostile perceptions of others. Furthermore, this association persisted over and above the common association of both hostile perceptions and aggression with negative affect (at both trait and state levels). Such results provide additional support for clinically meaningful differences between the behavioral subtypes of aggression and nonaggressive rule-breaking and for the independent role of hostile perceptions in aggressive behavior.

Principles of Statistics: What the Sports Medicine Professional Needs to Know.

PubMed

Riemann, Bryan L; Lininger, Monica R

2018-07-01

Understanding the results and statistics reported in original research remains a large challenge for many sports medicine practitioners and, in turn, may be among one of the biggest barriers to integrating research into sports medicine practice. The purpose of this article is to provide minimal essentials a sports medicine practitioner needs to know about interpreting statistics and research results to facilitate the incorporation of the latest evidence into practice. Topics covered include the difference between statistical significance and clinical meaningfulness; effect sizes and confidence intervals; reliability statistics, including the minimal detectable difference and minimal important difference; and statistical power. Copyright © 2018 Elsevier Inc. All rights reserved.

Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.

PubMed

Lauche, Romy; Langhorst, Jost; Dobos, Gustav J; Cramer, Holger

2013-08-01

The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from "much better" to "much worse", as anchor. MCID derived from the ROC was the score to distinguish "somewhat better" from "about the same", and the SCB was the score to distinguish "much better" from "somewhat better". The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment conditions might play an important role. Further studies on MCIDS and SCBs for chronic nonspecific neck pain seem warranted. Copyright © 2013 Elsevier Ltd. All rights reserved.

76 FR 68197 - Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0547] Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments AGENCY: Food and... clinically meaningful (e.g., subjective and objective assessments of memory, recall, anxiety, agitation, or...

Toward an Ecological Perspective of Resident Teaching Clinic

ERIC Educational Resources Information Center

Smith, C. Scott; Francovich, Chris; Morris, Magdalena; Hill, William; Langlois-Winkle, Francine; Rupper, Randall; Roth, Craig; Wheeler, Stephanie; Vo, Anthony

2010-01-01

Teaching clinic managers struggle to convert performance data into meaningful behavioral change in their trainees, and quality improvement measures in medicine have had modest results. This may be due to several factors including clinical performance being based more on team function than individual action, models of best practice that are…

Effect of an obesity best practice alert on physician documentation and referral practices.

PubMed

Fitzpatrick, Stephanie L; Dickins, Kirsten; Avery, Elizabeth; Ventrelle, Jennifer; Shultz, Aaron; Kishen, Ekta; Rothschild, Steven

2017-12-01

The Centers for Medicare & Medicaid Services Electronic Health Record Meaningful Use Incentive Program requires physicians to document body mass index (BMI) and a follow-up treatment plan for adult patients with BMI ≥ 25. To examine the effect of a best practice alert on physician documentation of obesity-related care and referrals to weight management treatment, in a cluster-randomized design, 14 primary care clinics at an academic medical center were randomized to best practice alert intervention (n = 7) or comparator (n = 7). The alert was triggered when both height and weight were entered and BMI was ≥30. Both intervention and comparator clinics could document meaningful use by selecting a nutrition education handout within the alert. Intervention clinics could also select a referral option from the list of clinic and community-based weight management programs embedded in the alert. Main outcomes were proportion of eligible patients with (1) obesity-related documentation and (2) referral. There were 26,471 total primary care encounters with 12,981 unique adult patients with BMI ≥ 30 during the 6-month study period. Documentation doubled (17 to 33%) with implementation of the alert. However, intervention clinics were not significantly more likely to refer patients to weight management than comparator clinics (2.8 vs. 1.3%, p = 0.07). Although the alert was associated with increased physician meaningful use compliance, it was not an effective strategy for improving patient access to weight management services. Further research is needed to understand system-level characteristics that influence obesity management in primary care.

Implementing EHRs: An Exploratory Study to Examine Current Practices in Migrating Physician Practice

PubMed Central

Dolezel, Diane; Moczygemba, Jackie

2015-01-01

Implementation of electronic health record (EHR) systems in physician practices is challenging and complex. In the past, physicians had little incentive to move from paper-based records. With the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, Medicare and Medicaid incentive payments are now available for physicians who implement EHRs for meaningful use. The Office of the National Coordinator for Health Information Technology (ONC) has ample detail on clinical data needed for meaningful use in order to assess the quality of patient care. Details are lacking, however, on how much clinical data, if any, should be transferred from the old paper records during an EHR implementation project. The purpose of this exploratory study was to investigate and document the elements of longitudinal clinical data that are essential for inclusion in the EHR of physicians in a clinical practice setting, as reported by the office managers of the physicians in the study group. PMID:26807077

Reflective learning in community-based dental education.

PubMed

Deogade, Suryakant C; Naitam, Dinesh

2016-01-01

Community-based dental education (CBDE) is the implementation of dental education in a specific social context, which shifts a substantial part of dental clinical education from dental teaching institutional clinics to mainly public health settings. Dental students gain additional value from CBDE when they are guided through a reflective process of learning. We propose some key elements to the existing CBDE program that support meaningful personal learning experiences. Dental rotations of 'externships' in community-based clinical settings (CBCS) are year-long community-based placements and have proven to be strong learning environments where students develop good communication skills and better clinical reasoning and management skills. We look at the characteristics of CBDE and how the social and personal context provided in communities enhances dental education. Meaningfulness is created by the authentic context, which develops over a period of time. Structured reflection assignments and methods are suggested as key elements in the existing CBDE program. Strategies to enrich community-based learning experiences for dental students include: Photographic documentation; written narratives; critical incident reports; and mentored post-experiential small group discussions. A directed process of reflection is suggested as a way to increase the impact of the community learning experiences. We suggest key elements to the existing CBDE module so that the context-rich environment of CBDE allows for meaningful relations and experiences for dental students and enhanced learning.

Clinical Utility of Chest Computed Tomography in Patients with Rib Fractures CT Chest and Rib Fractures.

PubMed

Chapman, Brandon C; Overbey, Douglas M; Tesfalidet, Feven; Schramm, Kristofer; Stovall, Robert T; French, Andrew; Johnson, Jeffrey L; Burlew, Clay C; Barnett, Carlton; Moore, Ernest E; Pieracci, Fredric M

2016-12-01

Chest CT is more sensitive than a chest X-ray (CXR) in diagnosing rib fractures; however, the clinical significance of these fractures remains unclear. The purpose of this study was to determine the added diagnostic use of chest CT performed after CXR in patients with either known or suspected rib fractures secondary to blunt trauma. Retrospective cohort study of blunt trauma patients with rib fractures at a level I trauma center that had both a CXR and a CT chest. The CT finding of ≥ 3 additional fractures in patients with ≤ 3 rib fractures on CXR was considered clinically meaningful. Student's t-test and chi-square analysis were used for comparison. We identified 499 patients with rib fractures: 93 (18.6%) had CXR only, 7 (1.4%) had chest CT only, and 399 (79.9%) had both CXR and chest CT. Among these 399 patients, a total of 1,969 rib fractures were identified: 1,467 (74.5%) were missed by CXR. The median number of additional fractures identified by CT was 3 (range, 4 - 15). Of 212 (53.1%) patients with a clinically meaningful increase in the number of fractures, 68 patients underwent one or more clinical interventions: 36 SICU admissions, 20 pain catheter placements, 23 epidural placements, and 3 SSRF. Additionally, 70 patients had a chest tube placed for retained hemothorax or occult pneumothorax. Overall, 138 patients (34.5%) had a change in clinical management based upon CT chest. The chest X-ray missed ~75% of rib fractures seen on chest CT. Although patients with a clinical meaningful increase in the number of rib fractures were more likely to be admitted to the intensive care unit, there was no associated improvement in pulmonary outcomes.

Patients' perception of risk: informed choice in prenatal testing for foetal aneuploidy.

PubMed

Choolani, Mahesh; Biswas, Arijit

2012-10-01

Each of us perceives risk differently, and so do our patients. This perception of risk gets even more complex when multiple individuals and interactions are involved: the doctor, the patient-pregnant mother, the spouse-father and the foetus-unborn child. In this review, we address the relationship between different levels of information gathering, from clinical data to experiential knowledge - data, information, knowledge, perception, attitude, wisdom - and how these would impact the perception of risk and informed consent. We discuss how patients might interpret the risks of the same event differently based upon past experiences, and suggest how risk data could be presented more meaningfully for patients and family to assimilate for informed decision making. Finally, we demonstrate how patients' expectations and risk management can impact scientific research and clinical progress by way of the most topical subject of risk screening in pregnancy - non-invasive prenatal testing using cell-free DNA in maternal plasma.

Hemispheric Differences in Processing Dichotic Meaningful and Non-Meaningful Words

ERIC Educational Resources Information Center

Yasin, Ifat

2007-01-01

Classic dichotic-listening paradigms reveal a right-ear advantage (REA) for speech sounds as compared to non-speech sounds. This REA is assumed to be associated with a left-hemisphere dominance for meaningful speech processing. This study objectively probed the relationship between ear advantage and hemispheric dominance in a dichotic-listening…

Incorporating Semantics into Data Driven Workflows for Content Based Analysis

NASA Astrophysics Data System (ADS)

Argüello, M.; Fernandez-Prieto, M. J.

Finding meaningful associations between text elements and knowledge structures within clinical narratives in a highly verbal domain, such as psychiatry, is a challenging goal. The research presented here uses a small corpus of case histories and brings into play pre-existing knowledge, and therefore, complements other approaches that use large corpus (millions of words) and no pre-existing knowledge. The paper describes a variety of experiments for content-based analysis: Linguistic Analysis using NLP-oriented approaches, Sentiment Analysis, and Semantically Meaningful Analysis. Although it is not standard practice, the paper advocates providing automatic support to annotate the functionality as well as the data for each experiment by performing semantic annotation that uses OWL and OWL-S. Lessons learnt can be transmitted to legacy clinical databases facing the conversion of clinical narratives according to prominent Electronic Health Records standards.

An investigation of meaningful understanding and effectiveness of the implementation of Piagetian and Ausubelian theories in physics instruction

NASA Astrophysics Data System (ADS)

Williams, Karen Ann

One section of college students (N = 25) enrolled in an algebra-based physics course was selected for a Piagetian-based learning cycle (LC) treatment while a second section (N = 25) studied in an Ausubelian-based meaningful verbal reception learning treatment (MVRL). This study examined the students' overall (concept + problem solving + mental model) meaningful understanding of force, density/Archimedes Principle, and heat. Also examined were students' meaningful understanding as measured by conceptual questions, problems, and mental models. In addition, students' learning orientations were examined. There were no significant posttest differences between the LC and MVRL groups for students' meaningful understanding or learning orientation. Piagetian and Ausubelian theories explain meaningful understanding for each treatment. Students from each treatment increased their meaningful understanding. However, neither group altered their learning orientation. The results of meaningful understanding as measured by conceptual questions, problem solving, and mental models were mixed. Differences were attributed to the weaknesses and strengths of each treatment. This research also examined four variables (treatment, reasoning ability, learning orientation, and prior knowledge) to find which best predicted students' overall meaningful understanding of physics concepts. None of these variables were significant predictors at the.05 level. However, when the same variables were used to predict students' specific understanding (i.e. concept, problem solving, or mental model understanding), the results were mixed. For forces and density/Archimedes Principle, prior knowledge and reasoning ability significantly predicted students' conceptual understanding. For heat, however, reasoning ability was the only significant predictor of concept understanding. Reasoning ability and treatment were significant predictors of students' problem solving for heat and forces. For density/Archimedes Principle, treatment was the only significant predictor of students' problem solving. None of the variables were significant predictors of mental model understanding. This research suggested that Piaget and Ausubel used different terminology to describe learning yet these theories are similar. Further research is needed to validate this premise and validate the blending of the two theories.

Handling Big Data in Modern Healthcare.

PubMed

Aziz, Hassan A

2016-11-01

The constant growth of medical knowledge and the increases in specialization in clinical practice have created a significant need to share and access patient information with speed and efficiency. However, current technology is centered on processing data, rather than gathering information. To realize the potential of modern technology in improving patient health, merely collecting and storing data are insufficient: one must convert these data into information and knowledge. In this article, I present an overview of 2 recent advances in technology and their assimilation into the practice of medicine, in the attempt to make clinical data meaningful and then to learn from aggregated clinical data. We address the emergence of clinical data warehouses (CDWs) and health information exchanges (HIEs), as features of the Health Information Technology for Economic and Clinical Health (HITECH) Act. This act, enacted in the United States as part of the American Recovery and Reinvestment Act of 2009, was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Comparison of short-term response to two spinal manipulation techniques for patients with low back pain in a military beneficiary population.

PubMed

Sutlive, Thomas G; Mabry, Lance M; Easterling, Emmanuel J; Durbin, Jose D; Hanson, Stephen L; Wainner, Robert S; Childs, John D

2009-07-01

To determine whether military health care beneficiaries with low back pain (LBP) who are likely to respond successfully to spinal manipulation experience a difference in short-term clinical outcomes based on the manipulation technique that is used. Sixty patients with LBP identified as likely responders to manipulation underwent a standardized clinical examination and were randomized to receive a lumbopelvic (LP) or lumbar neutral gap (NG) manipulation technique. Outcome measures were a numeric pain rating scale and the modified Oswestry Disability Questionnaire. Both the LP and NG groups experienced statistically significant reductions in pain and disability at 48 hours postmanipulation. The improvements seen in each group were small because of the short follow-up. There were no statistically significant or clinically meaningful differences in pain or disability between the two groups. The two manipulation techniques used in this study were equally effective at reducing pain and disability when compared at 48 hours posttreatment. Clinicians may employ either technique for the treatment of LBP and can expect similar outcomes in those who satisfy the clinical prediction rule (CPR). Further research is required to determine whether differences exist at longer-term follow-up periods, after multiple treatment sessions, or in different clinical populations.

The effect of perinatal education on Iranian mothers' stress and labor pain.

PubMed

Firouzbakht, Mozhgan; Nikpour, Maryam; Salmalian, Hajar; Ledari, Farideh Mohsenzadeh; Khafri, Sorya

2013-10-14

Lack of sufficient knowledge about the unknowns of pregnancy increases stress and requires more medical interventions. This study was conducted to assess the effects of prenatal education on mothers' stress and labor. This clinical trial was conducted to study 195 women (132 in the control group and 63 in the experimental group) who had attended healthcare centers in the city of Amol after their 16th gestational week. The experimental group participated in educational classes to learn how to experience a safe childbirth for 6-8 sessions of 1.5 hours almost every three weeks. The control group received only a routine care, pain assessment scales like Visual Analogue Scale (VAS) and McGill questionnaire, and Hospital Anxiety and Depression Scale (HADS) were employed to collect data. The data were analyzed using SPSS software through t-test and Chi Square test to compare the groups. The results of the t-test showed a meaningful difference in levels of stress felt by the experimental group compared to control group (p=0.002). The Visual Analogue Scale suggested that in the transitional stages (8-10 cm cervical dilation), the level of pain felt by the experimental group was meaningfully lower than that felt by the control group (p=0.03). However, this was not significantly different between the two groups at 3-4 cm cervical dilation and the second stage of childbirth. The McGill scale's results for measuring pain levels, proved a meaningful difference between the experimental group and the control group (p=0.018).Educational and supportive interventions increased mothers' knowledge during pregnancy and reduced their fear of unknown environment and people. These trained women learned how to effectively overcome their problems and labor pain.

The Northern California Perinatal Research Unit: A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

PubMed Central

Garrido, Terhilda; Barbeau, Rosemarie

2010-01-01

Kaiser Permanente (KP) has a long-standing commitment to conduct research and report publicly. Simultaneously, it faces a different imperative: harnessing information systems to leverage internal improvements in outcomes, efficiency, and costs. Now that KP HealthConnect, the KP electronic health record, is fully implemented, research challenges at KP are moving away from issues of data access and toward the mechanisms through which raw data create meaningful clinical knowledge that is based on rigorous research. In this report we describe a model for research—the Northern California Division of Research Perinatal Research Unit—that leverages internal and external resources to fulfill these twin missions. PMID:20844705

Clinically significant psychiatric symptoms among male carriers of the fragile X premutation, with and without FXTAS, and the mediating influence of executive functioning.

PubMed

Grigsby, Jim; Brega, Angela G; Bennett, Rachael E; Bourgeois, James A; Seritan, Andreea L; Goodrich, Glenn K; Hagerman, Randi J

2016-08-01

To clarify the neuropsychiatric phenotype of fragile X-associated tremor/ataxia syndrome (FXTAS), and assess the extent to which it is mediated by the dysexecutive syndrome that is a major feature of the disorder. We examined the prevalence of clinically meaningful psychiatric symptoms among male carriers of the fragile X premutation, with and without FXTAS, in comparison with men with a normal allele. Measures included the Neuropsychiatric Inventory (NPI), Symptom Checklist-90-R (SCL-90-R), and the Behavioral Dyscontrol Scale, a measure of executive functioning. Between-group differences were evaluated using logistic regression, followed by a mediation analysis with ordinary least squares regression to assess the contribution of dysexecutive syndrome to the observed psychiatric domains. Men with FXTAS showed higher rates of clinically significant symptoms overall and in specific domains: somatization, obsessive compulsive, depression, anxiety, psychoticism, agitation/aggression, apathy/indifference, irritability, and nighttime behavior problems. Post hoc analyses suggested that findings of psychoticism among men with FXTAS may be associated with participants' accurate acknowledgment of cognitive and physical dysfunction, rather than reflecting psychosis. Asymptomatic carriers showed no evidence of clinically significant psychiatric symptoms, but when all carriers were compared with men having a normal FMR1 allele, executive function deficits were found to mediate scores in several domains on both NPI and SCL-90-R. Building on prior research, the results provide evidence that the psychiatric phenotype for men includes clinically meaningful depression, hostility, and irritability, in association with behavioral and attentional disinhibition. It is likely that these problems reflect the effects of impaired executive functioning.

What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study).

PubMed

Kwon, S; Perera, S; Pahor, M; Katula, J A; King, A C; Groessl, E J; Studenski, S A

2009-06-01

Performance measures provide important information, but the meaning of change in these measures is not well known. The purpose of this research is to 1) examine the effect of treatment assignment on the relationship between self-report and performance; 2) to estimate the magnitude of meaningful change in 400-meter walk time (400MWT), 4-meter gait speed (4MGS), and Short Physical Performance Battery (SPPB) and 3) to evaluate the effect of direction of change on estimates of magnitude. This is a secondary analysis of data from the LIFE-P study, a single blinded randomized clinical trial. Using change over one year, we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT, 4MGS and SPPB. Four university-based clinical research sites. Sedentary adults aged 70-89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline (n=424). A structured exercise program versus health education. 400MWT, 4MGS, SPPB. Relationships between self-report and performance measures were consistent between treatment arms. Minimally significant change estimates were 400MWT: 20-30 seconds, 4MGS: 0.03-0.05m/s and SPPB: 0.3 - 0.8 points. Substantial changes were 400MWT: 50-60 seconds, 4MGS: 0.08m/s, SPPB: 0.4 - 1.5 points. Magnitudes of change for improvement and decline were not significantly different. The magnitude of clinically important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise. Due to limited power, the effect of direction of change on estimates of magnitude remains uncertain.

Identifying clinically meaningful symptom response cut-off values on the SANS in predominant negative symptoms.

PubMed

Levine, Stephen Z; Leucht, Stefan

2013-04-01

The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change is unclear. To offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms (SANS). Patients were intention-to-treat participants (n=383) in two double-blind randomized placebo-controlled clinical trials that compared amisulpride with placebo for the treatment of predominant negative symptoms. Equipercentile linking was used to examine extrapolation from (a) CGI-S to SANS severity ratings, and (b) CGI-I to SANS percentage change (n=383). Linking was conducted at baseline, 8-14 days, 28-30 days, and 56-60 days of the trials. Across visits, CGI-S ratings of 'not ill' linked to SANS scores of 0-13, and ranged to 'extreme' ratings that linked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed a linear trend (1=0-13, 2=15-56, 3=37-61, 4=49-66, 5=63-75, 6=79-89, 7=102-105). Similarly the relationship between CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of 'very much improved' were linked to SANS percent changes of -90 to -67, 'much improved' to -50 to -42, and 'minimally improved' to -21 to -13. The current results uniquely contribute to the debate surrounding negative symptoms by providing clinical meaning to SANS severity and change scores and so offer direction regarding clinically meaningful response cut-off scores to guide treatment targets of predominant negative symptoms. Copyright © 2013 Elsevier B.V. All rights reserved.

Investigation of Personality Traits between Infertile Women Submitted to Assisted Reproductive Technology or Surrogacy.

PubMed

Asgari, Najmeh; Yazdkhasti, Fariba; Nasr Esfahani, Mohammad Hossein

2016-01-01

Personality traits affect human relationships, social interactions, treatment procedures, and essentially all human activities. The purpose of this study is to investigate the personality traitsincluding sensation seeking, flexibility, and happiness among a variety of infertile women who were apt to choose assisted reproductive technology (ART) or surrogacy. This is a cross-sectional study that was performed on 251 infertile women who visited Isfahan and Tehran Reproductive Medicine Center. These fertility clinics are located in Isfahan and Tehran, Iran. In this study, 201 infertile women who underwent treatment using ART and 50 infertile women who tended to have surrogacy were chosen by convenience sampling. Zuckerman's Sensation Seeking Scale Form V (SSS-V), Psychological Flexibility Questionnaire (adapted from NEO Personality Inventory-Revised) and Oxford Happiness Questionnaire (OHQ) were used as research instruments. All participants had to complete the research instruments in order to be included in this study. Data were analyzed by descriptive-analytical statistics and statistical tests including multivariate analysis of variance (MANOVA) and Z Fisher. Statistically significant effects were accepted for P<0.05. In the sensation-seeking variable, there was a meaningful difference between under-study groups. However, the flexibility and happiness variables did not have a significant difference between under-study groups (P<0.001). Interaction between education, employment, and financial status was effective in happiness of infertile women underwent ART (P<0.05), while age, education and financial status were also effective in happiness of infertile women sought surrogacy (P<0.05). A positive meaningful relationship was seen between sensation seeking and flexibility variables in both groups (P<0.05). And a negative meaningful relationship was seen between sensation seeking and happiness in infertile women who sought surrogacy (P<0.05). The difference in rate of relationship between sensation seeking and flexibility was meaningful in infertile women who sought either ART or surrogacy (P<0.05). Sensations seeking as a personality trait is lower in infertile women who underwent treatment using ART compared women who tended to have surrogacy. This study shows that demographic variables are effective in happiness of infertile women. Also, there is a significant relation among sensation seeking, flexibility and happiness in infertile women.

Assessing clinical significance of treatment outcomes using the DASS-21.

PubMed

Ronk, Fiona R; Korman, James R; Hooke, Geoffrey R; Page, Andrew C

2013-12-01

Standard clinical significance classifications are based on movement between the "dysfunctional" and "functional" distributions; however, this dichotomy ignores heterogeneity within the "dysfunctional" population. Based on the methodology described by Tingey, Lambert, Burlingame, and Hansen (1996), the present study sought to present a 3-distribution clinical significance model for the 21-item version of the Depression Anxiety Stress Scales (DASS-21; P. F. Lovibond & Lovibond, 1995) using data from a normative sample (n = 2,914), an outpatient sample (n = 1,000), and an inpatient sample (n = 3,964). DASS-21 scores were collected at pre- and post-treatment for both clinical samples, and patients were classified into 1 of 5 categories based on whether they had made a reliable change and whether they had moved into a different functional range. Evidence supported the validity of the 3-distribution model for the DASS-21, since inpatients who were classified as making a clinically significant change showed lower symptom severity, higher perceived quality of life, and higher clinician-rated functioning than those who did not make a clinically significant change. Importantly, results suggest that the new category of recovering is an intermediate point between recovered and making no clinically significant change. Inpatients and outpatients have different treatment goals and therefore use of the concept of clinical significance needs to acknowledge differences in what constitutes a meaningful change. (c) 2013 APA, all rights reserved.

A business case for HIT adoption: effects of "meaningful use" EHR financial incentives on clinic revenue.

PubMed

Behkami, Nima A; Dorr, David A; Morrice, Stuart

2010-01-01

The goal of this study is to describe a framework that allows decision makers to efficiently evaluate factors that affect Electronic Health Record (EHR) adoption and test suitable interventions; specifically financial incentives. The United States healthcare delivery system is experiencing a transformation to improve population health. There is strong agreement that "meaningful use" of Health Information Technology (HIT) is a major enabler in this effort. However it's also understood that the high cost of implementing an EHR is an obstacle for adoption. To help understand these complexities we developed a simulation model designed to capture the dynamic nature of policy interventions that affect the adoption of EHR. We found that "Effective" use of HIT approaches break-even-point and larger clinic revenue many times faster that "average" or "poor" use of HIT. This study uses a systems perspective to the evaluate EHR adoption process through the "meaningful use" redesign as proposed in the American Reinvestment and Recovery Act 2009 in the United States healthcare industry by utilizing the System Dynamics methodology and Scenario Analysis.

Dissociative complexity: Antecedents and clinical correlates of a new construct.

PubMed

Briere, John; Dietrich, Anne; Semple, Randye J

2016-09-01

To the extent that dissociation is a multidimensional phenomenon, and given a growing literature on complex posttraumatic outcomes, we hypothesized a new construct: dissociative complexity (DC). DC is defined as the tendency to simultaneously endorse multiple, relatively independent dissociative dimensions into their clinical ranges, and therefore represents the overall breadth or complexity of an individual's dissociative response. DC was evaluated in general population and prison participants using the Multiscale Dissociation Inventory (MDI; Briere, 2002). DC was higher among prisoners and women, and, as hypothesized, was associated with cumulative trauma and serious comorbidities (suicidality and substance abuse), even when controlling for generally elevated dissociation. DC appears to be a meaningful clinical construct that is phenomenologically and empirically different from a unidimensional index of dissociative severity. DC may serve as a clinical marker for multiple trauma exposures, complex dissociative outcomes, and risk of problematic comorbidities. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

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

Integrated Analysis of Pharmacologic, Clinical, and SNP Microarray Data using Projection onto the Most Interesting Statistical Evidence with Adaptive Permutation Testing

PubMed Central

Pounds, Stan; Cao, Xueyuan; Cheng, Cheng; Yang, Jun; Campana, Dario; Evans, William E.; Pui, Ching-Hon; Relling, Mary V.

2010-01-01

Powerful methods for integrated analysis of multiple biological data sets are needed to maximize interpretation capacity and acquire meaningful knowledge. We recently developed Projection Onto the Most Interesting Statistical Evidence (PROMISE). PROMISE is a statistical procedure that incorporates prior knowledge about the biological relationships among endpoint variables into an integrated analysis of microarray gene expression data with multiple biological and clinical endpoints. Here, PROMISE is adapted to the integrated analysis of pharmacologic, clinical, and genome-wide genotype data that incorporating knowledge about the biological relationships among pharmacologic and clinical response data. An efficient permutation-testing algorithm is introduced so that statistical calculations are computationally feasible in this higher-dimension setting. The new method is applied to a pediatric leukemia data set. The results clearly indicate that PROMISE is a powerful statistical tool for identifying genomic features that exhibit a biologically meaningful pattern of association with multiple endpoint variables. PMID:21516175

Clinical validity of prototype personality disorder ratings in adolescents.

PubMed

Defife, Jared A; Haggerty, Greg; Smith, Scott W; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure-Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients' individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median intraclass correlation coefficient =.75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning.

Clinical Validity of Prototype Personality Disorder Ratings in Adolescents

PubMed Central

DeFife, Jared A.; Haggerty, Greg; Smith, Scott W.; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure – Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients’ individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median ICC = .75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning. PMID:25457971

42 CFR 495.8 - Demonstration of meaningful use criteria.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) “Report ambulatory clinical quality measures to CMS or, in the case of Medicaid EPs, the States.” (C) Must... during the EHR reporting period for which a selected measure is applicable. (ii) Reporting of clinical quality information. For § 495.6(d)(10), “Report ambulatory clinical quality measures to CMS or, in the...

Job enrichment: creating meaningful career development opportunities for nurses.

PubMed

Duffield, Christine; Baldwin, Richard; Roche, Michael; Wise, Sarah

2014-09-01

This paper presents an evaluation of a career development policy in South Australia which increased the number of senior staff nurse positions and provided senior registered nurses with time away from clinical duties to undertake agreed projects. We use Kanter's model of structural power and commitment theory to understand the dimensions of this policy. Development strategies for experienced staff who wish to remain at the bedside are needed, especially in smaller health services with limited opportunities for horizontal or vertical mobility. Face-to-face semistructured interviews were conducted with 54 senior staff nurses who participated in the career structure arrangements. The policy enhanced the structure of opportunity in three ways: by increasing the number of senior staff nurse positions, the ladder steps were improved; undertaking strategic projects developed new skills; and the job enrichment approach facilitated time out from the immediate pressures of ward work and challenged nurses in a different way. Through job enrichment, South Australia has found a novel way of providing meaningful career development opportunities for experienced nurses. Methods of job enrichment need to be considered as part of career development policy, especially where movement between clinical facilities is limited and staff wish to remain at the bedside. © 2013 John Wiley & Sons Ltd.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

PubMed

Griffith, Niesha; McBride, Ali; Stevenson, James G; Green, Larry

2014-10-01

Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions' information technology systems.

Racial/ethnic differences in video game and Internet use among US adolescents with mental health and educational difficulties.

PubMed

Carson, Nicholas; Lê Cook, Benjamin; Chen, Chih-Nan; Alegria, Margarita

2012-01-01

Video game and Internet use can be associated with poor mental health and educational outcomes among adolescents. Racial/ethnic minority youth use these media more than White youth. Video game and Internet use among adolescents with mental health and educational difficulties may therefore differ by race/ethnicity in clinically meaningful ways. We analyzed a representative sample of 8 th grade students in the United States from the Early Childhood Longitudinal Survey-Kindergarten (N=6,700). Stratifying by gender, we assessed racial/ethnic differences in the associations between video game and Internet use, mental health, and reading and math achievement. Significant minority-White differences were identified in associations between media use and mental health and educational achievement. Video game use was relatively high among black females with prior mental health diagnoses and Asian-American males with high internalizing symptoms. Understanding video game and Internet use among racial/ethnic minority youth with mental health and educational difficulties may improve clinical practice.

Racial/ethnic differences in video game and Internet use among US adolescents with mental health and educational difficulties

PubMed Central

Carson, Nicholas; Lê Cook, Benjamin; Chen, Chih-Nan; Alegria, Margarita

2013-01-01

Video game and Internet use can be associated with poor mental health and educational outcomes among adolescents. Racial/ethnic minority youth use these media more than White youth. Video game and Internet use among adolescents with mental health and educational difficulties may therefore differ by race/ethnicity in clinically meaningful ways. We analyzed a representative sample of 8th grade students in the United States from the Early Childhood Longitudinal Survey-Kindergarten (N=6,700). Stratifying by gender, we assessed racial/ethnic differences in the associations between video game and Internet use, mental health, and reading and math achievement. Significant minority-White differences were identified in associations between media use and mental health and educational achievement. Video game use was relatively high among black females with prior mental health diagnoses and Asian-American males with high internalizing symptoms. Understanding video game and Internet use among racial/ethnic minority youth with mental health and educational difficulties may improve clinical practice. PMID:29167696

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists

PubMed Central

McBride, Ali; Stevenson, James G.; Green, Larry

2014-01-01

Abstract Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions’ information technology systems. PMID:25477613

Public Health Surveillance and Meaningful Use Regulations: A Crisis of Opportunity

PubMed Central

Sundwall, David N.

2012-01-01

The Health Information Technology for Economic and Clinical Health Act is intended to enhance reimbursement of health care providers for meaningful use of electronic health records systems. This presents both opportunities and challenges for public health departments. To earn incentive payments, clinical providers must exchange specified types of data with the public health system, such as immunization and syndromic surveillance data and notifiable disease reporting. However, a crisis looms because public health’s information technology systems largely lack the capabilities to accept the types of data proposed for exchange. Cloud computing may be a solution for public health information systems. Through shared computing resources, public health departments could reap the benefits of electronic reporting within federal funding constraints. PMID:22390523

Public health surveillance and meaningful use regulations: a crisis of opportunity.

PubMed

Lenert, Leslie; Sundwall, David N

2012-03-01

The Health Information Technology for Economic and Clinical Health Act is intended to enhance reimbursement of health care providers for meaningful use of electronic health records systems. This presents both opportunities and challenges for public health departments. To earn incentive payments, clinical providers must exchange specified types of data with the public health system, such as immunization and syndromic surveillance data and notifiable disease reporting. However, a crisis looms because public health's information technology systems largely lack the capabilities to accept the types of data proposed for exchange. Cloud computing may be a solution for public health information systems. Through shared computing resources, public health departments could reap the benefits of electronic reporting within federal funding constraints.

Comparison of the antibiotic activities of Daptomycin, Vancomycin, and the investigational Fluoroquinolone Delafloxacin against biofilms from Staphylococcus aureus clinical isolates.

PubMed

Siala, Wafi; Mingeot-Leclercq, Marie-Paule; Tulkens, Paul M; Hallin, Marie; Denis, Olivier; Van Bambeke, Françoise

2014-11-01

Biofilm-related infections remain a scourge. In an in vitro model of biofilms using Staphylococcus aureus reference strains, delafloxacin and daptomycin were found to be the most active among the antibiotics from 8 different pharmacological classes (J. Bauer, W. Siala, P. M. Tulkens, and F. Van Bambeke, Antimicrob. Agents Chemother. 57:2726-2737, 2013, doi:10.1128/AAC.00181-13). In this study, we compared delafloxacin to daptomycin and vancomycin using biofilms produced by 7 clinical strains (S. aureus epidemic clones CC5 and CC8) in order to rationalize the differences observed between the antibiotics and strains. The effects of the antibiotics on bacterial viability (resazurin reduction assay) and biomass (crystal violet staining) were measured and correlated with the proportion of polysaccharides in the matrix, the local microenvironmental pH (micro-pH), and the antibiotic penetration in the biofilm. At clinically meaningful concentrations, delafloxacin, daptomycin, and vancomycin caused a ≥25% reduction in viability against the biofilms formed by 5, 4, and 3 strains, respectively. The antibiotic penetration within the biofilms ranged from 0.6 to 52% for delafloxacin, 0.2 to 10% for daptomycin, and 0.2 to 1% for vancomycin; for delafloxacin, this was inversely related to the polysaccharide proportion in the matrix. Six biofilms were acidic, explaining the high potency of delafloxacin (lower MICs at acidic pH). Norspermidine and norspermine (disassembling the biofilm matrix) drastically increased delafloxacin potency and efficacy (50% reduction in viability for 6 biofilms at clinically meaningful concentrations) in direct correlation with its increased penetration within the biofilm, while they only modestly improved daptomycin efficacy (50% reduction in viability for 2 biofilms) and penetration, and they showed marginal effects with vancomycin. Delafloxacin potency and efficacy against biofilms are benefited by its penetration into the matrix and the local acidic micro-pH. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Comparison of the Antibiotic Activities of Daptomycin, Vancomycin, and the Investigational Fluoroquinolone Delafloxacin against Biofilms from Staphylococcus aureus Clinical Isolates

PubMed Central

Siala, Wafi; Mingeot-Leclercq, Marie-Paule; Tulkens, Paul M.; Hallin, Marie; Denis, Olivier

2014-01-01

Biofilm-related infections remain a scourge. In an in vitro model of biofilms using Staphylococcus aureus reference strains, delafloxacin and daptomycin were found to be the most active among the antibiotics from 8 different pharmacological classes (J. Bauer, W. Siala, P. M. Tulkens, and F. Van Bambeke, Antimicrob. Agents Chemother. 57:2726–2737, 2013, doi:10.1128/AAC.00181-13). In this study, we compared delafloxacin to daptomycin and vancomycin using biofilms produced by 7 clinical strains (S. aureus epidemic clones CC5 and CC8) in order to rationalize the differences observed between the antibiotics and strains. The effects of the antibiotics on bacterial viability (resazurin reduction assay) and biomass (crystal violet staining) were measured and correlated with the proportion of polysaccharides in the matrix, the local microenvironmental pH (micro-pH), and the antibiotic penetration in the biofilm. At clinically meaningful concentrations, delafloxacin, daptomycin, and vancomycin caused a ≥25% reduction in viability against the biofilms formed by 5, 4, and 3 strains, respectively. The antibiotic penetration within the biofilms ranged from 0.6 to 52% for delafloxacin, 0.2 to 10% for daptomycin, and 0.2 to 1% for vancomycin; for delafloxacin, this was inversely related to the polysaccharide proportion in the matrix. Six biofilms were acidic, explaining the high potency of delafloxacin (lower MICs at acidic pH). Norspermidine and norspermine (disassembling the biofilm matrix) drastically increased delafloxacin potency and efficacy (50% reduction in viability for 6 biofilms at clinically meaningful concentrations) in direct correlation with its increased penetration within the biofilm, while they only modestly improved daptomycin efficacy (50% reduction in viability for 2 biofilms) and penetration, and they showed marginal effects with vancomycin. Delafloxacin potency and efficacy against biofilms are benefited by its penetration into the matrix and the local acidic micro-pH. PMID:25114142

Clinical evaluation of a combination therapy of imepitoin with phenobarbital in dogs with refractory idiopathic epilepsy.

PubMed

Neßler, Jasmin; Rundfeldt, Chris; Löscher, Wolfgang; Kostic, Draginja; Keefe, Thomas; Tipold, Andrea

2017-01-25

Imepitoin was tested as a combination treatment with phenobarbital in an open-label mono-centre cohort study in dogs with drug-resistant epilepsy. Diagnosis of idiopathic epilepsy was based on clinical findings, magnetic resonance imaging and cerebrospinal fluid analysis. Three cohorts were treated. In cohort A, dogs not responding to phenobarbital with or without established add-on treatment of potassium bromide or levetiracetam were treated add-on with imepitoin, starting at 10 mg/kg BID, with titration allowed to 30 mg/kg BID. In cohort B, the only difference to cohort A was that the starting dose of imepitoin was reduced to 5 mg/kg BID. In cohort C, animals not responding to imepitoin at >20 mg/kg BID were treated with phenobarbital add-on starting at 0.5 mg/kg BID. The add-on treatment resulted in a reduction in monthly seizure frequency (MSF) in all three cohorts. A reduction of ≥50% was obtained in 36-42% of all animals, without significant difference between cohorts. The lower starting dose of 5 mg/kg BID imepitoin was better tolerated, and an up-titration to on average of 15 mg/kg BID was sufficient in cohort A and B. In cohort C, a mean add-on dose of 1.5 mg/kg BID phenobarbital was sufficient to achieve a clinically meaningful effect. Six dogs developed a clinically meaningful increase in MSF of ≥ 50%, mostly in cohort A. Neither imepitoin nor phenobarbital add-on treatment was capable of suppressing cluster seizure activity, making cluster seizure activity an important predictor for drug-resistance. A combination treatment of imepitoin and phenobarbital is a useful treatment option for a subpopulation of dogs with drug-resistant epilepsy, a low starting dose with 5 mg/kg BID is recommended.

Diagnostic utility of 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET) in asymptomatic subjects at increased risk for Alzheimer's disease.

PubMed

Drzezga, Alexander; Altomare, Daniele; Festari, Cristina; Arbizu, Javier; Orini, Stefania; Herholz, Karl; Nestor, Peter; Agosta, Federica; Bouwman, Femke; Nobili, Flavio; Walker, Zuzana; Frisoni, Giovanni Battista; Boccardi, Marina

2018-05-13

To assess the clinical utility of 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET) for detection of early signs of neurodegeneration in conditions of increased risk for Alzheimer's disease (AD) as defined by: subjective cognitive decline (SCD), evidence of cerebral amyloid-pathology, apolipoprotein E (APOE) ε4-positive genotype, or autosomal dominant forms of AD (ADAD) in asymptomatic stages. A comprehensive literature search was conducted using the PICO model to extract evidence from relevant studies. An expert panel then voted using the Delphi method on three different diagnostic scenarios. The level of empirical study evidence for the use of FDG-PET to detect meaningful early signs of neurodegeneration was considered to be poor for ADAD and lacking for SCD and asymptomatic persons at risk, based on APOE ε4-positive genotype or cerebral amyloid pathology. Consequently, and consistent with current diagnostic criteria, panelists decided not to recommend routine clinical use of FDG-PET in these situations and to currently mainly reserve it for research purposes. Currently, there is limited evidence on which to base recommendations regarding the clinical routine use of FDG-PET to detect diagnostically meaningful early signs of neurodegeneration in asymptomatic subjects with ADAD, with APOE ε4-positive genotype, or with cerebral amyloid pathology, and in subjects with SCD. Future prospective studies are warranted and in part already ongoing, aiming to assess the added value of FDG-PET in this context beyond research applications.

[Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

PubMed

Fu, Yingkun; Xie, Yanming

2011-10-01

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

A review of the in vitro and in vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu Anti-static VHC

PubMed Central

Dissanayake, Sanjeeva; Suggett, Jason

2018-01-01

Valved holding chambers (VHCs) reduce the need for inhalation-actuation coordination with pressurized metered dose inhalers (pMDIs), reduce oropharyngeal drug deposition and may improve lung deposition and clinical outcomes compared to pMDIs used alone. While VHCs are thus widely advocated for use in vulnerable patient groups within clinical and regulatory guidelines, there is less consensus as to whether the performance differences between different VHCs have clinical implications. This review evaluates the VHC literature, in particular the data pertaining to large- versus small-volume chambers, aerosol performance with a VHC adjunct versus a pMDI alone, charge dissipative/conducting versus non-conducting VHCs, and facemasks, to ascertain whether potentially meaningful differences between VHCs exist. Inconsistencies in the literature are examined and explained, and relationships between in vitro and in vivo data are discussed. A particular focus of this review is the AeroChamber Plus® Flow-Vu® Anti-static VHC, the most recent iteration of the AeroChamber VHC family. PMID:29378477

Interprofessional Education and Practice Guide No. 6: Developing practice-based interprofessional learning using a short placement model.

PubMed

Anderson, Elizabeth Susan; Ford, Jenny; Kinnair, Daniel James

2016-07-01

Offering undergraduate and post-qualified learners opportunities to take part in, and reflect on, the nature of interprofessional working when in practice remains an important goal for interprofessional educators. There are a plethora of opportunities within hospital and community care for learners to actively participate in health and social care delivery where collaborative practice prevails. However, it remains challenging to know how to establish and sustain meaningful interprofessional practice-based learning. This is because profession-specific teaching is prioritised and many teams are under-resourced, leaving little time for additional teaching activities. In some instances, practitioners lack the knowledge concerning how to design meaningful interprofessional learning and often feel unprepared for this teaching because of limited interprofessional faculty development. Others are simply unaware of the presence of the different students within their practice area. This guide offers key lessons developed over many years for setting up practice-based interprofessional education. The learning model has been adapted and adopted in different settings and countries and offers a method for engaging clinical front-line practitioners in learning with, and from learners who can help support and in some instances advance care delivery.

Integrating historical clinical and financial data for pharmacological research.

PubMed

Deshmukh, Vikrant G; Sower, N Brett; Hunter, Cheri Y; Mitchell, Joyce A

2011-11-18

Retrospective research requires longitudinal data, and repositories derived from electronic health records (EHR) can be sources of such data. With Health Information Technology for Economic and Clinical Health (HITECH) Act meaningful use provisions, many institutions are expected to adopt EHRs, but may be left with large amounts of financial and historical clinical data, which can differ significantly from data obtained from newer systems, due to lack or inconsistent use of controlled medical terminologies (CMT) in older systems. We examined different approaches for semantic enrichment of financial data with CMT, and integration of clinical data from disparate historical and current sources for research. Snapshots of financial data from 1999, 2004 and 2009 were mapped automatically to the current inpatient pharmacy catalog, and enriched with RxNorm. Administrative metadata from financial and dispensing systems, RxNorm and two commercial pharmacy vocabularies were used to integrate data from current and historical inpatient pharmacy modules, and the outpatient EHR. Data integration approaches were compared using percentages of automated matches, and effects on cohort size of a retrospective study. During 1999-2009, 71.52%-90.08% of items in use from the financial catalog were enriched using RxNorm; 64.95%-70.37% of items in use from the historical inpatient system were integrated using RxNorm, 85.96%-91.67% using a commercial vocabulary, 87.19%-94.23% using financial metadata, and 77.20%-94.68% using dispensing metadata. During 1999-2009, 48.01%-30.72% of items in use from the outpatient catalog were integrated using RxNorm, and 79.27%-48.60% using a commercial vocabulary. In a cohort of 16304 inpatients obtained from clinical systems, 4172 (25.58%) were found exclusively through integration of historical clinical data, while 15978 (98%) could be identified using semantically enriched financial data. Data integration using metadata from financial/dispensing systems and pharmacy vocabularies were comparable. Given the current state of EHR adoption, semantic enrichment of financial data and integration of historical clinical data would allow the repurposing of these data for research. With the push for HITECH meaningful use, institutions that are transitioning to newer EHRs will be able to use their older financial and clinical data for research using these methods.

Integrating historical clinical and financial data for pharmacological research

PubMed Central

2011-01-01

Background Retrospective research requires longitudinal data, and repositories derived from electronic health records (EHR) can be sources of such data. With Health Information Technology for Economic and Clinical Health (HITECH) Act meaningful use provisions, many institutions are expected to adopt EHRs, but may be left with large amounts of financial and historical clinical data, which can differ significantly from data obtained from newer systems, due to lack or inconsistent use of controlled medical terminologies (CMT) in older systems. We examined different approaches for semantic enrichment of financial data with CMT, and integration of clinical data from disparate historical and current sources for research. Methods Snapshots of financial data from 1999, 2004 and 2009 were mapped automatically to the current inpatient pharmacy catalog, and enriched with RxNorm. Administrative metadata from financial and dispensing systems, RxNorm and two commercial pharmacy vocabularies were used to integrate data from current and historical inpatient pharmacy modules, and the outpatient EHR. Data integration approaches were compared using percentages of automated matches, and effects on cohort size of a retrospective study. Results During 1999-2009, 71.52%-90.08% of items in use from the financial catalog were enriched using RxNorm; 64.95%-70.37% of items in use from the historical inpatient system were integrated using RxNorm, 85.96%-91.67% using a commercial vocabulary, 87.19%-94.23% using financial metadata, and 77.20%-94.68% using dispensing metadata. During 1999-2009, 48.01%-30.72% of items in use from the outpatient catalog were integrated using RxNorm, and 79.27%-48.60% using a commercial vocabulary. In a cohort of 16304 inpatients obtained from clinical systems, 4172 (25.58%) were found exclusively through integration of historical clinical data, while 15978 (98%) could be identified using semantically enriched financial data. Conclusions Data integration using metadata from financial/dispensing systems and pharmacy vocabularies were comparable. Given the current state of EHR adoption, semantic enrichment of financial data and integration of historical clinical data would allow the repurposing of these data for research. With the push for HITECH meaningful use, institutions that are transitioning to newer EHRs will be able to use their older financial and clinical data for research using these methods. PMID:22099213

[Study of correlation dimension on EEG].

PubMed

Yang, Hao; Fang, Liang; He, Wei

2004-02-01

The study of non-linear EEG is of great significance in clinical practice and research work. This paper has gone into the feasibility of calculating the correlation dimension and has developed some subjects with the characters of correlation dimension and the difference under four conditions: (1) passive eyes closed(PEC); (2) mental arithmetic with eyes closed(MAEC); (3) passive eyes open(PEO); (4) mental reasoning with eyes open (MRED). The results show it is feasible and meaningful to calculate correlation dimension and the correlation dimension can reflect the regular patterns of mental activity.

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

PubMed

Malfait, Simon; Eeckloo, Kristof; Lust, Elisa; Van Biesen, Wim; Van Hecke, Ann

2017-02-01

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design. © 2016 John Wiley & Sons Ltd.

Age differences in memory for meaningful and arbitrary associations: A memory retrieval account.

PubMed

Amer, Tarek; Giovanello, Kelly S; Grady, Cheryl L; Hasher, Lynn

2018-02-01

Older adults typically show poor associative memory performance relative to younger adults. This age-related effect, however, is mediated by the meaningfulness of the materials used, such that age differences are minimized with the use of information that is consistent with prior knowledge. While this effect has been interpreted as facilitative learning through schematic support, the role of memory retrieval on this effect has yet to be explored. Using an associative memory paradigm that varied the extent of controlled retrieval for previously studied meaningful or arbitrary associations, older and younger adults in the present study retrieved realistic and unrealistic grocery item prices in a speeded, or in a slow, more control-based retrieval condition. There were no age differences in memory for realistic (meaningful) prices in either condition; however, younger adults showed better memory than older adults for unrealistic prices in the controlled retrieval condition only. These results suggest that age differences in memory for arbitrary associations can, at least partly, be accounted for by age reductions in strategic, controlled retrieval. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Childhood Developmental Disorders: An Academic and Clinical Convergence Point for Psychiatry, Neurology, Psychology and Pediatrics

ERIC Educational Resources Information Center

Reiss, Allan L.

2009-01-01

Background: Significant advances in understanding brain development and behavior have not been accompanied by revisions of traditional academic structure. Disciplinary isolation and a lack of meaningful interdisciplinary opportunities are persistent barriers in academic medicine. To enhance clinical practice, research, and training for the next…

Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl.

PubMed

Anthony, Lowell; Ervin, Claire; Lapuerta, Pablo; Kulke, Matthew H; Kunz, Pamela; Bergsland, Emily; Hörsch, Dieter; Metz, David C; Pasieka, Janice; Pavlakis, Nick; Pavel, Marianne; Caplin, Martyn; Öberg, Kjell; Ramage, John; Evans, Emily; Yang, Qi Melissa; Jackson, Shanna; Arnold, Karie; Law, Linda; DiBenedetti, Dana B

2017-11-01

Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in TELESTAR, a Phase III study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview substudy was conducted to provide insight into the patient experience in TELESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful. Participating sites were asked to invite (before randomization) all eligible patients to telephone interviews scheduled at the end of the double-blind treatment period. Patients and interviewers were blinded to treatment. All 35 interviewed participants reported diarrhea and/or excessive BMs at baseline. Patients reported that these symptoms negatively affected emotional, social, physical, and occupational well-being. Prespecified criteria for treatment response (achieving ≥30% reduction in BM frequency for at least 50% of the days) were met by 8 of 26 patients taking telotristat ethyl and 1 of 9 patients taking placebo. All 8 patients taking telotristat ethyl described clinically meaningful reductions in BM frequency and were very satisfied with the ability of the study drug to control their carcinoid syndrome symptoms. Overall, reports of being very satisfied were observed in 12 patients taking telotristat ethyl and 0 taking placebo. Patient interviews revealed that TELESTAR patients, at baseline, were significantly affected by their high BM frequency. Patient reports of their clinical trial experience supported the significance of the primary end point and clinical responder analysis in TELESTAR, helping identify and understand clinically meaningful change produced by telotristat ethyl. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Designing image segmentation studies: Statistical power, sample size and reference standard quality.

PubMed

Gibson, Eli; Hu, Yipeng; Huisman, Henkjan J; Barratt, Dean C

2017-12-01

Segmentation algorithms are typically evaluated by comparison to an accepted reference standard. The cost of generating accurate reference standards for medical image segmentation can be substantial. Since the study cost and the likelihood of detecting a clinically meaningful difference in accuracy both depend on the size and on the quality of the study reference standard, balancing these trade-offs supports the efficient use of research resources. In this work, we derive a statistical power calculation that enables researchers to estimate the appropriate sample size to detect clinically meaningful differences in segmentation accuracy (i.e. the proportion of voxels matching the reference standard) between two algorithms. Furthermore, we derive a formula to relate reference standard errors to their effect on the sample sizes of studies using lower-quality (but potentially more affordable and practically available) reference standards. The accuracy of the derived sample size formula was estimated through Monte Carlo simulation, demonstrating, with 95% confidence, a predicted statistical power within 4% of simulated values across a range of model parameters. This corresponds to sample size errors of less than 4 subjects and errors in the detectable accuracy difference less than 0.6%. The applicability of the formula to real-world data was assessed using bootstrap resampling simulations for pairs of algorithms from the PROMISE12 prostate MR segmentation challenge data set. The model predicted the simulated power for the majority of algorithm pairs within 4% for simulated experiments using a high-quality reference standard and within 6% for simulated experiments using a low-quality reference standard. A case study, also based on the PROMISE12 data, illustrates using the formulae to evaluate whether to use a lower-quality reference standard in a prostate segmentation study. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Pharmacokinetic Drug-Drug Interactions Between Vonoprazan and Low-Dose Aspirin or Nonsteroidal Anti-inflammatory Drugs: A Phase 2, Open-Label, Study in Healthy Japanese Men.

PubMed

Sakurai, Yuuichi; Shiino, Madoka; Horii, Sayako; Okamoto, Hiroyuki; Nakamura, Koki; Nishimura, Akira; Sakata, Yukikuni

2017-01-01

Gastroprotective agents are recommended for patients receiving low-dose aspirin (LDA) or nonsteroidal anti-inflammatory drugs (NSAIDs). Vonoprazan is a potassium-competitive acid blocker recently approved for the prevention of peptic ulcer recurrence in patients receiving LDA or NSAIDs. This phase 2, open-label, single-center study in healthy Japanese males evaluated drug-drug interactions between vonoprazan 40 mg and LDA (100 mg) or NSAIDs [loxoprofen sodium (60 mg), diclofenac sodium (25 mg), or meloxicam (10 mg)] and vice versa. Subjects were allocated to one of eight cohorts and received their orally administered treatment regimen (to assess the effect of vonoprazan vs. NSAID or LDA, or vice versa) once daily. Endpoints were the pharmacokinetics of plasma concentrations of the study drugs alone and in combination (primary), safety (secondary), and vonoprazan effects on aspirin-mediated inhibition of platelet-aggregation. Of 109 subjects screened, 64 were assigned to one of eight cohorts (n = 8 per cohort) and received treatment, one subject discontinued due to a treatment-emergent adverse event (TEAE), and 63 completed the study. There were few differences in the pharmacokinetics of vonoprazan when administered with LDA or NSAIDs, and few differences in the pharmacokinetics of LDA or NSAIDs when administered with vonoprazan. The differences were small and not clinically meaningful. Inhibition of arachidonic-induced platelet aggregation by LDA was not influenced by vonoprazan. Six patients experienced a TEAE, all were mild and were deemed unrelated to study drugs. One subject withdrew due to infection (tonsillitis). No clinically meaningful drug-drug interactions were observed and vonoprazan was well tolerated when administered with LDA or NSAIDs. JapicCTI-153100.

Predicting loss of employment over three years in multiple sclerosis: clinically meaningful cognitive decline.

PubMed

Morrow, Sarah A; Drake, Allison; Zivadinov, Robert; Munschauer, Frederick; Weinstock-Guttman, Bianca; Benedict, Ralph H B

2010-10-01

Cognitive dysfunction is common in multiple sclerosis (MS), yet the magnitude of change on objective neuropsychological (NP) tests that is clinically meaningful is unclear. We endeavored to determine NP markers of the transition from employment to work disability in MS, as indicated by degree of decline on individual tests. Participants were 97 employed MS patients followed over 41.3 ± 17.6 months with a NP battery covering six domains of cognitive function. Deterioration at follow-up was designated as documented and paid disability benefits (conservative definition) or a reduction in hours/work responsibilities (liberal definition). Using the conservative definition, 28.9% reported deteriorated employment status and for the liberal definition, 45.4%. The Symbol Digit Modalities Test (SDMT) and California Verbal Learning Test, Total Learning (CVLT2-TL) measures distinguished employed and disabled patients at follow-up. Controlling for demographic and MS characteristics, the odds ratio of a deterioration based on a change of 2.0 on the CVLT2-TL was 3.7 (95% CI 1.2-11.4 and SDMT by 4.0 was 4.2 (95% CI 1.2-14.8), accounting for 86.7% of the area under the ROC curve. We conclude that decline on NP testing over time is predictive of deterioration in vocational status, establishing a magnitude of decline on NP tests that is clinically meaningful.

Self-organizing neural networks--an alternative way of cluster analysis in clinical chemistry.

PubMed

Reibnegger, G; Wachter, H

1996-04-15

Supervised learning schemes have been employed by several workers for training neural networks designed to solve clinical problems. We demonstrate that unsupervised techniques can also produce interesting and meaningful results. Using a data set on the chemical composition of milk from 22 different mammals, we demonstrate that self-organizing feature maps (Kohonen networks) as well as a modified version of error backpropagation technique yield results mimicking conventional cluster analysis. Both techniques are able to project a potentially multi-dimensional input vector onto a two-dimensional space whereby neighborhood relationships remain conserved. Thus, these techniques can be used for reducing dimensionality of complicated data sets and for enhancing comprehensibility of features hidden in the data matrix.

Clinical modeling--a critical analysis.

PubMed

Blobel, Bernd; Goossen, William; Brochhausen, Mathias

2014-01-01

Modeling clinical processes (and their informational representation) is a prerequisite for optimally enabling and supporting high quality and safe care through information and communication technology and meaningful use of gathered information. The paper investigates existing approaches to clinical modeling, thereby systematically analyzing the underlying principles, the consistency with and the integration opportunity to other existing or emerging projects, as well as the correctness of representing the reality of health and health services. The analysis is performed using an architectural framework for modeling real-world systems. In addition, fundamental work on the representation of facts, relations, and processes in the clinical domain by ontologies is applied, thereby including the integration of advanced methodologies such as translational and system medicine. The paper demonstrates fundamental weaknesses and different maturity as well as evolutionary potential in the approaches considered. It offers a development process starting with the business domain and its ontologies, continuing with the Reference Model-Open Distributed Processing (RM-ODP) related conceptual models in the ICT ontology space, the information and the computational view, and concluding with the implementation details represented as engineering and technology view, respectively. The existing approaches reflect at different levels the clinical domain, put the main focus on different phases of the development process instead of first establishing the real business process representation and therefore enable quite differently and partially limitedly the domain experts' involvement. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Comparison of three versions of Partin tables to predict final pathologic stage in a Chinese cohort: a decision curve analysis.

PubMed

Xiao, Wen-Jun; Ye, Ding-Wei; Yao, Xu-Dong; Zhang, Shi-Lin; Dai, Bo

2013-01-01

To compare Partin tables (PTs) 1997, 2001, and 2007 for their clinical applicability in a Chinese cohort based upon a decision curve analysis (DCA). Clinical and pathologic data of 264 consecutive Chinese patients with clinically localized prostate cancer were used. These patients underwent open radical prostatectomy between 2005 and 2011. DCA quantified the net benefit of different PT versions relating to specific threshold probabilities of established capsular penetration (ECP), seminal vesicle involvement (SVI), and lymph node involvement (LNI). Overall, ECP, SVI, and LNI were recorded in 23.1, 10.2, and 6.1%, respectively. When the threshold probability was below the prevalence for LNI and ECP predictions, the DCA favored the 2007 version versus the 1997 version for SVI. DCA indicates that for low threshold probability, decision models are useful to discriminate the performance differences of three PT versions, although net benefit differences were not apparent. For high threshold probability, there may not be an important benefit from the use of PTs and the current analysis cannot translate into meaningful net gains differences. Copyright © 2013 S. Karger AG, Basel.

Significant Work Is About Self-Realization and Broader Purpose: Defining the Key Dimensions of Meaningful Work.

PubMed

Martela, Frank; Pessi, Anne B

2018-01-01

Research on meaningful work has proliferated in recent years, with an increasing understanding of the centrality of meaningfulness for work-related motivation, commitment, and well-being. However, ambiguity around the main construct, "meaningful work," has hindered this progress as various researchers have used partly overlapping, partly differing conceptualizations. To bring clarity to this issue, we examine a broad range of various definitions of meaningful work and come to argue that meaningfulness in the broadest sense is about work significance as an overall evaluation of work as regards whether it is intrinsically valuable and worth doing. Furthermore, we argue that there are two key sub-dimensions to this work significance: Broader purpose as work serving some greater good or prosocial goals (the intrinsic value of work beyond the person in question). And self-realization as a sense of autonomy, authenticity and self-expression at work (the intrinsic value of work for the person in question). Previous definitions of meaningful work feature typically one or two of these elements-significance, broader purpose, self-realization -, but in the future it would be beneficial to clearly acknowledge all three elements in both definitions and operationalizations of meaningful work.

Significant Work Is About Self-Realization and Broader Purpose: Defining the Key Dimensions of Meaningful Work

PubMed Central

Martela, Frank; Pessi, Anne B.

2018-01-01

Research on meaningful work has proliferated in recent years, with an increasing understanding of the centrality of meaningfulness for work-related motivation, commitment, and well-being. However, ambiguity around the main construct, “meaningful work,” has hindered this progress as various researchers have used partly overlapping, partly differing conceptualizations. To bring clarity to this issue, we examine a broad range of various definitions of meaningful work and come to argue that meaningfulness in the broadest sense is about work significance as an overall evaluation of work as regards whether it is intrinsically valuable and worth doing. Furthermore, we argue that there are two key sub-dimensions to this work significance: Broader purpose as work serving some greater good or prosocial goals (the intrinsic value of work beyond the person in question). And self-realization as a sense of autonomy, authenticity and self-expression at work (the intrinsic value of work for the person in question). Previous definitions of meaningful work feature typically one or two of these elements—significance, broader purpose, self-realization –, but in the future it would be beneficial to clearly acknowledge all three elements in both definitions and operationalizations of meaningful work. PMID:29632502

Patients' and Caregivers' Attributes in a Meaningful Care Encounter: Similarities and Notable Differences

PubMed Central

Snellman, Ingrid; Gustafsson, Christine; Gustafsson, Lena-Karin

2012-01-01

In today's healthcare system, there is an imbalance between what patients expect of caregivers' care and their perception of the care they get. How is it possible to reduce this imbalance? The aim of this paper was to describe attributes associated with meaningful encounters in the Swedish healthcare system based on patients' and caregivers' written narratives and to note the differences and similarities between the attributes identified by the two groups. This paper is a qualitative descriptive study. The analysis was guided by qualitative content analyses. Based on patients' narratives, attributes associated with a meaningful encounter fell into four categories: the kind-hearted caregiver, the thoughtful caregiver, the mutually oriented caregiver, and the helpful caregiver. Based on caregivers' narratives, the attributes were categorized as being humane, caring through physical contact, caring by nurturing communication, joy and laughter in care, and a sense of mutuality. The results show that there are both similarities and differences in patients' and caregivers' opinions about the attributes of a meaningful encounter. Knowing more about the attributes associated with meaningful encounters makes it possible for caregivers to individualize care for patients and makes it easier to help and support patients in what they most need support with. PMID:22701802

Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110.

PubMed

Scrima, Lawrence; Emsellem, Helene A; Becker, Philip M; Ruoff, Chad; Lankford, Alan; Bream, Gary; Khayrallah, Moise; Lu, Yuan; Black, Jed

2017-10-01

While scores ≤10 on the Epworth Sleepiness Scale (ESS) are within the normal range, the reduction in elevated ESS score that is clinically meaningful in patients with narcolepsy has not been established. This post hoc analysis of a clinical trial of patients with narcolepsy evaluated correlations between Patient Global Impression of Change (PGI-C) and ESS. Data of adult patients with narcolepsy from a double-blind, 12-week placebo-controlled study of JZP-110, a wake-promoting agent, were used in this analysis. Descriptive statistics and receiver operating characteristic (ROC) analysis compared PGI-C (anchor measure) to percent change from baseline in ESS to establish the responder criterion from patients taking either placebo or JZP-110 (treatments). At week 12, patients (n = 10) who reported being "very much improved" on the PGI-C had a mean 76.7% reduction in ESS score, and patients (n = 33) who reported being "much improved" on the PGI-C had a mean 49.1% reduction in ESS score. ROC analysis showed that patients who improved were almost exclusively from JZP-110 treatment group, with an area-under-the-curve of 0.9, and revealed that a 25% reduction in ESS (sensitivity, 81.4%; specificity, 80.9%) may be an appropriate threshold for defining a meaningful patient response to JZP-110 and placebo. A ≥25% reduction in patients' subjective ESS score may be useful as a threshold to identify patients with narcolepsy who respond to JZP-110 treatment. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

[Therapeutic education didactic techniques].

PubMed

Valverde, Maite; Vidal, Mercè; Jansa, Margarida

2012-10-01

This article includes an introduction to the role of Therapeutic Education for Diabetes treatment according to the recommendations of the American Diabetes Association (ADA), the Diabetes Education Study Group (DESG) of the "European Association for Study of Diabetes (EASD) and the clinical Practice Guidelines (CPG) of the Spanish Ministry of Health. We analyze theoretical models and the differences between teaching vs. learning as well as current trends (including Internet), that can facilitate meaningful learning of people with diabetes and their families and relatives. We analyze the differences, similarities, advantages and disadvantages of individual and group education. Finally, we describe different educational techniques (metaplan, case method, brainstorming, role playing, games, seminars, autobiography, forums, chats,..) applicable to individual, group or virtual education and its application depending on the learning objective.

Meaningfulness of Sex Differences in Selected Interest-Values Test Scores.

ERIC Educational Resources Information Center

Plant, Walter T.; Southern, Mara L.

This research paper examines the meaningfulness of sex differences in the Allport, Vernon and Lindzey (AVL) Study of Values Scale and in selected scales of the Strong-Campbell Interest Inventory (SCII), using somewhat diverse groups of men and women. By comparing men's and women's scores on the two measures, it was found that little accuracy in…

Representing and Practising Meaningful Differences in a Well-Structured but Complex Art Curriculum

ERIC Educational Resources Information Center

Cunliffe, Leslie

2010-01-01

This paper conceptualizes the secondary art curriculum as a well-structured but complex knowledge-domain, with the aim of emphasizing meaningful differences in the way creative grammar operates in the following gatherings of art practices: Pre-historic and non-European cultures; Ancient and European cultures before c. 1800; Romantic and Modern…

Sexual intercourse for cervical ripening and induction of labour.

PubMed

Kavanagh, J; Kelly, A J; Thomas, J

2001-01-01

The role of prostaglandins for cervical ripening and induction of labour has been examined extensively. Human semen is the biological source that is presumed to contain the highest prostaglandin concentration. The role of sexual intercourse in the initiation of labour is uncertain. The action of sexual intercourse in stimulating labour is unclear, it may in part be due to the physical stimulation of the lower uterine segment, or endogenous release of oxytocin as a result of orgasm or from the direct action of prostaglandins in semen. Furthermore nipple stimulation may be part of the process of initiation. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. To determine the effects of sexual intercourse for third trimester cervical ripening or induction of labour in comparison with other methods of induction. The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. (1) clinical trials comparing sexual intercourse for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. There was one included study of 28 women which reported very limited data, from which no meaningful conclusions can be drawn. The role of sexual intercourse as a method of induction of labour is uncertain. Any future trials investigating sexual intercourse as a method of induction need to be of sufficient power to detect clinically relevant differences in standard outcomes. However, it may prove difficult to standardise sexual intercourse as an intervention to allow meaningful comparisons with other methods of induction of labour.

Reliability of Performance-Based Clinical Measurements to Assess Shoulder Girdle Kinematics and Positioning: Systematic Review.

PubMed

D'hondt, Norman E; Kiers, Henri; Pool, Jan J M; Hacquebord, Sijmen T; Terwee, Caroline B; Veeger, Dirkjan H E J

2017-01-01

Deviant shoulder girdle movement is suggested as an eminent factor in the etiology of shoulder pain. Reliable measurements of shoulder girdle kinematics are a prerequisite for optimizing clinical management strategies. The purpose of this study was to evaluate the reliability, measurement error, and internal consistency of measurements with performance-based clinical tests for shoulder girdle kinematics and positioning in patients with shoulder pain. The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception to August 2015. Articles published in Dutch, English, or German were included if they involved the evaluation of at least one of the measurement properties of interest. Two reviewers independently evaluated the methodological quality per studied measurement property with the 4-point-rating scale of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist, extracted data, and assessed the adequacy of the measurement properties. Forty studies comprising more than 30 clinical tests were included. Actual reported measurements of the tests were categorized into: (1) positional measurement methods, (2) measurement methods to determine dynamic characteristics, and (3) tests to diagnose impairments of shoulder girdle function. Best evidence synthesis of the tests was performed per measurement for each measurement property. All studies had significant limitations, including incongruence between test description and actual reported measurements and a lack of reporting on minimal important change. In general, the methodological quality of the selected studies was fair to poor. High-quality evidence indicates that measurements obtained with the Modified Scapular Assistance Test are not reliable for clinical use. Sound recommendations for the use of other tests could not be made due to inadequate evidence. Across studies, diversity in description, performance, and interpretation of similar tests was present, and different criteria were used to establish similar diagnoses, mostly without taking into account a clinically meaningful context. Consequently, these tests lack face validity, which hampers their clinical use. Further research on validity and how to integrate a clinically meaningful context of movement into clinical tests is warranted. © 2017 American Physical Therapy Association

The Effect of Clinical Simulation with Debriefing for Meaningful Learning in Courses of Nursing Theory and Practicum on Student Knowledge and Perception of Instruction

ERIC Educational Resources Information Center

Shea, Kathleen

2015-01-01

Nursing students are expected to apply knowledge from lectures and laboratories to the clinical setting. One major challenge of nursing educators is facilitating the transfer of knowledge to the clinical-practice setting. Simulation-based education provides students with an experiential-learning activity within the context of a simulated clinical…

Suicide in the oldest old: an observational study and cluster analysis.

PubMed

Sinyor, Mark; Tan, Lynnette Pei Lin; Schaffer, Ayal; Gallagher, Damien; Shulman, Kenneth

2016-01-01

The older population are at a high risk for suicide. This study sought to learn more about the characteristics of suicide in the oldest-old and to use a cluster analysis to determine if oldest-old suicide victims assort into clinically meaningful subgroups. Data were collected from a coroner's chart review of suicide victims in Toronto from 1998 to 2011. We compared two age groups (65-79 year olds, n = 335, and 80+ year olds, n = 191) and then conducted a hierarchical agglomerative cluster analysis using Ward's method to identify distinct clusters in the 80+ group. The younger and older age groups differed according to marital status, living circumstances and pattern of stressors. The cluster analysis identified three distinct clusters in the 80+ group. Cluster 1 was the largest (n = 124) and included people who were either married or widowed who had significantly more depression and somewhat more medical health stressors. In contrast, cluster 2 (n = 50) comprised people who were almost all single and living alone with significantly less identified depression and slightly fewer medical health stressors. All members of cluster 3 (n = 17) lived in a retirement residence or nursing home, and this group had the highest rates of depression, dementia, other mental illness and past suicide attempts. This is the first study to use the cluster analysis technique to identify meaningful subgroups among suicide victims in the oldest-old. The results reveal different patterns of suicide in the older population that may be relevant for clinical care. Copyright © 2015 John Wiley & Sons, Ltd.

[Effect of sociodemographic factors, cancer, psychiatric disorder on suicide: gender and age-specific patterns].

PubMed

Park, Jae Young; Moon, Ki Tae; Chae, Yoo Mi; Jung, Sang Hyuk

2008-01-01

We examined the effect of sociodemographic factors, cancer, and psychiatric disorders on suicide by gender and age-specific patterns in South Korea. The study is a case-control study. Claim data was obtained from the national health insurance database and national death registration database. The number of people who committed suicide was 11,523, which was matched with a control group consisting of ten times as many people at 115,230 selected from the national health insurance and medical aids beneficiaries. The medical utilization of the case group was one year before death and that of the control group was from July 1,2003 to June 30, 2004. Four variables-address, economic status, presence of a psychiatric disease, and cancer-were used in multiple logistic regression analyses. Living in cities or in rural areas showed a greater risk for suicide than living in a metropolitan city. Low economic status, the presence of a psychiatric disorder, and cancer were also statistically meaningful risk factors for suicide. The three major psychiatric diseases, schizophrenia, alcohol abuse, and bipolar disorder, were meaningful in all age groups, but the scale of the odds ratio differed by the age group. Only the psychiatric disorder variable was meaningful in the adolescent group, whereas a psychiatric disorder and economic status were meaningful for the young adult group, and all variables were meaningful for the middle-aged group. A psychiatric disorder and cancer were meaningful in the elderly group, economic status was meaningful for male subjects, and address was meaningful for female subjects. Factors such as living in city or rural areas, low economic status, the presence of a psychiatric disorder, and cancer were statistically meaningful risk factors in suicide. These factors also differed by age group. Therefore, policymakers should establish policies for suicide prevention that are relevant for each age group.

Directions in Marriage and Family Therapy, 1994.

ERIC Educational Resources Information Center

Cermele, Debra E., Ed.

1994-01-01

In an effort to help practitioners deal with the great volume of current literature in the field of marriage and family therapy, this compilation attempts to present clinically relevant material in a user-friendly format. Topics selected for inclusion are believed to be up-to-date, informative, and clinically meaningful--as well as theoretically…

Has Modern Biology Entered the Mouth? The Clinical Impact of Biological Research.

ERIC Educational Resources Information Center

Baum, Bruce J.

1991-01-01

Three areas of biological research that are beginning to have an impact on clinical medicine are examined, including molecular biology, cell biology, and biotechnology. It is concluded that oral biologists and educators must work cooperatively to bring rapid biological and biomedical advances into dental training in a meaningful way. (MSE)

Directions in Marriage and Family Therapy: Volume 1.

ERIC Educational Resources Information Center

Directions in Marriage and Family Therapy, 1993

1993-01-01

In an effort to help practitioners deal with the great volume of current literature in the field of marriage and family therapy, this compilation attempts to present clinically relevant material in a user-friendly format. Topics selected for inclusion are believed to be up-to-date, informative, and clinically meaningful--as well as theoretically…

Construction of an efficient evaluative instrument for myasthenia gravis: the MG composite.

PubMed

Burns, Ted M; Conaway, Mark R; Cutter, Gary R; Sanders, Donald B

2008-12-01

We assessed the performance of items from the Quantitative Myasthenia Gravis (QMG), MMT (Manual Muscle Test), and MG-ADL (Myasthenia Gravis - Activities of Daily Living) scales, using data from two recently completed treatment trials of generalized MG. Items were selected that were relevant to manifestations of MG, meaningful to both the physician and the patient, and responsive to clinical change. After the 10 items were chosen, they were weighted based on input from MG experts from around the world, considering factors such as quality of life, disease severity, risk, prognosis, validity, and reliability. The MG Composite is easy to administer, takes less than 5 minutes to complete, and requires no equipment. Weighting of the response options of the 10 items should result in ordinal scores that better represent MG status and are more responsive to meaningful clinical change. To better determine its suitability for clinical use and for treatment trials, the MG Composite will be tested prospectively at several academic medical centers and will be used as a secondary measure of efficacy in pending clinical trials of MG.

Engaging clinical nurses in quality and performance improvement activities.

PubMed

Albanese, Madeline P; Evans, Dietra A; Schantz, Cathy A; Bowen, Margaret; Disbot, Maureen; Moffa, Joseph S; Piesieski, Patricia; Polomano, Rosemary C

2010-01-01

Nursing performance measures are an integral part of quality initiatives in acute care; however, organizations face numerous challenges in developing infrastructures to support quality improvement processes and timely dissemination of outcomes data. At the Hospital of the University of Pennsylvania, a Magnet-designated organization, extensive work has been conducted to incorporate nursing-related outcomes in the organization's quality plan and to integrate roles for clinical nurses into the Department of Nursing and organization's core performance-based programs. Content and strategies that promote active involvement of nurses and prepare them to be competent and confident stakeholders in quality initiatives are presented. Engaging clinical nurses in the work of quality and performance improvement is essential to achieving excellence in clinical care. It is important to have structures and processes in place to bring meaningful data to the bedside; however, it is equally important to incorporate outcomes into practice. When nurses are educated about performance and quality measures, are engaged in identifying outcomes and collecting meaningful data, are active participants in disseminating quality reports, and are able to recognize the value of these activities, data become one with practice.

Knee Contact Force Asymmetries in Patients Who Failed Return-to-Sport Readiness Criteria 6 Months After Anterior Cruciate Ligament Reconstruction

PubMed Central

Gardinier, Emily S.; Di Stasi, Stephanie; Manal, Kurt; Buchanan, Thomas S.; Snyder-Mackler, Lynn

2015-01-01

Background After anterior cruciate ligament (ACL) injury, contact forces are decreased in the injured knee when compared with the uninjured knee. The persistence of contact force asymmetries after ACL reconstruction may increase the risk of reinjury and may play an important role in the development of knee osteoarthritis in these patients. Functional performance may also be useful in identifying patients who demonstrate potentially harmful joint contact force asymmetries after ACL reconstruction. Hypothesis Knee joint contact force asymmetries would be present during gait after ACL reconstruction, and performance on a specific set of validated return-to-sport (RTS) readiness criteria would discriminate between those who demonstrated contact force asymmetries and those who did not. Study Design Descriptive laboratory study. Methods A total of 29 patients with ACL ruptures participated in gait analysis and RTS readiness testing 6 months after reconstruction. Muscle and joint contact forces were estimated using an electromyography (EMG)–driven musculoskeletal model of the knee. The magnitude of typical limb asymmetry in uninjured controls was used to define limits of meaningful limb asymmetry in patients after ACL reconstruction. The RTS testing included isometric quadriceps strength testing, 4 unilateral hop tests, and 2 self-report questionnaires. Paired t tests were used to assess limb symmetry for peak medial and tibiofemoral contact forces in all patients, and a mixed-design analysis of variance was used to analyze the effect of passing or failing RTS testing on contact force asymmetry. Results Among all patients, neither statistically significant nor meaningful contact force asymmetries were identified. However, patients who failed RTS testing exhibited meaningful contact force asymmetries, with tibiofemoral contact force being significantly lower for the involved knee. Conversely, patients who passed RTS testing exhibited neither significant nor meaningful contact force asymmetries. Conclusion Joint contact force asymmetries during gait are present in some patients 6 months after ACL reconstruction. Patients who demonstrated poor functional performance on RTS readiness testing exhibited significant and meaningful contact force asymmetries. Clinical Relevance When assessing all patients together, variability in the functional status obscured significant and meaningful differences in contact force asymmetry in patients 6 months after ACL reconstruction. These specific RTS readiness criteria appear to differentiate between those who demonstrate joint contact force symmetry after ACL reconstruction and those who do not. PMID:25318940

“Meaningful use” of electronic health records and its relevance to laboratories and pathologists

PubMed Central

Henricks, Walter H.

2011-01-01

Electronic health records (EHRs) have emerged as a major topic in health care and are central to the federal government’s strategy for transforming healthcare delivery in the United States. Recent federal actions that aim to promote the use of EHRs promise to have significant implications for laboratories and for pathology practices. Under the HITECH (Health Information Technology Economic and Clinical Health) Act, an EHR incentive program has been established through which individual physicians and hospitals can qualify to receive incentive payments if they achieve “meaningful use” of “certified” EHR technology. The rule also establishes payment penalties in future years for eligible providers who have not met the requirements for meaningful use of EHRs. Meaningful use must be achieved using EHR technology that has been certified in accordance with functional and technical criteria that are set forth a regulation that parallels the meaningful use criteria in the incentive program. These actions and regulations are important to laboratories and pathologists for a number of reasons. Several of the criteria and requirements in the meaningful use rules and EHR certification criteria relate directly or indirectly to laboratory testing and laboratory information management, and future stage requirements are expected to impact the laboratory as well. Furthermore, as EHR uptake expands, there will be greater expectations for electronic interchange of laboratory information and laboratory information system (LIS)-EHR interfaces. Laboratories will need to be aware of the technical, operational, and business challenges that they may face as expectations for LIS-EHR increase. This paper reviews the important recent federal efforts aimed at accelerating EHR use, including the incentive program for EHR meaningful use, provider eligibility, and EHR certification criteria, from a perspective of their relevance for laboratories and pathology practices. PMID:21383931

Myasthenia Gravis Impairment Index: Responsiveness, meaningful change, and relative efficiency.

PubMed

Barnett, Carolina; Bril, Vera; Kapral, Moira; Kulkarni, Abhaya V; Davis, Aileen M

2017-12-05

To study responsiveness and meaningful change of the Myasthenia Gravis Impairment Index (MGII) and its relative efficiency compared to other measures. We enrolled 95 patients receiving prednisone, IV immunoglobulin (IVIg), or plasma exchange (PLEX) and 54 controls. Patients were assessed with the MGII and other measures-including the Quantitative Myasthenia Gravis Score, Myasthenia Gravis Composite, and Myasthenia Gravis Activities of Daily Living-at baseline and 3-4 weeks after treatment. Statistical markers of responsiveness included between-groups and within-group differences, and we estimated the relative efficiency of the MGII compared to other measures. Patient-meaningful change was assessed with an anchor-based method, using the patient's impression of change. We determined the minimal detectable change (MDC) and the minimal important difference (MID) at the group and individual level. Treated patients had a higher change in MGII scores than controls (analysis of covariance p < 0.001). The ocular domain changed more with prednisone than with IVIg/PLEX (effect size 0.67 and 0.13, analysis of covariance p = 0.001). The generalized domain changed more with IVIg/PLEX than with prednisone (effect size 0.50 and 0.22, analysis of covariance p = 0.07). For the total MGII score, the individual MDC95 was 9.1 and the MID was 5.5 for individuals and 8.1 for groups. Relative efficiency ratios were >1 favoring the MGII. The MGII demonstrated responsiveness to prednisone, IVIg, and PLEX in patients with myasthenia. There is a differential response in ocular and generalized symptoms to type of therapy. The MGII has higher relative efficiency than comparison measures and is viable for use in clinical trials. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Comparing the effect of group-based and compact disk-based training on midwives' knowledge and attitude toward domestic violence in women of reproductive age.

PubMed

Vakily, Masoomeh; Noroozi, Mahnaz; Yamani, Nikoo

2017-01-01

Training the health personnel about domestic violence would cause them to investigate and evaluate this issue more than before. Considering the new educational approaches for transferring knowledge, the goal of this research was to compare the effect of group-based and compact disk (CD)-based training on midwives' knowledge and attitude toward domestic violence. In this clinical experiment, seventy midwives working at health centers and hospitals of Isfahan were randomly allocated into two classes of group-based and CD-based trainings and were trained in the fields of recognition, prevention, and management of domestic violence. Data were collected by questionnaires which were completed by the midwives for evaluation of their knowledge and attitude. The mean score of midwives' knowledge and attitude toward domestic violence had a meaningful increase after the training (16.1, 46.9) compared to the score of before the training (12.1, 39.1) in both of the classes (group-based training: 17.7, 45.4) (CD-based training: 11.7, 38.6). No meaningful difference was observed between the two groups regarding midwives' attitude toward domestic violence after the intervention; however, regarding their knowledge level, the difference was statistically meaningful ( P = 0.001), and this knowledge increase was more in the CD-based training group. In spite of the effectiveness of both of the training methods in promoting midwives' knowledge and attitude about domestic violence, training with CD was more effective in increasing their knowledge; as a result, considering the benefits of CD-based training such as cost-effectiveness and possibility of use at any time, it is advised to be used in training programs for the health personnel.

Evaluation of the advantageous anesthetic properties of dexmedetomidine used as hypotensive agent compared with nitroglycerin in orthognathic surgery.

PubMed

Rummasak, Duangdee; Apipan, Benjamas

2014-12-01

To evaluate the advantageous anesthetic properties, such as the decrease of intraoperative analgesic requirement, time to extubation and recovery, and early postoperative pain, of dexmedetomidine used as hypotensive agent compared with nitroglycerin in orthognathic surgery. The authors implemented a prospective, single-blinded, randomized clinical trial. The sample was composed of healthy patients who were admitted for bimaxillary osteotomies and were assigned to 1 of 2 groups by a computer-generated random number and blinded to the group. Dexmedetomidine or nitroglycerin was used as the hypotensive drug for each group. All patients underwent hypotensive anesthesia and surgery according to standard protocol. Intraoperative amount of fentanyl, time to eye opening, time to follow basic verbal commands, time to extubation, early postoperative pain scores, and analgesics were recorded. Compared means were analyzed using the unpaired Student t test. A 2-sided statistical test was used. A P value less than .05 was considered significant. The sample was composed of 40 participants. The intraoperative fentanyl requirement was significantly lower in the dexmedetomidine group than in the nitroglycerin group (168.75±56.29 and 222.50±96.12 μg, respectively; P=.037). Times to eye opening and following commands were considerably longer in the dexmedetomidine group, but the time to extubation showed no meaningful difference. Early postoperative pain after 30 and 60 minutes and the requirement for meperidine were not meaningfully different between the 2 groups. Dexmedetomidine, used as a hypotensive drug, has anesthetic benefits compared with nitroglycerin. Dexmedetomidine decreases the intraoperative fentanyl requirement and does not meaningfully change the time to extubation, early postoperative pain, and analgesic drug requirement. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Comparing the effect of group-based and compact disk-based training on midwives’ knowledge and attitude toward domestic violence in women of reproductive age

PubMed Central

Vakily, Masoomeh; Noroozi, Mahnaz; Yamani, Nikoo

2017-01-01

BACKGROUND: Training the health personnel about domestic violence would cause them to investigate and evaluate this issue more than before. Considering the new educational approaches for transferring knowledge, the goal of this research was to compare the effect of group-based and compact disk (CD)-based training on midwives’ knowledge and attitude toward domestic violence. METHODS: In this clinical experiment, seventy midwives working at health centers and hospitals of Isfahan were randomly allocated into two classes of group-based and CD-based trainings and were trained in the fields of recognition, prevention, and management of domestic violence. Data were collected by questionnaires which were completed by the midwives for evaluation of their knowledge and attitude. RESULTS: The mean score of midwives’ knowledge and attitude toward domestic violence had a meaningful increase after the training (16.1, 46.9) compared to the score of before the training (12.1, 39.1) in both of the classes (group-based training: 17.7, 45.4) (CD-based training: 11.7, 38.6). No meaningful difference was observed between the two groups regarding midwives’ attitude toward domestic violence after the intervention; however, regarding their knowledge level, the difference was statistically meaningful (P = 0.001), and this knowledge increase was more in the CD-based training group. CONCLUSIONS: In spite of the effectiveness of both of the training methods in promoting midwives’ knowledge and attitude about domestic violence, training with CD was more effective in increasing their knowledge; as a result, considering the benefits of CD-based training such as cost-effectiveness and possibility of use at any time, it is advised to be used in training programs for the health personnel. PMID:28852660

Stimulus Set Meaningfulness and Neurophysiological Differentiation: A Functional Magnetic Resonance Imaging Study

PubMed Central

Boly, Melanie; Sasai, Shuntaro; Gosseries, Olivia; Oizumi, Masafumi; Casali, Adenauer; Massimini, Marcello; Tononi, Giulio

2015-01-01

A meaningful set of stimuli, such as a sequence of frames from a movie, triggers a set of different experiences. By contrast, a meaningless set of stimuli, such as a sequence of ‘TV noise’ frames, triggers always the same experience—of seeing ‘TV noise’—even though the stimuli themselves are as different from each other as the movie frames. We reasoned that the differentiation of cortical responses underlying the subject’s experiences, as measured by Lempel-Ziv complexity (incompressibility) of functional MRI images, should reflect the overall meaningfulness of a set of stimuli for the subject, rather than differences among the stimuli. We tested this hypothesis by quantifying the differentiation of brain activity patterns in response to a movie sequence, to the same movie scrambled in time, and to ‘TV noise’, where the pixels from each movie frame were scrambled in space. While overall cortical activation was strong and widespread in all conditions, the differentiation (Lempel-Ziv complexity) of brain activation patterns was correlated with the meaningfulness of the stimulus set, being highest in the movie condition, intermediate in the scrambled movie condition, and minimal for ‘TV noise’. Stimulus set meaningfulness was also associated with higher information integration among cortical regions. These results suggest that the differentiation of neural responses can be used to assess the meaningfulness of a given set of stimuli for a given subject, without the need to identify the features and categories that are relevant to the subject, nor the precise location of selective neural responses. PMID:25970444

Pilot testing a couples-focused intervention for mild cognitive impairment.

PubMed

Lu, Yvonne Yueh-Feng; Haase, Joan E; Weaver, Michael

2013-05-01

The purpose of this pilot was to evaluate the acceptability, feasibility, and potential benefits of the multicomponent, Daily Enhancement of Meaningful Activity (DEMA) intervention, which was tailored to help couples facing mild cognitive impairment (MCI) work together to meet goals, remain engaged in meaningful activities, and adapt to changes over time. Using a single-group design, 10 individuals with MCI and their family caregivers were recruited to participate in the DEMA intervention over 6 biweekly sessions. Data were collected pre-and at 1 week and 3 months postintervention completion rates indicated the program and study procedures were well accepted. Qualitative and quantitative finding indicated positive trends in meaningful activity performance and maintenance of health-related outcomes, as well as high program satisfaction. The DEMA intervention is potentially promising but needs further testing in a randomized clinical trial.

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.

Examining the use of comparative and cost-effectiveness analyses in radiology.

PubMed

Goehler, Alexander; Gazelle, G Scott

2014-11-01

This article explores key principles of comparative effectiveness analysis--in particular, how radiologic comparative and cost-effectiveness studies differ from other clinical trials. Exemplary studies are reviewed to show how comparative effectiveness has been implemented in radiology and how future studies might be conducted. Finally, the article closes with a discussion of several additional key themes relevant to quality and value in clinical radiology going forward. Comparative effectiveness is likely to require a paradigm shift in thinking within the discipline. For new radiologic applications to be accepted, we will need to show at least a significant change in treatment planning and at best a meaningful change in patient outcomes. This shift will require a forward-thinking approach to robust evidence generation for new imaging modalities or indications and the inclusion of other modes of value demonstration such as clinical decision support and intelligent data mining.

Alternative Medicine and Alzheimer's Disease

PubMed Central

Kelley, Brendan J.; Knopman, David S.

2009-01-01

Background Alternative medicine has an extensive worldwide history and is commonly used by older patients. A number of different alternative medicines are used by patients having Alzheimer's disease. It is both desirable and expected for clinicians to be acquainted with these medications. Review Summary This paper discusses the available clinical trial evidence regarding eight agents commonly used by people having Alzheimer's disease. We provide an overview of the history and basic scientific evidence available for each agent, followed by a critical analysis of the evidence available from clinical trials, including the number of participants, trial duration and specific outcomes evaluated. Conclusion While many of these compounds have been associated with interesting basic science, none has shown clear clinical benefit to date. Data available for some, such as ginkgo biloba, curcumin and huperzine A, suggest that further evaluation is warranted. Familiarity with this literature will allow clinicians to provide meaningful recommendations to patients who wish to use these agents. PMID:18784599

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials.

PubMed

Siddiqui, Afzal A; Siddiqui, Sabrina Z

2017-03-01

Mass antiparasitic drug administration programs and other control strategies have made important contributions in reducing the global prevalence of helminths. Schistosomiasis, however, continues to spread to new geographic areas. The advent of a viable vaccine and its deployment, coupled with existing control efforts, is expected to make significant headway towards sustained schistosomiasis control. In 2016, Science ranked the schistosomiasis vaccine as one of the top 10 vaccines that needs to be urgently developed. A vaccine that is effective against geographically distinct forms of intestinal/hepatic and urinary disease is essential to make a meaningful impact in global reduction of the disease burden. In this opinion article, we focus on salient features of schistosomiasis vaccines in different phases of the clinical development pipeline and highlight the Sm-p80-based vaccine which is now being prepared for human clinical trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

Discrete subgroups of adolescents diagnosed with borderline personality disorder: a latent class analysis of personality features.

PubMed

Ramos, Vera; Canta, Guilherme; de Castro, Filipa; Leal, Isabel

2014-08-01

Research suggests that borderline personality disorder (BPD) can be diagnosed in adolescents and is marked by considerable heterogeneity. This study aimed to identify personality features characterizing adolescents with BPD and possible meaningful patterns of heterogeneity that could lead to personality subgroups. The authors analyzed data on 60 adolescents, ages 15 to 18 years, who met DSM criteria for a BPD diagnosis. The authors used latent class analysis (LCA) to identify subgroups based on the personality pattern scales from the Millon Adolescent Clinical Inventory (MACI). LCA indicated that the best-fitting solution was a two-class model, identifying two discrete subgroups of BPD adolescents that were described as internalizing and externalizing. The subgroups were then compared on clinical and sociodemographic variables, measures of personality dimensions, DSM BPD criteria, and perception of attachment styles. Adolescents with a BPD diagnosis constitute a heterogeneous group and vary meaningfully on personality features that can have clinical implications for treatment.

The Resource Team: an innovative service delivery support model for mental health services.

PubMed

O'Sullivan, Julie; Powell, Jacinta; Gibbon, Peter; Emmerson, Brett

2009-04-01

This paper outlines the development of the Resource Team, an innovative service delivery model supporting clinical services at the Inner North Brisbane Mental Health Service, Royal Brisbane and Women's Hospital Health Service District. The team aims to provide a base for specialist mental health support staff, improve knowledge management and support the development of meaningful community partnerships. Development of the team included a literature review and consultation with internal and external stakeholders. From this, the objectives, roles and functions of the team were clarified and disseminated to stakeholders. The team currently encompasses 12 positions and has initiated a number of programs and service developments. These include improved IT management of clinical resources and the development of partnerships with the community and non-government sectors. The Resource Team effectively coordinates specialist clinical support positions, addresses knowledge management issues and facilitates meaningful engagement with the community and non-government sectors. The model could easily be applied in other mental health and general health services.

Inclusive jet cross sections in proton-proton collisions at 7.0 TeV center-of-mass energy with the ATLAS detector at the Large Hadron Collider

NASA Astrophysics Data System (ADS)

Park-Martinez, Jayne Irene

The purpose of this study was to assess the effects of node-link mapping on students' meaningful learning and conceptual change in a 1-semester introductory life-science course. This study used node-link mapping to integrate and apply the National Research Council's (NRC, 2005) three principles of human learning: engaging students' prior knowledge, fostering their metacognition, and supporting their formulation of a scientific conceptual framework. The study was a quasi-experimental, pretest-posttest, control group design. The sample consisted of 68 primarily freshmen non-science majors enrolled in two intact sections of the targeted course. Both groups received the same teacher-centered instruction and student-centered activities designed to promote meaningful learning and conceptual change; however, the activity format differed. Control group activities were written; treatment group activities were node-link mapped. Prior to instruction, both groups demonstrated equivalent knowledge and misconceptions associated with genetics and evolution (GE), and ecology and environmental science (EE). Mean differences, pre-to-post instruction, on the GE and EE meaningful learning exam scores and the EE conceptual change inventory scores between the writing group (control) and the node-link mapping group (treatment) were analyzed using repeated measures MANOVAs. There were no significant mean pre-to-post differences between groups with respect to meaningful learning in the GE or EE units, or conceptual change in the EE unit. However, independent of group membership, the overall mean pre-to-post increases in meaningful learning and conceptual change were significant. These findings suggest that both node-link mapping and writing, when used in conjunction with the National Research Council's (NRC, 2005) three principles of human learning, can promote meaningful learning and conceptual change. The only significant interaction found with respect to meaningful learning, conceptual change, and learning styles (Kolb, 2005) was a positive effect of node-link mapping on converger's meaningful learning. However, that result was probably an artifact of small sample size rather than a true treatment effect. No other significant interactions were found. These results suggest that all students, regardless of their learning style, can benefit from either node-link mapping or writing to promote meaningful learning and conceptual change in general life-science courses.

Effects of Extended-Release Niacin and Extended-Release Niacin/Laropiprant on the Pharmacokinetics of Simvastatin in Healthy Subjects.

PubMed

Lauring, Brett; Dishy, Victor; De Kam, Pieter-Jan; Crumley, Tami; Wenning, Larissa; Liu, Fang; Sisk, Christine; Wagner, John; Lai, Eseng

2015-01-01

The use of multiple lipid-modifying agents with different mechanisms of action is often required to regulate lipid levels in patients with dyslipidemia. During combination therapy, alterations in the pharmacokinetics of any of the drugs used and their metabolites may occur. Three separate open-label, randomized, crossover studies evaluated the potential for pharmacokinetic interaction between extended-release niacin (with and without concomitant laropiprant) and simvastatin in healthy subjects. Study 1 used single doses of extended-release niacin and simvastatin; study 2 used multiple-dose coadministration of extended-release niacin/laropiprant and simvastatin in healthy subjects; and study 3 used single doses of both extended-release niacin and the coadministration of extended-release niacin/laropiprant and simvastatin in healthy Chinese subjects. During each treatment period, plasma samples were collected predose and at prespecified postdose time points for pharmacokinetic analyses. The safety and tolerability of simvastatin with and without coadministered extended-release niacin (or extended-release niacin/laropiprant) were assessed by clinical evaluation of adverse experiences. In 2 studies in healthy subjects, modest increases in exposure to simvastatin acid (by ∼60%) by extended-release niacin and extended-release niacin/laropiprant were observed. Based on the clinical experience with simvastatin, these effects are not believed to be clinically meaningful. In the third study on healthy Chinese subjects, no statistically meaningful increases in exposure to simvastatin by extended-release niacin and extended-release niacin/laropiprant were observed. In all populations examined in these studies, the coadministration of extended-release niacin and simvastatin was generally well tolerated.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.

PubMed

Simpson, J Steven A; Crawford, Susan G; Goldstein, Estelle T; Field, Catherine; Burgess, Ellen; Kaplan, Bonnie J

2011-04-18

Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.

Food Environment and Weight Change: Does Residential Mobility Matter?: The Diabetes Study of Northern California (DISTANCE).

PubMed

Laraia, Barbara A; Downing, Janelle M; Zhang, Y Tara; Dow, William H; Kelly, Maggi; Blanchard, Samuel D; Adler, Nancy; Schillinger, Dean; Moffet, Howard; Warton, E Margaret; Karter, Andrew J

2017-05-01

Associations between neighborhood food environment and adult body mass index (BMI; weight (kg)/height (m)2) derived using cross-sectional or longitudinal random-effects models may be biased due to unmeasured confounding and measurement and methodological limitations. In this study, we assessed the within-individual association between change in food environment from 2006 to 2011 and change in BMI among adults with type 2 diabetes using clinical data from the Kaiser Permanente Diabetes Registry collected from 2007 to 2011. Healthy food environment was measured using the kernel density of healthful food venues. Fixed-effects models with a 1-year-lagged BMI were estimated. Separate models were fitted for persons who moved and those who did not. Sensitivity analysis using different lag times and kernel density bandwidths were tested to establish the consistency of findings. On average, patients lost 1 pound (0.45 kg) for each standard-deviation improvement in their food environment. This relationship held for persons who remained in the same location throughout the 5-year study period but not among persons who moved. Proximity to food venues that promote nutritious foods alone may not translate into clinically meaningful diet-related health changes. Community-level policies for improving the food environment need multifaceted strategies to invoke clinically meaningful change in BMI among adult patients with diabetes. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Infrared Skin Thermometry: Validating and Comparing Techniques to Detect Periwound Skin Infection.

PubMed

Mufti, Asfandyar; Somayaji, Ranjani; Coutts, Patricia; Sibbald, R Gary

2018-01-01

Diagnosis of wound infection can be challenging because it relies on a combination of clinical signs and symptoms that are often nonspecific. Increased periwound cutaneous temperature is a classic sign of deep and surrounding wound infection, and its quantitative measurement is one of the most reliable and valid clinical signs of deep and surrounding skin infection at the bedside. Skin surface temperature differences may be detected using commercially available noncontact infrared thermometers. However, techniques to detect temperature using noncontact infrared thermometers vary, and no studies have evaluated these methods. Two such measurement techniques include the "4-point" and "whole-wound" scanning methods. This study assessed the ability of different infrared thermometers using the aforementioned techniques to detect clinically meaningful differences in periwound cutaneous temperatures used in the diagnosis of wound infection. A prospective cohort study was conducted from 2015 to 2016 of consenting adult patients 18 years or older with an open wound attending a regional wound care clinic. One hundred patients with wounds underwent surface temperature measurement. Infection was not a specific inclusion criterion as the primary objective was to conduct a comparative assessment of infrared thermometry devices. Demographic data (age, height, weight, gender, and ethnicity) were also collected. Each wound was measured using 4 different noncontact infrared thermometers: Exergen DermaTemp 1001 (Exergen Corporation, Watertown, Massachusetts), Mastercraft Digital Temperature Reader (Mastercraft, Toronto, Ontario, Canada), Mastercool MSC52224-A (Mastercool Inc, Randolph, New Jersey), and Etekcity ETC-8250 Temperature Heat Pen (Etekcity, Anaheim, California). Data analysis was based on a comparison of 4 periwound skin surface temperature measurement differences (ΔT in degrees Fahrenheit) between the wound site and an equivalent contralateral control site. The primary outcome of the ability of each thermometer to detect a clinically significant difference in temperature was assessed with χ analysis. Paired t tests were conducted to compare the ΔT measurements of each specific thermometry device between the 2 measurement techniques. Pearson product moment correlation coefficients were calculated for the temperature ΔT for both measuring techniques for all devices to determine level of agreement. A 1-way analysis of variance was conducted to compare temperature measurements among the infrared thermometry devices. There was no significant difference in the ability of each thermometer to detect a clinically meaningful difference of 3° F by either the 4-point (P = .10) or whole-wound techniques (P = .67). When a definition of 4° F was used, results were similar (4-point, P = .15; whole wound, P = .20). Comparisons among devices and techniques showed strong correlations (>0.80). Etekcity ETC-8250 and the 4-point measurement compared with the Exergen device using the whole-wound technique had a correlation coefficient of 0.72. Spearman ρ demonstrated a similarly high degree of correlation between techniques and devices, and only the Etekcity ETC-8250 device had a coefficient of 0.71 to 0.90 when compared with others. Paired t testing for each thermometry device comparing measurement techniques for raw temperatures ΔT demonstrated no significant difference (P > .05). No statistical differences among the ΔT values for the 3 different thermometers were noted when using the whole-wound method (P = .095). Similarly, no significant differences among the ΔT values were noted for the 4 different thermometers when using the 4-point method (P = .10). The results of this study demonstrate that both the 4-point and whole-wound methods of temperature acquisition using cost-efficient infrared thermometers provide accurate and similar results in clinical wound care settings.

Category-contingent face adaptation for novel colour categories: Contingent effects are seen only after social or meaningful labelling.

PubMed

Little, Anthony C; DeBruine, Lisa M; Jones, Benedict C

2011-01-01

A face appears normal when it approximates the average of a population. Consequently, exposure to faces biases perceptions of subsequently viewed faces such that faces similar to those recently seen are perceived as more normal. Simultaneously inducing such aftereffects in opposite directions for two groups of faces indicates somewhat discrete representations for those groups. Here we examine how labelling influences the perception of category in faces differing in colour. We show category-contingent aftereffects following exposure to faces differing in eye spacing (wide versus narrow) for blue versus red faces when such groups are consistently labelled with socially meaningful labels (Extravert versus Introvert; Soldier versus Builder). Category-contingent aftereffects were not seen using identical methodology when labels were not meaningful or were absent. These data suggest that human representations of faces can be rapidly tuned to code for meaningful social categories and that such tuning requires both a label and an associated visual difference. Results highlight the flexibility of the cognitive visual system to discriminate categories even in adulthood. Copyright © 2010 Elsevier B.V. All rights reserved.

Clinical correlates of enlarged cavum septum pellucidum in schizophrenia: A revisit through computed tomography.

PubMed

Srivastava, Naveen Kumar; Khanra, Sourav; Chail, Vivek; Khess, Christoday R J

2015-06-01

Like prevalence of abnormal cavum septum pellucidum in patients of schizophrenia remains controversial, its role in clinical outcome, duration of illness and effect on treatment remains less understood as well. Our study examined clinical correlates of enlarged cavum septum pellucidum in schizophrenia. A total of 139 patients diagnosed with schizophrenia during the year 2012 and 2013 were taken for the study. We compared them in respect to the presence and absence of enlarged cavum septum pellucidum. We found 16 patients with enlarged cavum septum pellucidum and were compared with those without enlarged cavum septum pellucidum for socio-demographic and clinical variables. We also correlated these clinical variables with dimension of cavum septum pellucidum. We found statistically significant increased current age and duration of illness in patients with enlarged cavum septum pellucidum. The implications of these findings are discussed with possible confounding effect of current age on neuroimaging. No meaningful correlation was found. No difference in clinical variables was found. Retrospective design and use of computed tomography were limitation of our study. Copyright © 2015 Elsevier B.V. All rights reserved.

Assessing organizational capacity for achieving meaningful use of electronic health records.

PubMed

Shea, Christopher M; Malone, Robb; Weinberger, Morris; Reiter, Kristin L; Thornhill, Jonathan; Lord, Jennifer; Nguyen, Nicholas G; Weiner, Bryan J

2014-01-01

Health care institutions are scrambling to manage the complex organizational change required for achieving meaningful use (MU) of electronic health records (EHR). Assessing baseline organizational capacity for the change can be a useful step toward effective planning and resource allocation. The aim of this article is to describe an adaptable method and tool for assessing organizational capacity for achieving MU of EHR. Data on organizational capacity (people, processes, and technology resources) and barriers are presented from outpatient clinics within one integrated health care delivery system; thus, the focus is on MU requirements for eligible professionals, not eligible hospitals. We conducted 109 interviews with representatives from 46 outpatient clinics. Most clinics had core elements of the people domain of capacity in place. However, the process domain was problematic for many clinics, specifically, capturing problem lists as structured data and having standard processes for maintaining the problem list in the EHR. Also, nearly half of all clinics did not have methods for tracking compliance with their existing processes. Finally, most clinics maintained clinical information in multiple systems, not just the EHR. The most common perceived barriers to MU for eligible professionals included EHR functionality, changes to workflows, increased workload, and resistance to change. Organizational capacity assessments provide a broad institutional perspective and an in-depth clinic-level perspective useful for making resource decisions and tailoring strategies to support the MU change effort for eligible professionals.

What big size you have! Using effect sizes to determine the impact of public health nursing interventions.

PubMed

Johnson, K E; McMorris, B J; Raynor, L A; Monsen, K A

2013-01-01

The Omaha System is a standardized interface terminology that is used extensively by public health nurses in community settings to document interventions and client outcomes. Researchers using Omaha System data to analyze the effectiveness of interventions have typically calculated p-values to determine whether significant client changes occurred between admission and discharge. However, p-values are highly dependent on sample size, making it difficult to distinguish statistically significant changes from clinically meaningful changes. Effect sizes can help identify practical differences but have not yet been applied to Omaha System data. We compared p-values and effect sizes (Cohen's d) for mean differences between admission and discharge for 13 client problems documented in the electronic health records of 1,016 young low-income parents. Client problems were documented anywhere from 6 (Health Care Supervision) to 906 (Caretaking/parenting) times. On a scale from 1 to 5, the mean change needed to yield a large effect size (Cohen's d ≥ 0.80) was approximately 0.60 (range = 0.50 - 1.03) regardless of p-value or sample size (i.e., the number of times a client problem was documented in the electronic health record). Researchers using the Omaha System should report effect sizes to help readers determine which differences are practical and meaningful. Such disclosures will allow for increased recognition of effective interventions.

Investigation of Personality Traits between Infertile Women Submitted to Assisted Reproductive Technology or Surrogacy

PubMed Central

Asgari, Najmeh; Yazdkhasti, Fariba; Nasr Esfahani, Mohammad Hossein

2016-01-01

Background Personality traits affect human relationships, social interactions, treatment procedures, and essentially all human activities. The purpose of this study is to investigate the personality traitsincluding sensation seeking, flexibility, and happiness among a variety of infertile women who were apt to choose assisted reproductive technology (ART) or surrogacy. Materials and Methods This is a cross-sectional study that was performed on 251 infertile women who visited Isfahan and Tehran Reproductive Medicine Center. These fertility clinics are located in Isfahan and Tehran, Iran. In this study, 201 infertile women who underwent treatment using ART and 50 infertile women who tended to have surrogacy were chosen by convenience sampling. Zuckerman’s Sensation Seeking Scale Form V (SSS-V), Psychological Flexibility Questionnaire (adapted from NEO Personality Inventory-Revised) and Oxford Happiness Questionnaire (OHQ) were used as research instruments. All participants had to complete the research instruments in order to be included in this study. Data were analyzed by descriptive-analytical statistics and statistical tests including multivariate analysis of variance (MANOVA) and Z Fisher. Statistically significant effects were accepted for P<0.05. Results In the sensation-seeking variable, there was a meaningful difference between under-study groups. However, the flexibility and happiness variables did not have a significant difference between under-study groups (P<0.001). Interaction between education, employment, and financial status was effective in happiness of infertile women underwent ART (P<0.05), while age, education and financial status were also effective in happiness of infertile women sought surrogacy (P<0.05). A positive meaningful relationship was seen between sensation seeking and flexibility variables in both groups (P<0.05). And a negative meaningful relationship was seen between sensation seeking and happiness in infertile women who sought surrogacy (P<0.05). The difference in rate of relationship between sensation seeking and flexibility was meaningful in infertile women who sought either ART or surrogacy (P<0.05). Conclusion Sensations seeking as a personality trait is lower in infertile women who underwent treatment using ART compared women who tended to have surrogacy. This study shows that demographic variables are effective in happiness of infertile women. Also, there is a significant relation among sensation seeking, flexibility and happiness in infertile women. PMID:27123206

Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.

PubMed

Agiostratidou, Gina; Anhalt, Henry; Ball, Dana; Blonde, Lawrence; Gourgari, Evgenia; Harriman, Karen N; Kowalski, Aaron J; Madden, Paul; McAuliffe-Fogarty, Alicia H; McElwee-Malloy, Molly; Peters, Anne; Raman, Sripriya; Reifschneider, Kent; Rubin, Karen; Weinzimer, Stuart A

2017-12-01

To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A 1c (HbA 1c ) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work. A Steering Committee-comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange-was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees. The Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome's short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes-specific development is needed. The Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA 1c in the research, development, and evaluation of type 1 diabetes therapies. © 2017 by the American Diabetes Association.

What Do Medical Students Perceive as Meaningful in the Psychiatry Clerkship Learning Environment? A Content Analysis of Critical Incident Narratives.

PubMed

Gathright, Molly M; Thrush, Carol; Guise, J Benjamin; Krain, Lewis; Clardy, James

2016-04-01

In order to better understand the professional development of medical students during their psychiatry clerkship, this study identifies common themes and characteristics of students' critical incident narratives which are designed to capture a recount of clerkship experiences they perceived as meaningful. A total of 205 narratives submitted by psychiatry clerkship students in 2010-2011 were subjected to a thematic analysis using a methodological approach and adaptation of categories derived from prior similar research. Descriptive content analysis was also carried out to assess the valence of the narrative content, characters involved, and whether there was evidence that the experience changed students' perspectives in some way. Narratives contained a variety of positive (19%) and negative content (24%) and many contained a hybrid of both (57%). The most common theme (29%) concerned issues of respect and disrespect in patient, clinical, and coworker interactions. In general, the majority (68%) of students' meaningful experience narratives reflected a change in their perspective (e.g., I learned that...). Narratives containing positive and hybrid content were associated with a change in students' perspective (χ(2) = 10.61, df = 2, p < 0.005). Medical students are keenly aware of the learning environment. Positive and hybrid critical incident narratives were associated with a stated change in their beliefs, attitudes, or behaviors due to the experience. Understanding the events that are meaningful to students can also provide rich feedback to medical educators regarding the ways in which students perceive clinical learning environments and how to best foster their professional development.

The re-emergence of clinical service line management.

PubMed

Litch, Bonnie K

2007-01-01

As healthcare leaders are positioning their organizations for a more competitive environment characterized by expanding consumer choice models, they are renewing their attention on organizing along clinical service lines. Bringing together clinical services in ways meaningful to patients can improve quality b better integrating care, while at the same time strengthening an organization's market position and creating new opportunities for increased physician collaboration--from collaborative planning to management to economic participation.

Structured representation for core elements of common clinical decision support interventions to facilitate knowledge sharing.

PubMed

Zhou, Li; Hongsermeier, Tonya; Boxwala, Aziz; Lewis, Janet; Kawamoto, Kensaku; Maviglia, Saverio; Gentile, Douglas; Teich, Jonathan M; Rocha, Roberto; Bell, Douglas; Middleton, Blackford

2013-01-01

At present, there are no widely accepted, standard approaches for representing computer-based clinical decision support (CDS) intervention types and their structural components. This study aimed to identify key requirements for the representation of five widely utilized CDS intervention types: alerts and reminders, order sets, infobuttons, documentation templates/forms, and relevant data presentation. An XML schema was proposed for representing these interventions and their core structural elements (e.g., general metadata, applicable clinical scenarios, CDS inputs, CDS outputs, and CDS logic) in a shareable manner. The schema was validated by building CDS artifacts for 22 different interventions, targeted toward guidelines and clinical conditions called for in the 2011 Meaningful Use criteria. Custom style sheets were developed to render the XML files in human-readable form. The CDS knowledge artifacts were shared via a public web portal. Our experience also identifies gaps in existing standards and informs future development of standards for CDS knowledge representation and sharing.

Primary Care Practices' Abilities And Challenges In Using Electronic Health Record Data For Quality Improvement.

PubMed

Cohen, Deborah J; Dorr, David A; Knierim, Kyle; DuBard, C Annette; Hemler, Jennifer R; Hall, Jennifer D; Marino, Miguel; Solberg, Leif I; McConnell, K John; Nichols, Len M; Nease, Donald E; Edwards, Samuel T; Wu, Winfred Y; Pham-Singer, Hang; Kho, Abel N; Phillips, Robert L; Rasmussen, Luke V; Duffy, F Daniel; Balasubramanian, Bijal A

2018-04-01

Federal value-based payment programs require primary care practices to conduct quality improvement activities, informed by the electronic reports on clinical quality measures that their electronic health records (EHRs) generate. To determine whether EHRs produce reports adequate to the task, we examined survey responses from 1,492 practices across twelve states, supplemented with qualitative data. Meaningful-use participation, which requires the use of a federally certified EHR, was associated with the ability to generate reports-but the reports did not necessarily support quality improvement initiatives. Practices reported numerous challenges in generating adequate reports, such as difficulty manipulating and aligning measurement time frames with quality improvement needs, lack of functionality for generating reports on electronic clinical quality measures at different levels, discordance between clinical guidelines and measures available in reports, questionable data quality, and vendors that were unreceptive to changing EHR configuration beyond federal requirements. The current state of EHR measurement functionality may be insufficient to support federal initiatives that tie payment to clinical quality measures.

Primary Care Practices’ Abilities And Challenges In Using Electronic Health Record Data For Quality Improvement

PubMed Central

Cohen, Deborah J.; Dorr, David A.; Knierim, Kyle; DuBard, C. Annette; Hemler, Jennifer R.; Hall, Jennifer D.; Marino, Miguel; Solberg, Leif I.; McConnell, K. John; Nichols, Len M.; Nease, Donald E.; Edwards, Samuel T.; Wu, Winfred Y.; Pham-Singer, Hang; Kho, Abel N.; Phillips, Robert L.; Rasmussen, Luke V.; Duffy, F. Daniel; Balasubramanian, Bijal A.

2018-01-01

Federal value-based payment programs require primary care practices to conduct quality improvement activities, informed by the electronic reports on clinical quality measures that their electronic health records (EHRs) generate. To determine whether EHRs produce reports adequate to the task, we examined survey responses from 1,492 practices across twelve states, supplemented with qualitative data. Meaningful-use participation, which requires the use of a federally certified EHR, was associated with the ability to generate reports—but the reports did not necessarily support quality improvement initiatives. Practices reported numerous challenges in generating adequate reports, such as difficulty manipulating and aligning measurement time frames with quality improvement needs, lack of functionality for generating reports on electronic clinical quality measures at different levels, discordance between clinical guidelines and measures available in reports, questionable data quality, and vendors that were unreceptive to changing EHR configuration beyond federal requirements. The current state of EHR measurement functionality may be insufficient to support federal initiatives that tie payment to clinical quality measures. PMID:29608365

Inclusion of Sexual Orientation and Gender Identity in Stage 3 Meaningful Use Guidelines: A Huge Step Forward for LGBT Health.

PubMed

Cahill, Sean R; Baker, Kellan; Deutsch, Madeline B; Keatley, Joanne; Makadon, Harvey J

2016-04-01

Final rules issued by the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health Information Technology in October 2015 require electronic health record software certified for Meaningful Use to include sexual orientation and gender identity (SO/GI) fields. This is a critical step toward making SO/GI data collection a standard practice in clinical settings. Sexual orientation identity-whether one identifies as gay, lesbian, or bisexual-correlates with behavioral health burden, and it is important to collect these data. Providers should also collect sex assigned at birth data as well as current gender identity data. Training of clinical staff in collection and use of SO/GI data, education of LGBT patients, and SO/GI nondiscrimination policies are critical for successful implementation.

Cumulative response curves to enhance interpretation of treatment differences on the Self-Esteem And Relationship questionnaire for men with erectile dysfunction.

PubMed

Cappelleri, Joseph C; Zou, Kelly H; Bushmakin, Andrew G; Carlsson, Martin O; Symonds, Tara

2013-03-01

What's known on the subject? and What does the study add? Studies on erectile dysfunction (ED) therapies rely heavily on patient-reported outcomes (PROs) to measure efficacy on treatment response. A challenge when using PROs is interpretation of the clinical meaning of changes in scores. A responder analysis provides a threshold score to indicate whether a change in score qualifies a patient as a responder. However, a major consideration with responder analysis is the sometimes arbitrary nature of defining the threshold for a response. By contrast, cumulative response curves (CRCs) display patient response rates over a continuum of possible thresholds, thus eliminating problems with a rigid threshold definition, allowing for a variety of response thresholds to be examined simultaneously, and encompassing all data. With respect to the psychosocial factors addressed in the Self-Esteem And Relationship questionnaire in ED, CRCs clearly, distinctly, and meaningfully highlighted the favourable profiles of responses to sildenafil compared with placebo. CRCs for PROs in urology can provide a clear, transparent and meaningful visual depiction of efficacy data that can supplement and complement other analyses. To use cumulative response curves (CRCs) to enrich meaning and enhance interpretation of scores on the Self-Esteem And Relationship (SEAR) questionnaire with respect to treatment differences for men with erectile dysfunction (ED). This post hoc analysis used data from all patients who took at least one dose of study drug and had at least one post-baseline efficacy evaluation in a previously published 12-week, multicentre, randomized, double-blind, placebo-controlled trial of flexible-dose (25, 50, or 100 mg) sildenafil citrate (Viagra) in adult men with ED who had scored ≤ 75 out of 100 on the Self-Esteem subscale of the SEAR questionnaire. CRCs were used on the numeric change in transformed SEAR scores from baseline to end-of-study for each SEAR component. The horizontal axis of the CRC represented change from baseline on the SEAR score, and the vertical axis represented the percentage of patients experiencing that change or greater. The differences between CRCs for the sildenafil group vs the placebo group were assessed using the Kolmogorov-Smirov test. For each of the SEAR components, there was essentially no overlap in the CRCs between the sildenafil group (n = 113) and placebo group (n = 115 or 116, depending on the component), showing that a greater percentage of sildenafil recipients compared with placebo recipients had a more favourable change across the spectrum of response thresholds (P ≤ 0.01). Previous research showed that a 10-point score increase is the minimal clinically meaningful improvement for most SEAR components. In the sildenafil vs placebo groups, a ≥10-point score increase occurred in 72 vs 37% of patients, respectively, on the Sexual Relationship Satisfaction domain, 71 vs 41% on the Confidence domain, 76 vs 49% on the Self-Esteem subscale, 60 vs 44% on the Overall Relationship Satisfaction subscale, and 75 vs 38% on the Overall score. With respect to the psychosocial factors addressed in the SEAR questionnaire, CRCs clearly, distinctly, and meaningfully highlighted the favourable profiles of responses to sildenafil compared with placebo. CRCs for patient-reported outcomes in urology can provide a clear, transparent, and meaningful visual depiction of efficacy data that can supplement and complement other analyses. © 2012 BJU INTERNATIONAL.

Biosimilars and market access: a question of comparability and costs?

PubMed

Simoens, Steven; Verbeken, Gilbert; Huys, Isabelle

2012-12-01

This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.

Culture and Hallucinations: Overview and Future Directions

PubMed Central

Larøi, Frank; Luhrmann, Tanya Marie; Bell, Vaughan; Christian, William A.; Deshpande, Smita; Fernyhough, Charles; Jenkins, Janis; Woods, Angela

2014-01-01

A number of studies have explored hallucinations as complex experiences involving interactions between psychological, biological, and environmental factors and mechanisms. Nevertheless, relatively little attention has focused on the role of culture in shaping hallucinations. This article reviews the published research, drawing on the expertise of both anthropologists and psychologists. We argue that the extant body of work suggests that culture does indeed have a significant impact on the experience, understanding, and labeling of hallucinations and that there may be important theoretical and clinical consequences of that observation. We find that culture can affect what is identified as a hallucination, that there are different patterns of hallucination among the clinical and nonclinical populations, that hallucinations are often culturally meaningful, that hallucinations occur at different rates in different settings; that culture affects the meaning and characteristics of hallucinations associated with psychosis, and that the cultural variations of psychotic hallucinations may have implications for the clinical outcome of those who struggle with psychosis. We conclude that a clinician should never assume that the mere report of what seems to be a hallucination is necessarily a symptom of pathology and that the patient’s cultural background needs to be taken into account when assessing and treating hallucinations. PMID:24936082

Redefining meaningful age groups in the context of disease.

PubMed

Geifman, Nophar; Cohen, Raphael; Rubin, Eitan

2013-12-01

Age is an important factor when considering phenotypic changes in health and disease. Currently, the use of age information in medicine is somewhat simplistic, with ages commonly being grouped into a small number of crude ranges reflecting the major stages of development and aging, such as childhood or adolescence. Here, we investigate the possibility of redefining age groups using the recently developed Age-Phenome Knowledge-base (APK) that holds over 35,000 literature-derived entries describing relationships between age and phenotype. Clustering of APK data suggests 13 new, partially overlapping, age groups. The diseases that define these groups suggest that the proposed divisions are biologically meaningful. We further show that the number of different age ranges that should be considered depends on the type of disease being evaluated. This finding was further strengthened by similar results obtained from clinical blood measurement data. The grouping of diseases that share a similar pattern of disease-related reports directly mirrors, in some cases, medical knowledge of disease-age relationships. In other cases, our results may be used to generate new and reasonable hypotheses regarding links between diseases.

Biosimilar safety considerations in clinical practice.

PubMed

Choy, Edwin; Jacobs, Ira Allen

2014-02-01

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed. © 2014 Elsevier Inc. All rights reserved.

Binge Eating, Purging, or Both: Eating Disorder Psychopathology Findings from an Internet Community Survey

PubMed Central

Roberto, Christina A.; Grilo, Carlos M.; Masheb, Robin M.; White, Marney A.

2010-01-01

Objective This study aimed to compare bulimia nervosa (BN), binge eating disorder (BED), and purging disorder (PD) on clinically significant variables and examine the utility of once versus twice-weekly diagnostic thresholds for disturbed eating behaviors. Method 234 women with BN, BED, or PD were identified through self-report measures via an online survey and categorized based on either once-weekly or twice-weekly disturbed eating behaviors. Results BN emerged as a more severe disorder than BED and PD. The three groups differed significantly in self-reported restraint and disinhibition and the BN and BED groups reported higher levels of depression than PD. For BN, those engaging in behaviors twice-weekly versus once-weekly were more symptomatic. Discussion The BN, BED, and PD groups differed in clinically meaningful ways. Future research need to clarify the relationship between mood disturbances and eating behaviors. Reducing the twice-weekly behavior threshold for BN would capture individuals with clinically significant eating disorders, though the twice-weekly threshold may provide important information about disorder severity for both BN and BED. PMID:19862702

Predictors of doctoral student success in professional psychology: characteristics of students, programs, and universities.

PubMed

Graham, James M; Kim, Yang-Hyang

2011-04-01

In the face of the rising number of doctoral recipients in professional psychology, many have voiced concerns about the quality of nontraditional training programs. Past research suggests that, on a variety of outcomes, graduates from clinical PhD programs outperform graduates from clinical PsyD and, to a lesser extent, counseling PhD programs. We examine an aggregate archival dataset to determine whether student or university characteristics account for the differences in outcomes among programs. The data show meaningful differences in the outcomes of clinical PhD, PsyD, and counseling PhD programs. Furthermore, graduates from research-intensive universities perform better on the psychology licensure exam and are more likely to become American Board of Professional Psychology diplomates. The available data support the notion that the ability to conduct research is an essential component of graduate education. In this light, PsyD programs represent a unique opportunity to train students in the types of evaluation and outcomes assessments used by practicing psychologists. We discuss implications for graduate-level training in professional psychology. © 2011 Wiley Periodicals, Inc.

Reaching Out to Older Veterans in Need: The Elko Clinic Demonstration Project

ERIC Educational Resources Information Center

Juretic, Meghan; Hill, Robert; Luptak, Marilyn; Rupper, Randall; Bair, Byron; Floyd, James; Westfield, Brian; Dailey, Nancy K.

2010-01-01

Context: The challenge of providing meaningful health care services to veterans living in rural communities is a major public health concern that involves redefining the traditional facility-based model of care delivery employed in urban areas. Purpose: This paper describes the steps of a demonstration project, the Elko Telehealth Outreach Clinic.…

Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma.

PubMed

De Moraes, C Gustavo; Liebmann, Jeffrey M; Levin, Leonard A

2017-01-01

Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP-lowering therapies, it is expected that effects on IOP will translate into benefits in long-term patient-reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12-18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life, as defined by validated instruments designed to measure that endpoint. Copyright © 2016 Elsevier Ltd. All rights reserved.

Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma

PubMed Central

De Moraes, C. Gustavo; Liebmann, Jeffrey M.; Levin, Leonard A.

2016-01-01

Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP-lowering therapies, it is expected that effects on IOP will translate into benefits in long-term patient-reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12–18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life, as defined by validated instruments designed to measure that endpoint. PMID:27773767

Meaningful use in the safety net: a rapid ethnography of patient portal implementation at five community health centers in California.

PubMed

Ackerman, Sara L; Sarkar, Urmimala; Tieu, Lina; Handley, Margaret A; Schillinger, Dean; Hahn, Kenneth; Hoskote, Mekhala; Gourley, Gato; Lyles, Courtney

2017-09-01

US health care institutions are implementing secure websites (patient portals) to achieve federal Meaningful Use (MU) certification. We sought to understand efforts to implement portals in "safety net" health care systems that provide services for low-income populations. Our rapid ethnography involved visits at 4 California safety net health systems and in-depth interviews at a fifth. Visits included interviews with clinicians and executives ( n  = 12), informal focus groups with front-line staff ( n  = 35), observations of patient portal sign-up procedures and clinic work, review of marketing materials and portal use data, and a brief survey ( n  = 45). Our findings demonstrate that the health systems devoted considerable effort to enlisting staff support for portal adoption and integrating portal-related work into clinic routines. Although all health systems had achieved, or were close to achieving, MU benchmarks, patients faced numerous barriers to portal use and our participants were uncertain how to achieve and sustain "meaningful use" as defined by and for their patients. Health systems' efforts to achieve MU certification united clinic staff under a shared ethos of improved quality of care. However, MU's assumptions about patients' demand for electronic access to health information and ability to make use of it directed clinics' attention to enrollment and message routing rather than to the relevance and usability of a tool that is minimally adaptable to the safety net context. We found a mismatch between MU-based metrics of patient engagement and the priorities and needs of safety net patient populations. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

In search for genetic determinants of clinically meaningful differential cardiovascular event reduction by pravastatin in the PHArmacogenetic study of Statins in the Elderly at risk (PHASE)/PROSPER study.

PubMed

Postmus, Iris; Johnson, Paul C D; Trompet, Stella; de Craen, Anton J M; Slagboom, P Eline; Devlin, James J; Shiffman, Dov; Sacks, Frank M; Kearney, Patricia M; Stott, David J; Buckley, Brendan M; Sattar, Naveed; Ford, Ian; Westendorp, Rudi G J; Jukema, J Wouter

2014-07-01

Statin therapy is widely used in the prevention and treatment of cardiovascular events and is associated with significant risk reductions. However, there is considerable variation in response to statin therapy both in terms of LDL cholesterol reduction and clinical outcomes. It has been hypothesized that genetic variation contributes importantly to this individual drug response. We investigated the interaction between genetic variants and pravastatin or placebo therapy on the incidence of cardiovascular events by performing a genome-wide association study in the participants of the PROspective Study of Pravastatin in the Elderly at Risk for vascular disease--PHArmacogenetic study of Statins in the Elderly at risk (PROSPER/PHASE) study (n = 5244). We did not observe genome-wide significant associations with a clinically meaningful differential cardiovascular event reduction by pravastatin therapy. In addition, SNPs with p-values lower than 1 × 10(-4) were assessed for replication in a case-only analysis within two randomized placebo controlled pravastatin trials, CARE (n = 711) and WOSCOPS (n = 522). rs7102569, on chromosome 11 near the ODZ4 gene, was replicated in the CARE study (p = 0.008), however the direction of effect was opposite. This SNP was not associated in WOSCOPS. In addition, none of the SNPs replicated significantly after correcting for multiple testing. We could not identify genetic variation that was significantly associated at genome-wide level with a clinically meaningful differential event reduction by pravastatin treatment in a large prospective study. We therefore assume that in daily practice the use of genetic characteristics to personalize pravastatin treatment to improve prevention of cardiovascular disease will be limited. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

PubMed Central

Stargardt, Tom; Gonder-Frederick, Linda; Krobot, Karl J; Alexander, Charles M

2009-01-01

Background To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia. Methods An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. Results 112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0). Conclusion We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents. PMID:19849828

Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients

PubMed Central

Winterstein, Andrew P.; McGuine, Timothy A.; Carr, Kathleen E.; Hetzel, Scott J.

2013-01-01

Background: Knee injury among young, active female patients remains a public health issue. Clinicians are called upon to pay greater attention to patient-oriented outcomes to evaluate the impact of these injuries. Little agreement exists on which outcome measures are best, and clinicians cite several barriers to their use. Single Assessment Numerical Evaluation (SANE) may provide meaningful outcome information while lessening the time burden associated with other patient-oriented measures. Hypothesis: The SANE and International Knee Documentation Committee (IKDC) scores would be strongly correlated in a cohort of young active female patients with knee injuries from preinjury through 1-year follow-up and that a minimal clinically important difference (MCID) could be calculated for the SANE score. Study Design: Observational prospective cohort. Methods: Two hundred sixty-three subjects completed SANE and IKDC at preinjury by recall, time of injury, and 3, 6, and 12 months postinjury. Pearson correlation coefficients were used to assess the association between SANE and IKDC. Repeated-measures analysis of variance was used to determine differences in SANE and IKDC over time. MCID was calculated for SANE using IKDC MCID as an anchor. Results: Moderate to strong correlations were seen between SANE and IKDC (0.65-0.83). SANE, on average, was 2.7 (95% confidence interval, 1.5-3.9; P < 0.00) units greater than IKDC over all time points. MCID for the SANE was calculated as 7 for a 6-month follow-up and 19 for a 12-month follow-up. Conclusion: SANE scores were moderately to strongly correlated to IKDC scores across all time points. Reported MCID values for the SANE should be utilized to measure meaningful changes over time for young, active female patients with knee injuries. Clinical Relevance: Providing clinicians with patient-oriented outcome measures that can be obtained with little clinician and patient burden may allow for greater acceptance and use of outcome measures in clinical settings. PMID:24427427

Children and adolescents referred for treatment of anxiety disorders: differences in clinical characteristics.

PubMed

Waite, Polly; Creswell, Cathy

2014-01-01

Reports of the clinical characteristics of children and adolescents with anxiety disorders are typically based on community populations or from clinical samples with exclusion criterion applied. Little is known about the clinical characteristics of children and adolescents routinely referred for treatment for anxiety disorders. Furthermore, children and adolescents are typically treated as one homogeneous group although they may differ in ways that are clinically meaningful. A consecutive series of children (n=100, aged 6-12 years) and adolescents (n=100, aged 13-18 years), referred to a routine clinical service, were assessed for anxiety and comorbid disorders, school refusal and parental symptoms of psychopathology. Children with a primary anxiety disorder were significantly more likely to be diagnosed with separation anxiety disorder than adolescents. Adolescents with a primary anxiety disorder had significantly higher self and clinician rated anxiety symptoms and had more frequent primary diagnoses of social anxiety disorder, diagnoses and symptoms of mood disorders, and irregular school attendance. Childhood and adolescence were considered categorically as distinct, developmental periods; in reality changes would be unlikely to occur in such a discrete manner. The finding that children and adolescents with anxiety disorders have distinct clinical characteristics has clear implications for treatment. Simply adapting treatments designed for children to make the materials more 'adolescent-friendly' is unlikely to sufficiently meet the needs of adolescents. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Pilot Testing a Couples-focused Intervention for Mild Cognitive Impairment

PubMed Central

Lu, Yvonne Yueh-Feng; Haase, Joan E.; Weaver, Michael

2014-01-01

The purpose of this pilot study was to evaluate the acceptability, feasibility, and potential benefits of the multi-component Daily Enhancement of Meaningful Activity (DEMA) intervention, which was tailored to help couples facing mild cognitive impairment (MCI) work together to meet goals, remain engaged in meaningful activities, and adapt to changes over time. Using a single-group design, 10 persons with MCI and their family caregivers were recruited to receive DEMA over six bi-weekly sessions. Data were collected pre- and at one week and three months post-intervention. Consent, session, and questionnaire completion rates indicated the program and study procedures were well accepted. Qualitative and quantitative findings indicated positive trends in meaningful activity performance and maintenance of health-related outcomes, as well as high program satisfaction. The DEMA is a potentially promising intervention that will need further testing in a randomized clinical trial. PMID:23767062

Hospital budget increase for information technology during phase 1 meaningful use.

PubMed

Neumeier, Harold; Berner, Eta S; Burke, Darrell E; Azuero, Andres

2015-01-01

Federal policies have a significant effect on how businesses spend money. The 2009 HITECH (Health Information Technology for Economic and Clinical Health Act) authorized incentive payments through Medicare and Medicaid to clinicians and hospitals when they use certified electronic health records privately and securely to achieve specified improvements in care delivery. Federal incentive payments were offered in 2011 for hospitals that had satisfied "meaningful use" criteria. A longitudinal study of nonfederal hospital information technology (IT) budgets (N = 493) during the years 2009 to 2011 found increases in the percentage of hospital annual operating budgets allocated to IT in the years leading up to these federal incentives. This increase was most pronounced among hospitals receiving high proportions of their reimbursements from Medicaid, followed by hospitals receiving high proportions of their reimbursements from Medicare, possibly indicating a budget shift during this period to more IT spending to achieve meaningful-use policy guidelines.

Discussions in the home about sex: different recollections by parents and children.

PubMed

King, B M; Lorusso, J

1997-01-01

University students and their parents were asked whether they had ever had a meaningful discussion about sex. More than half of the students answered No, yet in 60% of these cases, one or both parents said that there had been meaningful discussions. Students and their parents most frequently disagreed about the topics of sexually transmitted diseases, sexual intercourse, reproduction, birth control, homosexuality, and sexual abuse. Mothers were more likely than fathers to have had discussions that daughters considered to be meaningful, and as likely as fathers in the case of sons. Parents who indicated that they had had meaningful discussions about sex with their parents while growing up were much more likely than other parents to have had discussions that their own children recognized as meaningful. Nevertheless, the results demonstrate that many parents greatly underestimate the extent of factual information that their children wish to learn about sexuality.

Caffeine Use Disorder: A Comprehensive Review and Research Agenda.

PubMed

Meredith, Steven E; Juliano, Laura M; Hughes, John R; Griffiths, Roland R

2013-09-01

Caffeine is the most commonly used drug in the world. Although consumption of low to moderate doses of caffeine is generally safe, an increasing number of clinical studies are showing that some caffeine users become dependent on the drug and are unable to reduce consumption despite knowledge of recurrent health problems associated with continued use. Thus, the World Health Organization and some health care professionals recognize caffeine dependence as a clinical disorder. In this comprehensive literature review, we summarize published research on the biological evidence for caffeine dependence; we provide a systematic review of the prevalence of caffeine dependence and rates of endorsement of clinically meaningful indicators of distress and functional impairment among habitual caffeine users; we discuss the diagnostic criteria for Caffeine Use Disorder-a condition for further study included in the Diagnostic and Statistical Manual of Mental Disorders ( 5 th ed .); and we outline a research agenda to help guide future clinical, epidemiological, and genetic investigations of caffeine dependence. Numerous controlled laboratory investigations reviewed in this article show that caffeine produces behavioral and physiological effects similar to other drugs of dependence. Moreover, several recent clinical studies indicate that caffeine dependence is a clinically meaningful disorder that affects a nontrivial proportion of caffeine users. Nevertheless, more research is needed to determine the reliability, validity, and prevalence of this clinically important health problem.

Caffeine Use Disorder: A Comprehensive Review and Research Agenda

PubMed Central

Meredith, Steven E.; Juliano, Laura M.; Hughes, John R.

2013-01-01

Caffeine is the most commonly used drug in the world. Although consumption of low to moderate doses of caffeine is generally safe, an increasing number of clinical studies are showing that some caffeine users become dependent on the drug and are unable to reduce consumption despite knowledge of recurrent health problems associated with continued use. Thus, the World Health Organization and some health care professionals recognize caffeine dependence as a clinical disorder. In this comprehensive literature review, we summarize published research on the biological evidence for caffeine dependence; we provide a systematic review of the prevalence of caffeine dependence and rates of endorsement of clinically meaningful indicators of distress and functional impairment among habitual caffeine users; we discuss the diagnostic criteria for Caffeine Use Disorder—a condition for further study included in the Diagnostic and Statistical Manual of Mental Disorders (5th ed.); and we outline a research agenda to help guide future clinical, epidemiological, and genetic investigations of caffeine dependence. Numerous controlled laboratory investigations reviewed in this article show that caffeine produces behavioral and physiological effects similar to other drugs of dependence. Moreover, several recent clinical studies indicate that caffeine dependence is a clinically meaningful disorder that affects a nontrivial proportion of caffeine users. Nevertheless, more research is needed to determine the reliability, validity, and prevalence of this clinically important health problem. PMID:24761279

Operating Room Delays: Meaningful Use in Electronic Health Record.

PubMed

Van Winkle, Rachelle A; Champagne, Mary T; Gilman-Mays, Meri; Aucoin, Julia

2016-06-01

Perioperative areas are the most costly to operate and account for more than 40% of expenses. The high costs prompted one organization to analyze surgical delays through a retrospective review of their new electronic health record. Electronic health records have made it easier to access and aggregate clinical data; 2123 operating room cases were analyzed. Implementing a new electronic health record system is complex; inaccurate data and poor implementation can introduce new problems. Validating the electronic health record development processes determines the ease of use and the user interface, specifically related to user compliance with the intent of the electronic health record development. The revalidation process after implementation determines if the intent of the design was fulfilled and data can be meaningfully used. In this organization, the data fields completed through automation provided quantifiable, meaningful data. However, data fields completed by staff that required subjective decision making resulted in incomplete data nearly 24% of the time. The ease of use was further complicated by 490 permutations (combinations of delay types and reasons) that were built into the electronic health record. Operating room delay themes emerged notwithstanding the significant complexity of the electronic health record build; however, improved accuracy could improve meaningful data collection and a more accurate root cause analysis of operating room delays. Accurate and meaningful use of data affords a more reliable approach in quality, safety, and cost-effective initiatives.

Co-infection does not predict disease signs in Gopherus tortoises

PubMed Central

Gov, Ryan; Sandmeier, Franziska C.; Snyder, Sarah J.; Tracy, C. Richard

2017-01-01

In disease ecology, the host immune system interacts with environmental conditions and pathogen properties to affect the impact of disease on the host. Within the host, pathogens may interact to facilitate or inhibit each other's growth, and pathogens interact with different hosts differently. We investigated co-infection of two Mycoplasma and the association of infection with clinical signs of upper respiratory tract disease in four congeneric tortoise host species (Gopherus) in the United States to detect differences in infection risk and disease dynamics in these hosts. Mojave Desert tortoises had greater prevalence of Mycoplasma agassizii than Texas tortoises and gopher tortoises, while there were no differences in Mycoplasma testudineum prevalence among host species. In some host species, the presence of each pathogen influenced the infection intensity of the other; hence, these two mycoplasmas interact differently within different hosts, and our results may indicate facilitation of these bacteria. Neither infection nor co-infection was associated with clinical signs of disease, which tend to fluctuate across time. From M. agassizii DNA sequences, we detected no meaningful differentiation of haplotypes among hosts. Experimental inoculation studies and recurrent resampling of wild individuals could help to decipher the underlying mechanisms of disease dynamics in this system. PMID:29134096

Different types of exercise in Multiple Sclerosis: Aerobic exercise or Pilates, a single-blind clinical study.

PubMed

Kara, Bilge; Küçük, Fadime; Poyraz, Esra Coşkuner; Tomruk, Melda Soysal; İdıman, Egemen

2017-01-01

The aim of our study is to examine effects of aerobic and Pilates exercises on disability, cognition, physical performance, balance, depression and fatigue in relapsing-remitting Multiple Sclerosis (MS) patients as compared to healthy controls. The subjects were divided as aerobic exercise (n = 26), Pilates (n = 9), and the healthy control group (n = 21). We used MSFC, physical performance, Berg balance scale, Beck depression scale, fatigue impact scale. All evaluations were performed before and after exercise training. There are statistically meaningful differences between Nine hole testing, PASAT 3, physical performance and fatique impact scale before and after aerobic exercise. Also we found significant difference for physical performance in the Pilates group. There are no significant differences in measures of fatique impact scale and depression between aerobic exercise group and the healthy controls after exercise. We found significant differences between Pilates and control group's after measurements except depression. There were significant differences between the Pilates and aerobic group for cognitive tests in favor of the Pilates group. Aerobic exercise and clinical Pilates exercises revealed moderate changes in levels of cognitive, physical performance, balance, depression, fatigue in MS patients.

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

PubMed

Park, Ki Byung; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Kim, Me-Riong; Lee, Jun-Hwan; Shin, Kyung-Min; Shin, Byung-Cheul; Cho, Jae-Heung; Ha, In-Hyuk

2017-04-15

.: Prospective observational 1-year study. .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. 3.

Features of asthma which provide meaningful insights for understanding the disease heterogeneity.

PubMed

Deliu, M; Yavuz, T S; Sperrin, M; Belgrave, D; Sahiner, U M; Sackesen, C; Kalayci, O; Custovic, A

2018-01-01

Data-driven methods such as hierarchical clustering (HC) and principal component analysis (PCA) have been used to identify asthma subtypes, with inconsistent results. To develop a framework for the discovery of stable and clinically meaningful asthma subtypes. We performed HC in a rich data set from 613 asthmatic children, using 45 clinical variables (Model 1), and after PCA dimensionality reduction (Model 2). Clinical experts then identified a set of asthma features/domains which informed clusters in the two analyses. In Model 3, we reclustered the data using these features to ascertain whether this improved the discovery process. Cluster stability was poor in Models 1 and 2. Clinical experts highlighted four asthma features/domains which differentiated the clusters in two models: age of onset, allergic sensitization, severity, and recent exacerbations. In Model 3 (HC using these four features), cluster stability improved substantially. The cluster assignment changed, providing more clinically interpretable results. In a 5-cluster model, we labelled the clusters as: "Difficult asthma" (n = 132); "Early-onset mild atopic" (n = 210); "Early-onset mild non-atopic: (n = 153); "Late-onset" (n = 105); and "Exacerbation-prone asthma" (n = 13). Multinomial regression demonstrated that lung function was significantly diminished among children with "Difficult asthma"; blood eosinophilia was a significant feature of "Difficult," "Early-onset mild atopic," and "Late-onset asthma." Children with moderate-to-severe asthma were present in each cluster. An integrative approach of blending the data with clinical expert domain knowledge identified four features, which may be informative for ascertaining asthma endotypes. These findings suggest that variables which are key determinants of asthma presence, severity, or control may not be the most informative for determining asthma subtypes. Our results indicate that exacerbation-prone asthma may be a separate asthma endotype and that severe asthma is not a single entity, but an extreme end of the spectrum of several different asthma endotypes. © 2017 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.

Decision curve analysis to compare 3 versions of Partin Tables to predict final pathologic stage.

PubMed

Augustin, Herbert; Sun, Maxine; Isbarn, Hendrik; Pummer, Karl; Karakiewicz, Pierre

2012-01-01

To perform a decision curve analysis (DCA) to compare the Partin Tables 1997, 2001, and 2007 for their clinical applicability. Clinical and pathologic data of 687 consecutive patients treated with open radical prostatectomy for clinically localized prostate cancer between 2003 and 2008 at a single institution were used. DCA quantified the net benefit relating to specific threshold probabilities of extraprostatic extension (EPE), seminal vesicle involvement (SVI), and lymph node involvement (LNI). Overall, EPE, SVI, and LNI were recorded in 17.8, 6.0, and 1.2%, respectively. For EPE predictions, the DCA favored the 2007 version vs. 1997 for SVI vs. none of the versions for LNI. DCA indicate that for very low prevalence conditions such as LNI (1.2%), decision models are not useful. For low prevalence rates such as SVI, the use of different versions of the Partin Tables does not translate into meaningful net gains differences. Finally, for intermediate prevalence conditions such as EPE (18%), despite apparent performance differences, the net benefit differences were also marginal. In consequence, the current analysis could not confirm an important benefit from the use of the Partin Tables and it could not identify a clearly better version of any of the 3 available iterations. Copyright © 2012 Elsevier Inc. All rights reserved.

Age-related invariance of abilities measured with the Wechsler Adult Intelligence Scale-IV.

PubMed

Sudarshan, Navaneetham J; Bowden, Stephen C; Saklofske, Donald H; Weiss, Lawrence G

2016-11-01

Assessment of measurement invariance across populations is essential for meaningful comparison of test scores, and is especially relevant where repeated measurements are required for educational assessment or clinical diagnosis. Establishing measurement invariance legitimizes the assumption that test scores reflect the same psychological trait in different populations or across different occasions. Examination of Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) U.S. standardization samples revealed that a first-order 5-factor measurement model was best fitting across 9 age groups from 16 years to 69 years. Strong metric invariance was found for 3 of 5 factors and partial intercept invariance for the remaining 2. Pairwise comparisons of adjacent age groups supported the inference that cognitive-trait group differences are manifested by group differences in the test scores. In educational and clinical settings these findings provide theoretical and empirical support to interpret changes in the index or subtest scores as reflecting changes in the corresponding cognitive abilities. Further, where clinically relevant, the subtest score composites can be used to compare changes in respective cognitive abilities. The model was supported in the Canadian standardization data with pooled age groups but the sample sizes were not adequate for detailed examination of separate age groups in the Canadian sample. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Does Treatment of the Tibia Matter in Bipolar Chondral Defects of the Knee? Clinical Outcomes with Greater Than 2 Years Follow-up.

PubMed

Hannon, Charles P; Weber, Alexander E; Gitelis, Matthew; Meyer, Maximillian A; Yanke, Adam B; Cole, Brian J

2018-04-01

To compare the osteochondral allograft (OCA) outcomes of bipolar defects with isolated femoral defects and to investigate the optimal treatment of bipolar defects by comparing femoral OCA with tibial debridement to femoral OCA and tibial microfracture. A series of patients with 2-year follow-up from March 2004 to September 2015 after femoral OCA for bipolar chondral defects was identified. Group 1 contained patients with tibial defects treated with debridement and group 2 contained patients with microfractured tibial defects. A third group (group 3) with isolated femoral defects treated with OCA was identified and matched by gender, body mass index (BMI), laterality, and OCA size to groups 1 and 2. Patient-specific, defect-specific, intraoperative, and postoperative data including patient-reported outcomes were collected on all patients. The study groups were compared using analyses of variance, paired sample t tests, and χ-square analyses. Thirty-six patients who had femoral OCA for bipolar lesions were identified with 20 patients in group 1 and 16 patients in group 2. Group 3 had 20 patients. There were no differences between the 3 groups in terms of gender (P = .616), BMI (P = .271), number of previous surgeries (P = .451), femoral or tibial defect size (P = .296), and OCA size (P = .981). Preoperative to postoperative patient-reported clinical outcomes (PROs) revealed statistical and clinically meaningful improvement in all 3 groups, but did not differ between groups. Patient-specific and defect-specific factors did not correlate with PROs. The graft survivorship for group 1 was 85% at 4.5 years, 100% for group 2 at 2.5 years, and 95% for group 3 at 3.8 years. Regardless of tibial treatment, patients with bipolar defects treated with femoral OCA have clinically meaningful improvements in PROs and excellent graft survivorship comparable to isolated femoral OCAs at more than 2 years. Level III, case-control study. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Can the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) be used to accurately report clinic total reproductive potential (TRP)?

PubMed

Stern, Judy E; Hickman, Timothy N; Kinzer, Donna; Penzias, Alan S; Ball, G David; Gibbons, William E

2012-04-01

To assess whether total reproductive potential (TRP), the chance of a live birth from each fresh cycle (fresh cycle plus frozen transfers), could be calculated from the national Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database and whether information not available in SART CORS resulted in significant changes to the TRP calculation. Retrospective study using SART CORS and clinic data. Three assisted reproductive technology clinics. Women undergoing ART. None. Two- and three-year TRPs for 2005 and 2006 were calculated according to patient age at cycle start by linking fresh to frozen cycles up to first live birth. Clinic records were used to adjust for (remove) frozen cycles that used more than one fresh cycle as a source of embryos and for any embryos donated to other patients or research or shipped to another facility before a live birth. TRP was higher than fresh per-cycle rates for most ages at all clinics, although accuracy was compromised when there were fewer than 20 cycles per category. Two- and 3-year TRPs differed in only 2 of 24 calculations. Adjusted TRPs differed less than three percentage points from unadjusted TRPs when volume was sufficient. Clinic TRP can be calculated from SART CORS. Data suggest that calculations of clinic TRP from the national dataset would be meaningful. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

XML-based scripting of multimodality image presentations in multidisciplinary clinical conferences

NASA Astrophysics Data System (ADS)

Ratib, Osman M.; Allada, Vivekanand; Dahlbom, Magdalena; Marcus, Phillip; Fine, Ian; Lapstra, Lorelle

2002-05-01

We developed a multi-modality image presentation software for display and analysis of images and related data from different imaging modalities. The software is part of a cardiac image review and presentation platform that supports integration of digital images and data from digital and analog media such as videotapes, analog x-ray films and 35 mm cine films. The software supports standard DICOM image files as well as AVI and PDF data formats. The system is integrated in a digital conferencing room that includes projections of digital and analog sources, remote videoconferencing capabilities, and an electronic whiteboard. The goal of this pilot project is to: 1) develop a new paradigm for image and data management for presentation in a clinically meaningful sequence adapted to case-specific scenarios, 2) design and implement a multi-modality review and conferencing workstation using component technology and customizable 'plug-in' architecture to support complex review and diagnostic tasks applicable to all cardiac imaging modalities and 3) develop an XML-based scripting model of image and data presentation for clinical review and decision making during routine clinical tasks and multidisciplinary clinical conferences.

Meaningful use of health information technology by rural hospitals.

PubMed

McCullough, Jeffrey; Casey, Michelle; Moscovice, Ira; Burlew, Michele

2011-01-01

This study examines the current status of meaningful use of health information technology (IT) in Critical Access Hospitals (CAHs), other rural, and urban US hospitals, and it discusses the potential role of Medicare payment incentives and disincentives in encouraging CAHs and other rural hospitals to achieve meaningful use. Data from the American Hospital Association (AHA) Annual Survey IT Supplement were analyzed, using t tests and probit regressions to assess whether implementation rates in CAHs and other rural hospitals are significantly different from rates in urban hospitals. Of the many measures we examined, only 4 have been met by a majority of rural hospitals: electronic recording of patient demographics and electronic access to lab reports, radiology reports, and radiology images. Meaningful use is even less prevalent among CAHs. We also find that rural hospitals lag behind urban institutions in nearly every measure of meaningful use. These differences are particularly large and significant for CAHs. The meaningful use incentive system creates many challenges for CAHs. First, investments are evaluated and subsidies determined after adoption. Thus, CAHs must accept financial risk when adopting health IT; this may be particularly important for large expenditures. Second, the subsidies may be low for relatively small expenditures. Third, since the subsidies are based on observable costs, CAHs will receive no support for their intangible costs (eg, workflow disruption). A variety of policies may be used to address these problems of financial risk, uncertain returns in a rural setting, and limited resources. © 2011 National Rural Health Association.

Mediated Learning Experience and Concept Maps: A Pedagogical Tool for Achieving Meaningful Learning in Medical Physiology Students

ERIC Educational Resources Information Center

Gonzalez, Hilda Leonor; Palencia, Alberto Pardo; Umana, Luis Alfredo; Galindo, Leonor; Villafrade M., Luz Adriana

2008-01-01

Even though comprehension of human physiology is crucial in the clinical setting, students frequently learn part of this subject using rote memory and then are unable to transfer knowledge to other contexts or to solve clinical problems. This study evaluated the impact of articulating the concept map strategy with the mediated learning experience…

National Institutes of Health Clinical Alerts and Advisories

MedlinePlus

... Health & Toxicology Health Services Research & Public Health Health Information Technology NLM for You Grants & Funding Meaningful Use Tools Training & Outreach Network of Medical Libraries Regional ... Important Therapeutic Information on the Benefit of Zidovudine (AZT) for the ...

Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

PubMed

Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

2015-10-01

Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia. © The Author(s) 2015.

Evaluating linguistic equivalence of patient-reported outcomes in a cancer clinical trial.

PubMed

Hahn, Elizabeth A; Bode, Rita K; Du, Hongyan; Cella, David

2006-01-01

In order to make meaningful cross-cultural or cross-linguistic comparisons of health-related quality of life (HRQL) or to pool international research data, it is essential to create unbiased measures that can detect clinically important differences. When HRQL scores differ between cultural/linguistic groups, it is important to determine whether this reflects real group differences, or is the result of systematic measurement variability. To investigate the linguistic measurement equivalence of a cancer-specific HRQL questionnaire, and to conduct a sensitivity analysis of treatment differences in HRQL in a clinical trial. Patients with newly diagnosed chronic myelogenous leukemia (n = 1049) completed serial HRQL assessments in an international Phase III trial. Two types of differential item functioning (uniform and non-uniform) were evaluated using item response theory and classical test theory approaches. A sensitivity analysis was conducted to compare HRQL between treatment arms using items without evidence of differential functioning. Among 27 items, nine (33%) did not exhibit any evidence of differential functioning in both linguistic comparisons (English versus French, English versus German). Although 18 items functioned differently, there was no evidence of systematic bias. In a sensitivity analysis, adjustment for differential functioning affected the magnitude, but not the direction or interpretation of clinical trial treatment arm differences. Sufficient sample sizes were available for only three of the eight language groups. Identification of differential functioning in two-thirds of the items suggests that current psychometric methods may be too sensitive. Enhanced methodologies are needed to differentiate trivial from substantive differential item functioning. Systematic variability in HRQL across different groups can be evaluated for its effect upon clinical trial results; a practice recommended when data are pooled across cultural or linguistic groups to make conclusions about treatment effects.

Increased trunk extension endurance is associated with meaningful improvement in balance among older adults with mobility problems.

PubMed

Suri, Pradeep; Kiely, Dan K; Leveille, Suzanne G; Frontera, Walter R; Bean, Jonathan F

2011-07-01

To determine whether trunk extension endurance changes with training are associated with clinically meaningful improvements in balance among mobility-limited older adults. Longitudinal data from a randomized controlled trial. Outpatient rehabilitation research center. Community-dwelling older adults (N=64; mean age, 75.9y) with mobility limitations as defined by a score of 4 to 10 on the Short Physical Performance Battery. Sixteen weeks of progressive resistance training. Outcomes were the Berg Balance Scale (BBS) and the Unipedal Stance Time (UST). Predictors included leg strength, leg power, trunk extension endurance, and the product of heart rate and blood pressure (RPP) at the final stage of an exercise tolerance test. We performed an analysis of data from participants who completed 16 weeks of training by using binary outcomes defined by a clinically meaningful change (CMC) from baseline to completion of the intervention (BBS=4 units; UST=5s). The association of predictor variables with balance outcomes was examined separately and together in multivariate adjusted logistic regression models. Trunk extension endurance in seconds (1.04 [1.00-1.09]) was independently associated with CMC on the BBS. Trunk extension endurance (1.02 [1.00-1.03]) was independently associated with CMC on the UST. Other physical attributes were not associated with meaningful change in balance. Improvements in trunk extension endurance were independently associated with CMCs in balance in older adults. Leg strength, leg power, and RPP were not associated with CMC in balance. Poor trunk extension endurance may be a rehabilitative impairment worthy of further study as a modifiable factor linked to balance among older adults. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Low Cardiorespiratory Fitness in African Americans: A Health Disparity Risk Factor?

PubMed Central

Swift, Damon L.; Staiano, Amanda E.; Johannsen, Neil M.; Lavie, Carl J.; Earnest, Conrad P.; Katzmarzyk, Peter T.; Blair, Steven N.; Newton, Robert L.; Church, Timothy S.

2013-01-01

Low cardiorespiratory fitness (CRF) is a well-established risk factor for all-cause and cardiovascular disease mortality. African Americans have higher rates of cardiovascular disease compared to their Caucasian counterparts. However, the extent to which lower CRF levels contribute to the excess risk in African Americans has not been fully explored. The purpose of this review is to: 1) explore the literature evaluating the relationship between CRF and mortality specifically in African American populations; and 2) critically evaluate the studies which have compared CRF between African American and Caucasians in epidemiological studies and clinical trials. We have further discussed several potential mechanisms that may contribute to the observation of lower CRF levels in African American compared to Caucasian adults including potential racial differences in physical activity levels, muscle fiber type distribution, and hemoglobin levels. If lower CRF is generally present in African Americans compared to Caucasians, and is of a clinically meaningful difference, this may represent an important public health concern. PMID:23982718

The Potato Chip Really Does Look Like Elvis! Neural Hallmarks of Conceptual Processing Associated with Finding Novel Shapes Subjectively Meaningful

PubMed Central

Federmeier, Kara D.; Paller, Ken A.

2012-01-01

Clouds and inkblots often compellingly resemble something else—faces, animals, or other identifiable objects. Here, we investigated illusions of meaning produced by novel visual shapes. Individuals found some shapes meaningful and others meaningless, with considerable variability among individuals in these subjective categorizations. Repetition for shapes endorsed as meaningful produced conceptual priming in a priming test along with concurrent activity reductions in cortical regions associated with conceptual processing of real objects. Subjectively meaningless shapes elicited robust activity in the same brain areas, but activity was not influenced by repetition. Thus, all shapes were conceptually evaluated, but stable conceptual representations supported neural priming for meaningful shapes only. During a recognition memory test, performance was associated with increased frontoparietal activity, regardless of meaningfulness. In contrast, neural conceptual priming effects for meaningful shapes occurred during both priming and recognition testing. These different patterns of brain activation as a function of stimulus repetition, type of memory test, and subjective meaningfulness underscore the distinctive neural bases of conceptual fluency versus episodic memory retrieval. Finding meaning in ambiguous stimuli appears to depend on conceptual evaluation and cortical processing events similar to those typically observed for known objects. To the brain, the vaguely Elvis-like potato chip truly can provide a substitute for the King himself. PMID:22079921

Authentic Leadership and Altruism: The Mediating Role of Meaningfulness

ERIC Educational Resources Information Center

Sagnak, Mesut; Kuruöz, Mehmet

2017-01-01

The purpose of this study was to investigate the mediating effects of meaningfulness on the relationship between authentic leadership and altruistic behavior. The participants consisted of 356 teachers randomly selected from 14 primary and secondary schools in Nigde. Three different instruments were used in this study. The scales were translated…

Making a Natural Product Chemistry Course Meaningful with a Mini Project Laboratory

ERIC Educational Resources Information Center

Hakim, Aliefman; Liliasari; Kadarohman, Asep; Syah, Yana Maolana

2016-01-01

This paper discusses laboratory activities that can improve the meaningfulness of natural product chemistry course. These laboratory activities can be useful for students from many different disciplines including chemistry, pharmacy, and medicine. Students at the third-year undergraduate level of chemistry education undertake the project to…

Transsexual subtypes: clinical and theoretical significance.

PubMed

Smith, Yolanda L S; van Goozen, Stephanie H M; Kuiper, A J; Cohen-Kettenis, Peggy T

2005-12-15

The present study was designed to investigate whether transsexuals can be validly subdivided into subtypes on the basis of sexual orientation, and whether differences between subtypes of transsexuals are similar for male-to-female (MF) and female-to-male transsexuals (FMs). Within a large transsexual sample (n=187), homosexual and nonhomosexual subjects were compared on a number of characteristics before the start of treatment. Differences within MF and FM groups were also investigated. Homosexual transsexuals were found to be younger when applying for sex reassignment, reported a stronger cross-gender identity in childhood, had a more convincing cross-gender appearance, and functioned psychologically better than nonhomosexual transsexuals. Moreover, a lower percentage of the homosexual transsexuals reported being (or having been) married and sexually aroused while cross-dressing. The pattern of findings was different for MFs and FMs. No differences between homosexuals and nonhomosexuals were found in height, weight, or body mass index. A distinction between subtypes of transsexuals on the basis of sexual orientation seems theoretically and clinically meaningful. The results support the notion that in the two groups different factors influence the decision to apply for sex reassignment. The more vulnerable nonhomosexual transsexuals may particularly benefit from additional professional guidance before and/or during treatment.

Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence.

PubMed

Bosworth, Hayden B; Zullig, Leah L; Mendys, Phil; Ho, Michael; Trygstad, Troy; Granger, Christopher; Oakes, Megan M; Granger, Bradi B

2016-03-15

The use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain. The aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT. We describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence. The four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed. To make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health

PubMed Central

2011-01-01

Background Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. Methods All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. Results Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. Conclusions This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment. PMID:21501484

Experience by children and adolescents of more than one type of maltreatment: Association of different classes of maltreatment profiles with clinical outcome variables.

PubMed

Witt, Andreas; Münzer, Annika; Ganser, Helene G; Fegert, Jörg M; Goldbeck, Lutz; Plener, Paul L

2016-07-01

Most victims of child abuse have experienced more than one type of maltreatment, yet there is a lack of understanding of the impact of specific combinations of types of maltreatment. This study aimed to identify meaningful classes of maltreatment profiles and to associate them with short-term clinical outcomes. A total of 358 German children and adolescents aged 4-17 with a known history of child maltreatment were included in the study. Through interviews and questionnaires, information was obtained from participants and their primary caregivers on history of maltreatment, sociodemographics, psychopathology, level of psychosocial functioning, and health-related quality of life. Types of abuse were categorized into six major groups: sexual abuse in general, sexual abuse with penetration, physical abuse, emotional abuse, neglect, and exposure to domestic violence. A latent class analysis (LCA) was performed to determine distinct multi-type maltreatment profiles, which were then assessed for their associations with the sociodemographic and clinical outcome variables. The LCA revealed that participants could be categorized into three meaningful classes according to history of maltreatment: (1) experience of multiple types of maltreatment excluding sexual abuse (63.1%), (2) experience of multiple types of maltreatment including sexual abuse (26.5%), and (3) experience of predominantly sexual abuse (10.3%). Members of Class 2 showed significantly worse short-term outcomes on psychopathology, level of functioning, and quality of life compared to the other classes. Three distinct profiles of multiple types of maltreatment were empirically identified in this sample. Exposure to multiple types of abuse was associated with poorer outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study.

PubMed

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-11-01

Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. A single-blinded quasi-experimental study with a one-group pretest-posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm(2). The non-intervention group had no significant changes in ROM or NPRS scores. After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials.

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study

PubMed Central

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-01-01

Objective: Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. Methods: A single-blinded quasi-experimental study with a one-group pretest–posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. Results: The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm2. The non-intervention group had no significant changes in ROM or NPRS scores. Discussion: After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials. PMID:25395827

The psychosocial impact of an abnormal cervical smear result.

PubMed

Drolet, Mélanie; Brisson, Marc; Maunsell, Elizabeth; Franco, Eduardo L; Coutlée, François; Ferenczy, Alex; Fisher, William; Mansi, James A

2012-10-01

Data on the impact of abnormal cervical smear results on health-related quality of life (HrQoL) are scarce. We aimed to (i) prospectively assess the HrQoL of women who were informed of an abnormal smear result; (ii) identify predictors of greater negative psychosocial impact of an abnormal result; and (iii) prospectively estimate the quality-adjusted life-years (QALYs) lost following an abnormal result. Between 08/2006 and 08/2008, 492 women with an abnormal result and 460 women with a normal result, frequency matched for age and clinic, were recruited across Canada. HrQoL was measured at recruitment and 4 and 12 weeks later with the EuroQol, Short Form-12, short Spielberg State-Trait Anxiety Inventory (STAI) and HPV Impact Profile. Three blocks of potential predictors of higher psychosocial impact were tested by hierarchical modeling: (i) socio-demographics; (ii) sexual activity; and (iii) smear result severity, communication, and understanding. Receiving an abnormal result significantly increased anxiety (STAI mean difference between both groups = 8.3). Initial anxiety decreased over time for the majority of women. However, 35% of women had clinically meaningful anxiety at 12 weeks (i.e. STAI scores ≥0.5 standard deviation of the controls). These women reported a lower socio-economic level, did not completely understand the information about their result and perceived themselves at higher risk of cancer. QALY lost following an abnormal result were between 0.007 and 0.009. Receiving an abnormal smear has a statistically significant and clinically meaningful negative impact on mental health. However, this negative impact subsides after 12 weeks for the majority of women. Copyright © 2011 John Wiley & Sons, Ltd.

Sub-grouping patients with non-specific low back pain based on cluster analysis of discriminatory clinical items.

PubMed

Billis, Evdokia; McCarthy, Christopher J; Roberts, Chris; Gliatis, John; Papandreou, Maria; Gioftsos, George; Oldham, Jacqueline A

2013-02-01

To identify potential subgroups amongst patients with non-specific low back pain based on a consensus list of potentially discriminatory examination items. Exploratory study. A convenience sample of 106 patients with non-specific low back pain (43 males, 63 females, mean age 36 years, standard deviation 15.9 years) and 7 physiotherapists. Based on 3 focus groups and a two-round Delphi involving 23 health professionals and a random stratified sample of 150 physiotherapists, respectively, a comprehensive examination list comprising the most "discriminatory" items was compiled. Following reliability analysis, the most reliable clinical items were assessed with a sample of patients with non-specific low back pain. K-means cluster analysis was conducted for 2-, 3- and 4-cluster options to explore for meaningful homogenous subgroups. The most clinically meaningful cluster was a two-subgroup option, comprising a small group (n = 24) with more severe clinical presentation (i.e. more widespread pain, functional and sleeping problems, other symptoms, increased investigations undertaken, more severe clinical signs, etc.) and a larger less dysfunctional group (n = 80). A number of potentially discriminatory clinical items were identified by health professionals and sub-classified, based on a sample of patients with non-specific low back pain, into two subgroups. However, further work is needed to validate this classification process.

Intuition, Affect, and Peculiar Beliefs

PubMed Central

Boden, Matthew Tyler; Berenbaum, Howard; Topper, Maurice

2012-01-01

Research with college students has found that intuitive thinking (e.g., using hunches to ascribe meaning to experiences) and positive affect interactively predict ideas of reference and odd/magical beliefs. We investigated whether these results would generalize to a diverse community sample of adults that included individuals with elevated levels of peculiar perceptions and beliefs. We measured positive and negative affect and intuitive thinking through questionnaires, and peculiar beliefs (i.e., ideas of reference and odd/magical beliefs) through structured clinical interviews. We found that peculiar beliefs were associated with intuitive thinking and negative affect, but not positive affect. Furthermore, in no instance did the interaction of affect and intuitive thinking predict peculiar beliefs. These results suggest that there are important differences in the factors that contribute to peculiar beliefs between college students and clinically meaningful samples. PMID:22707815

Testing telehealth using technology-enhanced nurse monitoring.

PubMed

Grant, Leslie A; Rockwood, Todd; Stennes, Leif

2014-10-01

Technology-enhanced nurse monitoring is a telehealth solution that helps nurses with assessment, diagnosis, and triage of older adults living in community-based settings. This technology links biometric and nonbiometric sensors to a data management system that is monitored remotely by RNs and unlicensed support staff. Nurses faced a number of challenges related to data interpretation, including making clinical inferences from nonbiometric data, integrating data generated by three different telehealth applications into a clinically meaningful cognitive framework, and figuring out how best to use nursing judgment to make valid inferences from online reporting systems. Nurses developed expertise over the course of the current study. The sponsoring organization achieved a high degree of organizational knowledge about how to use these systems more effectively. Nurses saw tremendous value in the telehealth applications. The challenges, learning curve, and organizational improvements are described. Copyright 2014, SLACK Incorporated.

The significance of routines in nursing practice.

PubMed

Rytterström, Patrik; Unosson, Mitra; Arman, Maria

2011-12-01

The aim of this study was to illuminate the significance of routines in nursing practice. Clinical nursing is performed under the guidance of routines to varying degrees. In the nursing literature, routine is described as having both negative and positive aspects, but use of the term is inconsistent, and empirical evidence is sparse. In the research on organisational routines, a distinction is made between routine as a rule and routine as action. A qualitative design using a phenomenological-hermeneutic approach. Data collection from three focus groups focused on nurses' experience of routines. Seventeen individual interviews from a previous study focusing on caring culture were also analysed in a secondary qualitative analysis. All participants were employed as 'qualified nursing pool' nurses. Routines are experienced as pragmatic, obstructive and meaningful. The aim of the pragmatic routine was to ensure that daily working life works; this routine is practised more on the basis of rational arguments and obvious intentions. The obstructive routine had negative consequences for nursing practice and was described as nursing losing its humanity and violating the patient's integrity. The meaningful routine involved becoming one with the routine and for the nurses, it felt right and meaningful to adapt to it. Routines become meaningful when the individual action is in harmony with the cultural pattern on which the nursing work is based. Instead of letting contemporary practice passively become routine, routines can be assessed and developed using research and theoretical underpinnings as a starting point for nursing practice. Leaders have a special responsibility to develop and support meaningful routines. One approach could be to let wards examine their routines from a patient perspective on the basis of the themes of pragmatic, meaningful and obstructive routine. © 2010 Blackwell Publishing Ltd.

Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea.

PubMed

Ida, Motoko; Nishida, Akito; Akiho, Hiraku; Nakashima, Yoshihiro; Matsueda, Kei; Fukudo, Shin

2017-01-01

Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess "clinically meaningful improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D). The same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of ramosetron ( n  = 47) or placebo ( n  = 51) once daily for 12 weeks after a one-week baseline period. To explore and examine endpoints that allow evaluation of "clinically meaningful improvements focusing on the patient's chief complaint," the chief complaint and its relief by this study drug were assessed in this exploratory study. Rates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point, P  = 0.027) throughout the treatment period, except at week 6. Ramosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).

Corpus callosum atrophy as a marker of clinically meaningful cognitive decline in secondary progressive multiple sclerosis. Impact on employment status.

PubMed

Papathanasiou, Athanasios; Messinis, Lambros; Zampakis, Petros; Papathanasopoulos, Panagiotis

2017-09-01

Cognitive impairment in Multiple Sclerosis (MS) is more frequent and pronounced in secondary progressive MS (SPMS). Cognitive decline is an important predictor of employment status in patients with MS. Magnetic Resonance Imaging (MRI) markers have been used to associate tissue damage with cognitive dysfunction. The aim of the study was to designate the MRI marker that predicts cognitive decline in SPMS and explore its effect on employment status. 30 SPMS patients and 30 healthy participants underwent neuropsychological assessment using the Trail Making Test (TMT) parts A and B, semantic and phonological verbal fluency task and a computerized cognitive screening battery (Central Nervous System Vital Signs). Employment status was obtained as a quality of life measure. Brain MRI was performed in all participants. We measured total lesion volume, third ventricle width, thalamic and corpus callosum atrophy. The frequency of cognitive decline for our SPMS patients was 80%. SPMS patients differed significantly from controls in all neuropsychological measures. Corpus callosum area was correlated with cognitive flexibility, processing speed, composite memory, executive functions, psychomotor speed, reaction time and phonological verbal fluency task. Processing speed and composite memory were the most sensitive markers for predicting employment status. Corpus callosum area was the most sensitive MRI marker for memory and processing speed. Corpus callosum atrophy predicts a clinically meaningful cognitive decline, affecting employment status in our SPMS patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of Intrinsic Factors on the Clinical Pharmacokinetics of Vortioxetine.

PubMed

Chen, Grace; Nomikos, George G; Affinito, John; Jacobson, William; Zhao, Zhen; Wang, Shining; Xie, Jinhui

2018-06-19

Vortioxetine is an antidepressant agent with multimodal activity that is approved for the treatment of major depressive disorder at doses of 5 to 20 mg once daily. Vortioxetine is a medium-clearance drug that undergoes extensive metabolism via several cytochrome P450 isozymes. A series of single- and multiple-dose pharmacokinetic studies were performed to evaluate the impact of intrinsic (ie, subject-related) factors, such as age, sex, race, and renal and hepatic function, on the pharmacokinetics of vortioxetine. The point estimates on the ratios and their 90% confidence intervals (CIs) for the central values of AUC (area under the concentration-time curve) and C max (maximum plasma concentration) were obtained by taking the antilog of the differences and 90%CIs in the log-transformed least-squares means. The results demonstrate that there were no clinically meaningful differences (defined as exposure difference between 50% and 2-fold change) in the exposure to vortioxetine (as assessed by AUC and C max ) between elderly and younger subjects, men and women, and blacks and whites and among subjects with varying degrees of renal or hepatic impairment. These results suggest that no dosing adjustments of vortioxetine are required for the intrinsic factors investigated in these studies. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

PubMed Central

Collaku, Agron; Reed, Kenneth

2017-01-01

Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment. Results There were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670 PMID:28345425

Further thoughts on dualism, science, and the use of medication in psychoanalysis.

PubMed

Swoiskin, M H

2001-01-01

In response to Deborah Cabaniss's article, "Beyond Dualism: Psychoanalysis and Medication in the 21st Century," the author further considers the differences between the aims of symptom reduction and psychic integration, the concept of mind-body dualism, and the nature of scientific inquiry as they pertain to the use of medication in psychoanalytic therapies. He warns against the collapsing of concepts, aided by a misapplication of science, with respect to how we listen to, organize, and respond to clinical material. He argues that only when such scrutiny occurs can the important and challenging questions pertaining to the use of medication in psychoanalytic therapies be meaningfully considered.

Clinical Practice Informs Secure Messaging Benefits and Best Practices.

PubMed

Haun, Jolie N; Hathaway, Wendy; Chavez, Margeaux; Antinori, Nicole; Vetter, Brian; Miller, Brian K; Martin, Tracey L; Kendziora, Lisa; Nazi, Kim M; Melillo, Christine

2017-10-01

Background Clinical care team members in Department of Veterans' Affairs (VA) facilities nationwide are working to integrate the use of Secure Messaging (SM) into care delivery and identify innovative uses. Identifying best practices for proactive use of SM is a key factor in its successful implementation and sustained use by VA clinical care team members and veterans. Objectives A collaborative project solicited input from VA clinical care teams about their local practices using SM to provide access to proactive patient-centered care for veterans and enhance workflow. Methods This project implemented a single-item cross-sectional qualitative electronic survey via internal e-mail to local coordinators in all 23 Veterans Integrated Service Networks (VISNs). Content analysis was used to manage descriptive data responses. Descriptive statistics described sample characteristics. Results VA clinical care team members across 15 of 23 VISNs responded to the questionnaire. Content analysis of 171 responses produced two global domains: (1) benefits of SM and (2) SM best practices. Benefits of SM use emphasize enhanced and efficient communication and increased access to care. Care team members incorporate SM into their daily clinical practices, using it to provide services before, during, and after clinical encounters as a best practice. SM users suggest improvements in veteran care, clinical team workflow, and efficient use of health resources. Clinical team members invested in the successful implementation of SM integrate SM into their daily practices to provide meaningful and useful veteran-centered care and improve workflow. Conclusion VA clinical care team members can use SM proactively to create an integrated SM culture. With adequate knowledge and motivation to proactively use this technology, all clinical team members within the VA system can replicate best practices shared by other clinical care teams to generate meaningful and useful interactions with SM to enrich veterans' health care experience.

Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group.

PubMed

Rodeghiero, Francesco; Stasi, Roberto; Gernsheimer, Terry; Michel, Marc; Provan, Drew; Arnold, Donald M; Bussel, James B; Cines, Douglas B; Chong, Beng H; Cooper, Nichola; Godeau, Bertrand; Lechner, Klaus; Mazzucconi, Maria Gabriella; McMillan, Robert; Sanz, Miguel A; Imbach, Paul; Blanchette, Victor; Kühne, Thomas; Ruggeri, Marco; George, James N

2009-03-12

Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.

A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis.

PubMed

Grotz, V Lee; Pi-Sunyer, Xavier; Porte, Daniel; Roberts, Ashley; Richard Trout, J

2017-08-01

The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control. Copyright © 2017 Heartland Food Products Group. Published by Elsevier Inc. All rights reserved.

The art and science of choosing efficacy endpoints for rare disease clinical trials.

PubMed

Cox, Gerald F

2018-04-01

An important challenge in rare disease clinical trials is to demonstrate a clinically meaningful and statistically significant response to treatment. Selecting the most appropriate and sensitive efficacy endpoints for a treatment trial is part art and part science. The types of endpoints should align with the stage of development (e.g., proof of concept vs. confirmation of clinical efficacy). The patient characteristics and disease stage should reflect the treatment goal of improving disease manifestations or preventing disease progression. For rare diseases, regulatory approval requires demonstration of clinical benefit, defined as how a patient, feels, functions, or survives, in at least one adequate and well-controlled pivotal study conducted according to Good Clinical Practice. In some cases, full regulatory approval can occur using a validated surrogate biomarker, while accelerated, or provisional, approval can occur using a biomarker that is likely to predict clinical benefit. Rare disease studies are small by necessity and require the use of endpoints with large effect sizes to demonstrate statistical significance. Understanding the quantitative factors that determine effect size and its impact on powering the study with an adequate sample size is key to the successful choice of endpoints. Interpreting the clinical meaningfulness of an observed change in an efficacy endpoint can be justified by statistical methods, regulatory precedence, and clinical context. Heterogeneous diseases that affect multiple organ systems may be better accommodated by endpoints that assess mean change across multiple endpoints within the same patient rather than mean change in an individual endpoint across all patients. © 2018 Wiley Periodicals, Inc.

How to define responders in osteoarthritis

PubMed Central

Cooper, Cyrus; Adachi, Jonathan D.; Bardin, Thomas; Berenbaum, Francis; Flamion, Bruno; Jonsson, Helgi; Kanis, John A.; Pelousse, Franz; Lems, Willem F.; Pelletier, Jean-Pierre; Martel-Pelletier, Johanne; Reiter, Susanne; Reginster, Jean-Yves; Rizzoli, René; Bruyère, Olivier

2013-01-01

Background Osteoarthritis is a clinical syndrome of failure of the joint accompanied by varying degrees of joint pain, functional limitation, and reduced quality of life due to deterioration of articular cartilage and involvement of other joint structures. Scope Regulatory agencies require relevant clinical benefit on symptoms and structure modification for registration of a new therapy as a disease-modifying osteoarthritis drug (DMOAD). An international Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and International Osteoporosis Foundation was convened to explore the current burden of osteoarthritis, review current regulatory guidelines for the conduct of clinical trials, and examine the concept of responder analyses for improving drug evaluation in osteoarthritis. Findings The ESCEO considers that the major challenges in DMOAD development are the absence of a precise definition of the disease, particularly in the early stages, and the lack of consensus on how to detect structural changes and link them to clinically meaningful endpoints. Responder criteria should help identify progression of disease and be clinically meaningful. The ideal criterion should be sensitive to change over time and should predict disease progression and outcomes such as joint replacement. Conclusion The ESCEO considers that, for knee osteoarthritis, clinical trial data indicate that radiographic joint space narrowing >0.5 mm over 2 or 3 years might be a reliable surrogate measure for total joint replacement. On-going research using techniques such as magnetic resonance imaging and biochemical markers may allow the identification of these patients earlier in the disease process. PMID:23557069

Does Constructivist Approach Applicable through Concept Maps to Achieve Meaningful Learning in Science?

ERIC Educational Resources Information Center

Jena, Ananta Kumar

2012-01-01

This study deals with the application of constructivist approach through individual and cooperative modes of spider and hierarchical concept maps to achieve meaningful learning on science concepts (e.g. acids, bases & salts, physical and chemical changes). The main research questions were: Q (1): is there any difference in individual and…

Behavioral approach and avoidance in schizophrenia: an evaluation of motivational profiles.

PubMed

Felice Reddy, L; Green, Michael F; Rizzo, Shemra; Sugar, Catherine A; Blanchard, Jack J; Gur, Raquel E; Kring, Ann M; Horan, William P

2014-10-01

Schizophrenia is associated with motivational deficits that interfere with a wide range of goal directed activities. Despite their clinical importance, our current understanding of these motivational impairments is limited. Furthermore, different types of motivational problems are commonly seen among individuals within the broad diagnosis of schizophrenia. The goal of the current study was to examine whether clinically meaningful subgroups could be identified based on approach and avoidance motivational tendencies. We measured these tendencies in 151 individuals with schizophrenia. Although prior studies demonstrate elevated BIS sensitivity in schizophrenia at the overall group level, none have explored various combinations of BIS/BAS sensitivities within this disorder. Cluster analyses yielded five subgroups with different combinations of low, moderate, or high BIS and BAS. The subgroups had interpretable differences in clinically rated negative symptoms and self-reported anhedonia/socio-emotional attitudes, which were not detectable with the more commonly used linear BIS/BAS scores. Two of the subgroups had significantly elevated negative symptoms but different approach/avoidance profiles: one was characterized by markedly low BIS, low BAS and an overall lack of social approach motivation; the other had markedly high BIS but moderate BAS and elevated social avoidance motivation. The two subgroups with relatively good clinical functioning showed patterns of BAS greater than BIS. Our findings indicate that there are distinct motivational pathways that can lead to asociality in schizophrenia and highlight the value of considering profiles based on combined patterns of BIS and BAS in schizophrenia. Published by Elsevier B.V.

In Pursuit of Neurophenotypes: The Consequences of Having Autism and a Big Brain

PubMed Central

Amaral, David G.; Li, Deana; Libero, Lauren; Solomon, Marjorie; Van de Water, Judy; Mastergeorge, Ann; Naigles, Letitia; Rogers, Sally; Nordahl, Christine Wu

2017-01-01

A consensus has emerged that despite common core features, autism spectrum disorder (ASD) has multiple etiologies and various genetic and biological characteristics. The fact that there are likely to be subtypes of ASD has complicated attempts to develop effective therapies. The UC Davis MIND Institute Autism Phenome Project is a longitudinal, multidisciplinary analysis of children with autism and age-matched typically developing controls; nearly 400 families are participating in this study. The overarching goal is to gather sufficient biological, medical, and behavioral data to allow definition of clinically meaningful subtypes of ASD. One reasonable hypothesis is that different subtypes of autism will demonstrate different patterns of altered brain organization or development i.e., different neurophenotypes. In this Commentary, we discuss one neurophenotype that is defined by megalencephaly, or having brain size that is large and disproportionate to body size. We have found that 15% of the boys with autism demonstrate this neurophenotype, though it is far less common in girls. We review behavioral and medical characteristics of the large-brained group of boys with autism in comparison to those with typically sized brains. While brain size in typically developing individuals is positively correlated with cognitive function, the children with autism and larger brains have more severe disabilities and poorer prognosis. This research indicates that phenotyping in autism, like genotyping, requires a very substantial cohort of subjects. Moreover, since brain and behavior relationships may emerge at different times during development, this effort highlights the need for longitudinal analyses to carry out meaningful phenotyping. PMID:28239961

Dropout revisited: patient- and therapist-initiated discontinuation of psychotherapy as a function of organizational instability.

PubMed

Werbart, Andrzej; Andersson, Håkan; Sandell, Rolf

2014-01-01

To explore the association between the stability or instability of services' organizational structure and patient- and therapist-initiated discontinuation of therapy in routine mental health. Three groups, comprising altogether 750 cases in routine mental health care in eight different clinics, were included: cases with patient-initiated discontinuation, therapist-initiated discontinuation, and patients remaining in treatment. Multilevel multinomial regression was used to estimate three models: An initial, unconditional intercept-only model, another one including patient variables, and a final model with significant patient and therapist variables including the organizational stability of the therapists' clinic. High between-therapist variability was noted. Odds ratios and significance tests indicated a strong association of organizational instability with patient-initiated premature termination in particular. The question of how organizational factors influence the treatment results needs further research. Future studies have to be designed in ways that permit clinically meaningful subdivision of the patients' and the therapists' decisions for premature termination.

Stem cell therapy clinical research: A regulatory conundrum for academia.

PubMed

Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

2017-12-01

The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

Simulation in Nursing Education-International Perspectives and Contemporary Scope of Practice.

PubMed

Kelly, Michelle A; Berragan, Elizabeth; Husebø, Sissel Eikeland; Orr, Fiona

2016-05-01

This article provides insights and perspectives from four experienced educators about their approaches to developing, delivering, and evaluating impactful simulation learning experiences for undergraduate nurses. A case study format has been used to illustrate the commonalities and differences of where simulation has been positioned within curricula, with examples of specialized clinical domains and others with a more generic focus. The importance of pedagogy in developing and delivering simulations is highlighted in each case study. A range of learning theories appropriate for healthcare simulations are a reminder of the commonalities across theories and that no one theory can account for the engaging and impactful learning that simulation elicits. Creating meaningful and robust learning experiences through simulation can benefit students' performance in subsequent clinical practice. The ability to rehearse particular clinical scenarios, which may be difficult to otherwise achieve, assists students in anticipating likely patient trajectories and understanding how to respond to patients, relatives, and others in the healthcare team. © 2016 Sigma Theta Tau International.

"Our commonality is our past:" a qualitative analysis of re-entry community health workers' meaningful experiences.

PubMed

Bedell, Precious; Wilson, John L; White, Ann Marie; Morse, Diane S

Re-entry community health workers (CHWs) are individuals who connect diverse community residents at risk for chronic health issues such as Hepatitis C virus and cardiovascular disease with post-prison healthcare and re-entry services. While the utilization of CHWs has been documented in other marginalized populations, there is little knowledge surrounding the work of re-entry CHWs with individuals released from incarceration. Specifically, CHWs' experiences and perceptions of the uniqueness of their efforts to link individuals to healthcare have not been documented systematically. This study explored what is meaningful to formerly incarcerated CHWs as they work with released individuals. The authors conducted a qualitative thematic analysis of twelve meaningful experiences written by re-entry CHWs employed by the Transitions Clinic Network who attended a CHW training program during a conference in San Francisco, CA. Study participants were encouraged to recount meaningful CHW experiences and motivations for working with re-entry populations in a manner consistent with journal-based qualitative analysis techniques. Narratives were coded using an iterative process and subsequently organized according to themes in ATLAS.ti. Study personnel came to consensus with coding and major themes. The narratives highlighted thought processes and meaning related to re-entry CHWs' work helping patients navigate complex social services for successful re-integration. Six major themes emerged from the analysis: advocacy and support, empathy relating to a personal history of incarceration, giving back, professional satisfaction and responsibilities, resiliency and educational advancement, and experiences of social inequities related to race. Re-entry CHWs described former incarceration, employment, and social justice as sources of meaning for assisting justice-involved individuals receive effective, efficient, and high-quality healthcare. Health clinics for individuals released from incarceration provide a unique setting that links high risk patients to needed care and professionalizes career opportunities for formerly incarcerated re-entry CHWs. The commonality of past correctional involvement is a strong indicator of the meaning and perceived effectiveness re-entry CHWs find in working with individuals leaving prison. Expansion of reimbursable visits with re-entry CHWs in transitions clinics designed for re-entering individuals is worthy of further consideration.

Effect of Weight Losing on the Improving Clinical Statement of Patients With Knee Osteoarthritis.

PubMed

Sadeghi, Alireza; Rad, Zahra Abbaspour; Sajedi, Behnam; Heydari, Amir Hossein; Akbarieh, Samira; Jafari, Behzad

2017-11-01

Osteoarthritis causes severe pain and disability in joints, one of the most prevalent involved joints is the knee joint. There are several therapeutics ways to control pain and disability, but almost none of them are definite treatment. In this article, we tried to reveal the effect of weight loss on improving symptoms of knee osteoarthritis as an effective and permanent therapeutic approach. We chose 62 patients with grade 1-2 (mild to moderate) knee osteoarthritis and divided them equally into case and control groups. Patients should not had used NSAIDs at least for 6 months before study initiation. Symptoms severity was measured by WOMAC and VAS questionnaires before and after 3 months follow up. Weight and BMI were recorded too. Case group was suggested to have weight loss diet of less fat and carbohydrates and control group did not have any limitation. Comparison of variables' average of case and control groups was not logistically meaningful at the initiation and after the end of the study. But there was a meaningful correlation between variables' changes and lifestyle change in both groups, especially in WOMAC and VAS scores. All variables in case group had statistically meaningful differences between their amounts at the beginning and after the end of the study, on the contrary of the control group. In the comparison of our study with similar studies in the world. We deduced that weight loss can improve symptoms of knee osteoarthritis even in short time weight loss diet (3 months). ZUMS.REC.1394.94. Copyright © 2017. Publicado por Elsevier España, S.L.U.

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

PubMed

Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

2015-06-03

A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

Just enough, but not too much interactivity leads to better clinical skills performance after a computer assisted learning module.

PubMed

Kalet, A L; Song, H S; Sarpel, U; Schwartz, R; Brenner, J; Ark, T K; Plass, J

2012-01-01

Well-designed computer-assisted instruction (CAI) can potentially transform medical education. Yet little is known about whether specific design features such as direct manipulation of the content yield meaningful gains in clinical learning. We designed three versions of a multimedia module on the abdominal exam incorporating different types of interactivity. As part of their physical diagnosis course, 162 second-year medical students were randomly assigned (1:1:1) to Watch, Click or Drag versions of the abdominal exam module. First, students' prior knowledge, spatial ability, and prior experience with abdominal exams were assessed. After using the module, students took a posttest; demonstrated the abdominal exam on a standardized patient; and wrote structured notes of their findings. Data from 143 students were analyzed. Baseline measures showed no differences among groups regarding prior knowledge, experience, or spatial ability. Overall there was no difference in knowledge across groups. However, physical exam scores were significantly higher for students in the Click group. A mid-range level of behavioral interactivity was associated with small to moderate improvements in performance of clinical skills. These improvements were likely mediated by enhanced engagement with the material, within the bounds of learners' cognitive capacity. These findings have implications for the design of CAI materials to teach procedural skills.

Making the most of sparse clinical data by using a predictive-model-based analysis, illustrated with a stavudine pharmacokinetic study.

PubMed

Zhang, L; Price, R; Aweeka, F; Bellibas, S E; Sheiner, L B

2001-02-01

A small-scale clinical investigation was done to quantify the penetration of stavudine (D4T) into cerebrospinal fluid (CSF). A model-based analysis estimates the steady-state ratio of AUCs of CSF and plasma concentrations (R(AUC)) to be 0.270, and the mean residence time of drug in the CSF to be 7.04 h. The analysis illustrates the advantages of a causal (scientific, predictive) model-based approach to analysis over a noncausal (empirical, descriptive) approach when the data, as here, demonstrate certain problematic features commonly encountered in clinical data, namely (i) few subjects, (ii) sparse sampling, (iii) repeated measures, (iv) imbalance, and (v) individual design variation. These features generally require special attention in data analysis. The causal-model-based analysis deals with features (i) and (ii), both of which reduce efficiency, by combining data from different studies and adding subject-matter prior information. It deals with features (iii)--(v), all of which prevent 'averaging' individual data points directly, first, by adjusting in the model for interindividual data differences due to design differences, secondly, by explicitly differentiating between interpatient, interoccasion, and measurement error variation, and lastly, by defining a scientifically meaningful estimand (R(AUC)) that is independent of design.

Culture and hallucinations: overview and future directions.

PubMed

Larøi, Frank; Luhrmann, Tanya Marie; Bell, Vaughan; Christian, William A; Deshpande, Smita; Fernyhough, Charles; Jenkins, Janis; Woods, Angela

2014-07-01

A number of studies have explored hallucinations as complex experiences involving interactions between psychological, biological, and environmental factors and mechanisms. Nevertheless, relatively little attention has focused on the role of culture in shaping hallucinations. This article reviews the published research, drawing on the expertise of both anthropologists and psychologists. We argue that the extant body of work suggests that culture does indeed have a significant impact on the experience, understanding, and labeling of hallucinations and that there may be important theoretical and clinical consequences of that observation. We find that culture can affect what is identified as a hallucination, that there are different patterns of hallucination among the clinical and nonclinical populations, that hallucinations are often culturally meaningful, that hallucinations occur at different rates in different settings; that culture affects the meaning and characteristics of hallucinations associated with psychosis, and that the cultural variations of psychotic hallucinations may have implications for the clinical outcome of those who struggle with psychosis. We conclude that a clinician should never assume that the mere report of what seems to be a hallucination is necessarily a symptom of pathology and that the patient's cultural background needs to be taken into account when assessing and treating hallucinations. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Topology-aware illumination design for volume rendering.

PubMed

Zhou, Jianlong; Wang, Xiuying; Cui, Hui; Gong, Peng; Miao, Xianglin; Miao, Yalin; Xiao, Chun; Chen, Fang; Feng, Dagan

2016-08-19

Direct volume rendering is one of flexible and effective approaches to inspect large volumetric data such as medical and biological images. In conventional volume rendering, it is often time consuming to set up a meaningful illumination environment. Moreover, conventional illumination approaches usually assign same values of variables of an illumination model to different structures manually and thus neglect the important illumination variations due to structure differences. We introduce a novel illumination design paradigm for volume rendering on the basis of topology to automate illumination parameter definitions meaningfully. The topological features are extracted from the contour tree of an input volumetric data. The automation of illumination design is achieved based on four aspects of attenuation, distance, saliency, and contrast perception. To better distinguish structures and maximize illuminance perception differences of structures, a two-phase topology-aware illuminance perception contrast model is proposed based on the psychological concept of Just-Noticeable-Difference. The proposed approach allows meaningful and efficient automatic generations of illumination in volume rendering. Our results showed that our approach is more effective in depth and shape depiction, as well as providing higher perceptual differences between structures.

Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

PubMed

Triratana, Terdphong; Kraivaphan, Petcharat; Amornchat, Cholticha; Mateo, Luis R; Morrison, Boyce M; Dibart, Serge; Zhang, Yun-Po

2015-04-01

To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

Accepting Lower Salaries for Meaningful Work

PubMed Central

Hu, Jing; Hirsh, Jacob B.

2017-01-01

A growing literature indicates that people are increasingly motivated to experience a sense of meaning in their work lives. Little is known, however, about how perceptions of work meaningfulness influence job choice decisions. Although much of the research on job choice has focused on the importance of financial compensation, the subjective meanings attached to a job should also play a role. The current set of studies explored the hypothesis that people are willing to accept lower salaries for more meaningful work. In Study 1, participants reported lower minimum acceptable salaries when comparing jobs that they considered to be personally meaningful with those that they considered to be meaningless. In Study 2, an experimental enhancement of a job’s apparent meaningfulness lowered the minimum acceptable salary that participants required for the position. In two large-scale cross-national samples of full-time employees in 2005 and 2015, Study 3 found that participants who experienced more meaningful work lives were more likely to turn down higher-paying job offers elsewhere. The strength of this effect also increased significantly over this time period. Study 4 replicated these findings in an online sample, such that participants who reported having more meaningful work were less willing to leave their current jobs and organizations for higher paying opportunities. These patterns of results remained significant when controlling for demographic factors and differences in job characteristics. PMID:29085310

Meaningful Ways of Understanding and Measuring Change for People with Borderline Personality Disorder: A Thematic Analysis.

PubMed

McCusker, Louise; Turner, Marie-Louise; Pike, Georgina; Startup, Helen

2018-02-19

The effective treatment of Borderline Personality Disorder (BPD) presents healthcare providers with a significant challenge. The evidence base remains limited partially due to a lack of professional consensus and service user involvement regarding ways of measuring change. As a result, the limited evidence that is available draws on such a wide range of outcome measures, that comparison across treatment types is hindered, maintaining a lack of clarity regarding the clinical needs of this group. This investigation aimed to follow the National Institute of Clinical Excellence (NICE, 2009) research recommendations by asking service users about meaningful change within their recovery. This forms a starting point for the future development of a tailored outcome measure. Fifteen service users with a diagnosis of BPD participated in three focus groups across two specialist Personality Disorder services. The focus groups were analysed using Thematic Analysis. Two superordinate themes were synthesized from the data: (1) recovery to what?: 'How do you rewrite who you are?'; and (2) conditions for change. Each superordinate theme further consisted of three subordinate themes which elucidated the over-arching themes. This investigation highlights the complex nature of measuring change in people who have received a BPD diagnosis. Further research is needed to develop meaningful ways of measuring change according to the needs and priorities of people with BPD.

From differences in means between cases and controls to risk stratification: a business plan for biomarker development.

PubMed

Wentzensen, Nicolas; Wacholder, Sholom

2013-02-01

Researchers developing biomarkers for early detection can determine the potential for clinical benefit at early stages of development. We provide the theoretical background showing the quantitative connection between biomarker levels in cases and controls and clinically meaningful risk measures, as well as a spreadsheet for researchers to use in their own research. We provide researchers with tools to decide whether a test is useful, whether it needs technical improvement, whether it may work only in specific populations, or whether any further development is futile. The methods described here apply to any method that aims to estimate risk of disease based on biomarkers, clinical tests, genetics, environment, or behavior. Many efforts go into futile biomarker development and premature clinical testing. In many instances, predictions for translational success or failure can be made early, simply based on critical analysis of case–control data. Our article presents well-established theory in a form that can be appreciated by biomarker researchers. Furthermore, we provide an interactive spreadsheet that links biomarker performance with specific disease characteristics to evaluate the promise of biomarker candidates at an early stage.

Subjective binge eating with compensatory behaviors: a variant presentation of bulimia nervosa.

PubMed

Watson, Hunna J; Fursland, Anthea; Bulik, Cynthia M; Nathan, Paula

2013-03-01

To determine whether a variant bulimic-type presentation, whereby one meets criteria for bulimia nervosa (BN) except that binge eating episodes are not objectively large (i.e., "subjective bulimia nervosa," SBN), has comparable clinical severity to established eating disorders, particularly BN. Treatment-seeking adults with BN (N = 112), SBN (N = 28), anorexia nervosa restricting type (AN-R) (N = 45), and AN-binge/purge type (AN-B/P) (N = 24) were compared. Overall, SBN could not be meaningfully distinguished from BN. SBN and BN had equivalent eating pathology, depression and anxiety symptoms, low quality of life, impulsivity, Axis I comorbidity, and lifetime psychiatric history, and comparable clinical severity to AN-R and AN-B/P. Individuals with SBN, differing from BN only by the smaller size of their binge eating episodes, had a form of eating disorder comparable in clinical severity to threshold AN and BN and warranting clinical attention. Health professionals and the community require greater awareness of this variant to optimize detection, treatment-seeking, and outcomes. Copyright © 2012 Wiley Periodicals, Inc.

Clinical Decision Making in the Management of Patients With Cervicogenic Dizziness: A Case Series.

PubMed

Jung, Francis C; Mathew, Sherin; Littmann, Andrew E; MacDonald, Cameron W

2017-11-01

Study Design Case series. Background Although growing recognition of cervicogenic dizziness (CGD) is emerging, there is still no gold standard for the diagnosis of CGD. The purpose of this case series is to describe the clinical decision making utilized in the management of 7 patients presenting with CGD. Case Description Patients presenting with neck pain and accompanying subjective symptoms, including dizziness, unsteadiness, light-headedness, and visual disturbance, were selected. Clinical evidence of a temporal relationship between neck pain and dizziness, with or without sensorimotor disturbances, was assessed. Clinical decision making followed a 4-step process, informed by the current available best evidence. Outcome measures included the numeric rating scale for dizziness and neck pain, the Dizziness Handicap Inventory, Patient-Specific Functional Scale, and global rating of change. Outcomes Seven patients (mean age, 57 years; range, 31-86 years; 7 female) completed physical therapy management at an average of 13 sessions (range, 8-30 sessions) over a mean of 7 weeks. Clinically meaningful improvements were observed in the numeric rating scale for dizziness (mean difference, 5.7; 95% confidence interval [CI]: 4.0, 7.5), neck pain (mean difference, 5.4; 95% CI: 3.8, 7.1), and the Dizziness Handicap Inventory (mean difference, 32.6; 95% CI: 12.9, 52.2) at discontinuation. Patients also demonstrated overall satisfaction via the Patient-Specific Functional Scale (mean difference, 9) and global rating of change (mean, +6). Discussion This case series describes the physical therapist decision making, management, and outcomes in patients with CGD. Further investigation is warranted to develop a valid clinical decision-making guideline to inform management of patients with CGD. Level of Evidence Diagnosis, therapy, level 4. J Orthop Sports Phys Ther 2017;47(11):874-884. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7425.

The Effectiveness of Neurofeedback on Enhancing Cognitive Process Involved in Entrepreneurship Abilities among Primary School Students in District No. 3 Tehran.

PubMed

Rahmati, Narges; Rostami, Reza; Zali, Mohammad Reza; Nowicki, Stephen; Zarei, Jamilah

2014-10-01

The aim of this study is to investigate the entrepreneurial traits of school children in the city of Tehran. For this purpose, 48 students were selected with an average IQ between 90 and 119. Ranging from 7th to 12th grades, all the subjects were assessed using Nowicki-Strickland's Locus of Control Scale (N-SLCS), Torrance Tests of Creative Thinking (TTCT), and Hyperkinetic Syndrome Assessment Method (HKSD). The obtained results were then organized and categorized into three groups. One of the groups was randomly chosen as experimental and the other as the control group and the last play group. In this empirical study, the students received Sensory Motor Rhythm (SMR) and Beta neurofeedback for 20 sessions. The play group was assigned to play mind games for 20 sessions. At the same time, the control group received no experiments. After the end of the experiments, all the students in three groups were reassessed by Torrance Tests of Creative Thinking, Hyperkinetic Syndrome Assessment Method, and Nowicki-Strickland's Locus of Control Scale. The results from MANOVA showed that the neurofeedback group had demonstrated a meaningful change in creativity and locus of control while the adaptability of risk-taking was on a meaningful level for the experimental group. The results also indicate an improvement in creativity for the neurofeedback group in comparison with the play group on a 0.02 meaningful level. Similarly, the results suggest an improvement in creativity for the neurofeedback group on a 0.000 meaningful level in comparison with the control group. This is while the play group and the control group do not show any meaningful difference. The results also show an improvement in the internal locus of control for the neurofeedback group in comparison with the play group on a 0.032 meaningful level; while, it is meaningful on a 0.01 level for the neurofeedback group in comparison with the control group. The findings for the play group and control group do not show any meaningful difference. The paper concludes that neurofeedback training can be used for increasing the level of entrepreneurial traits in students.

Memory assessment and depression: testing for factor structure and measurement invariance of the Wechsler Memory Scale-Fourth Edition across a clinical and matched control sample.

PubMed

Pauls, Franz; Petermann, Franz; Lepach, Anja Christina

2013-01-01

Between-group comparisons are permissible and meaningfully interpretable only if diagnostic instruments are proved to measure the same latent dimensions across different groups. Addressing this issue, the present study was carried out to provide a rigorous test of measurement invariance. Confirmatory factor analyses were used to determine which model solution could best explain memory performance as measured by the Wechsler Memory Scale-Fourth Edition (WMS-IV) in a clinical depression sample and in healthy controls. Multigroup confirmatory factor analysis was conducted to evaluate the evidence for measurement invariance. A three-factor model solution including the dimensions of auditory memory, visual memory, and visual working memory was identified to best fit the data in both samples, and measurement invariance was partially satisfied. The results supported clinical utility of the WMS-IV--that is, auditory and visual memory performances of patients with depressive disorders are interpretable on the basis of the WMS-IV standardization data. However, possible differences in visual working memory functions between healthy and depressed individuals could restrict comparisons of the WMS-IV working memory index.

The prevalence, clinical correlates and structure of phobic fears in Han Chinese women with recurrent major depression.

PubMed

Yang, Fuzhong; Qiu, Jianyin; Zhao, Hongsu; Wang, Zhoubing; Tao, Danhong; Xiao, Xue; Niu, Qihui; Wang, Qian; Li, Yajuan; Guo, Liyang; Li, Jianying; Li, Kan; Xia, Jing; Wang, Lina; Shang, Xiaofang; Sang, Wenhua; Gan, Zhaoyu; He, Kangmei; Zhao, Xiaochuan; Tian, Tian; Xu, Dan; Gu, Danhua; Weng, Xiaoqin; Li, Haimin; Tian, Jing; Yang, Lijun; Li, Qiang; Yang, Qingzhen; Wang, Hui; Dang, Yamei; Dai, Lei; Cui, Yanping; Ye, Dong; Cao, Juling; Guo, Li; Kang, Zhen; Liu, Jimeng; Chen, Bin; Liu, Jinhua; Zhang, Jinling; Yang, Donglin; Jiao, Bin; Yu, Fengyu; Geng, Feng; Li, Ling; Yang, Haiying; Dai, Hong; Wang, Hongli; Liu, Caixing; Liu, Haijun; Peng, Longyan; Wang, Xiaoping; Wei, Shaojun; Liu, Xiaojuan; Li, Chang; Liu, Zhengrong; Zhang, Qiwen; Di, Dongchuan; Shi, Shenxun; Flint, Jonathan; Kendler, Kenneth S

2014-03-01

Phobic fears are common in the general population and among individuals with major depression (MD). We know little about the prevalence, clinical correlates, and structure of phobic fears in Chinese women with MD. We assessed 22 phobic fears in 6017 Han Chinese women with MD. We used exploratory factor analysis to examine the structure of these phobic fears. We examined the relationship between individual phobic fears and the severity of MD, neuroticism, comorbid panic disorder, generalized anxiety disorder and dysthymia using logistic regression models. The frequency of phobic fears ranged from 3.0% (eating in public) to 36.0% (snakes). Phobic fears were significantly associated with more severe MD, high neuroticism, and co-morbid panic disorder, generalized anxiety disorder and dysthymia. Our factor analysis suggested four underlying subgroups of phobic fears which differed in their clinical correlates, severity and patterns of comorbidity. Data were collected retrospectively through interview and recall bias may have affected the results. Phobic fears are correlated with comorbid MD and more severe MD. These phobic fears clearly subdivide into four subgroups that differ meaningfully from each other. Copyright © 2014 Elsevier B.V. All rights reserved.

The Pharmacokinetic Exposure to Fexofenadine is Volume‐Dependently Reduced in Healthy Subjects Following Oral Administration With Apple Juice

PubMed Central

Luo, J; Ohyama, T; Hashimoto, S; Hasunuma, T; Inoue, Y; Kotegawa, T; Ohashi, K; Uemura, N

2016-01-01

Pharmacokinetic exposures to fexofenadine (FEX) are reduced by apple juice (AJ); however, the relationship between the AJ volume and the degree of AJ‐FEX interaction has not been understood. In this crossover study, 10 healthy subjects received single doses of FEX 60 mg with different volumes (150, 300, and 600 mL) of AJ or water (control). To identify an AJ volume lacking clinically meaningful interaction, we tested a hypothesis that the 90% confidence interval (CI) for geometric mean ratio (GMR) of FEX AUCAJ/AUCwater is contained within a biocomparability bound of 0.5–2.0, with at least one tested volume of AJ. GMR (90% CI) of AUCAJ 150mL/AUCwater, AUCAJ 300mL/AUCwater, and AUCAJ 600mL/AUCwater were 0.903 (0.752–1.085), 0.593 (0.494–0.712), and 0.385 (0.321–0.462), respectively. While a moderate to large AJ‐FEX interaction is caused by a larger volumes of AJ (e.g., 300 to 600 mL), the effect of a small volume (e.g., 150 mL) appears to be not meaningful. PMID:27197662

Brief Report: Autism-like Traits are Associated With Enhanced Ability to Disembed Visual Forms.

PubMed

Sabatino DiCriscio, Antoinette; Troiani, Vanessa

2017-05-01

Atypical visual perceptual skills are thought to underlie unusual visual attention in autism spectrum disorders. We assessed whether individual differences in visual processing skills scaled with quantitative traits associated with the broader autism phenotype (BAP). Visual perception was assessed using the Figure-ground subtest of the Test of visual perceptual skills-3rd Edition (TVPS). In a large adult cohort (n = 209), TVPS-Figure Ground scores were positively correlated with autistic-like social features as assessed by the Broader autism phenotype questionnaire. This relationship was gender-specific, with males showing a correspondence between visual perceptual skills and autistic-like traits. This work supports the link between atypical visual perception and autism and highlights the importance in characterizing meaningful individual differences in clinically relevant behavioral phenotypes.

Social Determinants of Racial Disparities in CKD

PubMed Central

Norton, Jenna M.; Moxey-Mims, Marva M.; Eggers, Paul W.; Narva, Andrew S.; Star, Robert A.; Rodgers, Griffin P.

2016-01-01

Significant disparities in CKD rates and outcomes exist between black and white Americans. Health disparities are defined as health differences that adversely affect disadvantaged populations, on the basis of one or more health outcomes. CKD is the complex result of genetic and environmental factors, reflecting the balance of nature and nurture. Social determinants of health have an important role as environmental components, especially for black populations, who are disproportionately disadvantaged. Understanding the social determinants of health and appreciating the underlying differences associated with meaningful clinical outcomes may help nephrologists treat all their patients with CKD in an optimal manner. Altering the social determinants of health, although difficult, may embody important policy and research efforts, with the ultimate goal of improving outcomes for patients with kidney diseases, and minimizing the disparities between groups. PMID:27178804

Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report.

PubMed

Lu, William; Krellman, Jason W; Dijkers, Marcel P

2016-01-01

Individuals with traumatic brain injury (TBI) often develop sleep disorders post-injury. The most common one is insomnia, which can exacerbate other post-injury symptoms, including fatigue, impaired cognition, depression, anxiety, and pain. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a manualized treatment that effectively treats insomnia with secondary effects on cognition, mood, and pain in various populations. This paper reviews the use of CBT-I for three participants with TBI of different severities. Pre- and post-treatment assessments of insomnia, fatigue, depression, anxiety, and pain were conducted. Mood was further assessed at follow-up. Minimal clinically important difference (MCID) scores derived from the research literature were used to establish clinically meaningful symptom improvement on self-report questionnaires. The reduction in insomnia severity scores for all three participants were not large enough to be considered a clinically significant improvement following CBT-I, although trends toward improvement were observed. However, all participants showed clinically significant reductions in anxiety at post-treatment; the effects persisted for 2 participants at follow-up. Reductions in depression symptoms were observed for 2 participants at post-treatment, and treatment effects persisted for 1 participant at follow-up. One participant endorsed clinically significant improvements in fatigue and pain severity. We conclude that CBT-I may provide secondary benefits for symptoms commonly experienced by individuals with TBI, especially mood disturbances.

Systematic review and benchmarking of Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) in oncology.

PubMed

Solem, Caitlyn T; Kwon, Youngmin; Shah, Ruchit M; Aly, Abdalla; Botteman, Marc F

2018-02-05

The Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) has been used to evaluate the clinical benefits and risks of oncology treatments. However, limited information is available to interpret and contextualize Q-TWiST results. Areas covered: A systematic review of Q-TWiST literature was conducted to provide contextualizing benchmarks for future studies. 51 articles with 81 unique Q-TWiST comparisons were identified. The mean (95% CI) and median absolute Q-TWiST gains for treatment versus control arms were 2.78 (1.82-3.73) months and 2.20 months across all cancers, respectively. The mean (median) relative Q-TWiST gains were 7.8% (7.2%) across all cancers. Most (88%) studies reported positive gains. The percentage of studies with relative Q-TWiST gains ≥10% (ie, clinically important difference) and ≥15% (ie, clearly clinically important difference) were 40.0% and 22.7%, respectively. Expert commentary: The relevance of Q-TWiST in assessing net clinical benefits of cancer therapy has not diminished, despite an arguably low number of published studies. The interest in such assessment is highlighted by the recent emergence of oncology value frameworks. The Q-TWiST should be compelling to clinicians as it integrates clinical information (ie, toxicity, relapse/progression, and survival) and patient preferences for each of these states into a single meaningful index.

Making Each Other’s Daily Life: Nurse Assistants’ Experiences and Knowledge on Developing a Meaningful Daily Life in Nursing Homes

PubMed Central

James, Inger; Fredriksson, Carin; Wahlström, Catrin; Kihlgren, Annica; Blomberg, Karin

2014-01-01

Background: In a larger action research project, guidelines were generated for how a meaningful daily life could be developed for older persons. In this study, we focused on the nurse assistants’ (NAs) perspectives, as their knowledge is essential for a well-functioning team and quality of care. The aim was to learn from NAs’ experiences and knowledge about how to develop a meaningful daily life for older persons in nursing homes and the meaning NAs ascribe to their work. Methods: The project is based on Participatory and Appreciative Action and Reflection. Data were generated through interviews, participating observations and informal conversations with 27 NAs working in nursing homes in Sweden, and a thematic analysis was used. Result: NAs developed a meaningful daily life by sensing and finding the “right” way of being (Theme 1). They sense and read the older person in order to judge how the person was feeling (Theme 2). They adapt to the older person (Theme 3) and share their daily life (Theme 4). NAs use emotional involvement to develop a meaningful daily life for the older person and meaning in their own work (Theme 5), ultimately making each other’s daily lives meaningful. Conclusion: It was obvious that NAs based the development of a meaningful daily life on different forms of knowledge: the oreticaland practical knowledge, and practical wisdom, all of which are intertwined. These results could be used within the team to constitute a meaningful daily life for older persons in nursing homes. PMID:25246997

Fatigue as a Driver of Overall Quality of Life in Cancer Patients.

PubMed

McCabe, Ryan M; Grutsch, James F; Braun, Donald P; Nutakki, Swetha B

2015-01-01

This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain--a validated surrogate variable for overall cancer patient well-being. A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients' quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated.

Fatigue as a Driver of Overall Quality of Life in Cancer Patients

PubMed Central

McCabe, Ryan M.; Grutsch, James F.; Braun, Donald P.; Nutakki, Swetha B.

2015-01-01

Background This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain—a validated surrogate variable for overall cancer patient well-being. Methods A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Findings Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients’ quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. Interpretation By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated. PMID:26070133

Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

PubMed Central

Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

2014-01-01

Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

Hypoglycemia evaluation and reporting in diabetes: Importance for the development of new therapies.

PubMed

Klonoff, David C; Alexander Fleming, G; Muchmore, Douglas B; Frier, Brian M

2017-07-01

Hypoglycemia complicating diabetes therapy is well recognized to be an ever-present threat to patients, their families, providers, payers, and regulators. Despite this being widely acknowledged, the regulatory stance on hypoglycemia as an endpoint in clinical trials to support new product registration has not evolved in any meaningful way since the publication of a position paper by an American Diabetes Association (ADA) Workgroup in 2005. As the impact of hypoglycemia on persons affected by diabetes is of major importance when assessing new treatments, the historical position of regulatory agencies on hypoglycemia is reviewed with respect to product approvals. The purpose of this article is to present proposals for facilitating development of therapies that reduce hypoglycemia risk through (1) development of composite measures of benefit for regulatory endpoints and (2) facilitation of the fulfillment of an unmet clinical need for reducing hypoglycemia. In view of greater comprehension of the effects of hypoglycemia, coupled with improved methodology to assess its frequency, the authors recommend: (1) a numerical cut point of <54 mg/dl (<3.0 mmol/L) as a clinically relevant level with which to define meaningful hypoglycemia for trials of diabetes therapies; (2) utilization in clinical trials of mature glucose monitoring technologies for purposes of regulatory evaluation and clinical decision-making; and (3) development of primary efficacy endpoint composites that include hypoglycemia rates and glycemic control. Copyright © 2017 John Wiley & Sons, Ltd.

The Jensen and The Hunt and Sternberg Comments: From Penetrating to Absurd

ERIC Educational Resources Information Center

Templer, Donald I.; Arikawa, Hiroko

2006-01-01

We praised the comments of Jensen and regard most of the contentions of Hunt and Sternberg as absurd. It is ridiculous to question the validity of the skin color map and its application since meaningful group differences and meaningful correlations between temperature and skin color were found. It was inappropriate for Hunt and Sternberg to…

Sources of Meaningfulness in the Workplace: A Study in the US Hospitality Sector

ERIC Educational Resources Information Center

Dimitrov, Danielle

2012-01-01

Purpose: The purpose of this paper is to explore the sources of meaningfulness at the workplace, according to the perceptions of hospitality employees from different national cultures in one US-based hotel, based on Dimitrov's empirical study about the features of the humane organization. Design/methodology/approach: This was an exploratory…

Meaningful Learning with Mobile Devices: Pre-Service Class Teachers' Experiences of Mobile Learning in the Outdoors

ERIC Educational Resources Information Center

Kärki, Tomi; Keinänen, Heli; Tuominen, Anu; Hoikkala, Marianna; Matikainen, Eila; Maijala, Hanna

2018-01-01

The authors consider the use of mobile learning environment ActionTrack in teacher education. Pre-service class teachers' (N = 277) experiences of the mobile learning environment were measured with a 7-point Likert-scale questionnaire based on seven attributes of meaningful learning. Students' ratings for different attributes were analysed…

MotorBrain: A mobile app for the assessment of users' motor performance in neurology.

PubMed

Vianello, Andrea; Chittaro, Luca; Burigat, Stefano; Budai, Riccardo

2017-05-01

Human motor skills or impairments have been traditionally assessed by neurologists by means of paper-and-pencil tests or special hardware. More recently, technologies such as digitizing tablets and touchscreens have offered neurologists new assessment possibilities, but their use has been restricted to a specific medical condition, or to stylus-operated mobile devices. The objective of this paper is twofold. First, we propose a mobile app (MotorBrain) that offers six computerized versions of traditional motor tests, can be used directly by patients (with and without the supervision of a clinician), and aims at turning millions of smartphones and tablets available to the general public into data collection and assessment tools. Then, we carry out a study to determine whether the data collected by MotorBrain can be meaningful for describing aging in human motor performance. A sample of healthy participants (N= 133) carried out the motor tests using MotorBrain on a smartphone. Participants were split into two groups (Young, Old) based on their age (less than or equal to 30 years, greater than or equal to 50 years, respectively). The data collected by the app characterizes accuracy, reaction times, and speed of movement. It was analyzed to investigate differences between the two groups. The app does allow measuring differences in neuromotor performance. Data collected by the app allowed us to assess performance differences due to the aging of the neuromuscular system. Data collected through MotorBrain is suitable to make meaningful distinctions among different kinds of performance, and allowed us to highlight performance differences associated to aging. MotorBrain supports the building of a large database of neuromotor data, which can be used for normative purposes in clinical use. Copyright © 2017 Elsevier B.V. All rights reserved.

Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder.

PubMed

Husted, David S; Shapira, Nathan A; Murphy, Tanya K; Mann, Giselle D; Ward, Herbert E; Goodman, Wayne K

2007-01-01

Currently, there are limited published data evaluating the effects of tics on serotonin reuptake inhibitor (SRI) monotherapy responses in treating obsessive-compulsive disorder (OCD). One retrospective case-controlled analysis of OCD patients treated with SRI monotherapy showed lesser improvement in OCD symptoms in patients with tics than those without. However, more recently there were preliminary reports of OCD subjects treated with SRI monotherapy which did not demonstrate poorer response in subjects with tics or Tourette's Syndrome (TS). The specific aim of this study was to investigate whether the presence of comorbid chronic tics affected "clinically meaningful improvement" [McDougle, C.J., Goodman, W.K., Leckman, J.F., Barr, L.C., Heninger, G.R., Price, L.H., 1993. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. Journal of Clinical Psychopharmacology 13, 354-358] of OCD in an 8-week open-label trial of fluoxetine monotherapy. Seventy-four adult subjects (13 patients with comorbid chronic tics and 61 patients without tics) with a primary DSM-IV OCD diagnosis were treated with up to 40mg fluoxetine for 8 weeks and had at least one post-baseline evaluation. The results indicate that there was a significant response by time in both fluoxetine-with-tic subjects and fluoxetine-without-tic subjects. Additionally, there were 3 (23.0%) OCD subjects with tics who had clinically meaningful improvement versus 16 (26.2%) OCD subjects without tics that demonstrated similar levels of improvement. These findings indicate that OCD patients with or without chronic tic disorders did not have a differential response to an 8-week open-label trial of fluoxetine. Limitations include the relatively low number of tic subjects and the open-label nature of the study. Additional data are needed on how comorbid tics may affect SRI treatment response in OCD.

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. The first part (current issue) of this 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (next issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972618

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 2

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. In this 2-part series, the first part (previous issue) described the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (current issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972619

Sending memorable messages to the old: age differences in preferences and memory for advertisements.

PubMed

Fung, Helene H; Carstensen, Laura L

2003-07-01

Socioemotional selectivity theory holds that people of different ages prioritize different types of goals. As people age and increasingly perceive time as finite, they attach greater importance to goals that are emotionally meaningful. Because the goals that people pursue so centrally influence cognition, the authors hypothesize that persuasive messages, specifically advertisements, would be preferred and better remembered by older adults when they promise to help realize emotionally meaningful goals, whereas younger adults would not show this bias. The authors also predict that modifying time perspective would reduce age differences. Findings provide qualified support for each of these predictions.

Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

PubMed

Mühlebach, Stefan; Borchard, Gerrit; Yildiz, Selcan

2015-03-01

Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.

Gratitude and well being: the benefits of appreciation.

PubMed

Sansone, Randy A; Sansone, Lori A

2010-11-01

The word "gratitude" has a number of different meanings, depending on the context. However, a practical clinical definition is as follows-gratitude is the appreciation of what is valuable and meaningful to oneself; it is a general state of thankfulness and/or appreciation. The majority of empirical studies indicate that there is an association between gratitude and a sense of overall well being. However, there are several studies that indicate potential nuances in the relationship between gratitude and well being as well as studies with negative findings. In terms of assessing gratitude, numerous assessment measures are available. From a clinical perspective, there are suggested therapeutic exercises and techniques to enhance gratitude, and they appear relatively simple and easy to integrate into psychotherapy practice. However, the therapeutic efficacy of these techniques remains largely unknown. Only future research will clarify the many questions around assessment, potential benefits, and enhancement of gratitude.

Gratitude and Well Being

PubMed Central

Sansone, Lori A.

2010-01-01

The word “gratitude” has a number of different meanings, depending on the context. However, a practical clinical definition is as follows—gratitude is the appreciation of what is valuable and meaningful to oneself; it is a general state of thankfulness and/or appreciation. The majority of empirical studies indicate that there is an association between gratitude and a sense of overall well being. However, there are several studies that indicate potential nuances in the relationship between gratitude and well being as well as studies with negative findings. In terms of assessing gratitude, numerous assessment measures are available. From a clinical perspective, there are suggested therapeutic exercises and techniques to enhance gratitude, and they appear relatively simple and easy to integrate into psychotherapy practice. However, the therapeutic efficacy of these techniques remains largely unknown. Only future research will clarify the many questions around assessment, potential benefits, and enhancement of gratitude. PMID:21191529

The importance of parent and child opinion in detecting change in movement capabilities.

PubMed

Green, Dido; Wilson, Brenda N

2008-10-01

Children and parents can make valid judgments about movement difficulties, which aids in the screening and assessment of Developmental Coordination Disorder (DCD). When considering therapy outcomes, child and family-centred practice supports the inclusion of parent and child perspectives to reflect progress made in meaningful daily contexts. This paper describes an evaluation of the use of questionnaires for parents and children to measure change in motor performance. Questionnaires were administered to 43 children with DCD and their parents five times over two-anda-quarter years in conjunction with other clinical measures. Parent report, using the Developmental Coordination Disorder Questionnaire, correlated significantly with clinical measures of motor skill, whilst parent and child perceptions differed. Children's confidence and resilience may influence their opinions of their ability. These results raise questions of whose perspective of progress is most valid and relevant - the therapist's, child's or parent's?

[Electroencephalography (EEG) recording techniques and artifact detection in early premature babies].

PubMed

Wallois, F; Vecchierini, M-F; Héberlé, C; Walls-Esquivel, E

2007-01-01

EEG recording techniques in early premature babies are not very different from those used for full-term neonates. Here, we emphasise the most important points: asepsis precautions, full knowledge of the clinical data and drug therapies, the fundamental role of a well-trained technician in supervising the EEG recording and monitoring the baby. The best electrode positions, the most informative montages and their standardisation between neurophysiological laboratories, are suggested. Artifact detection constitutes an important aspect of EEG signal analysis in preterm babies of less than 30 weeks. It is obviously necessary to discriminate between meaningful information and artefacts. The complexity of the signal in neonates makes artifact detection difficult. We present some characteristic features and describe some methods for eliminating them. We underline the positive aspect of some artifacts and their clinical use. We emphasise the crucial role of the technicians.

Improving risk-stratification of Diabetes complications using temporal data mining.

PubMed

Sacchi, Lucia; Dagliati, Arianna; Segagni, Daniele; Leporati, Paola; Chiovato, Luca; Bellazzi, Riccardo

2015-01-01

To understand which factor trigger worsened disease control is a crucial step in Type 2 Diabetes (T2D) patient management. The MOSAIC project, funded by the European Commission under the FP7 program, has been designed to integrate heterogeneous data sources and provide decision support in chronic T2D management through patients' continuous stratification. In this work we show how temporal data mining can be fruitfully exploited to improve risk stratification. In particular, we exploit administrative data on drug purchases to divide patients in meaningful groups. The detection of drug consumption patterns allows stratifying the population on the basis of subjects' purchasing attitude. Merging these findings with clinical values indicates the relevance of the applied methods while showing significant differences in the identified groups. This extensive approach emphasized the exploitation of administrative data to identify patterns able to explain clinical conditions.

Should waist circumference be used to identify metabolic disorders than BMI in South Korea?

PubMed

Lee, S-K

2010-11-01

Although indicators of central obesity have been suggested as a better alternative to body mass index (BMI), yet mixed results exist. This study examined whether waist circumference (WC) was better in identifying metabolic disorders than BMI at two time points. This study used nationally representative 1998 and 2005 Korea National Health and Nutrition Examination Survey data sets. Odds ratios from logistic regressions and area under the curves (AUC) were calculated. BMI and WC showed similar level of odds ratios (1.1-1.6) to diabetes, hypertension, dyslipidemia and having two or three metabolic syndrome criteria. The AUC comparison, however, indicated that, in only women, WC was a better discriminator for diabetes, hypertension and having two or three metabolic syndrome criteria. No meaningful differences were found between 1998 and 2005. Prospective studies to weigh practical and clinical relevance are needed to assert the use of WC over BMI in clinical and public health settings.

Rigor in electronic health record knowledge representation: Lessons learned from a SNOMED CT clinical content encoding exercise.

PubMed

Monsen, Karen A; Finn, Robert S; Fleming, Thea E; Garner, Erin J; LaValla, Amy J; Riemer, Judith G

2016-01-01

Rigor in clinical knowledge representation is necessary foundation for meaningful interoperability, exchange and reuse of electronic health record (EHR) data. It is critical for clinicians to understand principles and implications of using clinical standards for knowledge representation within EHRs. To educate clinicians and students about knowledge representation and to evaluate their success of applying the manual lookups method for assigning Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) concept identifiers using formally mapped concepts from the Omaha System interface terminology. Clinicians who were students in a doctoral nursing program conducted 21 lookups for Omaha System terms in publicly available SNOMED CT browsers. Lookups were deemed successful if results matched exactly with the corresponding code from the January 2013 SNOMED CT-Omaha System terminology cross-map. Of the 21 manual lookups attempted, 12 (57.1%) were successful. Errors were due to semantic gaps differences in granularity and synonymy or partial term matching. Achieving rigor in clinical knowledge representation across settings, vendors and health systems is a globally recognized challenge. Cross-maps have potential to improve rigor in SNOMED CT encoding of clinical data. Further research is needed to evaluate outcomes of using of terminology cross-maps to encode clinical terms with SNOMED CT concept identifiers based on interface terminologies.

Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

PubMed

Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Baron, Ralf; Bellamy, Nicholas; Burke, Laurie B; Chappell, Amy; Chartier, Kevin; Cleeland, Charles S; Costello, Ann; Cowan, Penney; Dimitrova, Rozalina; Ellenberg, Susan; Farrar, John T; French, Jacqueline A; Gilron, Ian; Hertz, Sharon; Jadad, Alejandro R; Jay, Gary W; Kalliomäki, Jarkko; Katz, Nathaniel P; Kerns, Robert D; Manning, Donald C; McDermott, Michael P; McGrath, Patrick J; Narayana, Arvind; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Reeve, Bryce B; Rhodes, Thomas; Sampaio, Cristina; Simpson, David M; Stauffer, Joseph W; Stucki, Gerold; Tobias, Jeffrey; White, Richard E; Witter, James

2010-05-01

There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain. Copyright 2010 International Association for the Study of Pain. All rights reserved.

Concept mapping to promote meaningful learning, help relate theory to practice and improve learning self-efficacy in Asian mental health nursing students: A mixed-methods pilot study.

PubMed

Bressington, Daniel T; Wong, Wai-Kit; Lam, Kar Kei Claire; Chien, Wai Tong

2018-01-01

Student nurses are provided with a great deal of knowledge within university, but they can find it difficult to relate theory to nursing practice. This study aimed to test the appropriateness and feasibility of assessing Novak's concept mapping as an educational strategy to strengthen the theory-practice link, encourage meaningful learning and enhance learning self-efficacy in nursing students. This pilot study utilised a mixed-methods quasi-experimental design. The study was conducted in a University school of Nursing in Hong Kong. A total of 40 third-year pre-registration Asian mental health nursing students completed the study; 12 in the concept mapping (CM) group and 28 in the usual teaching methods (UTM) group. The impact of concept mapping was evaluated thorough analysis of quantitative changes in students' learning self-efficacy, analysis of the structure and contents of the concept maps (CM group), a quantitative measure of students' opinions about their reflective learning activities and content analysis of qualitative data from reflective written accounts (CM group). There were no significant differences in self-reported learning self-efficacy between the two groups (p=0.38). The concept mapping helped students identify their current level of understanding, but the increased awareness may cause an initial drop in learning self-efficacy. The results highlight that most CM students were able to demonstrate meaningful learning and perceived that concept mapping was a useful reflective learning strategy to help them to link theory and practice. The results provide preliminary evidence that the concept mapping approach can be useful to help mental health nursing students visualise their learning progress and encourage the integration of theoretical knowledge with clinical knowledge. Combining concept mapping data with quantitative measures and qualitative reflective journal data appears to be a useful way of assessing and understanding the effectiveness of concept mapping. Future studies should utilise a larger sample size and consider using the approach as a targeted intervention immediately before and during clinical learning placements. Copyright © 2017 Elsevier Ltd. All rights reserved.

Minimal clinically important difference in the fibromyalgia impact questionnaire.

PubMed

Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

2009-06-01

The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

An operational definition of a statistically meaningful trend.

PubMed

Bryhn, Andreas C; Dimberg, Peter H

2011-04-28

Linear trend analysis of time series is standard procedure in many scientific disciplines. If the number of data is large, a trend may be statistically significant even if data are scattered far from the trend line. This study introduces and tests a quality criterion for time trends referred to as statistical meaningfulness, which is a stricter quality criterion for trends than high statistical significance. The time series is divided into intervals and interval mean values are calculated. Thereafter, r(2) and p values are calculated from regressions concerning time and interval mean values. If r(2) ≥ 0.65 at p ≤ 0.05 in any of these regressions, then the trend is regarded as statistically meaningful. Out of ten investigated time series from different scientific disciplines, five displayed statistically meaningful trends. A Microsoft Excel application (add-in) was developed which can perform statistical meaningfulness tests and which may increase the operationality of the test. The presented method for distinguishing statistically meaningful trends should be reasonably uncomplicated for researchers with basic statistics skills and may thus be useful for determining which trends are worth analysing further, for instance with respect to causal factors. The method can also be used for determining which segments of a time trend may be particularly worthwhile to focus on.

Meaningful participation for children in the Dutch child protection system: A critical analysis of relevant provisions in policy documents.

PubMed

Bouma, Helen; López López, Mónica; Knorth, Erik J; Grietens, Hans

2018-05-01

Policymakers are increasingly focusing on the participation of children in the child protection system (CPS). However, research shows that actual practice still needs to be improved. Embedding children's participation in legislation and policy documents is one important prerequisite for achieving meaningful participation in child protection practice. In this study, the participation of children in the Dutch CPS under the new Youth Act 2015 is critically analyzed. National legislation and policy documents were studied using a model of "meaningful participation" based on article 12 of the UNCRC. Results show that the idea of children's participation is deeply embedded in the current Dutch CPS. However, Dutch policy documents do not fully cover the three dimensions of what is considered to be meaningful participation for children: informing, hearing, and involving. Furthermore, children's participation differs among the organizations included in the child protection chain. A clear overall policy concerning the participation of children in the Dutch CPS is lacking. The conclusions of this critical analysis of policy documents and the framework of meaningful participation presented may provide a basis for the embedding of meaningful participation for children in child protection systems of other countries. Copyright © 2018 Elsevier Ltd. All rights reserved.

The quality of registration of clinical trials.

PubMed

Viergever, Roderik F; Ghersi, Davina

2011-02-24

Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.

The Quality of Registration of Clinical Trials

PubMed Central

Viergever, Roderik F.; Ghersi, Davina

2011-01-01

Background Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. Methods and Findings A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Conclusions Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. PMID:21383991

Advances in the management of multiple sclerosis spasticity: recent clinical trials.

PubMed

Fernández, Oscar

2014-01-01

Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use. © 2014 S. Karger AG, Basel.

Chatting in the face of the eyewitness: The impact of extraneous cell-phone conversation on memory for a perpetrator.

PubMed

Marsh, John E; Patel, Krupali; Labonté, Katherine; Threadgold, Emma; Skelton, Faye C; Fodarella, Cristina; Thorley, Rachel; Battersby, Kirsty L; Frowd, Charlie D; Ball, Linden J; Vachon, François

2017-09-01

Cell-phone conversation is ubiquitous within public spaces. The current study investigates whether ignored cell-phone conversation impairs eyewitness memory for a perpetrator. Participants viewed a video of a staged crime in the presence of 1 side of a comprehensible cell-phone conversation (meaningful halfalogue), 2 sides of a comprehensible cell-phone conversation (meaningful dialogue), 1 side of an incomprehensible cell-phone conversation (meaningless halfalogue), or quiet. Between 24 and 28 hr later, participants freely described the perpetrator's face, constructed a single composite image of the perpetrator from memory, and attempted to identify the perpetrator from a sequential lineup. Further, participants rated the likeness of the composites to the perpetrator. Face recall and lineup identification were impaired when participants witnessed the staged crime in the presence of a meaningful halfalogue compared to a meaningless halfalogue, meaningful dialogue, or quiet. Moreover, likeness ratings showed that the composites constructed after ignoring the meaningful halfalogue resembled the perpetrator less than did those constructed after experiencing quiet or ignoring a meaningless halfalogue or a meaningful dialogue. The unpredictability of the meaningful content of the halfalogue, rather than its acoustic unexpectedness, produces distraction. The results are novel in that they suggest that an everyday distraction, even when presented in a different modality to target information, can impair the long-term memory of an eyewitness. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Sleep and pulmonary outcomes for clinical trials of airway plexiform neurofibromas in NF1.

PubMed

Plotkin, Scott R; Davis, Stephanie D; Robertson, Kent A; Akshintala, Srivandana; Allen, Julian; Fisher, Michael J; Blakeley, Jaishri O; Widemann, Brigitte C; Ferner, Rosalie E; Marcus, Carole L

2016-08-16

Plexiform neurofibromas (PNs) are complex, benign nerve sheath tumors that occur in approximately 25%-50% of individuals with neurofibromatosis type 1 (NF1). PNs that cause airway compromise or pulmonary dysfunction are uncommon but clinically important. Because improvement in sleep quality or airway function represents direct clinical benefit, measures of sleep and pulmonary function may be more meaningful than tumor size as endpoints in therapeutic clinical trials targeting airway PN. The Response Evaluation in Neurofibromatosis and Schwannomatosis functional outcomes group reviewed currently available endpoints for sleep and pulmonary outcomes and developed consensus recommendations for response evaluation in NF clinical trials. For patients with airway PNs, polysomnography, impulse oscillometry, and spirometry should be performed to identify abnormal function that will be targeted by the agent under clinical investigation. The functional group endorsed the use of the apnea hypopnea index (AHI) as the primary sleep endpoint, and pulmonary resistance at 10 Hz (R10) or forced expiratory volume in 1 or 0.75 seconds (FEV1 or FEV0.75) as primary pulmonary endpoints. The group defined minimum changes in AHI, R10, and FEV1 or FEV0.75 for response criteria. Secondary sleep outcomes include desaturation and hypercapnia during sleep and arousal index. Secondary pulmonary outcomes include pulmonary resistance and reactance measurements at 5, 10, and 20 Hz; forced vital capacity; peak expiratory flow; and forced expiratory flows. These recommended sleep and pulmonary evaluations are intended to provide researchers with a standardized set of clinically meaningful endpoints for response evaluation in trials of NF1-related airway PNs. © 2016 American Academy of Neurology.

Making Meaningful Decisions about Time, Workload and Pedagogy in the Digital Age: The Course Resource Appraisal Model

ERIC Educational Resources Information Center

Kennedy, Eileen; Laurillard, Diana; Horan, Bernard; Charlton, Patricia

2015-01-01

This article reports on a design-based research project to create a modelling tool to analyse the costs and learning benefits involved in different modes of study. The Course Resource Appraisal Model (CRAM) provides accurate cost-benefit information so that institutions are able to make more meaningful decisions about which kind of…

Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy.

PubMed

Mercuri, Eugenio; Darras, Basil T; Chiriboga, Claudia A; Day, John W; Campbell, Craig; Connolly, Anne M; Iannaccone, Susan T; Kirschner, Janbernd; Kuntz, Nancy L; Saito, Kayoko; Shieh, Perry B; Tulinius, Már; Mazzone, Elena S; Montes, Jacqueline; Bishop, Kathie M; Yang, Qingqing; Foster, Richard; Gheuens, Sarah; Bennett, C Frank; Farwell, Wildon; Schneider, Eugene; De Vivo, Darryl C; Finkel, Richard S

2018-02-15

Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 ( SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale-Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (≥3 points), an outcome that indicates improvement in at least two motor skills. In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by -1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P<0.001). This result prompted early termination of the trial. Results of the final analysis were consistent with results of the interim analysis. In the final analysis, 57% of the children in the nusinersen group as compared with 26% in the control group had an increase from baseline to month 15 in the HFMSE score of at least 3 points (P<0.001), and the overall incidence of adverse events was similar in the nusinersen group and the control group (93% and 100%, respectively). Among children with later-onset SMA, those who received nusinersen had significant and clinically meaningful improvement in motor function as compared with those in the control group. (Funded by Biogen and Ionis Pharmaceuticals; CHERISH ClinicalTrials.gov number, NCT02292537 .).

Case mix adjustment of health outcomes, resource use and process indicators in childbirth care: a register-based study.

PubMed

Mesterton, Johan; Lindgren, Peter; Ekenberg Abreu, Anna; Ladfors, Lars; Lilja, Monica; Saltvedt, Sissel; Amer-Wåhlin, Isis

2016-05-31

Unwarranted variation in care practice and outcomes has gained attention and inter-hospital comparisons are increasingly being used to highlight and understand differences between hospitals. Adjustment for case mix is a prerequisite for meaningful comparisons between hospitals with different patient populations. The objective of this study was to identify and quantify maternal characteristics that impact a set of important indicators of health outcomes, resource use and care process and which could be used for case mix adjustment of comparisons between hospitals. In this register-based study, 139 756 deliveries in 2011 and 2012 were identified in regional administrative systems from seven Swedish regions, which together cover 67 % of all deliveries in Sweden. Data were linked to the Medical birth register and Statistics Sweden's population data. A number of important indicators in childbirth care were studied: Caesarean section (CS), induction of labour, length of stay, perineal tears, haemorrhage > 1000 ml and post-partum infections. Sociodemographic and clinical characteristics deemed relevant for case mix adjustment of outcomes and resource use were identified based on previous literature and based on clinical expertise. Adjustment using logistic and ordinary least squares regression analysis was performed to quantify the impact of these characteristics on the studied indicators. Almost all case mix factors analysed had an impact on CS rate, induction rate and length of stay and the effect was highly statistically significant for most factors. Maternal age, parity, fetal presentation and multiple birth were strong predictors of all these indicators but a number of additional factors such as born outside the EU, body mass index (BMI) and several complications during pregnancy were also important risk factors. A number of maternal characteristics had a noticeable impact on risk of perineal tears, while the impact of case mix factors was less pronounced for risk of haemorrhage > 1000 ml and post-partum infections. Maternal characteristics have a large impact on care process, resource use and outcomes in childbirth care. For meaningful comparisons between hospitals and benchmarking, a broad spectrum of sociodemographic and clinical maternal characteristics should be accounted for.

Longitudinal numbers-needed-to-treat (NNT) for achieving various levels of analgesic response and improvement with etoricoxib, naproxen, and placebo in ankylosing spondylitis.

PubMed

Peloso, Paul M; Gammaitoni, Arnold; Smugar, Steven S; Wang, Hongwei; Moore, Andrew R

2011-07-18

Clinical analgesic trials typically report response as group mean results. However, research has shown that few patients are average and most have responses at the extremes. Moreover, group mean results do not convey response levels and thus have limited value in representing the benefit-risk at an individual level. Responder analyses and numbers-needed-to-treat (NNT) are considered more relevant for evaluating treatment response. We evaluated levels of analgesic response and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score improvement and the associated NNTs. This was a post-hoc analysis of a 6-week, randomized, double-blind study (N = 387) comparing etoricoxib 90 mg, etoricoxib 120 mg, naproxen 1000 mg, and placebo in AS. Spine pain and BASDAI were measured on a 100-mm visual analog scale. The number and percentage of patients achieving ≥30% and ≥50% improvement in both BASDAI and spine pain were calculated and used to determine the corresponding NNTs. Patients who discontinued from the study for any reason were assigned zero improvement beyond 7 days of the time of discontinuation. For etoricoxib 90 mg, etoricoxib 120 mg and naproxen 1000 mg, the NNTs at 6 weeks compared with placebo were 2.0, 2.0, and 2.7 respectively for BASDAI ≥30% improvement, and 3.2, 2.8, and 4.1 for ≥50% improvement. For spine pain, the NNTs were 1.9, 2.0, and 3.2, respectively, for ≥30% improvement, and 2.7, 2.5, and 3.7 for ≥50% improvement. The differences between etoricoxib and naproxen exceeded the limit of ±0.5 units described as a clinically meaningful difference for pain. Response rates and NNTs were generally similar and stable over 2, 4, and 6 weeks. For every 2 patients treated with etoricoxib, 1 achieved a clinically meaningful (≥30%) improvement in spine pain and BASDAI beyond that expected from placebo, whereas the corresponding values were approximately 1 in every 3 patients treated with naproxen. Use of NNTs and responder analyses provide additional, complementary information beyond population mean responses when assessing efficacy compared to placebo and amongst active therapies.

Clearing the smoke around medical marijuana.

PubMed

Ware, M A

2011-12-01

The hazy world of "medical marijuana" continues to cry out for clear data on which to base medical decision making and rational policy design. In this issue of Clinical Pharmacology & Therapeutics, Abrams and colleagues report that vaporized cannabis does not meaningfully affect opioid plasma levels and may even augment the efficacy of oxycodone and morphine in patients with chronic non-cancer pain. This Commentary considers the implications of this work for clinical practice and further research initiatives.

The categorisation of dysthymic disorder: can its constituents be meaningfully apportioned?

PubMed

Rhebergen, Didi; Graham, Rebecca; Hadzi-Pavlovic, Dusan; Stek, Max; Friend, Paul; Barrett, Melissa; Parker, Gordon

2012-12-20

Since its introduction in DSM-III, the validity of dysthymia has been debated. Our objective is to further examine the concept of dysthymia in an outpatient sample, and explore whether its constituents can be meaningfully apportioned. 318 patients attending the Black Dog Institute Depression Clinic were assessed by the Mini-International Neuropsychiatric Interview, and completed several self-report measures, in addition to a clinical assessment by an Institute psychiatrist. The characteristics of patients with major depressive disorder (MDD), dysthymic disorder and double depression were examined. Latent Class Analysis (LCA) and Latent Profile Analysis (LPA) were then conducted with the aim of detecting distinct classes based on depressive symptomatology and personality domains, respectively. Finally, clinicians' formulations of the study patients were examined. Depression groups mainly differed on parameters of severity. Although LCA and LPA analyses indicated the presence of distinct classes, these only moderately correlated with the MINI-diagnosed groups. Finally, there was evidence for considerable heterogeneity within clinicians' formulations of dysthymia. Inadequate sample numbers for various measures limited the power of the LPA and our sample was weighted to patients with a more severe depressive condition which may affect the detection of a distinct 'dysthymic' personality profile. Despite employing a variety of techniques, we were unable to obtain a clear homogeneous picture of dysthymia. Rather, there was evidence for a distinct heterogeneity in clinician-derived diagnoses. These findings allude to the questionable discriminant validity of dysthymia and may encourage future research and discussion on this important topic. Copyright © 2012 Elsevier B.V. All rights reserved.

Test-retest reliability and stability of N400 effects in a word-pair semantic priming paradigm.

PubMed

Kiang, Michael; Patriciu, Iulia; Roy, Carolyn; Christensen, Bruce K; Zipursky, Robert B

2013-04-01

Elicited by any meaningful stimulus, the N400 event-related potential (ERP) component is reduced when the stimulus is related to a preceding one. This N400 semantic priming effect has been used to probe abnormal semantic relationship processing in clinical disorders, and suggested as a possible biomarker for treatment studies. Validating N400 semantic priming effects as a clinical biomarker requires characterizing their test-retest reliability. We assessed test-retest reliability of N400 semantic priming in 16 healthy adults who viewed the same related and unrelated prime-target word pairs in two sessions one week apart. As expected, N400 amplitudes were smaller for related versus unrelated targets across sessions. N400 priming effects (amplitude differences between unrelated and related targets) were highly correlated across sessions (r=0.85, P<0.0001), but smaller in the second session due to larger N400s to related targets. N400 priming effects have high reliability over a one-week interval. They may decrease with repeat testing, possibly because of motivational changes. Use of N400 priming effects in treatment studies should account for possible magnitude decreases with repeat testing. Further research is needed to delineate N400 priming effects' test-retest reliability and stability in different age and clinical groups, and with different stimulus types. Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Facilitating Occupational Therapy Student Learning to Enhance Cross-Cultural Effectiveness

ERIC Educational Resources Information Center

Gilbertson, Barbara Carol Hooper

2012-01-01

Developing cultural awareness and effectiveness is critical to meaningful and successful occupational therapy practice and of concern to occupational therapists worldwide (World Federation of Occupational Therapists, 2010). Occupational therapy graduates, not fully representative of the demographics of the populations they will meet clinically,…

Toward Balancing the Goals of Legal Education.

ERIC Educational Resources Information Center

Rowles, James P.

1981-01-01

The boredom of law students in their second and third years raises questions about the meaningfulness and appropriateness of traditional courses and the place of clinical and interdisciplinary courses in the curriculum. Seven curriculum priorities were identified, among them: legal history, social sciences, economics, international law, and…

Weight Loss Five Years After Behavioral Treatment.

ERIC Educational Resources Information Center

Levitz, Leonard S.; And Others

The behaviorally-based weight control program conducted by Levitz and Jordan at the University of Pennsylvania and the Institute for Behavioral Education is tailored to patient needs and includes stimulus control, cognitive restructuring, and nutrition education. The success of patients in maintaining the clinically meaningful weight losses…

Minimal Clinically Important Difference of Berg Balance Scale in People With Multiple Sclerosis.

PubMed

Gervasoni, Elisa; Jonsdottir, Johanna; Montesano, Angelo; Cattaneo, Davide

2017-02-01

To identify the minimal clinically important difference (MCID) to define clinically meaningful patient's improvement on the Berg Balance Scale (BBS) in people with multiple sclerosis (PwMS) in response to rehabilitation. Cohort study. Neurorehabilitation institute. PwMS (N=110). This study comprised inpatients and outpatients who participated in research on balance and gait rehabilitation. All received 20 rehabilitation sessions with different intensities. Inpatients received daily treatments over a period of 4 weeks, while outpatients received 2 to 3 treatments per week for 10 weeks. An anchor-based approach using clinical global impression of improvement in balance (Activities-specific Balance Confidence [ABC] Scale) was used to determine the MCID of the BBS. The MCID was defined as the minimum change in the BBS total score (postintervention - preintervention) that was needed to perceive at least a 10% improvement on the ABC Scale. Receiver operating characteristic curves were used to define the cutoff of the optimal MCID of the BBS discriminating between improved and not improved subjects. The MCID for change on the BBS was 3 points for the whole sample, 3 points for the inpatients, and 2 points for the outpatients. The area under the curve was .65 for the whole sample, .64 for inpatients, and .68 for outpatients. The MCID for improvement in balance as measured by the BBS was 3 points, meaning that PwMS are likely to perceive that as a reproducible and clinically important change in their balance performance. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

[Autoantibody-associated autoimmune encephalitis and cerebellitis : Clinical presentation, diagnostic work-up and treatment].

PubMed

Lewerenz, J; Jarius, S; Wildemann, B; Wandinger, K-P; Leypoldt, F

2016-12-01

There is no other field of neurology where clinically relevant serological biomarkers have witnessed a surge in importance over the past decade resembling that in autoimmune encephalitis and cerebellitis. A multitude of newly discovered neuronal autoantibodies facilitate early diagnosis, estimation of prognosis, and therapeutic decision-making. However, this has led to growing uncertainty with regard to meaningful patient selection, the appropriate extent of testing, and management of seronegative cases. This review summarizes the essential aspects of the clinical presentation, diagnostic work-up, pathophysiology, and treatment of autoimmune encephalitis and cerebellitis.

Optimal neurocognitive, personality and behavioral measures for assessing impulsivity in cocaine dependence.

PubMed

LoBue, Christian; Cullum, C Munro; Braud, Jacqueline; Walker, Robrina; Winhusen, Theresa; Suderajan, Prabha; Adinoff, Bryon

2014-11-01

Impulsivity may underlie the poor treatment retention and high relapse rates observed in cocaine-dependent persons. However, observed differences in measures of impulsivity between cocaine-dependent and healthy control participants often do not reach clinical significance, suggesting that the clinical relevance of these differences may be limited. To examine which measures of impulsivity (i.e. self-report impulsivity, self-report personality, neurocognitive testing) best distinguish cocaine-dependent and healthy control participants (i.e. showing differences at least 1.5 standard deviations [SD] from controls). Optimal measures were considered to demonstrate sufficient classification accuracy. Sixty-five recently abstinent cocaine-dependent and 25 healthy control participants were assessed using select neurocognitive tests and self-report questionnaires including the NEO Personality Inventory-Revised (NEO-PI-R), Temperament and Character Inventory (TCI), Barratt Impulsiveness Scale (BIS-11a), and the Frontal Systems Behavior Scale (FrSBe). When corrected for years of education and gender, neurocognitive measures did not demonstrate clinically significant differences between cocaine-dependent and control participants. The personality measures TCI Purposefulness and Congruent Second Nature and NEO-PI-R Impulsiveness, and the self-rating measures FrSBe Disinhibition and BIS-11 Motor Impulsivity and Total successfully identified clinically meaningful elevations in impulsivity within cocaine-dependent participants (>1.5 SDs from controls). Furthermore, these measures achieved 84-93% accuracy in discriminating cocaine-dependent from control participants. Clinically significant neurocognitive impairment in cocaine-dependent participants was not observed in this sample. As the BIS-11 or FrSBe are brief to administer, accurate, and have been shown to predict treatment retention and relapse, these measures appear to be optimal, relative to the personality measures, for examining trait impulsivity in cocaine dependence.

Optimal neurocognitive, personality and behavioral measures for assessing impulsivity in cocaine dependence

PubMed Central

LoBue, Christian; Cullum, C. Munro; Braud, Jacqueline; Walker, Robrina; Winhusen, Theresa; Suderajan, Prabha; Adinoff, Bryon

2015-01-01

Background Impulsivity may underlie the poor treatment retention and high relapse rates observed in cocaine-dependent persons. However, observed differences in measures of impulsivity between cocaine-dependent and healthy control participants often do not reach clinical significance, suggesting that the clinical relevance of these differences may be limited. Objectives To examine which measures of impulsivity (i.e. self-report impulsivity, self-report personality, neurocognitive testing) best distinguish cocaine-dependent and healthy control participants (i.e. showing differences at least 1.5 standard deviations [SD] from controls). Optimal measures were considered to demonstrate sufficient classification accuracy. Methods Sixty-five recently abstinent cocaine-dependent and 25 healthy control participants were assessed using select neurocognitive tests and self-report questionnaires including the NEO Personality Inventory-Revised (NEO-PI-R), Temperament and Character Inventory (TCI), Barratt Impulsiveness Scale (BIS-11a), and the Frontal Systems Behavior Scale (FrSBe). Results When corrected for years of education and gender, neurocognitive measures did not demonstrate clinically significant differences between cocaine-dependent and control participants. The personality measures TCI Purposefulness and Congruent Second Nature and NEO-PI-R Impulsiveness, and the self-rating measures FrSBe Disinhibition and BIS-11 Motor Impulsivity and Total successfully identified clinically meaningful elevations in impulsivity within cocaine-dependent participants (>1.5 SDs from controls). Furthermore, these measures achieved 84–93% accuracy in discriminating cocaine-dependent from control participants. Conclusion Clinically significant neurocognitive impairment in cocaine-dependent participants was not observed in this sample. As the BIS-11 or FrSBe are brief to administer, accurate, and have been shown to predict treatment retention and relapse, these measures appear to be optimal, relative to the personality measures, for examining trait impulsivity in cocaine dependence. PMID:25083938

In vivo predictive release methods for medicated chewing gums.

PubMed

Gajendran, Jayachandar; Kraemer, Johannes; Langguth, Peter

2012-10-01

Understanding the performance of a drug product in vivo plays a key role in the development of meaningful in vitro drug release methodology. In case of functional chewing gums, the mode and the mechanism of release and the site of application differ significantly from other conventional solid oral dosage forms and require a special consideration to extract meaningful information from clinical studies. In the current study, suitable drug release methodology was developed to predict the in vivo performance of an investigated chewing gum product. Different parameters of the drug release testing apparatus described in the Ph. Eur. and Pharmeuropa were evaluated. Drug release data indicate that the parameters, chewing distance, chewing frequency and twisting motion, affect the drug release. Higher drug release was observed when the frequency was changed from 40 chews/min to 60 chews/min for apparatus A and B, as was the case for the twisting motion when changed from 20º to 40º for apparatus B. As far as the chewing distance is concerned, the release rate was in the following order; apparatus A: 0.3 mm > 0.5 mm > 0.7 mm; apparatus B: 1.4 mm > 1.6 mm > 1.8 mm. A suitable apparatus set-up for in vitro release testing was identified. The method will be useful for the establishment of in vitro in vivo correlations (IVIVC) for medicated chewing gums. Interchangeability of the apparatus for a product is not generally recommended without prior knowledge of the performance of the product, as the construction and principle of operation for the apparatus differ considerably. Copyright © 2012 John Wiley & Sons, Ltd.

The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients

PubMed Central

Ramírez, Jacqueline; Wu, Kehua; Janisch, Linda; Karrison, Theodore; House, Larry K.; Innocenti, Federico; Cohen, Ezra E. W.; Ratain, Mark J.

2011-01-01

Purpose Irinotecan and thalidomide are commonly administered antineoplastic drugs. Combination treatment may potentiate their antitumor effect and protect against irinotecan's intestinal toxicity. We investigated whether thalidomide can modulate the pharmacokinetics of irinotecan and metabolites. Methods The study employed a crossover design in which advanced solid tumor patients were randomized to two arms and treated with irinotecan 350 mg/m2 intravenously (IV) every 3 weeks and thalidomide orally (p.o.) 400 mg daily. Pharmacokinetic data when irinotecan was administered as a single agent in each arm were compared to data when the two study agents were co-administered using paired t tests. Eighty percent and 90% confidence intervals for the true difference were also calculated. Results The differences in pharmacokinetic parameters and metabolic markers after thalidomide administration were small and unlikely to be clinically significant. With the exception of APC T1/2, none of the upper confidence limits exceeds a 50% increase. Conclusions This study did not find any clinically meaningful effects of thalidomide on the pharmacokinetics of irinotecan or its metabolites. PMID:21861128

'Only a click away - DTC genetics for ancestry, health, love…and more: A view of the business and regulatory landscape'.

PubMed

Phillips, Andelka M

2016-03-01

I provide an overview of the current state of the direct-to-consumer (DTC) genetic testing industry and the challenges that different types of testing pose for regulation. I consider the variety of services currently available. These range from health and ancestry tests to those for child talent, paternity, and infidelity. In light of the increasingly blurred lines among different categories of testing, I call for a broader discussion of DTC governance. I stress the importance of shifting our attention from the activities of the most prominent companies to viewing DTC genetics as an industry with a wide spectrum of services and raising a wide variety of issues. These issues go beyond questions of clinical utility and validity to those of data security, personal identity, race, and the nature of the family. Robust DTC testing has the power to provide meaningful clinical, genealogical and even forensic information to those who want it; in unscrupulous hands, however, it also has the power to deceive and exploit. I consider approaches to help ensure the former and minimize the latter.

Cryotherapy decreases intraarticular temperature after ACL reconstruction.

PubMed

Glenn, Ronald Edward; Spindler, Kurt Paul; Warren, Todd Alan; McCarty, Eric Cleveland; Secic, Michelle

2004-04-01

Cryotherapy has been shown to decrease intraarticular temperature in all regions of the knee after arthroscopy. The purpose of our study was to determine if similar declines in intraarticular temperature were seen with the use of cryotherapy after anterior cruciate ligament reconstruction, a procedure which, unlike simple arthroscopy, produces postoperative hemarthrosis. Sixteen patients had intraarticular temperatures measured for 2 hours after anterior cruciate ligament reconstruction with cryotherapy instituted for only 1 of the 2 hours (eight patients for the first hour and eight patients for the second hour). Significant declines were seen in the suprapatellar pouch after either hour (-2.7 degrees C in Group 1, -2.7 degrees C in Group 2) but not in the lateral gutter. The difference between cryotherapy versus no cryotherapy in the first hour in the suprapatellar pouch was 6.0 degrees C, a clinically meaningful temperature difference. We hypothesize the swelling and hemarthrosis was more pronounced in the lateral gutter because of its dependent position and therefore blunted the effect of cryotherapy seen in the lateral gutter. Cooling of the intraarticular temperature should be considered in the clinical benefits of cryotherapy.

Same But Different: FIM Summary Scores May Mask Variability in Physical Functioning Profiles.

PubMed

Fisher, Steve R; Middleton, Addie; Graham, James E; Ottenbacher, Kenneth J

2018-02-08

To examine how similar summary scores of physical functioning using the FIM can represent different patient clinical profiles. Retrospective cohort study. Inpatient rehabilitation facilities. Medicare fee-for-service beneficiaries (N=765,441) discharged from inpatient rehabilitation. Not applicable. We used patients' scores on items of the FIM to quantify their level of independence on both self-care and mobility domains. We then identified patients as requiring "no physical assistance" at discharge from inpatient rehabilitation by using a rule and score-based approach. In those patients with FIM self-care and mobility summary scores suggesting no physical assistance needed, we found that physical assistance was in fact needed frequently in bathroom-related activities (eg, continence, toilet and tub transfers, hygiene, clothes management) and with stairs. It was not uncommon for actual performance to be lower than what may be suggested by a summary score of those domains. Further research is needed to create clinically meaningful descriptions of summary scores from combined performances on individual items of physical functioning. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Race, money and medicines.

PubMed

Bloche, M Gregg

2006-01-01

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaningfully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be "locked-in," once drugs or other therapies are approved. These incentives should be revisited.

Early Maladaptive Schemas and Cognitive Distortions in Adults with Morbid Obesity: Relationships with Mental Health Status.

PubMed

da Luz, Felipe Q; Sainsbury, Amanda; Hay, Phillipa; Roekenes, Jessica A; Swinbourne, Jessica; da Silva, Dhiordan C; da S Oliveira, Margareth

2017-02-28

Dysfunctional cognitions may be associated with unhealthy eating behaviors seen in individuals with obesity. However, dysfunctional cognitions commonly occur in individuals with poor mental health independently of weight. We examined whether individuals with morbid obesity differed with regard to dysfunctional cognitions when compared to individuals of normal weight, when mental health status was controlled for. 111 participants-53 with morbid obesity and 58 of normal weight-were assessed with the Mini-Mental State Examination, Young Schema Questionnaire, Cognitive Distortions Questionnaire, Depression, Anxiety and Stress Scale, and a Demographic and Clinical Questionnaire. Participants with morbid obesity showed higher scores in one (insufficient self-control/self-discipline) of 15 early maladaptive schemas and in one (labeling) of 15 cognitive distortions compared to participants of normal weight. The difference between groups for insufficient self-control/self-discipline was not significant when mental health status was controlled for. Participants with morbid obesity showed more severe anxiety than participants of normal weight. Our findings did not show clinically meaningful differences in dysfunctional cognitions between participants with morbid obesity or of normal weight. Dysfunctional cognitions presented by individuals with morbid obesity are likely related to their individual mental health and not to their weight.

Measuring changes in lipid and blood glucose values in the health and wellness program of Prudential Financial, Inc.

PubMed

Short, Meghan E; Goetzel, Ron Z; Young, Jared S; Kowlessar, Niranjana M; Liss-Levinson, Rivka C; Tabrizi, Maryam J; Roemer, Enid Chung; Sabatelli, Adriano A; Winick, Keith; Montes, Myrtho; Crighton, K Andrew

2010-08-01

To determine the effect of health promotion programs of Prudential Financial, Inc on biometric measures of blood lipids and glucose. Using actual biometric and self-reported measures of blood lipids and glucose values for the employees of Prudential Financial, Inc, we examined 1) the extent to which self-reported lipid and blood glucose values correlate to laboratory data, 2) whether self-reported and measured lipid values differ for physically active and sedentary employees, and 3) whether participation in a disease management program affects employees' lipid measures. We found significant differences in self-reported and measured total cholesterol and low-density lipoprotein values, although these differences and those for all lipid and blood glucose values were not clinically meaningful. Supporting previous clinical studies, high-density lipoprotein values were significantly higher for fitness center users compared with sedentary employees. Finally, disease management participants showed a significant reduction in total cholesterol and low-density lipoprotein during a 3-year period compared with nonparticipants. On average, the employees of Prudential Financial, Inc were aware of and accurately reported their lipid and blood glucose levels. Results from this study support the value of evaluating corporate health promotion programs, using measured biometric outcomes.

Detection of Interictal Discharges With Convolutional Neural Networks Using Discrete Ordered Multichannel Intracranial EEG.

PubMed

Antoniades, Andreas; Spyrou, Loukianos; Martin-Lopez, David; Valentin, Antonio; Alarcon, Gonzalo; Sanei, Saeid; Cheong Took, Clive

2017-12-01

Detection algorithms for electroencephalography (EEG) data, especially in the field of interictal epileptiform discharge (IED) detection, have traditionally employed handcrafted features, which utilized specific characteristics of neural responses. Although these algorithms achieve high accuracy, mere detection of an IED holds little clinical significance. In this paper, we consider deep learning for epileptic subjects to accommodate automatic feature generation from intracranial EEG data, while also providing clinical insight. Convolutional neural networks are trained in a subject independent fashion to demonstrate how meaningful features are automatically learned in a hierarchical process. We illustrate how the convolved filters in the deepest layers provide insight toward the different types of IEDs within the group, as confirmed by our expert clinicians. The morphology of the IEDs found in filters can help evaluate the treatment of a patient. To improve the learning of the deep model, moderately different score classes are utilized as opposed to binary IED and non-IED labels. The resulting model achieves state-of-the-art classification performance and is also invariant to time differences between the IEDs. This paper suggests that deep learning is suitable for automatic feature generation from intracranial EEG data, while also providing insight into the data.

A visual analytics approach for pattern-recognition in patient-generated data.

PubMed

Feller, Daniel J; Burgermaster, Marissa; Levine, Matthew E; Smaldone, Arlene; Davidson, Patricia G; Albers, David J; Mamykina, Lena

2018-06-13

To develop and test a visual analytics tool to help clinicians identify systematic and clinically meaningful patterns in patient-generated data (PGD) while decreasing perceived information overload. Participatory design was used to develop Glucolyzer, an interactive tool featuring hierarchical clustering and a heatmap visualization to help registered dietitians (RDs) identify associative patterns between blood glucose levels and per-meal macronutrient composition for individuals with type 2 diabetes (T2DM). Ten RDs participated in a within-subjects experiment to compare Glucolyzer to a static logbook format. For each representation, participants had 25 minutes to examine 1 month of diabetes self-monitoring data captured by an individual with T2DM and identify clinically meaningful patterns. We compared the quality and accuracy of the observations generated using each representation. Participants generated 50% more observations when using Glucolyzer (98) than when using the logbook format (64) without any loss in accuracy (69% accuracy vs 62%, respectively, p = .17). Participants identified more observations that included ingredients other than carbohydrates using Glucolyzer (36% vs 16%, p = .027). Fewer RDs reported feelings of information overload using Glucolyzer compared to the logbook format. Study participants displayed variable acceptance of hierarchical clustering. Visual analytics have the potential to mitigate provider concerns about the volume of self-monitoring data. Glucolyzer helped dietitians identify meaningful patterns in self-monitoring data without incurring perceived information overload. Future studies should assess whether similar tools can support clinicians in personalizing behavioral interventions that improve patient outcomes.

You Don’t See What I See: Individual Differences in the Perception of Meaning from Visual Stimuli

PubMed Central

Partos, Timea R.; Cropper, Simon J.; Rawlings, David

2016-01-01

Everyone has their own unique version of the visual world and there has been growing interest in understanding the way that personality shapes one’s perception. Here, we investigated meaningful visual experiences in relation to the personality dimension of schizotypy. In a novel approach to this issue, a non-clinical sample of subjects (total n = 197) were presented with calibrated images of scenes, cartoons and faces of varying visibility embedded in noise; the spatial properties of the images were constructed to mimic the natural statistics of the environment. In two experiments, subjects were required to indicate what they saw in a large number of unique images, both with and without actual meaningful structure. The first experiment employed an open-ended response paradigm and used a variety of different images in noise; the second experiment only presented a series of faces embedded in noise, and required a forced-choice response from the subjects. The results in all conditions indicated that a high positive schizotypy score was associated with an increased tendency to perceive complex meaning in images comprised purely of random visual noise. Individuals high in positive schizotypy seemed to be employing a looser criterion (response bias) to determine what constituted a ‘meaningful’ image, while also being significantly less sensitive at the task than those low in positive schizotypy. Our results suggest that differences in perceptual performance for individuals high in positive schizotypy are not related to increased suggestibility or susceptibility to instruction, as had previously been suggested. Instead, the observed reductions in sensitivity along with increased response bias toward seeing something that is not there, indirectly implicated subtle neurophysiological differences associated with the personality dimension of schizotypy, that are theoretically pertinent to the continuum of schizophrenia and hallucination-proneness. PMID:26954696

Effects of desmopressin (DDAVP) on memory impairment following electroconvulsive therapy (ECT).

PubMed

Abdollahian, Ebrahim; Sargolzaee, Mohammad R; Hajzade, Moosareza; Mohebbi, Mohammad D; Javanbakht, Arash

2004-06-01

Memory impairment is a common adverse effect of electroconvulsive therapy (ECT). Studies on animals and humans suggest that vasopressin improves the cognitive function, and positive effects of desmopressin on memory and learning have been reported. This research was performed for evaluation of the effects of desmopressin in the prevention of memory impairment following ECT. This randomized, double-blind controlled clinical trial with placebo administration was performed on 50 patients with psychiatric disorders who were candidates for ECT. Subjects in the case group received 60 µm of intranasal desmopressin daily (in three doses of 20 µm). For the control group 0.9% saline solution was administered in the same way. Memory function was evaluated using Wechsler's Memory Scale three times a week (the first time before the start of ECT and the second and third times after the third and sixth sessions, respectively). Results were analyzed by t-test and Paired t-test. The mean age of patients was 29 years (range 20-40). During the course of ECT, patients in the control group demonstrated a meaningful decrease in memory scores (from a base score of 80.15-75.45 in the second test and 72.60 in the third test). Despite this, a meaningful increase in memory scores was observed during the treatment with desmopressin in the case group (from a base score of 73.27-75.70 and 79.13 in the second and the third tests, respectively). There was a meaningful difference between the two groups (P < 0.0001). This study confirms the protective effect of desmopressin against memory impairment. The results confirm that memory impairment is a common side-effect of ECT and suggest that desmopressin may prevent ECT-induced memory impairment by its effects on memory and the learning process.

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.

Effect of State-mandated Insurance Coverage on Accrual to Community Cancer Clinical Trials

PubMed Central

Ellis, Shellie D.; Carpenter, William R.; Minasian, Lori M.; Weiner, Bryan J.

2012-01-01

Thirty-five U.S. states and territories have implemented policies requiring insurers to cover patient care costs in the context of cancer clinical trials; however, evidence of the effectiveness of these policies is limited. This study assesses the impact of state insurance mandates on clinical trial accrual among community-based practices participating in the NCI Community Clinical Oncology Program (CCOP), which enrolls approximately one-third of all NCI cancer trial participants. We analyzed CCOP clinical trial enrollment over 17 years in 37 states, 14 of which implemented coverage policies, using fixed effects least squares regression to estimate the effect of state policies on trial accrual among community providers, controlling for state and CCOP differences in capacity to recruit. Of 91 CCOPs active during this time, 28 were directly affected by coverage mandates. Average recruitment per CCOP between 1991 and 2007 was 95.1 participants per year (SD = 55.8). CCOPs in states with a mandate recruited similar numbers of participants compared to states without a mandate. In multivariable analysis, treatment trial accrual among CCOPs in states that had implemented a coverage mandate, was not statistically different than accrual among CCOPs in states that did not implement a coverage mandate (β = 2.95, p = 0.681). State mandates did not appear to confer a benefit in terms of CCOP clinical trial accrual. State policies vary in strength, which may have diluted their effect on accrual. Nonetheless, policy mandates alone may not have a meaningful impact on participation in clinical trials in these states. PMID:22683991

False memories, negative affects, and psychic reality: the role of extra-clinical data in psychoanalysis.

PubMed

Good, Michael I; Dayand, Max; Rowell, Eve

2005-12-01

Psychoanalysis as a treatment originated in the idea that neurosis is related to the ways in which individual psychic reality departs from actuality. Psychic reality includes memories, beliefs and their associated affects and fantasies connected with an individual's experience of the inner and outer world. The psychoanalytic determination of what meaningful memories or beliefs are inaccurate, distorted or false ordinarily relies upon principles of intra-clinical validation. By itself, however, intra-clinical validation is subject to limitations and pitfalls that conviction alone about what is actual cannot circumvent. Despite this fact, there are remarkably few analytic case reports demonstrating false or significantly distorted memories through the use of data obtained from outside the consulting room. This paucity of reports may be related, at least in part, to the belief that the use of extra-clinical data is essentially unanalytic or supports resistance. Based on the views that (a) psychic reality cannot be regarded as exclusively subjective or objective but is inherently both; and that (b) a goal of analysis is to achieve a different, acceptable and more accurate view of reality, the authors report a clinical case involving a confirmably false pivotal memory and its associated negative affects. They discuss theoretical and technical considerations in utilizing extra-clinical data during the treatment process.

An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder

PubMed Central

Algorta, Guillermo Perez; Youngstrom, Eric A.; Phelps, James; Jenkins, Melissa M.; Kogos, Jennifer L.; Findling, Robert L.

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient settings. Families (N=273) completed family history, rating scales, MINI and KSADS interviews about youths 5–18 (median=11) years presenting to an outpatient clinic. Primary caregivers completed a half page Family Index of Risk for Mood issues (FIRM). All families completed the FIRM quickly and easily. Most (78%) reported 1+ relatives having history of mood or substance issues, M=3.7 (SD=3.3). A simple sum of familial mood issues discriminated cases with PBD from all other cases, AUROC=.63, p=.006. FIRM scores were specific to youth mood disorder and not ADHD or disruptive behavior disorder. FIRM scores significantly improved the detection of PBD even controlling for rating scales. No subset of family risk items performed better than the total. Family history information showed clinically meaningful discrimination of PBD. Two different approaches to clinical interpretation showed validity in these clinically realistic data. Inexpensive and clinically practical methods of gathering family history can help to improve the detection of PBD. PMID:22800090

Management Control Systems and Clinical Experience of Managers in Public Hospitals

PubMed Central

Naranjo-Gil, David

2018-01-01

Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector. PMID:29673192

Management Control Systems and Clinical Experience of Managers in Public Hospitals.

PubMed

Lunkes, Rogério Joao; Naranjo-Gil, David; Lopez-Valeiras, Ernesto

2018-04-17

Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector.

The Effectiveness of Neurofeedback on Enhancing Cognitive Process Involved in Entrepreneurship Abilities among Primary School Students in District No. 3 Tehran

PubMed Central

Rahmati, Narges; Rostami, Reza; Zali, Mohammad Reza; Nowicki, Stephen; Zarei, Jamilah

2014-01-01

Introduction: The aim of this study is to investigate the entrepreneurial traits of school children in the city of Tehran. Methods: For this purpose, 48 students were selected with an average IQ between 90 and 119. Ranging from 7th to 12th grades, all the subjects were assessed using Nowicki-Strickland’s Locus of Control Scale (N-SLCS), Torrance Tests of Creative Thinking (TTCT), and Hyperkinetic Syndrome Assessment Method (HKSD). The obtained results were then organized and categorized into three groups. One of the groups was randomly chosen as experimental and the other as the control group and the last play group. In this empirical study, the students received Sensory Motor Rhythm (SMR) and Beta neurofeedback for 20 sessions. The play group was assigned to play mind games for 20 sessions. At the same time, the control group received no experiments. After the end of the experiments, all the students in three groups were reassessed by Torrance Tests of Creative Thinking, Hyperkinetic Syndrome Assessment Method, and Nowicki-Strickland’s Locus of Control Scale. Results: The results from MANOVA showed that the neurofeedback group had demonstrated a meaningful change in creativity and locus of control while the adaptability of risk-taking was on a meaningful level for the experimental group. The results also indicate an improvement in creativity for the neurofeedback group in comparison with the play group on a 0.02 meaningful level. Similarly, the results suggest an improvement in creativity for the neurofeedback group on a 0.000 meaningful level in comparison with the control group. This is while the play group and the control group do not show any meaningful difference. The results also show an improvement in the internal locus of control for the neurofeedback group in comparison with the play group on a 0.032 meaningful level; while, it is meaningful on a 0.01 level for the neurofeedback group in comparison with the control group. Discussion: The findings for the play group and control group do not show any meaningful difference. The paper concludes that neurofeedback training can be used for increasing the level of entrepreneurial traits in students. PMID:27284392

MMPI Profiles of Adolescents Charged with Homicide.

ERIC Educational Resources Information Center

Cornell, Dewey G.; And Others

Violent individuals are a heterogeneous group, making it unrealistic to think that a single psychological profile can classify them. Adolescents (N=72) at the Michigan Center for Forensic Psychiatry who had committed homicides were studied in an effort to distinguish clinically meaningful subtypes based on the motives and circumstance of their…

The Structure and Function of Biological Networks

ERIC Educational Resources Information Center

Wu, Daniel Duanqing

2010-01-01

Biology has been revolutionized in recent years by an explosion in the availability of data. Transforming this new wealth of data into meaningful biological insights and clinical breakthroughs requires a complete overhaul both in the questions being asked and the methodologies used to answer them. A major challenge in organizing and understanding…

Self-Entrustment: How Trainees' Self-Regulated Learning Supports Participation in the Workplace

ERIC Educational Resources Information Center

Sagasser, Margaretha H.; Kramer, Anneke W. M.; Fluit, Cornelia R. M. G.; van Weel, Chris; van der Vleuten, Cees P. M.

2017-01-01

Clinical workplaces offer postgraduate trainees a wealth of opportunities to learn from experience. To promote deliberate and meaningful learning self-regulated learning skills are foundational. We explored trainees' learning activities related to patient encounters to better understand what aspects of self-regulated learning contribute to…

Personality Subtypes among Driving-While-Intoxicated Offenders: Relationship to Drinking Behavior and Driving Risk.

ERIC Educational Resources Information Center

Donovan, Dennis M.; Marlatt, G. Alan

1982-01-01

Investigated the empirical derivation of clinically and theoretically meaningful subtypes among males arrested for driving while intoxicated. Five subtypes were defined through cluster analysis of driving--attitudinal, personality, and hostility measures. Two subtypes were found to have particularly high levels of risk-enhancing traits. (Author)

Relational Reasoning in Medical Education: Patterns in Discourse and Diagnosis

ERIC Educational Resources Information Center

Dumas, Denis; Alexander, Patricia A.; Baker, Lisa M.; Jablansky, Sophie; Dunbar, Kevin N.

2014-01-01

Relational reasoning, which has been defined as the ability to discern meaningful patterns within any informational stream, is a foundational cognitive ability associated with education, including in scientific domains. This study entailed the analysis of instructional conversations in which an attending clinical neurologist and his team of…

Facial Structure Analysis Separates Autism Spectrum Disorders into Meaningful Clinical Subgroups

ERIC Educational Resources Information Center

Obafemi-Ajayi, Tayo; Miles, Judith H.; Takahashi, T. Nicole; Qi, Wenchuan; Aldridge, Kristina; Zhang, Minqi; Xin, Shi-Qing; He, Ying; Duan, Ye

2015-01-01

Varied cluster analysis were applied to facial surface measurements from 62 prepubertal boys with essential autism to determine whether facial morphology constitutes viable biomarker for delineation of discrete Autism Spectrum Disorders (ASD) subgroups. Earlier study indicated utility of facial morphology for autism subgrouping (Aldridge et al. in…

Negative and Atypical Story Content Themes Depicted by Children with Behaviour Problems

ERIC Educational Resources Information Center

Wan, Ming Wai; Green, Jonathan

2010-01-01

Background: Specific thematic content arising from children's doll play is often considered to give clinically meaningful information regarding their mental state, but has received little systematic enquiry. This exploratory study examined the negative and atypical content themes in the attachment story narratives of children with behaviour…

Thinking in Music from the Very Beginning: Introducing an After-School Band Project

ERIC Educational Resources Information Center

Sindberg, Laura K.

2016-01-01

This article describes a collaborative clinical field experience initiative conceived to provide meaningful fieldwork for preservice music educators, musically engage underserved students in a high-poverty school, and include instruction on composition and improvisation. The author chronicles the planning, implementation, and subsequent revisions…

Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference

PubMed Central

Selvin, Elizabeth

2016-01-01

Studies that have compared HbA1c levels by race have consistently demonstrated higher HbA1c levels in African Americans than in whites. These racial differences in HbA1c have not been explained by measured differences in glycemia, sociodemographic factors, clinical factors, access to care, or quality of care. Recently, a number of nonglycemic factors and several genetic polymorphisms that operate through nonglycemic mechanisms have been associated with HbA1c. Their distributions across racial groups and their impact on hemoglobin glycation need to be systematically explored. Thus, on the basis of evidence for racial differences in HbA1c, current clinical guidelines from the American Diabetes Association state: “It is important to take…race/ethnicity…into consideration when using the A1C to diagnose diabetes.” However, it is not clear from the guidelines how this recommendation might be actualized. So, the critical question is not whether racial differences in HbA1c exist between African Americans and whites; the important question is whether the observed differences in HbA1c level are clinically meaningful. Therefore, given the current controversy, we provide a Point-Counterpoint debate on this issue. In the preceding point narrative, Dr. Herman provides his argument that the failure to acknowledge that HbA1c might be a biased measure of average glycemia and an unwillingness to rigorously investigate this hypothesis will slow scientific progress and has the potential to do great harm. In the counterpoint narrative below, Dr. Selvin argues that there is no compelling evidence for racial differences in the validity of HbA1c as a measure of hyperglycemia and that race is a poor surrogate for differences in underlying causes of disease risk. —William T. Cefalu Editor in Chief, Diabetes Care PMID:27457637

Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue.

PubMed

Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A; Christodoulou, Christopher; Broderick, Joan E

2014-04-01

This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. One-hundred women completed daily diaries and weekly PROMIS assessments over 4weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps<.0001) and post-menstrual (ps<.0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

Recovery capital pathways: Modelling the components of recovery wellbeing.

PubMed

Cano, Ivan; Best, David; Edwards, Michael; Lehman, John

2017-12-01

In recent years, there has been recognition that recovery is a journey that involves the growth of recovery capital. Thus, recovery capital has become a commonly used term in addiction treatment and research yet its operationalization and measurement has been limited. Due to these limitations, there is little understanding of long-term recovery pathways and their clinical application. We used the data of 546 participants from eight different recovery residences spread across Florida, USA. We calculated internal consistency for recovery capital and wellbeing, then assessed their factor structure via confirmatory factor analysis. The relationships between time, recovery barriers and strengths, wellbeing and recovery capital, as well as the moderating effect of gender, were estimated using structural equations modelling. The proposed model obtained an acceptable fit (χ 2 (141, N=546)=533.642, p<0.001; CMIN/DF=3.785; CFI=0.915; TLI=0.896; RMSEA=0.071). Findings indicate a pathway to recovery capital that involves greater time in residence ('retention'), linked to an increase in meaningful activities and a reduction in barriers to recovery and unmet needs that, in turn, promote recovery capital and positive wellbeing. Gender differences were observed. We tested the pathways to recovery for residents in the recovery housing population. Our results have implications not only for retention as a predictor of sustained recovery and wellbeing but also for the importance of meaningful activities in promoting recovery capital and wellbeing. Copyright © 2017 Elsevier B.V. All rights reserved.

HIT: time to end behavioral health discrimination.

PubMed

Rosenberg, Linda

2012-10-01

While the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009, provided $20.6 billion for incentive payments to support the adoption and meaningful use of health information technology (HIT), behavioral health organizations were not eligible to receive facility payments. The consequences of excluding behavioral health from HIT incentive payments are found in the results of the "HIT Adoption and Meaningful Use Readiness in Community Behavioral Health" survey. The survey found that only 2% of community behavioral health organizations are able to meet federal meaningful use (MU) requirements-compare this to the 27% of Federally Qualified Health Centers and 20% of hospitals that already meet some level of MU requirements. Behavioral health organizations, serving more than eight million adults, children, and families with mental illnesses and addiction disorders, are ready and eager to adopt HIT to meet the goals of better healthcare, better health, and lower costs. But reaching these goals may prove impossible unless behavioral health achieves "parity" within healthcare and receives resources for the adoption of HIT.

Identifying models of HIV care and treatment service delivery in Tanzania, Uganda, and Zambia using cluster analysis and Delphi survey.

PubMed

Tsui, Sharon; Denison, Julie A; Kennedy, Caitlin E; Chang, Larry W; Koole, Olivier; Torpey, Kwasi; Van Praag, Eric; Farley, Jason; Ford, Nathan; Stuart, Leine; Wabwire-Mangen, Fred

2017-12-06

Organization of HIV care and treatment services, including clinic staffing and services, may shape clinical and financial outcomes, yet there has been little attempt to describe different models of HIV care in sub-Saharan Africa (SSA). Information about the relative benefits and drawbacks of different models could inform the scale-up of antiretroviral therapy (ART) and associated services in resource-limited settings (RLS), especially in light of expanded client populations with country adoption of WHO's test and treat recommendation. We characterized task-shifting/task-sharing practices in 19 diverse ART clinics in Tanzania, Uganda, and Zambia and used cluster analysis to identify unique models of service provision. We ran descriptive statistics to explore how the clusters varied by environmental factors and programmatic characteristics. Finally, we employed the Delphi Method to make systematic use of expert opinions to ensure that the cluster variables were meaningful in the context of actual task-shifting of ART services in SSA. The cluster analysis identified three task-shifting/task-sharing models. The main differences across models were the availability of medical doctors, the scope of clinical responsibility assigned to nurses, and the use of lay health care workers. Patterns of healthcare staffing in HIV service delivery were associated with different environmental factors (e.g., health facility levels, urban vs. rural settings) and programme characteristics (e.g., community ART distribution or integrated tuberculosis treatment on-site). Understanding the relative advantages and disadvantages of different models of care can help national programmes adapt to increased client load, select optimal adherence strategies within decentralized models of care, and identify differentiated models of care for clients to meet the growing needs of long-term ART patients who require more complicated treatment management.

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes

PubMed Central

Chin, William Wei Lim; Wieschowski, Susanne; Prokein, Jana; Illig, Thomas

2016-01-01

Modern approaches for research with human biospecimens employ a variety of substantially different types of ethics approval and informed consent. In most cases, standard ethics reporting such as “consent and approval was obtained” is no longer meaningful. A structured analysis of 120 biospecimen studies recently published in top journals revealed that more than 85% reported on consent and approval, but in more than 90% of cases, this reporting was insufficient and thus potentially misleading. Editorial policies, reporting guidelines, and material transfer agreements should include recommendations for meaningful ethics reporting in biospecimen research. Meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research. PMID:27483445

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

PubMed

Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K; Valentine, James E; Roberts, Jamie N

2018-03-01

To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM): Design and Implementation of a Prospective/Retrospective Rolling Cohort Study

PubMed Central

Unger, Elizabeth R.; Lin, Jin-Mann S.; Tian, Hao; Natelson, Benjamin H.; Lange, Gudrun; Vu, Diana; Blate, Michelle; Klimas, Nancy G.; Balbin, Elizabeth G.; Bateman, Lucinda; Allen, Ali; Lapp, Charles W.; Springs, Wendy; Kogelnik, Andreas M.; Phan, Catrina C.; Danver, Joan; Podell, Richard N.; Fitzpatrick, Trisha; Peterson, Daniel L.; Gottschalk, C. Gunnar; Rajeevan, Mangalathu S.

2017-01-01

In the Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM), we relied on expert clinician diagnoses to enroll patients from 7 specialty clinics in the United States in order to perform a systematic collection of data on measures of myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS). Healthy persons and those with other illnesses that share some features with ME/CFS were enrolled in comparison groups. The major objectives were to: 1) use standardized questionnaires to measure illness domains of ME/CFS and to evaluate patient heterogeneity overall and between clinics; 2) describe the course of illness, identify the measures that best correlate with meaningful clinical differences, and assess the performances of questionnaires as patient/person-reported outcome measures; 3) describe prescribed medications, orders for laboratory and other tests, and management tools used by expert clinicians to care for persons with ME/CFS; 4) collect biospecimens for future hypothesis testing and for evaluation of morning cortisol profiles; and 5) identify measures that best distinguish persons with ME/CFS from those in the comparison groups and detect subgroups of persons with ME/CFS who may have different underlying causes. Enrollment began in 2012 and is planned to continue in multiple stages through 2017. We present the MCAM methods in detail, along with an initial description of the 471 patients with ME/CFS who were enrolled in stage 1. PMID:28338983

Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis.

PubMed

Nathan, Steven D; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; du Bois, Roland M; Fagan, Elizabeth A; Fishman, Robert S; Glaspole, Ian; Glassberg, Marilyn K; Glasscock, Kenneth F; King, Talmadge E; Lancaster, Lisa; Lederer, David J; Lin, Zhengning; Pereira, Carlos A; Swigris, Jeffrey J; Valeyre, Dominique; Noble, Paul W; Wells, Athol U

2016-05-01

The assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment. The source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population. Outcomes following a ≥10% decline in FVC were evaluated by comparing the proportion of patients in the pirfenidone and placebo groups who experienced a ≥10% decline in FVC or death during the subsequent 6 months. A weak negative correlation was observed between FVC changes during consecutive intervals in the placebo population (coefficient, -0.146, p<0.001), indicating substantial variability. Thirty-four (5.5%) and 68 (10.9%) patients in the pirfenidone and placebo groups, respectively, experienced a ≥10% decline in FVC by month 6. During the subsequent 6 months, fewer patients in the pirfenidone group compared with placebo experienced a ≥10% decline in FVC or death (5.9% vs 27.9%; relative difference, 78.9%). There was one (2.9%) death in the pirfenidone group and 14 (20.6%) deaths in the placebo group (relative difference, 85.7%). Longitudinal FVC data from patients with IPF showed substantial intrasubject variability, underscoring the inability to reliably assess therapeutic response using serial FVC trends. In patients who progressed during treatment, continued treatment with pirfenidone resulted in a lower risk of subsequent FVC decline or death. NCT01366209, NCT00287729, NCT00287716. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis

PubMed Central

Nathan, Steven D; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; du Bois, Roland M; Fagan, Elizabeth A; Fishman, Robert S; Glaspole, Ian; Glassberg, Marilyn K; King, Talmadge E; Lancaster, Lisa; Lederer, David J; Lin, Zhengning; Pereira, Carlos A; Swigris, Jeffrey J; Valeyre, Dominique; Noble, Paul W; Wells, Athol U

2016-01-01

Background The assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment. Methods The source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population. Outcomes following a ≥10% decline in FVC were evaluated by comparing the proportion of patients in the pirfenidone and placebo groups who experienced a ≥10% decline in FVC or death during the subsequent 6 months. Results A weak negative correlation was observed between FVC changes during consecutive intervals in the placebo population (coefficient, −0.146, p<0.001), indicating substantial variability. Thirty-four (5.5%) and 68 (10.9%) patients in the pirfenidone and placebo groups, respectively, experienced a ≥10% decline in FVC by month 6. During the subsequent 6 months, fewer patients in the pirfenidone group compared with placebo experienced a ≥10% decline in FVC or death (5.9% vs 27.9%; relative difference, 78.9%). There was one (2.9%) death in the pirfenidone group and 14 (20.6%) deaths in the placebo group (relative difference, 85.7%). Conclusions Longitudinal FVC data from patients with IPF showed substantial intrasubject variability, underscoring the inability to reliably assess therapeutic response using serial FVC trends. In patients who progressed during treatment, continued treatment with pirfenidone resulted in a lower risk of subsequent FVC decline or death. Trial registration numbers NCT01366209, NCT00287729, NCT00287716. PMID:26968970

Assessment of critical thinking: a Delphi study.

PubMed

Paul, Sheila A

2014-11-01

Nurse educators are responsible for preparing nurses who critically analyze patient information and provide meaningful interventions in today's complex health care system. By using the Delphi research method, this study, utilized the specialized and experiential knowledge of Certified Nurse Educators. This original Delphi research study asked Certified Nurse Educators how to assess the critical-thinking ability of nursing students in the clinical setting. The results showed that nurse educators need time, during the clinical experience, to accurately assess each individual nursing student. This study demonstrated the need for extended student clinical time, and a variety of clinical learning assessment tools. Copyright © 2014 Elsevier Ltd. All rights reserved.

Training in the implementation of prolonged exposure therapy: provider correlates of treatment outcome.

PubMed

Eftekhari, Afsoon; Crowley, Jill J; Ruzek, Josef I; Garvert, Donn W; Karlin, Bradley E; Rosen, Craig S

2015-02-01

The authors examined the degree to which provider characteristics, such as profession, treatment orientation, prior experience in treating posttraumatic stress disorder (PTSD), prior experience with prolonged exposure (PE) therapy, and attitudes about PE, were related to the clinical outcomes of veterans receiving care from clinicians participating in the national Department of Veterans Affairs (VA) PE Training Program. Positive patient outcomes were achieved by providers of every profession, theoretical orientation, level of clinical experience treating PTSD, and prior PE training experience. With 1,105 providers and 32 predictors (13 provider variables), power was at least 90% power to detect an effect of β = .15. Profession was the only provider characteristic significantly related to outcomes, but the mean effect (a 2 point difference on the PTSD Checklist) was too small to be clinically meaningful. The results support the intensive training model used in the VA PE training program and demonstrate that clinicians of varying backgrounds can be trained using interactive training workshops followed by case consultation to deliver PE effectively. Published 2015. This article is a US Government work and is in the public domain in the USA.

Improving public health by improving clinical trial guidelines and their application

PubMed Central

Landray, Martin J.; Bax, Jeroen J.; Alliot, Laurence; Buyse, Marc; Cohen, Adam; Collins, Rory; Hindricks, Gerhard; James, Stefan K.; Lane, Sile; Maggioni, Aldo P.; Meeker-O'Connell, Ann; Olsson, Gunnar; Pocock, Stuart J.; Rawlins, Michael; Sellors, Jonathan; Shinagawa, Kaori; Sipido, Karin R.; Smeeth, Liam; Stephens, Richard; Stewart, Murray W.; Stough, Wendy Gattis; Sweeney, Fergus; Van de Werf, Frans; Woods, Kerrie; Casadei, Barbara

2017-01-01

Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries. Costly infrastructure has developed to meet the increasingly complex organizational and operational requirements of these clinical trials. Concerns have been raised that this approach is unsustainable, inhibiting the reliable evaluation of new and existing treatments, to the detriment of patient care. These issues were considered by patients, regulators, funders, and trialists at a meeting of the European Society of Cardiology Cardiovascular Roundtable in October 2015. This paper summarizes the key insights and discussions from the workshop, highlights subsequent progress, and identifies next steps to produce meaningful change in the conduct of cardiovascular clinical research. PMID:28329235

Dementia Research: Populations, Progress, Problems, and Predictions.

PubMed

Hunter, Sally; Smailagic, Nadja; Brayne, Carol

2018-05-16

Alzheimer's disease (AD) is a clinicopathologically defined syndrome leading to cognitive impairment. Following the recent failures of amyloid-based randomized controlled trials to change the course of AD, there are growing calls for a re-evaluation of basic AD research. Epidemiology offers one approach to integrating the available evidence. Here we examine relationships between evidence from population-based, clinicopathological studies of brain aging and a range of hypotheses from all areas of AD research. We identify various problems, including a lack of systematic approach to measurement of clinical and neuropathological factors associated with dementia in experimental and clinical settings, poor understanding of the strengths and weaknesses of different observational and experimental designs, a lack of clarity in relation to disease definitions from the clinical, neuropathological, and molecular perspectives, inadequate characterization of brain aging in the human population, difficulties in translation between laboratory-based and population-based evidence bases, and a lack of communication between different sections of the dementia research community. Population studies highlight complexity and predict that therapeutic approaches based on single disease features will not be successful. Better characterization of brain aging in the human population is urgently required to select biomarkers and therapeutic targets that are meaningful to human disease. The generation of detailed and reliable evidence must be addressed before progress toward therapeutic interventions can be made.

Auditory Cortical Maturation in a Child with Cochlear Implant: Analysis of Electrophysiological and Behavioral Measures

PubMed Central

Silva, Liliane Aparecida Fagundes; Couto, Maria Inês Vieira; Tsuji, Robinson Koji; Bento, Ricardo Ferreira; de Carvalho, Ana Claudia Martinho; Matas, Carla Gentile

2015-01-01

The purpose of this study was to longitudinally assess the behavioral and electrophysiological hearing changes of a girl inserted in a CI program, who had bilateral profound sensorineural hearing loss and underwent surgery of cochlear implantation with electrode activation at 21 months of age. She was evaluated using the P1 component of Long Latency Auditory Evoked Potential (LLAEP); speech perception tests of the Glendonald Auditory Screening Procedure (GASP); Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS); and Meaningful Use of Speech Scales (MUSS). The study was conducted prior to activation and after three, nine, and 18 months of cochlear implant activation. The results of the LLAEP were compared with data from a hearing child matched by gender and chronological age. The results of the LLAEP of the child with cochlear implant showed gradual decrease in latency of the P1 component after auditory stimulation (172 ms–134 ms). In the GASP, IT-MAIS, and MUSS, gradual development of listening skills and oral language was observed. The values of the LLAEP of the hearing child were expected for chronological age (132 ms–128 ms). The use of different clinical instruments allow a better understanding of the auditory habilitation and rehabilitation process via CI. PMID:26881163

A New Classification System to Report Complications in Growing Spine Surgery: A Multicenter Consensus Study.

PubMed

Smith, John T; Johnston, Charles; Skaggs, David; Flynn, John; Vitale, Michael

2015-12-01

The use of growth-sparing instrumentation in pediatric spinal deformity is associated with a significant incidence of adverse events. However, there is no consistent way to report these complications, allowing for meaningful comparison of different growth-sparing techniques and strategies. The purpose of this study is to develop consensus for a new classification system to report these complications. The authors, who represent lead surgeons from 5 major pediatric spine centers, collaborated to develop a classification system to report complications associated with growing spine surgery. Following IRB approval, this system was then tested using a minimum of 10 patients from each center with at least 2-year follow-up after initial implantation of growing instrumentation to assess ease of use and consistency in reporting complications. Inclusion criteria were only patients who had surgical treatment of early onset scoliosis and did not include casting or bracing.Complications are defined as an unplanned medical event in the course of treatment that may or may not affect final outcome. Severity refers to the level of care and urgency required to treat the complication, and can be classified as device related or disease related. Severity grade (SV) I is a complication that does not require unplanned surgery, and can be corrected at the next scheduled surgery. SVII requires an unplanned surgery, with SVIIA requiring a single trip and SVIIB needing multiple trips for resolution. SVIII is a complication that substantially alters the planned course of treatment. Disease-related complications are classified as grade SVI if no hospitalization is required and grade SVII if hospitalization is required. SVIV was defined as death, either disease or device related. A total of 65 patients from 5 institutions met enrollment criteria for the study; 56 patients had at least 1 complication and 9 had no complications. There were 14 growing rods, 47 VEPTRs, ,and 4 hybrid constructs. The average age at implant was 4.7 years. There were an average of 5.4 expansions, 1.6 revisions, and 0.8 exchanges per patient. The minimum follow-up was 2 years. The most common complications were migration (60), infection (31), pneumonia (21), and instrumentation failure (23). When classified, the complications were grade I (57), grade IIA (79), grade IIB (10), and grade III (6). Well-documented uncertainty in clinical decision making in this area highlights the need for more rigorous clinical research. Reporting complications standardized for severity and impact on the course of treatment in growing spine surgery is a necessary prerequisite for meaningful comparative evaluation of different treatment options. This study shows that although complications were common, only 9% (SVIII) were severe enough to change the planned course of treatment. We propose that future studies reporting complications of different methods of growth-sparing spine surgery use this classification moving forward so that meaningful comparisons can be made between different treatment techniques.

Item response theory analysis to evaluate reliability and minimal clinically important change of the Roland-Morris Disability Questionnaire in patients with severe disability due to back pain from vertebral compression fractures.

PubMed

Lee, Minji K; Yost, Kathleen J; McDonald, Jennifer S; Dougherty, Ryne W; Vine, Roanna L; Kallmes, David F

2017-06-01

The majority of validation done on the Roland-Morris Disability Questionnaire (RMDQ) has been in patients with mild or moderate disability. There is paucity of research focusing on the psychometric quality of the RMDQ in patients with severe disability. To evaluate the psychometric quality of the RMDQ in patients with severe disability. Observational clinical study. The sample consisted of 214 patients with painful vertebral compression fractures who underwent vertebroplasty or kyphoplasty. The 23-item version of the RMDQ was completed at two time points: baseline and 30-day postintervention follow-up. With the two-parameter logistic unidimensional item response theory (IRT) analyses, we derived the range of scores that produced reliable measurement and investigated the minimal clinically important difference (MCID). Scores for 214 (100%) patients at baseline and 108 (50%) patients at follow-up did not meet the reliability criterion of 0.90 or higher, with the majority of patients having disability due to back pain that was too severe to be reliably measured by the RMDQ. Depending on methodology, MCID estimates ranged from 2 to 8 points and the proportion of patients classified as having experienced meaningful improvement ranged from 26% to 68%. A greater change in score was needed at the extreme ends of the score scale to be classified as having achieved MCID using IRT methods. Replacing items measuring moderate disability with items measuring severe disability could yield a version of the RMDQ that better targets patients with severe disability due to back pain. Improved precision in measuring disability would be valuable to clinicians who treat patients with greater functional impairments. Caution is needed when choosing criteria for interpreting meaningful change using the RMDQ. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial.

PubMed

Alexander, John C; Minhajuddin, Abu; Joshi, Girish P

2017-08-01

Use of healthcare-related smartphone applications is common. However, there is concern that inaccurate information from these applications may lead patients to make erroneous healthcare decisions. The objective of this study is to study smartphone applications purporting to measure vital sign data using only onboard technology compared with monitors used routinely in clinical practice. This is a prospective trial comparing correlation between a clinically utilized vital sign monitor (Propaq CS, WelchAllyn, Skaneateles Falls, NY, USA) and four smartphone application-based monitors Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter, and Pulse Oximeter Pro. We performed measurements of heart rate (HR), systolic blood pressures (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO 2 ) using standard monitor and four smartphone applications. Analysis of variance was used to compare measurements from the applications to the routine monitor. The study was completed on 100 healthy volunteers. Comparison of routine monitor with the smartphone applications shows significant differences in terms of HR, SpO 2 and DBP. The SBP values from the applications were not significantly different from those from the routine monitor, but had wide limits of agreement signifying a large degree of variation in the compared values. The degree of correlation between monitors routinely used in clinical practice and the smartphone-based applications studied is insufficient to recommend clinical utilization. This lack of correlation suggests that the applications evaluated do not provide clinically meaningful data. The inaccurate data provided by these applications can potentially contribute to patient harm.

Relationships between students' meaningful learning orientation and their understanding of genetics topics

NASA Astrophysics Data System (ADS)

Cavallo, Ann M. Liberatore; Schafer, Larry E.

This study explored factors predicting the extent to which high school students (N = 140) acquired meaningful understanding of the biological topics of meiosis, the Punnett-square method, and the relationships between these topics. This study (a) examined mental modeling as a technique for measuring students' meaningful understanding of the topics, (b) measured students' predisposed, generalized tendency to learn meaningfully (meaningful learning orientation), (c) determined the extent to which students' meaningful learning orientation predicted meaningful understanding beyond that predicted by aptitude and achievement motivation, (d) experimentally tested two instructional treatments (relationships presented to students, relationships generated by students), (e) explored the relationships of meaningful learning orientation, prior knowledge, instructional treatment, and all interactions of these variables in predicting meaningful understanding. The results of correlations and multiple regressions indicated that meaningful learning orientation contributed to students' attainment of meaningful understanding independent of aptitude and achievement motivation. Meaningful learning orientation and prior knowledge interacted in unique ways for each topic to predict students' attainment of meaningful understanding. Instructional treatment had relatively little relationship to students' acquisition of meaningful understanding, except for learners midrange between meaningful and rote. These findings imply that a meaningful learning approach among students may be important, perhaps as much or more than aptitude and achievement motivation, for their acquisition of interrelated, meaningful understandings of science.

Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

PubMed

Schneider, Lon S

2014-03-01

The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Does Hip Arthroscopy Provide Meaningful Outcome Improvement for Adolescent Femoroacetabular Impingement

PubMed Central

Nwachukwu, Benedict Uchenna; Chang, Brenda; Kahlenberg, Cynthia A.; Fields, Kara G.; Nawabi, Danyal H.; Kelly, Bryan T.; Ranawat, Anil S.

2017-01-01

Objectives: Arthroscopic treatment of femoroacetabular impingement (FAI) produces meaningful outcome improvement in adults. Hip arthroscopy for pediatric FAI is now established as a safe procedure however there is a paucity of evidence reporting on outcome improvement after arthroscopic treatment of FAI in this population. Methods: A prospective institutional hip preservation registry was reviewed to identify hip arthroscopies performed for pediatric FAI. Patients with pre-existing hip conditions such as slipped capital femoral epiphysis and Legg-Calve-Perthese were excluded. Included patients were 18 years and younger. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS) and the international Hip Outcome Tool (iHOT-33) are routinely collected as part of the registry. Minimal clinically important difference (MCID) was calculated using a distribution based method and substantial clinical benefit (SCB) was calculated using the an anchor question. Receiver operating characteristic (ROC) analysis with area under the curve was used. AUC > 0.7 was considered significantly predictive. Results: Forty-seven children and adolescents were identified. The majority of patients were female (N=32, 68.1%) with a mean age of 16.5 (+ 1.1) years. The MCID (% achieving) for the mHHS, HOS activities of daily living (ADL), HOS Sport and iHOT-33 was 9.5 (85%), 9.8 (79%), 12.1 (85%) and 10.7 (94%) respectively. MCID values on these outcome tools were comparable to adult patients within the registry however for each outcome measure pediatric patients were more likely to achieve MCID. In univariate analysis acetabular version was the only predictive variable for achieving MCID in pediatric FAI (p<0.05). The majority of children (91%) reported improved physical ability based on the anchor question and 53% (compared to 40% in adult registry patients) were classified as achieving SCB. The following one-year raw outcome scores were significantly predictive of SCB on the mHHS, HOS ADL, HOS Sport and mHHS respectively (AUC): 93.5 (0.79), 98.5 (0.84), 96.9 (0.81), 85.9 (0.76). These pediatric SCB values were all higher than SCB values for adult registry patients (82.5, 93.3, 84.4, 63.5 respectively) Conclusion: Pediatric patients undergoing arthroscopic FAI treatment can achieve meaningful outcome improvement and compared to adults, a larger proportion of children achieve meaningful outcome improvement. Additionally, while MCID values are comparable in children and adults, children appear to require substantially higher overall post-operative scores to perceive SCB. These findings highlight that commonly administered adult FAI outcome tools may have a relative ceiling effect in capturing outcome after treatment of pediatric FAI.

Caring for individual patients and beyond: enhancing care through secondary use of data in a general practice setting.

PubMed

Tolar, Marianne; Balka, Ellen

2012-07-01

It is argued that with the introduction of electronic medical record (EMR) systems into the primary care sector, data collected can be used for secondary purposes which extend beyond individual patient care (e.g., for chronic disease management, prevention and clinical performance evaluation). However, EMR systems are primarily designed to support clinical tasks, and data entry practices of clinicians focus on the treatment of individual patients. Hence data collected through EMRs is not always useful in meeting these ends. In this paper we follow a community health centre (CHC), and document the changes in work practices of the personnel that were necessary in order to make EMR data useful for secondary purposes. This project followed an action research approach, in which ethnographic data were collected mainly by participant observations, by a researcher who also acted as an IT support person for the clinic's secondary usage of EMR data. Additionally, interviews were carried out with the clinical and administrative personnel of the CHC. The case study demonstrates that meaningful use of secondary data occurs only after a long process, aimed at creating the pre-conditions for meaningful use of secondary data, has taken place. PRECONDITIONS: Specific areas of focus have to be chosen for secondary data use, and initiatives have to be continuously evaluated and adapted to the workflow through a team approach. Collaboration between IT support and physicians is necessary to tailor the software to allow for the collection of clinically relevant data. Data entry procedures may have to be changed to encourage the usage of an agreed-upon coding scheme, required for meaningful use of secondary data. And finally resources in terms of additional personnel or dedicated time are necessary to keep up with data collection and other tasks required as a pre-condition to secondary use of data, communication of the results to the clinic, and eventual re-evaluation. Changes in the work practices observed in this case which were required to support secondary data use from the EMR included completion of additional tasks by clinical and administrative personnel related to the organization of follow-up tasks. Among physicians increased awareness of specific initiatives and guideline compliance in terms of chronic disease management and prevention was noticed. Finally, the clinic was able to evaluate their own practice and present the results to varied stakeholders. The case describes the secondary usage of data by a clinic aimed at improving management of the clinic's patients. It illustrates that creating the pre-conditions for secondary use of data from EMRs is a complex process which can be seen as a shift in paradigms from a focus on individual patient care to chronic disease management and performance measurement. More research is needed about how to best support clinics in the process of change management necessitated by emerging clinical management goals. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Pursuing Improvement in Clinical Reasoning: The Integrated Clinical Education Theory.

PubMed

Jessee, Mary Ann

2018-01-01

The link between clinical education and development of clinical reasoning is not well supported by one theoretical perspective. Learning to reason during clinical education may be best achieved in a supportive sociocultural context of nursing practice that maximizes reasoning opportunities and facilitates discourse and meaningful feedback. Prelicensure clinical education seldom incorporates these critical components and thus may fail to directly promote clinical reasoning skill. Theoretical frameworks supporting the development of clinical reasoning during clinical education were evaluated. Analysis of strengths and gaps in each framework's support of clinical reasoning development was conducted. Commensurability of philosophical underpinnings was confirmed, and complex relationships among key concepts were elucidated. Six key concepts and three tenets comprise an explanatory predictive theory-the integrated clinical education theory (ICET). ICET provides critical theoretical support for inquiry and action to promote clinical education that improves development of clinical reasoning skill. [J Nurs Educ. 2018;57(1):7-13.]. Copyright 2018, SLACK Incorporated.

Experiences of clinical teaching for dental core trainees working in hospital.

PubMed

Mannion, C J; Brotherton, P

2014-07-11

There is recognition that the provision of excellence in education and training results in a skilled and competent workforce. However, the educational experiences of dental core trainees (DCT's) working in the hospital oral and maxillofacial surgery (OMFS) setting have not been previously investigated. In this paper, we examine DCT's learning experiences both 'formal' and 'non-formal' within the hospital setting of ward and clinic-based teaching. Are hospital dental core trainees receiving a meaningful educational experience? To conclude this paper, the authors recommend methods, based upon sound educational principles, to maximise the value of clinical sessions for teaching.

Improving Terminology Mapping in Clinical Text with Context-Sensitive Spelling Correction.

PubMed

Dziadek, Juliusz; Henriksson, Aron; Duneld, Martin

2017-01-01

The mapping of unstructured clinical text to an ontology facilitates meaningful secondary use of health records but is non-trivial due to lexical variation and the abundance of misspellings in hurriedly produced notes. Here, we apply several spelling correction methods to Swedish medical text and evaluate their impact on SNOMED CT mapping; first in a controlled evaluation using medical literature text with induced errors, followed by a partial evaluation on clinical notes. It is shown that the best-performing method is context-sensitive, taking into account trigram frequencies and utilizing a corpus-based dictionary.

What is the effect of surgery on the quality of life of the adolescent with adolescent idiopathic scoliosis? A review and statistical analysis of the literature.

PubMed

Rushton, Paul R P; Grevitt, Michael P

2013-04-20

Review and statistical analysis of studies evaluating the effect of surgery on the health-related quality of life of adolescents with adolescent idiopathic scoliosis, using Scoliosis Research Society (SRS) outcomes. Apply published minimum clinical important differences (MCID) values for the SRS22r questionnaire to the literature to identify what areas of health-related quality of life are consistently affected by surgery and whether changes are clinically meaningful. The interpretation of published studies using the SRS outcomes has been limited by the lack of MCID values for the questionnaire domains. The recent publication of these data allows the clinical importance of any changes in these studies to be examined for the first time. A literature search was undertaken to locate suitable studies that were then analyzed. Statistically significant differences from baseline to 2 years postoperatively were ascertained by narratively reporting the analyses within included studies. When possible, clinically significant changes were assessed using 95% confidence intervals for the change in mean domain score. If the lower bound of the confidence intervals for the change exceeded the MCID for that domain, the change was considered clinically significant. The numbers of cohorts available for the different analyses varied (5-16). Eighty-one percent and 94% of included cohorts experienced statistically significant improvements in pain and self-image domains. In terms of clinical significance, it was only self-image that regularly improved by more than MCID, doing so in 4 of 5 included cohorts (80%) compared with 1 of 12 cohorts (8%) for pain. No clinically relevant changes occurred in mental health or activity domains. Evidence suggests that surgery can lead to clinically important improvement in patient self-image. Surgeons and patients should be aware of the limited evidence for improvements in domains other than self-image after surgery. Surgical decision-making will also be influenced by the natural history of adolescent idiopathic scoliosis.

Integrative topological analysis of mass spectrometry data reveals molecular features with clinical relevance in esophageal squamous cell carcinoma

PubMed Central

Gao, She-Gan; Liu, Rui-Min; Zhao, Yun-Gang; Wang, Pei; Ward, Douglas G.; Wang, Guang-Chao; Guo, Xiang-Qian; Gu, Juan; Niu, Wan-Bin; Zhang, Tian; Martin, Ashley; Guo, Zhi-Peng; Feng, Xiao-Shan; Qi, Yi-Jun; Ma, Yuan-Fang

2016-01-01

Combining MS-based proteomic data with network and topological features of such network would identify more clinically relevant molecules and meaningfully expand the repertoire of proteins derived from MS analysis. The integrative topological indexes representing 95.96% information of seven individual topological measures of node proteins were calculated within a protein-protein interaction (PPI) network, built using 244 differentially expressed proteins (DEPs) identified by iTRAQ 2D-LC-MS/MS. Compared with DEPs, differentially expressed genes (DEGs) and comprehensive features (CFs), structurally dominant nodes (SDNs) based on integrative topological index distribution produced comparable classification performance in three different clinical settings using five independent gene expression data sets. The signature molecules of SDN-based classifier for distinction of early from late clinical TNM stages were enriched in biological traits of protein synthesis, intracellular localization and ribosome biogenesis, which suggests that ribosome biogenesis represents a promising therapeutic target for treating ESCC. In addition, ITGB1 expression selected exclusively by integrative topological measures correlated with clinical stages and prognosis, which was further validated with two independent cohorts of ESCC samples. Thus the integrative topological analysis of PPI networks proposed in this study provides an alternative approach to identify potential biomarkers and therapeutic targets from MS/MS data with functional insights in ESCC. PMID:26898710

The use of Data Mining in the categorization of patients with Azoospermia.

PubMed

Mikos, Themistoklis; Maglaveras, Nikolaos; Pantazis, Konstantinos; Goulis, Dimitrios G; Bontis, John N; Papadimas, John

2005-01-01

Data Mining is a relatively new field of Medical Informatics. The aim of this study was to compare Data Mining diagnosis with clinical diagnosis by applying a Data Miner (DM) to a clinical dataset of infertile men with azoospermia. One hundred and forty-seven azoospermic men were clinically classified into four groups: a) obstructive azoospermia (n=63), b) non-obstructive azoospermia (n=71), c) hypergonadotropic hypogonadism (n=2), and d) hypogonadotropic hypogonadism (n=11). The DM (IBM's DB2/Intelligent Miner for Data 6.1) was asked to reproduce a four-cluster model. DM formed four groups of patients: a) eugonadal men with normal testicular volume and normal FSH levels (n=86), b) eugonadal men with significantly reduced testicular volume (median 6.5 cm3) and very high FSH levels (n=29), c) eugonadal men with moderately reduced testicular volume (median 14.5 cm3) and raised FSH levels (n=20), and d) hypogonadal men (n=12). Overall DM concordance rate in hypogonadal men was 92%, in obstructive azoospermia 73%, and in non-obstructive azoospermia 69%. Data Mining produces clinically meaningful results but different from those of the clinical diagnosis. It is possible that the use of large sets of structured and formalised data and continuous evaluation of DM results will generate a useful methodology for the Clinician.

Patient similarity for precision medicine: a systematic review.

PubMed

Parimbelli, E; Marini, S; Sacchi, L; Bellazzi, R

2018-06-01

Evidence-based medicine is the most prevalent paradigm adopted by physicians. Clinical practice guidelines typically define a set of recommendations together with eligibility criteria that restrict their applicability to a specific group of patients. The ever-growing size and availability of health-related data is currently challenging the broad definitions of guideline-defined patient groups. Precision medicine leverages on genetic, phenotypic, or psychosocial characteristics to provide precise identification of patient subsets for treatment targeting. Defining a patient similarity measure is thus an essential step to allow stratification of patients into clinically-meaningful subgroups. The present review investigates the use of patient similarity as a tool to enable precision medicine. 279 articles were analyzed along four dimensions: data types considered, clinical domains of application, data analysis methods, and translational stage of findings. Cancer-related research employing molecular profiling and standard data analysis techniques such as clustering constitute the majority of the retrieved studies. Chronic and psychiatric diseases follow as the second most represented clinical domains. Interestingly, almost one quarter of the studies analyzed presented a novel methodology, with the most advanced employing data integration strategies and being portable to different clinical domains. Integration of such techniques into decision support systems constitutes and interesting trend for future research. Copyright © 2018. Published by Elsevier Inc.

Establishing a clinically relevant cutoff to the Dependency Scale from the dimensional clinical personality inventory.

PubMed

Carvalho, Lucas de F; Pianowski, Giselle; Filho, Nelson H

2017-05-01

The Clinical Dimensional Personality Inventory (IDCP) is a 163-item self-report tool developed for the assessment of 12 dimensions of personality pathology. One of the scales comprising the instrument-the Dependency scale-is intended to provide psychometric information on traits closely related to the Dependent Personality Disorder (DPD). In the present study, we used both Item Response Theory modeling and Receiver Operating Characteristic curve analysis to establishing a clinically meaningful cutoff for the IDCP Dependency Scale. Participants were 2.481 adults, comprised by outpatients diagnosed with DPD, outpatients diagnosed with other PDs, and adults from the general population. The Wright's item map graphing technique revealed that outpatients were located at the very high levels in the latent scale continuum of the Dependency Scale, with a very large effect size for the mean difference between patients and non-patients. The ROC curve analysis supported a cutoff at 2.3 points in the Dependency Scale, which yielded 0.86 of sensitivity and 0.79 of specificity. Findings from the present investigation suggest the IDCP Dependency Scale is useful as a screening tool of the core features of the DPD. We address potential clinical applications for the instrument, and discuss limitations from the present study. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Secure Messaging in Electronic Health Records and Its Impact on Diabetes Clinical Outcomes: A Systematic Review.

PubMed

Kuo, Alyce; Dang, Stuti

2016-09-01

In 2009, President Barack Obama signed into law the Health Information Technology for Economic and Clinical Health (HITECH) Act, which aims for the universal adoption of electronic health records (EHRs) in primary care settings and "meaningful use" of this technology. The objectives of "meaningful use" are well defined and executed in stages; one of the objectives of stage 2, beginning in 2014, was implementation of a secure messaging system between patients and providers. Secure messaging has been shown to positively affect patients who struggle with managing chronic diseases on a day to day basis. This review aims to assess the clinical evidence supporting the use of secure messaging in EHRs in self-management of diabetes. A systematic search of PubMed was conducted, and 320 results were returned. Of these, 11 were selected based on outlined criteria. Evidence from 7 of the 11 included studies suggests significant improvement in patients' hemoglobin A1c (HbA1c) with the use of secure messaging. However, improvements in patients' secondary outcomes, such as blood pressure and cholesterol, were inconsistent. Further work must be done to determine how to best maximize the potential of available tools such as secure messaging and EHRs to improve patient outcomes.

Developing a case mix classification for child and adolescent mental health services: the influence of presenting problems, complexity factors and service providers on number of appointments.

PubMed

Martin, Peter; Davies, Roger; Macdougall, Amy; Ritchie, Benjamin; Vostanis, Panos; Whale, Andy; Wolpert, Miranda

2017-09-01

Case-mix classification is a focus of international attention in considering how best to manage and fund services, by providing a basis for fairer comparison of resource utilization. Yet there is little evidence of the best ways to establish case mix for child and adolescent mental health services (CAMHS). To develop a case mix classification for CAMHS that is clinically meaningful and predictive of number of appointments attended and to investigate the influence of presenting problems, context and complexity factors and provider variation. We analysed 4573 completed episodes of outpatient care from 11 English CAMHS. Cluster analysis, regression trees and a conceptual classification based on clinical best practice guidelines were compared regarding their ability to predict number of appointments, using mixed effects negative binomial regression. The conceptual classification is clinically meaningful and did as well as data-driven classifications in accounting for number of appointments. There was little evidence for effects of complexity or context factors, with the possible exception of school attendance problems. Substantial variation in resource provision between providers was not explained well by case mix. The conceptually-derived classification merits further testing and development in the context of collaborative decision making.

Inspiring hope-A physician's responsibility, translating the science into clinical practice.

PubMed

Temple, Walley J

2018-03-01

Giving hope to patients is our responsibility. It is the essence of a meaningful practice in medicine. Science now allows us to understand this complex and multidimensional human dynamic, and translate it into clinical practice. Quantitative research has shown hope is strong even in terminal illness. Through qualitative methodology hope fostering strategies and hope hindering behaviors have been identified. This exciting new knowledge facilitates the challenging task of disclosure of bad news while enabling hope. © 2017 Wiley Periodicals, Inc.

Meaningful participation of minors with HIV/AIDS in decisions regarding medical treatment. Balancing the rights of children, parents, and state.

PubMed

Walker, Nancy E

2002-01-01

The ability to define clinical classifications and articulate theoretical frameworks must be balanced with deep respect for and awareness of the impact of HIV on clients' lives. Working with these youngsters and their families calls us to dare to be in touch with their very spirits as well as with their clinical issues. So, what should we do for the children? At the risk of oversimplifying, the best answer still is to walk with them.

Ontogeny of Emotional and Behavioral Problems in a Low-Income, Mexican American Sample

ERIC Educational Resources Information Center

Lin, Betty; Crnic, Keith A.; Luecken, Linda J.; Gonzales, Nancy A.

2017-01-01

Clinically meaningful behavior problems are thought to be present beginning in the early toddler years, yet few studies have investigated correlates of behavior problems assessed before age 2 years. The current study investigated the direct and interactive contributions of early infant and caregiver characteristics thought to play an important…

The Validity and Clinical Uses of the Pepper Visual Skills for Reading Test.

ERIC Educational Resources Information Center

Watson, G.; And Others

1990-01-01

The Pepper Visual Skills for Reading Test was assessed as a measure of reading ability with meaningful text in 38 adults with macular degeneration; scores were compared with assessment made using the Gray Oral Reading Test, a previously standardized assessment. The test's validity was confirmed. (Author/JDD)

Guidance on Performing Focused Ethnographies with an Emphasis on Healthcare Research

ERIC Educational Resources Information Center

Higginbottom, Gina M. A.; Pillay, Jennifer J.; Boadu, Nana Y.

2013-01-01

Focused ethnographies can have meaningful and useful application in primary care, community, or hospital healthcare practice, and are often used to determine ways to improve care and care processes. They can be pragmatic and efficient ways to capture data on a specific topic of importance to individual clinicians or clinical specialties. While…

Consensus Report on Impulsive Aggression as a Symptom across Diagnostic Categories in Child Psychiatry: Implications for Medication Studies

ERIC Educational Resources Information Center

Jensen, Peter S.; Youngstrom, Eric A.; Steiner, Hans; Findling, Robert L.; Meyer, Roger E.; Malone, Richard P.; Carlson, Gabrielle A.; Coccaro, Emil F.; Aman, Michael G.; Blair, James; Dougherty, Donald; Ferris, Craig; Flynn, Laurie; Green, Evelyn; Hoagwood, Kimberly; Hutchinson, Janice; Laughren, Tom; Leve, Leslie D.; Novins, Douglas K.; Vitiello, Benedetto

2007-01-01

Objective: To determine whether impulsive aggression (IA) is a meaningful clinical construct and to ascertain whether it is sufficiently similar across diagnostic categories, such that parallel studies across disorders might constitute appropriate evidence for pursuing indications. If so, how should IA be assessed, pharmacological studies…

Librarian contributions to clinical practice guidelines.

PubMed

Cruse, Peggy; Protzko, Shandra

2014-01-01

Librarians have become more involved in developing high quality systematic reviews. Evidence-based practice guidelines are an extension of systematic reviews and offer another significant area for librarian involvement. This column highlights opportunities and challenges for the librarian working on guideline panels and provides practical considerations for meaningful contributions to the guideline creation process.

Toward Meaningful Evaluation of Medical Trainees: The Influence of Participants' Perceptions of the Process

ERIC Educational Resources Information Center

Watling, Christopher J.; Lingard, Lorelei

2012-01-01

An essential goal of evaluation is to foster learning. Across the medical education spectrum, evaluation of clinical performance is dominated by subjective feedback to learners based on observation by expert supervisors. Research in non-medical settings has suggested that participants' perceptions of evaluation processes exert considerable…

Supervision that Improves Teaching: Strategies and Techniques. Second Edition

ERIC Educational Resources Information Center

Sullivan, Susan; Glanz, Jeffrey

2004-01-01

In this exciting, new edition of "Supervision That Improves Teaching," the authors have taken their reflective clinical supervision process to a new level, with the planning conference now the heart of the supervision cycle. Sullivan and Glanz have addressed the dilemmas of preserving meaningful supervision in an era of high-stakes…

Efficient 3D multi-region prostate MRI segmentation using dual optimization.

PubMed

Qiu, Wu; Yuan, Jing; Ukwatta, Eranga; Sun, Yue; Rajchl, Martin; Fenster, Aaron

2013-01-01

Efficient and accurate extraction of the prostate, in particular its clinically meaningful sub-regions from 3D MR images, is of great interest in image-guided prostate interventions and diagnosis of prostate cancer. In this work, we propose a novel multi-region segmentation approach to simultaneously locating the boundaries of the prostate and its two major sub-regions: the central gland and the peripheral zone. The proposed method utilizes the prior knowledge of the spatial region consistency and employs a customized prostate appearance model to simultaneously segment multiple clinically meaningful regions. We solve the resulted challenging combinatorial optimization problem by means of convex relaxation, for which we introduce a novel spatially continuous flow-maximization model and demonstrate its duality to the investigated convex relaxed optimization problem with the region consistency constraint. Moreover, the proposed continuous max-flow model naturally leads to a new and efficient continuous max-flow based algorithm, which enjoys great advantages in numerics and can be readily implemented on GPUs. Experiments using 15 T2-weighted 3D prostate MR images, by inter- and intra-operator variability, demonstrate the promising performance of the proposed approach.

Impact of a Pilot Videogame-Based Physical Activity Program on Walking Speed in Adults with Schizophrenia.

PubMed

Leutwyler, H; Hubbard, E; Cooper, B A; Dowling, G

2017-11-10

The purpose of this report is to describe the impact of a videogame-based physical activity program using the Kinect for Xbox 360 game system (Microsoft, Redmond, WA) on walking speed in adults with schizophrenia. In this randomized controlled trial, 28 participants played either an active videogame for 30 min (intervention group) or played a sedentary videogame for 30 min (control group), once a week for 6 weeks. Walking speed was measured objectively with the Short Physical Performance Battery at enrollment and at the end of the 6-week program. The intervention group (n = 13) showed an average improvement in walking speed of 0.08 m/s and the control group (n = 15) showed an average improvement in walking speed of 0.03 m/s. Although the change in walking speed was not statistically significant, the intervention group had between a small and substantial clinically meaningful change. The results suggest a videogame based physical activity program provides clinically meaningful improvement in walking speed, an important indicator of health status.

The relationship between perceived parenting, adult attachment style and alexithymia in alcoholic inpatients.

PubMed

De Rick, Ann; Vanheule, Stijn

2006-07-01

In this paper we examine the understudied relationship between alexithymia on the one hand, and adult attachment and perceived parenting on the other hand, in a clinical sample of alcoholic inpatients (N=101). We test whether differences between a high and a low scoring group on trait alexithymia can be predicted on the basis of attachment style and perceived parenting. We observed that the avoidant attachment style is a strong predictor. Subsequently we test whether three dimensions of alexithymia - affective, cognitive and social - are meaningfully linked to adult attachment and perceived parenting. We noticed that cognitive alexithymia especially was predicted by the avoidant attachment style and a lack of warmth perceived in the relationship to the father.

Clinical benefit of eculizumab in patients with no transfusion history in the International Paroxysmal Nocturnal Haemoglobinuria Registry.

PubMed

Almeida, Antonio M; Bedrosian, Camille; Cole, Alexander; Muus, Petra; Schrezenmeier, Hubert; Szer, Jeff; Rosse, Wendell F

2017-09-01

Eculizumab reduces intravascular haemolysis and improves disease symptoms in patients with paroxysmal nocturnal haemoglobinuria (PNH). To characterise, in a real-world setting, the effect of eculizumab in patients with haemolytic PNH (lactase dehydrogenase (LDH) ≥ 1.5 upper limit of normal) and no history of red blood cell transfusion, including those with high disease activity (HDA). Three populations from the International PNH Registry were studied: (i) non-transfused, untreated; (ii) non-transfused, eculizumab-treated and (iii) transfused, eculizumab-treated (≥1 transfusions in 6 months prior to eculizumab initiation). Using multivariate linear regression, the primary outcome was mean absolute change from baseline to 6 months in LDH (U/L) in non-transfused patients who were treated with eculizumab versus those who remained untreated. Secondary outcomes were mean changes in functional assessment of chronic illness therapy (FACIT)-Fatigue and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30 Fatigue scores from baseline to last available assessment. The study population included (i) 144 non-transfused, untreated patients; (ii) 45 non-transfused, eculizumab-treated patients and (iii) 105 transfused, eculizumab-treated patients. Of these, 136/144, 43/45 and 99/105 had HDA respectively. Compared with untreated patients, non-transfused, treated patients had greater absolute reduction in LDH (-1318.8 vs -39.4; P < 0.001) and greater percentage reduction in LDH (-69.9 vs -1.6%; P < 0.001). Clinically meaningful improvements in FACIT-Fatigue (73.7 vs 24.6%, respectively) and in EORTC-QLQ-C30 (84.2 vs 33.3%, respectively) were observed. Non-transfused, treated patients with HDA had significantly reduced LDH levels (P < 0.001) and clinically meaningful improvements in FACIT-Fatigue (P = 0.003) and EORTC-QLQ-C30 (P = 0.020) versus untreated patients. Significant LDH reduction and clinically meaningful improvement in fatigue were observed in patients with PNH and HDA treated with eculizumab versus untreated patients, irrespective of transfusion history. © 2017 Royal Australasian College of Physicians.

A comparison of film and computer workstation measurements of degenerative spondylolisthesis: intraobserver and interobserver reliability.

PubMed

Bolesta, Michael J; Winslow, Lauren; Gill, Kevin

2010-06-01

A comparison of measurements of degenerative spondylolisthesis made on film and on computer workstations. To determine whether the 2 methodologies are comparable in some of the parameters used to assess lumbar degenerative spondylolisthesis. Digital radiology has been replacing analog radiographs. In scoliosis, several studies have shown that measurements made on digital and analog films are similar and that they are also similar to those made on computer workstations. Such work has not been done in spondylolisthesis. Twenty-four cases of lumbar degenerative spondylolisthesis were identified from our clinic practice. Three observers measured anterior displacement, sagittal rotation, and lumbar lordosis on digital films using the same protractor and pencil. The same parameters were measured on the same studies at clinical workstations. All measurements were repeated 2 weeks later. A statistician determined the intra and interobserver reliability of the 2 measurement methods and the degree of agreement between the 2 methods. The differences between the first and second readings did reach statistical significance in some cases, but none of them were large enough to be clinically meaningful. The interclass correlation coefficients (ICCs) were >or=0.80 except for one (0.67). The difference among the 3 observers was similarly statistically significant in a few instances but not enough to influence clinical decisions and with good ICCs (0.67 and better). Similarly, the differences in the 2 methods were small, and ICCs ranged from 0.69 to 0.98. This study supports the use of computer workstation measurements in lumbar degenerative spondylolisthesis. The parameters used in this study were comparable, whether measured on film or at clinical workstations.

Comparing Pain and Depressive Symptoms of Chronic Opioid Therapy Patients Receiving Dose Reduction and Risk Mitigation Initiatives With Usual Care.

PubMed

Thakral, Manu; Walker, Rod L; Saunders, Kathleen; Shortreed, Susan M; Parchman, Michael; Hansen, Ryan N; Ludman, Evette; Sherman, Karen J; Dublin, Sascha; Von Korff, Michael

2018-01-01

Dose reduction and risk mitigation initiatives have been recommended to reduce opioid-related risks among patients receiving chronic opioid therapy (COT), but questions remain over whether these initiatives worsen pain control and quality of life. In 2014 to 2015, we interviewed 1,588 adult COT patients within a health care system in Washington State and compared those who received dose reduction and risk mitigation initiatives in primary care clinics (intervention) with patients in comparable health care settings without initiatives (control). The primary outcomes were pain assessed using the pain, enjoyment, and general activity (PEG) scale, a 3-item scale to assess global pain intensity and interference, with secondary measures including depression (Patient Health Questionnaire-8 scale). Generalized estimating equations for linear regression models were used to estimate differences in mean scores between intervention and control sites. Estimated differences, adjusted for patient characteristics and weighted for nonresponse, between patients at intervention and control clinics were not clinically significant for the PEG (-.03, 95% confidence interval = -.25 to .19) or Patient Health Questionnaire-8 (-.64, 95% confidence interval = -1.19 to -.08). We found no evidence that COT patients in clinics with dose reduction and risk mitigation initiatives had clinically meaningful differences in pain intensity, interference with activities and enjoyment of life, or depressive symptoms compared with control health care settings. This article evaluates the effect of dose reduction and risk mitigation initiatives, such as those recently recommended by the Centers for Disease Control and Prevention, to reduce risks associated with COT on global pain and interference, depressive symptoms, and perceived pain relief and bothersomeness of side effects. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

PubMed

Harrison, Robert W; Radhakrishnan, Vaishnavi; Lam, Peter S; Allocco, Dominic J; Brar, Sandeep; Fahy, Martin; Fisher, Rebecca; Ikeno, Fumiaki; Généreux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Mintz, Gary S; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Allen, John C; Krucoff, Mitchell W

2016-12-01

The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation. The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up. Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus.

PubMed

Staecker, Hinrich; Morelock, Michael; Kramer, Timothy; Chrbolka, Pavel; Ahn, Joong Ho; Meyer, Thomas

2017-09-01

Objective To evaluate the safety and tolerability of repeated intratympanic administration of the gel-formulated NMDA receptor antagonist AM-101 in acute patients with inner ear tinnitus. Study Design Prospective, double-blind, randomized, placebo-controlled study. Setting Sixty-nine secondary and tertiary sites in North America, Europe, and Asia. Subjects and Methods In total, 343 subjects with persistent acute tinnitus after traumatic cochlear injury or otitis media were randomized to receive 3 intratympanic doses of either AM-101 0.87 mg/mL or placebo over 3 to 5 days. They were followed for 84 days. The primary safety end point was the incidence of a clinically meaningful hearing deterioration from baseline to study day 35. Further safety assessments included tympanic membrane closure rates, analysis of adverse events, hematology, blood chemistry, and vital signs. In addition, data were collected on applied anesthetics and injection techniques. Results The treatment was well tolerated, with no intervention-related serious adverse events. The incidence of clinically meaningful hearing deterioration was low, comparable between treatment groups ( P = .82 for the primary safety end point) and not different between treated and untreated ears in unilaterally treated subjects. The rate of treatment and procedure-related adverse events was similar among treatment groups. The tympanic membrane was closed in 92% of subjects within 1 week and in all subjects by study day 84. Blood values and vital signs were inconspicuous. Conclusion Repeated intratympanic injections of AM-101 over a 3- to 5-day period appear to be safe and well tolerated, demonstrating the ability to potentially use this delivery approach over longer time periods.

Reliable Change Indices and Standardized Regression-Based Change Score Norms for Evaluating Neuropsychological Change in Children with Epilepsy

PubMed Central

Busch, Robyn M.; Lineweaver, Tara T.; Ferguson, Lisa; Haut, Jennifer S.

2015-01-01

Reliable change index scores (RCIs) and standardized regression-based change score norms (SRBs) permit evaluation of meaningful changes in test scores following treatment interventions, like epilepsy surgery, while accounting for test-retest reliability, practice effects, score fluctuations due to error, and relevant clinical and demographic factors. Although these methods are frequently used to assess cognitive change after epilepsy surgery in adults, they have not been widely applied to examine cognitive change in children with epilepsy. The goal of the current study was to develop RCIs and SRBs for use in children with epilepsy. Sixty-three children with epilepsy (age range 6–16; M=10.19, SD=2.58) underwent comprehensive neuropsychological evaluations at two time points an average of 12 months apart. Practice adjusted RCIs and SRBs were calculated for all cognitive measures in the battery. Practice effects were quite variable across the neuropsychological measures, with the greatest differences observed among older children, particularly on the Children’s Memory Scale and Wisconsin Card Sorting Test. There was also notable variability in test-retest reliabilities across measures in the battery, with coefficients ranging from 0.14 to 0.92. RCIs and SRBs for use in assessing meaningful cognitive change in children following epilepsy surgery are provided for measures with reliability coefficients above 0.50. This is the first study to provide RCIs and SRBs for a comprehensive neuropsychological battery based on a large sample of children with epilepsy. Tables to aid in evaluating cognitive changes in children who have undergone epilepsy surgery are provided for clinical use. An excel sheet to perform all relevant calculations is also available to interested clinicians or researchers. PMID:26043163

Quality indicators and their regular use in clinical practice: results from a survey among users of two cardiovascular National Registries in Sweden.

PubMed

Algurén, Beatrix; Andersson-Gäre, Boel; Thor, Johan; Andersson, Ann-Christine

2018-05-14

To examine the regular use of quality indicators from Swedish cardiovascular National Quality Registries (NQRs) by clinical staff; particularly differences in use between the two NQRs and between nurses and physicians. Cross-sectional online survey study. Two Swedish cardiovascular NQRs: (a) Swedish Heart Failure Registry and (b) Swedeheart. Clinicians (n =185; 70% nurses, 26% physicians) via the NQRs' email networks. Frequency of NQR use for (a) producing healthcare activity statistics; (b) comparing results between similar departments; (c) sharing results with colleagues; (d) identifying areas for quality improvement (QI); (e) surveilling the impact of QI efforts; (f) monitoring effects of implementation of new treatment methods; (g) doing research and (h) educating and informing healthcare professionals and patients. Median use of NQRs was 10 times a year (25th and 75th percentiles range: 3-23 times/year). Quality indicators from the NQRs were used mainly for producing healthcare activity statistics. Median use of Swedeheart was six times greater than Swedish Heart Failure Registry (SwedeHF; P < 0.000). Physicians used the NQRs more than twice as often as nurses (18 vs. 7.5 times/year; P < 0.000) and perceived NQR work more often as meaningful. Around twice as many Swedeheart users had the role to participate in data analysis and in QI efforts compared to SwedeHF users. Most respondents used quality indicators from the two cardiovascular NQRs infrequently (<3 times/year). The results indicate that linking registration of quality indicators to using them for QI activities increases their routine use and makes them meaningful tools for professionals.

Research to encourage exercise for fibromyalgia (REEF): use of motivational interviewing, outcomes from a randomized-controlled trial.

PubMed

Ang, Dennis C; Kaleth, Anthony S; Bigatti, Silvia; Mazzuca, Steven A; Jensen, Mark P; Hilligoss, Janna; Slaven, James; Saha, Chandan

2013-04-01

Regular exercise is associated with important benefits in patients with fibromyalgia (FM). Unfortunately, long-term maintenance of exercise after a structured program is rare. The present study tested the efficacy of Motivational Interviewing (MI) to promote exercise and improve symptoms in patients with FM. A total of 216 patients with FM were randomized to 6 MI sessions (n=107) or an equal number of FM self-management lessons (education control/EC, n=109). Co-primary endpoints were an increase of 30 minutes in moderate-vigorous physical activity and improvement in the Fibromyalgia Impact Questionnaire (FIQ)-Physical Impairment score, assessed at pretreatment, posttreatment, and 3-month and 6-month follow-up. Secondary outcomes included clinically meaningful improvements in FIQ score, pain severity ratings, and a 6-minute walk test. There were no significant treatment group differences in either co-primary endpoint at 6-month follow-up. However, more MI participants than controls exhibited meaningful improvements in FIQ score at 6-month follow-up (62.9% vs. 49.5%, P=0.06). Compared with EC participants, MI participants also displayed a larger increment in their 6-minute walk test (43.9 vs. 24.8 m, P=0.03). In addition, MI was superior to EC in increasing the number of hours of physical activity immediately postintervention and in reducing pain severity both immediately after the intervention and at 3-month follow-up. Despite a lack of benefits on long-term outcome, MI seems to have short-term benefits with respect to self-report physical activity and clinical outcomes. This is the first study in FM that explicitly addresses exercise maintenance as a primary aim.

Detection of Alzheimer's disease using group lasso SVM-based region selection

NASA Astrophysics Data System (ADS)

Sun, Zhuo; Fan, Yong; Lelieveldt, Boudewijn P. F.; van de Giessen, Martijn

2015-03-01

Alzheimer's disease (AD) is one of the most frequent forms of dementia and an increasing challenging public health problem. In the last two decades, structural magnetic resonance imaging (MRI) has shown potential in distinguishing patients with Alzheimer's disease and elderly controls (CN). To obtain AD-specific biomarkers, previous research used either statistical testing to find statistically significant different regions between the two clinical groups, or l1 sparse learning to select isolated features in the image domain. In this paper, we propose a new framework that uses structural MRI to simultaneously distinguish the two clinical groups and find the bio-markers of AD, using a group lasso support vector machine (SVM). The group lasso term (mixed l1- l2 norm) introduces anatomical information from the image domain into the feature domain, such that the resulting set of selected voxels are more meaningful than the l1 sparse SVM. Because of large inter-structure size variation, we introduce a group specific normalization factor to deal with the structure size bias. Experiments have been performed on a well-designed AD vs. CN dataset1 to validate our method. Comparing to the l1 sparse SVM approach, our method achieved better classification performance and a more meaningful biomarker selection. When we vary the training set, the selected regions by our method were more stable than the l1 sparse SVM. Classification experiments showed that our group normalization lead to higher classification accuracy with fewer selected regions than the non-normalized method. Comparing to the state-of-art AD vs. CN classification methods, our approach not only obtains a high accuracy with the same dataset, but more importantly, we simultaneously find the brain anatomies that are closely related to the disease.

Segmenting high-cost Medicare patients into potentially actionable cohorts.

PubMed

Joynt, Karen E; Figueroa, Jose F; Beaulieu, Nancy; Wild, Robert C; Orav, E John; Jha, Ashish K

2017-03-01

Providers are assuming growing responsibility for healthcare spending, and prior studies have shown that spending is concentrated in a small proportion of patients. Using simple methods to segment these patients into clinically meaningful subgroups may be a useful and accessible strategy for targeting interventions to control costs. Using Medicare fee-for-service claims from 2011 (baseline year, used to determine comorbidities and subgroups) and 2012 (spending year), we used basic demographics and comorbidities to group beneficiaries into 6 cohorts, defined by expert opinion and consultation: under-65 disabled/ESRD, frail elderly, major complex chronic, minor complex chronic, simple chronic, and relatively healthy. We considered patients in the highest 10% of spending to be "high-cost." 611,245 beneficiaries were high-cost; these patients were less often white (76.2% versus 80.9%) and more often dually-eligible (37.0% versus 18.3%). By segment, frail patients were the most likely (46.2%) to be high-cost followed by the under-65 (14.3%) and major complex chronic groups (11.1%); fewer than 5% of the beneficiaries in the other cohorts were high-cost in the spending year. The frail elderly ($70,196) and under-65 disabled/ESRD ($71,210) high-cost groups had the highest spending; spending in the frail high-cost group was driven by inpatient ($23,704) and post-acute care ($24,080), while the under 65-disabled/ESRD spent more through part D costs ($23,003). Simple criteria can segment Medicare beneficiaries into clinically meaningful subgroups with different spending profiles. Under delivery system reform, interventions that focus on frail or disabled patients may have particularly high value as providers seek to reduce spending. IV. Copyright © 2016 Elsevier Inc. All rights reserved.

Improvements in Functional Exercise Capacity after a Residential Behavioural Change, Diet and Fitness Program for Obese Adults.

PubMed

Errickson, Sadye Paez; Kolotkin, Ronette L; Skidmore, Megan Simmons; Endress, Gerald; Østbye, Truls; Crosby, Ross; Eisenson, Howard

2016-06-01

Obese adults are at an increased risk for mobility-related problems. National guidelines recommend calorie restrictions and exercise for obese adults as a means to improve functional fitness capacity and to increase mobility. Yet, lifestyle weight loss interventions often fail to measure fitness changes. The aim of this study was to assess whether a 1-month, intensive behavioural change, diet and fitness intervention for overweight and obese adults would result in statistically significant and clinically meaningful changes in functional exercise. A pre-post test design was used in this study. Seventy-two participants (40 women, 32 men; mean baseline body mass index (BMI) = 42.6 + 9.0; mean age = 45.8 + 16.8) completed a modified 6-minute walk test (6MWT), performed on a treadmill, at baseline and at end of treatment. Significant improvements included decreased BMI (2.7 + 1.7 kg m(-2) , p < 0.001) and increased 6MWT distance (66.4 + 73.0 m, p < 0.001). The 6MWT improved by 66 m on average, a reported clinically meaningful difference. Greater improvements in the 6MWT were significantly correlated with greater weight loss and BMI reduction. Our findings suggest that rehabilitation beyond weight loss may be derived from participation in a brief, intensive behavioural change, diet and fitness programme. Physiotherapists are in a prime position to address the physical and motivational challenges participants face while living with severe obesity: targeting functional exercise capacity is one key strategy for addressing immobility associated with obesity. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Reliable change indices and standardized regression-based change score norms for evaluating neuropsychological change in children with epilepsy.

PubMed

Busch, Robyn M; Lineweaver, Tara T; Ferguson, Lisa; Haut, Jennifer S

2015-06-01

Reliable change indices (RCIs) and standardized regression-based (SRB) change score norms permit evaluation of meaningful changes in test scores following treatment interventions, like epilepsy surgery, while accounting for test-retest reliability, practice effects, score fluctuations due to error, and relevant clinical and demographic factors. Although these methods are frequently used to assess cognitive change after epilepsy surgery in adults, they have not been widely applied to examine cognitive change in children with epilepsy. The goal of the current study was to develop RCIs and SRB change score norms for use in children with epilepsy. Sixty-three children with epilepsy (age range: 6-16; M=10.19, SD=2.58) underwent comprehensive neuropsychological evaluations at two time points an average of 12 months apart. Practice effect-adjusted RCIs and SRB change score norms were calculated for all cognitive measures in the battery. Practice effects were quite variable across the neuropsychological measures, with the greatest differences observed among older children, particularly on the Children's Memory Scale and Wisconsin Card Sorting Test. There was also notable variability in test-retest reliabilities across measures in the battery, with coefficients ranging from 0.14 to 0.92. Reliable change indices and SRB change score norms for use in assessing meaningful cognitive change in children following epilepsy surgery are provided for measures with reliability coefficients above 0.50. This is the first study to provide RCIs and SRB change score norms for a comprehensive neuropsychological battery based on a large sample of children with epilepsy. Tables to aid in evaluating cognitive changes in children who have undergone epilepsy surgery are provided for clinical use. An Excel sheet to perform all relevant calculations is also available to interested clinicians or researchers. Copyright © 2015 Elsevier Inc. All rights reserved.

Trajectories of health-related quality of life in children with epilepsy: a cohort study.

PubMed

Ferro, Mark A; Camfield, Carol S; Levin, Simon D; Smith, Mary Lou; Wiebe, Samuel; Zou, Guangyong; Speechley, Kathy N

2013-11-01

Little is known about subgroups of children with epilepsy who may experience less favorable outcomes over time. The objectives of this study were to document trajectories of health-related quality of life (HRQL) and to identify predictors of the trajectory group in children with new-onset epilepsy. Data were obtained from the Health Related Quality of Life in Children with Epilepsy Study, a prospective multisite study of children 4-12 years old with new-onset epilepsy followed for 24 months. Health-related quality of life was measured using the Quality of Life in Childhood Epilepsy questionnaire. Trajectories of HRQL were investigated using latent class trajectory modeling. Multinomial logistic regression was used to identify child, parent, and family predictors of HRQL trajectories. A total of 374 families responded at baseline and 283 (76%) completed the study. Five HRQL trajectories were observed: low-increasing (4%), moderate-decreasing (12%), moderate-increasing (22%), high-increasing (32%), and high-stable (30%). Many children in the low-increasing, moderate-increasing, high-increasing, and high-stable had clinically meaningful improvements in HRQL: 82%, 47%, 63%, and 44%, respectively. In contrast, the majority of children in the moderate-decreasing group (56%) experienced clinically meaningful declines in their HRQL. Factors predicting trajectories were number of antiepileptic drugs prescribed, presence of comorbid behavior or cognitive problems, parent depression, and family functioning and demands. Results suggested that children with epilepsy are not homogenous but rather consist of groups with different trajectories and unique predictors of HRQL. Problems associated with child behavior and cognition were the strongest predictors identified. Given that several risk factors are modifiable, it is important to examine these as potential targets within a family-centered framework to improve HRQL of children with new-onset epilepsy. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Minimal clinically important difference of voice handicap index-10 in vocal fold paralysis.

PubMed

Young, VyVy N; Jeong, Kwonho; Rothenberger, Scott D; Gillespie, Amanda I; Smith, Libby J; Gartner-Schmidt, Jackie L; Rosen, Clark A

2018-06-01

The Voice Handicap Index-10 (VHI-10) is commonly used to measure patients' perception of vocal handicap. Clinical consensus has previously defined clinically meaningful improvement as a decrease ≥5. This study determines the minimal clinically important difference (MCID) for VHI-10 in patients with unilateral vocal fold paralysis (UVFP) using anchor-based methodology. Prospective cohort questionnaire analysis. Two hundred eighty-one UVFP patients completed the VHI-10 on two consecutive visits (within 3 months). At the follow-up visit, patients answered an 11-point Global Rating of Change Questionnaire (GRCQ) scored from -5 to +5. Relationship between the GRCQ and change in VHI-10 was quantified using analysis of variance, and MCID for the VHI-10 was determined using receiver operating characteristic (ROC) curve analysis. Overall mean VHI-10 change was -3.71 (standard deviation [SD] = 8.89) and mean GRCQ was 1.37 (SD = 2.51). Average interval between measurements was 1.73 months (SD = 0.83). Mean changes in VHI-10 scores were -7.45, -0.53, and +4.40 for patients whose GRCQ scores indicated improvement, no change, and worsening, respectively. Differences between mean scores were statistically significant (P < .001). Area under the ROC curve was 0.80, demonstrating the classification accuracy of VHI-10 change scores. A VHI-10 change of -4 was determined to be the optimal threshold that discriminated between improvement and no improvement (sensitivity and specificity 0.62 and 0.88, respectively). The MCID for improvement in VHI-10 in UVFP patients is a decrease of 4. This information improves understanding of patients' response to treatment and allows comparison between different treatments. Future research should determine MCID for VHI-10 across all voice disorders. 4. Laryngoscope, 128:1419-1424, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review.

PubMed

Mehta, Saurabh P; Fulton, Allison; Quach, Cedric; Thistle, Megan; Toledo, Cesar; Evans, Neil A

2016-03-01

Systematic review of measurement properties. Many primary studies have examined the measurement properties, such as reliability, validity, and sensitivity to change, of the Lower Extremity Functional Scale (LEFS) in different clinical populations. A systematic review summarizing these properties for the LEFS may provide an important resource. To locate and synthesize evidence on the measurement properties of the LEFS and to discuss the clinical implications of the evidence. A literature search was conducted in 4 databases (PubMed, MEDLINE, Embase, and CINAHL), using predefined search terms. Two reviewers performed a critical appraisal of the included studies using a standardized assessment form. A total of 27 studies were included in the review, of which 18 achieved a very good to excellent methodological quality level. The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs (Pearson correlation coefficient values of greater than 0.7). The responsiveness of the LEFS scores was excellent, as suggested by consistently high effect sizes (greater than 0.8) in patients with different lower extremity conditions. Minimal detectable change at the 90% confidence level (MDC90) for the LEFS scores varied between 8.1 and 15.3 across different reassessment intervals in a wide range of patient populations. The pooled estimate of the MDC90 was 6 points and the minimal clinically important difference was 9 points in patients with lower extremity musculoskeletal conditions, which are indicative of true change and clinically meaningful change, respectively. The results of this review support the reliability, validity, and responsiveness of the LEFS scores for assessing functional impairment in a wide array of patient groups with lower extremity musculoskeletal conditions.

The effect of bronchodilators on forced vital capacity measurement in patients with idiopathic pulmonary fibrosis

PubMed Central

Assayag, Deborah; Vittinghoff, Eric; Ryerson, Christopher J.; Cocconcelli, Elisabetta; Tonelli, Roberto; Hu, Xiaowen; Elicker, Brett M.; Golden, Jeffrey A.; Jones, Kirk D.; King, Talmadge E.; Koth, Laura L.; Lee, Joyce S.; Ley, Brett; Shum, Anthony K.; Wolters, Paul J.; Ryu, Jay H.; Collard, Harold R.

2015-01-01

Background Forced vital capacity (FVC) is a key measure of disease severity in patients with idiopathic pulmonary fibrosis (IPF) and is an important clinical trial endpoint. We hypothesize that reversible airflow limitation co-exists in a subgroup of patients with IPF, and that bronchodilator use will improve the performance characteristics of FVC. Methods IPF patients with pre and post-bronchodilator spirometry testing performed were identified from two tertiary referral cohorts. The difference between pre and post-bronchodilator FVC (intra-test difference) was calculated. The test characteristics of pre and post-bronchodilator FVC change over time (inter-test difference) were assessed in patients with sequential spirometry, and were used to generate sample size estimates for hypothetical clinical trials using change in FVC as the primary endpoint. Results There were 551 patients, contributing 967 unique spirometry tests. The mean intra-test increase in FVC with bronchodilator use was 0.04 liters (2.71 vs. 2.75 liters, p <0.001). Reversible airflow limitation (increase in FEV1 or FVC of ≥12% and ≥200 milliliters) occurred in 9.1% of patients. The inter-test difference in change in FVC over time were equivalent for pre and post-bronchodilator (p = 0.65), leading to similar sample size estimates in a hypothetical clinical trial using change in FVC as the primary endpoint. Conclusion Approximately one in ten patients with IPF has physiological evidence of reversible airflow limitation, and bronchodilator use in these patients may improve the assessment of disease progression based on FVC change over time. Bronchodilator use does not appear to meaningfully impact the precision of FVC as an endpoint in clinical trials. PMID:26140806

Patient educational media preferences for information about irritable bowel syndrome (IBS).

PubMed

Halpert, Albena; Dalton, Christine B; Palsson, Olafur; Morris, Carolyn; Hu, Yuming; Bangdiwala, Shrikant; Hankins, Jane; Norton, Nancy; Drossman, Douglas A

2008-12-01

To identify the educational media preferences of patients with irritable bowel syndrome (IBS). The IBS-Patient Education Questionnaire (PEQ) was administered to a national sample of IBS patients. Frequencies of item endorsements were compared and meaningful clinical differences were used to identify differences among subgroups. 1,242 patients completed the survey, mean age 39.3 years, 85% female, IBS duration 6.9 years, 79% had seen an MD for IBS within 6 months, and 92.6% used the web for medical information. The most desired source of education was "my doctor" (68%), followed by Internet (62%) and brochure (45%). Notably, patients favored an increase in use of media in the future (past vs. future): doctor (43 vs. 68%); Internet (36 vs. 62%); and brochures (26 vs. 45%). IBS patients expect more education than they have received. Understanding IBS patients' learning preferences can be highly valuable in the development or implementation of educational interventions.

Cross-Cultural Studies of Personality Traits and their Relevance to Psychiatry

PubMed Central

Terracciano, Antonio; McCrae, Robert R.

2009-01-01

Aims This article provides a brief review of recent cross-cultural research on personality traits at both individual and culture levels, highlighting the relevance of recent findings for psychiatry. Method In most cultures around the world, personality traits can be clearly summarized by the five broad dimensions of the Five-Factor Model (FFM), which makes it feasible to compare cultures on personality and psychopathology. Results Maturational patterns and sex differences in personality traits generally show cultural invariance, which generates the hypothesis that age of onset, clinical evolution, and sex differences in the prevalence of psychiatric disorders might follow similar universal patterns. The average personality profiles from 51 cultures show meaningful geographical distributions and associations with culture-level variables, but are clearly unrelated to national character stereotypes. Conclusions Aggregate personality scores can potentially be related to epidemiological data on psychiatric disorders, and dimensional personality models have implications for psychiatric diagnosis and treatment around the world. PMID:17128620

Application of Control Volume Analysis to Cerebrospinal Fluid Dynamics

NASA Astrophysics Data System (ADS)

Wei, Timothy; Cohen, Benjamin; Anor, Tomer; Madsen, Joseph

2011-11-01

Hydrocephalus is among the most common birth defects and may not be prevented nor cured. Afflicted individuals face serious issues, which at present are too complicated and not well enough understood to treat via systematic therapies. This talk outlines the framework and application of a control volume methodology to clinical Phase Contrast MRI data. Specifically, integral control volume analysis utilizes a fundamental, fluid dynamics methodology to quantify intracranial dynamics within a precise, direct, and physically meaningful framework. A chronically shunted, hydrocephalic patient in need of a revision procedure was used as an in vivo case study. Magnetic resonance velocity measurements within the patient's aqueduct were obtained in four biomedical state and were analyzed using the methods presented in this dissertation. Pressure force estimates were obtained, showing distinct differences in amplitude, phase, and waveform shape for different intracranial states within the same individual. Thoughts on the physiological and diagnostic research and development implications/opportunities will be presented.

Sexual Orientation and Gender Identity Data Collection Update: U.S. Government Takes Steps to Promote Sexual Orientation and Gender Identity Data Collection Through Meaningful Use Guidelines.

PubMed

Cahill, Sean; Makadon, Harvey J

2014-09-01

Collecting data on sexual orientation and gender identity (SO/GI) in healthcare settings and in electronic health records (EHRs) is essential to understanding, addressing, and reducing LGBT health disparities. The federal government took two key steps in early 2014 in support of asking SO/GI questions in clinical settings as part of the meaningful use of EHRs. First, the Office of the National Coordinator for Health Information Technology issued proposed 2015 Edition Certified EHR Technology (CEHRT) Criteria, which suggest Systematized Nomenclature of Medicine (SNOMED) code sets for SO/GI data collection in 2017. To facilitate the effective and accurate collection of SO/GI data, 153 LGBT and HIV groups recommended that the national coordinator request that the National Library of Medicine develop new codes to reflect SO/GI data. Second, the Health Information Technology Policy Committee submitted recommendations to the national coordinator, including the recommendation that "CEHRT [certified EHR technology] provides the functionality to capture … sexual orientation, gender identity." If the national coordinator accepts this recommendation, it will be put up for public comment in fall 2014 along with other Stage 3 proposed rules. Also, the 2017 Edition CEHRT Notice of Proposed Rule Making Criteria will be up for comment in fall 2014. Final Stage 3 Meaningful Use Guidelines will be published in summer 2015, and other key steps will take place into 2017. A critical parallel step is the training of clinical staff on LGBT health disparities and how to use SO/GI data and manage them in ways that meet the clinical needs of LGBT patients and protect confidentiality and privacy. We must also educate LGBT community members about why offering this information is important for their health and how collecting SO/GI data in EHRs is an important step to understanding LGBT health, reducing disparities, and improving outcomes.

A qualitative study of perceptions of meaningful change in spinal muscular atrophy.

PubMed

McGraw, Sarah; Qian, Ying; Henne, Jeff; Jarecki, Jill; Hobby, Kenneth; Yeh, Wei-Shi

2017-04-04

This qualitative study examined how individuals with Spinal Muscular Atrophy (SMA), their caregivers, and clinicians defined meaningful change, primarily in the Type II and non-ambulant type III patient populations, associated with treatment of this condition. In addition, we explored participants' views about two measures of motor function routinely used in clinical trials for these SMA subtypes, namely the expanded version of the Hammersmith Functional Motor Scale (HFMSE) and the Upper Limb Module (ULM). The 123 participants (21 with SMA, 64 parents, and 11 clinicians), recruited through SMA advocacy organizations, participated in one of 16 focus groups or 37 interviews. The sessions were audio-recorded, and verbatim transcripts were analyzed using a grounded theory approach. For the participants, meaningful change was relative to functional ability, and small changes in motor function could have an important impact on quality of life. Because patients and families feared progressive loss of functional ability, the participants saw maintenance of abilities as a meaningful outcome. They believed that measures of motor function covered important items, but worried that the HFMSE and ULM might not be sensitive enough to capture small changes. In addition, they felt that outcome measures should assess other important features of life with SMA, including the ability to perform daily activities, respiratory function, swallowing, fatigue, and endurance. Given the heterogeneity of SMA, it is important to expand the assessment of treatment effects to a broader range of outcomes using measures sensitive enough to detect small changes.

Early- versus Late-Onset Dysthymia

PubMed Central

Sansone, Lori A.

2009-01-01

In the current Diagnostic and Statistical Manual of Mental Disorders, dysthymic disorder is categorized as either early-onset or late-onset, based upon the emergence of symptoms before or after the age of 21, respectively. Does this diagnostic distinction have any meaningful clinical implications? In this edition of The Interface, we present empirical studies that have, within a single study, compared individuals with early-versus late-onset dysthymia. In this review, we found that, compared to those with late-onset dysthymia, early-onset patients are more likely to harbor psychiatric comorbidity both on Axis I and II, exhibit less psychological resilience, and have more prominent family loadings for mood disorders. These findings suggest that this distinction is meaningful and that the early-onset subtype of dysthymia is more difficult to effectively treat. PMID:20049145

Understanding mechanisms and seeking cures for Alzheimer's disease: why we must be "extraordinarily diverse".

PubMed

Thambisetty, Madhav

2017-10-01

After more than a century since Dr. Alois Alzheimer first described the pathological hallmarks accompanying the defining clinical features of the disease, we have yet to deliver any meaningful disease-modifying treatments to our patients. In this article, I present a rationale for the need to be "extraordinarily diverse" in seeking effective ways to treat or prevent this devastating disease. This approach is based on applying a systems-biology perspective at the population level, using a diverse array of "OMICS" methodologies to identify molecular mechanisms associated with well-established AD risk factors including systemic inflammation, obesity, and insulin resistance. We believe that applying this strategy to understand longitudinal changes in human physiology during aging is of paramount importance in identifying meaningful opportunities to intervene effectively in AD.

The Rules of Engagement

PubMed Central

Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K.; Valentine, James E.; Roberts, Jamie N.

2017-01-01

Objective: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. Methods: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Results: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations. Conclusions: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct. PMID:29714514

The effect of a supervised community-based exercise program on balance, balance confidence, and gait in individuals with lower limb amputation.

PubMed

Miller, Carol A; Williams, Jennifer E; Durham, Katey L; Hom, Selena C; Smith, Julie L

2017-10-01

Many individuals with lower limb loss report concern with walking ability after completing structured traditional rehabilitation. The purpose of this study was to explore the impact of a supervised community-based exercise program on balance, balance confidence, and gait in individuals with lower limb amputation. Repeated measures. The supervised exercise program was offered biweekly for 6 weeks. The GAITRite System by CIR Systems, Inc., the Figure-of-8 Walk Test, and Activity-specific Balance Confidence Scale were used to measure clinical outcomes pre- and post-intervention. In total, 16 participants with lower limb amputation (mean age: 50.8 years) completed the study. A multivariate, repeated measures analysis of variance indicated a statistically significant effect of training across six clinical outcome measures ( F(6, 10) = 4.514, p = .018). Moderate effect sizes were found for the Figure-of-8 Walk Test ( η 2 = .586), Activity-specific Balance Confidence Scale ( η 2 = .504), and gait velocity at comfortable walking speed ( η 2 = .574). The average increase in gait speed was clinically meaningful at .14 m/s. The supervised community-based exercise program implemented in this study was designed to address specific functional needs for individuals with lower limb loss. Each participant experienced clinically meaningful improvements in balance, balance confidence, and walking ability. Clinical relevance The provision of a supervised community-based exercise program, after traditional rehabilitation, provides opportunity to offer a continuum of care that may enhance prosthetic functional ability and active participation in the community for individuals with lower limb amputation.

Executive functioning and visual working memory.

PubMed

Lepach, Anja C; Pauls, Franz; Petermann, Franz

2015-01-01

The matter of modality is controversially discussed in the context of working memory (WM). There is evidence that modality-specific processes are accompanied by amodal processes to some extent. We investigated the relationship between executive-functioning tasks and visual WM (VWM) and were especially interested in the issue of amodal processes. Our correlational analyses suggest modality-independent relations of the tasks. We also aimed to quantify to what extent executive functioning is meaningful for VWM performances. We therefore estimated the relationship between executive tasks and VWM performances in a healthy (n = 710) and a clinical traumatic brain injury sample (n = 151) as well as in the combined total sample. The results indicate a substantial relevance of the verbal task for VWM performances in the total and the clinical sample but a low relevance in the healthy sample. These results could support assumptions of resource-depending differences in the relations of executive functioning and VWM but need further validation due to limitations of our study.

Influence of social support on health-related quality of life outcomes in head and neck cancer.

PubMed

Karnell, Lucy Hynds; Christensen, Alan J; Rosenthal, Eben L; Magnuson, J Scott; Funk, Gerry F

2007-02-01

Evidence that social support influences health-related quality of life (HRQOL) in oncologic patients could be particularly important for head and neck cancer because this disease can affect speech, eating, and facial aesthetics. Multiple regression analyses were used in this prospective, observational study to determine the association between 394 patients' ratings of perceived post-treatment social support and HRQOL outcomes while controlling for possible confounding variables. Higher social support scores were significantly associated with higher scores in speech (p = .007), aesthetics (p = .015), social disruption (p = .045), and general mental health (p = .016) and with fewer depressive symptoms (p = .023) but not with general physical health (p = .191) or eating (p = .114). The magnitude of differences in the HRQOL outcomes for patients whose social support scores fell in the lowest and highest quartiles were clinically meaningful. Given the association between social support and HRQOL outcomes in this patient population, modification of perceived social support through clinical interventions could improve the survivorship of these patients.

Virtual Constraint Control of a Powered Prosthetic Leg: From Simulation to Experiments with Transfemoral Amputees.

PubMed

Gregg, Robert D; Lenzi, Tommaso; Hargrove, Levi J; Sensinger, Jonathon W

2014-12-01

Recent powered (or robotic) prosthetic legs independently control different joints and time periods of the gait cycle, resulting in control parameters and switching rules that can be difficult to tune by clinicians. This challenge might be addressed by a unifying control model used by recent bipedal robots, in which virtual constraints define joint patterns as functions of a monotonic variable that continuously represents the gait cycle phase. In the first application of virtual constraints to amputee locomotion, this paper derives exact and approximate control laws for a partial feedback linearization to enforce virtual constraints on a prosthetic leg. We then encode a human-inspired invariance property called effective shape into virtual constraints for the stance period. After simulating the robustness of the partial feedback linearization to clinically meaningful conditions, we experimentally implement this control strategy on a powered transfemoral leg. We report the results of three amputee subjects walking overground and at variable cadences on a treadmill, demonstrating the clinical viability of this novel control approach.

Virtual Constraint Control of a Powered Prosthetic Leg: From Simulation to Experiments with Transfemoral Amputees

PubMed Central

Lenzi, Tommaso; Hargrove, Levi J.; Sensinger, Jonathon W.

2014-01-01

Recent powered (or robotic) prosthetic legs independently control different joints and time periods of the gait cycle, resulting in control parameters and switching rules that can be difficult to tune by clinicians. This challenge might be addressed by a unifying control model used by recent bipedal robots, in which virtual constraints define joint patterns as functions of a monotonic variable that continuously represents the gait cycle phase. In the first application of virtual constraints to amputee locomotion, this paper derives exact and approximate control laws for a partial feedback linearization to enforce virtual constraints on a prosthetic leg. We then encode a human-inspired invariance property called effective shape into virtual constraints for the stance period. After simulating the robustness of the partial feedback linearization to clinically meaningful conditions, we experimentally implement this control strategy on a powered transfemoral leg. We report the results of three amputee subjects walking overground and at variable cadences on a treadmill, demonstrating the clinical viability of this novel control approach. PMID:25558185

Oral tolerance induction for human food allergy.

PubMed

Noh, Geunwoong; Lee, Jae Ho

2012-04-01

Food allergies are classified as IgE-mediated and non-IgE mediated type. The number of successful reports of immunotherapy, namely tolerance induction for food allergy (TIFA) are increasing, bringing hope for meaningful positive and radical treatment of food allergy. Therapeutic characteristics of the clinical course in TIFA for NFA are different from TIFA for IFA. Cytokines including IL-10, TGF-β and IFN-γ and regulatory cells such as Treg and Breg, are involved in immune tolerance. IFN-γ has been used for tolerance induction of food allergy as an immunomodulatory biologics. A definitive distinction between IgE-mediated and non-IgE-mediated food allergies is absolutely essential for diagnostic and therapeutic purposes. Original SOTI using IFN-γ is more effective then conventional SOTI without IFN-γ. Especially, IFN-γ is absolutely necessary for the tolerance induction of NFA. This review highlights and updates the advances in the conceptual immunological background and the clinical characteristics of oral tolerance induction for food allergy.

Biomarkers for immunotherapy in genitourinary malignancies.

PubMed

Slovin, Susan F

2016-04-01

Immunotherapy for genitourinary malignancies such as prostate, renal, and bladder cancers has experienced a resurgence since the development of 3 novel strategies: the autologous cellular product therapy, Sipuleucel-T for prostate cancer, the checkpoint inhibitors, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed cell death ligand 1 (anti-PD1), and anti-programmed cell death ligand 1), respectively. These agents have led to strikingly durable responses in several of these solid tumors, but their efficacy has been inconsistent. Why all solid tumors are not equal in their response to these therapies is unclear. More importantly, changes in humoral or cellular responses which may reflect changes in a tumor's biology have been limited due to differences in immune monitoring and lack of consistency in established reliable immunologic endpoints. How to design immunologic end points that reflect a meaningful effect on the cancer remains a challenge for clinical trial development. The issues faced by clinical investigators and the current state of immune monitoring are discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

Association between radiation therapy, surgery, or observation for localized prostate cancer and patient-reported outcomes after 3 years

PubMed Central

Barocas, Daniel A.; Alvarez, JoAnn; Resnick, Matthew J.; Koyama, Tatsuki; Hoffman, Karen E.; Tyson, Mark D.; Conwill, Ralph; McCollum, Dan; Cooperberg, Matthew R.; Goodman, Michael; Greenfield, Sheldon; Hamilton, Ann S.; Hashibe, Mia; Kaplan, Sherrie H.; Paddock, Lisa E.; Stroup, Antoinette M.; Wu, Xiao-Cheng; Penson, David F.

2017-01-01

Importance Prostate cancer treatments are associated with side effects. Understanding the side effects of contemporary approaches to management of localized prostate could inform shared decision-making. Objective To compare the harms of radical prostatectomy (RP), radiation (EBRT) and active surveillance (AS). Design The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, cohort study of men diagnosed with localized prostate cancer in 2011–2012. This study reports follow up through August 2015. Setting Patients accrued from five Surveillance Epidemiology, and End Results registry sites and the Cancer of the Prostate Strategic Urologic Research Endeavor. Participants Men < 80 years old with clinical stage cT1-2 disease, prostate specific antigen < 50 ng/mL, enrolled within six months of diagnosis, who completed a baseline survey and at least 1 follow-up survey. Exposure Treatment with RP, EBRT or AS was ascertained within one year of diagnosis. Main Outcome and Measures Patient-reported function in sexual, urinary incontinence, urinary irritative, bowel, and hormonal domains on the 26-item Expanded Prostate Cancer Index Composite (EPIC) 36 months after enrollment. Domain scores range from 0–100. Higher score indicates better function. Minimum clinically important difference defined as 10–12, 6, 5, 5, and 4, respectively. Results The cohort included 2550 men (mean age 63.8 years, 74% white, 55% intermediate or high risk), of whom 1523 (59.7%) underwent RP, 598 (23.5%) EBRT, and 429 (16.8%) AS. Men undergoing EBRT were older (mean age 68.1 vs. 61.5, p<0.001), and had worse baseline sexual function (mean EPIC domain score 52.3 vs. 65.2, p<0.001) than men undergoing RP. At 3 years, adjusted mean sexual domain score for men undergoing RP had declined more than for men undergoing EBRT (mean difference −11.9 points, 95% CI [−15.1, −8.7]). The difference in decline in sexual domain scores between EBRT and AS was not clinically significant (−4.3 points, 95% CI [−9.2, 0.7]). RP was associated with worse urinary incontinence than EBRT (−18.0 points, 95% CI [−20.5, −15.4]) or AS (−12.7 points, 95% CI [−16.0, −9.3]) and better urinary irritative symptoms compared to AS (5.2 points, 95% CI [3.2, 7.2]). No clinically significant differences for bowel or hormone function were noted beyond 12 months. No differences in global quality of life or disease-specific survival (3 deaths) were noted (99.7–100%). Conclusion and Relevance In this cohort of men with localized prostate cancer, RP was associated with a larger decline in sexual function and urinary incontinence than EBRT or AS after 3 years, and lesser urinary irritative symptoms compared to AS; however, there were no meaningful differences in bowel or hormonal function beyond 12 months and no meaningful differences in global quality of life measures. These findings may facilitate counseling regarding the comparative harms of contemporary treatments for prostate cancer. PMID:28324093

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

PubMed

Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

2017-11-01

This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

Designing Trials for Testing the Efficacy of Pre- Pro- and Synbiotics

NASA Astrophysics Data System (ADS)

Lewis, Stephen; Atkinson, Charlotte

Providing an evidence base for the rational delivery of medicines and treatments is the cornerstone of modern health care delivery. Much of this evidence base is gained through conducting clinical trials. Superficially, designing a clinical trial seems straightforward. However, in practice many unforeseen difficulties arise with long setting up times, poor recruitment rates and patients or interventions not behaving in the way expected. Unfortunately, clinical trials examining the efficacy of pre-, pro- and synbiotics have developed a reputation for being published in low impact journals and reaching unconvincing conclusions. As a generalization, the reason for this poor reputation is that the trials have tended to be too small and have not used meaningful clinical endpoints.

The number needed to treat: a clinically useful measure of treatment effect.

PubMed Central

Cook, R. J.; Sackett, D. L.

1995-01-01

The relative benefit of an active treatment over a control is usually expressed as the relative risk, the relative risk reduction, or the odds ratio. These measures are used extensively in both clinical and epidemiological investigations. For clinical decision making, however, it is more meaningful to use the measure "number needed to treat." This measure is calculated on the inverse of the absolute risk reduction. It has the advantage that it conveys both statistical and clinical significance to the doctor. Furthermore, it can be used to extrapolate published findings to a patient at an arbitrary specified baseline risk when the relative risk reduction associated with treatment is constant for all levels of risk. PMID:7873954

Motor unit number estimates correlate with strength in polio survivors.

PubMed

Sorenson, Eric J; Daube, Jasper R; Windebank, Anthony J

2006-11-01

Motor unit number estimation (MUNE) has been proposed as an outcome measure in clinical trials for the motor neuron diseases. One major criticism of MUNE is that it may not represent a clinically meaningful endpoint. We prospectively studied a cohort of polio survivors over a period of 15 years with respect to MUNE and strength. We identified a significant association between thenar MUNE and arm strength, extensor digitorum brevis MUNE and leg strength, and the summated MUNE and global strength of the polio survivors. These findings confirm the clinical relevance of MUNE as an outcome measure in the motor neuron diseases and provide further validation for its use in clinical trial research.

Building Data-Driven Pathways From Routinely Collected Hospital Data: A Case Study on Prostate Cancer

PubMed Central

Clark, Jeremy; Cooper, Colin S; Mills, Robert; Rayward-Smith, Victor J; de la Iglesia, Beatriz

2015-01-01

Background Routinely collected data in hospitals is complex, typically heterogeneous, and scattered across multiple Hospital Information Systems (HIS). This big data, created as a byproduct of health care activities, has the potential to provide a better understanding of diseases, unearth hidden patterns, and improve services and cost. The extent and uses of such data rely on its quality, which is not consistently checked, nor fully understood. Nevertheless, using routine data for the construction of data-driven clinical pathways, describing processes and trends, is a key topic receiving increasing attention in the literature. Traditional algorithms do not cope well with unstructured processes or data, and do not produce clinically meaningful visualizations. Supporting systems that provide additional information, context, and quality assurance inspection are needed. Objective The objective of the study is to explore how routine hospital data can be used to develop data-driven pathways that describe the journeys that patients take through care, and their potential uses in biomedical research; it proposes a framework for the construction, quality assessment, and visualization of patient pathways for clinical studies and decision support using a case study on prostate cancer. Methods Data pertaining to prostate cancer patients were extracted from a large UK hospital from eight different HIS, validated, and complemented with information from the local cancer registry. Data-driven pathways were built for each of the 1904 patients and an expert knowledge base, containing rules on the prostate cancer biomarker, was used to assess the completeness and utility of the pathways for a specific clinical study. Software components were built to provide meaningful visualizations for the constructed pathways. Results The proposed framework and pathway formalism enable the summarization, visualization, and querying of complex patient-centric clinical information, as well as the computation of quality indicators and dimensions. A novel graphical representation of the pathways allows the synthesis of such information. Conclusions Clinical pathways built from routinely collected hospital data can unearth information about patients and diseases that may otherwise be unavailable or overlooked in hospitals. Data-driven clinical pathways allow for heterogeneous data (ie, semistructured and unstructured data) to be collated over a unified data model and for data quality dimensions to be assessed. This work has enabled further research on prostate cancer and its biomarkers, and on the development and application of methods to mine, compare, analyze, and visualize pathways constructed from routine data. This is an important development for the reuse of big data in hospitals. PMID:26162314

The effect of xerostomia and hyposalivation on the quality of life of patients with type II diabetes mellitus

PubMed Central

Molania, Tahereh; Alimohammadi, Mona; Akha, Ozra; Mousavi, Jaber; Razvini, Ramin; Salehi, Maedeh

2017-01-01

Background Diabetes mellitus is a chronic metabolic disease which can have numerous physical effects for patient. Xerostomia is one of these complications. Compared to healthy people, patients with diabetes mellitus, have a worse quality of life, and complications of diabetes are the main determinants of quality of life in these patients. Objective The aim of this study was to determine the effects of xerostomia and hyposalivation on quality of life of patients with type 2 diabetes mellitus. Methods This descriptive-analytical epidemiological study was conducted on 200 patients with type 2 diabetes mellitus referred to the diabetes clinic of Shahid Mostafavi in Sari city from October 2015 to January in 2016. A questionnaire containing personal characteristics and medical situation was completed by each person. Then, the Persian Oral Health Impact Profile-14 (OHIP-14-PER) questionnaire was completed by the patients. Eventually, with the use of chewable paraffin for 1.5 min by the patient, stimulated salivary flow rate (SSFR) test was performed, and in order to determine hyposalivation, their saliva amount underwent a gravimetric test. Finally, using statistical software SPSS16, the information was statistically analyzed by independent-samples t-test, Mann-Whitney U, Chi-squared and fisher exact tests. Results The average age of patient was 56.41 years old (43% male and 57% female). Mean SSFR was 0.7 ml/min in patients and xerostomia were confirmed in 112 patients. Difference between age, gender, drug use, years affecting to diabetes and FBS amount in patient with hyposalivation were not statistically meaningful in proportion to patients without it. But difference between HbA1C and SSFR in patients with hyposalivation were statistically meaningful than to patients without it (p=0.03, p=0.001 respectively). The mean patient score to OHIP-14 were obtained as 38.17. The questionnaire score difference in patients with hyposalivation in proportion to patients without it were not statistically meaningful. Conclusion Hyposalivation possibility increases in diabetic patients with low metabolic control which can cause more severe side effects in relation to oral health. Xerostomia in diabetic patients has negative effects on oral health related quality of life. Diabetic control and patients’ oral problem improvement is effective in their quality of life promotion. PMID:29403624

The effect of xerostomia and hyposalivation on the quality of life of patients with type II diabetes mellitus.

PubMed

Molania, Tahereh; Alimohammadi, Mona; Akha, Ozra; Mousavi, Jaber; Razvini, Ramin; Salehi, Maedeh

2017-11-01

Diabetes mellitus is a chronic metabolic disease which can have numerous physical effects for patient. Xerostomia is one of these complications. Compared to healthy people, patients with diabetes mellitus, have a worse quality of life, and complications of diabetes are the main determinants of quality of life in these patients. The aim of this study was to determine the effects of xerostomia and hyposalivation on quality of life of patients with type 2 diabetes mellitus. This descriptive-analytical epidemiological study was conducted on 200 patients with type 2 diabetes mellitus referred to the diabetes clinic of Shahid Mostafavi in Sari city from October 2015 to January in 2016. A questionnaire containing personal characteristics and medical situation was completed by each person. Then, the Persian Oral Health Impact Profile-14 (OHIP-14-PER) questionnaire was completed by the patients. Eventually, with the use of chewable paraffin for 1.5 min by the patient, stimulated salivary flow rate (SSFR) test was performed, and in order to determine hyposalivation, their saliva amount underwent a gravimetric test. Finally, using statistical software SPSS16, the information was statistically analyzed by independent-samples t-test, Mann-Whitney U, Chi-squared and fisher exact tests. The average age of patient was 56.41 years old (43% male and 57% female). Mean SSFR was 0.7 ml/min in patients and xerostomia were confirmed in 112 patients. Difference between age, gender, drug use, years affecting to diabetes and FBS amount in patient with hyposalivation were not statistically meaningful in proportion to patients without it. But difference between HbA1C and SSFR in patients with hyposalivation were statistically meaningful than to patients without it (p=0.03, p=0.001 respectively). The mean patient score to OHIP-14 were obtained as 38.17. The questionnaire score difference in patients with hyposalivation in proportion to patients without it were not statistically meaningful. Hyposalivation possibility increases in diabetic patients with low metabolic control which can cause more severe side effects in relation to oral health. Xerostomia in diabetic patients has negative effects on oral health related quality of life. Diabetic control and patients' oral problem improvement is effective in their quality of life promotion.

Closing the clinical gap: translating best practice knowledge to performance with guidelines implementation.

PubMed

Ishii, Lisa E

2013-06-01

Unsustainable health care costs coupled with opportunity for improvement in health care outcomes in the United States are stimulating meaningful transformation in the way we deliver care. One approach in this transformation focuses on minimizing unnecessary variation in physician practices, instead focusing on evidence-based medicine in a more uniform manner. Clinical practice guidelines contain evidence-based recommendations, articulate goals of care, and can help to reduce unnecessary variation. While thousands of clinical practice guidelines are in existence, a clinical gap exists between knowledge and clinical performance. With thoughtful guidelines implementation strategies in place, organizations can begin to close the gap and translate best practice knowledge into care. Health systems that have done this effectively have seen improved clinical outcomes, improved patient satisfaction, and lower cost per patient.

A Purpose-Driven Fourth Year of Medical School.

PubMed

Dewan, Mantosh; Norcini, John

2017-10-03

The fourth year of medical school has been repeatedly found to be ineffective, and concerns exist about its purpose and academic quality, as well as grade inflation. Since Flexner, the purpose of undergraduate medical training has moved from readiness for independent practice to readiness for postgraduate training. However, training directors report that medical graduates are inadequately prepared to enter residency. The authors propose a fourth year with two components: first, a yearlong, longitudinal ambulatory experience of at least three days each week on an interprofessional team with consistent faculty supervision and mentoring, increasing independence, and a focus on education; and second, rigorous clinical-scales-based assessment of meaningful outcomes.In the proposed model, the medical student has generous time with a limited panel of patients, and increasing autonomy, with faculty moving from supervising physicians to collaborating physicians. There is regular assessment and formative feedback. This more independent, longitudinal clinical experience uniquely allows assessment of the most meaningful work-based performance outcomes-that is, patient outcomes assessed by validated clinical scales. The proposed fourth year will require a realignment of resources and faculty time; however, models already exist. Barriers and possible solutions are discussed.A purpose-driven, assessment-rich fourth year with patient and supervisor continuity will provide real-world experience, making medical graduates more competent and confident on the first day of residency. Use of clinical scales will also allow educators new confidence that the performance-based competence of these more experienced and expert graduates leads to demonstrable collaboration, healing, and good patient outcomes.

Prospective open-label evaluation of long-term low-dose doxycycline for difficult-to-treat chronic rhinosinusitis with nasal polyps.

PubMed

Pinto Bezerra Soter, A C; Bezerra, T F; Pezato, R; Teles Abdo, T R; Pilan, R M; Pinna, F R; Gevaert, P; van Zele, T; Bachert, C; Voegels, R L

2017-06-01

This study aimed to assess clinical outcomes of long-term low-dose oral doxycycline therapy in difficult-to-treat chronic rhinosinusitis with polyps (CRSwNP). This was a prospective, open-label study of 60 patients with difficult-to-treat CRSwNP who had undergone endoscopic sinus surgery. Patients were divided into two groups: 28 received nasal steroids, saline irrigation, and doxycycline (200 mg on the first day, followed by 100 mg once daily) for 12 weeks, while 30 received only nasal steroids and saline irrigation. The main outcome measure was an adequate effect size of doxycycline treatment on clinically meaningful significant improvement of SNOT-20. Other outcome measures were the SNOT-20, NOSE, and Lund-Kennedy scores. The following parameters were also analyzed: asthma, rhinitis, non-steroidal-exacerbated respiratory disease (NERD), and baseline serum IgG, IgA, IgE, IgM, ANCA, and eosinophil count. There was an adequate effect size of doxycycline treatment on clinically meaningful significant improvement of SNOT-20. Patients who received doxycycline also had significantly better outcomes regarding SNOT-20, NOSE, and Lund-Kennedy scores. There was a negative association among a clinically significant improvement of SNOT-20 and presence of asthma, NERD, and elevated serum IgE levels before treatment. These findings suggest that doxycycline may have a beneficial role for CRSwNP patients, especially for patients without asthma, NERD or high levels of serum IgE before treatment.

A Focused Observation Tool Using Dreyfus Stages of Skill Acquisition as an Evaluative Scale.

PubMed

Driver, Richard; Grose, Brian; Serafini, Mario; Cottrell, Scott; Sizemore, Daniel; Vallejo, Manuel

2017-01-01

Focused Observartion (FO) is associated with assessing complex skills and differs from generalized observations and evaluations. We've developed a FO assessing clinical procedural skills using Hubert Dreyfus Stages of Skill Acquisition as descriptive anchors. This study sought to analyze the effectiveness of this measure of skill progression. During week 1 and week 4 of training, FO was performed repetitively on 6 residents during endotracheal intubation. Skill stage ratings were converted to numerical scores. A dependent, paired samples t-test was calculated using total mean score (dependent variable) and an effect size. (Cohen's d) was performed to ascertain the standardized mean difference between observations. A significant improvement in mean scores occurred between Week 1 (AVG 1.2, STDV ± 0.1) and Week 4 (AVG 2.0, STDV ± 0.1) (t= -3.9, p<.05) Calculated Chohen's d indicates that this difference was meaningful. This study demonstrates success in adapting a Focused Observation technique and an innovative evaluative scale based upon Dreyfus stages of skill acquisition.

The challenge of racial difference: skills for clinical practice.

PubMed

Proctor, E K; Davis, L E

1994-05-01

Just as racial injustice negatively affects the plight of minorities in society, racial tensions impede professional helping. Often, the racially dissimilar social worker and client approach each other with little understanding of each other's social realities and with unfounded assumptions. Unfortunately, professionals find it difficult to acknowledge such differences or their effect on their relationships. Yet the fruitfulness of the helping encounter often depends on the ability to develop and invest in a trusting relationship. This article identifies the societal roots of the stresses associated with cross-racial relationships. Three concerns commonly experienced by clients whose workers are racially different are identified: (1) Is the helper a person of goodwill? (2) Is the helper trained and skilled? (3) Is the help offered valid and meaningful for me and my social reality? Case vignettes are used to illustrate how each concern is typically mishandled. The importance of successfully managing each concern is stressed, and skills for successful management are illustrated.

Apparently abnormal Wechsler Memory Scale index score patterns in the normal population.

PubMed

Carrasco, Roman Marcus; Grups, Josefine; Evans, Brittney; Simco, Edward; Mittenberg, Wiley

2015-01-01

Interpretation of the Wechsler Memory Scale-Fourth Edition may involve examination of multiple memory index score contrasts and similar comparisons with Wechsler Adult Intelligence Scale-Fourth Edition ability indexes. Standardization sample data suggest that 15-point differences between any specific pair of index scores are relatively uncommon in normal individuals, but these base rates refer to a comparison between a single pair of indexes rather than multiple simultaneous comparisons among indexes. This study provides normative data for the occurrence of multiple index score differences calculated by using Monte Carlo simulations and validated against standardization data. Differences of 15 points between any two memory indexes or between memory and ability indexes occurred in 60% and 48% of the normative sample, respectively. Wechsler index score discrepancies are normally common and therefore not clinically meaningful when numerous such comparisons are made. Explicit prior interpretive hypotheses are necessary to reduce the number of index comparisons and associated false-positive conclusions. Monte Carlo simulation accurately predicts these false-positive rates.

Early Maladaptive Schemas and Cognitive Distortions in Adults with Morbid Obesity: Relationships with Mental Health Status

PubMed Central

da Luz, Felipe Q.; Sainsbury, Amanda; Hay, Phillipa; Roekenes, Jessica A.; Swinbourne, Jessica; da Silva, Dhiordan C.; da S. Oliveira, Margareth

2017-01-01

Dysfunctional cognitions may be associated with unhealthy eating behaviors seen in individuals with obesity. However, dysfunctional cognitions commonly occur in individuals with poor mental health independently of weight. We examined whether individuals with morbid obesity differed with regard to dysfunctional cognitions when compared to individuals of normal weight, when mental health status was controlled for. 111 participants—53 with morbid obesity and 58 of normal weight—were assessed with the Mini-Mental State Examination, Young Schema Questionnaire, Cognitive Distortions Questionnaire, Depression, Anxiety and Stress Scale, and a Demographic and Clinical Questionnaire. Participants with morbid obesity showed higher scores in one (insufficient self-control/self-discipline) of 15 early maladaptive schemas and in one (labeling) of 15 cognitive distortions compared to participants of normal weight. The difference between groups for insufficient self-control/self-discipline was not significant when mental health status was controlled for. Participants with morbid obesity showed more severe anxiety than participants of normal weight. Our findings did not show clinically meaningful differences in dysfunctional cognitions between participants with morbid obesity or of normal weight. Dysfunctional cognitions presented by individuals with morbid obesity are likely related to their individual mental health and not to their weight. PMID:28264484

Comparison of meaningful learning characteristics in simulated nursing practice after traditional versus computer-based simulation method: a qualitative videography study.

PubMed

Poikela, Paula; Ruokamo, Heli; Teräs, Marianne

2015-02-01

Nursing educators must ensure that nursing students acquire the necessary competencies; finding the most purposeful teaching methods and encouraging learning through meaningful learning opportunities is necessary to meet this goal. We investigated student learning in a simulated nursing practice using videography. The purpose of this paper is to examine how two different teaching methods presented students' meaningful learning in a simulated nursing experience. The 6-hour study was divided into three parts: part I, general information; part II, training; and part III, simulated nursing practice. Part II was delivered by two different methods: a computer-based simulation and a lecture. The study was carried out in the simulated nursing practice in two universities of applied sciences, in Northern Finland. The participants in parts II and I were 40 first year nursing students; 12 student volunteers continued to part III. Qualitative analysis method was used. The data were collected using video recordings and analyzed by videography. The students who used a computer-based simulation program were more likely to report meaningful learning themes than those who were first exposed to lecture method. Educators should be encouraged to use computer-based simulation teaching in conjunction with other teaching methods to ensure that nursing students are able to receive the greatest educational benefits. Copyright © 2014 Elsevier Ltd. All rights reserved.

Role of meaningful subgroups in explaining differences in perceived variability for in-groups and out-groups.

PubMed

Park, B; Ryan, C S; Judd, C M

1992-10-01

Five aspects of the complexity of the knowledge representation of business and engineering majors were examined to see whether these differed by group membership and whether these differences were related to differences in perceived variability. Significantly more subgroups were generated when describing the in-group than the out-group; this difference predicted the relative tendency to see the in-group as more variable, and when controlled for statistically, out-group homogeneity effects were eliminated. Familiarity, redundancy, number of attributes used to describe the group, and the deviance of the subgroups from the larger group generally showed differences for in-group and out-group but did not show consistent evidence of mediation. In a 2nd study, Ss who were asked to sort group members into meaningful subgroups perceived greater variability relative to those who did not perform the sorting task.

Classifying Autism Spectrum Disorders by ADI-R: Subtypes or Severity Gradient?

ERIC Educational Resources Information Center

Cholemkery, Hannah; Medda, Juliane; Lempp, Thomas; Freitag, Christine M.

2016-01-01

To reduce phenotypic heterogeneity of Autism spectrum disorders (ASD) and add to the current diagnostic discussion this study aimed at identifying clinically meaningful ASD subgroups. Cluster analyses were used to describe empirically derived groups based on the Autism Diagnostic Interview-revised (ADI-R) in a large sample of n = 463 individuals…