Is the wrong question being asked in infertility research?

PubMed

Luke, Barbara; Stern, Judy E; Hornstein, Mark D; Kotelchuck, Milton; Diop, Hafsatou; Cabral, Howard; Declercq, Eugene R

2016-01-01

A persistent finding is that assisted reproductive technology (ART) is associated with compromised birth outcomes, including higher risks for prematurity, low birthweight, and congenital malformations, even among singletons. Over the past decade, our research group, the Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART), has evaluated pregnancy and birth outcomes among three groups of women, those women treated with ART, those with indicators of subfertility but without ART treatment, and fertile women. We have also explored the influence of infertility-related diagnoses on outcomes for women and infants. Over the course of our research, we have changed our perspective from an original focus on ART treatment parameters as the primary cause of excess morbidity to one centered instead on the underlying infertility-related diagnoses. This paper summarizes the research findings from our group that support this change in focus for infertility-based research from a primary emphasis on ART treatment to greater attention to the contribution of preexisting pathology underlying the infertility and suggests directions for future analyses.

Regulatory T cell effects in antitumor laser immunotherapy: a mathematical model and analysis

NASA Astrophysics Data System (ADS)

Dawkins, Bryan A.; Laverty, Sean M.

2016-03-01

Regulatory T cells (Tregs) have tremendous influence on treatment outcomes in patients receiving immunotherapy for cancerous tumors. We present a mathematical model incorporating the primary cellular and molecular components of antitumor laser immunotherapy. We explicitly model developmental classes of dendritic cells (DCs), cytotoxic T cells (CTLs), primary and metastatic tumor cells, and tumor antigen. Regulatory T cells have been shown to kill antigen presenting cells, to influence dendritic cell maturation and migration, to kill activated killer CTLs in the tumor microenvironment, and to influence CTL proliferation. Since Tregs affect explicitly modeled cells, but we do not explicitly model dynamics of Treg themselves, we use model parameters to analyze effects of Treg immunosuppressive activity. We will outline a systematic method for assigning clinical outcomes to model simulations and use this condition to associate simulated patient treatment outcome with Treg activity.

Human Hepatocyte Isolation: Does Portal Vein Embolization Affect the Outcome?

PubMed

Kluge, Martin; Reutzel-Selke, Anja; Napierala, Hendrik; Hillebrandt, Karl Herbert; Major, Rebeka Dalma; Struecker, Benjamin; Leder, Annekatrin; Siefert, Jeffrey; Tang, Peter; Lippert, Steffen; Sallmon, Hannes; Seehofer, Daniel; Pratschke, Johann; Sauer, Igor M; Raschzok, Nathanael

2016-01-01

Primary human hepatocytes are widely used for basic research, pharmaceutical testing, and therapeutic concepts in regenerative medicine. Human hepatocytes can be isolated from resected liver tissue. Preoperative portal vein embolization (PVE) is increasingly used to decrease the risk of delayed postoperative liver regeneration by induction of selective hypertrophy of the future remnant liver tissue. The aim of this study was to investigate the effect of PVE on the outcome of hepatocyte isolation. Primary human hepatocytes were isolated from liver tissue obtained from partial hepatectomies (n = 190) using the two-step collagenase perfusion technique followed by Percoll purification. Of these hepatectomies, 27 isolations (14.2%) were performed using liver tissue obtained from patients undergoing PVE before surgery. All isolations were characterized using parameters that had been described in the literature as relevant for the outcome of hepatocyte isolation. The isolation outcomes of the PVE and the non-PVE groups were then compared before and after Percoll purification. Metabolic parameters (transaminases, urea, albumin, and vascular endothelial growth factor secretion) were measured in the supernatant of cultured hepatocytes for more than 6 days (PVE: n = 4 and non-PVE: n = 3). The PVE and non-PVE groups were similar in regard to donor parameters (sex, age, and indication for surgery), isolation parameters (liver weight and cold ischemia time), and the quality of the liver tissue. The mean initial viable cell yield did not differ between the PVE and non-PVE groups (10.16 ± 2.03 × 10(6) cells/g vs. 9.70 ± 0.73 × 10(6) cells/g, p = 0.499). The initial viability was slightly better in the PVE group (77.8% ± 2.03% vs. 74.4% ± 1.06%). The mean viable cell yield (p = 0.819) and the mean viability (p = 0.141) after Percoll purification did not differ between the groups. PVE had no effect on enzyme leakage and metabolic activity of cultured hepatocytes. Although PVE leads to drastic metabolic alterations and changes in hepatic blood flow, embolized liver tissue is a suitable source for the isolation of primary human hepatocytes and is equivalent to untreated liver tissue in regard to cell yield and viability.

Effect of technical parameters on transjugular intrahepatic portosystemic shunts utilizing stent grafts.

PubMed

Andring, Brice; Kalva, Sanjeeva P; Sutphin, Patrick; Srinivasa, Rajiv; Anene, Alvin; Burrell, Marc; Xi, Yin; Pillai, Anil K

2015-07-14

To assess the effect of technical parameters on outcomes of transjugular intrahepatic portosystemic shunt (TIPS) created using a stent graft. The medical records of 68 patients who underwent TIPS placement with a stent graft from 2008 to 2014 were reviewed by two radiologists blinded to the patient outcomes. Digital Subtraction Angiographic images with a measuring catheter in two orthogonal planes was used to determine the TIPS stent-to-inferior vena cava distance (SIVCD), hepatic vein to parenchymal tract angle (HVTA), portal vein to parenchymal tract angle (PVTA), and the accessed portal vein. The length and diameter of the TIPS stent and the use of concurrent variceal embolization were recorded by review of the patient's procedure note. Data on re-intervention within 30 d of TIPS placement, recurrence of symptoms, and survival were collected through the patient's chart. Cox proportional regression analysis was performed to assess the effect of these technical parameters on primary patency of TIPS, time to recurrence of symptoms, and all-cause mortality. There was no significant association between the SIVCD and primary patency (P = 0.23), time to recurrence of symptoms (P = 0.83), or all-cause mortality (P = 0.18). The 3, 6, and 12-mo primary patency rates for a SIVCD ≥ 1.5 cm were 82.4%, 64.7%, and 50.3% compared to 89.3%, 83.8%, and 60.6% for a SIVCD of < 1.5 cm (P = 0.29). The median time to stenosis for a SIVCD of ≥ 1.5 cm was 19.1 mo vs 15.1 mo for a SIVCD of < 1.5 cm (P = 0.48). There was no significant association between the following factors and primary patency: HVTA (P = 0.99), PVTA (P = 0.65), accessed portal vein (P = 0.35), TIPS stent diameter (P = 0.93), TIPS stent length (P = 0.48), concurrent variceal embolization (P = 0.13) and reinterventions within 30 d (P = 0.24). Furthermore, there was no correlation between these technical parameters and time to recurrence of symptoms or all-cause mortality. Recurrence of symptoms was associated with stent graft stenosis (P = 0.03). TIPS stent-to-caval distance and other parameters have no significant effect on primary patency, time to recurrence of symptoms, or all-cause mortality following TIPS with a stent-graft.

Impact of a Pharmacy-Cardiology Collaborative Practice on Dofetilide Safety Monitoring.

PubMed

Quffa, Lieth H; Panna, Mark; Kaufmann, Michael R; McKillop, Matthew; Dietrich, Nicole Maltese; Franck, Andrew J

2017-01-01

Limited studies have been published examining dofetilide's postmarketing use and its recommended monitoring. To evaluate the impact of a collaborative pharmacy-cardiology antiarrhythmic drug (AAD) monitoring program on dofetilide monitoring. This retrospective cohort study was performed to assess if a novel monitoring program improved compliance with dofetilide-specific monitoring parameters based on the Food and Drug Administration's Risk Evaluation and Mitigation Strategy. A total of 30 patients were included in the analysis. The monitoring parameters evaluated included electrocardiogram, serum potassium, serum magnesium, and kidney function. The primary outcome evaluated was the composite of these dofetilide monitoring parameters obtained in each cohort. In the standard cohort, 245 of 352 (69.6%) monitoring parameters were completed versus 134 of 136 (98.5%) in the intervention group ( P < 0.05). A collaborative pharmacy-cardiology AAD monitoring program was associated with a significant improvement in dofetilide monitoring. This improvement could potentially translate into enhanced patient safety outcomes, such as prevention of adverse drug reactions and decreased hospitalizations.

The Predictive Value of the Maximal Liver Function Capacity Test for the Isolation of Primary Human Hepatocytes.

PubMed

Major, Rebeka D; Kluge, Martin; Jara, Maximilian; Nösser, Maximilian; Horner, Rosa; Gassner, Joseph; Struecker, Benjamin; Tang, Peter; Lippert, Steffen; Reutzel-Selke, Anja; Geisel, Dominik; Denecke, Timm; Stockmann, Martin; Pratschke, Johann; Sauer, Igor M; Raschzok, Nathanael

2018-03-01

The need for primary human hepatocytes is constantly growing for basic research, as well as for therapeutic applications. However, the isolation outcome strongly depends on the quality of liver tissue, and we are still lacking a preoperative test that allows the prediction of the hepatocyte isolation outcome. In this study, we evaluated the "maximal liver function capacity test" (LiMAx) as predictive test for the quantitative and qualitative outcome of hepatocyte isolation. This test is already used in clinical routine to measure preoperative and to predict postoperative liver function. The patient's preoperative mean LiMAx was obtained from the patient records, and preoperative computed tomography and magnetic resonance images were used to calculate the whole liver volume to adjust the mean LiMAx. The outcome parameters of the hepatocyte isolation procedures were analyzed in correlation with the adjusted mean LiMAx. Primary human hepatocytes were isolated from partial hepatectomies (n = 64). From these 64 hepatectomies we included 48 to our study and correlated their isolation outcome parameters with volume corrected LiMAx values. From a total of 11 hepatocyte isolation procedures, metabolic parameters (albumin, urea, and aspartate aminotransferase or AST) were assessed during the hepatocyte cultivation period of 5 days. The volume adjusted mean LiMAx showed a significant positive correlation with the total cell yield (p = 0.049; r = 0.242; n = 48). The correlations of volume adjusted LiMAx values with viable cell yield and cell viability did not reach statistical significance. To create a more homogenous study group regarding tumor entities, subgroup analyses were performed. A subgroup analysis of isolations from patients with colorectal metastasis revealed a significant correlation between volume adjusted mean LiMAx and total cell yield (p = 0.012; r = 0.488; n = 21) and viable cell yield (p = 0.034; r = 0.405; n = 21), whereas a subgroup analysis of isolations of patients with carcinoma of the biliary tree showed significant correlations of volume adjusted mean LiMAx with cell viability (r = 0.387; p = 0.046; n = 20) and lacked significant correlations with total cell yield (r = -0.060; p = 0.401; n = 20) and viable cell yield (r = 0.012; p = 0.480; n = 20). The volume-adjusted mean LiMAx did not show a significant correlation with any of the metabolic parameters. In conclusion, the LiMAx test might be a useful tool to predict the quantitative outcome of hepatocyte isolation, as long as underlying liver disease is taken into consideration.

Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

PubMed

Tammaa, Ayman; Aigmüller, Thomas; Hanzal, Engelbert; Umek, Wolfgang; Kropshofer, Stephan; Lang, Peter F J; Ralph, George; Riss, Paul; Koelle, Dieter; Jundt, Katharina; Tamussino, Karl; Bjelic-Radisic, Vesna

2018-01-01

To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare. © 2017 Wiley Periodicals, Inc.

Neutrophil-to-lymphocyte ratio as a predictor of worsening renal function in diabetic patients (3-year follow-up study).

PubMed

Azab, Basem; Daoud, Jacques; Naeem, Fahad Ben; Nasr, Rabih; Ross, Jennifer; Ghimire, Pratima; Siddiqui, Ayesha; Azzi, Nadine; Rihana, Nancy; Abdallah, Marie; Azzi, Nassif; Patel, Parishram; Kleiner, Morton; El-Sayegh, Suzanne

2012-01-01

Previous studies have demonstrated the role of inflammation in diabetic nephropathy (DN). Neutrophil to lymphocyte ratio (NLR) rather than other white cell parameters was found to be a useful inflammatory marker to predict adverse outcomes in medical and surgical conditions. Nevertheless, the value of NLR in predicting DN has not been elucidated. An observational study included 338 diabetic patients, who were followed at our clinic between 2007 and 2009. We arranged our patients into tertiles according to their 2007 NLR. The primary outcome was continuous decrease of GFR >12 mL/min between 2007 and 2009 with the last GFR <60 mL/min. The lowest NLR tertile had fewer patients (2.7%) with primary outcome (i.e., worsening renal function) compared with middle and highest NLR tertiles, which had more patients with primary outcomes (8.7% and 11.5%, respectively) with a significant p-value 0.0164. When other potential confounders were individually analyzed with NLR tertile, the NLR tertiles remained a significant predictor of poor GFR outcome in the presence of other variables (hemoglobin A1C, systolic blood pressure, diastolic blood pressure, age, and congestive heart failure with p-values 0.018, 0.019, 0.017, 0.033, and 0.022, respectively). NLR predicted the worsening of the renal function in diabetic patients. Further studies are needed to confirm this result.

Association of prothrombin complex concentrate administration and hematoma enlargement in non-vitamin K antagonist oral anticoagulant-related intracerebral hemorrhage.

PubMed

Gerner, Stefan T; Kuramatsu, Joji B; Sembill, Jochen A; Sprügel, Maximilian I; Endres, Matthias; Haeusler, Karl Georg; Vajkoczy, Peter; Ringleb, Peter A; Purrucker, Jan; Rizos, Timolaos; Erbguth, Frank; Schellinger, Peter D; Fink, Gereon R; Stetefeld, Henning; Schneider, Hauke; Neugebauer, Hermann; Röther, Joachim; Claßen, Joseph; Michalski, Dominik; Dörfler, Arnd; Schwab, Stefan; Huttner, Hagen B

2018-01-01

To investigate parameters associated with hematoma enlargement in non-vitamin K antagonist oral anticoagulant (NOAC)-related intracerebral hemorrhage (ICH). This retrospective cohort study includes individual patient data for 190 patients with NOAC-associated ICH over a 5-year period (2011-2015) at 19 departments of neurology across Germany. Primary outcome was the association of prothrombin complex concentrate (PCC) administration with hematoma enlargement. Subanalyses were calculated for blood pressure management and its association with the primary outcome. Secondary outcomes include associations with in-hospital mortality and functional outcome at 3 months assessed using the modified Rankin Scale. The study population for analysis of primary and secondary outcomes consisted of 146 NOAC-ICH patients with available follow-up imaging. Hematoma enlargement occurred in 49/146 (33.6%) patients with NOAC-related ICH. Parameters associated with hematoma enlargement were blood pressure ≥ 160mmHg within 4 hours and-in the case of factor Xa inhibitor ICH-anti-Xa levels on admission. PCC administration prior to follow-up imaging was not significantly associated with a reduced rate of hematoma enlargement either in overall NOAC-related ICH or in patients with factor Xa inhibitor intake (NOAC: risk ratio [RR] = 1.150, 95% confidence interval [CI] = 0.632-2.090; factor Xa inhibitor: RR = 1.057, 95% CI = 0.565-1.977), regardless of PCC dosage given or time interval until imaging or treatment. Systolic blood pressure levels < 160mmHg within 4 hours after admission were significantly associated with a reduction in the proportion of patients with hematoma enlargement (RR = 0.598, 95% CI = 0.365-0.978). PCC administration had no effect on mortality and functional outcome either at discharge or at 3 months. In contrast to blood pressure control, PCC administration was not associated with a reduced rate of hematoma enlargement in NOAC-related ICH. Our findings support the need of further investigations exploring new hemostatic reversal strategies for patients with factor Xa inhibitor-related ICH. Ann Neurol 2018;83:186-196. © 2018 American Neurological Association.

The direction of bilateral transfer depends on the performance parameter.

PubMed

Pan, Zhujun; van Gemmert, Arend W A

2013-10-01

To acquire a more comprehensive understanding of the learning benefits associated with bilateral transfer and to gain knowledge of possible mechanisms behind bilateral transfer, we investigated the transfer direction of several parameters which are assumed to represent important features of movement control in a visuo-motor task. During the study, participants learned a multidirectional point-to-point drawing task in which the visual feedback was rotated 45° and the gain was increased. Performance changes of the untrained hand in movement time, trajectory length, normalized jerk, initial direction error, ratio of the primary sub-movement time to the total movement time, and the accuracy of the aiming movement after the primary sub-movement were investigated as indices of learning from bilateral transfer. The results showed that performance parameters related to the initial production of the movement, such as the initial direction, ratio of primary sub-movement to the total movement time, and movement accuracy after the primary sub-movement, only transferred to the non-dominant, while hand performance variables related to the overall outcome, such as movement duration, movement smoothness, and trajectory length, transferred in both directions. The findings of the current study support the basic principle of the "dynamic dominance model" because it is suggested that overall improvements in the non-dominant system are controlled by trajectory parameters in visuo-motor tasks, which resulted in transference of the afore mentioned production parameters to rather occur to the non-dominant hand as opposed to transference to the dominant hand. Published by Elsevier B.V.

Outcome-dependent coactivation of lip and tongue primary somatosensory representation following hypoglossal-facial transfer after peripheral facial palsy.

PubMed

Rottler, Philipp; Schroeder, Henry W S; Lotze, Martin

2014-02-01

A hypoglossal-facial transfer is a common surgical strategy for reanimating the face after persistent total hemifacial palsy. We were interested in how motor recovery is associated with cortical reorganization of lip and tongue representation in the primary sensorimotor cortex after the transfer. Therefore, we used functional magnetic resonance imaging (fMRI) in 13 patients who underwent a hypoglossal-facial transfer after unilateral peripheral facial palsy. To identify primary motor and somatosensory tongue and lip representation sites, we measured repetitive tongue and lip movements during fMRI. Electromyography (EMG) of the perioral muscles during tongue and lip movements and standardized evaluation of lip elevation served as outcome parameters. We found an association of cortical representation sites in the pre- and postcentral gyrus (decreased distance of lip and tongue representation) with symmetry of recovered lip movements (lip elevation) and coactivation of the lip during voluntary tongue movements (EMG-activity of the lip during tongue movements). Overall, our study shows that hypoglossal-facial transfer resulted in an outcome-dependent cortical reorganization with activation of the cortical tongue area for restituded movement of the lip. Copyright © 2012 Wiley Periodicals, Inc.

Pediatric patients transferred for operative management of appendicitis: are they at a disadvantage?

PubMed

Farach, Sandra M; Danielson, Paul D; Walford, N Elizabeth; Harmel, Richard P; Chandler, Nicole M

2015-09-01

Many pediatric patients are initially diagnosed with appendicitis at referring hospitals and are subsequently transferred to pediatric facilities. We aimed to compare outcomes of patients transferred to a pediatric referral center to those who present primarily for operative management of appendicitis. A retrospective review of 326 patients with operative appendicitis from July 2012 to July 2013 was performed. Demographic data, clinical parameters, and outcomes were analyzed. Transferred (n=222, 68%) and primary patients (n=104, 32%) were similar except for mean age (primary 12.4 vs. transferred 11.2 years, p<0.01). Computed tomography scans were performed in 80% of transferred compared to 40% of primary patients. Primary patients were more likely to present between the hours of 09:00 and 17:59 (52%), while transferred arrived equally across all hours. Both groups were more likely to present with acute appendicitis (primary 56% vs. transfer 61%, p=NS). There was no difference in time of diagnosis to time of appendectomy, length of hospital stay, or 30 day complications (primary 8.6% vs. transfer 5.8%, p=NS). Patients transferred for definitive care of appendicitis are not found to have more advanced disease or have increased complications; however, they are exposed to significantly more ionizing radiation during evaluation for appendicitis. Copyright © 2015 Elsevier Inc. All rights reserved.

The Association between Outpatient Buprenorphine Detoxification Duration and Clinical Treatment Outcomes: A Review

PubMed Central

Sigmon, Stacey C.; Strain, Eric C.; Heil, Sarah H.; Higgins, Stephen T.

2011-01-01

Background The association between buprenorphine taper duration and treatment outcomes is not well understood. This review evaluated whether duration of outpatient buprenorphine taper is significantly associated with treatment outcomes. Methods Studies that were published in peer-reviewed journals, administered buprenorphine as an outpatient taper to opioid-dependent participants, and provided data on at least one of three primary treatment outcome measures (opioid abstinence, retention, peak withdrawal severity) were reviewed. Primary treatment outcomes were evaluated as a function of taper duration using hierarchical linear regressions using pre-taper maintenance as a cofactor. Results Twenty-eight studies were reviewed. Taper duration significantly predicted percent of opioid-negative samples provided during treatment, however pre-taper maintenance period predicted percent participants abstinent on the final day of treatment. High rates of relapse were reported. No significant association between taper duration and retention in treatment or peak withdrawal severity was observed. Conclusion The data reviewed here suggest taper duration is associated with opioid abstinence achieved during detoxification but not with other markers of treatment outcome. The reviewed studies varied widely on several parameters (e.g., frequency of urinalysis testing, provision of ancillary medications) that may influence treatment outcome and thus could have interfered with the ability to identify relationships between taper duration and outcomes. Future studies evaluating opioid detoxification should utilize rigorous experimental methods and report a wider range of outcome measures in order to help advance our understanding of the association between taper duration and treatment outcomes. PMID:21741781

Logistic regression for dichotomized counts.

PubMed

Preisser, John S; Das, Kalyan; Benecha, Habtamu; Stamm, John W

2016-12-01

Sometimes there is interest in a dichotomized outcome indicating whether a count variable is positive or zero. Under this scenario, the application of ordinary logistic regression may result in efficiency loss, which is quantifiable under an assumed model for the counts. In such situations, a shared-parameter hurdle model is investigated for more efficient estimation of regression parameters relating to overall effects of covariates on the dichotomous outcome, while handling count data with many zeroes. One model part provides a logistic regression containing marginal log odds ratio effects of primary interest, while an ancillary model part describes the mean count of a Poisson or negative binomial process in terms of nuisance regression parameters. Asymptotic efficiency of the logistic model parameter estimators of the two-part models is evaluated with respect to ordinary logistic regression. Simulations are used to assess the properties of the models with respect to power and Type I error, the latter investigated under both misspecified and correctly specified models. The methods are applied to data from a randomized clinical trial of three toothpaste formulations to prevent incident dental caries in a large population of Scottish schoolchildren. © The Author(s) 2014.

Effect of 6-month community-based exercise interventions on gait and functional fitness of an older population: a quasi-experimental study.

PubMed

Ramalho, Fátima; Santos-Rocha, Rita; Branco, Marco; Moniz-Pereira, Vera; André, Helô-Isa; Veloso, António P; Carnide, Filomena

2018-01-01

Gait ability in older adults has been associated with independent living, increased survival rates, fall prevention, and quality of life. There are inconsistent findings regarding the effects of exercise interventions in the maintenance of gait parameters. The aim of the study was to analyze the effects of a community-based periodized exercise intervention on the improvement of gait parameters and functional fitness in an older adult group compared with a non-periodized program. A quasi-experimental study with follow-up was performed in a periodized exercise group (N=15) and in a non-periodized exercise group (N=13). The primary outcomes were plantar pressure gait parameters, and the secondary outcomes were physical activity, aerobic endurance, lower limb strength, agility, and balance. These variables were recorded at baseline and after 6 months of intervention. Both programs were tailored to older adults' functional fitness level and proved to be effective in reducing the age-related decline regarding functional fitness and gait parameters. Gait parameters were sensitive to both the exercise interventions. These exercise protocols can be used by exercise professionals in prescribing community exercise programs, as well as by health professionals in promoting active aging.

The Effects of Phacoemulsification and Intraocular Lens Implantation on Anatomical and Functional Parameters in Patients with Primary Angle Closure: A Prospective Study. (An American Ophthalmological Society Thesis).

PubMed

Traverso, Carlo Enrico; Cutolo, Carlo Alberto

2017-08-01

To investigate the clinical, anatomical, and patient-reported outcomes of phacoemulsification (PE) with intraocular lens implantation performed to treat primary angle closure (PAC) and primary angle-closure glaucoma (PACG). Patients were evaluated at baseline and at 6 months after PE. The examination included visual acuity, intraocular pressure (IOP), visual field, optic nerve head, endothelial cell count (ECC), aqueous depth, and ocular biometric parameters. Patient-reported visual function and health status were assessed. Coprimary outcome measures were IOP changes, angle widening, and patient-reported visual function; secondary outcome measures were visual acuity changes, use of IOP-lowering medications, and complications. Univariate and multivariate analyses were performed to determine the predictors of IOP change. Thirty-nine cases were identified, and postoperative data were analyzed for 59 eyes, 39 with PACG and 20 with PAC. Globally, PE resulted in a mean reduction in IOP of -6.33 mm Hg (95% CI, -8.64 to -4.01, P <.001). Aqueous depth and angle measurements improved ( P <.01), whereas ECC significantly decreased ( P <.001). Both corrected and uncorrected visual acuity improved ( P <.01). The EQ visual analog scale did not change ( P =.16), but VFQ-25 improved ( P <.01). The IOP-lowering effect of PE was greater in the PACG compared to the PAC group ( P =.04). In both groups, preoperative IOP was the most significant predictor of IOP change ( P <.01). No sight-threatening complications were recorded. Our data support the usefulness of PE in lowering the IOP in patients with PAC and PACG. Although PE resulted in several anatomical and patient-reported visual improvements, we observe that a marked decrease in ECC should be carefully weighed before surgery.

Birth Outcomes by Infertility Diagnosis Analyses of the Massachusetts Outcomes Study of Assisted Reproductive Technologies (MOSART).

PubMed

Luke, Barbara; Stern, Judy E; Kotelchuck, Milton; Declercq, Eugene R; Cohen, Bruce; Diop, Hafsatou

2015-01-01

To evaluate assisted reproductive technology (ART) pregnancy outcomes by infertility diagnosis. ART data on women who were treated and gave birth in Massachusetts were linked to vital records and hospital utilization data. Live births were categorized by 8 mutually exclusive ART diagnoses. Risks of prematurity, low birthweight (LBW), small-for-gestational age (SGA), large-for-gestational age (LGA), pregnancy hypertension, gestational diabetes, prenatal hospitalizations, and primary cesarean delivery were modeled using logistic regression, adjusted for parental characteristics, treatment parameters, and plurality (adjusted odds ratios [AORs] and 95% confidence intervals); the reference group were pregnancies with the diagnosis of malefactor. Among the 7,354 singleton and twin pregnancies, there were nonsignificant differences in the risks for LBW, SGA, or LGA. Significantly increased risks included gestational diabetes (ovulation disorders, AOR 1.80, 1.35-2.41), prematurity (ovulation disorders, AOR 1.36, 1.08-1.71; other factors, AOR 1.33, 1.05-1.67), prenatal hospital admissions (endometriosis, tubal and other factors, ovulation disorders, and uterine factors, AORs ranging from 1.66-2.68), and primary cesarean section (uterine factors, AOR 1.96, 1.15-3.36). Although the infant outcomes of LBW, SGA, and LGA were generally similar across diagnosis groups, specific diagnoses had greater risks for prematurity, gestational diabetes, prenatal hospital utilization, and primary cesarean delivery. (J Reprod Med 2015;

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

PubMed

Raaben, Marco; Redzwan, Syaiful; Augustine, Robin; Blokhuis, Taco Johan

2018-04-12

Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

Motion in a modified Chermnykh's restricted three-body problem with oblateness

NASA Astrophysics Data System (ADS)

Singh, Jagadish; Leke, Oni

2014-03-01

In this paper, the restricted problem of three bodies is generalized to include a case when the passively gravitating test particle is an oblate spheroid under effect of small perturbations in the Coriolis and centrifugal forces when the first primary is a source of radiation and the second one an oblate spheroid, coupled with the influence of the gravitational potential from the belt. The equilibrium points are found and it is seen that, in addition to the usual three collinear equilibrium points, there appear two new ones due to the potential from the belt and the mass ratio. Two triangular equilibrium points exist. These equilibria are affected by radiation of the first primary, small perturbation in the centrifugal force, oblateness of both the test particle and second primary and the effect arising from the mass of the belt. The linear stability of the equilibrium points is explored and the stability outcome of the collinear equilibrium points remains unstable. In the case of the triangular points, motion is stable with respect to some conditions which depend on the critical mass parameter; influenced by the small perturbations, radiating effect of the first primary, oblateness of the test body and second primary and the gravitational potential from the belt. The effects of each of the imposed free parameters are analyzed. The potential from the belt and small perturbation in the Coriolis force are stabilizing parameters while radiation, small perturbation in the centrifugal force and oblateness reduce the stable regions. The overall effect is that the region of stable motion increases under the combine action of these parameters. We have also found the frequencies of the long and short periodic motion around stable triangular points. Illustrative numerical exploration is rendered in the Sun-Jupiter and Sun-Earth systems where we show that in reality, for some values of the system parameters, the additional equilibrium points do not in general exist even when there is a belt to interact with.

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

PubMed

Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial.

PubMed

Mainz, Jochen G; Schien, Claudia; Schiller, Isabella; Schädlich, Katja; Koitschev, Assen; Koitschev, Christiane; Riethmüller, Joachim; Graepler-Mainka, Uta; Wiedemann, Bärbel; Beck, James F

2014-07-01

Chronic rhinosinusitis significantly impairs CF patients' quality of life and overall health. The Pari-Sinus™ device delivers vibrating aerosol effectively to paranasal sinuses. After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo (isotonic saline) on potential sinonasal outcome measures, we present the subsequent prospective double-blind placebo-controlled crossover-trial. 23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28 days with the Pari-Sinus™ and after 28 days (wash-out) crossed over to the alternative treatment. The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 (SNOT-20: nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling). Primary nasal symptoms improved significantly with dornase alfa compared with no treatment, while small improvements with isotonic saline did not reach significance. SNOT-20 overall scores improved significantly after dornase alfa compared with isotonic saline (p=0.017). Additionally, sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function (FEF75-25: p=0.021). Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

Replacement of aprotinin by ε-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome.

PubMed

Martin, K; Gertler, R; MacGuill, M; Mayr, N P; Hapfelmeier, A; Hörer, J; Vogt, M; Tassani, P; Wiesner, G

2013-04-01

Once aprotinin was no longer available for clinical use, ε-aminocaproic acid (EACA) and tranexamic acid became the only two options for antifibrinolytic therapy. We compared aprotinin and EACA with respect to their blood-sparing efficacy and other major clinical outcome criteria in infants undergoing cardiac surgery. We retrospectively analysed data from a large consecutive cohort of infants (n=227) aged 31-365 days undergoing primary cardiac surgery requiring cardiopulmonary bypass encompassing the transition from aprotinin to EACA (aprotinin n=88, EACA n=139); all other aspects including the medical team and departmental protocols remained unchanged. The primary outcome was postoperative blood loss measured as chest tube output (CTO). Secondary outcome parameters were transfusion requirements, reoperation due to bleeding, renal, vascular, and neurological complications, and in-hospital mortality. CTO was significantly higher in the EACA patients {aprotinin 18 (13-27) ml kg(-1) 24 h(-1), EACA 23 (15-37) ml kg(-1) 24 h(-1) [mean (inter-quartile range)], P=0.001}, but transfusion requirements and donor exposures were not significantly different. A sensitivity analysis strengthened our finding that the increased blood loss in the EACA group was attributable to lower efficacy of EACA. There were no significant differences in the other clinical outcome measures. CTO was lower in aprotinin-treated patients. Nonetheless, EACA remains a suitable substitute without measurable differences in other clinical outcome criteria.

Effect of Ayurveda Medications (Kasīsa Bhasma and Dhātrī Avaleha) on Iron Deficiency Anaemia: A Randomized Controlled Study

PubMed Central

Tubaki, Basavaraj Ramappa; Benni, Jyoti Mahadev; Rao, Niranjan; Prasad, Uchangi Nagaraja Rao

2016-01-01

Background: This paper explores the role that Ayurveda can play in the management of Iron Deficiency Anaemia, a major nutritional deficiency disorder affecting people across the globe. Methodology: Forty (40) patients suffering from Iron deficiency anaemia as per WHO guidelines, between the age group of 20 to 60 yrs of either sex participated in the study. Study was a randomized, controlled, open label clinical study. Patients were randomly divided into two groups: Group D (n = 20) received Dhārī avaleha 10 g twice a day after food. Group K (n = 20) received capsules Kasīsa bhasma 125 mg thrice a day. Both interventions were administered for 30 days and the subjects were followed up for next 30 days with placebo capsules to assess the sustainability of the effects. Assessments were done at baseline, 30th and 60th days. Primary outcome measure was hemoglobin estimation (Hb) and secondary outcome measures were the other hematological parameters such as Red blood cell (RBC) indices, total RBC count, Packed Cell volume (PCV) and Peripheral Blood smear study. Results: Both interventions produced significant improvements (P < 0.001). Kasīsa bhasma was better compared to dhātrī avaleha in terms of primary (P < 0.0001) and secondary outcomes. Comparison of outcomes from base line – 30th day, base line – 60th day and 30th – 60th day showed significant (P < 0.0001) improvement in both the groups in parameters such as haemoglobin, MCV and MCH. Hence improvements sustained during placebo intervened sustainability period also. Conclusions: Study effectively shows that Kasīsa bhasma is better then Dhātrī avaleha. Improvements by both interventions were sustained even during the sustainability period. PMID:28182020

[Primary, single-stage arterial switch operations at a newly-established, comprehensive congenital cardiac center performed in the neonatal age and beyond].

PubMed

Király, László; Tamás, Csaba

2015-06-21

Outcome of arterial switch operation for transposition of the great arteries with/without ventricular septal defect is a service key-performance-indicator. The aim of the authors was to assess patient characteristics and parameters in the perioperative course. In the setting of a newly-established, comprehensive tertiary-care center, primary complete repair was performed including associated anomalies, e.g. transverse arch repairs. Patients with d-transposition were grouped according to coexistence of ventricular septal defect. 118 arterial switch operations were performed between 2007 and 2014 with 96.62% survival (114/118). Ventricular septal defect and repair of associated anomalies did not yield worse outcome. Left ventricular re-training with late presentation necessitated mechanical circulatory support for 4.5±1.5 days. D-transposition is suitable for standardization of clinical algorithm and surgical technique. Quality standards contribute to excellent outcomes, minimize complications, and serve as blueprint for other neonatal open-heart procedures. Availability of mechanical circulatory support is key for single-stage left ventricular re-training beyond the neonatal period.

Robot-assisted gait training in multiple sclerosis patients: a randomized trial.

PubMed

Schwartz, Isabella; Sajin, Anna; Moreh, Elior; Fisher, Iris; Neeb, Martin; Forest, Adina; Vaknin-Dembinsky, Adi; Karusis, Dimitrios; Meiner, Zeev

2012-06-01

Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5-7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

The effect of taping versus semi-rigid bracing on patient outcome and satisfaction in ankle sprains: a prospective, randomized controlled trial.

PubMed

Lardenoye, Sacha; Theunissen, Ed; Cleffken, Berry; Brink, Peter Rg; de Bie, Rob A; Poeze, Martijn

2012-05-28

Functional treatment is a widely used and generally accepted treatment for ankle sprain. A meta-analysis comparing the different functional treatment options could not make definitive conclusions regarding the effectiveness, and until now, little was known about patient satisfaction in relation to the outcome. Patients with acute ankle sprain received rest, ice, compression and elevation with an compressive bandage at the emergency department. After 5-7 days, 100 patients with grade II and III sprains were randomized into two groups: one group was treated with tape and the other with a semi-rigid ankle brace, both for 4 weeks. Post-injury physical and proprioceptive training was standardized. As primary outcome parameter patient satisfaction and skin complications were evaluated using a predefined questionnaire and numeric rating scale. As secondary outcome parameter the ankle joint function was assessed using the Karlsson scoring scale and range of motion. Patient-reported comfort and satisfaction during treatment with a semi-rigid brace was significantly increased. The rate of skin complication in this group was significantly lower compared to the tape group (14.6% versus 59.1%, P < 0.0001). Functional outcome of the ankle joint was similar between the two treatment groups, as well as reported pain. Treatment of acute ankle sprain with semi-rigid brace leads to significantly higher patient comfort and satisfaction, both with similar good outcome.

Primary Outcomes for Resuscitation Science Studies

PubMed Central

Becker, Lance B.; Aufderheide, Tom P.; Geocadin, Romergryko G.; Callaway, Clifton W.; Lazar, Ronald M.; Donnino, Michael W.; Nadkarni, Vinay M.; Abella, Benjamin S.; Adrie, Christophe; Berg, Robert A.; Merchant, Raina M.; O'Connor, Robert E.; Meltzer, David O.; Holm, Margo B.; Longstreth, William T.; Halperin, Henry R.

2013-01-01

Background and Purpose The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. Methods The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. Results There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases; however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple “alive versus dead,” hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post–cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes. Conclusions Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post–cardiac arrest patients is a major limitation to the field and should be a high priority for future development. PMID:21969010

Primary outcomes for resuscitation science studies: a consensus statement from the American Heart Association.

PubMed

Becker, Lance B; Aufderheide, Tom P; Geocadin, Romergryko G; Callaway, Clifton W; Lazar, Ronald M; Donnino, Michael W; Nadkarni, Vinay M; Abella, Benjamin S; Adrie, Christophe; Berg, Robert A; Merchant, Raina M; O'Connor, Robert E; Meltzer, David O; Holm, Margo B; Longstreth, William T; Halperin, Henry R

2011-11-08

The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases; however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple "alive versus dead," hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post-cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes. Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post-cardiac arrest patients is a major limitation to the field and should be a high priority for future development.

Higher Thyroid-Stimulating Hormone, Triiodothyronine and Thyroxine Values Are Associated with Better Outcome in Acute Liver Failure

PubMed Central

Sowa, Jan-Peter; Manka, Paul; Katsounas, Antonios; Syn, Wing-Kin; Führer, Dagmar; Gieseler, Robert K.; Bechmann, Lars P.; Gerken, Guido; Moeller, Lars C.; Canbay, Ali

2015-01-01

Introduction Changes in thyroid hormone levels, mostly as non-thyroidal illness syndrome (NTIS), have been described in many diseases. However, the relationship between acute liver failure (ALF) and thyroid hormone levels has not yet been clarified. The present study evaluates potential correlations of select thyroid functional parameters with ALF. Methods 84 consecutively recruited ALF patients were grouped according to the outcome of ALF (spontaneous recovery: SR; transplantation or death: NSR). TSH, free thyroxine (fT4), free triiodothyronine (fT3), T4, and T3 were determined. Results More than 50% of patients with ALF presented with abnormal thyroid parameters. These patients had greater risk for an adverse outcome than euthyroid patients. SR patients had significantly higher TSH, T4, and T3 concentrations than NSR patients. Albumin concentrations were significantly higher in SR than in NSR. In vitro T3 treatment was not able to rescue primary human hepatocytes from acetaminophen induced changes in mRNA expression. Conclusions In patients with ALF, TSH and total thyroid hormone levels differed significantly between SR patients and NSR patients. This might be related to diminished liver-derived transport proteins, such as albumin, in more severe forms of ALF. Thyroid parameters may serve as additional indicators of ALF severity. PMID:26147961

Higher Thyroid-Stimulating Hormone, Triiodothyronine and Thyroxine Values Are Associated with Better Outcome in Acute Liver Failure.

PubMed

Anastasiou, Olympia; Sydor, Svenja; Sowa, Jan-Peter; Manka, Paul; Katsounas, Antonios; Syn, Wing-Kin; Führer, Dagmar; Gieseler, Robert K; Bechmann, Lars P; Gerken, Guido; Moeller, Lars C; Canbay, Ali

2015-01-01

Changes in thyroid hormone levels, mostly as non-thyroidal illness syndrome (NTIS), have been described in many diseases. However, the relationship between acute liver failure (ALF) and thyroid hormone levels has not yet been clarified. The present study evaluates potential correlations of select thyroid functional parameters with ALF. 84 consecutively recruited ALF patients were grouped according to the outcome of ALF (spontaneous recovery: SR; transplantation or death: NSR). TSH, free thyroxine (fT4), free triiodothyronine (fT3), T4, and T3 were determined. More than 50% of patients with ALF presented with abnormal thyroid parameters. These patients had greater risk for an adverse outcome than euthyroid patients. SR patients had significantly higher TSH, T4, and T3 concentrations than NSR patients. Albumin concentrations were significantly higher in SR than in NSR. In vitro T3 treatment was not able to rescue primary human hepatocytes from acetaminophen induced changes in mRNA expression. In patients with ALF, TSH and total thyroid hormone levels differed significantly between SR patients and NSR patients. This might be related to diminished liver-derived transport proteins, such as albumin, in more severe forms of ALF. Thyroid parameters may serve as additional indicators of ALF severity.

Treating primary dysmenorrhoea with acupuncture: a narrative review of the relationship between acupuncture 'dose' and menstrual pain outcomes.

PubMed

Armour, Mike; Smith, Caroline A

2016-12-01

A number of randomised controlled trials have been performed to determine the effectiveness or efficacy of acupuncture in primary dysmenorrhoea. The objective of this review was to explore the relationship between the 'dose' of the acupuncture intervention and menstrual pain outcomes. Eight databases were systematically searched for trials examining penetrating body acupuncture for primary dysmenorrhoea published in English up to September 2015. Dose components for each trial were extracted, assessed by the two authors and categorised by neurophysiological dose (number of needles, retention time and mode of stimulation), cumulative dose (total number and frequency of treatments), needle location and treatment timing. Eleven trials were included. Components of acupuncture dose were well reported across all trials. The relationship between needle location and menstrual pain demonstrated conflicting results. Treatment before the menses appeared to produce greater reductions in pain than treatment starting at the onset of menses. A single needle during menses may provide greater pain reduction compared to multiple needles. Conversely, multiple needles before menses were superior to a single needle. Electroacupuncture may provide more rapid pain reduction compared to manual acupuncture but may not have a significantly different effect on overall menstrual pain. There appear to be relationships between treatment timing and mode of needle stimulation, and menstrual pain outcomes. Needle location, number of needles used and frequency of treatment show clear dose-response relationships with menstrual pain outcomes. Current research is insufficient to make definitive clinical recommendations regarding optimum dose parameters for treating primary dysmenorrhoea. 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/.

The impact of transmural multiprofessional simulation-based obstetric team training on perinatal outcome and quality of care in the Netherlands

PubMed Central

2014-01-01

Background Perinatal mortality and morbidity in the Netherlands is relatively high compared to other European countries. Our country has a unique system with an independent primary care providing care to low-risk pregnancies and a secondary/tertiary care responsible for high-risk pregnancies. About 65% of pregnant women in the Netherlands will be referred from primary to secondary care implicating multiple medical handovers. Dutch audits concluded that in the entire obstetric collaborative network process parameters could be improved. Studies have shown that obstetric team training improves perinatal outcome and that simulation-based obstetric team training implementing crew resource management (CRM) improves team performance. In addition, deliberate practice (DP) improves medical skills. The aim of this study is to analyse whether transmural multiprofessional simulation-based obstetric team training improves perinatal outcome. Methods/Design The study will be implemented in the south-eastern part of the Netherlands with an annual delivery rate of over 9,000. In this area secondary care is provided by four hospitals. Each hospital with referring primary care practices will form a cluster (study group). Within each cluster, teams will be formed of different care providers representing the obstetric collaborative network. CRM and elements of DP will be implemented in the training. To analyse the quality of care as perceived by patients, the Pregnancy and Childbirth Questionnaire (PCQ) will be used. Furthermore, self-reported collaboration between care providers will be assessed. Team performance will be measured by the Clinical Teamwork Scale (CTS). We employ a stepped-wedge trial design with a sequential roll-out of the trainings for the different study groups. Primary outcome will be perinatal mortality and/or admission to a NICU. Secondary outcome will be team performance, quality of care as perceived by patients, and collaboration among care providers. Conclusion The effect of transmural multiprofessional simulation-based obstetric team training on perinatal outcome has never been studied. We hypothesise that this training will improve perinatal outcome, team performance, and quality of care as perceived by patients and care providers. Trial registration The Netherlands National Trial Register, http://www.trialregister.nl/NTR4576, registered June 1, 2014 PMID:25145317

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

PubMed

Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

2016-01-01

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

Mining telemonitored physiological data and patient-reported outcomes of congestive heart failure patients

PubMed Central

Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja

2018-01-01

This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials. PMID:29494601

Mining telemonitored physiological data and patient-reported outcomes of congestive heart failure patients.

PubMed

Mlakar, Miha; Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja

2018-01-01

This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.

Pirfenidone for the treatment of Hermansky-Pudlak Syndrome pulmonary fibrosis

PubMed Central

O’Brien, Kevin; Troendle, James; Gochuico, Bernadette R.; Markello, Thomas C.; Salas, Jose; Cardona, Hilda; Yao, Jianhua; Bernardini, Isa; Hess, Richard; Gahl, William A.

2013-01-01

Hermansky-Pudlak syndrome (HPS) type is a rare disorder of oculocutaneous albinism, platelet dysfunction, and in some subtypes, fatal pulmonary fibrosis. There is no effective treatment for the pulmonary fibrosis except lung transplantation, but an initial trial using pirfenidone, an anti-fibrotic agent, showed promising results. The current, randomized, placebo-controlled, prospective, double-blind trial investigated the safety and efficacy of pirfenidone for mild to moderate HPS-1 and 4 pulmonary fibrosis. Subjects were evaluated every 4 months at the National Institutes of Health Clinical Center, and the primary outcome parameter was change in forced vital capacity using repeated measures analysis with random coefficients. Thirty-five subjects with HPS-1 pulmonary fibrosis were enrolled during a 4-year interval; 23 subjects received pirfenidone and 12 received placebo. Four subjects withdrew from the trial, 3 subjects died, and 10 serious adverse events were reported. Both groups experienced similar side effects, especially gastroesophageal reflux. Interim analysis of the primary outcome parameter, performed 12 months after 30 patients were enrolled, showed no statistical difference between the placebo and pirfenidone groups, and the study was stopped due to futility. There were no significant safety concerns. Other clinical trials are indicated to identify single or multiple drug regimens that may be effective in treatment for progressive HPS-1 pulmonary fibrosis. PMID:21420888

Global Sensitivity Analysis as Good Modelling Practices tool for the identification of the most influential process parameters of the primary drying step during freeze-drying.

PubMed

Van Bockstal, Pieter-Jan; Mortier, Séverine Thérèse F C; Corver, Jos; Nopens, Ingmar; Gernaey, Krist V; De Beer, Thomas

2018-02-01

Pharmaceutical batch freeze-drying is commonly used to improve the stability of biological therapeutics. The primary drying step is regulated by the dynamic settings of the adaptable process variables, shelf temperature T s and chamber pressure P c . Mechanistic modelling of the primary drying step leads to the optimal dynamic combination of these adaptable process variables in function of time. According to Good Modelling Practices, a Global Sensitivity Analysis (GSA) is essential for appropriate model building. In this study, both a regression-based and variance-based GSA were conducted on a validated mechanistic primary drying model to estimate the impact of several model input parameters on two output variables, the product temperature at the sublimation front T i and the sublimation rate ṁ sub . T s was identified as most influential parameter on both T i and ṁ sub , followed by P c and the dried product mass transfer resistance α Rp for T i and ṁ sub , respectively. The GSA findings were experimentally validated for ṁ sub via a Design of Experiments (DoE) approach. The results indicated that GSA is a very useful tool for the evaluation of the impact of different process variables on the model outcome, leading to essential process knowledge, without the need for time-consuming experiments (e.g., DoE). Copyright © 2017 Elsevier B.V. All rights reserved.

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

Reducing the Primary Cesarean Birth Rate: A Quality Improvement Project.

PubMed

Javernick, Julie A; Dempsey, Amy

2017-07-01

Research continues to support vaginal birth as the safest mode of childbirth, but despite this, cesarean birth has become the most common surgical procedure performed on women. The rate has increased 500% since the 1970s without a corresponding improvement in maternal or neonatal outcomes. A Colorado community hospital recognized that its primary cesarean birth rate was higher than national and state benchmark levels. To reduce this rate, the hospital collaborated with its largest maternity care provider group to implement a select number of physiologic birth practices and measure improvement in outcomes. Using a pre- and postprocess measure study design, the quality improvement project team identified and implemented 3 physiologic birth parameters over a 12-month period that have been shown to promote vaginal birth. These included reducing elective induction of labor in women less than 41 weeks' gestation; standardizing triage to admit women at greater than or equal to 4 cm dilation; and increasing the use of intermittent auscultation as opposed to continuous fetal monitoring for fetal surveillance. The team also calculated each obstetrician-gynecologist's primary cesarean birth rate monthly and delivered these rates to the providers. Outcomes showed that the provider group decreased its primary cesarean birth rate from 28.9% to 12.2% in the 12-month postprocess measure period. The 57.8% decrease is statistically significant (odds ratio [OR], 0.345; z = 6.52, P < .001; 95% confidence interval [CI], 0.249-0.479). While this quality improvement project cannot be translated to other settings, promotion of physiologic birth practices, along with audit and feedback, had a statistically significant impact on the primary cesarean birth rate for this provider group and, consequently, on the community hospital where they attend births. © 2017 by the American College of Nurse-Midwives.

Race, obesity, and the renin-angiotensin-aldosterone system: treatment response in children with primary hypertension.

PubMed

South, Andrew M; Arguelles, Lester; Finer, Gal; Langman, Craig B

2017-09-01

Pediatric primary hypertension (HTN) is increasingly recognized, but the effect of patient characteristics such as obesity and race on treatment outcomes is not well described. The renin-angiotensin-aldosterone system (RAAS) may also contribute to HTN. We hypothesized patient parameters of these factors, including baseline RAAS, influence blood pressure (BP) response to pharmacological treatment in HTN. This was a retrospective cohort of 102 consecutive patients with HTN. Primary outcomes were changes per year in systolic and diastolic BP (SBP, DBP). Secondary outcome was change per year in left ventricular mass index (LVMI). We evaluated whether baseline plasma renin activity (PRA), aldosterone, renin-to-aldosterone ratio, overweight/obesity, race, initial drug choice, and multidrug therapy were associated with the outcomes using general linear regression models adjusted for confounding variables. Racially diverse (43% Hispanic, 28% black, 25% white) and predominantly overweight/obese (75%) patients were studied. Median length of follow-up was 14.5 months. Higher baseline aldosterone was associated with decreased SBP (-1.03 mmHg/year), DBP (-0.95 mmHg/year), and DBP z score (-0.07/year) during the study period. Higher baseline PRA was associated with decreased SBP z score (-0.04/year) and LVMI (-2.89 g/m 2.7 /year). Stratified analyses revealed the relationships between baseline aldosterone and PRA, and annual reductions in outcomes were strengthened in nonobese and white patients. Pretreatment aldosterone and PRA predicted short-term follow-up BP and LVMI, especially in nonobese and white patients. The RAAS profile could guide treatment of HTN and suggests consideration of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers as first-line treatment options.

Individual patient meta-analysis of exercise training effects on systemic brain natriuretic peptide expression in heart failure.

PubMed

Smart, N A; Meyer, T; Butterfield, J A; Faddy, S C; Passino, C; Malfatto, G; Jonsdottir, S; Sarullo, F; Wisloff, U; Vigorito, C; Giallauria, F

2012-06-01

Brain natriuretic peptide (BNP) predicts exercise performance and exercise training may modulate BNP and its N-terminal portion (NT-pro-BNP), we therefore conducted an individual patient analysis of exercise training effects on BNP and NT-pro-BNP. To use an individual patient meta-analysis to relate changes in BNP, NT-pro-BNP, and peak VO(2); to link these changes to volume parameters of exercise training programmes (intensity etc.); and to identify patient characteristics likely to lead to greater improvements in BNP, NT-pro-BNP, and peak VO(2). Individual patient meta-analysis. A systematic search was conducted of Medline (Ovid), Embase.com, Cochrane Central Register of Controlled Trials, and CINAHL (until July 2008) to identify randomized controlled trials of aerobic and/or resistance exercise training in systolic heart failure patients measuring BNP and/or NT-pro-BNP. Primary outcome measures were change in BNP, NT-pro-BNP, and peak VO2. Subanalyses were conducted to identify (1) patient groups that benefit most and (2) exercise programme parameters enhancing favourable changes in primary outcome measures. Ten randomized controlled studies measuring BNP or NT-pro-BNP met eligibility criteria, authors provided individual patient data for 565 patients (313 exercise and 252 controls). Exercise training had favourable effects on BNP (-28.3%, p < 0.0001), NT-pro-BNP (-37.4%, p = < 0.0001), and peak VO(2) (17.8%, p < 0.0001). The analysis showed a significant change in primary outcome measures; moreover, change in BNP (r = -0.31, p < 0.0001) and NT-pro-BNP (r = -0.22, p < 0.0001) were correlated with peak VO(2) change. Exercise training has favourable effects on BNP, NT-pro-BNP, and peak VO(2) in heart failure patients and BNP/NT-pro-BNP changes were correlated with peak VO(2) changes.

Self-learning basic life support: A randomised controlled trial on learning conditions.

PubMed

Pedersen, Tina Heidi; Kasper, Nina; Roman, Hari; Egloff, Mike; Marx, David; Abegglen, Sandra; Greif, Robert

2018-05-01

To investigate whether pure self-learning without instructor support, resulted in the same BLS-competencies as facilitator-led learning, when using the same commercially available video BLS teaching kit. First-year medical students were randomised to either BLS self-learning without supervision or facilitator-led BLS-teaching. Both groups used the MiniAnne kit (Laerdal Medical, Stavanger, Norway) in the students' local language. Directly after the teaching and three months later, all participants were tested on their BLS-competencies in a simulated scenario, using the Resusci Anne SkillReporter™ (Laerdal Medical, Stavanger, Norway). The primary outcome was percentage of correct cardiac compressions three months after the teaching. Secondary outcomes were all other BLS parameters recorded by the SkillReporter and parameters from a BLS-competence rating form. 240 students were assessed at baseline and 152 students participated in the 3-month follow-up. For our primary outcome, the percentage of correct compressions, we found a median of 48% (interquartile range (IQR) 10-83) for facilitator-led learning vs. 42% (IQR 14-81) for self-learning (p = 0.770) directly after the teaching. In the 3-month follow-up, the rate of correct compressions dropped to 28% (IQR 6-59) for facilitator-led learning (p = 0.043) and did not change significantly in the self-learning group (47% (IQR 12-78), p = 0.729). Self-learning is not inferior to facilitator-led learning in the short term. Self-learning resulted in a better retention of BLS-skills three months after training compared to facilitator-led training. Copyright © 2018 Elsevier B.V. All rights reserved.

The influence of blood pressure management on neurological outcome in endovascular therapy for acute ischaemic stroke.

PubMed

Rasmussen, M; Espelund, U S; Juul, N; Yoo, A J; Sørensen, L H; Sørensen, K E; Johnsen, S P; Andersen, G; Simonsen, C Z

2018-06-01

Observational studies have suggested that low blood pressure and blood pressure variability may partially explain adverse neurological outcome after endovascular therapy with general anaesthesia (GA) for acute ischaemic stroke. The aim of this study was to further examine whether blood pressure related parameters during endovascular therapy are associated with neurological outcome. The GOLIATH trial randomised 128 patients to either GA or conscious sedation for endovascular therapy in acute ischaemic stroke. The primary outcome was 90 day modified Rankin Score. The haemodynamic protocol aimed at keeping the systolic blood pressure >140 mm Hg and mean blood pressure >70 mm Hg during the procedure. Blood pressure related parameters of interest included 20% reduction in mean blood pressure; mean blood pressure <70 mm Hg, <80 mm Hg, and <90 mm Hg, respectively; time with systolic blood pressure <140 mm Hg; procedural minimum and maximum mean and systolic blood pressure; mean blood pressure at the time of groin puncture; postreperfusion mean blood pressure; blood pressure variability; and use of vasopressors. Sensitivity analyses were performed in the subgroup of reperfused patients. Procedural average mean and systolic blood pressures were higher in the conscious sedation group (P<0.001). The number of patients with mean blood pressure <70-90 mm Hg and systolic blood pressure <140 mm Hg, blood pressure variability, and use of vasopressors were all higher in the GA group (P<0.001). There was no statistically significant association between any of the examined blood pressure related parameters and the modified Rankin Score in the overall patient population, and in the subgroup of patients with full reperfusion. We found no statistically significant association between blood pressure related parameters during endovascular therapy and neurological outcome. NCT 02317237. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Blood glucose concentrations in prehospital trauma patients with traumatic shock: A retrospective analysis.

PubMed

Kreutziger, Janett; Lederer, Wolfgang; Schmid, Stefan; Ulmer, Hanno; Wenzel, Volker; Nijsten, Maarten W; Werner, Daniel; Schlechtriemen, Thomas

2018-01-01

Deranged glucose metabolism after moderate to severe trauma with either high or low concentrations of blood glucose is associated with poorer outcome. Data on prehospital blood glucose concentrations and trauma are scarce. The primary aim was to describe the relationship between traumatic shock and prehospital blood glucose concentrations. The secondary aim was to determine the additional predictive value of prehospital blood glucose concentration for traumatic shock when compared with vital parameters alone. Retrospective analysis of the predefined, observational database of a nationwide Helicopter Emergency Medical Service (34 bases). Emergency trauma patients treated by Helicopter Emergency Medical Service between 2005 and 2013 were investigated. All adult trauma patients (≥18 years) with recorded blood glucose concentrations were enrolled. Primary outcome: upper and lower thresholds of blood glucose concentration more commonly associated with traumatic shock. Secondary outcome: additional predictive value of prehospital blood glucose concentrations when compared with vital parameters alone. Of 51 936 trauma patients, 20 177 were included. In total, 220 (1.1%) patients died on scene. Hypoglycaemia (blood glucose concentration 2.8 mmol l or less) was observed in 132 (0.7%) patients, hyperglycaemia (blood glucose concentration exceeding 15 mmol l) was observed in 265 patients (1.3%). Blood glucose concentrations more than 10 mmol l (n = 1308 (6.5%)) and 2.8 mmol l or less were more common in patients with traumatic shock (P < 0.0001). The Youden index for traumatic shock ((sensitivity + specificity) - 1) was highest when blood glucose concentration was 3.35 mmol l (P < 0.001) for patients with low blood glucose concentrations and 7.75 mmol l (P < 0.001) for those with high blood glucose concentrations. In logistic regression analysis of patients with spontaneous circulation on scene, prehospital blood glucose concentrations (together with common vital parameters: Glasgow Coma Scale, heart rate, blood pressure, breathing frequency) significantly improved the prediction of traumatic shock in comparison with prediction by common vital parameters alone (P < 0.0001). In adult trauma patients, low and high blood glucose concentrations were more common in patients with traumatic shock. Prehospital blood glucose concentration measurements in addition to common vital parameters may help identify patients at risk of traumatic shock.

The effect of taping versus semi-rigid bracing on patient outcome and satisfaction in ankle sprains: a prospective, randomized controlled trial

PubMed Central

2012-01-01

Background Functional treatment is a widely used and generally accepted treatment for ankle sprain. A meta-analysis comparing the different functional treatment options could not make definitive conclusions regarding the effectiveness, and until now, little was known about patient satisfaction in relation to the outcome. Methods Patients with acute ankle sprain received rest, ice, compression and elevation with an compressive bandage at the emergency department. After 5-7 days, 100 patients with grade II and III sprains were randomized into two groups: one group was treated with tape and the other with a semi-rigid ankle brace, both for 4 weeks. Post-injury physical and proprioceptive training was standardized. As primary outcome parameter patient satisfaction and skin complications were evaluated using a predefined questionnaire and numeric rating scale. As secondary outcome parameter the ankle joint function was assessed using the Karlsson scoring scale and range of motion. Results Patient-reported comfort and satisfaction during treatment with a semi-rigid brace was significantly increased. The rate of skin complication in this group was significantly lower compared to the tape group (14.6% versus 59.1%, P < 0.0001). Functional outcome of the ankle joint was similar between the two treatment groups, as well as reported pain. Conclusion Treatment of acute ankle sprain with semi-rigid brace leads to significantly higher patient comfort and satisfaction, both with similar good outcome. PMID:22639864

Endoscopic versus surgical treatment of ampullary adenomas: a systematic review and meta-analysis

PubMed Central

Mendonça, Ernesto Quaresma; Bernardo, Wanderley Marques; de Moura, Eduardo Guimarães Hourneaux; Chaves, Dalton Marques; Kondo, André; Pu, Leonardo Zorrón Cheng Tao; Baracat, Felipe Iankelevich

2016-01-01

The aim of this study is to address the outcomes of endoscopic resection compared with surgery in the treatment of ampullary adenomas. A systematic review and meta-analysis were performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. For this purpose, the Medline, Embase, Cochrane, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Scopus and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases were scanned. Studies included patients with ampullary adenomas and data considering endoscopic treatment compared with surgery. The entire analysis was based on a fixed-effects model. Five retrospective cohort studies were selected (466 patients). All five studies (466 patients) had complete primary resection data available and showed a difference that favored surgical treatment (risk difference [RD] = -0.24, 95% confidence interval [CI] = -0.44 to -0.04). Primary success data were identified in all five studies as well. Analysis showed that the surgical approach outperformed endoscopic treatment for this outcome (RD = -0.37, 95% CI = -0.50 to -0.24). Recurrence data were found in all studies (466 patients), with a benefit indicated for surgical treatment (RD = 0.10, 95% CI = -0.01 to 0.19). Three studies (252 patients) presented complication data, but analysis showed no difference between the approaches for this parameter (RD = -0.15, 95% CI = -0.53 to 0.23). Considering complete primary resection, primary success and recurrence outcomes, the surgical approach achieves significantly better results. Regarding complication data, this systematic review concludes that rates are not significantly different. PMID:26872081

The impact of prism adaptation test on surgical outcomes in patients with primary exotropia.

PubMed

Kiyak Yilmaz, Ayse; Kose, Suheyla; Guven Yilmaz, Suzan; Uretmen, Onder

2015-05-01

We aimed to determine the impact of the preoperative prism adaptation test (PAT) on surgical outcomes in patients with primary exotropia. Thirty-eight consecutive patients with primary exotropia were enrolled. Pre-operative PAT was performed in 18 randomly selected patients (Group 1). Surgery was based on the angle of deviation at distance measured after PAT. The remaining 20 patients in whom PAT was not performed comprised Group 2. Surgery was based on the angle of deviation at distance in these patients. Surgical success was defined as ocular alignment within eight prism dioptres (PD) of orthophoria. Satisfactory motor alignment (± 8 PD) was achieved in 16 Group 1 patients (88.9 per cent) and 16 Group 2 patients (80 per cent) one year after surgery (p = 0.6; chi-square test). There were no statistically significant differences in demographic parameters, pre-operative and post-operative angle of deviation between the two groups (p > 0.05; Mann-Whitney U and chi-square tests). Nine patients in Group 1 (50 per cent) and two patients in Group 2 (10 per cent) had increased binocular vision one year post-operatively. A statistically significant difference was determined in terms of change in binocular single vision between the two groups (p = 0.01; chi-square test). Although the prism adaptation test did not lead to a significant increment in motor success, it may be helpful in achieving a more favourable functional surgical outcome in patients with primary exotropia. © 2014 The Authors. Clinical and Experimental Optometry © 2014 Optometrists Association Australia.

Pay for performance in thoracic surgery.

PubMed

Varela, Gonzalo

2007-08-01

In the context of improving the quality of the medical practice, PFP programs have been developed to reward best medical practice. Early studies showed little gain in quality after implementing PFP family practice programs and some unintended consequences, like excluding high-risk patients from medical services when good outcomes were linked to payment. To date, no PFP programs have been implemented in surgical practice, but it is expected that value-based purchasing philosophy will be extended to surgical specialties in the near future. Quality initiatives in surgery can be based on outcome or process measures. Outcomes-focused quality approaches rely on accurate information obtained from multiinstitutional clinical databases for calculation of risk-adjusted models. Primary outcomes such surgical mortality are uncommon in modern thoracic surgery and outcome measures should rely on more prevalent intermediate outcomes such as specific postoperative morbidities or emergency readmission. Process-based quality approaches need to be based on scientific evidence linking process to outcomes. It is our responsibility to develop practice guidelines or international practice consensus to facilitate the parameters to be evaluated in the near future.

Effect of incident nocturnal home hemodialysis versus incident continuous ambulatory peritoneal dialysis on employment rate, clinical, and laboratory outcomes: A 1-year retrospective observation study.

PubMed

Li, John Wing; Wong, Joseph Ho Sing; Chak, Wai Leung; Chau, Ka Foon

2017-10-18

While studies demonstrated favorable outcomes of nocturnal home hemodialysis (NHHD), direct comparison on employment rate, clinical and laboratory outcomes between the NHHD and continuous ambulatory peritoneal dialysis (CAPD) had not been previously performed. A 1-year retrospective observation study was performed in 20 incidents alternate night NHHD and 81 incident CAPD patients of Chinese ethnicity, who were sex, diabetic status, and Charlson comorbidity index matched, but not age due to our center's age limit for NHHD enrollment. The primary outcome was the difference in employment rate at 1 year. Secondary outcomes included differences in clinical parameters (weight, blood pressure, number of antihypertensive medication, dosage of phosphate binders, and erythropoietin stimulating agent) and laboratory parameters (residual renal function, mineral metabolic markers, hemoglobin). NHHD subjects were 5 years younger than CAPD patients, and they had higher employment rate (80% vs. 33.3%, P < 0.01) at 1 year, with age-adjusted odds ratio for employment was 6.10 (95% confidence interval 1.77-20.99, P = 0.04). They consumed less aluminum-based phosphate binder (0 vs. 1800 mg, P < 0.01), but showed no significant disparities in other clinical parameters. Residual renal function in both groups declined comparably, nonetheless NHHD group had lower serum phosphate (1.37 vs. 1.71 mmol/L, P = 0.01) and calcium phosphate product (3.13 vs. 4.12 mmol 2 /L 2 , P < 0.01), with similar hemoglobin levels. NHHD appeared to offer higher employment rate, lower dosage of aluminum-based phosphate binder and mineral metabolic markers at 1 year compared with CAPD in Hong Kong. © 2017 International Society for Hemodialysis.

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient-based outcomes in patients with primary tinnitus undergoing tinnitus retraining therapy.

PubMed

Berry, Julie A; Gold, Susan L; Frederick, Ellen Alvarez; Gray, William C; Staecker, Hinrich

2002-10-01

To determine whether the Tinnitus Handicap Inventory (THI), a validated patient-based outcomes measure, may improve our ability to quantify impact and assess therapy for patients with tinnitus. Nonrandomized, prospective analysis of 32 patients undergoing tinnitus retraining therapy (TRT). Assessment tools included comprehensive audiology, a subjective self-assessment survey of tinnitus characteristics, and the THI. Tinnitus Handicap Inventory scores were assessed at baseline and 6 months following TRT. Baseline analysis revealed significant correlation between the subjective presence of hyperacusis and higher total, emotional, and catastrophic THI scores. Tinnitus Handicap Inventory scores correlated with subjective perception of overall tinnitus effect (P<.001). Mean pure-tone threshold average was 17.4 dB, and mean speech discrimination was 97.0%. There were no consistent correlations between baseline audiologic parameters and THI scores. Following 6 months of TRT, the total, emotional, functional, and catastrophic THI scores significantly improved (P<.001). Loudness discomfort levels also significantly improved (P< or =.02). There is significant improvement in self-perceived disability following TRT as measured by the THI. The results confirm the utility of the THI as a patient-based outcomes measure for quantifying treatment status in patients with primary tinnitus.

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

PubMed Central

Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat

2017-01-01

Background The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes. Methods We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63–1.1, I2 = 21%). Conclusion A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study. PMID:28234219

Oncologic outcomes following robot-assisted radical cystectomy with minimum 5-year follow-up: the Roswell Park cancer institute experience.

PubMed

Raza, Syed Johar; Al-Daghmin, Ali; Zhuo, Sharon; Mehboob, Zayn; Wang, Katy; Wilding, Gregory; Kauffman, Eric; Guru, Khurshid A

2014-11-01

Long-term oncologic outcomes following robot-assisted radical cystectomy (RARC) remain scarce. To report long-term oncologic outcomes following RARC at a single institution. Retrospective review of 99 patients who underwent RARC for urothelial carcinoma of bladder between 2005 and 2009. RARC was performed. Primary outcomes included recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS), measured by the Kaplan-Meier method. The association between primary outcomes and perioperative and pathologic factors was assessed using a multivariable Cox proportional hazards model. Fifty-one (52%) patients had stage pT3 or higher disease. Eight (8%) patients had positive margins and 30 (30%) had positive lymph nodes (LNs), with a median of 21 LNs removed. Median follow-up for patients alive was 74 mo. The 5-yr RFS, CSS, and OS rates were 52.5%, 67.8%, and 42.4%, respectively. Tumor stage, LN stage, and margin status were each significantly associated with RFS, CSS, and OS. On multivariable analysis, tumor and LN stage were independent predictors of RFS, CSS, and OS, while positive margin status and Charlson comorbidity index predicted worse OS and CSS. Adjuvant chemotherapy predicted RFS only. Retrospective design and lack of open comparison are main limitations of this study. Long-term oncologic outcomes following RARC demonstrate RFS and CSS estimates similar to those reported in literature for open radical cystectomy. Randomized controlled trials can better define outcomes of any alternative technique. Survival data 5 yr after RARC for bladder cancer demonstrate that survival outcomes are dependent on the same oncologic parameters as previously reported for open surgery. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

A third of systematic reviews changed or did not specify the primary outcome: a PROSPERO register study.

PubMed

Tricco, Andrea C; Cogo, Elise; Page, Matthew J; Polisena, Julie; Booth, Alison; Dwan, Kerry; MacDonald, Heather; Clifford, Tammy J; Stewart, Lesley A; Straus, Sharon E; Moher, David

2016-11-01

To examine outcome reporting bias of systematic reviews registered in PROSPERO. Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions, or downgrades. Relative risks (RRs) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favorable and statistically significant. Ninety-six systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR, 2.14; 95% CI: 0.53, 8.63) or decreased risk of downgrading (RR, 0.76; 95% CI: 0.27, 2.17) an outcome when the meta-analysis result was favorable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR, 0.89; 95% CI: 0.31, 2.53) or decreased risk of downgrading (RR, 0.56; 95% CI: 0.29, 1.08) an outcome when the conclusion was positive. We recommend review authors carefully consider primary outcome selection, and journals are encouraged to focus acceptance on registered systematic reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Medical Rapid Response in Psychiatry: Reasons for Activation and Immediate Outcome.

PubMed

Manu, Peter; Loewenstein, Kristy; Girshman, Yankel J; Bhatia, Padam; Barnes, Maira; Whelan, Joseph; Solderitch, Victoria A; Rogozea, Liliana; McManus, Marybeth

2015-12-01

Rapid response teams are used to improve the recognition of acute deteriorations in medical and surgical settings. They are activated by abnormal physiological parameters, symptoms or clinical concern, and are believed to decrease hospital mortality rates. We evaluated the reasons for activation and the outcome of rapid response interventions in a 222-bed psychiatric hospital in New York City using data obtained at the time of all activations from January through November, 2012. The primary outcome was the admission rate to a medical or surgical unit for each of the main reasons for activation. The 169 activations were initiated by nursing staff (78.7 %) and psychiatrists (13 %) for acute changes in condition (64.5 %), abnormal physiological parameters (27.2 %) and non-specified concern (8.3 %). The most common reasons for activation were chest pain (14.2 %), fluctuating level of consciousness (9.5 %), hypertension (9.5 %), syncope or fall (8.9 %), hypotension (8.3 %), dyspnea (7.7 %) and seizures (5.9 %). The rapid response team transferred 127 (75.2 %) patients to the Emergency Department and 46 (27.2 %) were admitted to a medical or surgical unit. The admission rates were statistically similar for acute changes in condition, abnormal physiological parameters, and clinicians' concern. In conclusion, a majority of rapid response activations in a self-standing psychiatric hospital were initiated by nursing staff for changes in condition, rather than for policy-specified abnormal physiological parameters. The findings suggest that a rapid response system may empower psychiatric nurses to use their clinical skills to identify patients requiring urgent transfer to a general hospital.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned.

Management of physical health in patients with schizophrenia: practical recommendations.

PubMed

Heald, A; Montejo, A L; Millar, H; De Hert, M; McCrae, J; Correll, C U

2010-06-01

Improved physical health care is a pressing need for patients with schizophrenia. It can be achieved by means of a multidisciplinary team led by the psychiatrist. Key priorities should include: selection of antipsychotic therapy with a low risk of weight gain and metabolic adverse effects; routine assessment, recording and longitudinal tracking of key physical health parameters, ideally by electronic spreadsheets; and intervention to control CVD risk following the same principles as for the general population. A few simple tools to assess and record key physical parameters, combined with lifestyle intervention and pharmacological treatment as indicated, could significantly improve physical outcomes. Effective implementation of strategies to optimise physical health parameters in patients with severe enduring mental illness requires engagement and communication between psychiatrists and primary care in most health settings. Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

Literature review of outcome parameters used in studies of Geriatric Fracture Centers.

PubMed

Liem, I S L; Kammerlander, C; Suhm, N; Kates, S L; Blauth, M

2014-02-01

A variety of multidisciplinary treatment models have been described to improve outcome after osteoporotic hip fractures. There is a tendency toward better outcomes after implementation of the most sophisticated model with a shared leadership for orthopedic surgeons and geriatricians; the Geriatric Fracture Center. The purpose of this review is to evaluate the use of outcome parameters in published literature on the Geriatric Fracture Center evaluation studies. A literature search was performed using Medline and the Cochrane Library to identify Geriatric Fracture Center evaluation studies. The outcome parameters used in the included studies were evaluated. A total of 16 outcome parameters were used in 11 studies to evaluate patient outcome in 8 different Geriatric Fracture Centers. Two of these outcome parameters are patient-reported outcome measures and 14 outcome parameters were objective measures. In-hospital mortality, length of stay, time to surgery, place of residence and complication rate are the most frequently used outcome parameters. The patient-reported outcomes included activities of daily living and mobility scores. There is a need for generally agreed upon outcome measures to facilitate comparison of different care models.

Motorcycles entering from access points and merging with traffic on primary roads in Malaysia: behavioral and road environment influence on the occurrence of traffic conflicts.

PubMed

Abdul Manan, Muhammad Marizwan

2014-09-01

This paper uses data from an observational study, conducted at access points in straight sections of primary roads in Malaysia in 2012, to investigate the effects of motorcyclists' behavior and road environment attributes on the occurrence of serious traffic conflicts involving motorcyclists entering primary roads via access points. In order to handle the unobserved heterogeneity in the small sample data size, this study applies mixed effects logistic regression with multilevel bootstrapping. Two statistically significant models (Model 2 and Model 3) are produced, with 2 levels of random effect parameters, i.e. motorcyclists' attributes and behavior at Level 1, and road environment attributes at Level 2. Among all the road environment attributes tested, the traffic volume and the speed limit are found to be statistically significant, only contributing to 26-29% of the variations affecting the traffic conflict outcome. The implication is that 71-74% of the unmeasured or undescribed attributes and behavior of motorcyclists still have an importance in predicting the outcome: a serious traffic conflict. As for the fixed effect parameters, both models show that the risk of motorcyclists being involved in a serious traffic conflict is 2-4 times more likely if they accept a shorter gap to a single approaching vehicle (time lag <4s) and in between two vehicles (time gap <4s) when entering the primary road from the access point. A road environment factor, such as a narrow lane (seen in Model 2), and a behavioral factor, such as stopping at the stop line (seen in Model 3), also influence the occurrence of a serious traffic conflict compared to those entering into a wider lane road and without stopping at the stop line, respectively. A discussion of the possible reasons for this seemingly strange result, including a recommendation for further research, concludes the paper. Copyright © 2014 Elsevier Ltd. All rights reserved.

Localized primary gastrointestinal diffuse large B cell lymphoma received a surgical approach: an analysis of prognostic factors and comparison of staging systems in 101 patients from a single institution.

PubMed

Zhang, Shengting; Wang, Li; Yu, Dong; Shen, Yang; Cheng, Shu; Zhang, Li; Qian, Ying; Shen, Zhixiang; Li, Qinyu; Zhao, Weili

2015-08-15

Diffuse large B cell lymphoma (DLBCL) represents the most common histological subtype of primary gastrointestinal lymphoma and is a heterogeneous group of disease. Prognostic characterization of individual patients is an essential prerequisite for a proper risk-based therapeutic choice. Clinical and pathological prognostic factors were identified, and predictive value of four previously described prognostic systems were assessed in 101 primary gastrointestinal DLBCL (PG-DLBCL) patients with localized disease, including Ann Arbor staging with Musshoff modification, International Prognostic Index (IPI), Lugano classification, and Paris staging system. Univariate factors correlated with inferior survival time were clinical parameters [age>60 years old, multiple extranodal/gastrointestinal involvement, elevated serum lactate dehydrogenase and β2-microglobulin, and decreased serum albumin], as well as pathological parameters (invasion depth beyond serosa, involvement of regional lymph node or adjacent tissue, Ki-67 index, and Bcl-2 expression). Major independent variables of adverse outcome indicated by multivariate analysis were multiple gastrointestinal involvement. In patients unfit for Rituximab but received surgery, radical surgery significantly prolonged the survival time, comparing with alleviative surgery. Addition of Rituximab could overcome the negative prognostic effect of alleviative surgery. Among the four prognostic systems, IPI and Lugano classification clearly separated patients into different risk groups. IPI was able to further stratify the early-stage patients of Lugano classification into groups with distinct prognosis. Radical surgery might be proposed for the patients unfit for Rituximab treatment, and a combination of clinical and pathological staging systems was more helpful to predict the disease outcome of PG-DLBCL patients.

The prediction of progression-free and overall survival in women with an advanced stage of epithelial ovarian carcinoma.

PubMed

Gerestein, C G; Eijkemans, M J C; de Jong, D; van der Burg, M E L; Dykgraaf, R H M; Kooi, G S; Baalbergen, A; Burger, C W; Ansink, A C

2009-02-01

Prognosis in women with ovarian cancer mainly depends on International Federation of Gynecology and Obstetrics stage and the ability to perform optimal cytoreductive surgery. Since ovarian cancer has a heterogeneous presentation and clinical course, predicting progression-free survival (PFS) and overall survival (OS) in the individual patient is difficult. The objective of this study was to determine predictors of PFS and OS in women with advanced stage epithelial ovarian cancer (EOC) after primary cytoreductive surgery and first-line platinum-based chemotherapy. Retrospective observational study. Two teaching hospitals and one university hospital in the south-western part of the Netherlands. Women with advanced stage EOC. All women who underwent primary cytoreductive surgery for advanced stage EOC followed by first-line platinum-based chemotherapy between January 1998 and October 2004 were identified. To investigate independent predictors of PFS and OS, a Cox' proportional hazard model was used. Nomograms were generated with the identified predictive parameters. The primary outcome measure was OS and the secondary outcome measures were response and PFS. A total of 118 women entered the study protocol. Median PFS and OS were 15 and 44 months, respectively. Preoperative platelet count (P = 0.007), and residual disease <1 cm (P = 0.004) predicted PFS with a optimism corrected c-statistic of 0.63. Predictive parameters for OS were preoperative haemoglobin serum concentration (P = 0.012), preoperative platelet counts (P = 0.031) and residual disease <1 cm (P = 0.028) with a optimism corrected c-statistic of 0.67. PFS could be predicted by postoperative residual disease and preoperative platelet counts, whereas residual disease, preoperative platelet counts and preoperative haemoglobin serum concentration were predictive for OS. The proposed nomograms need to be externally validated.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial.

PubMed

Gensichen, Jochen; Hiller, Thomas S; Breitbart, Jörg; Teismann, Tobias; Brettschneider, Christian; Schumacher, Ulrike; Piwtorak, Alexander; König, Hans-Helmut; Hoyer, Heike; Schneider, Nico; Schelle, Mercedes; Blank, Wolfgang; Thiel, Paul; Wensing, Michel; Margraf, Jürgen

2014-04-06

Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Current Controlled Trials [http://ISCRTN64669297].

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial

PubMed Central

2014-01-01

Background Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. Methods/Design This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Trial registration Current Controlled Trials [http://ISCRTN64669297] PMID:24708672

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © 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.

Fifteen years of continuous improvement of quality care of type 2 diabetes mellitus in primary care in Catalonia, Spain.

PubMed

Mata-Cases, M; Roura-Olmeda, P; Berengué-Iglesias, M; Birulés-Pons, M; Mundet-Tuduri, X; Franch-Nadal, J; Benito-Badorrey, B; Cano-Pérez, J F

2012-03-01

To assess the evolution of type 2 diabetes mellitus (T2DM) quality indicators in primary care centers (PCC) as part of the Group for the Study of Diabetes in Primary Care (GEDAPS) Continuous Quality Improvement (GCQI) programme in Catalonia. Sequential cross-sectional studies were performed during 1993-2007. Process and outcome indicators in random samples of patients from each centre were collected. The results of each evaluation were returned to each centre to encourage the implementation of correcting interventions. Sixty-four different educational activities were performed during the study period with the participation of 2041 professionals. Clinical records of 23,501 patients were evaluated. A significant improvement was observed in the determination of some annual process indicators: HbA(1c) (51.7% vs. 88.9%); total cholesterol (75.9% vs. 90.9%); albuminuria screening (33.9% vs. 59.4%) and foot examination (48.9% vs. 64.2%). The intermediate outcome indicators also showed significant improvements: glycemic control [HbA(1c) ≤ 7% (< 57 mmol/mol); (41.5% vs. 64.2%)]; total cholesterol [≤ 200 mg/dl (5.17 mmol/l); (25.5% vs. 65.6%)]; blood pressure [≤ 140/90 mmHg; (45.4% vs. 66.1%)]. In addition, a significant improvement in some final outcome indicators such as prevalence of foot ulcers (7.6% vs. 2.6%); amputations (1.9% vs. 0.6%) and retinopathy (18.8% vs. 8.6%) was observed. Although those changes should not be strictly attributed to the GCQI programme, significant improvements in some process indicators, parameters of control and complications were observed in a network of primary care centres in Catalonia. © 2012 Blackwell Publishing Ltd.

Fifteen years of continuous improvement of quality care of type 2 diabetes mellitus in primary care in Catalonia, Spain

PubMed Central

Mata-Cases, M; Roura-Olmeda, P; Berengué-Iglesias, M; Birulés-Pons, M; Mundet-Tuduri, X; Franch-Nadal, J; Benito-Badorrey, B; Cano-Pérez, J F

2012-01-01

Aims To assess the evolution of type 2 diabetes mellitus (T2DM) quality indicators in primary care centers (PCC) as part of the Group for the Study of Diabetes in Primary Care (GEDAPS) Continuous Quality Improvement (GCQI) programme in Catalonia. Methods Sequential cross-sectional studies were performed during 1993–2007. Process and outcome indicators in random samples of patients from each centre were collected. The results of each evaluation were returned to each centre to encourage the implementation of correcting interventions. Sixty-four different educational activities were performed during the study period with the participation of 2041 professionals. Results Clinical records of 23,501 patients were evaluated. A significant improvement was observed in the determination of some annual process indicators: HbA1c (51.7% vs. 88.9%); total cholesterol (75.9% vs. 90.9%); albuminuria screening (33.9% vs. 59.4%) and foot examination (48.9% vs. 64.2%). The intermediate outcome indicators also showed significant improvements: glycemic control [HbA1c ≤ 7% (< 57 mmol/mol); (41.5% vs. 64.2%)]; total cholesterol [≤ 200 mg/dl (5.17 mmol/l); (25.5% vs. 65.6%)]; blood pressure [≤ 140/90 mmHg; (45.4% vs. 66.1%)]. In addition, a significant improvement in some final outcome indicators such as prevalence of foot ulcers (7.6% vs. 2.6%); amputations (1.9% vs. 0.6%) and retinopathy (18.8% vs. 8.6%) was observed. Conclusions Although those changes should not be strictly attributed to the GCQI programme, significant improvements in some process indicators, parameters of control and complications were observed in a network of primary care centres in Catalonia. PMID:22340449

The ACTIVE conceptual framework as a structural equation model.

PubMed

Gross, Alden L; Payne, Brennan R; Casanova, Ramon; Davoudzadeh, Pega; Dzierzewski, Joseph M; Farias, Sarah; Giovannetti, Tania; Ip, Edward H; Marsiske, Michael; Rebok, George W; Schaie, K Warner; Thomas, Kelsey; Willis, Sherry; Jones, Richard N

2018-01-01

Background/Study Context: Conceptual frameworks are analytic models at a high level of abstraction. Their operationalization can inform randomized trial design and sample size considerations. The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) conceptual framework was empirically tested using structural equation modeling (N=2,802). ACTIVE was guided by a conceptual framework for cognitive training in which proximal cognitive abilities (memory, inductive reasoning, speed of processing) mediate treatment-related improvement in primary outcomes (everyday problem-solving, difficulty with activities of daily living, everyday speed, driving difficulty), which in turn lead to improved secondary outcomes (health-related quality of life, health service utilization, mobility). Measurement models for each proximal, primary, and secondary outcome were developed and tested using baseline data. Each construct was then combined in one model to evaluate fit (RMSEA, CFI, normalized residuals of each indicator). To expand the conceptual model and potentially inform future trials, evidence of modification of structural model parameters was evaluated by age, years of education, sex, race, and self-rated health status. Preconceived measurement models for memory, reasoning, speed of processing, everyday problem-solving, instrumental activities of daily living (IADL) difficulty, everyday speed, driving difficulty, and health-related quality of life each fit well to the data (all RMSEA < .05; all CFI > .95). Fit of the full model was excellent (RMSEA = .038; CFI = .924). In contrast with previous findings from ACTIVE regarding who benefits from training, interaction testing revealed associations between proximal abilities and primary outcomes are stronger on average by nonwhite race, worse health, older age, and less education (p < .005). Empirical data confirm the hypothesized ACTIVE conceptual model. Findings suggest that the types of people who show intervention effects on cognitive performance potentially may be different from those with the greatest chance of transfer to real-world activities.

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

PubMed

Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

2018-05-05

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

Role of tear location on outcomes of open primary repair of the anterior cruciate ligament: A systematic review of historical studies.

PubMed

van der List, Jelle P; DiFelice, Gregory S

2017-10-01

The general opinion is that outcomes of open primary repair of the anterior cruciate ligament (ACL) in the historical literature were disappointing. Since good outcomes of primary repair of proximal tears have recently been reported, we aimed to assess the role of tear location on open primary repair outcomes in the historical literature. All studies reporting outcomes of open primary ACL repair published between the inception of PubMed, Embase and Cochrane and 2000 were identified. Studies were included if tear location was reported. Outcome scores, return to sports, stability examinations, failures and patient satisfaction were collected and reviewed in the total study cohort and in a subgroup of studies treating only proximal tears. Spearman correlation analysis was performed between the percentage of proximal tears in the studies and all outcomes. Twenty-nine studies were included reporting outcomes of open primary in 1457 patients of which 72% had proximal and 23% midsubstance tears. Mean age was 30years, 65% were males, and mean follow-up was 3.6years. Good outcomes were noted in the total cohort, and excellent outcomes were noted following repair of proximal tears. Positive correlation was found between the percentage proximal tears in the studies and percentage satisfied patients (p=0.010). Tear location seems to have played a role on the outcomes of open primary ACL repair. Outcomes of open primary repair in patients with proximal tears were excellent, which confirms there may be a potential role for primary repair as treatment for proximal ACL tears. Copyright © 2017 Elsevier B.V. All rights reserved.

Correlation between radiographic parameters and functional scores in degenerative lumbar and thoracolumbar scoliosis.

PubMed

Simon, J; Longis, P-M; Passuti, N

2017-04-01

Adult scoliosis is a condition in which the spinal deformity occurs because of degeneration. Although various studies have agreed on the importance of restoring the sagittal balance, few have evaluated the relationship between functional scores and radiological parameters. The primary objective of this retrospective study was to demonstrate the correlation between radiographic parameters and functional outcomes in adult patients with lumbar or thoracolumbar degenerative scoliosis. The secondary objective was to assess the long-term effects of posterolateral fusion for treating this deformity. This single-centre retrospective study included 47 patients over 50years of age who had degenerative lumbar scoliosis treated with an instrumented posterolateral fusion; the mean follow-up was 6.4years (range 2 to 20). Radiographic analysis of A/P and lateral full spine standing radiographs was carried out with the KEOPS software. Three pelvic parameters (pelvic tilt, pelvic incidence, sacral slope), two spinal parameters (lumbar lordosis and thoracic kyphosis) and three sagittal balance parameters (C7 sagittal tilt, C7 Barrey's ratio and spinosacral angle) were calculated. The functional outcomes were evaluated through three self-assessment questionnaires: Oswestry Disability Index, SRS-30 and SF-36. The correlation between clinical and radiographic parameters was calculated with Spearman's correlation test. There was a significant correlation between the SF-36 (PCS) and the following three sagittal parameters: sacral slope (r=-0.31453; P=0.04), lumbar lordosis (r=-0.30198; P=0.0491) and spinosacral angle (r=-0.311967; P=0.0366). The mean ODI score was 33.61, which corresponds to minimal to moderate disability. The mean physical (PCS) and mental (MCS) component summary scores of the SF-36 were 37.70 and 38.40, respectively. The mean SRS-30 score was 3.07. It is essential that the sagittal balance be restored when treating degenerative lumbar scoliosis to generate better functional outcomes and better quality of life. To achieve this correction, instrumented posterolateral fusion appears to be a very reliable technique that leads to lasting improvement. IV. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Growth and Neurodevelopmental Outcomes of Early, High-Dose Parenteral Amino Acid Intake in Very Low Birth Weight Infants: A Randomized Controlled Trial.

PubMed

Balakrishnan, Maya; Jennings, Alishia; Przystac, Lynn; Phornphutkul, Chanika; Tucker, Richard; Vohr, Betty; Stephens, Bonnie E; Bliss, Joseph M

2017-03-01

Administration of high-dose parenteral amino acids (AAs) to premature infants within hours of delivery is currently recommended. This study compared the effect of lower and higher AA administration starting close to birth on short-term growth and neurodevelopmental outcomes at 18-24 months corrected gestational age (CGA). Infants <1250 g birth weight (n = 168) were randomly assigned in a blinded fashion to receive parenteral nutrition providing 1-2 g/kg/d AA and advancing daily by 0.5 g/kg/d to a goal of 4 g/kg/d (standard AA) or 3-4 g/kg/d and advancing to 4 g/kg/d by day 1. The primary outcome was neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development, Third Edition at 18-24 months CGA. Secondary outcomes were growth parameters at 36 weeks CGA among infants surviving to hospital discharge, serum bicarbonate, serum urea nitrogen, creatinine, AA profiles in the first week of life, and incidence of major morbidities and mortality. No differences in neurodevelopmental outcome were detected between the high and low AA groups. Infants in the high AA group had significantly lower mean weight, length, and head circumference percentiles than those in the standard AA group at 36 weeks CGA and at hospital discharge. These differences did not persist after controlling for birth growth parameters, except for head circumference. Infants in the high AA group had higher mean serum urea nitrogen than the standard group on each day throughout the first week. Current recommendations for high-dose AA starting at birth are not associated with improved growth or neurodevelopmental outcomes.

Functional parameters but not heart rate variability correlate with long-term outcomes in St-elevation myocardial infarction patients treated by primary angioplasty.

PubMed

Compostella, Leonida; Lakusic, Nenad; Russo, Nicola; Setzu, Tiziana; Compostella, Caterina; Vettore, Elia; Isabella, Giambattista; Tarantini, Giuseppe; Iliceto, Sabino; Bellotto, Fabio

2016-12-01

Depressed heart rate variability (HRV) is usually considered a negative long-term prognostic factor after acute myocardial infarction. Anyway, most of the supporting research was conducted before the era of immediate reperfusion by percutaneous coronary intervention (PCI). Main aim of this study was to evaluate if HRV still retains prognostic significance in our era of immediate PCI. Two weeks after STEMI treated by primary PCI, time-domain HRV was assessed from 24-h Holter recordings in 186 patients: markedly depressed HRV (SDNN <70ms or <50ms) was present in 16% and in 5% of cases, respectively; patients with left ventricle ejection fraction (LVEF) <40% presented more often SDNN values in the lowest quartile. Physical performance was also assessed, by 6-minute walk tests (6MWT) and by cardiopulmonary exercise test (CPET). After >2years from infarction, occurrence of major clinical events (MCE) was investigated. Cases with or without MCE did not differ by initial HRV parameters; Kaplan-Meier events-free survival curves were similar between patients with lowest quartile SDNN and the remaining ones (χ 2 0.981, p=0.322). By the contrary, events-free survival was worse if patients walked shorter distances at 6MWT (χ 2 6.435, p=0.011), developed poorer ventilatory efficiency at CPET (χ 2 10.060, p=0.002), or presented LVEF <40% (χ 2 7.085, p=0.008). In primary-PCI STEMI patients, markedly abnormal HRV was found in a small percentage of cases. HRV seems to have lost its prognostic significance, while parameters indicating LV function (LVEF and physical performance) could allow better prognostication in primary-PCI STEMI patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial.

PubMed

Baumbach, Sebastian Felix; Fasser, Mariette; Polzer, Hans; Sieb, Michael; Regauer, Markus; Mutschler, Wolf; Schieker, Matthias; Blauth, Michael

2013-01-14

Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. 60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains. NCT01702597.

Predictive relevance of clinical scores and inflammatory parameters in secondary peritonitis.

PubMed

Zügel, Nikolaus P; Kox, Martin; Lichtwark-Aschoff, Michael; Gippner-Steppert, Cornelia; Jochum, Marianne

2011-01-01

To measure and evaluate clinical scores and various inflammation parameters for providing a better outcome assessment of patients with secondary peritonitis. Prospective study. ICU of a university and a university affiliated hospital. Fifty-six patients with severe secondary peritonitis were enrolled in this study executed within 4 years. Blood samples were taken preoperatively and 2, 6, 8, 12, 18, 24, 30, 36, 42 and 48 hours post operation, thereafter every 12th hour until day 5 respectively once daily until day 14. Etiology of peritonitis, clinical score systems (APACHE II, MOF and SOFA), and 27 mainly with activity tests or enzyme-immunoassays measurable inflammation parameters were simultaneously analyzed and stratified into lethal outcome (n = 11) or survival (n = 45), respectively. The etiological distribution of peritonitis was identical among both groups. Proportion of intraperitoneal fungi, E. coli, and bacteroids was substantially higher during the primary operation in the group with lethal outcome. With increasing significance initial and follow-up APACHE II, MOF and SOFA scores provided higher values in this group. Various plasma/serum parameters of hemostasis, leukocyte proteolytic system, acute phase reaction, cytokine system, cell adhesion, opsonization, and main organ functions showed significantly different values between both groups at the preoperative stage and/or during observation period I (day 0-4). Logistic regression analysis revealed the SOFA score and neopterin concentration as the combination with the best sensitivity (63.6%) and specificity (93.2%) for predicting the patients' survival even at the preoperative stage. For the observation period I, the combination of SOFA score and TNF receptor II showed the highest predictive sensitivity (72.7%) and specificity (95.6%). Evaluation of the severity of secondary peritonitis using a scoring system with high prognostic relevance could conceivably result in an earlier and adequate application of intensive care such as hemofiltration, administration of immunoglobulins and serial abdominal lavage to improve successful outcome.

Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial

PubMed Central

2013-01-01

Background Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design 60 patients, aged 18–40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. Discussion This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains. Trial registration NCT01702597 PMID:23316791

Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

PubMed Central

Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

Scoping study into wound management nurse practitioner models of practice.

PubMed

Gibb, Michelle A; Edwards, Helen E; Gardner, Glenn E

2015-04-01

The primary objective of this research was to investigate wound management nurse practitioner (WMNP) models of service for the purposes of identifying parameters of practice and how patient outcomes are measured. A scoping study was conducted with all authorised WMNPs in Australia from October to December 2012 using survey methodology. A questionnaire was developed to obtain data on the role and practice parameters of authorised WMNPs in Australia. The tool comprised seven sections and included a total of 59 questions. The questionnaire was distributed to all members of the WMNP Online Peer Review Group, to which it was anticipated the majority of WMNPs belonged. Twenty-one WMNPs responded (response rate 87%), with the results based on a subset of respondents who stated that, at the time of the questionnaire, they were employed as a WMNP, therefore yielding a response rate of 71% (n=15). Most respondents (93%; n=14) were employed in the public sector, with an average of 64 occasions of service per month. The typical length of a new case consultation was 60 min, with 32 min for follow ups. The most frequently performed activity was wound photography (83%; n=12), patient, family or carer education (75%; n=12), Doppler ankle-brachial pressure index assessment (58%; n=12), conservative sharp wound debridement (58%; n=12) and counselling (50%; n=12). The most routinely prescribed medications were local anaesthetics (25%; n=12) and oral antibiotics (25%; n=12). Data were routinely collected by 91% of respondents on service-related and wound-related parameters to monitor patient outcomes, to justify and improve health services provided. This study yielded important baseline information on this professional group, including data on patient problems managed, the types of interventions implemented, the resources used to accomplish outcomes and how outcomes are measured.

Rituximab is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A phase-2 Randomised Controlled Trial.

PubMed

Khanna, Amardeep; Jopson, Laura; Howel, Denise; Bryant, Andrew; Blamire, Andrew; Newton, Julia L; Jones, David E

2018-05-23

Primary Biliary Cholangitis (PBC) is a chronic cholestatic liver disease. Half of patients experience debilitating fatigue which is currently untreatable. Previous studies have shown muscle bioenergetic abnormalities in PBC, including increased muscle acidosis with exercise linked to the anti-mitochondrial antibody (AMA) diagnostic of the disease, and reduced anaerobic threshold. In this study we addressed the hypothesis that fatigue in PBC is driven by muscle bioenergetic abnormality related to AMA, and that AMA reduction with B-cell depletion therapy will improve fatigue. In our single-centred Phase II randomised controlled trial (RCT) 57 participants aged ≥18 years with PBC and moderate or severe fatigue were randomized to receive 2 doses of either rituximab (1000mg) or saline (placebo). The primary outcome measure was fatigue severity assessed using the PBC-40 fatigue domain at 3 months. Secondary outcomes measures included patient-reported outcomes, immunological and bioenergetics disease parameters. Experimental outcomes included biochemical markers of disease severity. Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9 95%CI -4.6 to 3.1). Little difference was observed in other patient reported outcomes or physical activity. Significant anaerobic threshold improvement was seen in the Rituximab group only but this was not associated with fatigue improvement. No treatment-emergent SAEs were seen. Rituximab was safe over the 12 month study period but showed no evidence of effectiveness for the treatment of fatigue in PBC. Anaerobic threshold improvement was seen; potentially linking AMA with muscle bioenergetics dysfunction, however, this was not related to improvement in fatigue. Rituximab had some evidence of a beneficial effect on alkaline phosphatase levels in this largely UDCA-responding, early disease stage cohort. This article is protected by copyright. All rights reserved. © 2018 by the American Association for the Study of Liver Diseases.

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

PubMed Central

Saberi, Parya; Dong, Betty J; Johnson, Mallory O; Greenblatt, Ruth M; Cocohoba, Jennifer M

2012-01-01

Objective Due to the rapid proliferation of human immunodeficiency virus (HIV) treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes. Methods We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist’s roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD4+ cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables. Results Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies. Conclusion This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research. PMID:22536064

Assessment of the quality of primary care for the elderly according to the Chronic Care Model 1

PubMed Central

Silva, Líliam Barbosa; Soares, Sônia Maria; Silva, Patrícia Aparecida Barbosa; Santos, Joseph Fabiano Guimarães; Miranda, Lívia Carvalho Viana; Santos, Raquel Melgaço

2018-01-01

ABSTRACT Objective: to evaluate the quality of care provided to older people with diabetes mellitus and/or hypertension in the Primary Health Care (PHC) according to the Chronic Care Model (CCM) and identify associations with care outcomes. Method: cross-sectional study involving 105 older people with diabetes mellitus and/or hypertension. The Patient Assessment of Chronic Illness Care (PACIC) questionnaire was used to evaluate the quality of care. The total score was compared with care outcomes that included biochemical parameters, body mass index, pressure levels and quality of life. Data analysis was based on descriptive statistics and multiple logistic regression. Results: there was a predominance of females and a median age of 72 years. The median PACIC score was 1.55 (IQ 1.30-2.20). Among the PACIC dimensions, the “delivery system design/decision support” was the one that presented the best result. There was no statistical difference between the medians of the overall PACIC score and individual care outcomes. However, when the quality of life and health satisfaction were simultaneously evaluated, a statistical difference between the medians was observed. Conclusion: the low PACIC scores found indicate that chronic care according to the CCM in the PHC seems still to fall short of its assumptions. PMID:29538582

Assessment of the quality of primary care for the elderly according to the Chronic Care Model.

PubMed

Silva, Líliam Barbosa; Soares, Sônia Maria; Silva, Patrícia Aparecida Barbosa; Santos, Joseph Fabiano Guimarães; Miranda, Lívia Carvalho Viana; Santos, Raquel Melgaço

2018-03-08

to evaluate the quality of care provided to older people with diabetes mellitus and/or hypertension in the Primary Health Care (PHC) according to the Chronic Care Model (CCM) and identify associations with care outcomes. cross-sectional study involving 105 older people with diabetes mellitus and/or hypertension. The Patient Assessment of Chronic Illness Care (PACIC) questionnaire was used to evaluate the quality of care. The total score was compared with care outcomes that included biochemical parameters, body mass index, pressure levels and quality of life. Data analysis was based on descriptive statistics and multiple logistic regression. there was a predominance of females and a median age of 72 years. The median PACIC score was 1.55 (IQ 1.30-2.20). Among the PACIC dimensions, the "delivery system design/decision support" was the one that presented the best result. There was no statistical difference between the medians of the overall PACIC score and individual care outcomes. However, when the quality of life and health satisfaction were simultaneously evaluated, a statistical difference between the medians was observed. the low PACIC scores found indicate that chronic care according to the CCM in the PHC seems still to fall short of its assumptions.

Clinico-pathological and biological prognostic variables in squamous cell carcinoma of the vulva.

PubMed

Gadducci, Angiolo; Tana, Roberta; Barsotti, Cecilia; Guerrieri, Maria Elena; Genazzani, Andrea Riccardo

2012-07-01

Several clinical-pathological parameters have been related to survival of patients with invasive squamous cell carcinoma of the vulva, whereas few studies have investigated the ability of biological variables to predict the clinical outcome of these patients. The present paper reviews the literature data on the prognostic relevance of lymph node-related parameters, primary tumor-related parameters, FIGO stage, blood variables, and tissue biological variables. Regarding these latter, the paper takes into account the analysis of DNA content, cell cycle-regulatory proteins, apoptosis-related proteins, epidermal growth factor receptor [EGFR], and proteins that are involved in tumor invasiveness, metastasis and angiogenesis. At present, the lymph node status and FIGO stage according to the new 2009 classification system are the main predictors for vulvar squamous cell carcinoma, whereas biological variables do not have yet a clinical relevance and their role is still investigational. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

PubMed

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

[Utility of treatment with atorvastatin 40 mg plus ezetimibe 10 mg versus atorvastatin 80 mg in reducing the levels of LDL cholesterol in patients with ischaemic stroke or transient ischaemic attack].

PubMed

Palacio, Enrique; Viadero-Cervera, Raquel; Revilla, Marián; Larrosa-Campo, Davinia; Acha-Salazar, Olga; Novo-Robledo, Francisco; Oterino, Agustín

2016-03-01

After an ischaemic stroke, to reduce LDL cholesterol (LDLc) levels decreases the risk of recurrence. The risk of recurrence is lower with more intense reductions in LDLc levels. To evaluate the efficacy and security of atorvastatin 40 mg plus ezetimibe 10 mg after ischaemic stroke or transient ischaemic attack (TIA). We retrospectively evaluated stroke or TIA patients admitted to our hospital who received atorvastatin 40 mg plus ezetimibe 10 mg (n = 34) or atorvastatin 80 mg (n = 52) at discharge. We analyzed changes in lipid parameters and established as a primary outcome LDLc <= 70 mg/dL and/or reduction in LDLc >= 50%. Furthermore, safety parameters were assessed. Predictors associated with primary outcome achievement were treatment with atorvastatin 40 mg plus ezetimibe 10 mg (odds ratio: 11.94; 95% CI: 2.82-50.64; p = 0.001) and male (odds ratio: 4.76; 95% CI: 1.35-16.67; p = 0.02). Treatment with atorvastatin 40 mg plus ezetimibe 10 mg achieved significantly greater reductions in LDLc (p < 0.001), total cholesterol (p < 0.001) and non-HDLc (p < 0.001). Both treatments were safe and well tolerated, with a low number of secondary effects. Compared with atorvastatin 80 mg, atorvastatin 40 mg plus ezetimibe 10 mg increases the likelihood of achieving LDLc goals after ischaemic stroke or transient ischaemic attack. Both treatments were safe and well tolerated.

Initial fractal exponent of heart-rate variability is associated with success of early resuscitation in patients with severe sepsis or septic shock: a prospective cohort study

PubMed Central

Brown, Samuel M.; Tate, Quinn; Jones, Jason P.; Knox, Daniel; Kuttler, Kathryn G.; Lanspa, Michael; Rondina, Matthew T.; Grissom, Colin K.; Behera, Subhasis; Mathews, V.J.; Morris, Alan

2013-01-01

Introduction Heart-rate variability reflects autonomic nervous system tone as well as the overall health of the baroreflex system. We hypothesized that loss of complexity in heart-rate variability upon ICU admission would be associated with unsuccessful early resuscitation of sepsis. Methods We prospectively enrolled patients admitted to ICUs with severe sepsis or septic shock from 2009 to 2011. We studied 30 minutes of EKG, sampled at 500 Hz, at ICU admission and calculated heart-rate complexity via detrended fluctuation analysis. Primary outcome was vasopressor independence at 24 hours after ICU admission. Secondary outcome was 28-day mortality. Results We studied 48 patients, of whom 60% were vasopressor independent at 24 hours. Five (10%) died within 28 days. The ratio of fractal alpha parameters was associated with both vasopressor independence and 28-day mortality (p=0.04) after controlling for mean heart rate. In the optimal model, SOFA score and the long-term fractal alpha parameter were associated with vasopressor independence. Conclusions Loss of complexity in heart rate variability is associated with worse outcome early in severe sepsis and septic shock. Further work should evaluate whether complexity of heart rate variability (HRV) could guide treatment in sepsis. PMID:23958243

A 3-year Randomized Therapeutic Trial of Nitisinone in Alkaptonuria

PubMed Central

Introne, Wendy J.; Perry, Monique B.; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A.; Suwannarat, Pim; O’Brien, Kevin E.; Bryant, Joy; Sachdev, Vandana; Reynolds, James C.; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A.

2011-01-01

Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. PMID:21620748

A 3-year randomized therapeutic trial of nitisinone in alkaptonuria.

PubMed

Introne, Wendy J; Perry, Monique B; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A; Suwannarat, Pim; O'Brien, Kevin E; Bryant, Joy; Sachdev, Vandana; Reynolds, James C; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A

2011-08-01

Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. Published by Elsevier Inc.

Echocardiographic assessment of right ventricular function in routine practice: Which parameters are useful to predict one-year outcome in advanced heart failure patients with dilated cardiomyopathy?

PubMed

Kawata, Takayuki; Daimon, Masao; Kimura, Koichi; Nakao, Tomoko; Lee, Seitetsu L; Hirokawa, Megumi; Kato, Tomoko S; Watanabe, Masafumi; Yatomi, Yutaka; Komuro, Issei

2017-10-01

Right ventricular (RV) function has recently gained attention as a prognostic predictor of outcome even in patients who have left-sided heart failure. Since several conventional echocardiographic parameters of RV systolic function have been proposed, our aim was to determine if any of these parameters (tricuspid annular plane systolic excursion: TAPSE, tissue Doppler derived systolic tricuspid annular motion velocity: S', fractional area change: FAC) are associated with outcome in advanced heart failure patients with dilated cardiomyopathy (DCM). We retrospectively enrolled 68 DCM patients, who were New York Heart Association (NYHA) Class III or IV and had a left ventricular (LV) ejection fraction <35%. All patients were undergoing evaluation for heart transplantation or management of heart failure. Primary outcomes were defined as LV assist device implantation or cardiac death within one year. Thirty-nine events occurred (5 deaths, 32 LV assist devices implanted). Univariate analysis showed that age, systolic blood pressure, heart rate, NYHA functional class IV, plasma brain natriuretic peptide concentration, intravenous inotrope use, left atrial volume index, and FAC were associated with outcome, whereas TAPSE and S' were not. Receiver-operating characteristic curve analysis showed that the optimal FAC cut-off value to identify patients with an event was <26.7% (area under the curve=0.74). The event-free rate determined by Kaplan-Meier analysis was significantly higher in patients with FAC≥26.7% than in those with FAC<26.7% (log-lank, p=0.0003). Moreover, the addition of FAC<26.7% improved the prognostic utility of a model containing clinical variables and conventional echocardiographic indexes. FAC may provide better prognostic information than TAPSE or S' in advanced heart failure patients with DCM. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Modeling Test and Treatment Strategies for Presymptomatic Alzheimer Disease

PubMed Central

Burke, James F.; Langa, Kenneth M.; Hayward, Rodney A.; Albin, Roger L.

2014-01-01

Objectives In this study, we developed a model of presymptomatic treatment of Alzheimer disease (AD) after a screening diagnostic evaluation and explored the circumstances required for an AD prevention treatment to produce aggregate net population benefit. Methods Monte Carlo simulation methods were used to estimate outcomes in a simulated population derived from data on AD incidence and mortality. A wide variety of treatment parameters were explored. Net population benefit was estimated in aggregated QALYs. Sensitivity analyses were performed by individually varying the primary parameters. Findings In the base-case scenario, treatment effects were uniformly positive, and net benefits increased with increasing age at screening. A highly efficacious treatment (i.e. relative risk 0.6) modeled in the base-case is estimated to save 20 QALYs per 1000 patients screened and 221 QALYs per 1000 patients treated. Conclusions Highly efficacious presymptomatic screen and treat strategies for AD are likely to produce substantial aggregate population benefits that are likely greater than the benefits of aspirin in primary prevention of moderate risk cardiovascular disease (28 QALYS per 1000 patients treated), even in the context of an imperfect treatment delivery environment. PMID:25474698

A Case of Acute Budd-Chiari Syndrome Complicating Primary Antiphospholipid Syndrome Presenting as Acute Abdomen and Responding to Tight Anticoagulant Therapy.

PubMed

Chinen, Naofumi; Koyama, Yasushi; Sato, Shinji; Suzuki, Yasuo

2016-01-01

A 34-year-old woman with primary antiphospholipid syndrome was admitted to the Gastroenterology Department of our hospital with fever, acute abdomen, watery diarrhea, and extremely high levels of inflammatory parameters. She had a history of left lower limb deep vein thrombosis and pulmonary embolism and was taking warfarin potassium. Acute gastroenteritis was suspected and an antibiotic was administered, but symptoms progressed. Abdominal ultrasonography showed occlusion of the left hepatic vein and the middle hepatic vein and her D-dimer level was high. Accordingly, Budd-Chiari syndrome was diagnosed and high-dose intravenous infusion of heparin was initiated. Her abdominal symptoms improved and the levels of inflammatory parameters and D-dimer decreased rapidly. It is known that antiphospholipid syndrome can be complicated by Budd-Chiari syndrome that usually occurs as subacute or chronic onset, but acute onset is rare. It is difficult to diagnose acute Budd-Chiari syndrome complicating antiphospholipid syndrome and this complication generally has a poor outcome. However, the present case can get early diagnosis and successful treatment with tight anticoagulant therapy.

The effect of cultural and linguistic diversity on pregnancy outcome.

PubMed

Thomas, Penelope E; Beckmann, Michael; Gibbons, Kristen

2010-10-01

Cultural and linguistic diversity in Australia is increasing rapidly. Culturally and linguistically diverse (CALD) women include those born outside Australia/New Zealand, non-English speaking, non-Caucasian and refugees. Individually, each of these factors has the potential to influence health and pregnancy outcomes. The aim of this study was to determine whether CALD parameters, including country of birth, race, primary language spoken, need for an interpreter and refugee status are independent predictors of obstetric or neonatal outcomes. A retrospective analysis of 4751 women (including 461 women using an interpreter; 1046 non-Caucasian and 117 women identifying as refugees) was performed. Generalized ordered logistic modelling found no significant relationship between adverse outcomes and refugee status (P = 0.863). Use of interpreter services (P = 0.015) and country of birth (P < 0.001 when at least one adverse outcome has occurred) were significant indicating that using an interpreter and/or being born outside Australia/New Zealand reduced the likelihood of an adverse outcome. These findings are relevant to planning appropriate models of care and guiding effective use of resources. © 2010 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2010 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Evidence of selective reporting bias in hematology journals: A systematic review

PubMed Central

Scheckel, Caleb; Hicks, Chandler; Nissen, Timothy; Leduc, Linda; Som, Mousumi; Vassar, Matt

2017-01-01

Introduction Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. Methods Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. Results Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. Conclusion Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making. PMID:28570573

Dynamic multi-segmental postural control in patients with chronic non-specific low back pain compared to pain-free controls: A cross-sectional study.

PubMed

McCaskey, Michael A; Wirth, Brigitte; Schuster-Amft, Corina; de Bruin, Eling D

2018-01-01

Reduced postural control is thought to contribute to the development and persistence of chronic non-specific low back pain (CNLBP). It is therefore frequently assessed in affected patients and commonly reported as the average amount of postural sway while standing upright under a variety of sensory conditions. These averaged linear outcomes, such as mean centre of pressure (CP) displacement or mean CP surface areas, may not reflect the true postural status. Adding nonlinear outcomes and multi-segmental kinematic analysis has been reported to better reflect the complexity of postural control and may detect subtler postural differences. In this cross-sectional study, a combination of linear and nonlinear postural parameters were assessed in patients with CNLBP (n = 24, 24-75 years, 9 females) and compared to symptom-free controls (CG, n = 34, 22-67 years, 11 females). Primary outcome was postural control measured by variance of joint configurations (uncontrolled manifold index, UI), confidence ellipse surface areas (CEA) and approximate entropy (ApEn) of CP dispersion during the response phase of a perturbed postural control task on a swaying platform. Secondary outcomes were segment excursions and clinical outcome correlates for pain and function. Non-parametric tests for group comparison with P-adjustment for multiple comparisons were conducted. Principal component analysis was applied to identify patterns of segmental contribution in both groups. CNLBP and CG performed similarly with respect to the primary outcomes. Comparison of joint kinematics revealed significant differences of hip (P < .001) and neck (P < .025) angular excursion, representing medium to large group effects (r's = .36 - .51). Significant (P's < .05), but moderate correlations of ApEn (r = -.42) and UI (r = -.46) with the health-related outcomes were observed. These findings lend further support to the notion that averaged linear outcomes do not suffice to describe subtle postural differences in CNLBP patients with low to moderate pain status.

Pain and convalescence following laparoscopic ventral hernia repair.

PubMed

Eriksen, Jens Ravn

2011-12-01

Severe pain is usual after laparoscopic ventral hernia repair (LVHR). Mesh fixation with titanium tacks may play a key role in the development of acute and chronic pain and alternative fixation methods should therefore be investigated. This PhD thesis was based on three studies and aimed too: 1) assess the intensity and impact of postoperative pain by detailed patient-reported description of pain and convalescence after LVHR (Study I), 2) evaluate the feasibility of fibrin sealant (FS) for mesh fixation in an experimental pig model (Study II), and 3) investigate FS vs. tacks for mesh fixation in LVHR in a randomised, double-blinded, clinical controlled study with acute postoperative pain as the primary outcome (Study III). In Study I - a prospective descriptive study - 35 patients were prospectively included and underwent LVHR. Scores of pain, quality of life, convalescence, fatigue, and general well-being were obtained from each patient. Follow-up was six months. Average pain from postoperative day (POD) 0-2 and POD 0-6 measured on a 0-100 mm visual analogue scale (VAS) was 61 and 48, respectively. Pain scores reached preoperative values at POD 30. The incidence of severe chronic pain was 7%. No parameter predicted postoperative pain significantly. Significant correlations were found between pain, and general well-being (rS= -0.8, p < 0.001), satisfaction (rS= -0.67, p < quality of life score (rS= -0.63, p < 0.001) six months postoperatively. Patients resumed normal daily activity at POD 14. In Study II - a randomised experimental study in pigs - nine pigs were operated laparoscopically with insertion of two different meshes fixed with either FS or tacks. All pigs were euthanized on POD 30. The primary outcome parameter was strength of ingrowth between the mesh and the anterior abdominal wall. A mechanical peel test was performed for each tissue sample. The secondary outcome parameters were grade and strength of adhesions to the mesh, shrinkage and displacement/folding of the mesh and histological parameters. All nine pigs survived without complications until sacrifice. No meshes were displaced from their initial position at autopsy, but in two cases mesh folding was observed. No significant difference in strength of ingrowth was found between different fixation methods or mesh types. Furthermore, no significant difference was found in grade or strength of adhesions or any histological parameters. In Study III - a randomised, controlled, double-blinded, multicenter trial - 40 patients with umbilical hernia defects between 1.5-5 cm, were randomly assigned to receive FS or titanium tacks for mesh fixation in LVHR. Patients, care givers and those assessing the outcomes were blinded to group assignment. The primary outcome was average pain from POD 0-2 (VAS score). Secondary outcome parameters were fatigue, general well-being and time to resume normal daily activity. Follow-up was one month for all. Patients in the FS group reported significantly less pain at POD 0-2 (median VAS 38 (range 6-98) vs. 60 (18-96), p = 0.01). Absolute VAS score difference between groups was 20 mm (95% CI 4-35 mm) at activity, and 19 mm (95% CI 3-34 mm) at rest. Patients in the FS group reported significantly less discomfort from POD 0-2 and POD 0-10, compared with the tack group. No significant difference was found in fatigue score between groups. No significant difference in hospital stay, hernia diameter, or morphine consumption in the post anesthesia care unit was found between groups. Patients in the FS group resumed normal daily activity at POD 7 (1-66) versus POD 18 (1-95) in the tack group (p = 0.03). No recurrences were observed. No adverse events or side effects were observed. No significant differences in predefined complications were found between groups. In conclusion, pain is a significant clinical problem after LVHR with impact on general well-being, quality of life and patient satisfaction. This issue must have first priority in future ventral hernia repair research. It is now documented, that the simple application of fibrin glue instead of titanium tacks for mesh fixation in LVHR of defects < 5 cm significantly reduced acute pain, discomfort and the period of convalescence. Long-term follow-up will show the value of FS fixation in terms of chronic pain and recurrence. As FS potentially may solve many of the outcome problems associated with LVHR, future studies should include larger hernia defects including large incisional hernias, as the operative technique may be different.

High-grade poorly differentiated neuroendocrine carcinoma of the breast with low oncotype Dx recurrence score: A case report.

PubMed

Munoz-Zuluaga, Carlos A; Kotiah, Sandy; Studeman, Kimberley D

2017-01-01

Primary neuroendocrine carcinoma of the breast (NECB) is a rare malignant tumor with controversial biological behavior and a lack of data guiding treatment decisions due to its scarcity. Cancer gene-expression profiling tests provide a better indication of clinical prognosis and help determine the best clinical management versus the traditional clinical and pathological parameters. This is a report of a NECB with a genetic assay that showed a low-risk tumor despite high-grade and poorly differentiated histopathological features. Patient outcomes correlate with the low risk classification without the need for adjuvant chemotherapy despite the standard clinical-pathologic approach. Analysis of cancer related genes expression and outcomes in historical NECB may elucidate new insight of this rare disease.

Quality of chronic kidney disease management in primary care: a retrospective study.

PubMed

Van Gelder, Vincent A; Scherpbier-De Haan, Nynke D; De Grauw, Wim J C; Vervoort, Gerald M M; Van Weel, Chris; Biermans, Marion C J; Braspenning, Jozé C C; Wetzels, Jack F M

2016-01-01

Early detection and appropriate management of chronic kidney disease (CKD) in primary care are essential to reduce morbidity and mortality. To assess the quality of care (QoC) of CKD in primary healthcare in relation to patient and practice characteristics in order to tailor improvement strategies. Retrospective study using data between 2008 and 2011 from 47 general practices (207 469 patients of whom 162 562 were adults). CKD management of patients under the care of their general practitioner (GP) was qualified using indicators derived from the Dutch interdisciplinary CKD guideline for primary care and nephrology and included (1) monitoring of renal function, albuminuria, blood pressure, and glucose, (2) monitoring of metabolic parameters, and alongside the guideline: (3) recognition of CKD. The outcome indicator was (4) achieving blood pressure targets. Multilevel logistic regression analysis was applied to identify associated patient and practice characteristics. Kidney function or albuminuria data were available for 59 728 adult patients; 9288 patients had CKD, of whom 8794 were under GP care. Monitoring of disease progression was complete in 42% of CKD patients, monitoring of metabolic parameters in 2%, and blood pressure target was reached in 43.1%. GPs documented CKD in 31.4% of CKD patients. High QoC was strongly associated with diabetes, and to a lesser extent with hypertension and male sex. Room for improvement was found in all aspects of CKD management. As QoC was higher in patients who received structured diabetes care, future CKD care may profit from more structured primary care management, e.g. according to the chronic care model. Quality of care for chronic kidney disease patients in primary care can be improved. In comparison with guideline advice, adequate monitoring of disease progression was observed in 42%, of metabolic parameters in 2%, correct recognition of impaired renal function in 31%, and reaching blood pressure targets in 43% of chronic kidney disease patients. Quality of care was higher in patients with diabetes. Chronic kidney disease management may be improved by developing strategies similar to diabetes care.

Acute Management of Hemostasis in Patients With Neurological Injury.

PubMed

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

2017-10-01

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

Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

PubMed

Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

2017-12-19

Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Is more lordosis associated with improved outcomes in cervical laminectomy and fusion when baseline alignment is lordotic?

PubMed

Sielatycki, John A; Armaghani, Sheyan; Silverberg, Arnold; McGirt, Matthew J; Devin, Clinton J; O'Neill, Kevin

2016-08-01

In cervical spondylotic myelopathy (CSM), cervical sagittal alignment (CSA) is associated with disease severity. Increased kyphosis and C2-C7 sagittal vertical axis (SVA) correlate with worse myelopathy and poor outcomes. However, when alignment is lordotic, it is unknown whether these associations persist. The study aimed to investigate the associations between CSA parameters and patient-reported outcomes (PROs) following posterior decompression and fusion for CSM when baseline lordosis is maintained. This is an analysis of a prospective surgical cohort at a single academic institution. The sample includes adult patients undergoing primary cervical laminectomy and fusion for CSM over a 3-year period. The PROs included EuroQol-5D, Short-Form-12 (SF-12) physical composite (PCS) and mental composite scales (MCS), Neck Disability Index, and the modified Japanese Orthopaedic Association scores. Radiographic CSA parameters measured included C1-C2 Cobb, C2-C7 Cobb, C1-C7 Cobb, C2-C7 SVA, C1-C7 SVA, and T1 slope. The PROs were recorded at baseline and at 3 and 12 months postoperatively. The CSA parameters were measured on standing radiographs in the neutral position at baseline and 3 months. Wilcoxon rank test was used to test for changes in PROs and CSA parameters, and Pearson correlation coefficients were calculated for CSA parameters and PROs preoperatively and at 12 months. No external sources of funding were used for this work. There were 45 patients included with an average age of 63 years who underwent posterior decompression and fusion of 3.7±1.3 levels. Significant improvements were found in all PROs except SF-12 MCS (p=.06). Small but statistically significant changes were found in C2-C7 Cobb (mean change: +3.6°; p=.03) and C2-C7 SVA (mean change: +3 mm; p=.01). At baseline, only C2-C7 SVA associated with worse SF-12 PCS scores (r=-0.34, p=.02). Postoperatively, there were no associations found between PROs and any CSA parameters. Similarly, no CSA parameters were associated with changes in PROs. Although creating more lordosis and decreasing SVA are associated with improved myelopathy and outcomes in patients with kyphosis, our study did not find such associationsin patients with lordosis undergoing posterior laminectomy and fusion for CSM. This suggests that any amount of lordosis may be sufficient. Copyright © 2016 Elsevier Inc. All rights reserved.

Management of Simple Clavicle Fractures by Primary Care Physicians.

PubMed

Stepanyan, Hayk; Gendelberg, David; Hennrikus, William

2017-05-01

The clavicle is the most commonly fractured bone. Children with simple fractures are often referred to orthopedic surgeons by primary care physician to ensure adequate care. The objective of this study was to show that simple clavicle fractures have excellent outcomes and are within the scope of primary care physician's practice. We performed a retrospective chart review of 16 adolescents with simple clavicle fractures treated with a sling. Primary outcomes were bony union, pain, and function. The patients with simple clavicle fractures had excellent outcomes with no complications or complaints of pain or restriction of their activities of daily living. The outcomes are similar whether treated by an orthopedic surgeon or a primary care physician. The cost to society and the patient is less when the primary care physician manages the fracture. Therefore, primary care physicians should manage simple clavicle fractures.

Postconditioning effects of argon or xenon on early graft function in a porcine model of kidney autotransplantation.

PubMed

De Deken, J; Rex, S; Lerut, E; Martinet, W; Monbaliu, D; Pirenne, J; Jochmans, I

2018-07-01

Ischaemia-reperfusion injury is inevitable during renal transplantation and can lead to delayed graft function and primary non-function. Preconditioning, reconditioning and postconditioning with argon and xenon protects against renal ischaemia-reperfusion injury in rodent models. The hypothesis that postconditioning with argon or xenon inhalation would improve graft function in a porcine renal autotransplant model was tested. Pigs (n = 6 per group) underwent left nephrectomy after 60 min of warm ischaemia (renal artery and vein clamping). The procured kidney was autotransplanted in a separate procedure after 18 h of cold storage, immediately after a right nephrectomy. Upon reperfusion, pigs were randomized to inhalation of control gas (70 per cent nitrogen and 30 per cent oxygen), argon (70 per cent and 30 per cent oxygen) or xenon (70 per cent and 30 per cent oxygen) for 2 h. The primary outcome parameter was peak plasma creatinine; secondary outcome parameters included further markers of graft function (creatinine course, urine output), graft injury (aspartate aminotransferase, heart-type fatty acid-binding protein, histology), apoptosis and autophagy (western blot, terminal deoxynucleotidyl transferase dUTP nick-end labelling (TUNEL) staining), inflammatory mediators and markers of cell survival/growth (mRNA and tissue protein quantification), and animal survival. Results are presented as median (i.q.r.). ANOVA and Kruskal-Wallis tests were used where indicated. Peak plasma creatinine levels were similar between the groups: control 20·8 (16·4-23·1) mg/dl, argon 21·4 (17·1-24·9) mg/dl and xenon 19·4 (17·5-21·0) mg/dl (P = 0·607). Xenon was associated with an increase in autophagy and proapoptotic markers. Creatinine course, urine output, injury markers, histology, survival and inflammatory mediators were not affected by the intervention. Postconditioning with argon or xenon did not improve kidney graft function in this experimental model. Surgical relevance Ischaemia-reperfusion injury is inevitable during renal transplantation and can lead to delayed graft function and primary non-function. Based on mainly small animal experiments, noble gases (argon and xenon) have been proposed to minimize this ischaemia-reperfusion injury and improve outcomes after transplantation. The hypothesis that postconditioning with argon or xenon inhalation would improve graft function was tested in a porcine kidney autotransplantation model. The peak plasma creatinine concentration was similar in the control, argon and xenon groups. No other secondary outcome parameters, including animal survival, were affected by the intervention. Xenon was associated with an increase in autophagy and proapoptotic markers. Despite promising results in small animal models, postconditioning with argon or xenon in a translational model of kidney autotransplantation was not beneficial. Clinical trials would require better results. © 2018 BJS Society Ltd Published by John Wiley & Sons Ltd.

Application of Cox model in coagulation function in patients with primary liver cancer.

PubMed

Guo, Xuan; Chen, Mingwei; Ding, Li; Zhao, Shan; Wang, Yuefei; Kang, Qinjiong; Liu, Yi

2011-01-01

To analyze the distribution of coagulation parameters in patients with primary liver cancer; explore the relationship between clinical staging, survival, and coagulation parameters by using Coxproportional hazard model; and provide a parameter for clinical management and prognosis. Coagulation parameters were evaluated in 228 patients with primary liver cancer, 52 patients with common liver disease, and 52 normal healthy controls. The relationship between primary livercancer staging and coagulation parameters wasanalyzed. Follow-up examinations were performed. The Cox proportional hazard model was used to analyze the relationship between coagulationparameters and survival. The changes in the coagulation parameters in patients with primary liver cancer were significantly different from those in normal controls. The effect of the disease on coagulation function became more obvious as the severity of liver cancer increased (p<0.05). The levels of D-dimer, fibrinogen degradation products (FDP), fibrinogen (FIB), and platelets (PLT) were negatively correlated with the long-term survival of patients with advanced liver cancer. The stages of primary liver cancer are associated with coagulation parameters. Coagulation parameters are related to survival and risk factors. Monitoring of coagulation parameters may help ensure better surveillance and treatment for liver cancer patients.

Revision extension to the pelvis versus primary spinopelvic instrumentation in adult deformity: comparison of clinical outcomes and complications.

PubMed

Fu, Kai-Ming G; Smith, Justin S; Burton, Douglas C; Kebaish, Khaled M; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Arlet, Vincent; Hostin, Richard; Boachie, Oheneba; Akbarnia, Behrooz; Bess, Shay

2014-01-01

To evaluate the outcomes and complications of patients with adult spinal deformity treated in a primary versus revision fashion with long fusions to the sacropelvis. A retrospective review was performed of a multicenter consecutive series of patients with adult spinal deformity requiring fusion to the sacropelvis, either primarily or as revision, with minimum 2-year follow-up. Clinical (Scoliosis Research Society [SRS] 22 questionnaire) and radiographic parameters (including sagittal vertical axis [SVA], coronal Cobb angle, lumbar lordosis, and thoracic kyphosis) were compared between the groups. There were 63 patients who met inclusion criteria; mean patient age was 51.9 years, and mean follow-up was 43 months. Patients requiring primary fusion were older (58.0 years vs. 49.5 years, P=0.01) and at baseline had a lower SVA (2.1 cm vs. 6.8 cm, P=0.01) and greater thoracolumbar Cobb angle (51.2 degrees vs. 36.5 degrees, P=0.003). At last follow-up, patients undergoing primary fusion and patients undergoing revision treatment had similar SVA (2.9 cm vs. 1.8 cm, P=0.32) and lumbar lordosis (-42.3 degrees vs. -43.4 degrees, P=0.82); patients undergoing revision treatment had more favorable SRS 22 scores (3.65 vs. 3.14, P=0.005). There was no statistical difference in complication rates between the groups (44.4% vs. 35%, P=0.68). Patients requiring revision extension of instrumentation to the pelvis can be treated with the same expectation of radiographic and clinical success as patients treated primarily with fusion to the sacropelvis. The complication rate for the revision procedure is not insignificant and may be similar to a primary procedure that includes pelvic fixation. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomized Double-blind Trial of Ringer Lactate Versus Normal Saline in Pediatric Acute Severe Diarrheal Dehydration.

PubMed

Kartha, Gayathri Bhuvaneswaran; Rameshkumar, Ramachandran; Mahadevan, Subramanian

2017-12-01

The aim of this study was to compare the effectiveness of Ringer lactate (RL) versus normal saline (NS) in the correction of pediatric acute severe diarrheal dehydration, as measured by improvement in clinical status and pH (≥7.35). A total of 68 children ages 1 month to 12 years with acute severe diarrheal dehydration (World Health Organization [WHO] classification) were randomized into RL (n = 34) and NS groups (n = 34) and received 100 mL/kg of the assigned intravenous fluid according to WHO PLAN-C for the management of diarrheal dehydration. The primary outcome was an improvement in clinical status and pH (≥7.35) at the end of 6 hours. Secondary outcomes were changes in serum electrolytes, renal and blood gas parameters, the volume of fluid required for dehydration correction excluding the first cycle, time to start oral feeding, hospital stay, and cost-effectiveness analysis. Primary outcome was achieved in 38% versus 23% (relative risk = 1.63, 95% confidence interval 0.80-3.40) in RL and NS groups, respectively. No significant differences were observed in secondary outcomes in electrolytes, renal, and blood gas parameters. None required second cycle of dehydration correction. Median (interquartile range) time to start oral feeding (1.0 [0.19-2.0] vs 1.5 [0.5-2.0] hours) and hospital stay (2.0 [1.0-2.0] vs 2.0 [2.0-2.0] days) was similar. The median total cost was higher in RL than NS group ((Equation is included in full-text article.)120 [(Equation is included in full-text article.)120-(Equation is included in full-text article.)180] vs (Equation is included in full-text article.)55 [(Equation is included in full-text article.)55-(Equation is included in full-text article.)82], P ≤ 0.001). In pediatric acute severe diarrheal dehydration, resuscitation with RL and NS was associated with similar clinical improvement and biochemical resolution. Hence, NS is to be considered as the fluid of choice because of the clinical improvement, cost, and availability.

The proliferation marker Ki67, but not neuroendocrine expression, is an independent factor in the prediction of prognosis of primary prostate cancer patients

PubMed Central

Pascale, Mariarosa; Aversa, Cinzia; Barbazza, Renzo; Marongiu, Barbara; Siracusano, Salvatore; Stoffel, Flavio; Sulfaro, Sando; Roggero, Enrico; Stanta, Giorgio

2016-01-01

Abstract Background Neuroendocrine markers, which could indicate for aggressive variants of prostate cancer and Ki67 (a well-known marker in oncology for defining tumor proliferation), have already been associated with clinical outcome in prostate cancer. The aim of this study was to investigate the prognostic value of those markers in primary prostate cancer patients. Patients and methods NSE (neuron specific enolase), ChrA (chromogranin A), Syp (Synaptophysin) and Ki67 staining were performed by immunohistochemistry. Then, the prognostic impact of their expression on overall survival was investigated in 166 primary prostate cancer patients by univariate and multivariate analyses. Results NSE, ChrA, Syp and Ki67 were positive in 50, 45, 54 and 146 out of 166 patients, respectively. In Kaplan-Meier analysis only diffuse NSE staining (negative vs diffuse, p = 0.004) and Ki67 (≤ 10% vs > 10%, p < 0.0001) were significantly associated with overall survival. Ki67 expression, but not NSE, resulted as an independent prognostic factor for overall survival in multivariate analysis. Conclusions A prognostic model incorporating Ki67 expression with clinical-pathological covariates could provide additional prognostic information. Ki67 may thus improve prediction of prostate cancer outcome based on standard clinical-pathological parameters improving prognosis and management of prostate cancer patients. PMID:27679548

Characterizing Tumor Heterogeneity With Functional Imaging and Quantifying High-Risk Tumor Volume for Early Prediction of Treatment Outcome: Cervical Cancer as a Model

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

Mayr, Nina A., E-mail: Nina.Mayr@osumc.edu; Huang Zhibin; Wang, Jian Z.

2012-07-01

Purpose: Treatment response in cancer has been monitored by measuring anatomic tumor volume (ATV) at various times without considering the inherent functional tumor heterogeneity known to critically influence ultimate treatment outcome: primary tumor control and survival. This study applied dynamic contrast-enhanced (DCE) functional MRI to characterize tumors' heterogeneous subregions with low DCE values, at risk for treatment failure, and to quantify the functional risk volume (FRV) for personalized early prediction of treatment outcome. Methods and Materials: DCE-MRI was performed in 102 stage IB{sub 2}-IVA cervical cancer patients to assess tumor perfusion heterogeneity before and during radiation/chemotherapy. FRV represents the totalmore » volume of tumor voxels with critically low DCE signal intensity (<2.1 compared with precontrast image, determined by previous receiver operator characteristic analysis). FRVs were correlated with treatment outcome (follow-up: 0.2-9.4, mean 6.8 years) and compared with ATVs (Mann-Whitney, Kaplan-Meier, and multivariate analyses). Results: Before and during therapy at 2-2.5 and 4-5 weeks of RT, FRVs >20, >13, and >5 cm{sup 3}, respectively, significantly predicted unfavorable 6-year primary tumor control (p = 0.003, 7.3 Multiplication-Sign 10{sup -8}, 2.0 Multiplication-Sign 10{sup -8}) and disease-specific survival (p = 1.9 Multiplication-Sign 10{sup -4}, 2.1 Multiplication-Sign 10{sup -6}, 2.5 Multiplication-Sign 10{sup -7}, respectively). The FRVs were superior to the ATVs as early predictors of outcome, and the differentiating power of FRVs increased during treatment. Discussion: Our preliminary results suggest that functional tumor heterogeneity can be characterized by DCE-MRI to quantify FRV for predicting ultimate long-term treatment outcome. FRV is a novel functional imaging heterogeneity parameter, superior to ATV, and can be clinically translated for personalized early outcome prediction before or as early as 2-5 weeks into treatment.« less

Wound care clinical pathway: a conceptual model.

PubMed

Barr, J E; Cuzzell, J

1996-08-01

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

Nephroprotection with saxagliptin.

PubMed

Iazzetta, Nicolangelo; Garofalo, Carlo; Savino, Manuela; Sagliocca, Adelia; Santangelo, Sara; Pacilio, Mario; Liberti, Maria Elena; Camocardi, Andrea; Ambrosca, Camilla; Minutolo, Roberto; De Nicola, Luca; Conte, Giuseppe

2015-01-01

The nephroprotective effect of the new anti-diabetic drugs acting on incretin system is suggested by preclinical studies. However, no study evaluating kidney effects of these drugs as primary outcome on the long term has been conducted in patients followed in diabetes centers. We designed a pilot observational study involving two diabetes clinics to evaluate the effect of prolonged treatment with saxagliptin on renal function in type 2 diabetics. Patients were enrolled if treated for at least 12 months with saxagliptin without concurrent changes to anti-hypertensive and lipid-lowering therapy. Primary outcome was to evaluate the effect of saxagliptin on albuminuria and estimated glomerular filtration rate (eGFR). Secondary outcomes were the effects of treatment on common clinical and laboratory parameters. Sixty-three patients were enrolled. After 12 months of treatment with saxagliptin, albuminuria declined from a mean (95%CI) of 39 (25-52) to 22 (14-30) mg/l (P<0.001), and the prevalence of increased albuminuria (>20 mg/L) diminished by 27% versus baseline. The anti-albuminuric effect was independent of glycemic and blood pressure control. The eGFR remained unchanged after treatment in the presence of decreased glycated hemoglobin (from 7.1 to 6.7%). Therefore, this pilot study suggests that saxagliptin treatment in diabetic patients at high renal risk is associated with a reduction in albuminuria and GFR stability. Prospective trials are required to confirm the potential nephroprotective effects of saxagliptin.

Percutaneous Aspiration Thrombectomy for the Treatment of Arterial Thromboembolic Occlusions Following Percutaneous Transluminal Angioplasty

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

Schleder, Stephan, E-mail: stephan.schleder@ukr.de; Diekmann, Matthias; Manke, Christoph

2015-02-15

PurposeThis study was designed to evaluate the technical success and the early clinical outcome of patients undergoing percutaneous aspiration thrombectomy (PAT) for the treatment of arterial thromboembolism following percutaneous infrainguinal transluminal angioplasty (PTA).MethodsIn this single-center study, during a period of 7 years retrospectively, 47 patients (22 male, 47 %) with a mean age of 73 (range 53–96) years were identified in whom PAT was performed for the treatment of thromboembolic complications of infrainguinal PTA. Primary technical success was defined as residual stenosis of <50 % in diameter after sole PAT, whereas secondary technical success was defined as residual stenosis of <50 % in diametermore » after PAT and additional PTA and/or stenting. Clinical outcome parameters (e.g., need for further intervention, minor/major amputation) were evaluated for the 30-day postinterventional period.ResultsPrimary technical success was achieved in 64 % of patients (30/47); secondary technical success was obtained in 96 % of patients (45/47). Clinical outcome data were available in 38 patients. In 87 % of patients (33/38), there was no need for further intervention within the 30-day postinterventional period. In three patients, minor amputations were conducted due to preexisting ulcerations (Rutherford Category 5 respectively).ConclusionsPAT enables endovascular treatment of iatrogenic thromboembolic complications after PTA with good technical and early clinical results and minimal morbidity.« less

REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams.

PubMed

Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Williams, Julie; McCrone, Paul; Leamy, Mary

2011-11-23

There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. ISRCTN: ISRCTN02507940.

REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams

PubMed Central

2011-01-01

Background There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. Methods/Design A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. Discussion This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. Trial registration ISRCTN: ISRCTN02507940 PMID:22112008

TOP2A and EZH2 Provide Early Detection of an Aggressive Prostate Cancer Subgroup.

PubMed

Labbé, David P; Sweeney, Christopher J; Brown, Myles; Galbo, Phillip; Rosario, Spencer; Wadosky, Kristine M; Ku, Sheng-Yu; Sjöström, Martin; Alshalalfa, Mohammed; Erho, Nicholas; Davicioni, Elai; Karnes, R Jeffrey; Schaeffer, Edward M; Jenkins, Robert B; Den, Robert B; Ross, Ashley E; Bowden, Michaela; Huang, Ying; Gray, Kathryn P; Feng, Felix Y; Spratt, Daniel E; Goodrich, David W; Eng, Kevin H; Ellis, Leigh

2017-11-15

Purpose: Current clinical parameters do not stratify indolent from aggressive prostate cancer. Aggressive prostate cancer, defined by the progression from localized disease to metastasis, is responsible for the majority of prostate cancer-associated mortality. Recent gene expression profiling has proven successful in predicting the outcome of prostate cancer patients; however, they have yet to provide targeted therapy approaches that could inhibit a patient's progression to metastatic disease. Experimental Design: We have interrogated a total of seven primary prostate cancer cohorts ( n = 1,900), two metastatic castration-resistant prostate cancer datasets ( n = 293), and one prospective cohort ( n = 1,385) to assess the impact of TOP2A and EZH2 expression on prostate cancer cellular program and patient outcomes. We also performed IHC staining for TOP2A and EZH2 in a cohort of primary prostate cancer patients ( n = 89) with known outcome. Finally, we explored the therapeutic potential of a combination therapy targeting both TOP2A and EZH2 using novel prostate cancer-derived murine cell lines. Results: We demonstrate by genome-wide analysis of independent primary and metastatic prostate cancer datasets that concurrent TOP2A and EZH2 mRNA and protein upregulation selected for a subgroup of primary and metastatic patients with more aggressive disease and notable overlap of genes involved in mitotic regulation. Importantly, TOP2A and EZH2 in prostate cancer cells act as key driving oncogenes, a fact highlighted by sensitivity to combination-targeted therapy. Conclusions: Overall, our data support further assessment of TOP2A and EZH2 as biomarkers for early identification of patients with increased metastatic potential that may benefit from adjuvant or neoadjuvant targeted therapy approaches. Clin Cancer Res; 23(22); 7072-83. ©2017 AACR . ©2017 American Association for Cancer Research.

[Parameter of evidence-based medicine in health care economics].

PubMed

Wasem, J; Siebert, U

1999-08-01

In the view of scarcity of resources, economic evaluations in health care, in which not only effects but also costs related to a medical intervention are examined and a incremental cost-outcome-ratio is build, are an important supplement to the program of evidence based medicine. Outcomes of a medical intervention can be measured by clinical effectiveness, quality-adjusted life years, and monetary evaluation of benefits. As far as costs are concerned, direct medical costs, direct non-medical costs and indirect costs have to be considered in an economic evaluation. Data can be used from primary studies or secondary analysis; metaanalysis for synthesizing of data may be adequate. For calculation of incremental cost-benefit-ratios, models of decision analysis (decision tree models, Markov-models) often are necessary. Methodological and ethical limits for application of the results of economic evaluation in resource allocation decision in health care have to be regarded: Economic evaluations and the calculation of cost-outcome-rations should only support decision making but cannot replace it.

Prognostic Utility of Cell Cycle Progression Score in Men With Prostate Cancer After Primary External Beam Radiation Therapy

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

Freedland, Stephen J., E-mail: steve.freedland@duke.edu; Department of Surgery; Department of Pathology, Duke University School of Medicine, Durham, North Carolina

Purpose: To evaluate the prognostic utility of the cell cycle progression (CCP) score, a RNA signature based on the average expression level of 31 CCP genes, for predicting biochemical recurrence (BCR) in men with prostate cancer treated with external beam radiation therapy (EBRT) as their primary curative therapy. Methods and Materials: The CCP score was derived retrospectively from diagnostic biopsy specimens of men diagnosed with prostate cancer from 1991 to 2006 (n=141). All patients were treated with definitive EBRT; approximately half of the cohort was African American. Outcome was time from EBRT to BCR using the Phoenix definition. Median follow-upmore » for patients without BCR was 4.8 years. Association with outcome was evaluated by Cox proportional hazards survival analysis and likelihood ratio tests. Results: Of 141 patients, 19 (13%) had BCR. The median CCP score for patient samples was 0.12. In univariable analysis, CCP score significantly predicted BCR (P=.0017). The hazard ratio for BCR was 2.55 for 1-unit increase in CCP score (equivalent to a doubling of gene expression). In a multivariable analysis that included Gleason score, prostate-specific antigen, percent positive cores, and androgen deprivation therapy, the hazard ratio for CCP changed only marginally and remained significant (P=.034), indicating that CCP provides prognostic information that is not provided by standard clinical parameters. With 10-year censoring, the CCP score was associated with prostate cancer-specific mortality (P=.013). There was no evidence for interaction between CCP and any clinical variable, including ethnicity. Conclusions: Among men treated with EBRT, the CCP score significantly predicted outcome and provided greater prognostic information than was available with clinical parameters. If validated in a larger cohort, CCP score could identify high-risk men undergoing EBRT who may need more aggressive therapy.« less

The ACTIVE conceptual framework as a structural equation model

PubMed Central

Gross, Alden L.; Payne, Brennan R.; Casanova, Ramon; Davoudzadeh, Pega; Dzierzewski, Joseph M.; Farias, Sarah; Giovannetti, Tania; Ip, Edward H.; Marsiske, Michael; Rebok, George W.; Schaie, K. Warner; Thomas, Kelsey; Willis, Sherry; Jones, Richard N.

2018-01-01

Background/Study Context Conceptual frameworks are analytic models at a high level of abstraction. Their operationalization can inform randomized trial design and sample size considerations. Methods The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) conceptual framework was empirically tested using structural equation modeling (N=2,802). ACTIVE was guided by a conceptual framework for cognitive training in which proximal cognitive abilities (memory, inductive reasoning, speed of processing) mediate treatment-related improvement in primary outcomes (everyday problem-solving, difficulty with activities of daily living, everyday speed, driving difficulty), which in turn lead to improved secondary outcomes (health-related quality of life, health service utilization, mobility). Measurement models for each proximal, primary, and secondary outcome were developed and tested using baseline data. Each construct was then combined in one model to evaluate fit (RMSEA, CFI, normalized residuals of each indicator). To expand the conceptual model and potentially inform future trials, evidence of modification of structural model parameters was evaluated by age, years of education, sex, race, and self-rated health status. Results Preconceived measurement models for memory, reasoning, speed of processing, everyday problem-solving, instrumental activities of daily living (IADL) difficulty, everyday speed, driving difficulty, and health-related quality of life each fit well to the data (all RMSEA < .05; all CFI > .95). Fit of the full model was excellent (RMSEA = .038; CFI = .924). In contrast with previous findings from ACTIVE regarding who benefits from training, interaction testing revealed associations between proximal abilities and primary outcomes are stronger on average by nonwhite race, worse health, older age, and less education (p < .005). Conclusions Empirical data confirm the hypothesized ACTIVE conceptual model. Findings suggest that the types of people who show intervention effects on cognitive performance potentially may be different from those with the greatest chance of transfer to real-world activities. PMID:29303475

Strength of primary care service delivery: a comparative study of European countries, Australia, New Zealand, and Canada.

PubMed

Pavlič, Danica R; Sever, Maja; Klemenc-Ketiš, Zalika; Švab, Igor; Vainieri, Milena; Seghieri, Chiara; Maksuti, Alem

2018-05-01

AimWe sought to examine strength of primary care service delivery as measured by selected process indicators by general practitioners from 31 European countries plus Australia, Canada, and New Zealand. We explored the relation between strength of service delivery and healthcare expenditures. The strength of a country's primary care is determined by the degree of development of a combination of core primary care dimensions in the context of its healthcare system. This study analyses the strength of service delivery in primary care as measured through process indicators in 31 European countries plus Australia, New Zealand, and Canada. A comparative cross-sectional study design was applied using the QUALICOPC GP database. Data on the strength of primary healthcare were collected using a standardized GP questionnaire, which included 60 questions divided into 10 dimensions related to process, structure, and outcomes. A total of 6734 general practitioners participated. Data on healthcare expenditure were obtained from World Bank statistics. We conducted a correlation analysis to analyse the relationship between strength and healthcare expenditures.FindingsOur findings show that the strength of service delivery parameters is less than optimal in some countries, and there are substantial variations among countries. Continuity and comprehensiveness of care are significantly positively related to national healthcare expenditures; however, coordination of care is not.

Quantitative outcome measures for systemic sclerosis-related Microangiopathy - Reliability of image acquisition in Nailfold Capillaroscopy.

PubMed

Dinsdale, Graham; Moore, Tonia; O'Leary, Neil; Berks, Michael; Roberts, Christopher; Manning, Joanne; Allen, John; Anderson, Marina; Cutolo, Maurizio; Hesselstrand, Roger; Howell, Kevin; Pizzorni, Carmen; Smith, Vanessa; Sulli, Alberto; Wildt, Marie; Taylor, Christopher; Murray, Andrea; Herrick, Ariane L

2017-09-01

Nailfold capillaroscopic parameters hold increasing promise as outcome measures for clinical trials in systemic sclerosis (SSc). Their inclusion as outcomes would often naturally require capillaroscopy images to be captured at several time points during any one study. Our objective was to assess repeatability of image acquisition (which has been little studied), as well as of measurement. 41 patients (26 with SSc, 15 with primary Raynaud's phenomenon) and 10 healthy controls returned for repeat high-magnification (300×) videocapillaroscopy mosaic imaging of 10 digits one week after initial imaging (as part of a larger study of reliability). Images were assessed in a random order by an expert blinded observer and 4 outcome measures extracted: (1) overall image grade and then (where possible) distal vessel locations were marked, allowing (2) vessel density (across the whole nailfold) to be calculated (3) apex width measurement and (4) giant vessel count. Intra-rater, intra-visit and intra-rater inter-visit (baseline vs. 1week) reliability were examined in 475 and 392 images respectively. A linear, mixed-effects model was used to estimate variance components, from which intra-class correlation coefficients (ICCs) were determined. Intra-visit and inter-visit reliability estimates (ICCs) were (respectively): overall image grade, 0.97 and 0.90; vessel density, 0.92 and 0.65; mean vessel width, 0.91 and 0.79; presence of giant capillary, 0.68 and 0.56. These estimates were conditional on each parameter being measurable. Within-operator image analysis and acquisition are reproducible. Quantitative nailfold capillaroscopy, at least with a single observer, provides reliable outcome measures for clinical studies including randomised controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of Atomoxetine in Individuals with Attention-Deficit/Hyperactivity Disorder and Low-Functioning Autism Spectrum Disorder.

PubMed

Kilincaslan, Ayse; Mutluer, Tuba Duzman; Pasabeyoglu, Basak; Tutkunkardas, Mustafa Deniz; Mukaddes, Nahit Motavalli

2016-11-01

This naturalistic, retrospective study investigated the effects of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD) symptoms and autistic features in children with autism spectrum disorders (ASDs) and intellectual disability (ID). Participants (n = 37, age range 6-17 years, mean: 10.16 ± 3.60) were assessed at baseline, 4th and 12th weeks using Clinical Global Impressions (CGI) scales, DSM-IV-based ADHD-rating scale (ADHD-RS), and amended Turkish version of Aberrant Behavior Checklist (ABC). The primary outcome measure was a treatment response defined by a CGI-improvement score of 1 or 2 together with a decrease of at least 25% in the parent-rated ADHD-RS total score at the end of 12th week. Five patients (13.5%) stopped medication at 4 weeks due to ineffectivity (2) and intolerable side effects (increased motor activity and talkativeness [n = 1], irritability [n = 2], temper outbursts [n = 2], and increased blood pressure [n = 1]). Sixteen patients (43.2%) were judged to be responders according to primary outcome measure. Improvement rate on CGI scale was 48.8%. On ADHD-RS, there were significant reductions between baseline and 4th week and between baseline and 12th week in both hyperactivity and inattention, and between baseline and 12th week in impulsivity scores. Decrease was significant in hyperactivity and social withdrawal subscales of the parent-reported ABC. Responders based on primary outcome measure were not significantly different from nonresponders in terms of sociodemographic features or clinical parameters, including intellectual, language, autism symptom, and ADHD symptom levels. In this chart review, ATX appears to be safe and effective for social withdrawal and ADHD symptoms in children with ASD and ID.

Lack of effect of vitamin D3 supplementation in autism: a 20-week, placebo-controlled RCT.

PubMed

Kerley, Conor P; Power, Clare; Gallagher, Louise; Coghlan, David

2017-11-01

Data suggest a potential role for vitamin D in autism spectrum disorder (ASD). We wanted to assess the effect of vitamin D 3 supplementation compared with placebo in children with ASD. This was a double-blind, randomised, placebo-controlled trial. A paediatric outpatient centre at high latitude over the winter season in Dublin, Ireland (53°N). 42 children with ASD. 2000 IU vitamin D 3 supplementation or placebo daily for 20 weeks. Assessments were completed at baseline and after 20 weeks of supplementation. The primary outcome was the stereotypic behaviour subscale from the Aberrant Behaviour Checklist (ABC). Secondary exploratory outcomes included additional subscales from the ABC, the Social Responsiveness Scale and rating on the Developmental Disabilities-Children's Global Assessment Scale (DD-CGAS) as well as biochemical parameters of total vitamin D status (25-hydroxyvitamin D (25(OH)D)), immunity and systemic inflammation. 38 children completed the trial. Baseline 25(OH)D was 54.2±19.7 nmol/L. Following vitamin D 3 supplementation, there was a significant increase in 25(OH)D to 83.8 nmol/L (p=0.0016) but no effect on the primary endpoint. However, there was an improvement in self-care on DD-CGAS (p=0.02). In contrast, there was also a trend toward decreased inappropriate speech in the placebo group (p=0.08). Vitamin D supplementation had no effect on the primary outcome with limited and inconsistent effects in children with ASD. Considering the other promising data as well as the relative safety and cheapness of vitamin D supplementation, further trials are warranted. NCT02508922. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

PubMed Central

Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

2015-01-01

Objective Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. Setting All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Primary and secondary outcome measures Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. Results The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. Conclusions The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice. PMID:25986635

Impact of sacropelvic fixation on the development of postoperative sacroiliac joint pain following multilevel stabilization for degenerative spine disease.

PubMed

Finger, T; Bayerl, S; Bertog, M; Czabanka, M; Woitzik, J; Vajkoczy, P

2016-11-01

We hypothesised, that the inclusion of the ilium for multilevel lumbosacral fusions reduces the incidence of postoperative sacroiliac joint (SIJ) pain. The primary objective of this study was to compare the frequency of postoperative SIJ pain in patients undergoing multilevel stabilization with and without sacropelvic fixation for multilevel degenerative spine disease. In addition, we aimed at identifying factors that may predict the worsening or new onset of postoperative SIJ pain. A total of 63 patients with multisegmental fusion surgery with a minimum follow up of 12 months were evaluated. 34 patients received sacral fixation (SF group) and 29 patients received an additional sacropelvic fixation device (SPF group). Primary outcome parameters were changes in SIJ pain between the groups and the influence of pelvic parameters, the patient́s age, the patient́s body mass index (BMI) and the length of the stabilization on the SIJ pain. Between the two surgical groups there were no differences concerning age (p=0.3), BMI (p=0.56), length of follow up (p=0.96), length of the construct (p=0.56). In total 31.7% of the patients had a worsening/new onset of SIJ pain after surgery. An additional fixation of the SIJ with iliac screws or iliosacral plate did not have an influence on the SIJ pain (p=0.67). Likewise, pelvic parameters were not predictive for the outcome of the SIJ pain. Only an increased preoperative BMI correlated with a higher chance of a new onset of SIJ pain (p=0.037). In our retrospective study there was no influence of a sacropelvic fixation techniques on the SIJ pain in patients with multilevel degenerative spine disease after multilevel stabilization surgeries. The patients' BMI is the only preoperative factor that correlated with a higher incidence to develop postoperative SIJ pain, independently of the implantation of a sacropelvic fixation device. Copyright © 2016 Elsevier B.V. All rights reserved.

Apixaban versus Warfarin for the Prevention of Periprocedural Cerebral Thromboembolism in Atrial Fibrillation Ablation: Multicenter Prospective Randomized Study.

PubMed

Kuwahara, Taishi; Abe, Mitsunori; Yamaki, Masaru; Fujieda, Hiroyuki; Abe, Yumiko; Hashimoto, Katsushi; Ishiba, Misako; Sakai, Hirotsuka; Hishikari, Keiichi; Takigawa, Masateru; Okubo, Kenji; Takagi, Katsumasa; Tanaka, Yasuaki; Nakajima, Jun; Takahashi, Atsushi

2016-05-01

Stroke can be a life-threatening complication of atrial fibrillation (AF) catheter ablation. Uninterrupted warfarin treatment contributes to minimizing the risk of stroke complications. This was a prospective, open-label, randomized, multicenter study assessing the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating AF catheter ablation. Two hundred patients with drug-resistant AF were equally assigned to take either apixaban (5 mg or 2.5 mg twice daily) or warfarin (target international normalized ratio, 2-3) for at least 1 month before AF ablation. Neither drug regimen was interrupted throughout the operative period. Diffusion-weighted magnetic resonance imaging was performed for all patients to detect silent cerebral infarction (SCI) after the ablation. Primary outcomes were defined as the occurrence of stroke, transient ischemic attack, SCI, or major bleeding that required intervention. The secondary outcome was minor bleeding. The groups did not statistically differ in patients' backgrounds or procedural parameters. During AF ablation, the apixaban group required administration of more heparin to maintain an activated clotting time > 300 seconds than the warfarin group (apixaban, 14,000 ± 4,000 units; warfarin, 9,000 ± 3,000 units). Three primary outcome events occurred in each group (apixaban, 2 SCI and 1 major bleed; warfarin, 3 SCI, P = 1.00), and 3 and 4 secondary outcome events occurred in the apixaban and warfarin groups (P = 0.70), respectively. Apixaban has similar safety and effectiveness to warfarin for the prevention of cerebral thromboembolism during the periprocedural period of AF ablation. © 2016 Wiley Periodicals, Inc.

Systematic review of integrated models of health care delivered at the primary-secondary interface: how effective is it and what determines effectiveness?

PubMed

Mitchell, Geoffrey K; Burridge, Letitia; Zhang, Jianzhen; Donald, Maria; Scott, Ian A; Dart, Jared; Jackson, Claire L

2015-01-01

Integrated multidisciplinary care is difficult to achieve between specialist clinical services and primary care practitioners, but should improve outcomes for patients with chronic and/or complex chronic physical diseases. This systematic review identifies outcomes of different models that integrate specialist and primary care practitioners, and characteristics of models that delivered favourable clinical outcomes. For quality appraisal, the Cochrane Risk of Bias tool was used. Data are presented as a narrative synthesis due to marked heterogeneity in study outcomes. Ten studies were included. Publication bias cannot be ruled out. Despite few improvements in clinical outcomes, significant improvements were reported in process outcomes regarding disease control and service delivery. No study reported negative effects compared with usual care. Economic outcomes showed modest increases in costs of integrated primary-secondary care. Six elements were identified that were common to these models of integrated primary-secondary care: (1) interdisciplinary teamwork; (2) communication/information exchange; (3) shared care guidelines or pathways; (4) training and education; (5) access and acceptability for patients; and (6) a viable funding model. Compared with usual care, integrated primary-secondary care can improve elements of disease control and service delivery at a modestly increased cost, although the impact on clinical outcomes is limited. Future trials of integrated care should incorporate design elements likely to maximise effectiveness.

Analysis of surgical and oncological outcome in internal and external hemipelvectomy in 34 patients above the age of 65 years at a mean follow-up of 56 months.

PubMed

Guder, Wiebke K; Hardes, Jendrik; Gosheger, Georg; Henrichs, Marcel-Philipp; Nottrott, Markus; Streitbürger, Arne

2015-02-18

With an increasing life expectancy and improved treatment regimens for primary or secondary malignant diseases of soft tissue or bone, hemipelvectomy will have to be considered more often in elderly patients in the future. Scientific reviews concerned with the surgical and oncological outcome of elderly patients undergoing hemipelvectomy are scarce. Therefore, it is the purpose of this study to review the outcome of patients treated with that procedure at our hospital and investigate the feasibility of such extensive procedures at an increased age. A retrospective analysis of thirty-four patients who underwent hemipelvectomy at an age of 65 years or older was performed to determine their surgical and oncological outcome. The Kaplan-Meier method was used to calculate the cumulative probability of survival using the day of tumor resection as a starting point. Univariate analysis was carried out to investigate the influence of a particular single parameter. The mean age at operation was 70.2 years. Thirty patients were treated for intermediate- to high-grade sarcoma and 81.8% of tumors were larger than or equal to 10 cm in the longest diameter. Thirteen patients underwent internal hemipelvectomy and nine patients external hemipelvectomy as a primary procedure. Twelve patients were treated with external hemipelvectomy after failed local tumor control at primary operation. Wound infection occurred in 61.7% of cases. Three patients underwent amputation for non-manageable infection after internal hemipelvectomy. Hospital mortality was 8.8%. Clear resection margins were obtained in 88% of patients; in another 6% of patients planned intralesional resections were performed. Local recurrence occurred in 8.8% of patients at a mean time of 26 months after operation. Eleven patients are alive with no evidence of disease and 23 patients died of disease or other causes. Patients with pulmonary metastases had a mean survival period after operation to DOD of 22 months compared to 37 months in the curative group. Despite an elevated rate in hospital mortality and wound infection, this study suggests that hemipelvectomy is feasible in elderly patients, although requiring long hospitalization periods and causing a limited functional outcome.

Cost-Effectiveness Analysis of Chemoradiation Therapy Versus Transoral Robotic Surgery for Human Papillomavirus–Associated, Clinical N2 Oropharyngeal Cancer

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

Sher, David J., E-mail: david.sher@utsouthwestern.edu; Fidler, Mary Jo; Tishler, Roy B.

Purpose: To perform a cost-effectiveness analysis of primary chemoradiation therapy (CRT) versus transoral robotic surgery (TORS) for clinical N2, human papillomavirus (HPV)-positive oropharyngeal carcinoma. Methods and Materials: We developed a Markov model to describe the health states after treatment with CRT or TORS, followed by adjuvant radiation therapy or CRT in the presence of high-risk pathology (positive margins or extracapsular extension). Outcomes, toxicities, and costs were extracted from the literature. One-way sensitivity analyses (SA) were performed over a wide range of parameters, as were 2-way SA between the key variables. Probabilistic SA and value of information studies were performed over keymore » parameters. Results: The expected quality-adjusted life years (QALYs)/total costs for CRT and TORS were 7.31/$50,100 and 7.29/$62,200, respectively, so that CRT dominated TORS. In SA, primary CRT was almost always cost-effective up to a societal willingness-to-pay of $200,000/QALY, unless the locoregional recurrence risk after TORS was 30% to 50% lower, at which point it became cost effective at a willingness-to-pay of $50-100,000/QALY. Probabilistic SA confirmed the importance of locoregional recurrence risk, and the value of information in precisely knowing this parameter was more than $7M per year. If the long-term utility after TORS was 0.03 lower than CRT, CRT was cost-effective over nearly any assumption. Conclusions: Under nearly all assumptions, primary CRT was the cost-effective therapy for HPV-associated, clinical N2 OPC. However, in the hypothetical event of a large relative improvement in LRR with surgery and equivalent long-term utilities, primary TORS would become the higher-value treatment, arguing for prospective, comparative study of the 2 paradigms.« less

Comparison of standing postural control and gait parameters in people with and without chronic low back pain: a cross-sectional case-control study.

PubMed

MacRae, Catharine Siân; Critchley, Duncan; Lewis, Jeremy S; Shortland, Adam

2018-01-01

Differences in postural control and gait have been identified between people with and without chronic low back pain (CLBP); however, many previous studies present data from small samples, or have used methodologies with questionable reliability. This study, employing robust methodology, hypothesised that there would be a difference in postural control, and spatiotemporal parameters of gait in people with CLBP compared with asymptomatic individuals. This cross-sectional case-control study age-matched and gender-matched 16 CLBP and 16 asymptomatic participants. Participants were assessed barefoot (1) standing, over three 40 s trials, under four posture challenging conditions (2) during gait. Primary outcome was postural stability (assessed by root mean squared error of centre of pressure (CoP) displacement (CoP RMSEAP ) and mean CoP velocity (CoP VELAP ), both in the anteroposterior direction); gait outcomes were hip range of movement and peak moments, walking speed, cadence and stride length, assessed using force plates and a motion analysis system. There were no differences between groups in CoP RMSEAP (P=0.26), or CoP VELAP (P=0.60) for any standing condition. During gait, no differences were observed between groups for spatiotemporal parameters, maximum, minimum and total ranges of hip movement, or peak hip flexor or extensor moments in the sagittal plane. In contrast to previous research, this study suggests that people with mild to moderate CLBP present with similar standing postural control, and parameters of gait to asymptomatic individuals. Treatments directed at influencing postural stability (eg, standing on a wobble board) or specific parameters of gait may be an unnecessary addition to a treatment programme.

Long-term effects of melatonin on quality of life and sleep in haemodialysis patients (Melody study): a randomized controlled trial.

PubMed

Russcher, Marije; Koch, Birgit C P; Nagtegaal, J Elsbeth; van Ittersum, Frans J; Pasker-de Jong, Pieternel C M; Hagen, E Chris; van Dorp, Wim Th; Gabreëls, Bas; Wildbergh, Thierry X; van der Westerlaken, Monique M L; Gaillard, Carlo A J M; Ter Wee, Piet M

2013-11-01

The disturbed circadian rhythm in haemodialysis patients results in perturbed sleep. Short term melatonin supplementation has alleviated these sleep problems. Our aim was to investigate the effects of long-term melatonin supplementation on quality of life and sleep. In this randomized double-blind placebo-controlled trial haemodialysis patients suffering from subjective sleep problems received melatonin 3 mg day(-1) vs. placebo during 12 months. The primary endpoint quality of life parameter 'vitality' was measured with Medical Outcomes Study Short Form-36. Secondary outcomes were improvement of three sleep parameters measured by actigraphy and nighttime salivary melatonin concentrations. Sixty-seven patients were randomized. Forty-two patients completed the trial. With melatonin, no beneficial effect on vitality was seen. Other quality of life parameters showed both advantageous and disadvantageous effects of melatonin. Considering sleep, at 3 months sleep efficiency and actual sleep time had improved with melatonin compared with placebo on haemodialysis days (difference 7.6%, 95% CI 0.77, 14.4 and 49 min, 95% CI 2.1, 95.9, respectively). At 12 months none of the sleep parameters differed significantly from placebo. Melatonin salivary concentrations at 6 months had significantly increased in the melatonin group compared with the placebo group. The high drop-out rate limits the strength of our conclusions. However, although a previous study reported beneficial short term effects of melatonin on sleep in haemodialysis patients, in this long-term study the positive effects disappeared during follow up (6-12 months). Also the quality of life parameter, vitality, did not improve. Efforts should be made to elucidate the mechanism responsible for the loss of effect with chronic use. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

Incomplete Reporting: Addressing the Prevalence of Outcome-Reporting Bias in Educational Research

ERIC Educational Resources Information Center

Trainor, Brian; Polanin, Joshua; Williams, Ryan; Pigott, Terri

2015-01-01

Outcome reporting bias refers to the practice of omitting from primary studies outcomes that were actually collected. When primary studies do not report on all the outcomes assessed, there is an incomplete understanding of a phenomenon that may be compounded when the study is included in a systematic review of research. Outcome reporting bias is…

The cost-effectiveness of screening for gestational diabetes mellitus in primary and secondary care in the Republic of Ireland.

PubMed

Danyliv, Andriy; Gillespie, Paddy; O'Neill, Ciaran; Tierney, Marie; O'Dea, Angela; McGuire, Brian E; Glynn, Liam G; Dunne, Fidelma P

2016-03-01

The aim of the study was to assess the cost-effectiveness of screening for gestational diabetes mellitus (GDM) in primary and secondary care settings, compared with a no-screening option, in the Republic of Ireland. The analysis was based on a decision-tree model of alternative screening strategies in primary and secondary care settings. It synthesised data generated from a randomised controlled trial (screening uptake) and from the literature. Costs included those relating to GDM screening and treatment, and the care of adverse outcomes. Effects were assessed in terms of quality-adjusted life years (QALYs). The impact of the parameter uncertainty was assessed in a range of sensitivity analyses. Screening in either setting was found to be superior to no screening, i.e. it provided for QALY gains and cost savings. Screening in secondary care was found to be superior to screening in primary care, providing for modest QALY gains of 0.0006 and a saving of €21.43 per screened case. The conclusion held with high certainty across the range of ceiling ratios from zero to €100,000 per QALY and across a plausible range of input parameters. The results of this study demonstrate that implementation of universal screening is cost-effective. This is an argument in favour of introducing a properly designed and funded national programme of screening for GDM, although affordability remains to be assessed. In the current environment, screening for GDM in secondary care settings appears to be the better solution in consideration of cost-effectiveness.

Reduced Coffee Consumption Among Individuals with Primary Sclerosing Cholangitis but Not Primary Biliary Cirrhosis

PubMed Central

Lammert, Craig; Juran, Brian D.; Schlicht, Erik; Xie, Xiao; Atkinson, Elizabeth J.; de Andrade, Mariza; Lazaridis, Konstantinos N.

2014-01-01

Background & Aims Coffee consumption has been associated with decreased risk of liver disease and related outcomes. However, coffee drinking has not been investigated among patients with cholestatic autoimmune liver diseases, primary biliary cirrhosis (PBC), or primary sclerosing cholangitis (PSC). We investigated the relationship between coffee consumption and risk of PBC and PSC in a large North American cohort. Methods Lifetime coffee drinking habits were determined from responses to questionnaires from 606 patients with PBC, 480 with PSC, and 564 healthy volunteers (controls). Patients (those with PBC or PSC) were compared to controls utilizing the Wilcoxon rank sum test for continuous variables and c2 method for discrete variables. Logistic regression was used to analyze the estimate the effects of different coffee parameters (time, frequency, and type of coffee consumption) after adjusting for age, sex, smoking status, and education level. Results Patients with PBC and controls did not differ in coffee parameters. However, 24% of patients with PSC had never drank coffee compared to 16% of controls (P<.05), and only 67% were current drinkers compared with 77% of controls (P<.05). Patients with PSC also consumed fewer lifetime cups per month (45 vs 47 for controls, P<.05) and spent a smaller percentage of their lifetime of coffee drinking coffee (46.6% vs 66.7% for controls, P<.05). These differences remained significant in a multivariate model. Among PSC patients with concurrent ulcerative colitis, coffee protected against proctocolectomy (hazard ratio=0.34, P<.001). Conclusions Coffee consumption is lower among patients with PSC, but not PBC, compared to controls. PMID:24440215

Maintenance of improved lipid levels following attendance at a cardiovascular risk reduction clinic: a 10-year experience

PubMed Central

Pearson, Glen J; Olson, Kari L; Panich, Nicole E; Majumdar, Sumit R; Tsuyuki, Ross T; Gilchrist, Dawna M; Damani, Ali; Francis, Gordon A

2008-01-01

Background: Specialty cardiovascular risk reduction clinics (CRRC) increase the proportion of patients attaining recommended lipid targets; however, it is not known if the benefits are sustained after discharge. We evaluated the impact of a CRRC on lipid levels and assessed the long-term effect of a CRRC in maintaining improved lipid levels following discharge. Methods: The medical records of consecutive dyslipidemic patients discharged ×6 months from a tertiary hospital CRRC from January 1991 to January 2001 were retrospectively reviewed. The primary outcome was the change in patients’ lipid levels between the final CRRC visit and the most recent primary care follow-up. A worst-case analysis was conducted to evaluate the potential impact of the patients in whom the follow-up lipid profiles post-discharge from the CRRC were not obtained. Results: Within the CRRC (median follow-up = 1.28 years in 1064 patients), we observed statistically significant improvements in all lipid parameters. In the 411 patients for whom post-discharge lipid profiles were available (median follow-up = 2.41 years), there were no significant differences observed in low-density lipoprotein-cholesterol, total cholesterol (TC), or triglycerides since CRRC discharge; however, there were small improvements in high-density lipoprotein-cholesterol (HDL-C) and TC:HDL ratio (p < 0.05 for both). The unadjusted worst-case analysis (653 patients with no follow-up lipid profiles) demonstrated statistically significant worsening of all lipid parameters between CRRC discharge and the most recent follow-up. However, when the change in lipid parameters between the baseline and the most recent follow-up was assessed in this analysis, the changes in all lipid parameters were significantly improved (p < 0.05). Conclusions: This study demonstrates that a CRRC can improve lipid levels and suggests that these benefits are sustained once patients are returned to the care of their primary physician. PMID:19183763

Reproducibility of tumor uptake heterogeneity characterization through textural feature analysis in 18F-FDG PET.

PubMed

Tixier, Florent; Hatt, Mathieu; Le Rest, Catherine Cheze; Le Pogam, Adrien; Corcos, Laurent; Visvikis, Dimitris

2012-05-01

(18)F-FDG PET measurement of standardized uptake value (SUV) is increasingly used for monitoring therapy response and predicting outcome. Alternative parameters computed through textural analysis were recently proposed to quantify the heterogeneity of tracer uptake by tumors as a significant predictor of response. The primary objective of this study was to evaluate the reproducibility of these heterogeneity measurements. Double baseline (18)F-FDG PET scans were acquired within 4 d of each other for 16 patients before any treatment was considered. A Bland-Altman analysis was performed on 8 parameters based on histogram measurements and 17 parameters based on textural heterogeneity features after discretization with values between 8 and 128. The reproducibility of maximum and mean SUV was similar to that in previously reported studies, with a mean percentage difference of 4.7% ± 19.5% and 5.5% ± 21.2%, respectively. By comparison, better reproducibility was measured for some textural features describing local heterogeneity of tracer uptake, such as entropy and homogeneity, with a mean percentage difference of -2% ± 5.4% and 1.8% ± 11.5%, respectively. Several regional heterogeneity parameters such as variability in the intensity and size of regions of homogeneous activity distribution had reproducibility similar to that of SUV measurements, with 95% confidence intervals of -22.5% to 3.1% and -1.1% to 23.5%, respectively. These parameters were largely insensitive to the discretization range. Several parameters derived from textural analysis describing heterogeneity of tracer uptake by tumors on local and regional scales had reproducibility similar to or better than that of simple SUV measurements. These reproducibility results suggest that these (18)F-FDG PET-derived parameters, which have already been shown to have predictive and prognostic value in certain cancer models, may be used to monitor therapy response and predict patient outcome.

Reproducibility of tumor uptake heterogeneity characterization through textural feature analysis in 18F-FDG PET

PubMed Central

Tixier, Florent; Hatt, Mathieu; Le Rest, Catherine Cheze; Le Pogam, Adrien; Corcos, Laurent; Visvikis, Dimitris

2012-01-01

18F-FDG PET measurement of standardized uptake values (SUV) is increasingly used for monitoring therapy response or predicting outcome. Alternative parameters computed through textural analysis were recently proposed to quantify the tumor tracer uptake heterogeneity as significant predictors of response. The primary objective of this study was the evaluation of the reproducibility of these heterogeneity measurements. Methods Double-baseline 18F-FDG PET scans of 16 patients acquired within a period of 4 days prior to any treatment were considered. A Bland-Altman analysis was carried out on six parameters based on histogram measurements and 17 heterogeneity parameters based on textural features obtained after discretization with values between 8 and 128. Results SUVmax and SUVmean reproducibility were similar to previously reported studies with a mean percentage difference of 4.7±19.5% and 5.5±21.2% respectively. By comparison better reproducibility was measured for some of the textural features describing tumor tracer local heterogeneity, such as entropy and homogeneity with a mean percentage difference of −2±5.4% and 1.8±11.5% respectively. Several of the tumor regional heterogeneity parameters such as the variability in the intensity and size of homogeneous tumor activity distribution regions had similar reproducibility to the SUV measurements with 95% confidence intervals of −22.5% to 3.1% and −1.1% to 23.5% respectively. These parameters were largely insensitive to the discretization range values. Conclusion Several of the parameters derived from textural analysis describing tumor tracer heterogeneity at local and regional scales had similar or better reproducibility as simple SUV measurements. These reproducibility results suggest that these FDG PET image derived parameters which have already been shown to have a predictive and prognostic value in certain cancer models, may be used within the context of therapy response monitoring or predicting patient outcome. PMID:22454484

Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain.

PubMed

Resende, L; Merriwether, E; Rampazo, É P; Dailey, D; Embree, J; Deberg, J; Liebano, R E; Sluka, K A

2018-04-01

We conducted a systematic review and meta-analysis analysing the existing data on transcutaneous electrical nerve stimulation (TENS) or interferential current (IFC) for chronic low back pain (CLBP) and/or neck pain (CNP) taking into account intensity and timing of stimulation, examining pain, function and disability. Seven electronic databases were searched for TENS or IFC treatment in non-specific CLBP or CNP. Four reviewers independently selected randomized controlled trials (RCTs) of TENS or IFC intervention in adult individuals with non-specific CLBP or CNP. Primary outcomes were for self-reported pain intensity and back-specific disability. Two reviewers performed quality assessment, and two reviewers extracted data using a standardized form. Nine RCTs were selected (eight CLBP; one CNP), and seven studies with complete data sets were included for meta-analysis (655 participants). For CLBP, meta-analysis shows TENS/IFC intervention, independent of time of assessment, was significantly different from placebo/control (p < 0.02). TENS/IFC intervention was better than placebo/control, during therapy (p = 0.02), but not immediately after therapy (p = 0.08), or 1-3 months after therapy (p = 0.99). Analysis for adequate stimulation parameters was not significantly different, and there was no effect on disability. This systematic review provides inconclusive evidence of TENS benefits in low back pain patients because the quality of the studies was low, and adequate parameters and timing of assessment were not uniformly used or reported. Without additional high-quality clinical trials using sufficient sample sizes and adequate parameters and outcome assessments, the outcomes of this review are likely to remain unchanged. These data highlight the need for additional high-quality RCTs to examine the effects of TENS in CLBP. Trials should consider intensity of stimulation, timing of outcome assessment and assessment of pain, disability and function. © 2017 European Pain Federation - EFIC®.

Exercise prescription after fragility fracture in older adults: a scoping review

PubMed Central

Feehan, Lynne M.; Beck, Charlotte A.; Harris, Susan R.; MacIntyre, Donna L.; Li, Linda C.

2017-01-01

Purpose To identify and chart research literature on safety, efficacy or effectiveness of exercise prescription following fracture in older adults. Methods We conducted a systematic, research-user-informed, scoping review. The population of interest was adults aged ≥ 45 years with any fracture. ‘Exercise prescription’ included post-fracture therapeutic exercise, physical activity or rehabilitation interventions. Eligible designs included knowledge synthesis studies, primary interventional studies and observational studies. Trained reviewers independently evaluated citations for inclusion. Results A total of 9415 citations were reviewed with 134 citations (119 unique studies) identified: 13 knowledge syntheses, 95 randomized or controlled clinical trials, and 11 ‘other’ designs, representing 74 articles on lower extremity fractures, 34 on upper extremity, eight on vertebral, and three on mixed body region fractures. Exercise prescription characteristics were often missing or poorly described. Six general categories emerged describing exercise prescription characteristics: timing post-fracture, person prescribing, program design, functional focus, exercise script parameters and co-interventions. Upper extremity and ankle fracture studies focused on fracture healing or structural impairment outcomes, whereas hip fracture studies focused more on activity limitation outcomes. The variety of different outcome measures used made pooling or comparison of outcomes difficult. Conclusions There was insufficient information to identify evidence-informed parameters for safe and effective exercise prescription for older adults following fracture. Key gaps in the literature include limited numbers of studies on exercise prescription following vertebral fracture, poor delineation of effectiveness of different strategies for early post-fracture mobilization following upper extremity fracture, and inconsistent details of exercise prescription characteristics after lower extremity fracture. PMID:20967425

Body mass index is not associated with sperm-zona pellucida binding ability in subfertile males.

PubMed

Sermondade, Nathalie; Dupont, Charlotte; Faure, Céline; Boubaya, Marouane; Cédrin-Durnerin, Isabelle; Chavatte-Palmer, Pascale; Sifer, Christophe; Lévy, Rachel

2013-09-01

Lifestyle factors, such as weight and nutritional status may affect male fertility, including sperm fertilization ability. The objective of this retrospective study was to evaluate the association between body mass index (BMI) and sperm-zona pellucida binding ability assessed according to the zona binding (ZB) test, which has been described to be a relevant diagnostic tool for the prediction of in vitro fertilization (IVF) ability. Three hundred and six male patients from couples diagnosed with primary idiopathic or mild male factor infertility were included. Correlations between BMI and semen parameters according to ZB test indices were assessed, together with frequencies of positive and negative tests across the BMI categories. In this selected population, BMI was not related to conventional semen parameters or sperm quality assessed according to the ability of spermatozoa to bind to the zona pellucida. The previously described poor outcomes of IVF procedures in cases of male obesity could be due to other sperm defects, such as alterations of sperm capacitation or acrosome reaction. The link between male BMI and biological outcomes during IVF procedures, such as fertilization rates, should be further evaluated.

Value of tissue Doppler-derived Tei index and two-dimensional speckle tracking imaging derived longitudinal strain on predicting outcome of patients with light-chain cardiac amyloidosis.

PubMed

Liu, Dan; Hu, Kai; Herrmann, Sebastian; Cikes, Maja; Ertl, Georg; Weidemann, Frank; Störk, Stefan; Nordbeck, Peter

2017-06-01

Prognosis of patients with light-chain cardiac amyloidosis (AL-CA) is poor. Speckle tracking imaging (STI) derived longitudinal deformation parameters and Doppler-derived left ventricular (LV) Tei index are valuable predictors of outcome in patients with AL-CA. We estimated the prognostic utility of Tei index and deformation parameters in 58 comprehensively phenotyped patients with AL-CA after a median follow-up of 365 days (quartiles 121, 365 days). The primary end point was all-cause mortality. 19 (33%) patients died during follow-up. Tei index (0.89 ± 0.29 vs. 0.61 ± 0.16, p < 0.001) and E to global early diastolic strain rate ratio (E/GLSR dias ) were higher while global longitudinal systolic strain (GLS sys ) was lower in non-survivors than in survivors (all p < 0.05). Tei index, NYHA functional class, GLS sys and E/GLSR dias were independent predictors of all-cause mortality risk, and Tei index ≥0.9 (HR 7.01, 95% CI 2.43-20.21, p < 0.001) was the best predictor of poor outcome. Combining Tei index and GLS sys yielded the best results on predicting death within 1 year (100% with Tei index ≥0.9 and GLS sys ≤13%) or survival (95% with Tei index ≤0.9 and GLS sys ≥13%). We conclude that 1-year mortality risk in AL-CA patients can be reliably predicted using Tei index or deformation parameters, with combined analysis offering best performance.

Effects of dialysate to serum sodium (Na+) alignment in chronic hemodialysis (HD) patients: retrospective cohort study from a quality improvement project.

PubMed

Raimann, Jochen G; Ficociello, Linda H; Usvyat, Len A; Zhang, Hanjie; Pacelli, Lisa; Moore, Sandi; Sheppard, Penny; Xiao, Qingqing; Wang, Yuedong; Mullon, Claudy; Balter, Paul; Sullivan, Terry; Kotanko, Peter

2018-04-02

Evidence indicates favorable effects of dialysate (DNa + ) to serum sodium concentration (SNa + ) alignment, however, results from larger sample populations are needed. For this reason, we conducted a retrospective propensity score-matched cohort study from a quality improvement project to investigate the effects of alignment on population of maintenance hemodialysis patients. At 4 participating hemodialysis (HD) clinics, patients with SNa + lower than the standard DNa + of 137 mEq/L who received HD with DNa + aligned to the average of the last 4 SNa + measurements were evaluated (clinicaltrials.gov # NCT01825590 ). In this retrospective data analysis, an intention-to-treat (primary) and an as-treated "intervention" (secondary) cohort were created. "Aligned" patients from both cohorts (N = 163 for the primary and N = 137 for the secondary) were then propensity-score matched in a 1:1 fashion to "unaligned" patients from the Renal Research Institute database. The propensity score was generated based on age, gender, white race, Hispanic ethnicity, absence or presence of diabetes, hemodialysis vintage, interdialytic weight gain (IDWG; as a percentage of postdialysis body weight), catheter as primary dialysis access, predialysis systolic blood pressure, serum sodium concentration, hospitalization count during baseline. T-Test was employed for group comparisons of changes to the primary (volume-related and hemodynamic parameters) and tertiary outcomes. All-cause and fluid overload-related hospitalization admission rates were compared using Wilcoxon Rank Sum test and Cox regression analysis for repeated events. In the primary analysis, aligned and unaligned subjects showed comparable demographics at baseline. Treatment effects were significant for IDWG [-0.12 (95% CI -0.24 to 0) L] and showed decreasing non-significant trends for pre-dialysis hemodynamic parameters. Count comparison and Cox regression analysis showed no clear advantage of alignment in terms of all-cause and fluid overload-related hospitalization. Results from the largest sodium alignment program to date suggest positive treatment effects on volume-related and hemodynamic parameters, but no clear effect on risk of hospitalization. Well-matched control patients minimized confounding effects. Small effects and lack of significant differences may be explained by a low baseline DNa + limiting the interventional change.

Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

PubMed

Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

2018-01-11

Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n = 94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n = 72) these were not pre-specified in the protocol. Twenty-three percent (n = 60) had been asked to modify their overall conclusion, usually (n = 53; 88%) to provide a more cautious conclusion. Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.

Cavernous sinus involvement is not a risk factor for the primary tumor site treatment outcome of Sinonasal adenoid cystic carcinoma.

PubMed

Lee, Yi-Chan; Lee, Ta-Jen; Tsang, Ngan-Ming; Huang, Yenlin; Hsu, Cheng-Lung; Hsin, Li-Jen; Lee, Yi-Hsuan; Chang, Kai-Ping

2018-02-05

Sinonasal adenoid cystic carcinoma is a rare malignancy of the head and neck. Cavernous sinus invasion from sinonasal adenoid cystic carcinoma and its related management have rarely been investigated. This study evaluated the relationship between treatment outcome and cavernous sinus involvement in addition to other parameters. A retrospective case series study was conducted at a tertiary referral center. The medical records of 47 patients diagnosed with primary sinonasal adenoid cystic carcinoma between 1984 and 2015 were retrospectively reviewed. The survival impact of the primary treatment modalities and the anatomic sites of tumor involvement were analyzed. Cavernous sinus invasion was observed in 8 patients (17%), of whom 7 had ACC tumors originating from the maxillary sinus. The results of univariate analysis revealed that tumor stage, primary surgery, and the absence of skull-base and infratemporal fossa invasion were associated with better overall survival (P = 0.033, P = 0.012, P = 0.011, and P = 0.040, respectively) and better disease-free survival (P = 0.019, P = 0.001, P = 0.017, and P = 0.029, respectively). Multivariate analysis identified primary surgery as the only independent prognostic factor for disease-free survival (P = 0.026). Cavernous sinus invasion by sinonasal adenoid cystic carcinoma was not associated with worse overall survival or disease-free survival (P = 0.200 and P = 0.198, respectively). Because maxillary adenoid cystic carcinoma is associated with a higher rate of cavernous sinus invasion, such cases warrant caution during preoperative planning. Primary surgery as the initial therapy provides better locoregional control and survival for patients with sinonasal adenoid cystic carcinoma. Cavernous sinus invasion did not significantly impact survival; thus, it should not be regarded as a contraindication for curative treatment.

Probiotics as beneficial agents in the management of diabetes mellitus: a systematic review.

PubMed

Razmpoosh, Elham; Javadi, Maryam; Ejtahed, Hanieh-Sadat; Mirmiran, Parvin

2016-02-01

Probiotics have been suggested to play an important role in the management of diabetes. We conducted a systematic review on the role of probiotics in modulating parameters related to diabetes in animal and human experiments. We searched Pubmed, Scopus and Cochrane central until June 2014, concerning the effects of probiotics on hyperglycemia, hyperinsulinemia and their anti-diabetic efficacies by modulating the activities of proinflammatory and antioxidant factors. Our initial search retrieved 1120 reports. After screening titles and abstracts, 72 full-text articles were reviewed for eligibility. Ultimately, 33 articles met our inclusion criteria consisting of five human and twenty eight animal reports. Lactobacillus strains were, in particular, used in all studies with or without other strains. We found that probiotics have beneficial effects on glycemic controls, as all human studies showed significant reductions in at least one of the primary outcome endpoints which were the levels of fasting plasma glucose, postprandial blood glucose, glycated haemoglobin, insulin, insulin resistance and onset of diabetes; similarly, all the animal reports, except for two, documented significant changes in these parameters. Regarding secondary outcome measures, that is, lipid profiles, pro-inflammatory and anti-oxidant factors, only one human and one animal study failed to show any significant changes in any of these parameters. This systematic review generally demonstrated beneficial effects of the probiotic administration, especially Lactobacillus sub-strains, on the management of diabetes-related blood parameters, although, more evidence, especially from human trials, is needed to confirm these effects and also to conduct a meta-analysis. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

PubMed

Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

2017-10-01

Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to a large extent, to selective outcome reporting. Readers should be aware of this to avoid implementation of false or misleading results in clinical practice. No funding received and there are no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Prospective survey of veterinary practitioners’ primary assessment of equine colic: clinical features, diagnoses, and treatment of 120 cases of large colon impaction

PubMed Central

2014-01-01

Background Large colon impactions are a common cause of colic in the horse. There are no scientific reports on the clinical presentation, diagnostic tests and treatments used in first opinion practice for large colon impaction cases. The aim of this study was to describe the presentation, diagnostic approach and treatment at the primary assessment of horses with large colon impactions. Methods Data were collected prospectively from veterinary practitioners on the primary assessment of equine colic cases over a 12 month period. Inclusion criteria were a diagnosis of primary large colon impaction and positive findings on rectal examination. Data recorded for each case included history, signalment, clinical and diagnostic findings, treatment on primary assessment and final case outcome. Case outcomes were categorised into three groups: simple medical (resolved with single treatment), complicated medical (resolved with multiple medical treatments) and critical (required surgery, were euthanased or died). Univariable analysis using one-way ANOVA and Tukey’s post-hoc test, Kruskal Wallis with Dunn’s post-hoc test and Chi squared analysis were used to compare between different outcome categories. Results 1032 colic cases were submitted by veterinary practitioners: 120 cases met the inclusion criteria for large colon impaction. Fifty three percent of cases were categorised as simple medical, 36.6% as complicated medical, and 9.2% as critical. Most cases (42.1%) occurred during the winter. Fifty nine percent of horses had had a recent change in management, 43% of horses were not ridden, and 12.5% had a recent / current musculoskeletal injury. Mean heart rate was 43bpm (range 26-88) and most cases showed mild signs of pain (67.5%) and reduced gut sounds (76%). Heart rate was significantly increased and gut sounds significantly decreased in critical compared to simple medical cases (p<0.05). Fifty different treatment combinations were used, with NSAIDs (93%) and oral fluids (71%) being administered most often. Conclusions Large colon impactions typically presented with mild signs of colic; heart rate and gut sounds were the most useful parameters to distinguish between simple and critical cases at the primary assessment. The findings of seasonal incidence and associated management factors are consistent with other studies. Veterinary practitioners currently use a wide range of different treatment combinations for large colon impactions. PMID:25238179

Improving Primary Education in Pakistan: An Examination of the Association between School Autonomy and Children's Learning Outcomes

ERIC Educational Resources Information Center

Rahim, Bushra

2017-01-01

The purpose of this study is to explore the impact of the delegation of financial authority to public primary schools through Parent-Teacher Councils (PTCs) on learning outcomes of primary school children in the Khyber Pakhtunkhwa (KP) province, Pakistan. The learning outcomes were measured in three subject areas (Urdu, English, and Mathematics).…

Inadvertent P-hacking among trials and systematic reviews of the effect of progestogens in pregnancy? A systematic review and meta-analysis.

PubMed

Prior, M; Hibberd, R; Asemota, N; Thornton, J G

2017-06-01

Progestogens have been evaluated in numerous trials and meta-analyses, many of which concluded they were effective. However, two large trials PROMISE and OPPTIMUM have recently concluded that progesterone was ineffective. This raises the possibility that earlier studies and reviews had been biased by either selective publication or selective choice of outcomes, so called "P-hacking". To compare the findings all progestogen trials and systematic reviews with those of trials with pre-registered primary outcomes which avoided selective outcome reporting. Search of PubMed, the Cochrane Library and trial registries. Registration PROSPERO CRD42016035303. Systematic reviews of randomised trials comparing progestogen with placebo in pregnancy and the individual trials included in those reviews. The subset of trials reporting a pre-registered primary outcome were compared with the totality of trials and reviews. For reviews all outcomes were included. For individual trials all outcomes reported in the systematic reviews were included. For the comparison group we recorded the registered primary outcome from trials that were either registered before they started, or registered during the recruitment phase and also double blind. Nineteen of twenty-nine meta-analyses concluded that progestogens were effective. Twenty-two trials reported their pre-registered primary outcomes. There was no effect of progesterone on primary registered dichotomous outcome RR 1.00 (95% CI 0.94-1.07). Only one of the 22 showed a nominally statistically significant benefit. When evaluated in registered double-blind trials with analysis restricted to predefined primary outcomes, progestational agents in pregnancy are ineffective. Progestogens to prevent pregnancy loss, an example of P-hacking. © 2017 Royal College of Obstetricians and Gynaecologists.

Predicting Outcome in Patients with Anti-GBM Glomerulonephritis.

PubMed

van Daalen, Emma E; Jennette, J Charles; McAdoo, Stephen P; Pusey, Charles D; Alba, Marco A; Poulton, Caroline J; Wolterbeek, Ron; Nguyen, Tri Q; Goldschmeding, Roel; Alchi, Bassam; Griffiths, Meryl; de Zoysa, Janak R; Vincent, Beula; Bruijn, Jan A; Bajema, Ingeborg M

2018-01-06

Large studies on long-term kidney outcome in patients with anti-glomerular basement membrane (anti-GBM) GN are lacking. This study aimed to identify clinical and histopathologic parameters that predict kidney outcome in these patients. This retrospective analysis included a total of 123 patients with anti-GBM GN between 1986 and 2015 from six centers worldwide. Their kidney biopsy samples were classified according to the histopathologic classification for ANCA-associated GN. Clinical data such as details of treatment were retrieved from clinical records. The primary outcome parameter was the occurrence of ESRD. Kidney survival was analyzed using the log-rank test and Cox regression analyses. The 5-year kidney survival rate was 34%, with an improved rate observed among patients diagnosed after 2007 ( P =0.01). In patients with anti-GBM GN, histopathologic class and kidney survival were associated ( P <0.001). Only one of 15 patients with a focal class biopsy sample (≥50% normal glomeruli) developed ESRD. Patients with a sclerotic class biopsy sample (≥50% globally sclerotic glomeruli) and patients with 100% cellular crescents did not recover from dialysis dependency at presentation. In multivariable analysis, dialysis dependency at presentation (hazard ratio [HR], 3.17; 95% confidence interval [95% CI], 1.59 to 6.32), percentage of normal glomeruli (HR, 0.97; 95% CI, 0.95 to 0.99), and extent of interstitial infiltrate (HR, 2.02; 95% CI, 1.17 to 3.50) were predictors of ESRD during follow-up. Dialysis dependency, low percentage of normal glomeruli, and large extent of interstitial infiltrate are associated with poor kidney outcome in anti-GBM GN. Kidney outcome has improved during recent years; the success rate doubled after 2007. This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_11_21_CJASNPodcast_18_1_v.mp3. Copyright © 2018 by the American Society of Nephrology.

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial

PubMed Central

Younge, John O.; Wery, Machteld F.; Gotink, Rinske A.; Utens, Elisabeth M. W. J.; Michels, Michelle; Rizopoulos, Dimitris; van Rossum, Elisabeth F. C.

2015-01-01

Background Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease. Methods The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male) with heart disease in a 2:1 ratio (n = 215 versus n = 109) to a 12-week online mindfulness training in addition to usual care (UC) compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP), subjective health status (SF-36), perceived stress (PSS), psychological well-being (HADS), social support (PSSS12) and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention). Linear mixed models were used to evaluate differences between groups on the repeated outcome measures. Results Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050). There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033). No significant differences were seen on other outcomes. Conclusions Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease. Trial Registration Dutch Trial Register 3453 PMID:26641099

Development and integration of pharmacist clinical services into the patient-centered medical home.

PubMed

Berdine, Hildegarde J; Skomo, Monica L

2012-01-01

To describe the development of pharmacist clinical services within a primary care physician practice using a standardized business plan, the extent of clinical pharmacy service integration into the patient-centered medical home (PCMH), and the clinical changes in the pharmacist's patient cohort. A two-physician primary care/occupational care practice in Pittsburgh, PA, from May 2007 to December 2011. Pharmacist-led clinic receives physician referrals for medication management, adherence, and disease management services. Pharmacist practice in a primary care setting with emphasis on integration of clinical services into the medical home model designed by the American Academy of Family Physicians. Characterization of the patient's pharmacist and services provided by the pharmacist. Glycosylated hemoglobin (A1C), body mass index (BMI), low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides, and blood pressure. The top five primary referral reasons were diabetes self-management, weight management, medication adherence, hypertension, and dyslipidemia management. Improvements in clinical parameters were demonstrated for lipids and A1C at 1 and 2 years after baseline. Statistically significant improvements in BMI also were observed. The pharmacist developed and integrated clinical services into a primary care practice, became an integral member of the clinical team in the two-physician PCMH, and improved patient outcomes.

Prognostic relevance of the expressions of CAV1 and TES genes on 7q31 in melanoma.

PubMed

Vizkeleti, Laura; Ecsedi, Szilvia; Rakosy, Zsuzsa; Begany, Agnes; Emri, Gabriella; Toth, Reka; Orosz, Adrienn; Szollosi, Attila Gabor; Mehes, Gabor; Adany, Roza; Balazs, Margit

2012-01-01

The 7q31 locus contains several genes affected in cancer progression. Although evidences exist regarding its impact on tumorigenesis, the role of genetic alterations and the expressions of locus-related genes are still controversial. Our study aimed to define the 7q31 copy number alterations in primary melanomas, primary-metastatic tumor pairs and cell lines. Data were correlated with clinical-pathological parameters. Genetic data show that 7q31 copy number distribution was heterogeneous in both primary and metastatic tumors. Extra copies were highly accompanied by chromosome 7 polisomy, and significantly increased in primary lesions with poor prognosis. Additionally, we determined the mRNA and protein levels of the locus-related CAV1 and TES genes. TES mRNA level was associated with metastatic location. CAV1 mRNA and protein levels were significantly higher in thicker tumors, however, lack of protein was also observed in a subpopulation of thin lesions. Expressions of CAV1 and TES were not associated with 7q31 alterations. In conclusion, 7q31 amplification can predict unfavorable outcome. Alterations of TES mRNA level may predict the location of metastasis. CAV1 possibly affect the cancer cell invasion.

Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

PubMed

Murphy, Mairead; Hollinghurst, Sandra; Cowlishaw, Sean; Salisbury, Chris

2018-06-01

Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. Questionnaires were administered in primary care in South West England. Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective. © British Journal of General Practice 2018.

Focused extracorporeal shockwave therapy in Dupuytren's disease--a hypothesis.

PubMed

Knobloch, Karsten; Kuehn, Marie; Vogt, Peter M

2011-05-01

Dupuytren's disease is a progressive disease due to unknown causal agents or genetics. An epidemiological analysis of 566 cases in North Germany estimated that around 1.9 million Germans are suffering from Dupuytren's disease. Beside Dupuytren's disease, there are a number of further less common forms of progressive fibromatosis, such as knuckle pads, plantar fibromatosis or Peyronie's disease. Surgery in plantar fasciectomy yields to a 60% recurrence rate depending on the extent of the plantar fasciectomy. Peyronie's disease of the penis affects middle-aged men between 40 and 60 years with penile pain, curvature during erection and potential erectile dysfunction. In a clinical randomized-controlled trial in Peyronie's disease 2000 focused extracorporeal shock waves reduced pain significantly and improved erectile function and quality of life. We hypothesize that focused extracorporeal shock wave therapy is able to reduce Dupuytren's contracture, a fibromatosis of the palm and improve function. Given the fact that recurrence rate in Dupuytren's disease is high und unpredictable extracorporeal shockwave therapy as a non-invasive tool might be applicable both, in primary and secondary prevention of the progression as well as for treatment. As such we have planned a randomized-controlled trial (ClinicialTrials.gov, NCT01184586) studying the effect of high-energy focused extracorporeal shockwave therapy on patients suffering Dupuytren's disease with patient-related outcome measures such as the DASH score and the Michigan Hand Outcome Questionnaire (MHQ) as primary outcome parameters. Copyright © 2011 Elsevier Ltd. All rights reserved.

Advances in clinical immunology in 2015.

PubMed

Chinen, Javier; Notarangelo, Luigi D; Shearer, William T

2016-12-01

Advances in clinical immunology in the past year included the report of practice parameters for the diagnosis and management of primary immunodeficiencies to guide the clinician in the approach to these relatively uncommon disorders. We have learned of new gene defects causing immunodeficiency and of new phenotypes expanding the spectrum of conditions caused by genetic mutations such as a specific regulator of telomere elongation (RTEL1) mutation causing isolated natural killer cell deficiency and mutations in ras-associated RAB (RAB27) resulting in immunodeficiency without albinism. Advances in diagnosis included the increasing use of whole-exome sequencing to identify gene defects and the measurement of serum free light chains to identify secondary hypogammaglobulinemias. For several primary immunodeficiencies, improved outcomes have been reported after definitive therapy with hematopoietic stem cell transplantation and gene therapy. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Neuromuscular exercises prevent severe knee injury in adolescent team handball players.

PubMed

Achenbach, Leonard; Krutsch, Volker; Weber, Johannes; Nerlich, Michael; Luig, Patrick; Loose, Oliver; Angele, Peter; Krutsch, Werner

2017-10-20

Team handball is associated with a high risk of severe knee injury that needs to be reduced, particularly at the youth level. The purpose of this study was to show how an injury-prevention programme effectively reduces severe knee injury in adolescent team handball players. Of 23 adolescent handball teams of both sexes, 13 were randomly allocated into the intervention group (168 players) and 10 into the control group (111 players). Players of the intervention group regularly participated in an injury-prevention programme for one season. Handball exposure and sustained injuries were documented for both groups on a monthly basis. The primary outcome parameter of the injury-prevention programme was the incidence of severe knee injury. Of the 279 included players, 68 (24%) sustained 82 injuries yielding an overall incidence of 1.85 injuries per 1000 h handball exposure (intervention group: 50 injuries/incidence: 1.90/1000 h; control group: 32 injuries/incidence: 1.78/1000 h). Knee injury was the second most frequent injury in adolescent team handball. The primary outcome parameter, severe knee injury occurred significantly more often in the control group [mean age (SD) 15.1 (1.0), injury incidence 0.33/1000 h] than in the intervention group [mean age (SD) 14.9 (0.9), injury incidence 0.04/1000 h]. The odds ratio was 0.11 (95% CI 0.01-0.90), p = 0.019. Other injuries to the lower extremities showed no significant difference between the two groups. Frequent neuromuscular exercises prevent severe knee injury in adolescent team handball players and should thus be included in the practical routine as well as in the education of team coaches.

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

Can arthroscopic revision surgery for shoulder instability be a fair option?

PubMed

De Giorgi, Silvana; Garofalo, Raffaele; Tafuri, Silvio; Cesari, Eugenio; Rose, Giacomo Delle; Castagna, Alessandro

2014-04-01

the aim of this study was to evaluate the role of arthroscopic capsuloplasty in the treatment of failed primary arthroscopic treatment of glenohumeral instability. we retrospectively examined at a minimum of 3-years follow-up 22 patients who underwent arthroscopic treatment between 1999 and 2007 who had recurrent anterior shoulder instability with a post-surgical failure. A statistical analysis was performed to evaluate which variable could influence the definitive result and clinical outcomes at final follow-up. A p value of less than 0.05 was considered significant. we observed after revision surgery an overall failure rate of 8/22 (36.4%) including frank dislocations, subluxations and also apprehension that seriously inhibit the patient's quality of life. No significant differences were observed in the examined parameters. according to our outcomes we generally do not recommend an arthroscopic revision procedure for failed instability surgery.

Local Wound Care for Primary Cleft Lip Repair: Treatment and Outcomes With use of Topical Hydrogen Peroxide.

PubMed

Strong, Amy L; Nauta, Allison C; Kuang, Anna A

2015-12-01

This study highlights and validates a peroxide-based wound healing strategy for treatment of surgically closed facial wounds in a pediatric population. The authors identified pediatric patients undergoing primary cleft lip repair as a specific population to evaluate the outcomes of such a protocol. Through analysis of defined outcome measures, a reliable and reproducible protocol for postoperative wound care following primary cleft lip repair with favorable results is described. This retrospective study analyzes wound healing outcomes in pediatric patients undergoing primary cleft lip repair from 2006 to 2011 at a tertiary academic center. The wound healing protocol was used in both primary unilateral and bilateral repairs. One hundred fortysix patients between the ages of 0 and 4 years underwent primary cleft lip repair and cleft rhinoplasty by a single, fellowship-trained craniofacial surgeon. Postoperatively, wounds were treated with half-strength hydrogen peroxide and bacitracin, as well as scar massage. Incisional dehiscence, hypertrophic scar formation, discoloration, infection, and reoperation were studied. Outcomes were evaluated in light of parent compliance, demographics, preoperative nasoalveolar molding (PNAM), and diagnosis. The authors identified 146 patients for inclusion in this study. There was no wound or incisional dehiscence. One hundred twenty-four patients demonstrated favorable cosmetic outcome. Only 3 (2%) of patients who developed suboptimal outcomes underwent secondary surgical revision (> 1 year after surgery). Demographic differences were not statistically significant, and PNAM treatment did not influence outcomes. These data validate the use of halfstrength hydrogen peroxide and bacitracin as part of a wound healing strategy in pediatric incisional wounds. The use of hydrogen peroxide produced comparable outcomes to previously published studies utilizing other wound healing strategies and, therefore, these study findings support the further use of this regimen for this particular population.

Oral tranexamic acid is equivalent to topical tranexamic acid without drainage in primary total hip arthroplasty: A double-blind randomized clinical trial.

PubMed

Luo, Ze-Yu; Wang, Duan; Meng, Wei-Kun; Wang, Hao-Yang; Pan, Hui; Pei, Fu-Xing; Zhou, Zong-Ke

2018-05-01

To compare the efficacy of multiple doses of oral tranexamic acid (TXA) with topical TXA administration in reducing blood loss following total hip arthroplasty (THA). In this double-blinded trial, 117 patients undergoing primary THA were randomized to receive 2 g TXA orally 2 h preoperatively, and two doses of 1 g TXA postoperatively (oral group) or 3 g of TXA topical administration in the operating room (topical group). The primary outcome was a reduction in hemoglobin concentration. Other outcomes-such as blood loss, TXA-related cost (¥), length of hospital stay (days), complications such as pulmonary thromboembolism (PE), deep vein thrombosis (DVT), and infection, blood coagulation and fibrinolysis, and hip function-were recorded. The mean reduction in hemoglobin level was similar between the oral and topical groups (3.07 g/dL compared with 3.12 g/dL; p = 0.85). Similarly, there was no significant difference in the mean total blood loss between oral and topical administration (863 mL compared with 902 mL; p = 0.62). Three patients received an allogeneic blood transfusion, including one patient in the oral group and two patients in the topical group (p = 0.55). The oral group had a significantly lower TXA-related cost than the topical group: ¥944 and ¥4359, respectively (p = 0.01). No PE, DVT, cardiac infarction or renal failure occurred during the 90-day follow-up. The coagulation and fibrinolysis parameters were similar between the two groups. Oral TXA is equivalent to topical TXA administration in the reduction of blood loss in the setting of primary THA without drainage. Copyright © 2018. Published by Elsevier Ltd.

Methylphenidate use and school performance among primary school children: a descriptive study.

PubMed

van der Schans, Jurjen; Çiçek, Rukiye; Vardar, Sefike; Bos, Jens Hj; de Vries, Tjalling W; Hoekstra, Pieter J; Hak, Eelko

2017-03-29

There is no conclusive evidence that stimulants have beneficial effects on major associated outcome parameters, particularly school performance. We assessed the differences in school performance among children using methylphenidate at the end of primary school in relation to various parameters of methylphenidate use. We linked children from a pharmacy prescription database with standardized achievement test results at the end of primary school. We explored differences in test scores between current methylphenidate users versus never users and methylphenidate users who stopped treatment at least 6 months before the test, early versus late starters, different dosage of methylphenidate, and concurrent antipsychotic or asthma treatment. Out of the 7736 children, 377 (4.9%) children were treated with methylphenidate at the time of the test. After adjusting for confounders the methylphenidate users (532.58 ± .48) performed significantly lower on the test than never users (534.72 ± .11). Compared with late starters of methylphenidate treatment (536.94 ± 1.51) we found significantly lower test scores for the early starters (532.33 ± .50). Our study indicates that children using methylphenidate still perform less at school compared to their peers. Our study also suggests that earlier start of methylphenidate treatment is associated with a lower school performance compared to children starting later with the treatment. This result could either indicate a limited effect of long term treatment or a more strongly affected group of early starters.

The common characteristics and outcomes of multidisciplinary collaboration in primary health care: a systematic literature review

PubMed Central

Schepman, Sanneke; Hansen, Johan; de Putter, Iris D.; Batenburg, Ronald S.; de Bakker, Dinny H.

2015-01-01

Introduction Research on collaboration in primary care focuses on specific diseases or types of collaboration. We investigate the effects of such collaboration by bringing together the results of scientific studies. Theory and methods We conducted a systematic literature review of PubMed, CINAHL, Cochrane and EMBASE. The review was restricted to publications that test outcomes of multidisciplinary collaboration in primary care in high-income countries. A conceptual model is used to structure the analysis. Results Fifty-one studies comply with the selection criteria about collaboration in primary care. Approximately half of the 139 outcomes in these studies is non-significant. Studies among older patients, in particular, report non-significant outcomes (p < .05). By contrast, a higher proportion of significant results were found in studies that report on clinical outcomes. Conclusions and discussion This review shows a large diversity in the types of collaboration in primary care; and also thus a large proportion of outcomes do not seem to be positively affected by collaboration. Both the characteristics of the structure of the collaboration and the collaboration processes themselves affect the outcomes. More research is necessary to understand the mechanism behind the success of collaboration, especially on the exact nature of collaboration and the context in which collaboration takes place. PMID:26150765

Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial.

PubMed

Östlund-Lagerström, Lina; Kihlgren, Annica; Repsilber, Dirk; Björkstén, Bengt; Brummer, Robert J; Schoultz, Ida

2016-09-10

Diseases of the digestive system have been found to contribute to a higher symptom burden in older adults. Thus, therapeutic strategies able to treat gastrointestinal discomfort might impact the overall health status and help older adults to increase their overall health status and optimal functionality. The aim of this double-blinded, randomized, placebo-controlled clinical trial was to evaluate the effect of the probiotic strain Lactobacillus reuteri on digestive health and wellbeing in older adults. The study enrolled general older adults (>65 years). After eligibility screening qualified subjects (n = 290) participated in a 2-arm study design, with each arm consisting of 12 weeks of intervention of either active or placebo product. Primary outcome measure was set to changes in gastrointestinal symptoms and secondary outcome measures were changes in level of wellbeing, anxiety and stress. Follow up was performed at 8 and 12 weeks. No persistent significant effects were observed on the primary or secondary outcome parameters of the study. A modest effect was observed in the probiotic arm, were levels of stress decreased at week 8 and 12. Similarly, we found that subjects suffering from indigestion and abdominal pain, respectively, showed a significant decrease of anxiety at week 8 after probiotic treatment, but not at week 12. The RCT failed to show any improvement in digestive health after daily intake of a probiotic supplement containing L. reuteri. Neither was any significant improvement in wellbeing, stress or anxiety observed. Even though the RCT had a negative outcome, the study highlights issues important to take into consideration when designing trials among older adults. Clinicaltrials.gov/ NCT01837940 .

Non-traditional Serum Lipid Variables and Recurrent Stroke Risk

PubMed Central

Park, Jong-Ho; Lee, Juneyoung; Ovbiagele, Bruce

2014-01-01

Background and Purpose Expert consensus guidelines recommend low-density lipoprotein cholesterol (LDL-C) as the primary serum lipid target for recurrent stroke risk reduction. However, mounting evidence suggests that other lipid parameters might be additional therapeutic targets or at least also predict cardiovascular risk. Little is known about the effects of non-traditional lipid variables on recurrent stroke risk. Methods We analyzed the Vitamin Intervention for Stroke Prevention study database comprising 3680 recent (<120 days) ischemic stroke patients followed up for 2 years. Independent associations of baseline serum lipid variables with recurrent ischemic stroke (primary outcome) and the composite endpoint of ischemic stroke/coronary heart disease (CHD)/vascular death (secondary outcomes) were assessed. Results Of all variables evaluated, only triglycerides (TG)/high-density lipoprotein cholesterol (HDL-C) ratio was consistently and independently related to both outcomes: compared with the lowest quintile, the highest TG/HDL-C ratio quintile was associated with stroke (adjusted hazard ratio, 1.56; 95% CI, 1.05−2.32) and stroke/CHD/vascular death (1.39; 1.05−1.83), including adjustment for lipid modifier use. Compared with the lowest quintile, the highest total cholesterol/HDL-C ratio quintile was associated with stroke/CHD/vascular death (1.45; 1.03−2.03). LDL-C/HDL-C ratio, non-HDL-C, elevated TG alone, and low HDL-C alone were not independently linked to either outcome. Conclusions Of various non-traditional lipid variables, elevated baseline TG/HDL-C and TC/HDL-C ratios predict future vascular risk after a stroke, but only elevated TG/HDL-C ratio is related to risk of recurrent stroke. Future studies should assess the role of TG/HDL as a potential therapeutic target for global vascular risk reduction after stroke. PMID:25236873

The Utah Remote Monitoring Project: improving health care one patient at a time.

PubMed

Shane-McWhorter, Laura; Lenert, Leslie; Petersen, Marta; Woolsey, Sarah; McAdam-Marx, Carrie; Coursey, Jeffrey M; Whittaker, Thomas C; Hyer, Christian; LaMarche, Deb; Carroll, Patricia; Chuy, Libbey

2014-10-01

The expanding role of technology to augment diabetes care and management highlights the need for clinicians to learn about these new tools. As these tools continue to evolve and enhance improved outcomes, it is imperative that clinicians consider the role of telemonitoring, or remote monitoring, in patient care. This article describes a successful telemonitoring project in Utah. This was a nonrandomized prospective observational preintervention-postintervention study, using a convenience sample. Patients with uncontrolled diabetes and/or hypertension from four rural and two urban primary care clinics and one urban stroke center participated in a telemonitoring program. The primary clinical outcome measures were changes in hemoglobin A1C (A1C) and blood pressure. Other outcomes included fasting lipids, weight, patient engagement, diabetes knowledge, hypertension knowledge, medication adherence, and patient perceptions of the usefulness of the telemonitoring program. Mean A1C decreased from 9.73% at baseline to 7.81% at the end of the program (P<0.0001). Systolic blood pressure also declined significantly, from 130.7 mm Hg at baseline to 122.9 mm Hg at the end (P=0.0001). Low-density lipoprotein content decreased significantly, from 103.9 mg/dL at baseline to 93.7 mg/dL at the end (P=0.0263). Other clinical parameters improved nonsignificantly. Knowledge of diabetes and hypertension increased significantly (P<0.001 for both). Patient engagement and medication adherence also improved, but not significantly. Per questionnaires at study end, patients felt the telemonitoring program was useful. Telemonitoring improved clinical outcomes and may be a useful tool to help enhance disease management and care of patients with diabetes and/or hypertension.

Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study.

PubMed

Jaber, Bertrand L; Finkelstein, Fredric O; Glickman, Joel D; Hull, Alan R; Kraus, Michael A; Leypoldt, John K; Liu, Jiannong; Gilbertson, David; McCarthy, James; Miller, Brent W; Moran, John; Collins, Allan J

2009-02-01

Conventional thrice-weekly hemodialysis (HD) has limited the ability to generate further improvements in patient quality of life, morbidity, and mortality. Daily HD (DHD) offers the promise of providing clinical and economic benefits. The objectives of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study are to evaluate outcomes of DHD (6 times/wk) with the NxStage System One (NxStage Medical Inc, Lawrence, MA) device. Cohort study with matched control group. The DHD group will include up to 500 participants at 70 clinical sites, enrolling for 3 years with a minimum of 1-year follow-up. Study candidates include adult patients (age >or= 18 years) with end-stage renal disease who are considered suitable candidates for DHD with the NxStage System One device by the treating physician and who have Medicare as their primary insurance payer. The control group will consist of a matched thrice-weekly in-center HD cohort derived from the US Renal Data System database using a 10:1 ratio, totaling 5,000 patients. Treatment with DHD and "standard of care" thrice-weekly HD. The primary intent-to-treat analysis compares hospitalization days/patient-year between the DHD and thrice-weekly HD groups. Other outcomes recorded in both groups include non-treatment-related medical expenditures. In addition, in the DHD cohort, changes in quality-of-life measures (baseline, 4 and 12 months, and every 6 months thereafter); urea kinetics; parameters related to anemia, bone and mineral metabolism, and nutrition; vascular access interventions; and use of medications will be examined. This study has the potential to elucidate the health and economic benefits of DHD and complement results of current clinical trials.

The association between the supply of primary care physicians and population health outcomes in Korea.

PubMed

Lee, Juhyun; Park, Sangmin; Choi, Kyunghyun; Kwon, Soon-Man

2010-10-01

Several studies reported that primary care improves health outcomes for populations. The objective of this study was to examine the relationship between the supply of primary care physicians and population health outcomes in Korea. Data were extracted from the 2007 report of the Health Insurance Review, the 2005 report from the Korean National Statistical Office, and the 2008 Korean Community Health Survey. The dependent variables were age-adjusted all-cause and disease-specific mortality rates, and independent variables were the supply of primary care physicians, the ratio of primary care physicians to specialists, the number of beds, socioeconomic factors (unemployment rate, local tax, education), population (population size, proportion of the elderly over age 65), and health behaviors (smoking, exercise, using seat belts rates). We used multivariate linear regression as well as ANOVA and t tests. A higher number of primary care physicians was associated with lower all-cause mortality, cancer mortality, and cardiovascular mortality. However, the ratio of primary care physicians to specialists was not related to all-cause mortality. In addition, the relationship between socioeconomic variables and mortality rates was similar in strength to the relationship between the supply of primary care physicians and mortality rates. Accident mortality, suicide mortality, infection mortality, and perinatal mortality were not related to the supply of primary care physicians. The supply of primary care physicians is associated with improved health outcomes, especially in chronic diseases and cancer. However, other variables such as the socioeconomic factors and population factors seem to have a more significant influence on these outcomes.

Transitions of interaction outcomes in a uni-directional consumer-resource system

USGS Publications Warehouse

Wang, Y.; DeAngelis, D.L.

2011-01-01

A uni-directional consumer-resource system of two species is analyzed. Our aim is to understand the mechanisms that determine how the interaction outcomes depend on the context of the interaction; that is, on the model parameters. The dynamic behavior of the model is described and, in particular, it is demonstrated that no periodic orbits exist. Then the parameter (factor) space is shown to be divided into four regions, which correspond to the four forms of interaction outcomes; i.e. mutualism, commensalism, parasitism and amensalism. It is shown that the interaction outcomes of the system transition smoothly among these four forms when the parameters of the system are varied continuously. Varying each parameter individually or varying pairs of parameters can also lead to smooth transitions between the interaction outcomes. The analysis leads to both conditions for which each species achieves its maximal density, and situations in which periodic oscillations of the interaction outcomes emerge. ?? 2011 Elsevier Ltd.

An implemented MRI program to eliminate radiation from the evaluation of pediatric appendicitis.

PubMed

Kulaylat, Afif N; Moore, Michael M; Engbrecht, Brett W; Brian, James M; Khaku, Aliasgher; Hollenbeak, Christopher S; Rocourt, Dorothy V; Hulse, Michael A; Olympia, Robert P; Santos, Mary C; Methratta, Sosamma T; Dillon, Peter W; Cilley, Robert E

2015-08-01

Recent efforts have been directed at reducing ionizing radiation delivered by CT scans to children in the evaluation of appendicitis. MRI has emerged as an alternative diagnostic modality. The clinical outcomes associated with MRI in this setting are not well-described. Review of a 30-month institutional experience with MRI as the primary diagnostic evaluation for suspected appendicitis (n=510). No intravenous contrast, oral contrast, or sedation was administered. Radiologic and clinical outcomes were abstracted. MRI diagnostic characteristics were: sensitivity 96.8% (95% CI: 92.1%-99.1%), specificity 97.4% (95% CI: 95.3-98.7), positive predictive value 92.4% (95% CI: 86.5-96.3), and negative predictive value 98.9% (95% CI: 97.3%-99.7%). Radiologic time parameters included: median time from request to scan, 71 minutes (IQR: 51-102), imaging duration, 11 minutes (IQR: 8-17), and request to interpretation, 2.0 hours (IQR: 1.6-2.6). Clinical time parameters included: median time from initial assessment to admit order, 4.1 hours (IQR: 3.1-5.1), assessment to antibiotic administration 4.7 hours (IQR: 3.9-6.7), and assessment to operating room 9.1 hours (IQR: 5.8-12.7). Median length of stay was 1.2 days (range: 0.2-19.5). Given the diagnostic accuracy and favorable clinical outcomes, without the potential risks of ionizing radiation, MRI may supplant the role of CT scans in pediatric appendicitis imaging. Copyright © 2015 Elsevier Inc. All rights reserved.

Design of the Blood Pressure Goals in Dialysis pilot study.

PubMed

Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer; Harford, Antonia; Horowitz, Bruce; Chen, Joline; Paine, Susan; Bedrick, Edward; Kusek, John W; Unruh, Mark; Zager, Philip

2014-02-01

Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

Efficacy and safety of 3 versus 5 days of meloxicam as an analgesic for feline onychectomy and sterilization

PubMed Central

Ingwersen, Walt; Fox, Ronald; Cunningham, Gail; Winhall, Martha

2012-01-01

Three- or 5-day courses of meloxicam [0.2 mg/kg body weight (BW) subcutaneously pre- or postoperatively on Day 1 followed by 0.05 mg/kg BW, PO per day thereafter] were assessed for analgesic efficacy and safety in 50 client-owned cats undergoing onychectomy and sterilization. Primary outcome parameters were analgesia score, gait/lameness score, and need for rescue analgesia assessed at times 0, 1, 4, 7, 24, 28, 35, 48, 52, 57 hours and on Day 5. Packed cell volume/total solids and serum biochemistry were assessed at time 0 and Days 3 and 5. There were no differences in efficacy and safety parameters regardless of the treatment protocol employed and no cat required rescue analgesia. The patients that received meloxicam preoperatively had statistically better gait/lameness scores than those that received meloxicam postoperatively, supporting the principle of preemptive analgesia. PMID:22942440

Early clinical outcomes of primary percutaneous coronary intervention in bharatpur, Nepal.

PubMed

Dubey, Laxman; Bhattacharya, Rabindra; Guruprasad, Sogunuu; Subramanyam, Gangapatnam

2013-06-01

Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac surgery backup. This was a prospective descriptive study which included all consecutive patients who were admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent primary percutaneous coronary interventions as a mode of revascularization. The primary end point of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous coronary interventions. The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68 primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and 10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88% vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis (2.94%) and minor complications (14.70%). Primary percutaneous coronary intervention improves the early clinical outcomes in patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup, primary percutaneous coronary intervention was feasible with acceptable complications in a tertiary-care teaching hospital.

Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004).

PubMed

Morin, Charles M; Bootzin, Richard R; Buysse, Daniel J; Edinger, Jack D; Espie, Colin A; Lichstein, Kenneth L

2006-11-01

Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.

A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII.

PubMed

Bakker, E J; Ravensbergen, N J; Voute, M T; Hoeks, S E; Chonchol, M; Klimek, M; Poldermans, D

2011-09-01

This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery. A double-blind, placebo-controlled, randomised trial. A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension. This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters. Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

MRI assessed pancreatic morphology and exocrine function are associated with disease burden in chronic pancreatitis.

PubMed

Madzak, Adnan; Olesen, Søren Schou; Lykke Poulsen, Jakob; Bolvig Mark, Esben; Mohr Drewes, Asbjørn; Frøkjær, Jens Brøndum

2017-11-01

The aim of this study was to explore the association between morphological and functional secretin-stimulated MRI parameters with hospitalization, quality of life (QOL), and pain in patients with chronic pancreatitis (CP). This prospective cohort study included 82 patients with CP. Data were obtained from clinical information, QOL, and pain as assessed by questionnaires (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and modified Brief Pain Inventory short form). Secretin-stimulated MRI morphological parameters included pancreatic gland volume, main pancreatic duct diameter, the modified Cambridge Classification of Duct Abnormality, apparent diffusion coefficient, fat signal fraction, and the pancreatic secretion volume as a functional parameter. The primary outcomes were time to first hospitalization related to the CP, as well as annual hospitalization frequency and duration. The secondary outcomes were pain severity, QOL, and pain interference scores. A main pancreatic duct diameter below 5 mm was associated with reduced time to first hospitalization (hazard ratio=2.06; 95% confidence interval: 1.02-4.17; P=0.043). Pancreatic secretion volume was correlated with QOL (r=0.31; P=0.0072) and pain interference score (r=-0.27; P=0.032), and fecal elastase was also correlated with QOL (r=0.28; P=0.017). However, functional and morphological findings were not related to pain intensity. Advanced pancreatic imaging techniques may be a highly sensitive tool for prognostication and monitoring of disease activity and its consequences.

Cellular signaling identifiability analysis: a case study.

PubMed

Roper, Ryan T; Pia Saccomani, Maria; Vicini, Paolo

2010-05-21

Two primary purposes for mathematical modeling in cell biology are (1) simulation for making predictions of experimental outcomes and (2) parameter estimation for drawing inferences from experimental data about unobserved aspects of biological systems. While the former purpose has become common in the biological sciences, the latter is less common, particularly when studying cellular and subcellular phenomena such as signaling-the focus of the current study. Data are difficult to obtain at this level. Therefore, even models of only modest complexity can contain parameters for which the available data are insufficient for estimation. In the present study, we use a set of published cellular signaling models to address issues related to global parameter identifiability. That is, we address the following question: assuming known time courses for some model variables, which parameters is it theoretically impossible to estimate, even with continuous, noise-free data? Following an introduction to this problem and its relevance, we perform a full identifiability analysis on a set of cellular signaling models using DAISY (Differential Algebra for the Identifiability of SYstems). We use our analysis to bring to light important issues related to parameter identifiability in ordinary differential equation (ODE) models. We contend that this is, as of yet, an under-appreciated issue in biological modeling and, more particularly, cell biology. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

The effect of the inductive electric field on ion poloidal rotation in all collisionality regimes for the primary ions in tokamaks

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

Pan Chengkang; Wang Shaojie; Institute of Plasma Physics, Chinese Academy of Sciences, Hefei, 230031

2007-11-15

The expression for the poloidal rotation velocity of the primary ions that is caused by the parallel inductive electric field in tokamaks and valid in all collisionality regimes is derived via the Hirshman-Sigmar moment approach. Also the expression of the collisional impurity ions poloidal rotation velocity that is caused by the parallel inductive electric field in tokamaks is derived. The poloidal rotation velocities of the primary ions and the impurity ions are sensitive to the primary ion collisionality parameter and the impurity strength parameter. The poloidal rotation velocities of the primary ions and the impurity ions decrease with the primarymore » ion collisionality parameter and decrease with the impurity strength parameter.« less

Hashimoto's thyroiditis predicts outcome in intrathyroidal papillary thyroid cancer.

PubMed

Marotta, Vincenzo; Sciammarella, Concetta; Chiofalo, Maria Grazia; Gambardella, Claudio; Bellevicine, Claudio; Grasso, Marica; Conzo, Giovanni; Docimo, Giovanni; Botti, Gerardo; Losito, Simona; Troncone, Giancarlo; De Palma, Maurizio; Giacomelli, Laura; Pezzullo, Luciano; Colao, Annamaria; Faggiano, Antongiulio

2017-09-01

Hashimoto's thyroiditis (HT) seems to have favourable prognostic impact on papillary thyroid cancer (PTC), but data were obtained analysing all disease stages. Given that HT-related microenvironment involves solely the thyroid, we aimed to assess the relationship between HT, as detected through pathological assessment, and outcome in intrathyroidal PTC. This was a multicentre, retrospective, observational study including 301 PTC with no evidence of extrathyroidal disease. Primary study endpoint was the rate of clinical remission. Auxiliary endpoint was recurrence-free survival (RFS). HT was detected in 42.5% of the cohort and was associated to female gender, smaller tumour size, lower rate of aggressive PTC variants and less frequent post-surgery radio-iodine administration. HT showed relationship with significantly higher rate of clinical remission ( P  < 0.001, OR 4, 95% CI 1.78-8.94). PTCs with concomitant HT had significantly longer RFS, as compared with non-HT tumours ( P  = 0.004). After adjustment for other parameters affecting disease outcome at univariate analysis (age at diagnosis, histology, tumour size and multifocality), prognostic effect of HT remained significant ( P  = 0.006, OR 3.28, 95% CI 1.39-7.72). To verify whether HT could optimise the identification of PTCs with unfavourable outcome, we assessed the accuracy of 'non-HT status' as negative prognostic marker, demonstrating poor capability of identifying patients not maintaining clinical remission until final follow-up (probability of no clinical remission in PTCs without HT: 21.05%, 95% CI 15.20-27.93). In conclusion, our data show that HT represents an independent prognostic parameter in intrathyroidal PTC, but cannot improve prognostic specificity. © 2017 Society for Endocrinology.

Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.

PubMed

Chey, W D; Drossman, D A; Johanson, J F; Scott, C; Panas, R M; Ueno, R

2012-03-01

Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities. To demonstrate the long-term safety, tolerability and patient outcomes of lubiprostone in patients with IBS-C. This extension study enrolled 522 IBS-C patients who had completed one of two randomised phase 3 studies. All enrolled patients received open-label lubiprostone orally for 36-weeks (8 mcg, twice daily). The primary objective was the assessment of long-term safety and tolerability, monitored via adverse events (AEs), laboratory parameters and vital signs. Additional outcome endpoints included monthly responder rates and patient evaluations of IBS-C symptom severity and impact on quality of life. The evaluable safety population comprised of 520 patients; 476 of which had patient reported outcome data available. The overall safety profile of lubiprostone during this study was similar to that observed in the preceding phase 3 studies. The most common AEs were diarrhoea (11.0%), nausea (11.0%), urinary tract infection (9.0%), sinusitis (9.0%) and abdominal distention (5.8%). Diarrhoea and nausea were the most common treatment-related AEs. No serious AEs were considered treatment-related. Seventeen patients discontinued due to a treatment-related AE, of which diarrhoea and nausea accounted for six (1.2%) and three (0.6%) respectively. For responder rates and patient-evaluated parameters (n = 476), all groups experienced significant improvements from baseline, with initial improvements maintained throughout the study. In patients with irritable bowel syndrome with constipation, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9-13 months of treatment. © 2012 Blackwell Publishing Ltd.

Propolis Improves Periodontal Status and Glycemic Control in Patients With Type 2 Diabetes Mellitus and Chronic Periodontitis: A Randomized Clinical Trial.

PubMed

El-Sharkawy, Hesham M; Anees, Mohamed M; Van Dyke, Thomas E

2016-12-01

Propolis is a natural resin made by bees from various plant sources and exerts antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and antidiabetic properties. The purpose of this study is to assess adjunctive benefit of propolis supplementation in individuals with chronic periodontitis (CP) and type 2 diabetes mellitus (DMt2) receiving scaling and root planing (SRP). A 6-month masked, randomized clinical trial comparing SRP with placebo (placebo + SRP group, n = 26) or SRP combined with a 6-month regimen of 400 mg oral propolis once daily (propolis + SRP group, n = 24) was performed in patients with long-standing DMt2 and CP. Treatment outcomes included changes in hemoglobin (Hb) A1c (primary outcome), fasting plasma glucose (FPG), serum N € -(carboxymethyl) lysine (CML), and periodontal parameters (secondary outcomes). After 3 and 6 months, average HbA1c levels in the propolis group decreased significantly by 0.82% and 0.96% units, respectively (P <0.01); however, there were no significant differences in the placebo group. Likewise, FPG and CML levels were significantly reduced in the propolis group, but not in the placebo group. After therapy, periodontal parameters of CP were significantly improved in both groups. The propolis group showed significantly greater probing depth reduction and clinical attachment level gain than the control group after 3 and 6 months. A 6-month regimen of 400 mg propolis once daily is a potentially viable adjunct to SRP that significantly reduces levels of HbA1c, FPG, and CML, and improves periodontal therapy outcome in people with DMt2 and CP.

Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial.

PubMed

Myint, Ma Wai Wai; Wu, Jenny; Wong, Euann; Chan, Suk Ping; To, Tze Shing Jess; Chau, Mei Wa Rosanna; Ting, Kwai Hing; Fung, Pui Man; Au, Kit Sing Derrick

2013-01-01

malnutrition is an important risk factor for poor outcome in patients recovering after hip fracture surgery. This study aimed to investigate the clinical, nutritional and rehabilitation effects of an oral nutritional supplementation (ONS) in an inpatient rehabilitation setting. this was an observer-blinded randomised controlled trial of elderly post-surgical proximal femoral fracture patients. A ready-to-use oral liquid nutritional supplementation (18-24 g protein and 500 kcal per day) in addition to hospital diet was compared with hospital diet only. Both groups received usual rehabilitation therapy and oral calcium and vitamin D supplements. Outcomes were compared at discharge from rehabilitation and after 4 weeks of discharge. The primary outcome parameters were the serum albumin level, the body mass index (BMI), the functional independence measure (FIM) and the elderly mobility scale (EMS). Secondary outcome parameters were frequency of complications, inpatient length of stay, mortality and acute hospital use within 6 months after discharge. a total of 126 patients were recruited, 65 in the supplementation arm and 61 in the control arm. There was a significant difference in change in BMI with a decrease of 0.25 and 0.03 kg/m(2) in the ONS group and 0.72 and 0.49 kg/m(2) in the control group at hospital discharge and follow-up, respectively (P = 0.012). The length of stay in rehabilitation ward was shortened by 3.80 (SE = 1.81, P = 0.04) days favouring the ONS group. The total number of infection episodes was also reduced significantly. No difference was observed in the rate of change of the serum albumin level, the FIM and the EMS. clinical and nutritional benefits were seen in this trial but rehabilitation benefits could not be demonstrated.

Acute-Phase Blood Pressure Levels Correlate With a High Risk of Recurrent Strokes in Young-Onset Ischemic Stroke.

PubMed

Mustanoja, Satu; Putaala, Jukka; Gordin, Daniel; Tulkki, Lauri; Aarnio, Karoliina; Pirinen, Jani; Surakka, Ida; Sinisalo, Juha; Lehto, Mika; Tatlisumak, Turgut

2016-06-01

High blood pressure (BP) in acute stroke has been associated with a poor outcome; however, this has not been evaluated in young adults. The relationship between BP and long-term outcome was assessed in 1004 consecutive young, first-ever ischemic stroke patients aged 15 to 49 years enrolled in the Helsinki Young Stroke Registry. BP parameters included systolic (SBP) and diastolic BP, pulse pressure, and mean arterial pressure at admission and 24 hours. The primary outcome measure was recurrent stroke in the long-term follow-up. Adjusted for demographics and preexisting comorbidities, Cox regression models were used to assess independent BP parameters associated with outcome. Of our patients (63% male), 393 patients (39%) had prestroke hypertension and 358 (36%) used antihypertensive treatment. The median follow-up period was 8.9 years (interquartile range 5.7-13.2). Patients with a recurrent stroke (n=142, 14%) had significantly higher admission SBP, diastolic BP, pulse pressure, and mean arterial pressure (P<0.001) and 24-h SBP, diastolic BP, and mean arterial pressure compared with patients without the recurrent stroke. Patients with SBP ≥160 mm Hg compared with those with SBP <160 mm Hg had significantly more recurrent strokes (hazard ratio 3.3 [95% confidence interval, 2.05-4.55]; P<0.001) occurring earlier (13.9 years [13.0-14.6] versus 16.2 [15.8-16.6]; P<0.001) within the follow-up period. In multivariable analyses, higher admission SBP, diastolic BP, pulse pressure, and mean arterial pressure were independently associated with the risk of recurrent stroke, while the 24-hour BP levels were not. In young ischemic stroke patients, high acute phase BP levels are independently associated with a high risk of recurrent strokes. © 2016 American Heart Association, Inc.

Inpatient-Derived Vital Sign Parameters Implementation: An Initiative to Decrease Alarm Burden.

PubMed

Kipps, Alaina K; Poole, Sarah F; Slaney, Cheryl; Feehan, Shannon; Longhurst, Christopher A; Sharek, Paul J; Goel, Veena V

2017-08-01

To implement data-driven vital sign parameters to reduce bedside monitor alarm burden. Single-center, quality-improvement initiative with historical controls assessing the impact of age-based, inpatient-derived heart rate (HR) and respiratory rate (RR) parameters on a 20-bed acute care ward that serves primarily pediatric cardiology patients. The primary outcome was the number of alarms per monitored bed day (MBD) with the aim to decrease the alarms per MBD. Balancing measures included the frequency of missed rapid response team activations, acute respiratory code events, and cardiorespiratory arrest events in the unit with the new vital sign parameters. The median number of all cardiorespiratory monitor alarms per MBD decreased by 21% from 52 (baseline period) to 41 (postintervention period) ( P < .001). This included a 17% decrease in the median HR alarms (9-7.5 per MBD) and a 53% drop in RR alarms (16.8-8.0 per MBD). There were 57 rapid response team activations, 8 acute respiratory code events, and no cardiorespiratory arrest events after the implementation of the new parameters. An evaluation of HRs and RRs recorded at the time of the event revealed that all patients with HRs and/or RRs out of range per former default parameters would also be out of range with the new parameters. Implementation of data-driven HR and iteratively derived RR parameters safely decreased the total alarm frequency by 21% in a pediatric acute care unit. Copyright © 2017 by the American Academy of Pediatrics.

Pilot study of atomoxetine in patients with Parkinson's disease and dopa-unresponsive Freezing of Gait.

PubMed

Revuelta, Gonzalo J; Embry, Aaron; Elm, Jordan J; Gregory, Chris; Delambo, Amy; Kautz, Steve; Hinson, Vanessa K

2015-01-01

Freezing of gait (FoG) is a common and debilitating condition in Parkinson's disease (PD) associated with executive dysfunction. A subtype of FoG does not respond to dopaminergic therapy and may be related to noradrenergic deficiency. This pilot study explores the effects of atomoxetine on gait in PD patients with dopa-unresponsive FoG using a novel paradigm for objective gait assessment. Ten patients with PD and dopa-unresponsive FoG were enrolled in this eight-week open label pilot study. Assessments included an exploratory gait analysis protocol that quantified spatiotemporal parameters during straight-away walking and turning, while performing a dual task. Clinical, and subjective assessments of gait, quality of life, and safety were also administered. The primary outcome was a validated subjective assessment for FoG (FOG-Q). Atomoxetine was well tolerated, however, no significant change was observed in the primary outcome. The gait analysis protocol correlated well with clinical scales, but not with subjective assessments. DBS patients were more likely to increase gait velocity (p = 0.033), and improved in other clinical assessments. Objective gait analysis protocols assessing gait while dual tasking are feasible and useful for this patient population, and may be superior correlates of FoG severity than subjective measures. These findings can inform future trials in this population.

Radiofrequency for the Treatment of Lumbar Radicular Pain: Impact on Surgical Indications.

PubMed

Trinidad, José Manuel; Carnota, Ana Isabel; Failde, Inmaculada; Torres, Luis Miguel

2015-01-01

Study Design. Quasiexperimental study. Objective. To investigate whether radiofrequency treatment can preclude the need for spinal surgery in both the short term and long term. Background. Radiofrequency is commonly used to treat lumbosacral radicular pain. Only few studies have evaluated its effects on surgical indications. Methods. We conducted a quasiexperimental study of 43 patients who had been scheduled for spinal surgery. Radiofrequency was indicated for 25 patients. The primary endpoint was the decision of the patient to reject spinal surgery 1 month and 1 year after treatment (pulsed radiofrequency of dorsal root ganglion, 76%; conventional radiofrequency of the medial branch, 12%; combined technique, 12%). The primary endpoint was the decision of the patient to reject spinal surgery 1 month and 1 year after treatment. In addition, we also evaluated adverse effects, ODI, NRS. Results. We observed after treatment with radiofrequency 80% of patients rejected spinal surgery in the short term and 76% in the long term. We conclude that radiofrequency is a useful treatment strategy that can achieve very similar outcomes to spinal surgery. Patients also reported a very high level of satisfaction (84% satisfied/very satisfied). We also found that optimization of the electrical parameters of the radiofrequency improved the outcome of this technique.

A Randomized Controlled Trial of Music Use During Epidural Catheter Placement on Laboring Parturient Anxiety, Pain, and Satisfaction.

PubMed

Drzymalski, Dan M; Tsen, Lawrence C; Palanisamy, Arvind; Zhou, Jie; Huang, Chuan-Chin; Kodali, Bhavani S

2017-02-01

Although music is frequently used to promote a relaxing environment during labor and delivery, the effect of its use during the placement of neuraxial techniques is unknown. Our study sought to determine the effects of music use on laboring parturients during epidural catheter placement, with the hypothesis that music use would result in lower anxiety, lower pain, and greater patient satisfaction. We conducted a prospective, randomized, controlled trial of laboring parturients undergoing epidural catheter placement with or without music. The music group listened to the patient's preferred music on a Pandora® station broadcast through an external amplified speaker; the control group listened to no music. All women received a standardized epidural technique and local anesthetic dose. The primary outcomes were 3 measures of anxiety. Secondary outcomes included pain, patient satisfaction, hemodynamic parameters, obstetric parameters, neonatal outcomes, and anesthesia provider anxiety. Intention-to-treat analysis with Bonferroni correction was used for the primary outcomes. For secondary outcomes, a P value of <.001 was considered statistically significant. A total of 100 parturients were randomly assigned, with 99 included in the intention-to-treat analysis. Patient characteristics were similar in both groups; in the music group, the duration of music use was 31.1 ± 7.7 minutes (mean ± SD). The music group experienced higher anxiety as measured by Numeric Rating Scale scores immediately after epidural catheter placement (2.9 ± 3.3 vs 1.4 ± 1.7, mean difference 1.5 [95% confidence interval {CI} 0.2-2.7], P = .02), and as measured by fewer parturients being "very much relaxed" 1 hour after epidural catheter placement (51% vs 78%, odds ratio {OR} 0.3 [95% CI 0.1-0.9], P = .02). No differences in mean pain scores immediately after placement or patient satisfaction with the overall epidural placement experience were observed; however, the desire for music use with future epidural catheter placements was higher in the music group (84% vs 45%, OR 6.4 [95% CI 2.5-16.5], P < .0001). No differences in the difficulty with the epidural catheter placement or in the rate of cesarean delivery were observed. Music use during epidural catheter placement in laboring parturients is associated with higher postprocedure anxiety and no improvement in pain or satisfaction; however, a stronger desire for music with future epidural catheter placements was observed. Further investigation is needed to determine the effect of music use in parturients requesting and using epidural labor analgesia.

Diagnostic Consistency and Relation Between Optical Coherence Tomography and Standard Automated Perimetry in Primary Open-Angle Glaucoma.

PubMed

Toprak, Ibrahim; Yaylalı, Volkan; Yildirim, Cem

2017-01-01

To assess diagnostic consistency and relation between spectral-domain optical coherence tomography (SD-OCT) and standard automated perimetry (SAP) in patients with primary open-angle glaucoma (POAG). This retrospective study comprised 51 eyes of 51 patients with a confirmed diagnosis of POAG. The qualitative and quantitative SD-OCT parameters (retinal nerve fiber layer thicknesses [RNFL; average, superior, inferior, nasal and temporal], RNFL symmetry, rim area, disc area, average and vertical cup/disc [C/D] ratio and cup volume) were compared with parameters of SAP (mean deviation, pattern standard deviation, visual field index, and glaucoma hemifield test reports). Fifty-one eyes of 51 patients with POAG were recruited. Twenty-nine eyes (56.9%) had consistent RNFL and visual field (VF) damage. However, nine patients (17.6%) showed isolated RNFL damage on SD-OCT and 13 patients (25.5%) had abnormal VF test with normal RNFL. In patients with VF defect, age, average C/D ratio, vertical C/D ratio, and cup volume were significantly higher and rim area was lower when compared to those of the patients with normal VF. In addition to these parameters, worsening in average, superior, inferior, and temporal RNFL thicknesses and RNFL symmetry was significantly associated with consistent SD-OCT and SAP outcomes. In routine practice, patients with POAG can be manifested with inconsistent reports between SD-OCT and SAP. An older age, higher C/D ratio, larger cup volume, and lower rim area on SD-OCT appears to be associated with detectable VF damage. Moreover, additional worsening in RNFL parameters might reinforce diagnostic consistency between SD-OCT and SAP.

Phase II Clinical Trials: D-methionine to Reduce Noise-Induced Hearing Loss

DTIC Science & Technology

2012-03-01

loss (NIHL) and tinnitus in our troops. Hypotheses: Primary Hypothesis: Administration of oral D-methionine prior to and during weapons...reduce or prevent noise-induced tinnitus . Primary outcome to test the primary hypothesis: Pure tone air-conduction thresholds. Primary outcome to...test the secondary hypothesis: Tinnitus questionnaires. Specific Aims: 1. To determine whether administering oral D-methionine (D-met) can

Relationship of Kidney Injury Biomarkers with Long-Term Cardiovascular Outcomes after Cardiac Surgery.

PubMed

Parikh, Chirag R; Puthumana, Jeremy; Shlipak, Michael G; Koyner, Jay L; Thiessen-Philbrook, Heather; McArthur, Eric; Kerr, Kathleen; Kavsak, Peter; Whitlock, Richard P; Garg, Amit X; Coca, Steven G

2017-12-01

Clinical AKI, measured by serum creatinine elevation, is associated with long-term risks of adverse cardiovascular (CV) events and mortality in patients after cardiac surgery. To evaluate the relative contributions of urine kidney injury biomarkers and plasma cardiac injury biomarkers in adverse events, we conducted a multicenter prospective cohort study of 968 adults undergoing cardiac surgery. On postoperative days 1-3, we measured five urine biomarkers of kidney injury (IL-18, NGAL, KIM-1, L-FABP, and albumin) and five plasma biomarkers of cardiac injury (NT-proBNP, H-FABP, hs-cTnT, cTnI, and CK-MB). The primary outcome was a composite of long-term CV events or death, which was assessed via national health care databases. During a median 3.8 years of follow-up, 219 (22.6%) patients experienced the primary outcome (136 CV events and 83 additional deaths). Compared with patients without postsurgical AKI, patients who experienced AKI Network stage 2 or 3 had an adjusted hazard ratio for the primary composite outcome of 3.52 (95% confidence interval, 2.17 to 5.71). However, none of the five urinary kidney injury biomarkers were significantly associated with the primary outcome. In contrast, four out of five postoperative cardiac injury biomarkers (NT-proBNP, H-FABP, hs-cTnT, and cTnI) strongly associated with the primary outcome. Mediation analyses demonstrated that cardiac biomarkers explained 49% (95% confidence interval, 1% to 97%) of the association between AKI and the primary outcome. These results suggest that clinical AKI at the time of cardiac surgery is indicative of concurrent CV stress rather than an independent renal pathway for long-term adverse CV outcomes. Copyright © 2017 by the American Society of Nephrology.

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

PubMed Central

Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

2015-01-01

Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed. PMID:26581079

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

PubMed

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

PubMed Central

2013-01-01

Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial.

PubMed

van den Dool, Joost; Visser, Bart; Koelman, J Hans T M; Engelbert, Raoul H H; Tijssen, Marina A J

2013-07-15

Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Number Dutch Trial registration (Nederlands Trial Register): NTR3437.

SU-E-T-275: Radiobiological Evaluation of Intensity Modulated Radiotherapy Treatment for Locally Advanced Head and Neck Squamous Cell Carcinomas

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

Rekha Reddy, B.; Ravikumar, M.; Tanvir Pasha, C.R

2014-06-01

Purpose: To evaluate the radiobiological outcome of Intensity Modulated Radiotherapy Treatment (IMRT) for locally advanced head and neck squamous cell carcinomas using HART (Histogram Analysis in Radiation Therapy; J Appl Clin Med Phys 11(1): 137–157, 2010) program and compare with the clinical outcomes. Methods: We have treated 20 patients of stage III and IV HNSCC Oropharynx and hypopharynx with accelerated IMRT technique and concurrent chemotherapy. Delineation of tumor and normal tissues were done using Danish Head and Neck Cancer Group (DAHANCA) contouring guidelines and radiotherapy was delivered to a dose of 70Gy in 35 fractions to the primary and involvedmore » lymph nodes, 63Gy to intermediate risk areas and 56 Gy to lower risk areas, Monday to Saturday, 6 Days/week using 6 MV Photons with an expected overall treatment time of 6 weeks. The TCP and NTCP's were calculated from the dose-volume histogram (DVH) statistics using the Poisson Statistics (PS) and JT Lyman models respectively and the Resultwas correlated with clinical outcomes of the patients with mean follow up of 24 months. Results: Using HART program, the TCP (0.89± 0.01) of primary tumor and the NTCP for parotids (0.20±0.12), spinal cord (0.05±0.01), esophagus (0.30±0.2), mandible (0.35±0.21), Oral cavity (0.37±0.18), Larynx (0.30±0.15) were estimated and correlated with clinical outcome of the patients. Conclusion: Accelerated IMRT with Chemotherapy is a clinical feasible option in the treatment of locally advanced HNSCC with encouraging initial tumour response and acceptable acute toxicities. The correlation between the clinical outcomes and radiobiological model estimated parameters using HART programs are found to be satisfactory.« less

Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

PubMed Central

Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

2016-01-01

Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a control group, but low implementation fidelity precludes interpretation of the causal relationship. Trial Registration www.ClinicalTrials.gov NCT02012881 PMID:27341346

Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial.

PubMed

Tarp, Jakob; Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H; Andersen, Lars Bo; Bugge, Anna

2016-01-01

Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12-14 years old adolescents. A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p's>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4-38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39-0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0-9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p's>0.05). No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a control group, but low implementation fidelity precludes interpretation of the causal relationship. www.ClinicalTrials.gov NCT02012881.

Risk-adjusted payment and performance assessment for primary care.

PubMed

Ash, Arlene S; Ellis, Randall P

2012-08-01

Many wish to change incentives for primary care practices through bundled population-based payments and substantial performance feedback and bonus payments. Recognizing patient differences in costs and outcomes is crucial, but customized risk adjustment for such purposes is underdeveloped. Using MarketScan's claims-based data on 17.4 million commercially insured lives, we modeled bundled payment to support expected primary care activity levels (PCAL) and 9 patient outcomes for performance assessment. We evaluated models using 457,000 people assigned to 436 primary care physician panels, and among 13,000 people in a distinct multipayer medical home implementation with commercially insured, Medicare, and Medicaid patients. Each outcome is separately predicted from age, sex, and diagnoses. We define the PCAL outcome as a subset of all costs that proxies the bundled payment needed for comprehensive primary care. Other expected outcomes are used to establish targets against which actual performance can be fairly judged. We evaluate model performance using R(2)'s at patient and practice levels, and within policy-relevant subgroups. The PCAL model explains 67% of variation in its outcome, performing well across diverse patient ages, payers, plan types, and provider specialties; it explains 72% of practice-level variation. In 9 performance measures, the outcome-specific models explain 17%-86% of variation at the practice level, often substantially outperforming a generic score like the one used for full capitation payments in Medicare: for example, with grouped R(2)'s of 47% versus 5% for predicting "prescriptions for antibiotics of concern." Existing data can support the risk-adjusted bundled payment calculations and performance assessments needed to encourage desired transformations in primary care.

Examining the association between anthropometric parameters and telomere length and mortality risk

PubMed Central

Wu, Chen-Jung; Kao, Tung-Wei; Lin, Yuan-Yung; Liaw, Fang-Yih; Wu, Li-Wei; Chang, Yaw-Wen; Peng, Tao-Chun; Chen, Wei-Liang

2017-01-01

A shorter telomere length is associated with several systemic disorders. Telomere length may be an informative biomarker for the maintenance of the overall health status and mortality. There are a limited number of empirical studies concerning the effect of anthropometric parameters on telomere length. The data are derived from the National Health and Nutrition Examination Survey from 1999 to 2002. The primary outcomes of this study were to examine the potential relationships between the anthropometric indices and the telomere length, while secondary outcomes of this study was to investigate the association between different anthropometric indices and mortality risk. A significant positive correlation was noted between the mean telomere length and the thigh circumference (TC) and calf circumference (CC) in all designed models. Participants in the highest TC and CC quartiles tended to have a longer telomere length and lowered the hazards for all-cause mortality to 43% and 57%, respectively. Notably, the anthropometric indices involving the CC with higher values seemed to be surrogate markers for the reduction of the risk of all-cause, cardiovascular and malignancy-related mortality (all P < 0.05). The CCmay be a valuable tool to guide public health policy and a clinical prognostic indicator for the risk of mortality. PMID:28423661

Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema.

PubMed

Martín, Marta López; Hernández, Miguel A; Avendaño, Cristina; Rodríguez, Francisco; Martínez, Helena

2011-03-09

Lymphoedema is a common and troublesome condition that develops following breast cancer treatment. The aim of this study is to analyze the effectiveness of Manual Lymphatic Drainage in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema and evaluate the improvement of the concomitant symptomatology. A randomized, controlled clinical trial in 58 women with post-mastectomy lymphoedema. The control group includes 29 patients with standard treatment (skin care, exercise and compression measures, bandages for one month and, subsequently, compression garments). The experimental group includes 29 patients with standard treatment plus Manual Lymphatic Drainage. The therapy will be administered daily for four weeks and the patient's condition will be assessed one, three and six months after treatment.The primary outcome parameter is volume reduction of the affected arm after treatment, expressed as a percentage. Secondary outcome parameters include: duration of lymphoedema reduction and improvement of the concomitant symptomatology (degree of pain, sensation of swelling and functional limitation in the affected extremity, subjective feeling of being physically less attractive and less feminine, difficulty looking at oneself naked and dissatisfaction with the corporal image). The results of this study will provide information on the effectiveness of Manual Lymphatic Drainage and its impact on the quality of life and physical limitations of these patients. ClinicalTrials (NCT): NCT01152099.

Examining the association between anthropometric parameters and telomere length and mortality risk.

PubMed

Wu, Chen-Jung; Kao, Tung-Wei; Lin, Yuan-Yung; Liaw, Fang-Yih; Wu, Li-Wei; Chang, Yaw-Wen; Peng, Tao-Chun; Chen, Wei-Liang

2017-05-23

A shorter telomere length is associated with several systemic disorders. Telomere length may be an informative biomarker for the maintenance of the overall health status and mortality. There are a limited number of empirical studies concerning the effect of anthropometric parameters on telomere length. The data are derived from the National Health and Nutrition Examination Survey from 1999 to 2002. The primary outcomes of this study were to examine the potential relationships between the anthropometric indices and the telomere length, while secondary outcomes of this study was to investigate the association between different anthropometric indices and mortality risk. A significant positive correlation was noted between the mean telomere length and the thigh circumference (TC) and calf circumference (CC) in all designed models. Participants in the highest TC and CC quartiles tended to have a longer telomere length and lowered the hazards for all-cause mortality to 43% and 57%, respectively. Notably, the anthropometric indices involving the CC with higher values seemed to be surrogate markers for the reduction of the risk of all-cause, cardiovascular and malignancy-related mortality (all P < 0.05). The CCmay be a valuable tool to guide public health policy and a clinical prognostic indicator for the risk of mortality.

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

PubMed Central

Scott, Jared T.; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Background Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. Methods We searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. Results 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Conclusion Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes. PMID:28727834

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals.

PubMed

Howard, Benjamin; Scott, Jared T; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. We searched PubMed for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

Renal and Cardiovascular Effects of sodium–glucose cotransporter 2 (SGLT2) inhibition in combination with loop Diuretics in diabetic patients with Chronic Heart Failure (RECEDE-CHF): protocol for a randomised controlled double-blind cross-over trial

PubMed Central

Mordi, Natalie A; Mordi, Ify R; Singh, Jagdeep S; Baig, Fatima; Choy, Anna-Maria; McCrimmon, Rory J; Struthers, Allan D; Lang, Chim C

2017-01-01

Introduction Type 2 diabetes (T2D) and heart failure (HF) are a frequent combination, where treatment options remain limited. There has been increasing interest around the sodium–glucose cotransporter 2 (SGLT2) inhibitors and their use in patients with HF. Data on the effect of SGLT2 inhibitor use with diuretics are limited. We hypothesise that SGLT2 inhibition may augment the effects of loop diuretics and the benefits of SGLT2 inhibitors may extend beyond those of their metabolic (glycaemic parameters and weight loss) and haemodynamic parameters. The effects of SGLT2 inhibitors as an osmotic diuretic and on natriuresis may underlie the cardiovascular and renal benefits demonstrated in the recent EMPA-REG study. Methods and analysis To assess the effect of SGLT2 inhibitors when used in combination with a loop diuretic, the RECEDE-CHF (Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop Diuretics in diabetic patients with Chronic Heart Failure) trial is a single-centre, randomised, double-blind, placebo-controlled, cross-over trial conducted in a secondary care setting within NHS Tayside, Scotland. 34 eligible participants, aged between 18 and 80 years, with stable T2D and CHF will be recruited. Renal physiological testing will be performed at two points (week 1 and week 6) on each arm to assess the effect of 25 mg empagliflozin, on the primary and secondary outcomes. Participants will be enrolled in the trial for a total period between 14 and 16 weeks. The primary outcome will assess the effect of empagliflozin versus placebo on urine output. The secondary outcomes are to assess the effect of empagliflozin on glomerular filtration rate, cystatin C, urinary sodium excretion, urinary protein/creatinine ratio and urinary albumin/creatinine ratio when compared with placebo. Ethics and dissemination Ethics approval was obtained by the East of Scotland Research Ethics Service. Results of the trial will be submitted for publication in a peer-reviewed journal. Trial registration number NCT03226457; Pre-results. PMID:29042392

Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial

PubMed Central

2012-01-01

Introduction To evaluate whether alkaline phosphatase (AP) treatment improves renal function in sepsis-induced acute kidney injury (AKI), a prospective, double-blind, randomized, placebo-controlled study in critically ill patients with severe sepsis or septic shock with evidence of AKI was performed. Methods Thirty-six adult patients with severe sepsis or septic shock according to Systemic Inflammatory Response Syndrome criteria and renal injury defined according to the AKI Network criteria were included. Dialysis intervention was standardized according to Acute Dialysis Quality Initiative consensus. Intravenous infusion of alkaline phosphatase (bolus injection of 67.5 U/kg body weight followed by continuous infusion of 132.5 U/kg/24 h for 48 hours, or placebo) starting within 48 hours of AKI onset and followed up to 28 days post-treatment. The primary outcome variable was progress in renal function variables (endogenous creatinine clearance, requirement and duration of renal replacement therapy, RRT) after 28 days. The secondary outcome variables included changes in circulating inflammatory mediators, urinary excretion of biomarkers of tubular injury, and safety. Results There was a significant (P = 0.02) difference in favor of AP treatment relative to controls for the primary outcome variable. Individual renal parameters showed that endogenous creatinine clearance (baseline to Day 28) was significantly higher in the treated group relative to placebo (from 50 ± 27 to 108 ± 73 mL/minute (mean ± SEM) for the AP group; and from 40 ± 37 to 65 ± 30 mL/minute for placebo; P = 0.01). Reductions in RRT requirement and duration did not reach significance. The results in renal parameters were supported by significantly more pronounced reductions in the systemic markers C-reactive protein, Interleukin-6, LPS-binding protein and in the urinary excretion of Kidney Injury Molecule-1 and Interleukin-18 in AP-treated patients relative to placebo. The Drug Safety Monitoring Board did not raise any issues throughout the trial. Conclusions The improvements in renal function suggest alkaline phosphatase is a promising new treatment for patients with severe sepsis or septic shock with AKI. Trial Registration www.clinicaltrials.gov: NCTNCT00511186 PMID:22269279

Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial.

PubMed

Goldstein, Daniel J; Mehra, Mandeep R; Naka, Yoshifumi; Salerno, Christopher; Uriel, Nir; Dean, David; Itoh, Akinobu; Pagani, Francis D; Skipper, Eric R; Bhat, Geetha; Raval, Nirav; Bruckner, Brian A; Estep, Jerry D; Cogswell, Rebecca; Milano, Carmelo; Fendelander, Lahn; O'Connell, John B; Cleveland, Joseph

2018-01-01

Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Surgeon Reported Outcome Measure for Spine Trauma: An International Expert Survey Identifying Parameters Relevant for the Outcome of Subaxial Cervical Spine Injuries.

PubMed

Sadiqi, Said; Verlaan, Jorrit-Jan; Lehr, A Mechteld; Dvorak, Marcel F; Kandziora, Frank; Rajasekaran, S; Schnake, Klaus J; Vaccaro, Alexander R; Oner, F Cumhur

2016-12-15

International web-based survey. To identify clinical and radiological parameters that spine surgeons consider most relevant when evaluating clinical and functional outcomes of subaxial cervical spine trauma patients. Although an outcome instrument that reflects the patients' perspective is imperative, there is also a need for a surgeon reported outcome measure to reflect the clinicians' perspective adequately. A cross-sectional online survey was conducted among a selected number of spine surgeons from all five AOSpine International world regions. They were asked to indicate the relevance of a compilation of 21 parameters, both for the short term (3 mo-2 yr) and long term (≥2 yr), on a five-point scale. The responses were analyzed using descriptive statistics, frequency analysis, and Kruskal-Wallis test. Of the 279 AOSpine International and International Spinal Cord Society members who received the survey, 108 (38.7%) participated in the study. Ten parameters were identified as relevant both for short term and long term by at least 70% of the participants. Neurological status, implant failure within 3 months, and patient satisfaction were most relevant. Bony fusion was the only parameter for the long term, whereas five parameters were identified for the short term. The remaining six parameters were not deemed relevant. Minor differences were observed when analyzing the responses according to each world region, or spine surgeons' degree of experience. The perspective of an international sample of highly experienced spine surgeons was explored on the most relevant parameters to evaluate and predict outcomes of subaxial cervical spine trauma patients. These results form the basis for the development of a disease-specific surgeon reported outcome measure, which will be a helpful tool in research and clinical practice. 4.

Primary care physician workforce and Medicare beneficiaries' health outcomes.

PubMed

Chang, Chiang-Hua; Stukel, Therese A; Flood, Ann Barry; Goodman, David C

2011-05-25

Despite a widespread interest in increasing the numbers of primary care physicians to improve care and to moderate costs, the relationship of the primary care physician workforce to patient-level outcomes remains poorly understood. To measure the association between the adult primary care physician workforce and individual patient outcomes. A cross-sectional analysis of the outcomes of a 2007 20% sample of fee-for-service Medicare beneficiaries aged 65 years or older (N = 5,132,936), which used 2 measures of adult primary care physicians (general internists and family physicians) across Primary Care Service Areas (N = 6542): (1) American Medical Association (AMA) Masterfile nonfederal, office-based physicians per total population and (2) office-based primary care clinical full-time equivalents (FTEs) per Medicare beneficiary derived from Medicare claims. Annual individual-level outcomes (mortality, ambulatory care sensitive condition [ACSC] hospitalizations, and Medicare program spending), adjusted for individual patient characteristics and geographic area variables. Marked variation was observed in the primary care physician workforce across areas, but low correlation was observed between the 2 primary care workforce measures (Spearman r = 0.056; P < .001). Compared with areas with the lowest quintile of primary care physician measure using AMA Masterfile counts, beneficiaries in the highest quintile had fewer ACSC hospitalizations (74.90 vs 79.61 per 1000 beneficiaries; relative rate [RR], 0.94; 95% confidence interval [CI], 0.93-0.95), lower mortality (5.38 vs 5.47 per 100 beneficiaries; RR, 0.98; 95% CI, 0.97-0.997), and no significant difference in total Medicare spending ($8722 vs $8765 per beneficiary; RR, 1.00; 95% CI, 0.99-1.00). Beneficiaries residing in areas with the highest quintile of primary care clinician FTEs compared with those in the lowest quintile had lower mortality (5.19 vs 5.49 per 100 beneficiaries; RR, 0.95; 95% CI, 0.93-0.96), fewer ACSC hospitalizations (72.53 vs 79.48 per 1000 beneficiaries; RR, 0.91; 95% CI, 0.90-0.92), and higher overall Medicare spending ($8857 vs $8769 per beneficiary; RR, 1.01; 95% CI, 1.004-1.02). A higher level of primary care physician workforce, particularly with an FTE measure that may more accurately reflect ambulatory primary care, was generally associated with favorable patient outcomes.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

Does treatment of intestinal helminth infections influence malaria? Background and methodology of a longitudinal study of clinical, parasitological and immunological parameters in Nangapanda, Flores, Indonesia (ImmunoSPIN Study)

PubMed Central

2010-01-01

Background Given that helminth infections are thought to have strong immunomodulatory activity, the question whether helminth infections might affect responses to malaria antigens needs to be addressed. Different cross-sectional studies using diverse methodologies have reported that helminth infections might either exacerbate or reduce the severity of malaria attacks. The same discrepancies have been reported for parasitemia. Methods/Design To determine the effect of geohelminth infections and their treatment on malaria infection and disease outcome, as well as on immunological parameters, the area of Nangapanda on Flores Island, Indonesia, where malaria and helminth parasites are co-endemic was selected for a longitudinal study. Here a Double-blind randomized trial will be performed, incorporating repeated treatment with albendazole (400 mg) or placebo at three monthly intervals. Household characteristic data, anthropometry, the presence of intestinal helminth and Plasmodium spp infections, and the incidence of malaria episodes are recorded. In vitro cultures of whole blood, stimulated with a number of antigens, mitogens and toll like receptor ligands provide relevant immunological parameters at baseline and following 1 and 2 years of treatment rounds. The primary outcome of the study is the prevalence of Plasmodium falciparum and P. vivax infection. The secondary outcome will be incidence and severity of malaria episodes detected via both passive and active follow-up. The tertiary outcome is the inflammatory cytokine profile in response to parasite antigens. The project also facilitates the transfer of state of the art methodologies and technologies, molecular diagnosis of parasitic diseases, immunology and epidemiology from Europe to Indonesia. Discussion The study will provide data on the effect of helminth infections on malaria. It will also give information on anthelminthic treatment efficacy and effectiveness and could help develop evidence-based policymaking. Trial registration This study was approved by The Ethical Committee of Faculty of Medicine, University of Indonesia, ref:194/PT02.FK/Etik/2006 and has been filed by ethics committee of the Leiden University Medical Center. Clinical trial number:ISRCTN83830814. The study is reported in accordance with the CONSORT guidelines for cluster-randomized studies. PMID:20338054

Long-Face Dentofacial Deformities: Occlusion and Facial Esthetic Surgical Outcomes.

PubMed

Posnick, Jeffrey C; Liu, Samuel; Tremont, Timothy J

2018-06-01

The purpose of this study was to document malocclusion and facial dysmorphology in a series of patients with long face (LF) and chronic obstructive nasal breathing before treatment and the outcomes after bimaxillary orthognathic, osseous genioplasty, and intranasal surgery. A retrospective cohort study of patients with LF undergoing bimaxillary, chin, and intranasal (septoplasty and inferior turbinate reduction) surgery was implemented. Predictor variables were grouped into demographic, anatomic, operative, and longitudinal follow-up categories. Primary outcome variables were the initial postoperative occlusion achieved (T 2 ; 5 weeks after surgery) and the occulsion maintained long-term (>2 years after surgery). Six key occlusion parameters were assessed: overjet, overbite, coincidence of dental midlines, canine Angle classification, and molar vertical and transverse positions. The second outcome variable was the facial esthetic results. Photographs in 6 views were analyzed to document 7 facial contour characteristics. Seventy-eight patients met the inclusion criteria. Average age at surgery was 24 years (range, 13 to 54 yr). The study included 53 female patients (68%). Findings confirmed that occlusion after initial surgical healing (T 2 ) met the objectives for all parameters in 97% of patients (76 of 78). Most (68 of 78; 87%) maintained a favorable anterior and posterior occlusion for each parameter studied long-term (mean, 5 years 5 months). Facial contour deformities at presentation included prominent nose (63%), flat cheekbones (96%), flat midface (96%), weak chin (91%), obtuse neck-to-chin angle (56%), wide lip separation (95%), and excess maxillary dental show (99%). Correction of all pretreatment facial contour deformities was confirmed in 92% of patients after surgery. Long face patients with higher preoperative body mass index levels were more likely to have residual facial dysmorphology after surgery (P = .0009). Using orthognathic surgery techniques, patients with LF dentofacial deformity achieved the planned occlusion and most maintained the corrected occlusion long-term. In unoperated patients with LF, a "facial esthetic type" was identified. Orthognathic surgery proved effective in correcting associated facial dysmorphology in most patients. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Incidence, predictors, and outcome of difficult mask ventilation combined with difficult laryngoscopy: a report from the multicenter perioperative outcomes group.

PubMed

Kheterpal, Sachin; Healy, David; Aziz, Michael F; Shanks, Amy M; Freundlich, Robert E; Linton, Fiona; Martin, Lizabeth D; Linton, Jonathan; Epps, Jerry L; Fernandez-Bustamante, Ana; Jameson, Leslie C; Tremper, Tyler; Tremper, Kevin K

2013-12-01

Research regarding difficult mask ventilation (DMV) combined with difficult laryngoscopy (DL) is extremely limited even though each technique serves as a rescue for one another. Four tertiary care centers participating in the Multicenter Perioperative Outcomes Group used a consistent structured patient history and airway examination and airway outcome definition. DMV was defined as grade 3 or 4 mask ventilation, and DL was defined as grade 3 or 4 laryngoscopic view or four or more intubation attempts. The primary outcome was DMV combined with DL. Patients with the primary outcome were compared to those without the primary outcome to identify predictors of DMV combined with DL using a non-parsimonious logistic regression. Of 492,239 cases performed at four institutions among adult patients, 176,679 included a documented face mask ventilation and laryngoscopy attempt. Six hundred ninety-eight patients experienced the primary outcome, an overall incidence of 0.40%. One patient required an emergent cricothyrotomy, 177 were intubated using direct laryngoscopy, 284 using direct laryngoscopy with bougie introducer, 163 using videolaryngoscopy, and 73 using other techniques. Independent predictors of the primary outcome included age 46 yr or more, body mass index 30 or more, male sex, Mallampati III or IV, neck mass or radiation, limited thyromental distance, sleep apnea, presence of teeth, beard, thick neck, limited cervical spine mobility, and limited jaw protrusion (c-statistic 0.84 [95% CI, 0.82-0.87]). DMV combined with DL is an infrequent but not rare phenomenon. Most patients can be managed with the use of direct or videolaryngoscopy. An easy to use unweighted risk scale has robust discriminating capacity.

Implementation of the physician assistant in Dutch health care organizations: primary motives and outcomes.

PubMed

van Vught, Anneke J A H; van den Brink, Geert T W J; Wobbes, Theo

2014-01-01

Physician assistants (PAs) are trained to perform medical procedures that were traditionally performed by medical physicians. Physician assistants seem to be deployed not only to increase efficiency but also to ensure the quality of care. What is not known is the primary motive for employing PAs within Dutch health care and whether the employment of the PAs fulfills the perceived need for them. Supervising medical specialists who used PAs in their practices were interviewed about their primary motives and outcomes. The interviews were semistructured. Two scientists coded the findings with respect to motives and outcomes. In total, 55 specialists were interviewed about their motives for employing a PA, and 15 were interviewed about the outcomes of employing a PA. With respect to the primary motives for employing a PA, the most frequent motive was to increase continuity and quality of care, followed by relieving the specialist's workload, increasing efficiency of care, and substituting for medical residents. The outcomes were found to be consistent with the motives. In conclusion, the primary motive for employing a PA in Dutch health care is to increase continuity and quality of care.

The Effects of Career Calling and Perceived Overqualification on Work Outcomes for Primary and Secondary School Teachers

ERIC Educational Resources Information Center

Lobene, Eleni V.; Meade, Adam W.

2013-01-01

While perceived overqualification (POQ) has received increased research attention in recent years, the identification of variables that moderate POQ-outcome relationships is critical to our understanding of how the construct affects career outcomes. This study, involving 170 full-time primary and secondary school educators in a suburban…

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

PubMed

Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

2018-05-11

Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of this study confirm the effectiveness of mindfulness programmes in this population, it will be possible to improve quality of life and health while optimising public resources and reaching a greater number of people. In addition, on the basis of the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. ClinicalTrials.gov, NCT02893150 . Registered retrospectively on 30 March 2017.

Surrogate markers of visceral fat and response to anti-depressive treatment in patients with major depressive disorder: a prospective exploratory analysis.

PubMed

Tønning, Morten; Petersen, Dorthe; Steglich-Petersen, Marie; Csillag, Claudio

2017-02-01

Body mass index (BMI) and body weight have been shown to be associated to treatment outcome in patients with major depressive disorder, but this relationship is not clear. Visceral fat might be an underlying mechanism explaining this relationship. The aim of this study was to prospectively investigate whether visceral fat, as measured by hip-to-waist ratio and waist circumference, affects treatment outcome in patients with major depressive disorder in patients attending a hospital psychiatric care unit in Denmark. The study was conducted as an observational prospective study including 33 patients with major depressive disorder. Assessments were made at enrolment and after 8 weeks. Primary variables were hip-to-waist ratio and waist circumference. Outcome were remission or response of depressive symptoms measured with the Hamilton Depression Rating Scale (HAM-D 17 ) interviews and HAM-D 6 self-rating questionnaires. No differences were found in outcome between groups of patients with high vs low visceral fat in this population. The lack of association was evident for all surrogate markers of visceral fat, and suggests that visceral fat has no impact on outcomes of depressive symptoms. However, study limitations might have contributed to this lack of association, especially sample size and considerable variations on multiple parameters including treatment received during the 8 weeks of follow-up.

Knot positioning during McDonald cervical cerclage, does it make a difference? A cohort study.

PubMed

Atia, Hytham; Ellaithy, Mohamed; Altraigey, Ahmed; Ibrahim, Heba

2018-05-15

To study the effect of McDonald cerclage knot position on the different maternal and neonatal outcomes. This historical cohort study included women with singleton pregnancy who had a prophylactic McDonald cervical cerclage between 1 May 2010 and 31 September 2017. Maternal and neonatal outcome parameters were compared between the anterior and posterior knot cerclage procedures. The primary outcome measure was the rate of term birth. 550 Women had a prophylactic McDonald cervical cerclage, 306 with anterior knot (Group A) and 244 with posterior knot (Group B). There were no statistically significant differences regarding gestational age (GA) at delivery (36.3 ± 4.2 versus 35.8 ± 5.3 for groups A and B respectively), term birth rate, post-cerclage cervical length, symptomatic vaginitis, urinary tract infection, difficult cerclage removal and cervical lacerations. Similarly, there were no statistically significant differences as regards the studied neonatal outcomes including take home babies, neonatal intensive care admission, respiratory distress syndrome and neonatal sepsis. Survival analysis on GA at delivery demonstrated no statistically significant difference as regards the proportion of term deliveries in the anterior and posterior knot cerclage groups (log-rank test p-value = .478). Knot positioning during McDonald cervical cerclage, anteriorly or posteriorly, didn't significantly impact the studied maternal and neonatal outcomes.

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

PubMed

McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events. Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent. © 2015 Society for the Study of Addiction.

Serum Hepatocyte Growth Factor Is Probably Associated With 3-Month Prognosis of Acute Ischemic Stroke.

PubMed

Zhu, Zhengbao; Xu, Tan; Guo, Daoxia; Huangfu, Xinfeng; Zhong, Chongke; Yang, Jingyuan; Wang, Aili; Chen, Chung-Shiuan; Peng, Yanbo; Xu, Tian; Wang, Jinchao; Sun, Yingxian; Peng, Hao; Li, Qunwei; Ju, Zhong; Geng, Deqin; Chen, Jing; Zhang, Yonghong; He, Jiang

2018-02-01

Serum hepatocyte growth factor (HGF) is positively associated with poor prognosis of heart failure and myocardial infarction, and it can also predict the risk of ischemic stroke in population. The goal of this study was to investigate the association between serum HGF and prognosis of ischemic stroke. A total of 3027 acute ischemic stroke patients were included in this post hoc analysis of the CATIS (China Antihypertensive Trial in Acute Ischemic Stroke). The primary outcome was composite outcome of death or major disability (modified Rankin Scale score ≥3) within 3 months. After multivariate adjustment, elevated HGF levels were associated with an increased risk of primary outcome (odds ratio, 1.50; 95% confidence interval, 1.10-2.03; P trend =0.015) when 2 extreme quartiles were compared. Each SD increase of log-transformed HGF was associated with 14% (95% confidence interval, 2%-27%) increased risk of primary outcome. Adding HGF quartiles to a model containing conventional risk factors improved the predictive power for primary outcome (net reclassification improvement: 17.50%, P <0.001; integrated discrimination index: 0.23%, P =0.022). The association between serum HGF and primary outcome could be modified by heparin pre-treatment ( P interaction =0.001), and a positive linear dose-response relationship between HGF and primary outcome was observed in patients without heparin pre-treatment ( P linearity <0.001) but not in those with heparin pre-treatment. Serum HGF levels were higher in the more severe stroke at baseline, and elevated HGF levels were probably associated with 3-month poor prognosis independently of stroke severity among ischemic stroke patients, especially in those without heparin pre-treatment. Further studies from other samples of ischemic stroke patients are needed to validate our findings. © 2018 American Heart Association, Inc.

Nomogram for suboptimal cytoreduction at primary surgery for advanced stage ovarian cancer.

PubMed

Gerestein, Cornelis G; Eijkemans, Marinus J; Bakker, Jeanette; Elgersma, Otto E; van der Burg, Maria E L; Kooi, Geertruida S; Burger, Curt W

2011-11-01

Maximal cytoreduction to minimal residual tumor is the most important determinant of prognosis in patients with advanced stage epithelial ovarian cancer (EOC). Preoperative prediction of suboptimal cytoreduction, defined as residual tumor >1 cm, could guide treatment decisions and improve counseling. The objective of this study was to identify predictive computed tomographic (CT) scan and clinical parameters for suboptimal cytoreduction at primary cytoreductive surgery for advanced stage EOC and to generate a nomogram with the identified parameters, which would be easy to use in daily clinical practice. Between October 2005 and December 2008, all patients with primary surgery for suspected advanced stage EOC at six participating teaching hospitals in the South Western part of the Netherlands entered the study protocol. To investigate independent predictors of suboptimal cytoreduction, a Cox proportional hazard model with backward stepwise elimination was utilized. One hundred and fifteen patients with FIGO stage III/IV EOC entered the study protocol. Optimal cytoreduction was achieved in 52 (45%) patients. A suboptimal cytoreduction was predicted by preoperative blood platelet count (p=0.1990; odds ratio (OR)=1.002), diffuse peritoneal thickening (DPT) (p=0.0074; OR=3.021), and presence of ascites on at least two thirds of CT scan slices (p=0.0385; OR=2.294) with a for-optimism corrected c-statistic of 0.67. Suboptimal cytoreduction was predicted by preoperative platelet count, DPT and presence of ascites. The generated nomogram can, after external validation, be used to estimate surgical outcome and to identify those patients, who might benefit from alternative treatment approaches.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials

PubMed Central

Donovan, Dennis M.; Bigelow, George E.; Brigham, Gregory S.; Carroll, Kathleen M.; Cohen, Allan J.; Gardin, John G.; Hamilton, John A.; Huestis, Marilyn A.; Hughes, John R.; Lindblad, Robert; Marlatt, G. Alan; Preston, Kenzie L.; Selzer, Jeffrey A.; Somoza, Eugene C.; Wakim, Paul G.; Wells, Elizabeth A.

2012-01-01

Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them. PMID:21781202

Diffuse optical measurements of head and neck tumor hemodynamics for early prediction of chemoradiation therapy outcomes

NASA Astrophysics Data System (ADS)

Dong, Lixin; Kudrimoti, Mahesh; Irwin, Daniel; Chen, Li; Kumar, Sameera; Shang, Yu; Huang, Chong; Johnson, Ellis L.; Stevens, Scott D.; Shelton, Brent J.; Yu, Guoqiang

2016-08-01

This study used a hybrid near-infrared diffuse optical instrument to monitor tumor hemodynamic responses to chemoradiation therapy for early prediction of treatment outcomes in patients with head and neck cancer. Forty-seven patients were measured once per week to evaluate the hemodynamic status of clinically involved cervical lymph nodes as surrogates for the primary tumor response. Patients were classified into two groups: complete response (CR) (n=29) and incomplete response (IR) (n=18). Tumor hemodynamic responses were found to be associated with clinical outcomes (CR/IR), wherein the associations differed depending on human papillomavirus (HPV-16) status. In HPV-16 positive patients, significantly lower levels in tumor oxygenated hemoglobin concentration ([HbO2]) at weeks 1 to 3, total hemoglobin concentration at week 3, and blood oxygen saturation (StO2) at week 3 were found in the IR group. In HPV-16 negative patients, significantly higher levels in tumor blood flow index and reduced scattering coefficient (μs‧) at week 3 were observed in the IR group. These hemodynamic parameters exhibited significantly high accuracy for early prediction of clinical outcomes, within the first three weeks of therapy, with the areas under the receiver operating characteristic curves (AUCs) ranging from 0.83 to 0.96.

Diffuse optical measurements of head and neck tumor hemodynamics for early prediction of chemoradiation therapy outcomes

PubMed Central

Dong, Lixin; Kudrimoti, Mahesh; Irwin, Daniel; Chen, Li; Kumar, Sameera; Shang, Yu; Huang, Chong; Johnson, Ellis L.; Stevens, Scott D.; Shelton, Brent J.; Yu, Guoqiang

2016-01-01

Abstract. This study used a hybrid near-infrared diffuse optical instrument to monitor tumor hemodynamic responses to chemoradiation therapy for early prediction of treatment outcomes in patients with head and neck cancer. Forty-seven patients were measured once per week to evaluate the hemodynamic status of clinically involved cervical lymph nodes as surrogates for the primary tumor response. Patients were classified into two groups: complete response (CR) (n=29) and incomplete response (IR) (n=18). Tumor hemodynamic responses were found to be associated with clinical outcomes (CR/IR), wherein the associations differed depending on human papillomavirus (HPV-16) status. In HPV-16 positive patients, significantly lower levels in tumor oxygenated hemoglobin concentration ([HbO2]) at weeks 1 to 3, total hemoglobin concentration at week 3, and blood oxygen saturation (StO2) at week 3 were found in the IR group. In HPV-16 negative patients, significantly higher levels in tumor blood flow index and reduced scattering coefficient (μs′) at week 3 were observed in the IR group. These hemodynamic parameters exhibited significantly high accuracy for early prediction of clinical outcomes, within the first three weeks of therapy, with the areas under the receiver operating characteristic curves (AUCs) ranging from 0.83 to 0.96. PMID:27564315

Revision Ligament Reconstruction Tendon Interposition for Trapeziometacarpal Arthritis: A Case-Control Investigation

PubMed Central

Sadhu, Anita; Calfee, Ryan P.; Guthrie, Andre; Wall, Lindley B.

2016-01-01

Purpose To test the null hypothesis that there is no difference in patient-reported and objective outcomes of revision ligament reconstruction and tendon interposition (LRTI) compared to primary LRTI. Methods This case-control investigation enrolled 10 patients who had undergone revision LRTI at a tertiary care center. All patients had previously undergone primary trapeziectomy with LRTI. Patients with a minimum of two years of follow-up were eligible. All patients completed an in-office study evaluation. Controls (treated only with primary LRTI) were matched from our practice to reach a 1:2 case to control ratio. Outcome measures included Michigan Hand Questionnaire (primary outcome), Quick Disability of the Arm, Hand, and Shoulder (QuickDASH) Questionnaire, VAS for pain and improvement, and physical examination. Statistical analyses were conducted to compare the patient groups. Results Revision LRTI patients reported significantly worse outcomes on all measured standardized questionnaires compared with primary patients. The Michigan Hand Questionnaire indicated worse overall outcomes (54 versus 79) as well as worse pain, appearance, and ability to complete activities of daily living. Revision LRTI patients also reported more impairment (QuickDASH 47 versus 23), greater pain (VAS pain 6.3 versus 1), and less improvement after surgery (VAS improvement 2.7 versus 7.9). There was also a significantly higher rate of patient-reported depression in the revision LRTI group (50% versus 10% of primary LRTI patients). We did not find a significant difference in objective outcomes of pinch strength, grip strength, and thumb palmar abduction between the two groups. Conclusion Following revision LRTI patient-reported outcomes indicate worse perceived function and greater pain than expected following primary LRTI despite similar motion and strength. Revision surgery can be offered in the setting of persistent or recurrent symptoms, but patients should be counseled that improvement of symptoms is unpredictable. PMID:27751779

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

PubMed

Firouzi, Somayyeh; Majid, Hazreen Abdul; Ismail, Amin; Kamaruddin, Nor Azmi; Barakatun-Nisak, Mohd-Yusof

2017-06-01

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. A randomized, double-blind, parallel-group, controlled clinical trial. Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

Functional and morphological differences following Monarc and TVT-O procedures.

PubMed

Huang, W-C; Yang, S-H; Yang, J-M; Tzeng, C-R

2012-12-01

To explore function of the lower urinary tract and morphology of tape and urethra following Monarc or TVT-O suburethral tape placement for urodynamic stress incontinence (USI). We recruited prospectively women undergoing either Monarc or TVT-O placement for USI. Before and 3 months after the procedure, participants were evaluated by a question-directed interview, the measures of Sandvik Incontinence Severity Index (SISI), Incontinence Bother Scale (IBS), Ingelman-Sundberg Score (ISS) and short forms of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), physical examination, a cough stress test and 4D ultrasound investigation. The primary outcome was participants' responses to clinical assessments and the secondary outcome was ultrasound findings. A total of 67 women with Monarc procedures and 60 women with TVT-O procedures completed the survey both preoperatively and 3 months postoperatively. There were significant improvements in scores of SISI, IBS, ISS, UDI-6 and IIQ-7 after both Monarc and TVT-O procedures. At the 3-month follow-up, both procedures had similar success rates, SISI scores, IBS scores, ISS scores, UDI-6 scores and IIQ-7 scores, and similar incidences of postoperative voiding difficulty and overactive bladder symptoms. After Bonferroni correction, all ultrasound parameters representing tape location, tape tension and urethral mobility were similar between the two procedures. At short-term follow-up, Monarc and TVT-O procedures are comparable in both functional outcome of the lower urinary tract and morphology on ultrasound as assessed by parameters representing tape location, tape tension and urethral mobility. Copyright © 2012 ISUOG. Published by John Wiley & Sons, Ltd.

Open reduction and internal fixation compared to closed reduction and external fixation in distal radial fractures

PubMed Central

Kopylov, Philippe; Geijer, Mats; Tägil, Magnus

2009-01-01

Background and purpose In unstable distal radial fractures that are impossible to reduce or to maintain in reduced position, the treatment of choice is operation. The type of operation and the choice of implant, however, is a matter of discussion. Our aim was to investigate whether open reduction and internal fixation would produce a better result than traditional external fixation. Methods 50 patients with an unstable or comminute distal radius fracture were randomized to either closed reduction and bridging external fixation, or open reduction and internal fixation using the TriMed system. The primary outcome parameter was grip strength, but the patients were followed for 1 year with objective clinical assessment, subjective outcome using DASH, and radiographic examination. Results At 1 year postoperatively, grip strength was 90% (SD 16) of the uninjured side in the internal fixation group and 78% (17) in the external fixation group. Pronation/supination was 150° (15) in the internal fixation group and 136° (20) in the external fixation group at 1 year. There were no differences in DASH scores or in radiographic parameters. 5 patients in the external fixation group were reoperated due to malunion, as compared to 1 in the internal fixation group. 7 other cases were classified as radiographic malunion: 5 in the external fixation group and 2 in the internal fixation group. Interpretation Internal fixation gave better grip strength and a better range of motion at 1 year, and tended to have less malunions than external fixation. No difference could be found regarding subjective outcome. PMID:19857180

Effectiveness of workplace exercise supervised by a physical therapist among nurses conducting shift work: A randomized controlled trial

PubMed Central

Matsugaki, Ryutaro; Kuhara, Satoshi; Saeki, Satoru; Jiang, Ying; Michishita, Ryoma; Ohta, Masanori; Yamato, Hiroshi

2017-01-01

Objectives: This study aimed to evaluate the effectiveness of supervised exercise among nurses conducting shift work for health promotion. Methods: A total of 30 healthy female nurses conducting shift work participated in this study and they were randomly assigned to one of the following 2 groups: The supervised exercise group (SG; participants exercised under the supervision of a physical therapist (PT)) and the voluntary exercise group (VG; participants exercised without supervision). The study participants were asked to exercise twice/week for 12 weeks for 24 sessions. The primary outcome was aerobic fitness, and the secondary outcomes were muscle strength, anthropometric data, biochemical parameters, and mental health. We compared all the outcomes before and after the intervention within each group and between both groups at follow-up. Results: Aerobic fitness increased in the SG whereas it decreased in the VG, but these changes were not statistically significant (p=0.053 and 0.073, respectively). However, the between-group difference was significant in the intervention effect (p=0.010). Muscle strength, high-density lipoprotein cholesterol and metabolic profile (high-molecular weight adiponectin), and depressive symptom significantly improved in the SG over time, even though the SG exercised less as compared with the VG. Moreover, significant differences in muscle strength, and low-density lipoprotein cholesterol and reactive oxygen metabolite levels were observed between both groups, and these parameters were better in the SG than in the VG. Conclusions: Our data-suggest the effectiveness of exercise supervised by a PT at the workplace of nurses conducting shift work for health promotion. PMID:28638000

The comprehensive summary of surgical versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Cheng, Ji; Gao, Jinbo; Shuai, Xiaoming; Wang, Guobin; Tao, Kaixiong

2016-06-28

Bariatric surgery has emerged as a competitive strategy for obese patients. However, its comparative efficacy against non-surgical treatments remains ill-defined, especially among nonseverely obese crowds. Therefore, we implemented a systematic review and meta-analysis in order for an academic addition to current literatures. Literatures were retrieved from databases of PubMed, Web of Science, EMBASE and Cochrane Library. Randomized trials comparing surgical with non-surgical therapies for obesity were included. A Revised Jadad's Scale and Risk of Bias Summary were employed for methodological assessment. Subgroups analysis, sensitivity analysis and publication bias assessment were respectively performed in order to find out the source of heterogeneity, detect the outcome stability and potential publication bias. 25 randomized trials were eligibly included, totally comprising of 1194 participants. Both groups displayed well comparability concerning baseline parameters (P > 0.05). The pooled results of primary endpoints (weight loss and diabetic remission) revealed a significant advantage among surgical patients rather than those receiving non-surgical treatments (P < 0.05). Furthermore, except for certain cardiovascular indicators, bariatric surgery was superior to conventional arms in terms of metabolic secondary parameters (P < 0.05). Additionally, the pooled outcomes were confirmed to be stable by sensitivity analysis. Although Egger's test (P < 0.01) and Begg's test (P<0.05) had reported the presence of publication bias among included studies, "Trim-and-Fill" method verified that the pooled outcomes remained stable. Bariatric surgery is a better therapeutic option for weight loss, irrespective of follow-up duration, surgical techniques and obesity levels.

Prognostic value of serum phosphate level in adult patients resuscitated from cardiac arrest.

PubMed

Jung, Yong Hun; Lee, Byung Kook; Jeung, Kyung Woon; Youn, Chun Song; Lee, Dong Hun; Lee, Sung Min; Heo, Tag; Min, Yong Il

2018-07-01

Several studies have reported increased levels of phosphate after cardiac arrest. Given the relationship between phosphate level and the severity of ischaemic injury reported in previous studies, higher phosphate levels may be associated with worse outcomes. We investigated the prognostic value of phosphate level after the restoration of spontaneous circulation (ROSC) in adult cardiac arrest patients. This study was a retrospective observational study including adult cardiac arrest survivors treated at the Chonnam National University Hospital between January 2014 and June 2017. From medical records, data regarding clinical characteristics, outcome at hospital discharge, and laboratory parameters including phosphate levels after ROSC were collected. The primary outcome was poor outcome at hospital discharge, defined as Cerebral Performance Categories 3-5. Of the 674 included patients, 465 had poor outcome at hospital discharge. Serum phosphate level was significantly higher in patients with poor outcome than in those with good outcome (p < 0.001). Phosphate level was correlated with time to ROSC (r = 0.350, p < 0.001). Receiver operating characteristic curve analysis revealed an area under the curve of 0.805 (95% confidence interval [CI], 0.777-0.838) for phosphate level. In multivariate analysis, a higher phosphate level was independently associated with poor outcome at hospital discharge (odds ratio, 1.432; 95% CI, 1.245-1.626; p < 0.001). A higher phosphate level after ROSC was independently associated with poor outcome at hospital discharge in adult cardiac arrest patients. However, given its modest prognostic performance, phosphate level should be used in combination with other prognostic indicators. Copyright © 2018 Elsevier B.V. All rights reserved.

Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

PubMed

Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

2018-01-01

Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mhGAP), clinical competency (ENhancing Assessment of Common Therapeutic factors, ENACT), and implicit attitudes (Implicit Association Test, IAT), and patient outcomes including stigma-related barriers to care, daily functioning, and symptoms. The pilot and feasibility study will contribute to refining recommendations for implementation of mhGAP and other mental health services in primary healthcare settings in low-resource health systems. The pilot c-RCT findings will inform an effectiveness trial of RESHAPE to advance the evidence-base for optimal approaches to training and supervision for non-specialist providers. ClinicalTrials.gov identifier, NCT02793271.

Nasal irrigation as an adjunctive treatment in allergic rhinitis: a systematic review and meta-analysis.

PubMed

Hermelingmeier, Kristina E; Weber, Rainer K; Hellmich, Martin; Heubach, Christine P; Mösges, Ralph

2012-01-01

Saline nasal irrigation (SNI) is often recommended as additional nonpharmacologic treatment, having proven its efficacy in acute and chronic rhinosinusitis and for therapy after sinonasal surgery. To date, however, no systematic review or meta-analysis exists showing the influence of SNI on allergic rhinitis (AR). This study aimed to establish the impact of SNI on symptoms of AR in different patient groups. We conducted a systematic search of Medline, Embase, Cochrane Central Register of Controlled Trials, and ISI Web of Science databases for literature published from 1994 to 2010 on SNI in AR. Prospective, randomized, controlled trials that assessed the effects of SNI on four different outcome parameters were included. The evaluation focused on primary (symptom score) and secondary parameters (medicine consumption, mucociliary clearance, and quality of life). Three independent reviewers chose 10 originals that satisfied the inclusion criteria (>400 participants total) from 50 relevant trials. SNI performed regularly over a limited period of up to 7 weeks was observed to have a positive effect on all investigated outcome parameters in adults and children with AR. SNI produced a 27.66% improvement in nasal symptoms, a 62.1% reduction in medicine consumption, a 31.19% acceleration of mucociliary clearance time, and a 27.88% improvement in quality of life. SNI using isotonic solution can be recommended as complementary therapy in AR. It is well tolerated, inexpensive, easy to use, and there is no evidence showing that regular, daily SNI adversely affects the patient's health or causes unexpected side effects.

Effect of part-time practice on patient outcomes.

PubMed

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

2003-09-01

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

Effectiveness of temporary deafferentation of the arm on somatosensory and motor functions following stroke: a systematic review.

PubMed

Opsommer, Emmanuelle; Zwissig, Camille; Korogod, Natalya; Weiss, Thomas

2016-12-01

After stroke, regaining functional use of the upper limb can be challenging. Temporary deafferentation (TD) is a novel approach used in neurorehabilitation to voluntarily reduce the somatosensory input in a body part by temporary anesthesia; which has been shown to improve sensorimotor functions in the affected limb. The primary objective of this systematic review was to present the best available evidence related to the effects of TD of the affected arm on the recovery of motor function and activity of the upper limb (arm and hand) following stroke. Further, this review aimed to assess the effects of TD on sensory function, activities of daily living (ADL) and quality of life following stroke, the acceptability and safety of the intervention as well as adverse events. Adult patients (18 years and older) with a clinical diagnosis of stroke, either hemorrhagic or ischemic. Reports of rehabilitation that included the use of a pneumatic tourniquet, regional anesthesia or nerve block to achieve TD of an arm, or the use of TD as a stand-alone intervention. Primary outcomes were motor function and activity of the upper limb using assessment scales, motor tests and global motor functions.Secondary outcomes included measures of sensory function, ADL, impact of stroke and quality of life and pain.Additional outcomes were neurophysiological changes as studied with functional magnetic resonance imaging, magnetoencephalography and/or transcranial magnetic stimulation.Acceptability and safety of the intervention as well as adverse events were also included. We included any experimental and epidemiological studies. There were no randomized controlled trials. We included non-randomized controlled trials, quasi-experimental, before and after studies and case-control studies. We searched for both published and unpublished studies in major databases and all reference lists of relevant articles in English, German or French languages. We included studies published from January 1980 to October 2015. Data were extracted from included studies using a standardized data extraction tool from the Joanna Briggs Institute. There was heterogeneity in the types of intervention and outcome measures, therefore statistical pooling of the findings was not appropriate. As such, the studies were grouped according to type of outcome where possible. Findings are presented in a narrative form. Eight studies met the eligibility criteria. All outcome parameters related to the primary outcome (motor function and activity of the more affected upper extremity) showed an improvement during or after TD. The sensory functions significantly improved during or after TD when measured either by the grating orienting task or the grating orientation accuracy, and slightly improved when measured using the von Frey hair testing during TD. There is evidence supporting the use of TD of the upper extremity in adults after stroke. Temporary deafferentation can be recommended (Grade B).

Correlation of human papilloma virus status with quantitative perfusion/diffusion/metabolic imaging parameters in the oral cavity and oropharyngeal squamous cell carcinoma: comparison of primary tumour sites and metastatic lymph nodes.

PubMed

Han, M; Lee, S J; Lee, D; Kim, S Y; Choi, J W

2018-05-17

To investigate the differences in perfusion/diffusion/metabolic imaging parameters according to human papilloma virus (HPV) status in the oral cavity and oropharyngeal squamous cell carcinoma (OC-OPSCC), separately in primary tumour sites and metastatic lymph nodes. This retrospective study comprised 41 patients with primary OC-OPSCCs and 29 patients with metastatic lymph nodes. The perfusion/diffusion/metabolic imaging parameters were measured at the primary tumour and the largest ipsilateral metastatic lymph node. The quantitative parameters were compared between the HPV-positive and -negative groups. The HPV-positivity was 39% (16 patients) for the primary tumours and 51.7% (15 patients) for the metastatic lymph nodes. Patients with HPV-positive tumours had a lower T stage (p=0.034). The metastatic lymph nodes for the HPV-positive patients were bulkier (p=0.016) and more frequently had cystic morphology (p=0.005). The perfusion parameters were not different, regardless of HPV status. The diffusion parameter (ADC min , p=0.011) of the metastatic lymph nodes in the HPV-positive groups was lower and metabolic parameter (metabolic tumour volume p=0.035 and total lesion glycolysis p=0.037) were higher than those in HPV-negative groups. The diffusion and metabolic parameters of metastatic lymph nodes from OC-OPSCC were different according to HPV status. The perfusion parameters did not clearly represent HPV status. Copyright © 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Optimization of the water chemistry of the primary coolant at nuclear power plants with VVER

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

Barmin, L. F.; Kruglova, T. K.; Sinitsyn, V. P.

2005-01-15

Results of the use of automatic hydrogen-content meter for controlling the parameter of 'hydrogen' in the primary coolant circuit of the Kola nuclear power plant are presented. It is shown that the correlation between the 'hydrogen' parameter in the coolant and the 'hydrazine' parameter in the makeup water can be used for controlling the water chemistry of the primary coolant system, which should make it possible to optimize the water chemistry at different power levels.

A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty.

PubMed

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre; Vaes, Peter

2014-01-01

To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality.

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

PubMed Central

Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-01-01

Introduction A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). Methods and analysis The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethics and dissemination Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. Trial registration number ISCRTN88609453; Pre-results. PMID:28928192

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

PubMed

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

2015-12-01

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

Primary central nervous system lymphoma in immunocompetent individuals: a single center experience.

PubMed

Aki, Hilal; Uzunaslan, Didem; Saygin, Caner; Batur, Sebnem; Tuzuner, Nukhet; Kafadar, Ali; Ongoren, Seniz; Oz, Buge

2013-01-01

Primary central nervous system lymphoma (PCNSL) is defined as the involvement of brain, leptomeninges, eyes or spinal cord by non-Hodgkin lymphoma. The role of various prognostic markers in predicting adverse outcome is debated. To investigate the clinical and immunohistochemical findings of immunocompetent PCNSL cases (39 cases) diagnosed at the study center, and evaluate the influence of potential prognostic factors on overall survival (OS) of patients. Data regarding patient characteristics, neuroimaging, pathological and immunohistochemical features and follow-up were obtained from patient records. The influence of potential prognostic parameters on OS was investigated by log-rank test and Cox regression analysis. Patients who received combined chemotherapy and radiotherapy had a significantly better OS when compared to chemotherapy alone. Other variables included in this study were not associated with a significant survival advantage. In this study, we failed to demonstrate a relationship between different clinicopathological variables and OS of patients. Prospective studies with large patient series are needed to investigate other potential prognostic factors.

Deterministic Evolutionary Trajectories Influence Primary Tumor Growth: TRACERx Renal.

PubMed

Turajlic, Samra; Xu, Hang; Litchfield, Kevin; Rowan, Andrew; Horswell, Stuart; Chambers, Tim; O'Brien, Tim; Lopez, Jose I; Watkins, Thomas B K; Nicol, David; Stares, Mark; Challacombe, Ben; Hazell, Steve; Chandra, Ashish; Mitchell, Thomas J; Au, Lewis; Eichler-Jonsson, Claudia; Jabbar, Faiz; Soultati, Aspasia; Chowdhury, Simon; Rudman, Sarah; Lynch, Joanna; Fernando, Archana; Stamp, Gordon; Nye, Emma; Stewart, Aengus; Xing, Wei; Smith, Jonathan C; Escudero, Mickael; Huffman, Adam; Matthews, Nik; Elgar, Greg; Phillimore, Ben; Costa, Marta; Begum, Sharmin; Ward, Sophia; Salm, Max; Boeing, Stefan; Fisher, Rosalie; Spain, Lavinia; Navas, Carolina; Grönroos, Eva; Hobor, Sebastijan; Sharma, Sarkhara; Aurangzeb, Ismaeel; Lall, Sharanpreet; Polson, Alexander; Varia, Mary; Horsfield, Catherine; Fotiadis, Nicos; Pickering, Lisa; Schwarz, Roland F; Silva, Bruno; Herrero, Javier; Luscombe, Nick M; Jamal-Hanjani, Mariam; Rosenthal, Rachel; Birkbak, Nicolai J; Wilson, Gareth A; Pipek, Orsolya; Ribli, Dezso; Krzystanek, Marcin; Csabai, Istvan; Szallasi, Zoltan; Gore, Martin; McGranahan, Nicholas; Van Loo, Peter; Campbell, Peter; Larkin, James; Swanton, Charles

2018-04-19

The evolutionary features of clear-cell renal cell carcinoma (ccRCC) have not been systematically studied to date. We analyzed 1,206 primary tumor regions from 101 patients recruited into the multi-center prospective study, TRACERx Renal. We observe up to 30 driver events per tumor and show that subclonal diversification is associated with known prognostic parameters. By resolving the patterns of driver event ordering, co-occurrence, and mutual exclusivity at clone level, we show the deterministic nature of clonal evolution. ccRCC can be grouped into seven evolutionary subtypes, ranging from tumors characterized by early fixation of multiple mutational and copy number drivers and rapid metastases to highly branched tumors with >10 subclonal drivers and extensive parallel evolution associated with attenuated progression. We identify genetic diversity and chromosomal complexity as determinants of patient outcome. Our insights reconcile the variable clinical behavior of ccRCC and suggest evolutionary potential as a biomarker for both intervention and surveillance. Copyright © 2018 Francis Crick Institute. Published by Elsevier Inc. All rights reserved.

Continuous Quality Improvement and Comprehensive Primary Health Care: A Systems Framework to Improve Service Quality and Health Outcomes.

PubMed

McCalman, Janya; Bailie, Ross; Bainbridge, Roxanne; McPhail-Bell, Karen; Percival, Nikki; Askew, Deborah; Fagan, Ruth; Tsey, Komla

2018-01-01

Continuous quality improvement (CQI) processes for improving clinical care and health outcomes have been implemented by primary health-care services, with resultant health-care impacts. But only 10-20% of gain in health outcomes is contributed by health-care services; a much larger share is determined by social and cultural factors. This perspective paper argues that health care and health outcomes can be enhanced through applying CQI as a systems approach to comprehensive primary health care. Referring to the Aboriginal and Torres Strait Islander Australian context as an example, the authors provide a systems framework that includes strategies and conditions to facilitate evidence-based and local decision making by primary health-care services. The framework describes the integration of CQI vertically to improve linkages with governments and community members and horizontally with other sectors to influence the social and cultural determinants of health. Further, government and primary health-care service investment is required to support and extend integration and evaluation of CQI efforts vertically and horizontally.

Establishment and outcomes of a model primary care pharmacy service system.

PubMed

Carmichael, Jannet M; Alvarez, Autumn; Chaput, Ryan; DiMaggio, Jennifer; Magallon, Heather; Mambourg, Scott

2004-03-01

The establishment and outcomes of a model primary care pharmacy service system are described. A primary care pharmacy practice model was established at a government health care facility in March 1996. The original objective was to establish a primary pharmacy practice model that would demonstrate improved patient outcomes and maximize the pharmacist's contributions to drug therapy. Since its inception, many improvements have been realized and supported by advanced computer and automated systems, expanded disease state management practices, and unique practitioner and administrative support. Many outcomes studies have been performed on the pharmacist-initiated and -managed clinics, leading to improved patient care and conveying the quality-conscious and cost-effective role pharmacists can play as independent practitioners in this environment. These activities demonstrate cutting-edge leadership in health-system pharmacy. Redesign has been used to improve consistent access to a medication expert and has significantly improved the quality of patient care while easing physicians' workload without increasing health care costs. A system using pharmacists as independent practitioners to promote primary care has achieved high-quality and cost-effective patient care.

Continuous Quality Improvement and Comprehensive Primary Health Care: A Systems Framework to Improve Service Quality and Health Outcomes

PubMed Central

McCalman, Janya; Bailie, Ross; Bainbridge, Roxanne; McPhail-Bell, Karen; Percival, Nikki; Askew, Deborah; Fagan, Ruth; Tsey, Komla

2018-01-01

Continuous quality improvement (CQI) processes for improving clinical care and health outcomes have been implemented by primary health-care services, with resultant health-care impacts. But only 10–20% of gain in health outcomes is contributed by health-care services; a much larger share is determined by social and cultural factors. This perspective paper argues that health care and health outcomes can be enhanced through applying CQI as a systems approach to comprehensive primary health care. Referring to the Aboriginal and Torres Strait Islander Australian context as an example, the authors provide a systems framework that includes strategies and conditions to facilitate evidence-based and local decision making by primary health-care services. The framework describes the integration of CQI vertically to improve linkages with governments and community members and horizontally with other sectors to influence the social and cultural determinants of health. Further, government and primary health-care service investment is required to support and extend integration and evaluation of CQI efforts vertically and horizontally. PMID:29623271

Cervical necrotizing fasciitis: descriptive, retrospective analysis of 59 cases treated at a single center.

PubMed

Elander, Johanna; Nekludov, Michael; Larsson, Agneta; Nordlander, Britt; Eksborg, Staffan; Hydman, Jonas

2016-12-01

To provide retrospective, descriptive information on patients with cervical necrotizing fasciitis treated at a single center during the years 1998-2014, and to evaluate the outcome of a newly introduced treatment strategy. Retrospective analysis of clinical data obtained from medical records. Mortality, pre-morbidity, severity of illness, primary site of infection, type of bacteria, time parameters. The observed 3-month mortality was 6/59 (10 %). The most common initial foci of the infection were pharyngeal, dental or hypopharyngeal. The most common pathogen was Streptococcus milleri bacteria within the Streptococcus anginosus group (66 % of the cases). Using a combined treatment with early surgical debridement combined with hyperbaric oxygen treatment, it is possible to reduce the mortality rate among patients suffering from cervical necrotizing fasciitis, compared to the expected mortality rate and to previous historical reports. Data indicated that early onset of hyperbaric oxygen treatment may have a positive impact on survival rate, but no identifiable factor was found to prognosticate outcome.

Influence of land use configurations on river sediment pollution.

PubMed

Liu, An; Duodu, Godfred O; Goonetilleke, Ashantha; Ayoko, Godwin A

2017-10-01

Land use is an influential factor in river sediment pollution. However, land use type alone is found to be inadequate to explain pollutant contributions to the aquatic environment since configurations within the same land use type such as land cover and development layout could also exert an important influence. Consequently, this paper discusses a research study, which consisted of an in-depth investigation into the relationship between land use type and river sediment pollution by introducing robust parameters that represent configurations within the primary land use types. Urban water pollutants, namely, nutrients, total carbon, polycyclic aromatic hydrocarbons and metals were investigated in the study. The outcomes show that higher patch density and more diverse land use development forms contribute relatively greater pollutant loads to receiving waters and consequently leading to higher sediment pollution. The study outcomes are expected to contribute essential knowledge for creating robust management strategies to minimise waterway pollution and thereby protect the health of aquatic ecosystems. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prediction of Clinical Outcomes by Chemokine and Cytokine Profiling In CSF from Radiation Treated Breast Cancer Primary with Brain Metastases

NASA Astrophysics Data System (ADS)

Lok, Edwin

Whole brain radiation is the standard treatment for patients with brain metastasis but unfortunately tumors can recover from radiation-induced damage with the help of the immune system. The hypothesis that differences in immunokines in the cerebrospinal fluid (CSF) pre- and post-irradiation could reveal tumor biology and correlate with outcome of patients with metastatic breast cancer to the brain is tested. Collected CSF samples were analyzed using Luminex's multiplexing assays to survey global immunokine levels while Enzyme-Linked Immunosorbent Assays were used to quantify each individual immunokines. Cluster analysis was performed to segregate patients based on their common immunokine profile and each cluster was correlated with survival and other clinical parameters. Breast cancer brain metastasis was found to have altered immunokine profiles in the CSF, and that Interleukin-1α expression was elevated after irradiation. Therefore, immunokine profiling in the CSF could enable cancer physicians to monitor the status of brain metastases.

Computer-assisted revision total knee replacement.

PubMed

Sikorski, J M

2004-05-01

A technique for performing allograft-augmented revision total knee replacement (TKR) using computer assistance is described, on the basis of the results in 14 patients. Bone deficits were made up with impaction grafting. Femoral grafting was made possible by the construction of a retaining wall or dam which allowed pressurisation and retention of the graft. Tibial grafting used a mixture of corticocancellous and morsellised allograft. The position of the implants was monitored by the computer system and adjusted while the cement was setting. The outcome was determined using a six-parameter, quantitative technique (the Perth CT protocol) which measured the alignment of the prosthesis and provided an objective score. The final outcomes were not perfect with errors being made in femoral rotation and in producing a mismatch between the femoral and tibial components. In spite of the shortcomings the alignments were comparable in accuracy with those after primary TKR. Computer assistance shows considerable promise in producing accurate alignment in revision TKR with bone deficits.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.

PubMed

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-08-13

Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02). The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. ISRCTN08601529.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

PubMed Central

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-01-01

Background Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. Methods This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. Results There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02). Conclusion The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. Trial registration ISRCTN08601529. PMID:19678944

Eligibility for clinical trials in primary Sjögren’s syndrome: lessons from the UK Primary Sjögren’s Syndrome Registry

PubMed Central

Oni, Clare; Mitchell, Sheryl; James, Katherine; Ng, Wan-Fai; Griffiths, Bridget; Hindmarsh, Victoria; Price, Elizabeth; Pease, Colin T.; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; Hunter, John; Gupta, Monica; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, Ben; Rauz, Saaeha; Richards, Andrea; Bowman, Simon J.

2016-01-01

Abstract Objective: To identify numbers of participants in the UK Primary Sjögren’s Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. Methods: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. Results: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren’s Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren’s syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren’s Syndrome study (Tocilizumab), 46.3% for the Tolerance and Efficacy of Rituximab in Sjögren’s Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren’s Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters. PMID:26510429

Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry.

PubMed

Oni, Clare; Mitchell, Sheryl; James, Katherine; Ng, Wan-Fai; Griffiths, Bridget; Hindmarsh, Victoria; Price, Elizabeth; Pease, Colin T; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; Hunter, John; Gupta, Monica; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, Ben; Rauz, Saaeha; Richards, Andrea; Bowman, Simon J

2016-03-01

To identify numbers of participants in the UK Primary Sjögren's Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren's Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren's syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren's Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjögren's Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Primary Multiple Simultaneous Intracerebral Hemorrhages between 1950 and 2013: Analysis of Data on Age, Sex and Outcome.

PubMed

Laiwattana, Denchai; Sangsawang, Bussara; Sangsawang, Nucharee

2014-01-01

Primary multiple simultaneous intracerebral hemorrhages (MSICHs) are quite rare. Although occasional reports have been found, there have been no systematic reviews. The published case reports and case series contain overlapping data, leading to erroneous information about MSICHs. This is the first extensive review of accessible studies published in English on MSICHs. Our primary objective was to analyze the demographic data on age, sex, outcome and prognosis with regard to primary MSICHs. A PubMed search without language restriction for articles with results from human studies and registered between January 1950 and September 2013 yielded 677 articles. The following inclusion criteria were applied: (1) reported case(s) or case series on primary MSICHs; (2) text partly or fully in English, and (3) text contains identifiable data on age, sex and outcome of patients. A total of 24 articles met all the inclusion criteria. The reference lists of these 24 articles were inspected for additional relevant articles, which yielded another 20 articles. In all, 248 cases were identified; 143 cases were excluded for various reasons: 52 duplicate cases, 18 cases of multiple nonsimultaneous intracerebral hemorrhages, 25 cases of secondary MSICHs, and 48 cases with incomplete data on age, sex and outcome. The remaining 105 cases were analyzed. MSICHs were found to be more common in bilateral cases (53.33%): there were bilateral basal ganglia hemorrhages (33.33%), bilateral thalamic hemorrhages (18.10%), bilateral lobar hemorrhages (0.95%) and bilateral cerebellar hemorrhages (0.95%). Nonbilateral MSICHs were found in 46.67% of the cases. The hematomas were commonly distributed in the basal ganglia (45.83%), thalamus (30.56%) and cerebellum (10.19%). MSICHs were more frequently encountered in males (60.95%; average age: 59.13 ± 12.49 years). The average age of the female patients was higher (63.89 ± 13.11 years). Patients with primary MSICHs had a survival rate of 56.20%. There was a favorable outcome of primary MSICHs in 18.10% of all the cases, the highest proportion of which was in the nonbilateral MSICH group. The remaining 38.10% had unfavorable outcomes. Death occurred in 43.80% of all cases, the highest proportion being found in the bilateral basal ganglia hemorrhage group. Primary MSICHs share features with solitary intracerebral hemorrhage regarding age, sex, and the location and distribution of hematomas, but they have a poorer outcome (p < 0.05). Primary MSICHs are rare and share features with solitary intracerebral hemorrhage regarding age and the location and distribution of hematomas. Patients have a poorer prognosis but higher favorable outcome rates in case of survival. This information adds to the awareness of clinicians that higher rates of favorable outcomes can be achieved for MSICHs.

An exploratory study on the efficacy and safety of a BCAA preparation used in combination with cardiac rehabilitation for patients with chronic heart failure.

PubMed

Takata, Munenori; Amiya, Eisuke; Watanabe, Masafumi; Hosoya, Yumiko; Nakayama, Atsuko; Fujiwara, Takayuki; Taya, Masanobu; Oguri, Gaku; Hyodo, Kanako; Takayama, Naoko; Takano, Nami; Mashiko, Tomoe; Uemura, Yukari; Komuro, Issei

2017-07-27

Sarcopenia is generally complicated with patients with chronic heart failure (CHF) and its presence negatively affects the course of heart failure, however effective nutritional intervention had not been elucidated yet. The primary objective of this study is to explore whether the addition of a branched-chain amino acid (BCAA) preparation for cardiac rehabilitation (CR) of patients with CHF further improves cardiopulmonary functions, skeletal muscle functions, and metabolism in comparison with conventional CR. This is a randomized, parallel-group comparative study. The elderly patients that were participated in CR and complicated with left ventricular systolic or diastolic dysfunction are randomized into two groups, CR + BCAA and CR. 20 weeks later, the second randomization is performed, which divide subjects into two groups with and without BCAA intervention without CR. Primary outcome measure is the rate of change of the anaerobic threshold workload from baseline to post-intervention. Secondary outcome include parameters of exercise capacity, cardiac function and psychological status. In the current study the effect of a promising new intervention, BCAA, will be assessed to determine whether its addition to CR improve exercise capacity in patients with heart failure, who are generally complicated with sarcopenia. This clinical trial was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR; JPRN-UMIN R000022440 ).

Outcomes of 50 Patients With Ewing Sarcoma Family of Tumors Treated at a Single Institution in Taiwan

PubMed Central

Lee, Chih-Ying; Yen, Chueh-Chuan; Yen, Hsiu-Ju; Shiau, Cheng-Ying; Chao, Ta-Chung; Wu, Po-Kuei; Chen, Cheng-Fong; Chen, Paul Chih-Hsueh; Wu, Hung-Ta Hondar; Chiou, Hong-Jen; Chen, Chao-Chun; Hung, Giun-Yi; Chen, Wei-Ming

2016-01-01

Abstract To identify the prognostic factors and long-term outcome of the Ewing sarcoma family of tumors (ESFT), data on 50 patients with ESFT treated at Taipei Veterans General Hospital between February 1991 and March 2014 were retrospectively considered. The influence of patient demographics, tumor features, and clinical and therapeutic parameters on overall survival (OS) and progression-free survival (PFS) rates were assessed. The results revealed that 21 of the 50 patients (42%) were metastatic at diagnosis. The median follow-up time was 1.8 years. The 5-year OS and PFS for patients who were nonmetastatic were 61.6% and 55.5%, respectively, and 18.8% and 15.4% for patients who were metastatic, respectively. The key adverse prognostic factor was metastasis at diagnosis. Radiotherapy for local control was associated with improved PFS. The high rate of primary metastasis and poorer outcomes of nonmetastatic ESFT compared with results from Western studies, along with previously reported low rates of ESFT in Taiwanese people, suggest that genetic factors play a role in the pathogenesis of ESFT and chemotherapy pharmacokinetics and pharmacodynamics. Radiotherapy in local treatment should be considered more aggressively in Taiwanese patients with ESFT. PMID:27258529

Quantitative radiomic profiling of glioblastoma represents transcriptomic expression.

PubMed

Kong, Doo-Sik; Kim, Junhyung; Ryu, Gyuha; You, Hye-Jin; Sung, Joon Kyung; Han, Yong Hee; Shin, Hye-Mi; Lee, In-Hee; Kim, Sung-Tae; Park, Chul-Kee; Choi, Seung Hong; Choi, Jeong Won; Seol, Ho Jun; Lee, Jung-Il; Nam, Do-Hyun

2018-01-19

Quantitative imaging biomarkers have increasingly emerged in the field of research utilizing available imaging modalities. We aimed to identify good surrogate radiomic features that can represent genetic changes of tumors, thereby establishing noninvasive means for predicting treatment outcome. From May 2012 to June 2014, we retrospectively identified 65 patients with treatment-naïve glioblastoma with available clinical information from the Samsung Medical Center data registry. Preoperative MR imaging data were obtained for all 65 patients with primary glioblastoma. A total of 82 imaging features including first-order statistics, volume, and size features, were semi-automatically extracted from structural and physiologic images such as apparent diffusion coefficient and perfusion images. Using commercially available software, NordicICE, we performed quantitative imaging analysis and collected the dataset composed of radiophenotypic parameters. Unsupervised clustering methods revealed that the radiophenotypic dataset was composed of three clusters. Each cluster represented a distinct molecular classification of glioblastoma; classical type, proneural and neural types, and mesenchymal type. These clusters also reflected differential clinical outcomes. We found that extracted imaging signatures does not represent copy number variation and somatic mutation. Quantitative radiomic features provide a potential evidence to predict molecular phenotype and treatment outcome. Radiomic profiles represents transcriptomic phenotypes more well.

Deletion Diagnostics for Alternating Logistic Regressions

PubMed Central

Preisser, John S.; By, Kunthel; Perin, Jamie; Qaqish, Bahjat F.

2013-01-01

Deletion diagnostics are introduced for the regression analysis of clustered binary outcomes estimated with alternating logistic regressions, an implementation of generalized estimating equations (GEE) that estimates regression coefficients in a marginal mean model and in a model for the intracluster association given by the log odds ratio. The diagnostics are developed within an estimating equations framework that recasts the estimating functions for association parameters based upon conditional residuals into equivalent functions based upon marginal residuals. Extensions of earlier work on GEE diagnostics follow directly, including computational formulae for one-step deletion diagnostics that measure the influence of a cluster of observations on the estimated regression parameters and on the overall marginal mean or association model fit. The diagnostic formulae are evaluated with simulations studies and with an application concerning an assessment of factors associated with health maintenance visits in primary care medical practices. The application and the simulations demonstrate that the proposed cluster-deletion diagnostics for alternating logistic regressions are good approximations of their exact fully iterated counterparts. PMID:22777960

Ultraearly hematoma growth in active intracerebral hemorrhage

PubMed Central

Coscojuela, Pilar; Rubiera, Marta; Hill, Michael D.; Dowlatshahi, Dar; Aviv, Richard I.; Silva, Yolanda; Dzialowski, Imanuel; Lum, Cheemun; Czlonkowska, Anna; Boulanger, Jean-Martin; Kase, Carlos S.; Gubitz, Gord; Bhatia, Rohit; Padma, Vasantha; Roy, Jayanta; Tomasello, Alejandro; Demchuk, Andrew M.; Molina, Carlos A.

2016-01-01

Objective: To determine the association of ultraearly hematoma growth (uHG) with the CT angiography (CTA) spot sign, hematoma expansion, and clinical outcomes in patients with acute intracerebral hemorrhage (ICH). Methods: We analyzed data from 231 patients enrolled in the multicenter Predicting Haematoma Growth and Outcome in Intracerebral Haemorrhage Using Contrast Bolus CT study. uHG was defined as baseline ICH volume/onset-to-CT time (mL/h). The spot sign was used as marker of active hemorrhage. Outcome parameters included significant hematoma expansion (>33% or >6 mL, primary outcome), rate of hematoma expansion, early neurologic deterioration, 90-day mortality, and poor outcome. Results: uHG was higher in spot sign patients (p < 0.001) and in patients scanned earlier (p < 0.001). Both uHG >4.7 mL/h (p = 0.002) and the CTA spot sign (p = 0.030) showed effects on rate of hematoma expansion but not its interaction (2-way analysis of variance, p = 0.477). uHG >4.7 mL/h improved the sensitivity of the spot sign in the prediction of significant hematoma expansion (73.9% vs 46.4%), early neurologic deterioration (67.6% vs 35.3%), 90-day mortality (81.6% vs 44.9%), and poor outcome (72.8% vs 29.8%), respectively. uHG was independently related to significant hematoma expansion (odds ratio 1.06, 95% confidence interval 1.03–1.10) and clinical outcomes. Conclusions: uHG is a useful predictor of hematoma expansion and poor clinical outcomes in patients with acute ICH. The combination of high uHG and the spot sign is associated with a higher rate of hematoma expansion, highlighting the need for very fast treatment in ICH patients. PMID:27343067

A Systematic Review of Outcomes and Complications of Treating Unstable Distal Radius Fractures in the Elderly

PubMed Central

Diaz-Garcia, Rafael J.; Oda, Takashi; Shauver, Melissa J.; Chung, Kevin C.

2011-01-01

Purpose As the population in developed countries continues to age, the incidence of osteoporotic distal radius fractures (DRFs) will increase as well. Treatment of DRF in the elderly population is controversial. We systematically reviewed the existing literature for the management of DRFs in patients 60 and over with five common techniques: volar locking plate system (VLPS), non-bridging external fixation (non-BrEF), bridging external fixation (BrEF), percutaneous Kirschner-wire fixation (PKF), and cast immobilization (CI). Methods Articles retrieved from MEDLINE, Embase and CINAHL Plus that met predetermined inclusion and exclusion criteria were reviewed in two literature reviews. Outcomes of interest included wrist arc of motion, grip strength, functional outcome measurements, radiographic parameters, and the number and type of complications. The data were statistically analyzed using weighted means and proportions based on the sample size in each study. Results 2,039 papers were identified, and 21 papers fitting the inclusion criteria were selected in the primary review of articles with mean patient age of 60 and over. Statistically significant differences were detected for wrist arc of motion, grip strength, and DASH score, although these findings may not be clinically meaningful. Volar tilt and ulnar variance revealed significant differences amongst the groups, with CI resulting in the worst radiographic outcomes. The complications were significantly different, with CI having the lowest rate of complications, whereas VLPS had significantly more major complications requiring additional surgical intervention. Conclusions This systematic review suggests that despite worse radiographic outcomes associated with CI, functional outcomes were no different than surgically treated groups for patients 60 and over. Prospective comparative outcomes studies are necessary to evaluate the rate of functional recovery, cost, and outcomes associated with these 5 treatment methods. Level of Evidence Therapeutic, Level III PMID:21527140

Neuroendocrine Merkel cell nodal carcinoma of unknown primary site: management and outcomes of a rare entity.

PubMed

Kotteas, E A; Pavlidis, N

2015-04-01

Merkel cell nodal carcinoma of unknown primary (MCCUP) is a rare neuroendocrine tumour with distinct clinical and biological behaviour. We conducted a review of retrospective data extracted from 90 patients focusing on the management and outcome of this disease. We also compared life expectancy of these patients with the outcome of patients with known Merkel primaries and with neuroendocrine cancers of unidentifiable primary. There is a limited body of data for this type of malignancy, however, patients with Merkel cell nodal carcinoma of unknown primary site, seem to have better survival when treated aggressively than patients with cutaneous Merkel tumours of the same stage and equal survival with patients with low-grade neuroendocrine tumour of unknown origin. The lack of prospective trials, and the inadequate data, hamper the management of these tumours. Establishment of treatment guidelines is urgently needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Short-Term Outcomes of Simultaneous Laparoscopic Colectomy and Hepatectomy for Primary Colorectal Cancer With Synchronous Liver Metastases

PubMed Central

Inoue, Akira; Uemura, Mamoru; Yamamoto, Hirofumi; Hiraki, Masayuki; Naito, Atsushi; Ogino, Takayuki; Nonaka, Ryoji; Nishimura, Junichi; Wada, Hiroshi; Hata, Taishi; Takemasa, Ichiro; Eguchi, Hidetoshi; Mizushima, Tsunekazu; Nagano, Hiroaki; Doki, Yuichiro; Mori, Masaki

2014-01-01

Although simultaneous resection of primary colorectal cancer and synchronous liver metastases is reported to be safe and effective, the feasibility of a laparoscopic approach remains controversial. This study evaluated the safety, feasibility, and short-term outcomes of simultaneous laparoscopic surgery for primary colorectal cancer with synchronous liver metastases. From September 2008 to December 2013, 10 patients underwent simultaneous laparoscopic resection of primary colorectal cancer and synchronous liver metastases with curative intent at our institute. The median operative time was 452 minutes, and the median estimated blood loss was 245 mL. Median times to discharge from the hospital and adjuvant chemotherapy were 13.5 and 44 postoperative days, respectively. Negative resection margins were achieved in all cases, with no postoperative mortality or major morbidity. Simultaneous laparoscopic colectomy and hepatectomy for primary colorectal cancer with synchronous liver metastases appears feasible with low morbidity and favorable outcomes. PMID:25058762

Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis.

PubMed

Falk Delgado, Alberto; Falk Delgado, Anna

2017-08-23

Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associated with outcome switching. PubMed and Embase were searched for pharmaceutical randomized controlled trials (RCTs) in oncology reporting on a surrogate primary outcome published in 2015. Outcome switching was present in 18% (39/216). First-author male sex was significantly more likely associated with outcome switching compared to female sex with an OR of 3.05 (95% CI 1.07-8.64, p = 0.04) after multivariable adjustment. For-profit funded RCTs were less likely associated with outcome switching compared to non-profit funded research with an OR of 0.22 (95% CI 0.07-0.74, p = 0.01). First author male sex was more likely associated with outcome switching compared to female sex in drug oncology RCTs reporting on a primary surrogate endpoint. For-profit funded research was less likely associated with outcome switching compared to research funded by non-profit organizations. Furthermore, 18 percent of drug oncology trials reporting on a surrogate endpoint could have a higher risk of false positive results due to primary outcome switching.

Systematic reviews of therapeutic interventions frequently consider patient-important outcomes.

PubMed

Ameur, Hayet; Ravaud, Philippe; Fayard, Florence; Riveros, Carolina; Dechartres, Agnes

2017-04-01

To determine whether recently published and ongoing systematic reviews of therapeutic interventions assess patient-important outcomes. For this methodological review, we searched MEDLINE via PubMed for recently published systematic reviews and online registry of systematic reviews (PROSPERO) for ongoing systematic reviews. We selected systematic reviews with meta-analyses of randomized controlled trials. We extracted all outcomes defined in the methods section and categorized them. Mortality, other clinical events, pain, quality of life, function, and therapeutic decisions were considered patient-important outcomes. We included 420 systematic reviews: 90 Cochrane reviews, 200 other published reviews, and 130 registered ongoing reviews. Primary outcomes were defined in 85 Cochrane reviews (95%), 98 (49%) other published reviews and all ongoing reviews. At least one patient-important outcome was defined as a primary outcome in 81/85 Cochrane reviews (95%), 78/98 other published reviews (80%), and 117/130 ongoing reviews (90%). Considering all outcomes assessed, at least one patient-important outcome was evaluated in 90/90 Cochrane reviews (100%), 189/200 other published reviews (95%), and 121/130 ongoing reviews (93%). Most recent systematic reviews aim to assess patient-important outcomes, which contrasts with RCTs. These results suggest some important gaps between primary and secondary research. Copyright © 2017 Elsevier Inc. All rights reserved.

Direct observation of weight-related communication in primary care: a systematic review.

PubMed

McHale, Calum T; Laidlaw, Anita H; Cecil, Joanne E

2016-08-01

Primary care is ideally placed to play an effective role in patient weight management; however, patient weight is seldom discussed in this context. A synthesis of studies that directly observe weight discussion in primary care is required to more comprehensively understand and improve primary care weight-related communication. To systematically identify and examine primary care observational research that investigates weight-related communication and its relationship to patient weight outcomes. A systematic review of literature published up to August 2015, using seven electronic databases (including MEDLINE, Scopus and PsycINFO), was conducted using search terms such as overweight, obese and/or doctor-patient communication. Twenty papers were included in the final review. Communication analysis focused predominantly on 'practitioner' use of specific patient-centred communication. Practitioner use of motivational interviewing was associated with improved patient weight-related outcomes, including patient weight loss and increased patient readiness to lose weight; however, few studies measured patient weight-related outcomes. Studies directly observing weight-related communication in primary care are scarce and limited by a lack of focus on patient communication and patient weight-related outcomes. Future research should measure practitioner and patient communications during weight discussion and their impact on patient weight-related outcomes. This knowledge may inform the development of a communication intervention to assist practitioners to more effectively discuss weight with their overweight and/or obese patients. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Preoperative physiotherapy and short-term functional outcomes of primary total knee arthroplasty.

PubMed

Mat Eil Ismail, Mohd Shukry; Sharifudin, Mohd Ariff; Shokri, Amran Ahmed; Ab Rahman, Shaifuzain

2016-03-01

Physiotherapy is an important part of rehabilitation following arthroplasty, but the impact of preoperative physiotherapy on functional outcomes is still being studied. This randomised controlled trial evaluated the effect of preoperative physiotherapy on the short-term functional outcomes of primary total knee arthroplasty (TKA). 50 patients with primary knee osteoarthritis who underwent unilateral primary TKA were randomised into two groups: the physiotherapy group (n = 24), whose patients performed physical exercises for six weeks immediately prior to surgery, and the nonphysiotherapy group (n = 26). All patients went through a similar physiotherapy regime in the postoperative rehabilitation period. Functional outcome assessment using the algofunctional Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and range of motion (ROM) evaluation was performed preoperatively, and postoperatively at six weeks and three months. Both groups showed a significant difference in all algofunctional KOOS subscales (p < 0.001). The mean score difference at six weeks and three months was not significant in the sports and recreational activities subscale for both groups (p > 0.05). Significant differences were observed in the time-versus-treatment analysis between groups for the symptoms (p = 0.003) and activities of daily living (p = 0.025) subscales. No significant difference in ROM was found when comparing preoperative measurements and those at three months following surgery, as well as in time-versus-treatment analysis (p = 0.928). Six-week preoperative physiotherapy showed no significant impact on short-term functional outcomes (KOOS subscales) and ROM of the knee following primary TKA. Copyright: © Singapore Medical Association.

PubMed Central

SARTINI, M.; PANATTO, D.; PERDELLI, F.; CRISTINA, M.L.

2013-01-01

Summary An experimental study was conducted in a hospital in Liguria (northern Italy) on two groups of patients with the same disease severity who were undergoing the same type of surgery (primary hemiarthroplasty). Our aim was to assessing the results of a quality- improvement scheme implemented in the operating room. The quality-improvement protocol involved analyzing a set of parameters concerning the operating team's behavior and environmental conditions that could be attributed to the operating team itself. A program of training and sanitary education was carried to rectify any improper behavior of the operating staff. Two hundred and six hip-joint replacement operations (primary hip hemiarthroplasty - ICD9-CM 81.51) all conducted in the same operating room were studied: 103 patients, i.e. operations performed before the quality-improvement scheme and 103 patients, i.e. operations performed after the quality improvement scheme; all were comparable in terms of type of surgery and severity. The scheme resulted in an improvement in both behavioral and environmental parameters and an 80% reduction in the level of microbial air contamination (p < 0.001). Patient outcomes improved in terms of average postoperative hospitalization time, the occurrence and duration of fever (>37.5°C) and microbiological contamination of surgical wounds. From an economic point of view, facility efficiency increased by 28.57%, average hospitalization time decreased (p<0.001) and a theoretical increase of € 1,441,373.58 a year in revenues was achieved. PMID:24396985

Saline suppression test parameters may predict bilateral subtypes of primary aldosteronism.

PubMed

Hashimura, Hikaru; Shen, Jimmy; Fuller, Peter J; Chee, Nicholas Y N; Doery, James C G; Chong, Winston; Choy, Kay Weng; Gwini, Stella May; Yang, Jun

2018-06-06

The saline suppression test (SST) serves to confirm the diagnosis of primary aldosteronism (PA) while adrenal vein sampling (AVS) is used to determine whether the aldosterone hypersecretion is unilateral or bilateral. An accurate prediction of bilateral PA based on SST results could reduce the need for AVS. We sought to identify SST parameters that reliably predict bilateral PA. The results from 121 patients undergoing SSTs at Monash Health from January 2010 to January 2018 including screening blood tests, imaging, AVS and histopathology results were evaluated. Patients were subtyped into unilateral or bilateral PA based on AVS and surgical outcomes. Of 113 patients with confirmed PA, 33 had unilateral disease while 42 had bilateral disease. In those with bilateral disease, plasma aldosterone concentration (PAC) was significantly lower post-SST, together with a significant fall in the aldosterone-renin ratio (ARR). The combination of PAC <300 pmol/L and a reduction in ARR post-SST provided 96.8% specificity in predicting bilateral disease. Eighteen out of 39 patients (49%) with bilateral PA could have avoided AVS using these criteria. A combination of PAC <300 pmol/L and a lower ARR post-SST could reliably predict bilateral PA. An independent cohort will be needed to validate these findings. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Patients with Revision Modern Megaprostheses of the Distal Femur Have Improved Disease-Specific and Health-Related Outcomes Compared to Those with Primary Replacements.

PubMed

Heyberger, Clémence; Auberger, Guillaume; Babinet, Antoine; Anract, Philippe; Biau, David J

2017-12-21

We asked whether there would be any difference between primary and revision modern cemented fixed hinge megaprosthesis of the distal femur in function and activity-related outcomes following treatment of a bone tumor. An identical custom-made fixed hinge cemented megaprosthesis with a hydroxyapatite collar was used in all cases. The main outcomes were joint-specific function, disease-specific activity, and health-related quality of life. Implant survival was also evaluated. Patients in the revision group performed slightly better than patients in the primary group on disease-specific (Toronto Extremity Salvage Score, p  = 0.033; Musculoskeletal Tumor Society, p  = 0.072) and health-related outcomes (Short Form 36 [SF-36] physical component, p  = 0.085; SF-36 mental component, p  = 0.069) but not on joint-specific outcomes (Knee Society Score, p  = 0.94). The cumulative probabilities of revision for any reason were 14.5% (7-25%) at 5 years with no statistically significant difference between primary and revision procedures ( p  = 0.77). In conclusion, patients undergoing a revision have similar joint-specific functional outcome but improved disease-specific and health-related outcomes. Implant survival are similar between groups. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Similar Superior Patient-Reported Outcome Measures for Anterior and Posterolateral Approaches After Total Hip Arthroplasty: Postoperative Patient-Reported Outcome Measure Improvement After 3 months in 12,774 Primary Total Hip Arthroplasties Using the Anterior, Anterolateral, Straight Lateral, or Posterolateral Approach.

PubMed

Peters, Rinne M; van Beers, Loes W A H; van Steenbergen, Liza N; Wolkenfelt, Julius; Ettema, Harmen B; Ten Have, Bas L E F; Rijk, Paul C; Stevens, Martin; Bulstra, Sjoerd K; Poolman, Rudolf W; Zijlstra, Wierd P

2018-06-01

Patient-reported outcome measures (PROMs) are used to evaluate the outcome of total hip arthroplasty (THA). We determined the effect of surgical approach on PROMs after primary THA. All primary THAs, with registered preoperative and 3 months postoperative PROMs were selected from the Dutch Arthroplasty Register. Based on surgical approach, 4 groups were discerned: (direct) anterior, anterolateral, direct lateral, and posterolateral approaches. The following PROMs were recorded: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS); Oxford Hip Score; EQ-5D index score; EQ-5D thermometer; and Numeric Rating Scale measuring pain, both active and in rest. The difference between preoperative and postoperative scores was calculated (delta-PROM) and used as primary outcome measure. Multivariable linear regression analysis was performed for comparisons. Cohen's d was calculated as measure of effect size. All examined 4 approaches resulted in a significant increase of PROMs after primary THA in the Netherlands (n = 12,274). The anterior and posterolateral approaches were associated with significantly more improvement in HOOS-PS scores compared with the anterolateral and direct lateral approaches. Furthermore, the posterolateral and anterior approaches showed greater improvement on Numeric Rating Scale pain scores compared with the anterolateral approach. No relevant differences in delta-PROM were seen between the anterior and posterolateral surgical approaches. Anterior and posterolateral surgical approaches showed more improvement in self-reported physical functioning (HOOS-PS) compared with anterolateral and direct lateral approaches in patients receiving a primary THA. However, clinical differences were only small. Copyright © 2018 Elsevier Inc. All rights reserved.

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Considering disparities: How do nurse practitioner regulatory policies, access to care, and health outcomes vary across four states?

PubMed

Sonenberg, Andréa; Knepper, Hillary J

Health disparities persist among morbidity and mortality rates in the United States. Contributing significantly to these disparities are the ability to pay for health care (largely, access to health insurance) and access to, and capacity of, the primary care health workforce. This article examines key determinants of health (DOH) including demographics, public and regulatory policies, health workforce capacity, and primary health outcomes of four states of the United States. The context of this study is the potential association among health care disparities and myriad DOH, among them, the restrictive nurse practitioner (NP) scope of practice (SOP) regulatory environment, which are documented to influence access to care and health outcomes. This descriptive study explores current NP SOP regulations, access to primary care, and health outcomes of key chronic disease indicators-diabetes, hypertension, and obesity in Alabama, Colorado, Mississippi, and Utah. These states represent both the greatest disparity in chronic disease health outcomes (obesity, diabetes, and hypertension) and the greatest difference in modernization of their NP SOP laws. The Affordable Care Act has greatly expanded access to health care. However, it is estimated that 23 million Americans, 7% of its total population, will remain uninsured by 2019. Restrictive and inconsistent NP SOP policies may continue to contribute to health workforce capacity and population health disparities across the country, with particular concern for primary care indicators. The study findings bring into question whether states with more restrictive NP SOP regulations impact access to primary care, which may in turn influence population health outcomes. These findings suggest the need for further research. NPs are essential for meeting the increasing demands of primary care in the United States, and quality-of-care indicator research supports their use. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial.

PubMed

Muin, Dana A; Wolzt, Michael; Marculescu, Rodrig; Sheikh Rezaei, Safoura; Salama, Mohamed; Fuchs, Carola; Luger, Anton; Bragagna, Elia; Litschauer, Brigitte; Bayerle-Eder, Michaela

2015-09-01

To assess the effect of on-demand intranasal oxytocin administration on female sexual function and activity. Randomized, prospective, double-blind, placebo-controlled, crossover trial with duration of 22 weeks. Academic medical center. Thirty pre-and postmenopausal women with sexual dysfunction. Over 8 weeks, intranasal oxytocin (32 IU) or placebo self-administered by women within 50 minutes before sexual intercourse; after a washout period of 2 weeks, crossover with patients switched to the alternate group for another 8 weeks. Primary outcome parameter: Female Sexual Function Index (FSFI); secondary outcome parameters: Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Interest and Desire Inventory-Female (SIDI-F), and Hamilton depression scale (HDS). After oxytocin and placebo, the FSFI score increased by 26% and 31%, SQOL-F score by 144% and 125%, and SIDI-F score by 29% and 23%, respectively (repeated measures analysis of variance between groups). After oxytocin and placebo, the FSDS score decreased by 36% and 45%, respectively (repeated measures analysis of variance between groups). There was no statistically significant treatment, sequence (placebo first/second), or interaction effect. Long-term intranasal oxytocin and placebo administration both improved sexual function and symptoms of depression in women over time with no treatment, sequence (placebo first/second), or interaction effect. NCT02229721. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Ketogenic Diet in Refractory Childhood Epilepsy

PubMed Central

Weijenberg, Amerins; van Rijn, Margreet; de Koning, Tom J.; Brouwer, Oebele F.

2018-01-01

Background: Ketogenic diet in children with epilepsy has a considerable impact on daily life and is usually adopted for at least 3 months. Our aim was to evaluate whether the introduction of an all-liquid ketogenic diet in an outpatient setting is feasible, and if an earlier assessment of its efficacy can be achieved. Methods: The authors conducted a prospective, observational study in a consecutive group of children with refractory epilepsy aged 2 to 14 years indicated for ketogenic diet. Ketogenic diet was started as an all-liquid formulation of the classical ketogenic diet, KetoCal 4:1 LQ, taken orally or by tube. After 6 weeks, the liquid diet was converted into solid meals. The primary outcome parameter was time-to-response (>50% seizure reduction). Secondary outcome parameters were time to achieve stable ketosis, the number of children showing a positive response, and the retention rate at 26 weeks. Results: Sixteen children were included. Four of them responded well with respect to seizure frequency, the median time-to-response was 14 days (range 7-28 days). The mean time to achieve stable ketosis was 7 days. The retention rate at 26 weeks was 50%. Of the 8 children who started this protocol orally fed, 6 completed it without requiring a nasogastric tube. Conclusions: Introduction of ketogenic diet with a liquid formulation can be accomplished in orally fed children without major complications. It allowed for fast and stable ketosis. PMID:29872664

The role of the paravertebral muscles in adolescent idiopathic scoliosis evaluated by temporary paralysis.

PubMed

Wong, Christian; Gosvig, Kasper; Sonne-Holm, Stig

2017-01-01

Muscle imbalance has been suggested as implicated in the pathology of adolescent idiopathic scoliosis (AIS). The specific "pathomechanic" role of the paravertebral muscles as being scoliogenic (inducing scoliosis) or counteracting scoliosis in the initial development and maintenance of this spinal deformity has yet to be clarified in humans. In the present study, we investigated the radiographic changes of temporal paralysis using botulinum toxin A as localized injection therapy (ITB) in the psoas major muscle in AIS patients. Nine patients with AIS were injected one time with ITB using ultrasonic and EMG guidance in the selected spine muscles. Radiographic and clinical examinations were performed before and 6 weeks after the injection. Primary outcome parameters of radiological changes were analyzed using Wilcoxon signed-rank test and binomial test, and secondary outcome parameters of short- and long-term clinical effects were obtained. Significant radiological corrective changes were seen in the frontal plane in the thoracic and lumbar spine as well as significant derotational corrective change in the lumbar spine according to Cobb's angle measurements and to Nash and Moe's classification, respectively. No serious adverse events were detected at follow-up. In conclusion, this study demonstrated that the psoas major muscle do play a role into the pathology in adolescent idiopathic scoliosis by maintaining the curvature of the lumbar spine and thoracic spine. EudraCT number 2008-004584-19.

Triiodothyronine Administration in a Model of Septic Shock: A Randomized Blinded Placebo-Controlled Trial.

PubMed

Maiden, Matthew J; Chapman, Marianne J; Torpy, David J; Kuchel, Timothy R; Clarke, Iain J; Nash, Coralie H; Fraser, Jonathan D; Ludbrook, Guy L

2016-06-01

Triiodothyronine concentration in plasma decreases during septic shock and may contribute to multiple organ dysfunction. We sought to determine the safety and efficacy of administering triiodothyronine, with and without hydrocortisone, in a model of septic shock. Randomized blinded placebo-controlled trial. Preclinical research laboratory. Thirty-two sheep rendered septic with IV Escherichia coli and receiving protocol-guided sedation, ventilation, IV fluids, and norepinephrine infusion. Two hours following induction of sepsis, 32 sheep received a 24-hour IV infusion of 1) placebo + placebo, 2) triiodothyronine + placebo, 3) hydrocortisone + placebo, or 4) triiodothyronine + hydrocortisone. Primary outcome was the total amount of norepinephrine required to maintain a target mean arterial pressure; secondary outcomes included hemodynamic and metabolic indices. Plasma triiodothyronine levels increased to supraphysiological concentrations with hormonal therapy. Following 24 hours of study drug infusion, the amount of norepinephrine required was no different between the study groups (mean ± SD μg/kg; placebo + placebo group 208 ± 392; triiodothyronine + placebo group 501 ± 370; hydrocortisone + placebo group 167 ± 286; triiodothyronine + hydrocortisone group 466 ± 495; p = 0.20). There was no significant treatment effect on any hemodynamic variable, metabolic parameter, or measure of organ function. A 24-hour infusion of triiodothyronine, with or without hydrocortisone, in an ovine model of septic shock did not markedly alter norepinephrine requirement or any other physiological parameter.

Sputum purulence-guided antibiotic use in hospitalised patients with exacerbations of COPD.

PubMed

Soler, Néstor; Esperatti, Mariano; Ewig, Santiago; Huerta, Arturo; Agustí, Carlos; Torres, Antoni

2012-12-01

In patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) needing hospitalisation, sputum purulence is associated with bacteria in the lower respiratory tract. We performed a prospective non-randomised interventional pilot study applying a sputum purulence-guided strategy of antibiotic treatment and investigating the relationship between sputum purulence and biomarkers. In hospitalised patients with acute exacerbation of COPD antibiotics were restricted to those with purulent sputum. The primary end-point was rate of therapeutic failure during hospitalisation. Secondary end-points were parameters reflecting short- and long-term outcomes. We included 73 patients, 34 with non-purulent sputum. No differences were observed on therapeutic failure criteria (9% non-purulent versus 10% purulent (p=0.51)). Serum C-reactive protein (CRP) was significantly increased in the purulent group at admission (11.6 versus 5.3, p=0.006) and at day 3 (2.7 versus 1.2, p=0.01). Serum procalcitonin (PCT) was similar between the groups. No differences were found in short-term outcomes. The exacerbation rate at 180 days was higher in the purulent group. These results support the hypothesis of performing a randomised trial using a sputum purulence-guided antibiotic treatment strategy in patients with acute exacerbations of COPD. CRP, but not PCT, may be a useful parameter to increase confidence of the absence of bacterial bronchial infection.

Does the primary site of colorectal cancer impact outcomes for patients with metastatic disease?

PubMed

Price, Timothy J; Beeke, Carol; Ullah, Shahid; Padbury, Robert; Maddern, Guy; Roder, David; Townsend, Amanda R; Moore, James; Roy, Amitesh; Tomita, Yoko; Karapetis, Christos

2015-03-15

Previous reports have described differences in biology and outcome for colorectal cancer based on whether the primary is right or left sided. Further division by right, left, and rectum or even exact primary site has also been explored. Possible differences in response to biological agents have also been reported based on side of primary lesion. We explored the South Australian registry for metastatic colorectal cancer to assess if there were any differences in patient characteristics, prognostic markers, and treatment received and outcomes based on whether the primary was right or left sided. We also explored if differences exist based on left colon and rectum and by exact primary site. Two thousand nine hundred seventy-two patients were analyzed. Thirty-five percent had a right-sided primary. The median overall survival for the entire group right versus left was 9.6 versus 20.3 months (P < .001). Multivariate analysis confirmed side of primary as an independent prognostic factor. For the group that had active therapy, defined as chemotherapy (± metastasis resection), median overall survival was right, 18.2 months; and left, 29.4 months (P < .001). Importantly, we found no suggestion of major differences if left side was divided by left colon and rectum, and trends by individual site still supported a left and right division. Patients with a right-sided primary have more negative prognostic factors and indeed have inferior outcomes compared with those with a left-sided primary. Our data with further breakdown by exact site still favor a simple left-versus-right division moving forward for metastatic colorectal cancer. © 2014 American Cancer Society.

The assessment of dentofacial esthetics in restorative dentistry: a review of the literature.

PubMed

Frese, Cornelia; Staehle, Hans Joerg; Wolff, Diana

2012-05-01

The authors conducted a literature review to determine how dentofacial esthetics can be evaluated in restorative dentistry and which quantifiable clinical parameters can be used for this assessment of dentofacial esthetics. The authors selected 35 studies that focused on assessment strategies for dental professionals. The primary inclusion criteria were intraoral and extraoral esthetic assessment methods and indexes or rating scales evaluating esthetics in restorative dentistry. The studies' protocols and assessment methods were heterogeneous. The authors grouped the studies into six categories according to topic: golden proportion, soft-tissue measurement, smile and smile line assessment, orofacial indexes and scales, incisor proportion and angulation, and facial esthetics. These categories included various esthetic parameters, including the smile line, lip line, incisal offset, location of dental and facial midline, incisor angulations and width to height ratios of the maxillary anterior teeth, gingival contour, and root coverage and papilla height. These parameters should be considered when providing dental treatment in the anterior area, as they allow for quantification and objective judgment. The findings of this review might increase interest in a comprehensive dental esthetic index that allows for objective quantification and intrastudy and interstudy comparison of dental treatment outcomes.

Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.

PubMed

Saini, Pooja; Loke, Yoon K; Gamble, Carrol; Altman, Douglas G; Williamson, Paula R; Kirkham, Jamie J

2014-11-21

To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. Cohort study of systematic reviews from two databases. Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events. 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort). A 13 point classification system for missing outcome data on harm was developed and applied to the studies. 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393). The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews. © Saini et al 2014.

Does Previous Hip Surgery Effect the Outcome of Tönnis Triple Periacetabular Osteotomy? Mid-Term Results.

PubMed

Konya, Mehmet Nuri; Aydn, Bahattin Kerem; Yldrm, Timur; Sofu, Hakan; Gürsu, Sarper

2016-03-01

Hip dysplasia (HD) is 1 of the major reasons of coxarthrosis. The goal of the treatment of HD by Tönnis triple pelvic osteotomy (TPAO) is to improve the function of hip joint while relieving pain, delaying and possibly preventing end-stage arthritis. The aim of this study is to compare the clinical and radiological results of TPAO to determine if previous surgery has a negative effect on TPAO.Patients operated with TPAO between 2005 and 2010, included in this study. Patients divided into 2 groups: primary acetabular dysplasia (PAD) and residual acetabular dysplasia (RAD). Prepostoperatively, hip range of motion, Harris hip score (HHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) hip score, visual analog scores (VAS), impingement tests, and also the presence of Trendelenburg sign (TS) were investigated for clinical evaluation. For radiological analysis pre-postoperative, anterior-posterior (AP) pelvis and faux profile radiographs were used. Acetabular index, lateral center edge (LCE) angle, and Sharp angles were measured by AP pelvis; anterior center edge (ACE) angle were measured by faux profile radiography. All the clinical and radiological data of the groups were analyzed separately for the pre-postoperative scores also the amount of improvement in all parameters were analyzed.SPSS20 (SPSS Inc., Chicago, IL) was used for statistical analysis. Wilcoxon test, McNemar test, paired t tests, and Mann-Whitney U tests were used to compare the groups. P < 0.05 were defined as statistically significant.Study included 27 patients: 17 patients were in PAD and 10 patients were in RAD. The mean follow-up period was 6.2 years (5.2-10.3 years). In all patients, the radiological and the clinical outcomes were better after TPAO except the flexion of the hip parameter. When the patient groups were evaluated as pre-postoperatively, more statistically significant parameters were found in the PAD group when compared with RAD group. Extension, impingement, TS, VAS, HHS, WOMAC score parameters in clinical outcome and LCE, ACE, Sharp angle, coverage ratio in radiological results were significantly better in PAD group postoperatively but in RAD group; only extension, VAS, HHS, and WOMAC parameters were clinically and LCE and Coverage ratio were significantly different compared with the preoperative measurements. The change of the parameters that used for the evaluation of clinical and radiological results did not show a significant difference between groups.Our data suggest that TPAO can be performed on patients with HD for both groups. Although there were fewer parameters which changed significantly after TPAO in RAD patients; the improvement of radiological and clinical results was similar for groups. Further long-term follow-up studies with large number of patients are needed to determine the proper results of TPAO.

Evolution of target organ damage and haemodynamic parameters over 4 years in patients with increased insulin resistance: the LOD-DIABETES prospective observational study

PubMed Central

Gómez-Marcos, Manuel Ángel; Recio-Rodríguez, José Ignacio; Patino-Alonso, María Carmen; Agudo-Conde, Cristina; Rodríguez-Sanchez, Emiliano; Maderuelo-Fernandez, Jose Angel; Gómez-Sánchez, Leticia; Gomez-Sanchez, Marta; García-Ortiz, Luís

2016-01-01

Objectives We prospectively examined the impact of type 2 diabetes compared with metabolic syndrome (MetS) on the development of vascular disease over 4 years as determined by anatomic and functional markers of vascular disease. By comparing the vascular outcomes of the 2 disorders, we seek to determine the independent effect of elevated glucose levels on vascular disease. Setting 2 primary care centres in Salamanca, Spain. Participants We performed a prospective observational study involving 112 patients (68 with type 2 diabetes and 44 with MetS) who were followed for 4 years. Primary and secondary outcome measures Measurements included blood pressure, blood glucose, lipids, smoking, body mass index, waist circumference, Homeostasis Model Assessment Insulin Resistance (HOMA-IR), hs-c-reactive protein and fibrinogen levels. We also evaluated vascular, carotid intima media thickness (IMT), pulse wave velocity (PWV) and ankle/brachial index, heart and renal target organ damage (TOD). The haemodynamic parameters were central (CAIx) and peripheral (PAIx) augmentation indices. Results In year 4, participants with type 2 diabetes had increased IMT thickness. These patients had more plaques and an IMT>0.90 mm. In participants with MetS, we only found an increase in the number of plaques. We found no changes in PWV, CAIx and PAIx. The patients with diabetes had a greater frequency of vascular TOD. There were no differences neither in renal nor cardiac percentage of TOD in the patients with MetS or diabetes mellitus type 2. Conclusions This prospective study showed that the evolution of vascular TOD is different in participants with type 2 diabetes compared with those with MetS. While IMT and PWV increased in type 2 diabetes, these were not modified in MetS. The renal and cardiac TOD evolution, as well as the PAIx and CAIx, did not change in either group. Trial registration number NCT01065155; Results. PMID:27251684

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990-2011.

PubMed

Bikdeli, Behnood; Punnanithinont, Natdanai; Akram, Yasir; Lee, Ike; Desai, Nihar R; Ross, Joseph S; Krumholz, Harlan M

2017-03-21

Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes. We identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine , Lancet , and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high-impact journals. Although cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high-profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Laser-assisted in situ keratomileusis with optimized, fast-repetition, and cyclotorsion control excimer laser to treat hyperopic astigmatism with high cylinder.

PubMed

Alió Del Barrio, Jorge L; Tiveron, Mauro; Plaza-Puche, Ana B; Amesty, María A; Casanova, Laura; García, María J; Alió, Jorge L

2017-10-18

To evaluate the visual outcomes after femtosecond laser-assisted laser in situ keratomileusis (LASIK) surgery to correct primary compound hyperopic astigmatism with high cylinder using a fast repetition rate excimer laser platform with optimized aspheric profiles and cyclotorsion control. Eyes with primary simple or compound hyperopic astigmatism and a cylinder power ≥3.00 D had uneventful femtosecond laser-assisted LASIK with a fast repetition rate excimer laser ablation, aspheric profiles, and cyclotorsion control. Visual, refractive, and aberrometric results were evaluated at the 3- and 6-month follow-up. The astigmatic outcome was evaluated using the Alpins method and ASSORT software. This study enrolled 80 eyes at 3 months and 50 eyes at 6 months. The significant reduction in refractive sphere and cylinder 3 and 6 months postoperatively (p<0.01) was associated with an improved uncorrected distance visual acuity (p<0.01). A total of 23.75% required retreatment 3 months after surgery. Efficacy and safety indices at 6 months were 0.90 and 1.00, respectively. At 6 months, 80% of eyes had an SE within ±0.50 D and 96% within ±1.00 D. No significant differences were detected between the third and the sixth postoperative months in refractive parameters. A significant increase in the spherical aberration was detected, but not in coma. The correction index was 0.94 at 3 months. Laser in situ keratomileusis for primary compound hyperopic astigmatism with high cylinder (>3.00 D) using the latest excimer platforms with cyclotorsion control, fast repetition rate, and optimized aspheric profiles is safe, moderately effective, and predictable.

An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project

PubMed Central

Walton, David M; Carroll, Linda J; Kasch, Helge; Sterling, Michele; Verhagen, Arianne P; MacDermid, Joy C; Gross, Anita; Santaguida, P. Lina; Carlesso, Lisa

2013-01-01

Given the challenges of chronic musculoskeletal pain and disability, establishing a clear prognosis in the acute stage has become increasingly recognized as a valuable approach to mitigate chronic problems. Neck pain represents a condition that is common, potentially disabling, and has a high rate of transition to chronic or persistent problems. As a field of research, prognosis in neck pain has stimulated several empirical primary research papers, and a number of systematic reviews. As part of the International Consensus on Neck (ICON) project, we sought to establish the general state of knowledge in the area through a structured, systematic review of systematic reviews (overview). An exhaustive search strategy was created and employed to identify the 13 systematic reviews (SRs) that served as the primary data sources for this overview. A decision algorithm for data synthesis, which incorporated currency of the SR, risk of bias assessment of the SRs using AMSTAR scoring and consistency of findings across SRs, determined the level of confidence in the risk profile of 133 different variables. The results provide high confidence that baseline neck pain intensity and baseline disability have a strong association with outcome, while angular deformities of the neck and parameters of the initiating trauma have no effect on outcome. A vast number of predictors provide low or very low confidence or inconclusive results, suggesting there is still much work to be done in this field. Despite the presence of multiple SR and this overview, there is insufficient evidence to make firm conclusions on many potential prognostic variables. This study demonstrates the challenges in conducting overviews on prognosis where clear synthesis critieria and a lack of specifics of primary data in SR are barriers. PMID:24115971

Cognitive Rehabilitation in Alzheimer's Disease: A Controlled Intervention Trial.

PubMed

Brueggen, Katharina; Kasper, Elisabeth; Ochmann, Sina; Pfaff, Henrike; Webel, Steffi; Schneider, Wolfgang; Teipel, Stefan

2017-01-01

Cognitive Rehabilitation for Alzheimer's disease (AD) is an integrative multimodal intervention. It aims to maintain autonomy and quality of life by enhancing the patients' abilities to compensate for decreased cognitive functioning. We evaluated the feasibility of a group-based Cognitive Rehabilitation approach in mild AD dementia and assessed its effect on activities of daily living (ADL). We included 16 patients with AD dementia in a controlled partial-randomized design. We adapted the manual-guided Cognitive Rehabilitation program (CORDIAL) to a group setting. Over the course of three months, one group received the Cognitive Rehabilitation intervention (n = 8), while the other group received a standardized Cognitive Training as an active control condition (n = 8). ADL-competence was measured as primary outcome. The secondary outcome parameters included cognitive abilities related to daily living, functional cognitive state, and non-cognitive domains, e.g., quality of life. For each scale, we assessed the interaction effect 'intervention by time', i.e., from pre-to post-intervention. We found no significant interaction effect of intervention by time on the primary outcome ADL-competence. The interaction effect was significant for quality of life (Cohen's d: -1.43), showing an increase in the intervention group compared with the control group. Our study demonstrates the feasibility of a group-based Cognitive Rehabilitation program for patients with mild AD dementia. The Cognitive Rehabilitation showed no significant effect on ADL, possibly reflecting a lack of transfer between the therapy setting and real life. However, the group setting enhanced communication skills and coping mechanisms. Effects on ADL may not have reached statistical significance due to a limited sample size. Furthermore, future studies might use an extended duration of the intervention and integrate caregivers to a greater extent to increase transfer to activities of daily living.

Cost-utility analysis of 10- and 13-valent pneumococcal conjugate vaccines: Protection at what price in the Thai context?

PubMed Central

Kulpeng, Wantanee; Leelahavarong, Pattara; Rattanavipapong, Waranya; Sornsrivichai, Vorasith; Baggett, Henry C.; Meeyai, Aronrag; Punpanich, Warunee; Teerawattananon, Yot

2015-01-01

Objective This study aims to evaluate the costs and outcomes of offering the 10-valent pneumococcal conjugate vaccine (PCV10) and 13-valent pneumococcal conjugate vaccine (PCV13) in Thailand compared to the current situation of no PCV vaccination. Methods Two vaccination schedules were considered: two-dose primary series plus a booster dose (2 + 1) and three-dose primary series plus a booster dose (3 + 1). A cost-utility analysis was conducted using a societal perspective. A Markov simulation model was used to estimate the relevant costs and health outcomes for a lifetime horizon. Costs were collected and values were calculated for the year 2010. The results were reported as incremental cost-effectiveness ratios (ICERs) in Thai Baht (THB) per quality adjusted life year (QALY) gained, with future costs and outcomes being discounted at 3% per annum. One-way sensitivity analysis and probabilistic sensitivity analysis using a Monte Carlo simulation were performed to assess parameter uncertainty. Results Under the base case-scenario of 2 + 1 dose schedule and a five-year protection, without indirect vaccine effects, the ICER for PCV10 and PCV13 were THB 1,368,072 and THB 1,490,305 per QALY gained, respectively. With indirect vaccine effects, the ICER of PCV10 was THB 519,399, and for PCV13 was THB 527,378. The model was sensitive to discount rate, the change in duration of vaccine protection and the incidence of pneumonia for all age groups. Conclusions At current prices, PCV10 and PCV13 are not cost-effective in Thailand. Inclusion of indirect vaccine effects substantially reduced the ICERs for both vaccines, but did not result in cost effectiveness. PMID:23588084

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial.

PubMed

Strauss, Clara; Rosten, Claire; Hayward, Mark; Lea, Laura; Forrester, Elizabeth; Jones, Anna-Marie

2015-04-16

Obsessive Compulsive Disorder (OCD) is a distressing and debilitating condition affecting 1-2% of the population. Exposure and response prevention (ERP) is a behaviour therapy for OCD with the strongest evidence for effectiveness of any psychological therapy for the condition. Even so, only about half of people offered ERP show recovery after the therapy. An important reason for ERP failure is that about 25% of people drop out early, and even for those who continue with the therapy, many do not regularly engage in ERP tasks, an essential element of ERP. A mindfulness-based approach has the potential to reduce drop-out from ERP and to improve ERP task engagement with an emphasis on accepting difficult thoughts, feelings and bodily sessions and on becoming more aware of urges, rather than automatically acting on them. This is a pilot randomised controlled trial of mindfulness-based ERP (MB-ERP) with the aim of establishing parameters for a definitive trial. Forty participants diagnosed with OCD will be allocated at random to a 10-session ERP group or to a 10-session MB-ERP group. Primary outcomes are OCD symptom severity and therapy engagement. Secondary outcomes are depressive symptom severity, wellbeing and obsessive-compulsive beliefs. A semi-structured interview with participants will guide understanding of change processes. Findings from this pilot study will inform future research in this area, and if effect sizes on primary outcomes are in favour of MB-ERP in comparison to ERP, funding for a definitive trial will be sought. Current Controlled Trials registration number ISRCTN52684820. Registered on 30 January 2014.

Medial compartment knee osteoarthritis: age-stratified cost-effectiveness of total knee arthroplasty, unicompartmental knee arthroplasty, and high tibial osteotomy.

PubMed

Smith, William B; Steinberg, Joni; Scholtes, Stefan; Mcnamara, Iain R

2017-03-01

To compare the age-based cost-effectiveness of total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), and high tibial osteotomy (HTO) for the treatment of medial compartment knee osteoarthritis (MCOA). A Markov model was used to simulate theoretical cohorts of patients 40, 50, 60, and 70 years of age undergoing primary TKA, UKA, or HTO. Costs and outcomes associated with initial and subsequent interventions were estimated by following these virtual cohorts over a 10-year period. Revision and mortality rates, costs, and functional outcome data were estimated from a systematic review of the literature. Probabilistic analysis was conducted to accommodate these parameters' inherent uncertainty, and both discrete and probabilistic sensitivity analyses were utilized to assess the robustness of the model's outputs to changes in key variables. HTO was most likely to be cost-effective in cohorts under 60, and UKA most likely in those 60 and over. Probabilistic results did not indicate one intervention to be significantly more cost-effective than another. The model was exquisitely sensitive to changes in utility (functional outcome), somewhat sensitive to changes in cost, and least sensitive to changes in 10-year revision risk. HTO may be the most cost-effective option when treating MCOA in younger patients, while UKA may be preferred in older patients. Functional utility is the primary driver of the cost-effectiveness of these interventions. For the clinician, this study supports HTO as a competitive treatment option in young patient populations. It also validates each one of the three interventions considered as potentially optimal, depending heavily on patient preferences and functional utility derived over time.

Effects of Pilates exercises on health-related quality of life in individuals with juvenile idiopathic arthritis.

PubMed

Mendonça, Tânia M; Terreri, Maria T; Silva, Carlos H; Neto, Morun Bernardino; Pinto, Rogério M; Natour, Jamil; Len, Claudio A

2013-11-01

To determine the effects of Pilates exercises on health-related quality of life (HRQOL) in individuals with juvenile idiopathic arthritis (JIA). Randomized, prospective, single-blind trial. Outpatient clinic of pediatric rheumatology and the rehabilitation department. Children (N=50) with JIA according to the International League of Associations for Rheumatology criteria. Participants were randomly assigned into 2 groups. In group I (n=25), the participants were given a conventional exercise program for 6 months. Patients in group II (n=25) participated in a Pilates exercise program for 6 months. The primary outcome measure was HRQOL, as measured by the Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0). The secondary outcome measures provided an estimate of the clinical relevance of the primary outcome results and included joint pain intensity (according to a 10-cm visual analog scale), disability (according to the Childhood Health Assessment Questionnaire), joint status (using the Pediatric Escola Paulista de Medicina Range of Motion Scale), and the total PedsQL 4.0 score. All participants completed the study. The scores of the PedsQL 4.0 differed significantly between groups, indicating that Pilates exercises increased these scores when compared with the conventional exercise program. Group II participants showed significant improvements in the 10-cm visual analog scale-joint pain, Childhood Health Assessment Questionnaire, and Pediatric Escola Paulista de Medicina Range of Motion Scale. The use of Pilates exercises had a positive physical and psychosocial impact on HRQOL in individuals with JIA. Future multicenter studies with a follow-up beyond the period of treatment using more objective parameters will be useful to support the results of the present study. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Overdentures in the edentulous mandible supported by implants and retained by a Dolder bar: a 5-year prospective study.

PubMed

Heschl, Alexander; Payer, Michael; Clar, Volker; Stopper, Marlene; Wegscheider, Walther; Lorenzoni, Martin

2013-08-01

This prospective study was performed to evaluate the outcomes of XiVE® S plus implants (Dentsply Friadent, Mannheim, Germany) following conventional restoration with bar structures and overdentures in the edentulous mandible. A total of 39 patients were treated with four interforaminal implants (n = 156) splinted by a Dolder bar. Overdentures were attached to the bars after 3 months of healing. As primary outcome measures, clinical and radiological parameters were evaluated at the time of implant placement (baseline) and once a year (1, 2, 3, 4, 5 years) after functional loading. Secondary outcome measures included (i) primary stability and surgical complications, as well as (ii) Periotest® (Medizintechnik Gulden, Modautal, Germany) values, implant survival, and prosthetic complications at baseline and follow-up. A total of 156 implants were placed. The vast majority (n = 149) were tightened to >30 Ncm, while torques in the range of 20-30 Ncm were obtained in the remaining cases (n = 7). Mean crestal bone levels around the implants were 0.41 mm at baseline and 1.04/1.20/1.34/1.45/1.44 mm after 1/2/3/4/5 years respectively. The mean values of the plaque, calculus, bleeding, and mucosal indices remained low throughout this period. The reported follow-up periods involved one implant loss after 3 months (survival rate: 99.4%) and one implant failure after 4 years (success rate: 98.4%). Prosthetic complications included factures of bars (n = 3) and denture teeth (n = 7). Prosthetic survival was 100%. Dolder bars to restore oral implants in the edentulous mandible appear to offer a high rate of implant survival, good stability of the peri-implant tissue, and a low rate of prosthetic complications. © 2011 Wiley Periodicals, Inc.

Surgical management and perioperative morbidity of patients with primary borderline ovarian tumor (BOT).

PubMed

Trillsch, Fabian; Ruetzel, Jan David; Herwig, Uwe; Doerste, Ulrike; Woelber, Linn; Grimm, Donata; Choschzick, Matthias; Jaenicke, Fritz; Mahner, Sven

2013-07-09

Surgery is the cornerstone for clinical management of patients with borderline ovarian tumors (BOT). As these patients have an excellent overall prognosis, perioperative morbidity is the critical point for decision making when the treatment strategy is developed and the primary surgical approach is defined. Clinical and surgical parameters of patients undergoing surgery for primary BOT at our institutions between 1993 and 2008 were analyzed with regard to perioperative morbidity depending on the surgical approach (laparotomy vs. laparoscopy). A total of 105 patients were analyzed (44 with primary laparoscopy [42%], 61 with primary laparotomy [58%]). Complete surgical staging was achieved in 33 patients at primary surgical approach (31.4%) frequently leading to formal indication of re-staging procedures. Tumor rupture was significantly more frequent during laparoscopy compared to laparotomy (29.5% vs. 13.1%, p = 0.038) but no other intraoperative complications were seen in laparoscopic surgery in contrast to 7 of 61 laparotomies (0% vs. 11.5%, p = 0.020). Postoperative complication rates were similar in both groups (19.7% vs. 18.2%, p = 0.848). Irrespective of the surgical approach, surgical management of BOT has acceptable rates of perioperative complications and morbidity. Choice of initial surgical approach can therefore be made independent of complication-concerns. As the recently published large retrospective AGO ROBOT study observed similar oncologic outcome for both approaches, laparoscopy can be considered for staging of patients with BOT if this appears feasible. An algorithm for the surgical management of BOT patients has been developed.

Early functional outcome after lateral UKA is sensitive to postoperative lower limb alignment.

PubMed

van der List, J P; Chawla, H; Villa, J C; Zuiderbaan, H A; Pearle, A D

2017-03-01

The predictive role of patient-specific characteristics and radiographic parameters on medial unicompartmental knee arthroplasty (UKA) outcomes is well known, but knowledge of these predictors is lacking in lateral UKA. Therefore, purpose of this study was to assess the predictive role of these parameters on short-term functional outcomes of lateral UKA. In this retrospective cohort study, Western Ontario and McMaster Universities Arthritis Index scores were collected at 2-year follow-up (median 2.2 years, range 2.0-4.0 years) in 39 patients who underwent lateral UKA. Patient-specific characteristics included age, BMI and gender, while radiographic parameters included osteoarthritis severity of all three compartments and both preoperative and postoperative hip-knee-ankle alignment. BMI, gender, age and preoperative valgus alignment were not correlated with functional outcomes, while postoperative valgus alignment was correlated with functional outcomes (0.561; p = 0.001). Postoperative valgus of 3°-7° was correlated with better outcomes than more neutral (-2° to 3° valgus) alignment (96.7 vs. 85.6; p = 0.011). Postoperative alignment was a predictor when corrected for patient-specific characteristics (regression coefficient 4.1; p < 0.001) and radiological parameters (regression coefficient 3.8; p = 0.002). Postoperative valgus alignment of 3°-7° was correlated with the best short-term functional outcomes in lateral UKA surgery, while patient-specific parameters and preoperative alignment were not correlated with functional outcomes. Based on these findings, a surgeon should aim for valgus alignment of 3°-7° when performing lateral UKA surgery for optimal functional outcomes. Prognostic study, Level II.

Enhanced Diagnostic Capability for Glaucoma of 3-Dimensional versus 2-Dimensional Neuroretinal Rim Parameters Using Spectral Domain Optical Coherence Tomography

PubMed Central

Fan, Kenneth Chen; Tsikata, Edem; Khoueir, Ziad; Simavli, Huseyin; Guo, Rong; DeLuna, Regina; Pandit, Sumir; Que, Christian John; de Boer, Johannes F.; Chen, Teresa C.

2017-01-01

Purpose To compare the diagnostic capability of 3-dimensional (3D) neuroretinal rim parameters with existing 2-dimensional (2D) neuroretinal and retinal nerve fiber layer (RNFL) thickness rim parameters using spectral domain optical coherence tomography (SD-OCT) volume scans Materials and Methods Design Institutional prospective pilot study. Study population 65 subjects (35 open angle glaucoma patients, 30 normal patients). Observation procedures One eye of each subject was included. SD-OCT was used to obtain 2D retinal nerve fiber layer (RNFL) thickness values and five neuroretinal rim parameters [i.e. 3D minimum distance band (MDB) thickness, 3D Bruch’s membrane opening-minimum rim width (BMO-MRW), 3D rim volume, 2D rim area, and 2D rim thickness]. Main outcome measures Area under the receiver operating characteristic (AUROC) curve values, sensitivity, specificity. Results Comparing all 3D with all 2D parameters, 3D rim parameters (MDB, BMO-MRW, rim volume) generally had higher AUROC curve values (range 0.770–0.946) compared to 2D parameters (RNFL thickness, rim area, rim thickness; range 0.678–0.911). For global region analyses, all 3D rim parameters (BMO-MRW, rim volume, MDB) were equal to or better than 2D parameters (RNFL thickness, rim area, rim thickness; p-values from 0.023–1.0). Among the three 3D rim parameters (MDB, BMO-MRW, and rim volume), there were no significant differences in diagnostic capability (false discovery rate > 0.05 at 95% specificity). Conclusion 3D neuroretinal rim parameters (MDB, BMO-MRW, and rim volume) demonstrated better diagnostic capability for primary and secondary open angle glaucomas compared to 2D neuroretinal parameters (rim area, rim thickness). Compared to 2D RNFL thickness, 3D neuroretinal rim parameters have the same or better diagnostic capability. PMID:28234677

Pulmonary sporotrichosis: case series and systematic analysis of literature on clinico-radiological patterns and management outcomes.

PubMed

Aung, Ar Kar; Teh, Bing Mei; McGrath, Christopher; Thompson, Philip J

2013-07-01

Pulmonary infections by Sporothrix spp. manifest radiologically as cavitary or non-cavitary disease depending on whether the infection is primary pulmonary or multifocal sporotrichosis. Despite current guidelines, the optimal management for pulmonary sporotrichosis remains unclear. In order to clarify this, we present two cases of pulmonary sporotrichosis, as well as the results of a comprehensive literature review of treatment outcomes based on clinico-radiological presentation patterns of the disease. A literature search of all case reports in English language over the last 50 years (1960-2010) was conducted. Data on patient characteristics, risk factors, clinico-radiological patterns, treatment modalities and outcomes were collected and analyzed. A total of 86 cases were identified, i.e., 64 (74.4%) primary pulmonary and 22 (25.6%) multifocal sporotrichosis. Radiologically, primary pulmonary disease was commonly characterized by cavity formation which was lacking in multifocal infections (P = 0.0001). Immunosuppressant use was more common in multifocal sporotrichosis (P = 0.0001), while hemoptysis was more common in primary pulmonary form (P = 0.01). No other differences in patient characteristics or risk factors were noted. Extra-pulmonary multifocal sporotrichosis most commonly involved skin (81.8%) and joints (45.4%). For patients with cavitary primary pulmonary sporotrichosis, outcomes from medical therapy alone were inferior to surgical intervention (P = 0.02). However, for both primary pulmonary and multifocal sporotrichosis with non-cavitary disease, medical therapy alone provided good outcomes. Only 12 (16.7%) cases were treated with itraconazole. Treatment of pulmonary sporotrichosis should be guided by the clinico-radiological patterns of presentation. Medical therapy alone is likely sufficient for non-cavitary disease while early surgery should be considered for cavitary primary pulmonary sporotrichosis. The experience in treating cavitary disease with itraconazole alone is limited and further data are required.

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

PubMed

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

2013-12-01

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

Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

PubMed Central

Keithley, Joyce K.; Swanson, Barbara; Mikolaitis, Susan L.; DeMeo, Mark; Zeller, Janice M.; Fogg, Lou; Adamji, Jehan

2013-01-01

Background. Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods. Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces) of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results. A total of 53 participants (18–65 years of age; BMI 25–35 kg/m2) were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (−.40 ± .06 and −.43 ± .07, resp.) or other efficacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600. PMID:24490058

Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

PubMed

Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A; Lee, Verna K M; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P; Ismail, Mastura; Chan, Chun W; Abdul-Rahman, Yong R; Chew, Boon-How; Low, Wilson H H

2014-09-13

Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia. ClinicalTrials.gov NCT01545401.

Parameters and Scales Used to Assess and Report Findings From Stroboscopy: A Systematic Review.

PubMed

Bonilha, Heather Shaw; Desjardins, Maude; Garand, Kendrea L; Martin-Harris, Bonnie

2017-11-02

Laryngeal endoscopy with stroboscopy, a critical component of the assessment of voice disorders, is rarely used as a treatment outcome measure in the scientific literature. We hypothesized that this is because of the lack of a widely used standardized, validated, and reliable method to assess and report laryngeal anatomy and physiology, and undertook a systematic literature review to determine the extent of the inconsistencies of the parameters and scales used in voice treatment outcome studies. Systematic literature review. We searched PubMed, Ovid, and Cochrane for studies where laryngeal endoscopy with stroboscopy was used as a treatment outcome measure with search terms representing "stroboscopy" and "treatment" guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards. In the 62 included articles, we identified 141 terms representing 49 different parameters, which were further classified into 20 broad categories. The six most common parameters were magnitude of glottal gap, mucosal wave amplitude, location or shape of glottal gap, regularity of vibration, phase symmetry, and presence and size of specific lesions. Parameters were assessed on scales ranging from binary to 100 points. The number of scales used for each parameter varied from 1 to 24, with an average of four different scales per parameter. There is a lack of agreement in the scientific literature regarding which parameters should be assessed to measure voice treatment outcomes and which terms and scales should be used for each parameter. This greatly diminishes comparison and clinical implementation of the results of treatment outcomes research in voice disorders. We highlight a previously published tool and recommend it for future use in research and clinical settings. Copyright © 2017. Published by Elsevier Inc.

Specialist outreach clinics in primary care and rural hospital settings.

PubMed

Gruen, R L; Weeramanthri, T S; Knight, S E; Bailie, R S

2004-01-01

Specialist medical practitioners have conducted clinics in primary care and rural hospital settings for a variety of reasons in many different countries. Such clinics have been regarded as an important policy option for increasing the accessibility and effectiveness of specialist services and their integration with primary care services. To undertake a descriptive overview of studies of specialist outreach clinics and to assess the effectiveness of specialist outreach clinics on access, quality, health outcomes, patient satisfaction, use of services, and costs. We searched the Cochrane Effective Practice and Organisation of Care (EPOC) specialised register (March 2002), the Cochrane Controlled Trials Register (CCTR) (Cochrane Library Issue 1, 2002), MEDLINE (including HealthStar) (1966 to May 2002), EMBASE (1988 to March 2002), CINAHL (1982 to March 2002), the Primary-Secondary Care Database previously maintained by the Centre for Primary Care Research in the Department of General Practice at the University of Manchester, a collection of studies from the UK collated in "Specialist Outreach Clinics in General Practice" (Roland 1998), and the reference lists of all retrieved articles. Randomised trials, controlled before and after studies and interrupted time series analyses of visiting specialist outreach clinics in primary care or rural hospital settings, either providing simple consultations or as part of complex multifaceted interventions. The participants were patients, specialists, and primary care providers. The outcomes included objective measures of access, quality, health outcomes, satisfaction, service use, and cost. Four reviewers working in pairs independently extracted data and assessed study quality. 73 outreach interventions were identified covering many specialties, countries and settings. Nine studies met the inclusion criteria. Most comparative studies came from urban non-disadvantaged populations in developed countries. Simple 'shifted outpatients' styles of specialist outreach were shown to improve access, but there was no evidence of impact on health outcomes. Specialist outreach as part of more complex multifaceted interventions involving collaboration with primary care, education or other services was associated with improved health outcomes, more efficient and guideline-consistent care, and less use of inpatient services. The additional costs of outreach may be balanced by improved health outcomes. This review supports the hypothesis that specialist outreach can improve access, outcomes and service use, especially when delivered as part of a multifaceted intervention. The benefits of simple outreach models in urban non-disadvantaged settings seem small. There is a need for good comparative studies of outreach in rural and disadvantaged settings where outreach may confer most benefit to access and health outcomes.

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

PubMed

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

2018-06-13

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

Nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine review.

PubMed

Morin, C M; Hauri, P J; Espie, C A; Spielman, A J; Buysse, D J; Bootzin, R R

1999-12-15

This paper reviews the evidence regarding the efficacy of nonpharmacological treatments for primary chronic insomnia. It is based on a review of 48 clinical trials and two meta-analyses conducted by a task force appointed by the American Academy of Sleep Medicine to develop practice parameters on non-drug therapies for the clinical management of insomnia. The findings indicate that nonpharmacological therapies produce reliable and durable changes in several sleep parameters of chronic insomnia sufferers. The data indicate that between 70% and 80% of patients treated with nonpharmacological interventions benefit from treatment. For the typical patient with persistent primary insomnia, treatment is likely to reduce the main target symptoms of sleep onset latency and/or wake time after sleep onset below or near the 30-min criterion initially used to define insomnia severity. Sleep duration is also increased by a modest 30 minutes and sleep quality and patient's satisfaction with sleep patterns are significantly enhanced. Sleep improvements achieved with these behavioral interventions are sustained for at least 6 months after treatment completion. However, there is no clear evidence that improved sleep leads to meaningful changes in daytime well-being or performance. Three treatments meet the American Psychological Association (APA) criteria for empirically-supported psychological treatments for insomnia: Stimulus control, progressive muscle relaxation, and paradoxical intention; and three additional treatments meet APA criteria for probably efficacious treatments: Sleep restriction, biofeedback, and multifaceted cognitive-behavior therapy. Additional outcome research is needed to examine the effectiveness of treatment when it is implemented in clinical settings (primary care, family practice), by non-sleep specialists, and with insomnia patients presenting medical or psychiatric comorbidity.

Conceptualising a model to guide nursing and midwifery in the community guided by an evidence review.

PubMed

Leahy-Warren, Patricia; Mulcahy, Helen; Benefield, Lazelle; Bradley, Colin; Coffey, Alice; Donohoe, Ann; Fitzgerald, Serena; Frawley, Tim; Healy, Elizabeth; Healy, Maria; Kelly, Marcella; McCarthy, Bernard; McLoughlin, Kathleen; Meagher, Catherine; O'Connell, Rhona; O'Mahony, Aoife; Paul, Gillian; Phelan, Amanda; Stokes, Diarmuid; Walsh, Jessica; Savage, Eileen

2017-01-01

Successful models of nursing and midwifery in the community delivering healthcare throughout the lifespan and across a health and illness continuum are limited, yet necessary to guide global health services. Primary and community health services are the typical points of access for most people and the location where most care is delivered. The scope of primary healthcare is complex and multifaceted and therefore requires a practice framework with sound conceptual and theoretical underpinnings. The aim of this paper is to present a conceptual model informed by a scoping evidence review of the literature. A scoping evidence review of the literature was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Databases included CINAHL, MEDLINE, PsycINFO and SocINDEX using the EBSCO platform and the Cochrane Library using the keywords: model, nursing, midwifery, community, primary care. Grey literature for selected countries was searched using the Google 'advanced' search interface. Data extraction and quality appraisal for both empirical and grey literature were conducted independently by two reviewers. From 127 empirical and 24 non-empirical papers, data extraction parameters, in addition to the usual methodological features, included: the nature of nursing and midwifery; the population group; interventions and main outcomes; components of effective nursing and midwifery outcomes. The evidence was categorised into six broad areas and subsequently synthesised into four themes. These were not mutually exclusive: (1) Integrated and Collaborative Care; (2) Organisation and Delivery of Nursing and Midwifery Care in the Community; (3) Adjuncts to Nursing Care and (4) Overarching Conceptual Model. It is the latter theme that is the focus of this paper. In essence, the model depicts a person/client on a lifespan and preventative-curative trajectory. The health related needs of the client, commensurate with their point position, relative to both trajectories, determines the nurse or midwife intervention. Consequently, it is this need, that determines the discipline or speciality of the nurse or midwife with the most appropriate competencies. Use of a conceptual model of nursing and midwifery to inform decision-making in primary/community based care ensures clinical outcomes are meaningful and more sustainable. Operationalising this model for nursing and midwifery in the community demands strong leadership and effective clinical governance.

Prognosis estimation under the light of metabolic tumor parameters on initial FDG-PET/CT in patients with primary extranodal lymphoma

PubMed Central

Okuyucu, Kursat; Ozaydın, Sukru; Alagoz, Engin; Ozgur, Gokhan; Oysul, Fahrettin Guven; Ozmen, Ozlem; Tuncel, Murat; Ozturk, Mustafa; Arslan, Nuri

2016-01-01

Abstract Background Non-Hodgkin’s lymphomas arising from the tissues other than primary lymphatic organs are named primary extranodal lymphoma. Most of the studies evaluated metabolic tumor parameters in different organs and histopathologic variants of this disease generally for treatment response. We aimed to evaluate the prognostic value of metabolic tumor parameters derived from initial FDG-PET/CT in patients with a medley of primary extranodal lymphoma in this study. Patients and methods There were 67 patients with primary extranodal lymphoma for whom FDG-PET/CT was requested for primary staging. Quantitative PET/CT parameters: maximum standardized uptake value (SUVmax), average standardized uptake value (SUVmean), metabolic tumor volume (MTV) and total lesion glycolysis (TLG) were used to estimate disease-free survival and overall survival. Results SUVmean, MTV and TLG were found statistically significant after multivariate analysis. SUVmean remained significant after ROC curve analysis. Sensitivity and specificity were calculated as 88% and 64%, respectively, when the cut-off value of SUVmean was chosen as 5.15. After the investigation of primary presentation sites and histo-pathological variants according to recurrence, there is no difference amongst the variants. Primary site of extranodal lymphomas however, is statistically important (p = 0.014). Testis and central nervous system lymphomas have higher recurrence rate (62.5%, 73%, respectively). Conclusions High SUVmean, MTV and TLG values obtained from primary staging FDG-PET/CT are potential risk factors for both disease-free survival and overall survival in primary extranodal lymphoma. SUVmean is the most significant one amongst them for estimating recurrence/metastasis. PMID:27904443

Self-esteem and optimism in men and women infected with HIV.

PubMed

Anderson, E H

2000-01-01

Self-esteem and optimism have been associated with appraisal and outcomes in a variety of situations. The degree to which the contribution of self-esteem and optimism to outcomes over time is accounted for by the differences in threat (primary) or resource (secondary) appraisal has not been established in persons with human immunodeficiency virus (HIV). To examine the longitudinal relationship of personality (self-esteem and optimism) on primary and secondary appraisal and outcomes of well-being, mood, CD4+ T-lymphocyte count, and selected activities. Men (n = 56) and women (n = 42) infected with HIV completed eight self-report measures twice over 18 months. Hierarchical Multiple Regressions were used to examine the relationship of personality variables on appraisals and outcomes. The mediating effects of primary and secondary appraisals were explored. Self-esteem uniquely accounted for 6% of the variance in primary appraisal and 5% in secondary appraisal. Optimism accounted for 8% of the unique variance in secondary appraisal. Primary and secondary appraisal mediated differently between personality and outcome variables. A strong predictor of well-being, mood disturbance, and activity disruption at Time 2 was participants' initial level of these variables. Socioeconomic status was a strong predictor of mood. Self-esteem and optimism are important but different resources for adapting to HIV disease. Strategies for reducing threats and increasing resources associated with HIV may improve an individual's mood and sense of well-being.

The insertion torque-depth curve integral as a measure of implant primary stability: An in vitro study on polyurethane foam blocks.

PubMed

Di Stefano, Danilo Alessio; Arosio, Paolo; Gastaldi, Giorgio; Gherlone, Enrico

2017-07-08

Recent research has shown that dynamic parameters correlate with insertion energy-that is, the total work needed to place an implant into its site-might convey more reliable information concerning immediate implant primary stability at insertion than the commonly used insertion torque (IT), the reverse torque (RT), or the implant stability quotient (ISQ). Yet knowledge on these dynamic parameters is still limited. The purpose of this in vitro study was to evaluate whether an energy-related parameter, the torque-depth curve integral (I), could be a reliable measure of primary stability. This was done by assessing if (I) measurement was operator-independent, by investigating its correlation with other known primary stability parameters (IT, RT, or ISQ) by quantifying the (I) average error and correlating (I), IT, RT, and ISQ variations with bone density. Five operators placed 200 implants in polyurethane foam blocks of different densities using a micromotor that calculated the (I) during implant placement. Primary implant stability was assessed by measuring the ISQ, IT, and RT. ANOVA tests were used to evaluate whether measurements were operator independent (P>.05 in all cases). A correlation analysis was performed between (I) and IT, ISQ, and RT. The (I) average error was calculated and compared with that of the other parameters by ANOVA. (I)-density, IT-density, ISQ-density, and RT-density plots were drawn, and their slopes were compared by ANCOVA. The (I) measurements were operator independent and correlated with IT, ISQ, and RT. The average error of these parameters was not significantly different (P>.05 in all cases). The (I)-density, IT-density, ISQ-density, and RT-density curves were linear in the 0.16 to 0.49 g/cm³ range, with the (I)-density curves having a significantly greater slope than those regarding the other parameters (P≤.001 in all cases). The torque-depth curve integral (I) provides a reliable assessment of primary stability and shows a greater sensitivity to density variations than other known primary stability parameters. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Immune cell profile of sentinel lymph nodes in patients with malignant melanoma – FOXP3+ cell density in cases with positive sentinel node status is associated with unfavorable clinical outcome

PubMed Central

2013-01-01

Background Besides being a preferential site of early metastasis, the sentinel lymph node (SLN) is also a privileged site of T-cell priming, and may thus be an appropriate target for investigating cell types involved in antitumor immune reactions. Methods In this retrospective study we determined the prevalence of OX40+ activated T lymphocytes, FOXP3+ (forkhead box P3) regulatory T cells, DC-LAMP+ (dendritic cell-lysosomal associated membrane protein) mature dendritic cells (DCs) and CD123+ plasmacytoid DCs by immunohistochemistry in 100 SLNs from 60 melanoma patients. Density values of each cell type in SLNs were compared to those in non-sentinel nodes obtained from block dissections (n = 37), and analyzed with regard to associations with clinicopathological parameters and disease outcome. Results Sentinel nodes showed elevated amount of all cell types studied in comparison to non-sentinel nodes. Metastatic SLNs had higher density of OX40+ lymphocytes compared to tumor-negative nodes, while no significant difference was observed in the case of the other cell types studied. In patients with positive sentinel node status, high amount of FOXP3+ cells in SLNs was associated with shorter progression-free (P = 0.0011) and overall survival (P = 0.0014), while no significant correlation was found in the case of sentinel-negative patients. The density of OX40+, CD123+ or DC-LAMP+ cells did not show significant association with the outcome of the disease. Conclusions Taken together, our results are compatible with the hypothesis of functional competence of sentinel lymph nodes based on the prevalence of the studied immune cells. The density of FOXP3+ lymphocytes showed association with progression and survival in patients with positive SLN status, while the other immune markers studied did not prove of prognostic importance. These results, together with our previous findings on the prognostic value of activated T cells and mature DCs infiltrating primary melanomas, suggest that immune activation-associated markers in the primary tumor may have a higher impact than those in SLNs on the prognosis of the patients. On the other hand, FOXP3+ cell density in SLNs, but not in the primary tumor, was found predictive of disease outcome in melanoma patients. PMID:23418928

Accounting for parameter uncertainty in the definition of parametric distributions used to describe individual patient variation in health economic models.

PubMed

Degeling, Koen; IJzerman, Maarten J; Koopman, Miriam; Koffijberg, Hendrik

2017-12-15

Parametric distributions based on individual patient data can be used to represent both stochastic and parameter uncertainty. Although general guidance is available on how parameter uncertainty should be accounted for in probabilistic sensitivity analysis, there is no comprehensive guidance on reflecting parameter uncertainty in the (correlated) parameters of distributions used to represent stochastic uncertainty in patient-level models. This study aims to provide this guidance by proposing appropriate methods and illustrating the impact of this uncertainty on modeling outcomes. Two approaches, 1) using non-parametric bootstrapping and 2) using multivariate Normal distributions, were applied in a simulation and case study. The approaches were compared based on point-estimates and distributions of time-to-event and health economic outcomes. To assess sample size impact on the uncertainty in these outcomes, sample size was varied in the simulation study and subgroup analyses were performed for the case-study. Accounting for parameter uncertainty in distributions that reflect stochastic uncertainty substantially increased the uncertainty surrounding health economic outcomes, illustrated by larger confidence ellipses surrounding the cost-effectiveness point-estimates and different cost-effectiveness acceptability curves. Although both approaches performed similar for larger sample sizes (i.e. n = 500), the second approach was more sensitive to extreme values for small sample sizes (i.e. n = 25), yielding infeasible modeling outcomes. Modelers should be aware that parameter uncertainty in distributions used to describe stochastic uncertainty needs to be reflected in probabilistic sensitivity analysis, as it could substantially impact the total amount of uncertainty surrounding health economic outcomes. If feasible, the bootstrap approach is recommended to account for this uncertainty.

Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT.

PubMed

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Hüll, Michael; Rikkert, Marcel Olde; Vernooij-Dassen, Myrra

2011-08-09

Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053.

Cost utility analysis of reduced intensity hematopoietic stem cell transplantation in adolescence and young adult with severe thalassemia compared to hypertransfusion and iron chelation program.

PubMed

Sruamsiri, Rosarin; Chaiyakunapruk, Nathorn; Pakakasama, Samart; Sirireung, Somtawin; Sripaiboonkij, Nintita; Bunworasate, Udomsak; Hongeng, Suradej

2013-02-05

Hematopoieticic stem cell transplantation is the only therapeutic option that can cure thalassemia disease. Reduced intensity hematopoietic stem cell transplantation (RI-HSCT) has demonstrated a high cure rate with minimal complications compared to other options. Because RI-HSCT is very costly, economic justification for its value is needed. This study aimed to estimate the cost-utility of RI-HSCT compared with blood transfusions combined with iron chelating therapy (BT-ICT) for adolescent and young adult with severe thalassemia in Thailand. A Markov model was used to estimate the relevant costs and health outcomes over the patients' lifetimes using a societal perspective. All future costs and outcomes were discounted at a rate of 3% per annum. The efficacy of RI-HSCT was based a clinical trial including a total of 18 thalassemia patients. Utility values were derived directly from all patients using EQ-5D and SF-6D. Primary outcomes of interest were lifetime costs, quality adjusted life-years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) in US ($) per QALY gained. One-way and probabilistic sensitivity analyses (PSA) were conducted to investigate the effect of parameter uncertainty. In base case analysis, the RI-HSCT group had a better clinical outcomes and higher lifetime costs. The incremental cost per QALY gained was US $3,236 per QALY. The acceptability curve showed that the probability of RI-HSCT being cost-effective was 71% at the willingness to pay of 1 time of Thai Gross domestic product per capita (GDP per capita), approximately US $4,210 per QALY gained. The most sensitive parameter was utility of severe thalassemia patients without cardiac complication patients. At a societal willingness to pay of 1 GDP per capita, RI-HSCT was a cost-effective treatment for adolescent and young adult with severe thalassemia in Thailand compared to BT-ICT.

ACUDIN - ACUpuncture and laser acupuncture for treatment of DIabetic peripheral Neuropathy: a randomized, placebo-controlled, partially double-blinded trial.

PubMed

Meyer-Hamme, Gesa; Friedemann, Thomas; Greten, Henry Johannes; Plaetke, Rosemarie; Gerloff, Christian; Schroeder, Sven

2018-04-13

Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes mellitus with significant clinical sequelae that can affect a patient's quality of life. Metabolic and microvascular factors are responsible for nerve damage, causing loss of nerve function, numbness, painful sensory symptoms, and muscle weakness. Therapy is limited to anti-convulsant or anti-depressant drugs for neuropathic pain and paresthesia. However, reduced sensation, balance and gait problems are insufficiently covered by this treatment. Previous data suggests that acupuncture, which has been in use in Traditional Chinese Medicine for many years, may potentially complement the treatment options for peripheral neuropathy. Nevertheless, more objective data on clinical outcome is necessary to generally recommend acupuncture to the public. We developed a study design for a prospective, randomized (RCT), placebo-controlled, partially double-blinded trial for investigating the effect of acupuncture on DPN as determined by nerve conduction studies (NCS) with the sural sensory nerve action potential amplitude as the primary outcome. The sural sensory nerve conduction velocity, tibial motor nerve action potential amplitude, tibial motor nerve conduction velocity, the neuropathy deficit score, neuropathy symptom score, and numeric rating scale questionnaires are defined as secondary outcomes. One hundred and eighty patients with type 2 diabetes mellitus will be randomized into three groups (needle acupuncture, verum laser acupuncture, and placebo laser acupuncture). We hypothesize that needle and laser acupuncture have beneficial effects on electrophysiological parameters and clinical and subjective symptoms in relation to DPN in comparison with placebo. The ACUDIN trial aims at investigating whether classical needle acupuncture and/or laser acupuncture are efficacious in the treatment of DPN. For the purpose of an objective parameter, NCS were chosen as outcome measures. Acupuncture treatment may potentially improve patients' quality of life and reduce the socio-economic burden caused by DPN. German Clinical Trial Register (DRKS), No. DRKS00008562 , trial search portal of the WHO ( http://apps.who.int/trialsearch/ ).

Quality of resuscitation: flight attendants in an airplane simulator use a new mechanical resuscitation device--a randomized simulation study.

PubMed

Fischer, Henrik; Neuhold, Stephanie; Hochbrugger, Eva; Steinlechner, Barbara; Koinig, Herbert; Milosevic, Ljubisa; Havel, Christof; Frantal, Sophie; Greif, Robert

2011-04-01

Cardiopulmonary resuscitation (CPR) during flight is challenging and has to be sustained for long periods. In this setting a mechanical-resuscitation-device (MRD) might improve performance. In this study we compared the quality of resuscitation of trained flight attendants practicing either standard basic life support (BLS) or using a MRD in a cabin-simulator. Prospective, open, randomized and crossover simulation study. Study participants, competent in standard BLS were trained to use the MRD to deliver both chest compressions and ventilation. 39 teams of two rescuers resuscitated a manikin for 12 min in random order, standard BLS or mechanically assisted resuscitation. Primary outcome was "absolute hands-off time" (sum of all periods during which no hand was placed on the chest minus ventilation time). Various parameters describing the quality of chest compression and ventilation were analysed as secondary outcome parameters. Use of the MRD led to significantly less "absolute hands-off time" (164±33 s vs. 205±42 s, p<0.001). The quality of chest compression was comparable among groups, except for a higher compression rate in the standard BLS group (123±14 min(-1) vs. 95±11 min(-1), p<0.001). Tidal volume was higher in the standard BLS group (0.48±0.14 l vs. 0.34±0.13 l, p<0.001), but we registered fewer gastric inflations in the MRD group (0.4±0.3% vs. 16.6±16.9%, p<0.001). Using the MRD resulted in significantly less "absolute hands-off time", but less effective ventilation. The translation of higher chest compression rate into better outcome, as shown in other studies previously, has to be investigated in another human outcome study. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

PubMed

Migliorati, Marco; Amorfini, Leonardo; Signori, Alessio; Biavati, Armando Silvestrini; Benedicenti, Stefano

2015-10-01

The aesthetic outcome of an implant-supported restoration is first of all dependent on the soft tissue volume. Because the labial bone plate resorbs in every direction after tooth extraction, even when an implant is placed immediately, most patients end up with compromised aesthetics. In this parallel-designed, randomized clinical trial, participants were randomly assigned to the test group (immediate load post-extractive implant treated with subepithelial connective tissue graft placed using the tunnel technique in the labial area) and control group (immediate load post-extractive implant treated without raising a flap) with an allocation ratio of 1:1. Both groups received deproteinized bovine bone mineral. Patients were observed at baseline, crown insertion, 1-year follow-up, and 2-year follow-up. Clinical, radiological and aesthetic parameters were recorded to assess primary treatment outcomes. A random permuted block system was blindly generated ensuring uniformity of the patient allocation during the trial by randomly distributing three participants to the test and three participants to the control group every six treated patients. At the 2-year examination, all 47 implants were successfully integrated, demonstrating stability and healthy peri-implant soft tissues as documented by standard clinical parameters. The results showed a soft tissue remodeling of -10% in thickness and -18% in highness in the non-grafted group, whereas in the grafted group there was a gain of 35% in thickness and a slight reduction of -11% in highness. Test group reported an increase of aesthetic result (mean pink aesthetic score [PES] 8) compared with control group (mean PES 6.65). This prospective study demonstrates the effectiveness of placing a soft tissue graft at the time of immediate implant placement in the aesthetic zone. At the 2-year follow-up, test group revealed a better aesthetic outcomes and stable facial soft tissues compared with control group. © 2013 Wiley Periodicals, Inc.

Cost utility analysis of reduced intensity hematopoietic stem cell transplantation in adolescence and young adult with severe thalassemia compared to hypertransfusion and iron chelation program

PubMed Central

2013-01-01

Background Hematopoieticic stem cell transplantation is the only therapeutic option that can cure thalassemia disease. Reduced intensity hematopoietic stem cell transplantation (RI-HSCT) has demonstrated a high cure rate with minimal complications compared to other options. Because RI-HSCT is very costly, economic justification for its value is needed. This study aimed to estimate the cost-utility of RI-HSCT compared with blood transfusions combined with iron chelating therapy (BT-ICT) for adolescent and young adult with severe thalassemia in Thailand. Methods A Markov model was used to estimate the relevant costs and health outcomes over the patients’ lifetimes using a societal perspective. All future costs and outcomes were discounted at a rate of 3% per annum. The efficacy of RI-HSCT was based a clinical trial including a total of 18 thalassemia patients. Utility values were derived directly from all patients using EQ-5D and SF-6D. Primary outcomes of interest were lifetime costs, quality adjusted life-years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) in US ($) per QALY gained. One-way and probabilistic sensitivity analyses (PSA) were conducted to investigate the effect of parameter uncertainty. Results In base case analysis, the RI-HSCT group had a better clinical outcomes and higher lifetime costs. The incremental cost per QALY gained was US $ 3,236 per QALY. The acceptability curve showed that the probability of RI-HSCT being cost-effective was 71% at the willingness to pay of 1 time of Thai Gross domestic product per capita (GDP per capita), approximately US $ 4,210 per QALY gained. The most sensitive parameter was utility of severe thalassemia patients without cardiac complication patients. Conclusion At a societal willingness to pay of 1 GDP per capita, RI-HSCT was a cost-effective treatment for adolescent and young adult with severe thalassemia in Thailand compared to BT-ICT. PMID:23379888

Aerobic Interval vs. Continuous Training in Patients with Coronary Artery Disease or Heart Failure: An Updated Systematic Review and Meta-Analysis with a Focus on Secondary Outcomes.

PubMed

Pattyn, Nele; Beulque, Randy; Cornelissen, Véronique

2018-05-01

In a previous meta-analysis including nine trials comparing aerobic interval training with aerobic continuous training in patients with coronary artery disease, we found a significant difference in peak oxygen uptake favoring aerobic interval training. The objective of this study was to (1) update the original meta-analysis focussing on peak oxygen uptake and (2) evaluate the effect on secondary outcomes. We conducted a systematic review with a meta-analysis by searching PubMed and SPORTDiscus databases up to March 2017. We included randomized trials comparing aerobic interval training and aerobic continuous training in patients with coronary artery disease or chronic heart failure. The primary outcome was change in peak oxygen uptake. Secondary outcomes included cardiorespiratory parameters, cardiovascular risk factors, cardiac and vascular function, and quality of life. Twenty-four papers were identified (n = 1080; mean age 60.7 ± 10.7 years). Aerobic interval training resulted in a higher increase in peak oxygen uptake compared with aerobic continuous training in all patients (1.40 mL/kg/min; p < 0.001), and in the subgroups of patients with coronary artery disease (1.25 mL/kg/min; p = 0.001) and patients with chronic heart failure with reduced ejection fraction (1.46 mL/kg/min; p = 0.03). Moreover, a larger increase of the first ventilatory threshold and peak heart rate was observed after aerobic interval training in all patients. Other cardiorespiratory parameters, cardiovascular risk factors, and quality of life were equally affected. This meta-analysis adds further evidence to the clinically significant larger increase in peak oxygen uptake following aerobic interval training vs. aerobic continuous training in patients with coronary artery disease and chronic heart failure. More well-designed randomized controlled trials are needed to establish the safety of aerobic interval training and the sustainability of the training response over longer periods.

Pre-Liver Transplant Transthoracic Echocardiogram Findings and 6-Month Post-Transplant Outcomes: A Case-Control Analysis.

PubMed

Konerman, Monica A; Price, Jennifer C; Campbell, Catherine Y; Eluri, Swathi; Gurakar, Ahmet; Hamilton, James; Li, Zhiping

2016-07-05

BACKGROUND Cardiopulmonary (CP) outcomes remain a leading cause of morbidity and mortality following liver transplantation (LT). The optimal CP risk stratification of LT candidates remains unclear. The aim of this study was to evaluate the association of pre-LT transthoracic echocardiogram (TTE) findings and 6-month post-LT outcomes. MATERIAL AND METHODS This retrospective review analyzed adults who underwent LT, comparing those who died within 6 months of LT (cases; n=38) with age- and sex-matched patients who survived >6 months (controls; n=38). Cases were categorized by cause of death (COD) defined as either a primary CP process (n=20) or a non-CP process (n=18). Data were analyzed using logistic regression and survival analysis was performed using Kaplan-Meier curves. RESULTS There was a higher odds of death within 6 months of LT with ≥ mild mitral regurgitation (OR 3.44, p=0.03) or an incomplete assessment of right ventricular systolic function (RVSF) (OR 24, p=0.004). On subgroup analysis, these findings only persisted in patients with a CP COD. Patients with CP COD were older (61 vs. 54.5, p=0.04), had longer intervals between TTE and LT (122 vs. 29 days, p=0.05), less complete assessments of RVSF (p=0.009), and lower RV fractional area change (p=0.04) compared to patients with non-CP COD. CONCLUSIONS Multiple TTE parameters were associated with patients who died within 6 months of LT, and in particular patients with a CP COD. Our findings suggest that pre-LT TTEs can convey useful CP risk stratification information and emphasizes the importance of adequately assessing these parameters prior to LT.

Preoperative dipstick albuminuria and other urine abnormalities predict acute kidney injury and patient outcomes.

PubMed

Park, Sehoon; Lee, Soojin; Lee, Anna; Paek, Jin Hyuk; Chin, Ho Jun; Na, Ki Young; Chae, Dong-Wan; Kim, Sejoong

2018-05-01

It is unclear whether pathologic findings on preoperative urinalysis are associated with the risk of postoperative acute kidney injury (AKI). Therefore, we performed a retrospective review to investigate this association. We assessed the clinical significance of preoperative dipstick urinalysis in a 10-year surgery cohort from a tertiary hospital in Korea. Patients without available information on perioperative serum creatinine levels or kidney injury prior to surgery were excluded. Preoperative dipstick urinalysis parameters, including albuminuria, hematuria, pyuria, and others were studied. The primary outcome was postoperative acute kidney injury. Secondary outcomes were postoperative 1-year mortality and progression of poor kidney function parameters. We enrolled 40,090 patients. The presence of dipstick albuminuria was associated with an increased risk of postoperative AKI (adjusted odds ratio 1.47 [1.29-1.66], P < .001), and the association showed a dose-response relationship. High specific gravity was significantly associated with increased risk of AKI (adjusted odds ratio 1.30 [1.04-1.63], P = .02). Furthermore, in patients with postoperative AKI, those with baseline albuminuria had a worse prognosis with regard to 1-year mortality (adjusted hazard ratio 2.81 [1.56-5.09], P < .001) and persistent renal function impairment (adjusted odds ratio 2.07 [1.21-3.46], P = .007), independent of estimated glomerular filtration rate values. Patients with baseline hematuria and pyuria also had an inferior postoperative AKI prognosis when compared to those without the urinalysis abnormalities. Baseline dipstick urinalysis may predict postoperative AKI and may be significantly associated with prognosis after surgery. (Surgery 2017;160:XXX-XXX.). Copyright © 2017 Elsevier Inc. All rights reserved.

Hip kinetics during gait are clinically meaningful outcomes in young boys with Duchenne muscular dystrophy.

PubMed

Heberer, Kent; Fowler, Eileen; Staudt, Loretta; Sienko, Susan; Buckon, Cathleen E; Bagley, Anita; Sison-Williamson, Mitell; McDonald, Craig M; Sussman, Michael D

2016-07-01

Duchenne muscular dystrophy (DMD) is an X-linked genetic neuromuscular disorder characterized by progressive proximal to distal muscle weakness. The success of randomized clinical trials for novel therapeutics depends on outcome measurements that are sensitive to change. As the development of motor skills may lead to functional improvements in young boys with DMD, their inclusion may potentially confound clinical trials. Three-dimensional gait analysis is an under-utilized approach that can quantify joint moments and powers, which reflect functional muscle strength. In this study, gait kinetics, kinematics, spatial-temporal parameters, and timed functional tests were quantified over a one-year period for 21 boys between 4 and 8 years old who were enrolled in a multisite natural history study. At baseline, hip moments and powers were inadequate. Between the two visits, 12 boys began a corticosteroid regimen (mean duration 10.8±2.4 months) while 9 boys remained steroid-naïve. Significant between-group differences favoring steroid use were found for primary kinetic outcomes (peak hip extensor moments (p=.007), duration of hip extensor moments (p=.007), peak hip power generation (p=.028)), and spatial-temporal parameters (walking speed (p=.016) and cadence (p=.021)). Significant between-group differences were not found for kinematics or timed functional tests with the exception of the 10m walk test (p=.03), which improves in typically developing children within this age range. These results indicate that hip joint kinetics can be used to identify weakness in young boys with DMD and are sensitive to corticosteroid intervention. Inclusion of gait analysis may enhance detection of a treatment effect in clinical trials particularly for young boys with more preserved muscle function. Copyright © 2016 Elsevier B.V. All rights reserved.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

PubMed

McKinnon, Ross A; Cook, Matthew; Liauw, Winston; Marabani, Mona; Marschner, Ian C; Packer, Nicolle H; Prins, Johannes B

2018-02-01

The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies. The systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups. There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.

Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial.

PubMed

Al Tmimi, Layth; Van de Velde, Marc; Herijgers, Paul; Meyns, Bart; Meyfroidt, Geert; Milisen, Koen; Fieuws, Steffen; Coburn, Mark; Poesen, Koen; Rex, Steffen

2015-10-09

Postoperative delirium (POD) is a manifestation of acute postoperative brain dysfunction that is frequently observed after cardiac surgery. POD is associated with short-term complications such as an increase in mortality, morbidity, costs and length of stay, but can also have long-term sequelae, including persistent cognitive deficits, loss of independence, and increased mortality for up to 2 years. The noble gas xenon has been demonstrated in various models of neuronal injury to exhibit remarkable neuroprotective properties. We therefore hypothesize that xenon anesthesia reduces the incidence of POD in elderly patients undergoing cardiac surgery with the use of cardiopulmonary bypass. One hundred and ninety patients, older than 65 years, and scheduled for elective cardiac surgery, will be enrolled in this prospective, randomized, controlled trial. Patients will be randomized to receive general anesthesia with either xenon or sevoflurane. Primary outcome parameter will be the incidence of POD in the first 5 postoperative days. The occurrence of POD will be assessed by trained research personnel, blinded to study group, with the validated 3-minute Diagnostic Confusion Assessment Method (3D-CAM) (on the intensive care unit in its version specifically adapted for the ICU), in addition to chart review and the results of delirium screening tools that will be performed by the bedside nurses). Secondary outcome parameters include duration and severity of POD, and postoperative cognitive function as assessed with the Mini-Mental State Examination. Older patients undergoing cardiac surgery are at particular risk to develop POD. Xenon provides remarkable hemodynamic stability and has been suggested in preclinical studies to exhibit neuroprotective properties. The present trial will assess whether the promising profile of xenon can be translated into a better outcome in the geriatric population. EudraCT Identifier: 2014-005370-11 (13 May 2015).

Hyperglycaemia in infants with hypoxic-ischaemic encephalopathy is associated with improved outcomes after therapeutic hypothermia: a post hoc analysis of the CoolCap Study.

PubMed

Basu, Sudeepta K; Salemi, Jason L; Gunn, Alistair J; Kaiser, Jeffrey R

2017-07-01

To investigate whether glycaemic profile is associated with multiorgan dysfunction and with response to hypothermia after perinatal hypoxic-ischaemic encephalopathy (HIE). Post hoc analysis of the CoolCap Study. 25 perinatal centres in UK, USA and New Zealand during 1999-2002. 194/234 (83%) infants of ≥36 weeks' gestation with moderate-to-severe HIE enrolled in the CoolCap Study with documented plasma glucose levels and follow-up outcome. Infants were randomised to head cooling for 72 hours starting within 6 hours of birth or standard care. Plasma glucose levels were measured at predetermined time intervals after randomisation. Unfavourable primary outcome was defined as death and/or severe neurodevelopmental disability at 18 months. Glycaemic profile (hypoglycaemia (≤40 mg/dL, ≤2.2 mmol/L), hyperglycaemia (>150 mg/dL, >8.3 mmol/L) and normoglycaemia) during 12 hours after randomisation was investigated for association with multiorgan dysfunction or risk reduction of primary outcome after hypothermia treatment. Hypoglycaemia but not hyperglycaemia was associated with more deranged multiorgan function parameters (mean pH 7.23 (SD 0.16) vs 7.36 (0.13), p<0.001; aspartate transaminase 2101 (2450) vs 318 (516) IU/L, p=0.002; creatinine 1.95 (0.59) vs 1.26 (0.5) mg/dL, p<0.001) compared with normoglycaemia. After adjusting for Sarnat stage and 5 min Apgar score, only hyperglycaemic infants randomised to hypothermia had reduced risk of unfavourable outcome (adjusted risk ratio: 0.80, 95% CI 0.66 to 0.99), whereas hypoglycaemic and normoglycaemic infants did not. Early glycaemic profile in infants with moderate-to-severe HIE may help to identify risk of multiorgan dysfunction and response to therapeutic hypothermia. NCT00383305. 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/.

Definition of Failed Induction of Labor and Its Predictive Factors: Two Unsolved Issues of an Everyday Clinical Situation.

PubMed

Baños, Núria; Migliorelli, Federico; Posadas, Eduardo; Ferreri, Janisse; Palacio, Montse

2015-01-01

The objectives of this review were to identify the predictive factors of induction of labor (IOL) failure or success as well as to highlight the current heterogeneity regarding the definition and diagnosis of failed IOL. Only studies in which the main or secondary outcome was failed IOL, defined as not entering the active phase of labor after 24 h of prostaglandin administration ± 12 h of oxytocin infusion, were included in the review. The data collected were: study design, definition of failed IOL, induction method, IOL indications, failed IOL rate, cesarean section because of failed IOL and predictors of failed IOL. The database search detected 507 publications. The main reason for exclusion was that the primary or secondary outcomes were not the predetermined definition of failed IOL (not achieving active phase of labor). Finally, 7 studies were eligible. The main predictive factors identified in the review were cervical status, evaluated by the Bishop score or cervical length. Failed IOL should be defined as the inability to achieve the active phase of labor, considering that the definition of IOL is to enter the active phase of labor. A universal definition of failed IOL is an essential requisite to analyze and obtain solid results and conclusions on this issue. An important finding of this review is that only 7 of all the studies reviewed assessed achieving the active phase of labor as a primary or secondary IOL outcome. Another conclusion is that cervical status remains the most important predictor of IOL outcome, although the value of the parameters explored up to now is limited. To find or develop predictive tools to identify those women exposed to IOL who may not reach the active phase of labor is crucial to minimize the risks and costs associated with IOL failure while opening a great opportunity for investigation. Therefore, other predictive tools should be studied in order to improve IOL outcome in terms of health and economic burden. © 2015 S. Karger AG, Basel.

First-ever ischemic stroke in elderly patients: predictors of functional outcome following carotid artery stenting

PubMed Central

Lin, Chih-Ming; Chang, Yu-Jun; Liu, Chi-Kuang; Yu, Cheng-Sheng; Lu, Henry Horng-Shing

2016-01-01

Age is an important risk factor for stroke, and carotid artery stenosis is the primary cause of first-ever ischemic stroke. Timely intervention with stenting procedures can effectively prevent secondary stroke; however, the impact of stenting on various periprocedural physical functionalities has never been thoroughly investigated. The primary aim of this study was to investigate whether prestenting characteristics were associated with long-term functional outcomes in patients presenting with first-ever ischemic stroke. The secondary aim was to investigate whether patient age was an important factor in outcomes following stenting, measured by the modified Rankin scale (mRS). In total, 144 consecutive patients with first-ever ischemic stroke who underwent carotid artery stenting from January 2010 to November 2014 were included. Clinical data were obtained by review of medical records. The Barthel index (BI) and mRS were used to assess disability before stenting and at 12-month follow-up. In total, 72/144 patients showed improvement (mRS[+]), 71 showed stationary and one showed deterioration in condition (mRS[−]). The prestenting parameters, ratio of cerebral blood volume (1.41 vs 1.2 for mRS[−] vs mRS[+]), BI (75 vs 85), and high-sensitivity C-reactive protein (hsCRP 5.0 vs 3.99), differed significantly between the two outcome groups (P<0.05). The internal carotid artery/common carotid artery ratio (P=0.011), BI (P=0.019), ipsilateral internal carotid artery resistance index (P=0.003), and HbA1c (P=0.039) were all factors significantly associated with patient age group. There was no significant association between age and poststenting outcome measured by mRS with 57% of patients in the ≥75 years age group showing mRS(−) and 43% showing mRS(+) (P=0.371). Our findings indicate that in our elderly patient series, carotid artery stenting may benefit a significant proportion of carotid stenotic patients regardless of age. Ratio of cerebral blood volume, BI, and admission hsCRP could serve as important predictors of mRS improvement and may facilitate differentiation of patients at baseline. PMID:27555753

Systematic review of knowledge translation strategies in the allied health professions.

PubMed

Scott, Shannon D; Albrecht, Lauren; O'Leary, Kathy; Ball, Geoff D C; Hartling, Lisa; Hofmeyer, Anne; Jones, C Allyson; Klassen, Terry P; Kovacs Burns, Katharina; Newton, Amanda S; Thompson, David; Dryden, Donna M

2012-07-25

Knowledge translation (KT) aims to close the research-practice gap in order to realize and maximize the benefits of research within the practice setting. Previous studies have investigated KT strategies in nursing and medicine; however, the present study is the first systematic review of the effectiveness of a variety of KT interventions in five allied health disciplines: dietetics, occupational therapy, pharmacy, physiotherapy, and speech-language pathology. A health research librarian developed and implemented search strategies in eight electronic databases (MEDLINE, CINAHL, ERIC, PASCAL, EMBASE, IPA, Scopus, CENTRAL) using language (English) and date restrictions (1985 to March 2010). Other relevant sources were manually searched. Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Within each profession, evidence tables were created, grouping and analyzing data by research design, KT strategy, targeted behaviour, and primary outcome. The published descriptions of the KT interventions were compared to the Workgroup for Intervention Development and Evaluation Research (WIDER) Recommendations to Improve the Reporting of the Content of Behaviour Change Interventions. A total of 2,638 articles were located and the titles and abstracts were screened. Of those, 1,172 full-text articles were reviewed and subsequently 32 studies were included in the systematic review. A variety of single (n = 15) and multiple (n = 17) KT interventions were identified, with educational meetings being the predominant KT strategy (n = 11). The majority of primary outcomes were identified as professional/process outcomes (n = 25); however, patient outcomes (n = 4), economic outcomes (n = 2), and multiple primary outcomes (n = 1) were also represented. Generally, the studies were of low methodological quality. Outcome reporting bias was common and precluded clear determination of intervention effectiveness. In the majority of studies, the interventions demonstrated mixed effects on primary outcomes, and only four studies demonstrated statistically significant, positive effects on primary outcomes. None of the studies satisfied the four WIDER Recommendations. Across five allied health professions, equivocal results, low methodological quality, and outcome reporting bias limited our ability to recommend one KT strategy over another. Further research employing the WIDER Recommendations is needed to inform the development and implementation of effective KT interventions in allied health.

Conjunctival provocation tests: a predictive factor for patients' seasonal allergic rhinoconjunctivitis symptoms.

PubMed

Kruse, Kristian; Gerwin, Eva; Eichel, Andrea; Shah-Hosseini, Kija; Mösges, Ralph

2015-01-01

No parameters currently exist that can reliably predict the impact of preseasonal immunotherapy on the symptoms occurring during the season. The purpose of our studies was to prove a correlation between preseasonal conjunctival allergen challenge and coseasonal primary clinical endpoints using the total combined score, ie, a combination of symptoms and medication score, as the primary outcome parameter. Twelve weeks before both the birch and the grass pollen seasons, 2 separate prospective, double-blind, randomized, controlled studies were conducted followed by posttrial observations for each study during the active season. In the studies, patients who reacted to conjunctival allergen challenge were treated with sublingual immunotherapy tablets that contain either birch and/or alder or grass pollen allergoids. In all, 158 patients were included in the grass and 160 in the tree pollen study; of these, 100 and 109 patients, respectively, took part in the posttrial observations. When comparing patients with and without a positive reaction in the final conjunctival allergen challenge, the results revealed a significant difference in the total combined score (grass: P < .001; birch: P = .025). The same applied to the rescue medication score (P = .005; P = .025). A significant difference regarding the rhinoconjunctivitis symptom score was shown in the grass pollen study (P = .002), and the difference of well days was significant in the tree pollen study (P = .049). When comparing patients based on their reaction to allergen challenge after immunotherapy, each study leads to similarly significant results. Therefore, conjunctival allergen challenge can be used effectively as a parameter to predict allergic rhinoconjunctivitis symptoms during the season in patients treated with preseasonal sublingual immunotherapy tablets. Whether this can be transferred to untreated patients needs to be determined. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Panel management, team culture, and worklife experience.

PubMed

Willard-Grace, Rachel; Dubé, Kate; Hessler, Danielle; O'Brien, Bridget; Earnest, Gillian; Gupta, Reena; Shunk, Rebecca; Grumbach, Kevin

2015-09-01

Burnout and professional dissatisfaction are threats to the primary care workforce. We investigated the relationship between panel management capability, team culture, cynicism, and perceived "do-ability" of primary care among primary care providers (PCPs) and staff in primary care practices. We surveyed 326 PCPs and 142 staff members in 10 county-administered, 6 university-run, and 3 Veterans Affairs primary care clinics in a large urban area in 2013. Predictor variables included capability for performing panel management and perception of team culture. Outcome variables included 2 work experience measures--the Maslach Burnout Inventory cynicism scale and a 1-item measure of the "do-ability" of primary care this year compared with last year. Generalized Estimation Equation (GEE) models were used to account for clustering at the clinic level. Greater panel management capability and higher team culture were associated with lower cynicism among PCPs and staff and higher reported "do-ability" of primary care among PCPs. Panel management capability and team culture interacted to predict the 2 work experience outcomes. Among PCPs and staff reporting high team culture, there was little association between panel management capability and the outcomes, which were uniformly positive. However, there was a strong relationship between greater panel management capability and improved work experience outcomes for PCPs and staff reporting low team culture. Team-based processes of care such as panel management may be an important strategy to protect against cynicism and dissatisfaction in primary care, particularly in settings that are still working to improve their team culture. (c) 2015 APA, all rights reserved).

Effects of Balance Control Training on Functional Outcomes in Subacute Hemiparetic Stroke Patients.

PubMed

Huh, Jin Seok; Lee, Yang-Soo; Kim, Chul-Hyun; Min, Yu-Sun; Kang, Min-Gu; Jung, Tae-Du

2015-12-01

To investigate the efficacy of balance control training using a newly developed balance control trainer (BalPro) on the balance and gait of patients with subacute hemiparetic stroke. Forty-three subacute stroke patients were assigned to either a balance control training (BCT) group or a control group. The BCT group (n=23) was trained with BalPro for 30 minutes a day, 5 days a week for 2 weeks, and received one daily session of conventional physical therapy. The control group (n=20) received two sessions of conventional physical therapy every day for 2 weeks. The primary outcome was assessment with the Berg Balance Scale (BBS). Secondary outcomes were Functional Ambulation Category (FAC), the 6-minute walking test (6mWT), Timed Up and Go (TUG), the Korean version of Modified Barthel Index (K-MBI), and the manual muscle test (MMT) of the knee extensor. All outcome measures were evaluated before and after 2 weeks of training in both groups. There were statistically significant improvements in all parameters except MMT and FAC after 2 weeks of treatment in both groups. After training, the BCT group showed greater improvements in the BBS and the 6mWT than did the control group. Balance control training using BalPro could be a useful treatment for improving balance and gait in subacute hemiparetic stroke patients.

Effects of Balance Control Training on Functional Outcomes in Subacute Hemiparetic Stroke Patients

PubMed Central

Huh, Jin Seok; Lee, Yang-Soo; Kim, Chul-Hyun; Min, Yu-Sun; Kang, Min-Gu

2015-01-01

Objective To investigate the efficacy of balance control training using a newly developed balance control trainer (BalPro) on the balance and gait of patients with subacute hemiparetic stroke. Methods Forty-three subacute stroke patients were assigned to either a balance control training (BCT) group or a control group. The BCT group (n=23) was trained with BalPro for 30 minutes a day, 5 days a week for 2 weeks, and received one daily session of conventional physical therapy. The control group (n=20) received two sessions of conventional physical therapy every day for 2 weeks. The primary outcome was assessment with the Berg Balance Scale (BBS). Secondary outcomes were Functional Ambulation Category (FAC), the 6-minute walking test (6mWT), Timed Up and Go (TUG), the Korean version of Modified Barthel Index (K-MBI), and the manual muscle test (MMT) of the knee extensor. All outcome measures were evaluated before and after 2 weeks of training in both groups. Results There were statistically significant improvements in all parameters except MMT and FAC after 2 weeks of treatment in both groups. After training, the BCT group showed greater improvements in the BBS and the 6mWT than did the control group. Conclusion Balance control training using BalPro could be a useful treatment for improving balance and gait in subacute hemiparetic stroke patients. PMID:26798615

The Empirical Foundations of Telemedicine Interventions in Primary Care.

PubMed

Bashshur, Rashid L; Howell, Joel D; Krupinski, Elizabeth A; Harms, Kathryn M; Bashshur, Noura; Doarn, Charles R

2016-05-01

This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world.

The Empirical Foundations of Telemedicine Interventions in Primary Care

PubMed Central

Howell, Joel D.; Krupinski, Elizabeth A.; Harms, Kathryn M.; Bashshur, Noura; Doarn, Charles R.

2016-01-01

Abstract Introduction: This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. Materials and Methods: The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. Results: The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Conclusions: Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world. PMID:27128779

Overexpression of KCNJ3 gene splice variants affects vital parameters of the malignant breast cancer cell line MCF-7 in an opposing manner.

PubMed

Rezania, S; Kammerer, S; Li, C; Steinecker-Frohnwieser, B; Gorischek, A; DeVaney, T T J; Verheyen, S; Passegger, C A; Tabrizi-Wizsy, N Ghaffari; Hackl, H; Platzer, D; Zarnani, A H; Malle, E; Jahn, S W; Bauernhofer, T; Schreibmayer, W

2016-08-12

Overexpression the KCNJ3, a gene that encodes subunit 1 of G-protein activated inwardly rectifying K(+) channel (GIRK1) in the primary tumor has been found to be associated with reduced survival times and increased lymph node metastasis in breast cancer patients. In order to survey possible tumorigenic properties of GIRK1 overexpression, a range of malignant mammary epithelial cells, based on the MCF-7 cell line that permanently overexpress different splice variants of the KCNJ3 gene (GIRK1a, GIRK1c, GIRK1d and as a control, eYFP) were produced. Subsequently, selected cardinal neoplasia associated cellular parameters were assessed and compared. Adhesion to fibronectin coated surface as well as cell proliferation remained unaffected. Other vital parameters intimately linked to malignancy, i.e. wound healing, chemoinvasion, cellular velocities / motilities and angiogenesis were massively affected by GIRK1 overexpression. Overexpression of different GIRK1 splice variants exerted differential actions. While GIRK1a and GIRK1c overexpression reinforced the affected parameters towards malignancy, overexpression of GIRK1d resulted in the opposite. Single channel recording using the patch clamp technique revealed functional GIRK channels in the plasma membrane of MCF-7 cells albeit at very low frequency. We conclude that GIRK1d acts as a dominant negative constituent of functional GIRK complexes present in the plasma membrane of MCF-7 cells, while overexpression of GIRK1a and GIRK1c augmented their activity. The core component responsible for the cancerogenic action of GIRK1 is apparently presented by a segment comprising aminoacids 235-402, that is present exclusively in GIRK1a and GIRK1c, but not GIRK1d (positions according to GIRK1a primary structure). The current study provides insight into the cellular and molecular consequences of KCNJ3 overexpression in breast cancer cells and the mechanism upon clinical outcome in patients suffering from breast cancer.

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

PubMed

Kosa, Sarah Daisy; Mbuagbaw, Lawrence; Borg Debono, Victoria; Bhandari, Mohit; Dennis, Brittany B; Ene, Gabrielle; Leenus, Alvin; Shi, Daniel; Thabane, Michael; Valvasori, Sara; Vanniyasingam, Thuva; Ye, Chenglin; Yranon, Elgene; Zhang, Shiyuan; Thabane, Lehana

2018-02-01

The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Prediction of outcome of bright light treatment in patients with seasonal affective disorder: Discarding the early response, confirming a higher atypical balance, and uncovering a higher body mass index at baseline as predictors of endpoint outcome.

PubMed

Dimitrova, Tzvetelina D; Reeves, Gloria M; Snitker, Soren; Lapidus, Manana; Sleemi, Aamar R; Balis, Theodora G; Manalai, Partam; Tariq, Muhammad M; Cabassa, Johanna A; Karim, Naila N; Johnson, Mary A; Langenberg, Patricia; Rohan, Kelly J; Miller, Michael; Stiller, John W; Postolache, Teodor T

2017-11-01

We tested the hypothesis that the early improvement in mood after the first hour of bright light treatment compared to control dim-red light would predict the outcome at six weeks of bright light treatment for depressed mood in patients with Seasonal Affective Disorder (SAD). We also analyzed the value of Body Mass Index (BMI) and atypical symptoms of depression at baseline in predicting treatment outcome. Seventy-eight adult participants were enrolled. The first treatment was controlled crossover, with randomized order, and included one hour of active bright light treatment and one hour of control dim-red light, with one-hour washout. Depression was measured on the Structured Interview Guide for the Hamilton Rating Scale for Depression-SAD version (SIGH-SAD). The predictive association of depression scores changes after the first session. BMI and atypical score balance with treatment outcomes at endpoint were assessed using multivariable linear and logistic regressions. No significant prediction by changes in depression scores after the first session was found. However, higher atypical balance scores and BMI positively predicted treatment outcome. Absence of a control intervention for the six-weeks of treatment (only the first session in the laboratory was controlled). Exclusion of patients with comorbid substance abuse, suicidality and bipolar I disorder, and patients on antidepressant medications, reducing the generalizability of the study. Prediction of outcome by early response to light treatment was not replicated, and the previously reported prediction of baseline atypical balance was confirmed. BMI, a parameter routinely calculated in primary care, was identified as a novel predictor, and calls for replication and then exploration of possible mediating mechanisms. Published by Elsevier B.V.

Populations and outcome measures used in ongoing research in sarcopenia.

PubMed

Peña Ordóñez, Gloria Gabriela; Bustamante Montes, Lilia Patricia; Ramírez Duran, Ninfa; Sánchez Castellano, Carmen; Cruz-Jentoft, Alfonso J

2017-08-01

Sarcopenia research may be hampered by the heterogeneity of populations and outcome measures used in clinical studies. The aim of this study was to describe the inclusion/exclusion criteria and outcome measures used in ongoing research in sarcopenia. All active intervention studies registered in the World Health Organization with the keyword sarcopenia were included. Study design, type of intervention, inclusion/exclusion criteria and outcome measures were registered and classified. In April 2014, 151 studies on sarcopenia were registered in the WHO database. One hundred twenty-three were intervention studies. Most trials (94.3 %) were single centre and randomized (93.5 %), 51.2 % were double blind. Nutritional interventions (36.6 %), physical exercise (12.2 %) or both (19.5 %) were the most common interventions tested. Only 54.4 % included subjects of both genders, and 46.3 % had an upper age limit. Definition of the target populations was heterogeneous, with 57.7 % including healthy subjects and none using recent definitions of sarcopenia. Lifestyle and the degree of physical activity of subjects were not described or considered in most cases (79.7 %). Subjects with cardiovascular, neuropsychiatric or metabolic disorders and those with physical disability were usually excluded. Muscle mass and muscle strength were the primary outcome variables in 28.5 and 29.5 % of studies and physical performance in 19.5 %, but only 4.1 % used the three variables used the three of them. An additional 26.8 % used biological outcome variables. Little information and agreement existed in the way muscle and physical performance parameters were measured. We found a large heterogeneity in trial design, definition of populations and outcome measures in present research.

Severity of illness and outcome in adult patients with primary varicella pneumonia.

PubMed

Gregorakos, Leonidas; Myrianthefs, Pavlos; Markou, Nikolaos; Chroni, Despina; Sakagianni, Ekaterini

2002-01-01

Varicella pneumonia is a serious complication of primary varicella infection in adults that often results in respiratory failure and death. To analyze the clinical and laboratory manifestations of primary varicella pneumonia in patients admitted to our intensive care unit (ICU). Retrospective study on patients treated in our ICU with a diagnosis of primary varicella pneumonia during a period of 15 years. We recorded age, gender, smoking habits, clinical and laboratory findings, arterial blood gases, chest radiograph, illness severity (SAPS II), length of stay, necessity for mechanical ventilation, complications, therapy and survival. We examined the influence of the duration of respiratory symptoms and rash prior to admission, and the influence of illness severity on outcome. There was a statistically significant difference in duration of respiratory symptoms, duration of rash and SAPS II on admission between: (a) mechanically ventilated patients vs. spontaneously breathing patients (p < 0.007, p < 0.00, p < 0.00), (b) patients who survived vs. patients with poor outcome (p < 0.001, p < 0.000, p < 0.000), and (c) mechanically ventilated patients with poor outcome vs. mechanically ventilated patients who survived (p < 0.001, p < 0.00, p < 0.000). Overall mortality was 13.6%; death occurred only in mechanically ventilated patients (mortality 33.3%). Primary varicella pneumonia remains a critical problem with significant mortality. When recognized before respiratory failure ensues and mechanical ventilation becomes mandatory, patients could have an excellent outcome. Adult patients who delay asking for medical support, the disease may lead to the need for mechanical ventilation and severe complications with a fatal outcome. Copyright 2002 S. Karger AG, Basel

Preoperative physiotherapy and short-term functional outcomes of primary total knee arthroplasty

PubMed Central

Ismail, Mohd Shukry Mat Eil @; Sharifudin, Mohd Ariff; Shokri, Amran Ahmed; Rahman, Shaifuzain Ab

2016-01-01

INTRODUCTION Physiotherapy is an important part of rehabilitation following arthroplasty, but the impact of preoperative physiotherapy on functional outcomes is still being studied. This randomised controlled trial evaluated the effect of preoperative physiotherapy on the short-term functional outcomes of primary total knee arthroplasty (TKA). METHODS 50 patients with primary knee osteoarthritis who underwent unilateral primary TKA were randomised into two groups: the physiotherapy group (n = 24), whose patients performed physical exercises for six weeks immediately prior to surgery, and the nonphysiotherapy group (n = 26). All patients went through a similar physiotherapy regime in the postoperative rehabilitation period. Functional outcome assessment using the algofunctional Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and range of motion (ROM) evaluation was performed preoperatively, and postoperatively at six weeks and three months. RESULTS Both groups showed a significant difference in all algofunctional KOOS subscales (p < 0.001). The mean score difference at six weeks and three months was not significant in the sports and recreational activities subscale for both groups (p > 0.05). Significant differences were observed in the time-versus-treatment analysis between groups for the symptoms (p = 0.003) and activities of daily living (p = 0.025) subscales. No significant difference in ROM was found when comparing preoperative measurements and those at three months following surgery, as well as in time-versus-treatment analysis (p = 0.928). CONCLUSION Six-week preoperative physiotherapy showed no significant impact on short-term functional outcomes (KOOS subscales) and ROM of the knee following primary TKA. PMID:26996450

Effect of melatonin on depressive symptoms and anxiety in patients undergoing breast cancer surgery: a randomized, double-blind, placebo-controlled trial.

PubMed

Hansen, Melissa V; Andersen, Lærke T; Madsen, Michael T; Hageman, Ida; Rasmussen, Lars S; Bokmand, Susanne; Rosenberg, Jacob; Gögenur, Ismail

2014-06-01

Depression, anxiety and sleep disturbances are known problems in patients with breast cancer. The effect of melatonin as an antidepressant in humans with cancer has not been investigated. We investigated whether melatonin could lower the risk of depressive symptoms in women with breast cancer in a three-month period after surgery and assessed the effect of melatonin on subjective parameters: anxiety, sleep, general well-being, fatigue, pain and sleepiness. Randomized, double-blind, placebo-controlled trial undertaken from July 2011 to December 2012 at a department of breast surgery in Copenhagen, Denmark. Women, 30-75 years, undergoing surgery for breast cancer and without signs of depression on Major Depression Inventory (MDI) were included 1 week before surgery and received 6 mg oral melatonin or placebo for 3 months. The primary outcome was the incidence of depressive symptoms measured by MDI. The secondary outcomes were area under the curve (AUC) for the subjective parameters. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26) and 11 withdrew from the study (10 placebo group and 1 melatonin group, P = 0.002). The risk of developing depressive symptoms was significantly lower with melatonin than with placebo (3 [11 %] of 27 vs. 9 [45 %] of 20; relative risk 0.25 [95 % CI 0.077-0.80]), giving a NNT of 3.0 [95 % CI 1.7-11.0]. No significant differences were found between AUC for the subjective parameters. No differences in side effects were found (P = 0.78). Melatonin significantly reduced the risk of depressive symptoms in women with breast cancer during a three-month period after surgery.

A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties.

PubMed

Frazier, Thomas W; Krishna, Jyoti; Klingemier, Eric; Beukemann, Mary; Nawabit, Rawan; Ibrahim, Sally

2017-01-15

This preliminary study investigated the tolerability and efficacy of a novel mattress technology-the Sound-To-Sleep (STS) system-in the treatment of sleep problems in children with autism. After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off. STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05-4.54 vs. on mean = 4.9, 95%CI = 4.67-5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires. A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures. © 2017 American Academy of Sleep Medicine

Sedentary Behavior and Light Physical Activity Are Associated with Brachial and Central Blood Pressure in Hypertensive Patients

PubMed Central

Gerage, Aline M.; Benedetti, Tania R. B.; Farah, Breno Q.; Santana, Fábio da S.; Ohara, David; Andersen, Lars B.; Ritti-Dias, Raphael M.

2015-01-01

Background Physical activity is recommended as a part of a comprehensive lifestyle approach in the treatment of hypertension, but there is a lack of data about the relationship between different intensities of physical activity and cardiovascular parameters in hypertensive patients. The purpose of this study was to investigate the association between the time spent in physical activities of different intensities and blood pressure levels, arterial stiffness and autonomic modulation in hypertensive patients. Methods In this cross-sectional study, 87 hypertensive patients (57.5 ± 9.9 years of age) had their physical activity assessed over a 7 day period using an accelerometer and the time spent in sedentary activities, light physical activities, moderate physical activities and moderate-to-vigorous physical activities was obtained. The primary outcomes were brachial and central blood pressure. Arterial stiffness parameters (augmentation index and pulse wave velocity) and cardiac autonomic modulation (sympathetic and parasympathetic modulation in the heart) were also obtained as secondary outcomes. Results Sedentary activities and light physical activities were positively and inversely associated, respectively, with brachial systolic (r = 0.56; P < 0.01), central systolic (r = 0.51; P < 0.05), brachial diastolic (r = 0.45; P < 0.01) and central diastolic (r = 0.42; P < 0.05) blood pressures, after adjustment for sex, age, trunk fat, number of antihypertensive drugs, accelerometer wear time and moderate-to-vigorous physical activities. Arterial stiffness parameters and cardiac autonomic modulation were not associated with the time spent in sedentary activities and in light physical activities (P > 0.05). Conclusion Lower time spent in sedentary activities and higher time spent in light physical activities are associated with lower blood pressure, without affecting arterial stiffness and cardiac autonomic modulation in hypertensive patients. PMID:26717310

Outcome of focused pre-Ramadan education on metabolic and glycaemic parameters in patients with type 2 diabetes mellitus.

PubMed

El Toony, Lobna F; Hamad, Dina Ali; Omar, Omar Mohammed

2018-04-25

Ramadan fasting is associated with the risk of acute complications including hypoglycaemia. Therefore, patients' education before Ramadan and follow up during Ramadan is essential for safe fasting. To evaluate the effect of pre-Ramadan education program on biochemical parameters and the risk of hypoglycaemia in patients with type 2 diabetes mellitus. A prospective interventional controlled design was carried out on 320 Muslim patients with type 2 diabetes. They were divided into 2 groups; the control group (n = 200) who received standard diabetic care and the intervention group (n = 120) who received focused individualized diabetic education sessions before Ramadan. The study was carried out on 3 phases (before, during and after Ramadan). Post-education change of hypoglycaemia risk and biochemical parameters during Ramadan fasting were the primary outcomes. Fasting blood glucose decreased significantly during, and after Ramadan in both groups (P < 0.001). Hypoglycaemia during fasting occurred in 4.1% of patients in the intervention group vs. 19.5% in the control group. Post Ramadan reduction of HbA1c < 7% increased statistically significantly in the intervention group (from 20.8% of patients before Ramadan to 55.8% after Ramadan). Low-density lipoprotein cholesterol decreased in the intervention group (P = 0.024). The body weight of the patients did not significantly change in both groups. There was a significant impact of pre-Ramadan educational program on reduction of hypoglycaemic risk and other acute complications, reduction of low-density lipoprotein cholesterol and improvement of high-density lipoprotein cholesterol. Therefore, it is recommended for the fasting patients especially those with high and very high risk during Ramadan. Copyright © 2018. Published by Elsevier Ltd.

Intraoperative low tidal volume ventilation strategy has no benefits during laparoscopic cholecystectomy

PubMed Central

Arora, Vandna; Tyagi, Asha; Kumar, Surendra; Kakkar, Aanchal; Das, Shukla

2017-01-01

Background and Aims: Benefits of intraoperative low tidal volume ventilation during laparoscopic surgery are not conclusively proven, even though its advantages were seen in other situations with intraoperative respiratory compromise such as one-lung ventilation. The present study compared the efficacy of intraoperative low tidal volume ventilatory strategy (6 ml/kg along with positive end-expiratory pressure [PEEP] of 10 cmH2O) versus one with higher tidal volume (10 ml/kg with no PEEP) on various clinical parameters and plasma levels of interleukin (IL)-6 in patients undergoing laparoscopic cholecystectomy. Material and Methods: A total of 58 adult patients with American Society of Anesthesiologists physical status I or II, undergoing laparoscopic cholecystectomy were randomized to receive the low or higher tidal volume strategy as above (n = 29 each). The primary outcome measure was postoperative PaO2. Systemic levels of IL-6 along with clinical indices of intraoperative gas exchange, pulmonary mechanics, and hemodynamic consequences were measured as secondary outcome measures. Results: There was no statistically significant difference in oxygenation; intraoperative dynamic compliance, peak airway pressures, or hemodynamic parameters, or the IL-6 levels between the two groups (P > 0.05). Low tidal volume strategy was associated with significantly higher mean airway pressure, lower airway resistance, greater respiratory rates, and albeit clinically similar, higher PaCO2and lower pH (P < 0.05). Conclusion: Strategy using 6 ml/kg tidal volume along with 10 cmH2O of PEEP was not associated with any significant improvement in gas exchange, hemodynamic parameters, or systemic inflammatory response over ventilation with 10 ml/kg volume without PEEP during laparoscopic cholecystectomy. PMID:28413273

Current practice patterns and knowledge among gynecologic surgeons of InterStim® programming after implantation.

PubMed

Hobson, Deslyn T G; Gaskins, Jeremy T; Frazier, LaTisha; Francis, Sean L; Kinman, Casey L; Meriwether, Kate V

2017-10-03

The objective of this study was to describe surgeons' current practices in InterStim® programming after initial implantation and their knowledge of programming parameters. We hypothesized that surgeons performing their own reprogramming would have increased knowledge. We administered a written survey to attendees at the Society of Gynecologic Surgeons Scientific Meeting and analyzed those on which surgeons indicated they offer InterStim® care. The survey queried surgeon characteristics, experience with InterStim® implantation and programming, and clinical opinions regarding reprogramming and tested six knowledge-based questions about programming parameters. Correct response to all six questions was the primary outcome. One hundred and thirty-five of 407 (33%) attendees returned the survey, of which 99 met inclusion criteria. Most respondents (88 of 99; 89%) were between 36 and 60 years, 27 (73%) were women, 76 (77%) practiced in a university setting, and 76 (77%) were trained in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Surgeons who had InterStim® programming training were more likely to perform their own programming [15/46 (32%) vs 6/47 (13%), p = 0.03]. Most answered all knowledge-based questions correctly (62/90, 69%); no surgeon characteristics were significantly associated with this outcome. Most surgeons cited patient comfort (71/80, 89%) and symptom relief (64/80, 80%) as important factors when reprogramming, but no prevalent themes emerged on how and why surgeons change certain programming parameters. Surgeons who had formal InterStim® programming training are more likely to perform programming themselves. No surgeon characteristic was associated with improved programming knowledge. We found that surgeons prioritize patient comfort and symptoms when deciding to reprogram.

Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial.

PubMed

Hong, Shou-Hai; Ding, Sha-Sha; Wu, Fei; Bi, Ying; Xu, Fu; Wan, Yi-Jia; Xuan, Li-Hua

2017-03-06

Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thus generating different acupuncture responses or effects. Evidence has demonstrated that acupuncture is effective for functional dyspepsia (FD). However, the effects of different stimulating parameters of MA manipulations on FD remain unclear. This study is a randomized controlled trial with a four-arm, parallel-group structure. Patients with FD with epigastric pain syndrome (EPS) will be included and randomly allocated into four groups: three MA manipulation groups (separately treated with a frequency of 1 Hz, 2 Hz, or 3 Hz) and a control group. All groups will receive omeprazole as a basic treatment and acupuncture: in the MA manipulation groups, the needles will be manipulated manually with three different frequencies on the basis when de qi is reached, while in the control group, the needles will be inserted without any manipulation. All patients will receive acupuncture treatment of five consecutive sessions per week for 2 weeks and be followed up at 4, 8, and 12 weeks. The primary outcomes of the study include patients' response to the treatment. The secondary outcomes include dyspeptic symptoms, quality of life, mental status, fasting serum gastrin, motilin, and ghrelin concentrations, and adverse events. The protocol was approved by the Ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (2016-K-057-01). The aim of this study is to evaluate the efficacy and safety of MA manipulations with different stimulating parameters (different frequencies) on EPS in patients with FD. Chinese Clinical Trial Registry, ChiCTR-IOR-16008189 . Registered on 30 March 2016.

Impact of primary care depression intervention on employment and workplace conflict outcomes: is value added?

PubMed

Smith, Jeffrey L; Rost, Kathryn M; Nutting, Paul A; Libby, Anne M; Elliott, Carl E; Pyne, Jeffrey M

2002-03-01

Depression causes significant functional impairment in sufferers and often leads to adverse employment outcomes for working individuals. Recovery from depression has been associated with better employment outcomes at one year. The study s goals were to assess a primary care depression intervention s impact on subsequent employment and workplace conflict outcomes in employed patients with depression. In 1996-1997, the study enrolled 262 employed patients with depression from twelve primary care practices located across ten U.S. states; 219 (84%) of the patients were followed at one year. Intent-to-treat analyses assessing intervention effects on subsequent employment and workplace conflict were conducted using logistic regression models controlling for individual clinical and sociodemographic characteristics, job classification and local employment conditions. To meet criteria for subsequent employment, persons working full-time at baseline had to report they were working full-time at follow-up and persons working part-time at baseline had to report working part-/full-time at follow-up. Workplace conflict was measured by asking patients employed at follow-up whether, in the past year, they had arguments or other difficulties with people at work . Findings showed that 92.1% of intervention patients met criteria for subsequent employment at one year, versus 82.0% of usual care patients (c2=4.42, p=.04). Intervention patients were less likely than usual care patients to report workplace conflict in the year following baseline (8.1% vs. 18.9%, respectively; c2=4.11; p=.04). The intervention s effect on subsequent employment was not mediated by its effect on workplace conflict. The intervention significantly improved employment outcomes and reduced workplace conflict in depressed, employed persons at one year. Economic implications for employers related to reduced turnover costs, for workers related to retained earnings, and for governments related to reduced unemployment expenditures and increased tax receipts may be considerable. Although similar primary care depression interventions have been shown to produce comparable effects on subsequent employment at one year, replications in larger samples of depressed, employed patients in different economic climates may be necessary to increase the generalizability and precision of estimates. Primary care interventions that enhance depression treatment and improve clinical outcomes can contribute meaningful added value to society by improving employment and workplace outcomes. Federal/state governments may realize economic benefits from reduced unemployment expenditures and increased tax receipts should primary care depression interventions that improve employment outcomes be broadly disseminated. Policy initiatives to increase the dissemination of such interventions may be an innovative approach for improving labor force participation by depressed individuals. Formal cost-benefit analyses are needed to explore whether economic benefits to societal stakeholders from these and other labor outcomes equal or exceed the incremental costs of disseminating similar primary care interventions nationally. Researchers in other nations may wish to consider investigating the impact primary care depression interventions might have on employment and workplace outcomes in their countries.

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol.

PubMed

Denison, Fiona C; Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-09-18

A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. ISCRTN88609453; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Influence of workplace culture on nursing-sensitive nurse outcomes in municipal primary health care.

PubMed

Hahtela, Nina; Paavilainen, Eija; McCormack, Brendan; Slater, Paul; Helminen, Mika; Suominen, Tarja

2015-10-01

To explore the influence of workplace culture on sickness absences, overtime work and occupational injuries in municipal primary health care. The need to improve nursing sensitive outcomes has been highlighted. Therefore, an adequate understanding of the influence of workplace culture on nursing-sensitive nurse outcomes is essential for nurse managers to meet the requirements of improving nursing outcomes. A cross-sectional survey design was used to incorporating the data from 21 inpatient acute care units of nine organisations at the Finnish municipal primary health care system from 2011 to 2012. Findings emphasise in particular the importance of the practice environment as being an interpretative factor for nurses' absences owing to sickness, overtime work and occupational injuries. To ensure favourable nursing sensitive outcomes it is essential that there is a shared interest in the unit to invest in the creation of a supportive practice environment. Outcome improvements require a special focus on issues related to nursing management, adequate staffing and resources and intention to leave. © 2014 John Wiley & Sons Ltd.

Cue-elicited food seeking is eliminated with aversive outcomes following outcome devaluation.

PubMed

Eder, Andreas B; Dignath, David

2016-01-01

In outcome-selective Pavlovian-to-instrumental transfer (PIT), stimuli that are predictive of specific outcomes prime instrumental responses that are associated with these outcomes. Previous human studies yielded mixed evidence in respect to whether the PIT effect is affected by a posttraining devaluation of an outcome, with the PIT effect being preserved after a devaluation of a primary reinforcer (food, drugs) but not following the devaluation of a secondary reinforcer (money). The present research examined whether outcome-selective transfer is eliminated when the devaluation of a primary (liquid) reinforcer is strong and aversive. Experiment 1 confirmed these expectations following a devaluation with bad tasting Tween 20. However, outcome-selective transfer was still observed when the earned (devalued) outcome was not consumed immediately after each test (Experiment 2). These results suggest that the capacity of a Pavlovian cue to motivate a specific response is affected by the incentive value of the shared outcome only when the devaluation yields an aversive outcome that is consumed immediately.

Reducing the health consequences of opioid addiction in primary care.

PubMed

Bowman, Sarah; Eiserman, Julie; Beletsky, Leo; Stancliff, Sharon; Bruce, R Douglas

2013-07-01

Addiction to prescription opioids is prevalent in primary care settings. Increasing prescription opioid use is largely responsible for a parallel increase in overdose nationally. Many patients most at risk for addiction and overdose come into regular contact with primary care providers. Lack of routine addiction screening results in missed treatment opportunities in this setting. We reviewed the literature on screening and brief interventions for addictive disorders in primary care settings, focusing on opioid addiction. Screening and brief interventions can improve health outcomes for chronic illnesses including diabetes, hypertension, and asthma. Similarly, through the use of screening and brief interventions, patients with addiction can achieve improved health outcome. A spectrum of low-threshold care options can reduce the negative health consequences among individuals with opioid addiction. Screening in primary care coupled with short interventions, including motivational interviewing, syringe distribution, naloxone prescription for overdose prevention, and buprenorphine treatment are effective ways to manage addiction and its associated risks and improve health outcomes for individuals with opioid addiction. Copyright © 2013 Elsevier Inc. All rights reserved.

Systematic review of the effectiveness of primary care nursing.

PubMed

Keleher, Helen; Parker, Rhian; Abdulwadud, Omar; Francis, Karen

2009-02-01

This paper reports on a systematic review that sought to answer the research question: What is the impact of the primary and community care nurse on patient health outcomes compared with usual doctor-led care in primary care settings? A range of pertinent text-words with medical subject headings were combined and electronic databases were searched. Because of the volume of published articles, the search was restricted to studies with high-level evidence. Overall, 31 relevant studies were identified and included in the review. We found modest international evidence that nurses in primary care settings can provide effective care and achieve positive health outcomes for patients similar to that provided by doctors. Nurses are effective in care management and achieve good patient compliance. Nurses are also effective in a more diverse range of roles including chronic disease management, illness prevention and health promotion. Nevertheless, there is insufficient evidence about primary care nurses' roles and impact on patient health outcomes.

Contribution of primary care to health: an individual level analysis from Tibet, China.

PubMed

Wang, Wenhua; Shi, Leiyu; Yin, Aitian; Mao, Zongfu; Maitland, Elizabeth; Nicholas, Stephen; Liu, Xiaoyun

2015-11-30

There have been significant improvements in health outcomes in Tibet, health disparities between Tibet and the rest of China has been greatly reduced. This paper tests whether there was a positive association between good primary care and better health outcomes in Tibet. A validated Tibetan version of the Primary Care Assessment Tool (PCAT-T) was used to collect data on 1386 patients aged over 18 years old accessing primary care. Self-rated health (SRH) was employed to measure health outcomes. A multiple binary logistic regression model was used to explore the association between primary care quality and self-rated health status after controlling for socio-demographic and lifestyle variables. This study found that primary care quality had a significant positive association with self-rated health status. Among the nine domains of PCAT-T, family centeredness domain had the highest Odds Ratio (OR = 1.013) with SRH. Patients located in rural area, with higher education levels, without depression, and less frequent drinking were more likely to self-rate as "good health" compared with the reference group. In Tibet, higher quality primary care was associated with better self-rated health status. Primary care should be much strengthened in future health system reform in Tibet.

Echocardiographic predictors of atrial fibrillation recurrence after catheter ablation: A literature review.

PubMed

Liżewska-Springer, Aleksandra; Dąbrowska-Kugacka, Alicja; Lewicka, Ewa; Drelich, Łukasz; Królak, Tomasz; Raczak, Grzegorz

2018-06-20

Catheter ablation (CA) is a well-known treatment option for patients with symptomatic drug-resistant atrial fibrillation (AF). Multiple factors have been identified to determine AF recurrence after CA, however their predictive value is rather small. Identification of novel predictors of CA outcome is therefore of primary importance to reduce health costs and improve long-term results of this intervention. The recurrence of AF following CA is related to the severity of left ventricular (LV) dysfunction, extend of atrial dilatation and fibrosis. The aim of this paper was to present and discuss the latest studies on utility of echocardiographic parameters in terms of CA effectiveness in patients with paroxysmal and persistent AF. PubMed, Google Scholar, EBSCO databases were searched for studies reporting echocardiographic preprocedural predictors of AF recurrence after CA. LV systolic and diastolic function, as well as atrial size, strain and dyssynchrony were taken into consideration. Twenty one full-text articles were analyzed, including three meta-analyses. Several echocardiographic parameters have been reported to determine a risk of AF recurrence after CA. There are conventional methods that measure left atrial (LA) size and volume, LV ejection fraction, parameters assessing LV diastolic dysfunction, and methods using more innovative technologies based on speckle tracking echocardiography (STE) to determine LA synchrony and strain. Each of these parameters has its own predictive value. Regarding CA effectiveness, every patient has to be evaluated individually to estimate the risk of AF recurrence, optimally using a combination of several echocardiographic parameters.

Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial.

PubMed

Nguyen, Trang D; Judd, Peter L; Barrett, Edward J; Sidhu, Nicole; Casas, Michael J

2017-01-15

The purpose of this study was to compare outcomes and survival of ferric sulfate with mineral trioxide aggregate (FS+MTA) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors. In this parallel group noninferiority trial, asymptomatic carious vital primary incisors with pulp exposure in healthy 18- to 46-month-olds were allocated randomly to receive FS+MTA pulpotomy or RCT between September 2010 and September 2012. Each incisor was classified into one of the following radiographic outcomes: N (incisor without pathologic change); Po (pathologic change present, follow-up recommended); Px (pathologic change present, extract.) Clinical findings and incisor survival were secondary outcomes. Seventy subjects were enrolled with a total of 172 incisors. Twelve- and 18-month radiographic outcomes demonstrated no statistical difference between FS+MTA pulpotomy and RCT incisors for Px outcomes (P=0.38; odds ratio equals 0.60; 95 percent confidence interval equals 0.19 to 1.89; chi-square test). There was no statistical differences in clinical outcomes for FS+MTA pulpotomy and RCT at 12 and 18 months (P=0.51; Fisher's exact test) or survival for FS+MTA pulpotomy and RCT incisors (P=0.11; log-rank test). Ferric Sulfate with Mineral Trioxide Aggregate (FS+MTA) is an alternative to RCT for vital primary incisors.

The prognostic value of functional and anatomical parameters for the selection of patients receiving yttrium-90 microspheres for the treatment of liver cancer

NASA Astrophysics Data System (ADS)

Mesoloras, Geraldine

Yttrium-90 (90Y) microsphere therapy is being utilized as a treatment option for patients with primary and metastatic liver cancer due to its ability to target tumors within the liver. The success of this treatment is dependent on many factors, including the extent and type of disease and the nature of prior treatments received. Metabolic activity, as determined by PET imaging, may correlate with the number of viable cancer cells and reflect changes in viable cancer cell volume. However, contouring of PET images by hand is labor intensive and introduces an element of irreproducibility into the determination of functional target/tumor volume (FTV). A computer-assisted method to aid in the automatic contouring of FTV has the potential to substantially improve treatment individualization and outcome assessment. Commercial software to determine FTV in FDG-avid primary and metastatic liver tumors has been evaluated and optimized. Volumes determined using the automated technique were compared to those from manually drawn contours identified using the same cutoff in the standard uptake value (SUV). The reproducibility of FTV is improved through the introduction of an optimal threshold value determined from phantom experiments. Application of the optimal threshold value from the phantom experiments to patient scans was in good agreement with hand-drawn determinations of the FTV. It is concluded that computer-assisted contouring of the FTV for primary and metastatic liver tumors improves reproducibility and increases accuracy, especially when combined with the selection of an optimal SUV threshold determined from phantom experiments. A method to link the pre-treatment assessment of functional (PET based) and anatomical (CT based) parameters to post-treatment survival and time to progression was evaluated in 22 patients with colorectal cancer liver metastases treated using 90Y microspheres and chemotherapy. The values for pre-treatment parameters that were the best predictors of response were determined for FTV, anatomical tumor volume, total lesion glycolysis, and the tumor marker, CEA. Of the parameters considered, the best predictors of response were found to be pre-treatment FTV ≤153 cm3, ATV ≤163 cm3, TLG ≤144 g in the chemo-SIRT treated field, and CEA ≤11.6 ng/mL.

[Ambulatory care of patients with asthma in Germany and disease management program for asthma from the view of statutory health insured patients. A postal survey of statutory health insured patients].

PubMed

Bücker, B; Löscher, S; Schürer, C; Schaper, K; Abholz, H-H; Wilm, S

2015-03-01

In spite of a decline in mortality due to asthma in Germany various studies point towards deficits in asthma care. Our investigation should collect data about ambulatory care from the view of statutory health insured patients (SHI), who participate in the disease management program asthma (DMP-P) or do not (NP). Primary question was, if there is a difference between asthma control. Secondary questions referred to process parameters. The postal inquiry was conducted in 2010 with 8000 randomly selected members of a SHI company with asthma (4000 DMP-P and 4000 NP). The descriptive evaluation of categorical items was performed with cross-tables. The absolute risk reduction (ARR) and 97.5 %-confidence interval (CI; multiple level 5 %) was used to evaluate the primary question. Secondary questions were analysed by ARR and 95 %-CI. The response rate of the questionnaire accounted for 31.1 % (2565). 49.2 % of all respondents lived with an uncontrolled asthma with no differences between DMP-P and NP (ARR -2.7 %, 97.5 %-CI -7.9 -2.4 %). Results did not alter after adjustment for sex and age. The secondary questions revealed significant differences (DMP-P vs. NP) in participation in asthma trainings 50.6 vs. 32.3 %, use of a peak-flow-meter 49.3 vs. 25.3 % and asthma action plan within reach 21.7 vs. 11.0 %. Half of all respondents lives selfreported - even in the DMP-group - with an uncontrolled asthma. Process parameters showed better results in the DMP-group. It can be considered, that the DMP has its desired effect on patient-centered care, but does not lead to a better therapeutic outcome. Explanations can only be assumed: insufficient impact of the process parameters on the outcome, patient behavior, that minimizes a possible effect, or selection effects, if patients, who were more sick and at the same time more motivated, were mainly included in the DMP. These aspects should be addressed in studies with a prospective design. © Georg Thieme Verlag KG Stuttgart · New York.

Do Patients With Borderline Dysplasia Have Inferior Outcomes After Hip Arthroscopic Surgery for Femoroacetabular Impingement Compared With Patients With Normal Acetabular Coverage?

PubMed

Cvetanovich, Gregory L; Levy, David M; Weber, Alexander E; Kuhns, Benjamin D; Mather, Richard C; Salata, Michael J; Nho, Shane J

2017-07-01

The literature contains conflicting reports regarding whether outcomes of hip arthroscopic surgery for patients with borderline dysplasia are inferior to outcomes in patients with normal acetabular coverage. To assess differences in the outcomes of hip arthroscopic surgery for femoroacetabular impingement (FAI) in groups of patients with borderline dysplasia and normal coverage. Cohort study; Level of evidence, 3. A registry of consecutive patients who had undergone primary hip arthroscopic surgery with capsular plication for FAI between January 2012 and January 2014 were divided based on the preoperative lateral center-edge angle (LCEA) into 2 distinct groups: (1) borderline dysplasia (LCEA 18°-25°) and (2) normal acetabular coverage (LCEA 25.1°-40°). There were 36 patients in the borderline dysplastic group and 312 patients in the normal coverage group. The primary outcome measure was the Hip Outcome Score-Activities of Daily Living (HOS-ADL) at a minimum of 2 years postoperatively. Secondary outcome measures included the HOS-Sports and modified Harris Hip Score (mHHS). The mean preoperative LCEA differed significantly between groups (23.4° ± 1.5° for borderline dysplastic, 32.5° ± 3.8° for normal coverage; P < .001). The borderline dysplastic group had a higher percentage of female patients than the normal coverage group (27/36 [75%] vs 177/312 [57%], respectively; P = .048). There were no differences in other preoperative demographics and radiographic parameters. At a minimum 2 years after hip arthroscopic surgery (mean follow-up, 2.6 ± 0.6 years), both groups demonstrated significant improvements in all patient-reported outcome scores ( P < .001 in all cases). There were no significant differences between the borderline dysplastic and normal coverage groups in final outcome scores, score improvements, or percentage of patients experiencing clinically significant improvements. One patient in the borderline dysplastic group (3%) underwent revision hip arthroscopic surgery, and none underwent total hip arthroplasty during the follow-up period. There were no differences between the borderline dysplastic and normal coverage groups with regard to subsequent surgery. Female patients in the borderline dysplastic group had greater improvements in the mean HOS-ADL (25.9 ± 16.3 vs 10.8 ± 18.5, respectively; P = .05) and mHHS (27.9 ± 12.9 vs 8.1 ± 19.0, respectively; P = .005) compared with male patients in the borderline dysplastic group, but male and female patients did not differ in outcomes for the normal coverage group. Patients who underwent hip arthroscopic surgery for FAI with capsular plication experienced significant clinical improvements with low rates of subsequent surgery, regardless of whether their acetabulum had borderline dysplasia or normal coverage.

A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty

PubMed Central

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre

2014-01-01

Objective: To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. Data Sources: PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Review Methods: Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. Results: A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. Conclusion: This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality. PMID:26770730

A Graphical User Interface for Parameterizing Biochemical Models of Photosynthesis and Chlorophyll Fluorescence

NASA Astrophysics Data System (ADS)

Kornfeld, A.; Van der Tol, C.; Berry, J. A.

2015-12-01

Recent advances in optical remote sensing of photosynthesis offer great promise for estimating gross primary productivity (GPP) at leaf, canopy and even global scale. These methods -including solar-induced chlorophyll fluorescence (SIF) emission, fluorescence spectra, and hyperspectral features such as the red edge and the photochemical reflectance index (PRI) - can be used to greatly enhance the predictive power of global circulation models (GCMs) by providing better constraints on GPP. The way to use measured optical data to parameterize existing models such as SCOPE (Soil Canopy Observation, Photochemistry and Energy fluxes) is not trivial, however. We have therefore extended a biochemical model to include fluorescence and other parameters in a coupled treatment. To help parameterize the model, we then use nonlinear curve-fitting routines to determine the parameter set that enables model results to best fit leaf-level gas exchange and optical data measurements. To make the tool more accessible to all practitioners, we have further designed a graphical user interface (GUI) based front-end to allow researchers to analyze data with a minimum of effort while, at the same time, allowing them to change parameters interactively to visualize how variation in model parameters affect predicted outcomes such as photosynthetic rates, electron transport, and chlorophyll fluorescence. Here we discuss the tool and its effectiveness, using recently-gathered leaf-level data.

Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies.

PubMed

Boeckx, Nele; Koukakis, Reija; Op de Beeck, Ken; Rolfo, Christian; Van Camp, Guy; Siena, Salvatore; Tabernero, Josep; Douillard, Jean-Yves; André, Thierry; Peeters, Marc

2018-03-08

The primary tumor location has a prognostic impact in metastatic colorectal cancer (mCRC). We report the results from retrospective analyses assessing the effect of tumor location on prognosis and efficacy of second- and later-line panitumumab treatment in patients with RAS wild-type (WT) mCRC and on prognosis in all lines of treatment in patients with RAS mutant (MT) mCRC. RAS WT data (n = 483) from 2 randomized phase III panitumumab trials (ClinicalTrials.gov identifiers, NCT00339183 and NCT00113763) were analyzed for treatment outcomes stratified by tumor location. The second analysis assessed the effect of tumor location in RAS MT patients (n = 1205) from 4 panitumumab studies (ClinicalTrials.gov identifiers, NCT00364013, NCT00819780, NCT00339183, and NCT00113763). Primary tumors located in the cecum to transverse colon were coded as right-sided; those located from the splenic flexure to the rectum were coded as left-sided. Of all patients, the tumor location was ascertained for 83% to 88%; 71% to 77% of patients had left-sided tumors. RAS WT patients with right-sided tumors did worse for all efficacy parameters compared with those with left-sided tumors. The patients with left-sided tumors had better outcomes with panitumumab than with the comparator treatment. Because of the low patient numbers, no conclusions could be drawn for right-sided mCRC. The prognostic effect of tumor location on survival was unclear for RAS MT patients. These retrospective analyses have confirmed that RAS WT right-sided mCRC is associated with a poor prognosis, regardless of the treatment. RAS WT patients with left-sided tumors benefitted from the addition of panitumumab in second or later treatment lines. Further research is warranted to determine the optimum management of right-sided mCRC and RAS MT tumors. Copyright © 2018 Elsevier Inc. All rights reserved.

Information Literacy for Archives and Special Collections: Defining Outcomes

ERIC Educational Resources Information Center

Carini, Peter

2016-01-01

This article provides the framework for a set of standards and outcomes that would constitute information literacy with primary sources. Based on a working model used at Dartmouth College's Rauner Special Collections Library in Hanover, New Hampshire, these concepts create a framework for teaching with primary source materials intended to produce…

Physical Education in Primary Schools: Classroom Teachers' Perceptions of Benefits and Outcomes

ERIC Educational Resources Information Center

Morgan, Philip J.; Hansen, Vibeke

2008-01-01

Objective: The aim of the current study was to examine the perceptions of classroom teachers regarding the benefits and outcomes of their PE programs. Design: Cross-sectional. Setting: Thirty eight randomly selected primary schools in New South Wales (NSW), Australia. Method: A mixed-mode methodology was utilized, incorporating semi-structured…

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

PubMed

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

2018-03-01

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

Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study.

PubMed

Brocklehurst, Peter; Hardy, Pollyanna; Hollowell, Jennifer; Linsell, Louise; Macfarlane, Alison; McCourt, Christine; Marlow, Neil; Miller, Alison; Newburn, Mary; Petrou, Stavros; Puddicombe, David; Redshaw, Maggie; Rowe, Rachel; Sandall, Jane; Silverton, Louise; Stewart, Mary

2011-11-23

To compare perinatal outcomes, maternal outcomes, and interventions in labour by planned place of birth at the start of care in labour for women with low risk pregnancies. Prospective cohort study. England: all NHS trusts providing intrapartum care at home, all freestanding midwifery units, all alongside midwifery units (midwife led units on a hospital site with an obstetric unit), and a stratified random sample of obstetric units. 64,538 eligible women with a singleton, term (≥37 weeks gestation), and "booked" pregnancy who gave birth between April 2008 and April 2010. Planned caesarean sections and caesarean sections before the onset of labour and unplanned home births were excluded. A composite primary outcome of perinatal mortality and intrapartum related neonatal morbidities (stillbirth after start of care in labour, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus, or fractured clavicle) was used to compare outcomes by planned place of birth at the start of care in labour (at home, freestanding midwifery units, alongside midwifery units, and obstetric units). There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5). Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units. For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting. For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. Interventions during labour were substantially lower in all non-obstetric unit settings. Transfers from non-obstetric unit settings were more frequent for nulliparous women (36% to 45%) than for multiparous women (9% to 13%). The results support a policy of offering healthy women with low risk pregnancies a choice of birth setting. Women planning birth in a midwifery unit and multiparous women planning birth at home experience fewer interventions than those planning birth in an obstetric unit with no impact on perinatal outcomes. For nulliparous women, planned home births also have fewer interventions but have poorer perinatal outcomes.

Red Cell Distribution Width and Other Red Blood Cell Parameters in Patients with Cancer: Association with Risk of Venous Thromboembolism and Mortality

PubMed Central

Riedl, Julia; Posch, Florian; Königsbrügge, Oliver; Lötsch, Felix; Reitter, Eva-Maria; Eigenbauer, Ernst; Marosi, Christine; Schwarzinger, Ilse; Zielinski, Christoph; Pabinger, Ingrid; Ay, Cihan

2014-01-01

Background Cancer patients are at high risk of developing venous thromboembolism (VTE). Red cell distribution width (RDW) has been reported to be associated with arterial and venous thrombosis and mortality in several diseases. Here, we analyzed the association between RDW and other red blood cell (RBC) parameters with risk of VTE and mortality in patients with cancer. Methods RBC parameters were measured in 1840 patients with cancers of the brain, breast, lung, stomach, colon, pancreas, prostate, kidney; lymphoma, multiple myeloma and other tumor sites, that were included in the Vienna Cancer and Thrombosis Study (CATS), which is an ongoing prospective, observational cohort study of patients with newly diagnosed or progressive cancer after remission. Primary study outcome is occurrence of symptomatic VTE and secondary outcome is death during a maximum follow-up of 2 years. Results During a median follow-up of 706 days, 131 (7.1%) patients developed VTE and 702 (38.2%) died. High RDW (>16%) was not associated with a higher risk of VTE in the total study cohort; in competing risk analysis accounting for death as competing variable the univariable subhazard ratio (SHR) was 1.34 (95% confidence interval [CI]: 0.80–2.23, p = 0.269). There was also no significant association between other RBC parameters and risk of VTE. High RDW was associated with an increased risk of mortality in the total study population (hazard ratio [HR, 95% CI]: 1.72 [1.39–2.12], p<0.001), and this association prevailed after adjustment for age, sex, hemoglobin, leukocyte and platelet count (HR [95% CI]: 1.34 [1.06–1.70], p = 0.016). Conclusions RDW and other RBC parameters were not independently associated with risk of VTE in patients with cancer and might therefore not be of added value for estimating risk of VTE in patients with cancer. We could confirm that high RDW is an independent predictor of poor overall survival in cancer. PMID:25347577

Effect of Frequent or Extended Hemodialysis on Cardiovascular Parameters: A Meta-analysis

PubMed Central

Susantitaphong, Paweena; Koulouridis, Ioannis; Balk, Ethan M.; Madias, Nicolaos E.; Jaber, Bertrand L.

2012-01-01

Background Increased left ventricular (LV) mass is a risk factor for cardiovascular mortality in patients with chronic kidney failure. More frequent or extended hemodialysis (HD) has been hypothesized to have a beneficial effect on LV mass. Study Design Meta-analysis. Setting & Population MEDLINE literature search (inception-April 2011), Cochrane Central Register of Controlled Trials and ClinicalTrials.gov using the search terms “short daily HD”, “daily HD”, “quotidian HD”, “frequent HD”, “intensive HD”, “nocturnal HD”, and “home HD”. Selection Criteria for Studies Single-arm cohort studies (with pre- and post-study evaluations) and randomized controlled trials examining the effect of frequent or extended HD on cardiac morphology and function, and blood pressure parameters. Studies of hemofiltration, hemodiafiltration and peritoneal dialysis were excluded. Intervention Frequent (2–8 hours,> thrice weekly) or extended (>4 hours, thrice weekly) HD as compared with conventional (≤ 4 hours, thrice weekly) HD. Outcomes Absolute changes in cardiac morphology and function, including LV mass index (LVMI) (primary), and blood pressure parameters (secondary). Results We identified 38 single-arm studies, 5 crossover trials and 3 randomized controlled trials. By meta-analysis of 23 study arms, frequent or extended HD significantly reduced LVMI from baseline (−31.2 g/m2, 95% CI, −39.8 to −22.5; P<0.001).The 3 randomized trials found a less pronounced net reduction in LVMI (−7.0 g/m2; 95% CI, −10.2 to −3.7; P<0.001). LV ejection fraction improved by 6.7% (95% CI, 1.6 to 11.9; P=0.01). Other cardiac morphological parameters displayed similar improvements. There were also significant decreases in systolic, diastolic, and mean blood pressure, and mean number of anti-hypertensive medications. Limitations Paucity of randomized controlled trials. Conclusions Conversion from conventional to frequent or extended HD is associated with an improvement in cardiac morphology and function, including LVMI and LV ejection fraction, respectively, and in several blood pressure parameters, which collectively might confer long-term cardiovascular benefit. Trials with long-term clinical outcomes are needed. PMID:22370022

Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

PubMed

Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

2017-10-01

Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy. Despite trial registration being an accepted best practice, RCTs published in anesthesiology journals have a high rate of inadequate registration. While mandating trial registration has increased the proportion of adequately registered trials over time, there is still an unacceptably high proportion of inadequately registered RCTs. Among adequately registered trials, there are high rates of discrepancies between registered and reported outcomes, suggesting a need to compare a published RCT with its trial registry entry to be able to fully assess the quality of the study. If clinicians base their decisions on evidence distorted by primary outcome switching, patient care could be negatively affected.

Return to Sports and Physical Activities After Primary Partial Arthrodesis for Lisfranc Injuries in Young Patients.

PubMed

MacMahon, Aoife; Kim, Paul; Levine, David S; Burket, Jayme; Roberts, Matthew M; Drakos, Mark C; Deland, Jonathan T; Elliott, Andrew J; Ellis, Scott J

2016-04-01

Research regarding outcomes in sports and physical activities after primary partial arthrodesis for Lisfranc injuries has been sparse. The purposes of this study were to assess various sports and physical activities in young patients following primary partial arthrodesis for Lisfranc injuries and to compare these with clinical outcomes. Patients who underwent primary partial arthrodesis for a Lisfranc injury were identified by a retrospective registry review. Thirty-eight of 46 eligible patients (83%) responded for follow-up at a mean of 5.2 (range, 1.0 to 9.3) years with a mean age at surgery of 31.8 (range, 16.8 to 50.3) years. Physical activity participation was assessed with a new sports-specific, patient-administered questionnaire. Clinical outcomes were assessed with the Foot and Ankle Outcome Score (FAOS). Patients participated in 29 different and 155 total physical activities preoperatively, and 27 different and 145 total physical activities postoperatively. Preoperatively, 47.1% were high impact, and postoperatively, 44.8% were high impact. The most common activities were walking, bicycling, running, and weightlifting. Compared to preoperatively, difficulty was the same in 66% and increased in 34% of physical activities. Participation levels were improved in 11%, the same in 64%, and impaired in 25% of physical activities. Patients spent on average 4.2 (range, 0.0 to 19.8) hours per week exercising postoperatively. In regard to return to physical activity, 97% of respondents were satisfied with their operative outcome. Mean postoperative FAOS subscores were significantly worse for patients who had increased physical activity difficulty. Most patients were able to return to their previous physical activities following primary partial arthrodesis for a Lisfranc injury, many of which were high-impact. However, the decreased participation or increase in difficulty of some activities suggests that some patients experienced postoperative limitations in exercise. Future studies could compare sports outcomes between primary partial arthrodesis and open reduction internal fixation for Lisfranc injuries. Level IV, retrospective case series. © The Author(s) 2015.

Primary percutaneous coronary intervention for acute ST elevation myocardial infarction: Outcomes and determinants of outcomes: A tertiary care center study from North India.

PubMed

Dubey, Gajendra; Verma, Sunil Kumar; Bahl, Vinay Kumar

Primary percutaneous coronary intervention (PCI) is the current standard of care for acute ST elevation myocardial infarction (STEMI). Most of the data on primary PCI in acute STEMI is from western countries. We studied the outcomes of primary PCI for acute STEMI at a tertiary care center in North India. Consecutive patients undergoing primary PCI for STEMI were prospectively studied during the period from February 2103 to May 2015. The outcomes assessed were all cause in hospital mortality, factors associated with mortality, major adverse cardiac and cerebrovascular event rate (composite of all cause in hospital mortality, non-fatal re infarction and stroke) and procedural complications. 371 patients underwent primary PCI during the study period. The mean age was 54 years and 82.7% were males. The mean total ischemia time and door to balloon times were 6.8h and 51min respectively. 96.4% patients underwent successful primary PCI. The total in hospital mortality was 12.9%. Mortality with cardiogenic shock at presentation was 66.7% while non-shock mortality was 2.6%. In hospital MACCE rate was 13.5%. Factors significantly associated with mortality were KILLIP class (OR: 8.4), door to balloon time (OR 1.02), final TIMI flow (OR 0.44) and severe LV dysfunction (OR 22.0). Procedure related adverse events were rare and there was no non-CABG associated major TIMI bleeding. Primary PCI for acute STEMI is feasible in our setup and associated with high success rate, low mortality in non-shock patients and low complication rates. Copyright © 2016. Published by Elsevier B.V.

Risk prediction with triglycerides in patients with stable coronary disease on statin treatment.

PubMed

Werner, Christian; Filmer, Anja; Fritsch, Marco; Groenewold, Stephanie; Gräber, Stefan; Böhm, Michael; Laufs, Ulrich

2014-12-01

The aim of the prospective Homburg Cream and Sugar study was to analyze the role of fasting and postprandial serum triglycerides (TG) as risk modifiers in patients with coronary artery disease (CAD). A sequential oral triglyceride and glucose tolerance test was developed to obtain standardized measurements of postprandial TG kinetics and glucose in 514 consecutive patients with stable CAD confirmed by angiography (95% were treated with a statin). Fasting and postprandial TG predicted the primary outcome measure of cardiovascular death and hospitalizations after 48 months follow-up (fasting TG >150 vs. <106 mg/dl: Hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.31-2.45, p = 0.0001; area under the curve >1120 vs. <750 mg/dl/5 hr: HR 1.78, 95% CI 1.29-2.45, p = 0.0003). Parameters of the postprandial TG increase did not improve risk prediction compared to fasting TG. The number of cardiovascular deaths and myocardial infarctions was higher in the upper tertile of fasting TG (HR 1.79, 95%-CI 1.04-3.09, p = 0.03). Risk prediction by TG was independent of traditional risk factors, medication, glucose metabolism, LDL- and HDL-cholesterol. Total cholesterol, LDL- and HDL-cholesterol concentrations were not associated with the primary outcome. Fasting serum triglycerides >150 mg/dl independently predict cardiovascular events in patients with coronary artery disease on guideline-recommended medication. Assessment of postprandial TG does not improve risk prediction compared to fasting TG in these patients.

Long-term survivors of primary central nervous system lymphoma.

PubMed

Yamanaka, Ryuya; Morii, Ken; Sano, Masakazu; Homma, Jumpei; Yajima, Naoki; Tsukamoto, Yoshihiro; Ogura, Ryouske; Natsumeda, Manabu; Aoki, Hiroshi; Akiyama, Katsuhiko; Saitoh, Takafumi; Hondoh, Hiroaki; Kawaguchi, Atsushi; Takahashi, Hitoshi; Fujii, Yukihiko

2017-02-23

In this study, we provide long-term outcome data of patients with primary central nervous system lymphoma. The long-term outcomes of PCNSL patients diagnosed between 1982 and 2006 were reviewed. Neurological late neurotoxicity symptoms, neuroradiological brain atrophy and leukoencephalopathy were evaluated. Surviving patients completed the Quality of Life Questionnaire-30 and Brain Cancer Module-20. The differences in overall survival were assessed using the Kaplan-Meier method and log-rank test. The differences between groups in terms of each investigated parameter were analyzed using the Wilcoxon signed-rank test. Among 112 PCNSL patients, there were 33 (29.4%) long-term (> 5 years) survivors. The median survival of all long-term survivors was 105.7 months; of these, 8 (7.1%) were alive at the latest follow-up, with a mean survival time of 170.2 months (range, 121.8–286.4). Clinical assessment revealed severe neurotoxicity in 14 patients (42.4%), moderate neurotoxicity in 5 (15.1%), and normal status in 14 (42.4%). Correlations were seen between the neuroradiological imaging score changes and neurocognitive condition (P=0.0001), neurocognitive condition and the whole brain irradiation dose (P=0.0004), and atrophy and the whole brain irradiation dose (P=0.0035). A more severe clinical condition was found to be associated with increasing age and whole brain irradiation dose in long-term survivors with PCNSL. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Hitting the Optimal Vaccination Percentage and the Risks of Error: Why to Miss Right.

PubMed

Harvey, Michael J; Prosser, Lisa A; Messonnier, Mark L; Hutton, David W

2016-01-01

To determine the optimal level of vaccination coverage defined as the level that minimizes total costs and explore how economic results change with marginal changes to this level of coverage. A susceptible-infected-recovered-vaccinated model designed to represent theoretical infectious diseases was created to simulate disease spread. Parameter inputs were defined to include ranges that could represent a variety of possible vaccine-preventable conditions. Costs included vaccine costs and disease costs. Health benefits were quantified as monetized quality adjusted life years lost from disease. Primary outcomes were the number of infected people and the total costs of vaccination. Optimization methods were used to determine population vaccination coverage that achieved a minimum cost given disease and vaccine characteristics. Sensitivity analyses explored the effects of changes in reproductive rates, costs and vaccine efficacies on primary outcomes. Further analysis examined the additional cost incurred if the optimal coverage levels were not achieved. Results indicate that the relationship between vaccine and disease cost is the main driver of the optimal vaccination level. Under a wide range of assumptions, vaccination beyond the optimal level is less expensive compared to vaccination below the optimal level. This observation did not hold when the cost of the vaccine cost becomes approximately equal to the cost of disease. These results suggest that vaccination below the optimal level of coverage is more costly than vaccinating beyond the optimal level. This work helps provide information for assessing the impact of changes in vaccination coverage at a societal level.

Role of Positron Emission Tomography in the Treatment of Occult Disease in Head-and-Neck Cancer: A Modeling Approach

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

Phillips, Mark H., E-mail: markp@u.washington.ed; Smith, Wade P.; Parvathaneni, Upendra

2011-03-15

Purpose: To determine under what conditions positron emission tomography (PET) imaging will be useful in decisions regarding the use of radiotherapy for the treatment of clinically occult lymph node metastases in head-and-neck cancer. Methods and Materials: A decision model of PET imaging and its downstream effects on radiotherapy outcomes was constructed using an influence diagram. This model included the sensitivity and specificity of PET, as well as the type and stage of the primary tumor. These parameters were varied to determine the optimal strategy for imaging and therapy for different clinical situations. Maximum expected utility was the metric by whichmore » different actions were ranked. Results: For primary tumors with a low probability of lymph node metastases, the sensitivity of PET should be maximized, and 50 Gy should be delivered if PET is positive and 0 Gy if negative. As the probability for lymph node metastases increases, PET imaging becomes unnecessary in some situations, and the optimal dose to the lymph nodes increases. The model needed to include the causes of certain health states to predict current clinical practice. Conclusion: The model demonstrated the ability to reproduce expected outcomes for a range of tumors and provided recommendations for different clinical situations. The differences between the optimal policies and current clinical practice are likely due to a disparity between stated clinical decision processes and actual decision making by clinicians.« less

A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols.

PubMed

Newton, Robert L; Johnson, William D; Hendrick, Chelsea; Harris, Melissa; Andrews, Emanuel; Johannsen, Neil; Rodarte, Ruben Q; Hsia, Daniel S; Church, Timothy S

2015-07-01

Lack of regular physical activity at prescribed intensity levels is a modifiable risk factor for insulin resistance and the development of diabetes. African American men are at increased risk for developing diabetes and most African American men are not meeting the current recommended levels of physical activity. The primary objective of the Aerobic Plus Resistance Training and Insulin Resistance in African American Men (ARTIIS) study is to determine the effectiveness of an exercise training intervention aimed at reducing diabetes risk factors in African American men at risk for developing diabetes. Insufficiently active 35-70 year old African American men with a family history of diabetes were eligible for the study. The 5-month randomized controlled trial assigns 116 men to an exercise training or healthy living control arm. The exercise training arm combines aerobic and resistance training according to the current national physical activity recommendations and is conducted in community (YMCA) facilities. The healthy living arm receives information promoting healthy lifestyle changes. Insulin response to an oral glucose load is the primary outcome measure, and changes in physiological parameters, cardiorespiratory fitness, strength, body composition, and psychological well-being comprise the secondary outcomes. The ARTIIS study is one of the first adequately powered, rigorously designed studies to investigate the effects of an aerobic plus resistance exercise training program and to assess adherence to exercise training in community facilities, in African American men. Copyright © 2015 Elsevier Inc. All rights reserved.

A meta-analysis of vitrectomy with or without internal limiting membrane peeling for macular hole retinal detachment in the highly myopic eyes.

PubMed

Gao, Xinxiao; Guo, Jia; Meng, Xin; Wang, Jun; Peng, Xiaoyan; Ikuno, Yasushi

2016-06-13

To evaluate the anatomical and visual outcomes by par plana vitrectomy with or without internal limiting membrane (ILM) peeling in highly myopic eyes with macular hole retinal detachment (MHRD). MEDLINE (Ovid, PubMed) and EMBASE were used for data collection up to September 30, 2015. The parameters of anatomical success, macular hole closure and improved best corrected visual acuity (BCVA) at or beyond 6 months after operation were assessed as the primary outcome measurement. The meta-analysis was performed with the fixed-effects model. Seven comparative analyses involving a total of 373 patients were included in the present meta-analysis. Statistically the pooled data showed significant relative risk (RR) in terms of primary reattachment between ILM peeling and non-peeling groups (RR, 1.19; 95 % CI, 1.04 to 1.36; P = 0.012). An effect favoring ILM peeling with regard to macular hole closure was also detected (RR, 1.71; 95 % CI, 1.20 to 2.43; P = 0.003). However, no statistically significant difference was found in the improved BCVA (logarithm of the minimum angle of resolution) at 6 months or more (95 % CI, -0.31 to 0.44; P = 0.738). There is no proved benefit of postoperative visual improvement. However, the available evidences from this study suggested a superiority of ILM peeling over no peeling for myopic patients with MHRD.

Local or General Anesthesia for Open Hernia Repair: A Randomized Trial

PubMed Central

O’Dwyer, Patrick J.; Serpell, Michael G.; Millar, Keith; Paterson, Caron; Young, David; Hair, Alan; Courtney, Carol-Ann; Horgan, Paul; Kumar, Sudhir; Walker, Andrew; Ford, Ian

2003-01-01

Objective To compare patient outcome following repair of a primary groin hernia under local (LA) or general anesthesia (GA) in a randomized clinical trial. Summary Background Data LA hernia repair is thought to be safer for patients, causes less postoperative pain, cost less, and is associated with a more rapid recovery when compared with the same operation performed under GA. Methods All patients presenting to three surgeons during the study period with a primary groin hernia were considered eligible. Outcome parameters measured including tests of vigilance, divided attention, sustained attention, memory, cognitive function, pain, return to normal activity, and costs. Results Two hundred seventy-nine patients were randomized to LA or GA hernia repair; 276 of these had an operation, with 138 participants in each group. At 6, 24, and 72 hours postoperatively there were no differences in vigilance or divided attention between the groups. Similarly, memory, sustained attention, and cognitive function were not impaired in either group. Although physical activity was significantly impaired at 24 hours, this and return to usual social activities were similar in both groups. While patients in the LA group had significantly less pain on moving, at 6 hours they were less likely to recommend the same operation to someone else. GA hernia repair cost 4% more than the same operation under LA. Conclusions There are no major differences in patient recovery after LA or GA hernia repair. Patients should be offered a choice of anesthesia, LA or GA, for repair of their groin hernia. PMID:12677155

Moderators of remission with interpersonal counselling or drug treatment in primary care patients with depression: randomised controlled trial.

PubMed

Menchetti, Marco; Rucci, Paola; Bortolotti, Biancamaria; Bombi, Annarosa; Scocco, Paolo; Kraemer, Helena Chmura; Berardi, Domenico

2014-02-01

Despite depressive disorders being very common there has been little research to guide primary care physicians on the choice of treatment for patients with mild to moderate depression. To evaluate the efficacy of interpersonal counselling compared with selective serotonin reuptake inhibitors (SSRIs), in primary care attenders with major depression and to identify moderators of treatment outcome. A randomised controlled trial in nine centres (DEPICS, Australian New Zealand Clinical Trials Registry number: ACTRN12608000479303). The primary outcome was remission of the depressive episode (defined as a Hamilton Rating Scale for Depression score ≤7 at 2 months). Daily functioning was assessed using the Work and Social Adjustment Scale. Logistic regression models were used to identify moderators of treatment outcome. The percentage of patients who achieved remission at 2 months was significantly higher in the interpersonal counselling group compared with the SSRI group (58.7% v. 45.1%, P = 0.021). Five moderators of treatment outcome were found: depression severity, functional impairment, anxiety comorbidity, previous depressive episodes and smoking habit. We identified some patient characteristics predicting a differential outcome with pharmacological and psychological interventions. Should our results be confirmed in future studies, these characteristics will help clinicians to define criteria for first-line treatment of depression targeted to patients' characteristics.

What counts: outcome assessment after distal radius fractures in aged patients.

PubMed

Goldhahn, Jörg; Angst, Felix; Simmen, Beat R

2008-09-01

Outcome of surgical interventions at the distal radius does not only depend on the type of intervention used, it also depends on the way the outcome is measured. Substantial differences in outcome assessment between different measurement tools and poor correlation among them result in the question about the best instrument for the evaluation of treatment after distal radius fractures. The aim of the review is to discuss pros and cons of the parameters that are available to assess the outcome after distal radius fractures. The review should help to choose the appropriate instruments for a given research question in aged patients with distal radius fractures. Objective and subjective measures were reviewed with respect to their suitability in outcome assessment. Radiological parameters like inclination, palmar slope, and length of the radius are most common and used to determine especially surgical success. Grip strength and range of motion are considered objective and used as study endpoints in many studies. Functional tests like the Jebsen test provide a realistic feedback about disability but require special skills and resources of the testing personnel. Patient self-assessment adds perceived patient benefit. The patient-rated wrist evaluation (PRWE) provides a reliable and valid instrument for subjective outcome assessment. A combination of objective and subjective parameters should be used to assess the outcome of different treatment strategies due to the known discrepancies. Objective parameters like shortening, radial shift, or others should be clearly defined in the study methodology.

Octanoic acid in alcohol-responsive essential tremor

PubMed Central

McCrossin, Gayle; Lungu, Codrin; Considine, Elaine; Toro, Camilo; Nahab, Fatta B.; Auh, Sungyoung; Buchwald, Peter; Grimes, George J.; Starling, Judith; Potti, Gopal; Scheider, Linda; Kalowitz, Daniel; Bowen, Daniel; Carnie, Andrea; Hallett, Mark

2013-01-01

Objective: To assess safety and efficacy of an oral, single, low dose of octanoic acid (OA) in subjects with alcohol-responsive essential tremor (ET). Methods: We conducted a double-blind, placebo-controlled, crossover, phase I/II clinical trial evaluating the effect of 4 mg/kg OA in 19 subjects with ET. The primary outcome was accelerometric postural tremor power of the dominant hand 80 minutes after administration. Secondary outcomes included digital spiral analysis, pharmacokinetic sampling, as well as safety measures. Results: OA was safe and well tolerated. Nonserious adverse events were mild (Common Terminology Criteria for Adverse Events grade 1) and equally present after OA and placebo. At the primary outcome, OA effects were not different from placebo. Secondary outcome analyses of digital spiral analysis, comparison across the entire time course in weighted and nonweighted accelerometry, as well as nondominant hand tremor power did not show a benefit of OA over placebo. The analysis of individual time points showed that OA improved tremor at 300 minutes (dominant hand, F1,16 = 5.49, p = 0.032 vs placebo), with a maximum benefit at 180 minutes after OA (both hands, F1,16 = 6.1, p = 0.025). Conclusions: Although the effects of OA and placebo at the primary outcome were not different, secondary outcome measures suggest superiority of OA in reducing tremor at later time points, warranting further trials at higher dose levels. Classification of evidence: This study provides Class I evidence that a single 4-mg/kg dose of OA is not effective in reducing postural tremor in patients with ET at a primary outcome of 80 minutes, but is effective for a secondary outcome after 180 minutes. PMID:23408867

A systematic review of chronic disease management interventions in primary care.

PubMed

Reynolds, Rebecca; Dennis, Sarah; Hasan, Iqbal; Slewa, Jan; Chen, Winnie; Tian, David; Bobba, Sangeetha; Zwar, Nicholas

2018-01-09

Primary and community care are key settings for the effective management of long term conditions. We aimed to evaluate the pattern of health outcomes in chronic disease management interventions for adults with physical health problems implemented in primary or community care settings. The methods were based on our previous review published in 2006. We performed database searches for articles published from 2006 to 2014 and conducted a systematic review with narrative synthesis using the Cochrane Effective Practice and Organisation of Care taxonomy to classify interventions and outcomes. The interventions were mapped to Chronic Care Model elements. The pattern of outcomes related to interventions was summarized by frequency of statistically significant improvements in health care provision and patient outcomes. A total of 9589 journal articles were retrieved from database searches and snowballing. After screening and verification, 165 articles that detailed 157 studies were included. There were few studies with Health Care Organization (1.9% of studies) or Community Resources (0.6% of studies) as the primary intervention element. Self-Management Support interventions (45.8% of studies) most frequently resulted in improvements in patient-level outcomes. Delivery System Design interventions (22.6% of studies) showed benefits in both professional and patient-level outcomes for a narrow range of conditions. Decision Support interventions (21.3% of studies) had impact limited to professional-level outcomes, in particular use of medications. The small number of studies of Clinical Information System interventions (8.9%) showed benefits for both professional- and patient-level outcomes. The published literature has expanded substantially since 2006. This review confirms that Self-Management Support is the most frequent Chronic Care Model intervention that is associated with statistically significant improvements, predominately for diabetes and hypertension.

Shoulder dystocia in primary midwifery care in the Netherlands.

PubMed

Kallianidis, Athanasios F; Smit, Marrit; Van Roosmalen, Jos

2016-02-01

In the Netherlands, low-risk pregnancies are managed by midwives in primary care. Despite strict definitions of low risk, obstetric complications can occur. Midwives seldom encounter uncommon labour complications, but are sufficiently trained to manage these. We assessed neonatal and maternal outcome after management of shoulder dystocia in primary midwifery care. In this 2-year prospective cohort study from April 2008 to April 2010, primary-care midwives, who participated in an obstetric emergency course, reported all obstetric complications. Main outcome was neonatal and maternal outcome. In sixty-four cases of shoulder dystocia McRoberts was the first maneuver in 42/64 (65.6%) cases with a success rate of 23.8%. All-fours maneuver was most frequently used as the second maneuver (24/45; 53.3%). No neonatal mortality occurred, none of the infants suffered from hypoxic ischemic injury, two (3.1%) had transient brachial plexus injuries, two (3.1%) had fractured clavicles and one (1.6%) had a fractured humerus. Eight (12.5%) neonates were successfully resuscitated because of birth asphyxia. All infants fully recovered. In neonates with immediate adverse outcome significantly more maneuvers were used compared with those without adverse neonatal outcome (p = 0.02). Postpartum hemorrhage occurred in 2/64 (3.1%) women, deep vaginal lacerations in 2/64 (3.1%), perineal tears in 23/64 (35.9%). No anal sphincter injuries occurred. McRoberts and all-fours maneuvers are widely used by primary-care midwives in the management of shoulder dystocia. Low rates of adverse neonatal and maternal outcomes were observed in cases of shoulder dystocia up to 6 weeks postpartum. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Effect of renal function status on the prognostic value of heart rate in acute ischemic stroke patients.

PubMed

Zhu, Zhengbao; Zhong, Chongke; Xu, Tian; Wang, Aili; Peng, Yanbo; Xu, Tan; Peng, Hao; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Geng, Deqin; Sun, Yingxian; Du, Qingjuan; Li, Yongqiu; Chen, Jing; Zhang, Yonghong; He, Jiang

2017-08-01

The association between heart rate and prognosis of ischemic stroke remains debatable, and whether renal function status influences the relationship between them is still not elucidated. A total of 3923 ischemic stroke patients were included in this prospective multicenter study from the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS). The primary outcome was a combination of death and major disability (modified Rankin Scale score ≥3) at 3 months after stroke. Secondary outcomes were, separately, death and major disability. The association between heart rate tertiles and primary outcome was appreciably modified by renal function status (p interaction  = 0.037). After multivariate adjustment, high heart rate was associated with increased risk of primary outcome in patients with abnormal renal function (odds ratio, 1.61; 95% confidence interval, 1.02-2.54; p trend  = 0.039) but not in patients with normal renal function (odds ratio, 0.96; 95% confidence interval, 0.75-1.23; p trend  = 0.741), when two extreme tertiles were compared. Each 10 bpm increase of heart rate was associated with 21% (95% CI: 1%-44%) increased risk of primary outcome, and a linear association between heart rate and risk of primary outcome was observed among patients with abnormal renal function (p for linearity = 0.002). High heart rate may be merely a strong predictor of poor prognosis in acute ischemic stroke patients with abnormal renal function, suggesting that heart rate reduction should be applied to ischemic stroke patients with abnormal renal function to improve their prognosis. Copyright © 2017 Elsevier B.V. All rights reserved.

Variability in in vitro fertilization outcomes of prepubertal goat oocytes explained by basic semen analyses.

PubMed

Palomo, M J; Quintanilla, R; Izquierdo, M D; Mogas, T; Paramio, M T

2016-12-01

This work analyses the changes that caprine spermatozoa undergo during in vitro fertilization (IVF) of in vitro matured prepubertal goat oocytes and their relationship with IVF outcome, in order to obtain an effective model that allows prediction of in vitro fertility on the basis of semen assessment. The evolution of several sperm parameters (motility, viability and acrosomal integrity) during IVF and their relationship with three IVF outcome criteria (total penetration, normal penetration and cleavage rates) were studied in a total of 56 IVF replicates. Moderate correlation coefficients between some sperm parameters and IVF outcome were observed. In addition, stepwise multiple regression analyses were conducted that considered three grouping of sperm parameters as potential explanatory variables of the three IVF outcome criteria. The proportion of IVF outcome variation that can be explained by the fitted models ranged from 0.62 to 0.86, depending upon the trait analysed and the variables considered. Seven out of 32 sperm parameters were selected as partial covariates in at least one of the nine multiple regression models. Among these, progressive sperm motility assessed immediately after swim-up, the percentage of dead sperm with intact acrosome and the incidence of acrosome reaction both determined just before the gamete co-culture, and finally the proportion of viable spermatozoa at 17 h post-insemination were the most frequently selected sperm parameters. Nevertheless, the predictive ability of these models must be confirmed in a larger sample size experiment.

Preoperative nutrition status and postoperative outcome in elderly general surgery patients: a systematic review.

PubMed

van Stijn, Mireille F M; Korkic-Halilovic, Ines; Bakker, Marjan S M; van der Ploeg, Tjeerd; van Leeuwen, Paul A M; Houdijk, Alexander P J

2013-01-01

Poor nutrition status is considered a risk factor for postoperative complications in the adult population. In elderly patients, who often have a poor nutrition status, this relationship has not been substantiated. Thus, the aim of this systematic review was to assess the merit of preoperative nutrition parameters used to predict postoperative outcome in elderly patients undergoing general surgery. A systematic literature search of 10 consecutive years, 1998-2008, in PubMed, EMBASE, and Cochrane databases was performed. Search terms used were nutrition status, preoperative assessment, postoperative outcome, and surgery (hip or general), including their synonyms and MeSH terms. Limits used in the search were human studies, published in English, and age (65 years or older). Articles were screened using inclusion and exclusion criteria. All selected articles were checked on methodology and graded. Of 463 articles found, 15 were included. They showed profound heterogeneity in the parameters used for preoperative nutrition status and postoperative outcome. The only significant preoperative predictors of postoperative outcome in elderly general surgery patients were serum albumin and ≥ 10% weight loss in the previous 6 months. This systematic review revealed only 2 preoperative parameters to predict postoperative outcome in elderly general surgery patients: weight loss and serum albumin. Both are open to discussion in their use as a preoperative nutrition parameter. Nonetheless, serum albumin seems a reliable preoperative parameter to identify a patient at risk for nutrition deterioration and related complicated postoperative course.

Surrogate outcomes in health technology assessment: an international comparison.

PubMed

Velasco Garrido, Marcial; Mangiapane, Sandra

2009-07-01

Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Antigen expression level threshold tunes the fate of CD8 T cells during primary hepatic immune responses.

PubMed

Tay, Szun Szun; Wong, Yik Chun; McDonald, David M; Wood, Nicole A W; Roediger, Ben; Sierro, Frederic; Mcguffog, Claire; Alexander, Ian E; Bishop, G Alex; Gamble, Jennifer R; Weninger, Wolfgang; McCaughan, Geoffrey W; Bertolino, Patrick; Bowen, David G

2014-06-24

CD8 T-cell responses to liver-expressed antigens range from deletional tolerance to full effector differentiation resulting in overt hepatotoxicity. The reasons for these heterogeneous outcomes are not well understood. To identify factors that govern the fate of CD8 T cells activated by hepatocyte-expressed antigen, we exploited recombinant adenoassociated viral vectors that enabled us to vary potential parameters determining these outcomes in vivo. Our findings reveal a threshold of antigen expression within the liver as the dominant factor determining T-cell fate, irrespective of T-cell receptor affinity or antigen cross-presentation. Thus, when a low percentage of hepatocytes expressed cognate antigen, high-affinity T cells developed and maintained effector function, whereas, at a high percentage, they became functionally exhausted and silenced. Exhaustion was not irreversibly determined by initial activation, but was maintained by high intrahepatic antigen load during the early phase of the response; cytolytic function was restored when T cells primed under high antigen load conditions were transferred into an environment of low-level antigen expression. Our study reveals a hierarchy of factors dictating the fate of CD8 T cells during hepatic immune responses, and provides an explanation for the different immune outcomes observed in a variety of immune-mediated liver pathologic conditions.

The use of actigraphy in the monitoring of sleep and activity in ADHD: A meta-analysis.

PubMed

De Crescenzo, Franco; Licchelli, Serena; Ciabattini, Marco; Menghini, Deny; Armando, Marco; Alfieri, Paolo; Mazzone, Luigi; Pontrelli, Giuseppe; Livadiotti, Susanna; Foti, Francesca; Quested, Digby; Vicari, Stefano

2016-04-01

Attention deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. There is an increasing need to find objective measures and markers of the disorder in order to assess the efficacy of the therapies and to improve follow-up strategies. Actigraphy is an objective method for recording motor activity and sleep parameters that has been used in many studies in ADHD. Our meta-analysis aimed to assess the current evidence on the role of actigraphy in both the detection of changes in motor activity and in sleep patterns in ADHD. A systematic review was carried out to find studies comparing children with unmedicated ADHD versus controls, using actigraphic measures as an outcome. The primary outcome measures were "sleep duration" and daytime "activity mean". As secondary outcome measures we analyzed "sleep onset latency", "sleep efficiency" and "wake after sleep onset". Twenty-four studies comprising 2179 children were included in this review. We show evidence that ADHD compared to typically developing children present a higher mean activity during structured sessions, a similar sleep duration, and a moderately altered sleep pattern. This study highlights the role of actigraphy as an objective tool for the ambulatory monitoring of sleep and activity in ADHD. Copyright © 2015 Elsevier Ltd. All rights reserved.

Systematic review of nonoperative versus operative treatment of uncomplicated appendicitis.

PubMed

Gorter, Ramon R; The, Sarah-May M L; Gorter-Stam, Marguerite A W; Eker, Hasan H; Bakx, Roel; van der Lee, Johanna H; Heij, Hugo A

2017-08-01

To compare the risk of complications between initial nonoperative treatment and appendectomy of uncomplicated (simple) appendicitis in children. Systematic literature search. Eligible for inclusion were both and randomized controlled trials and cohort studies including children in which the outcome of nonoperative treatment of uncomplicated appendicitis was reported with a minimum follow-up period of one year. Two authors extracted data independently and assessed quality. Primary outcome parameter was the percentage of children experiencing complications. Secondary outcomes were early failures, recurrent appendicitis and appendectomies, for all indications and on request. Five of the 2051 articles screened were eligible for inclusion, including 147 children (nonoperative treatment) and 173 children (appendectomy) with one year follow-up. Percentage of children experiencing complications ranged from 0 to 13% versus 0-17% for nonoperative and appendectomy, respectively. Nonoperative treatment avoided an appendectomy in 62-81% of the children after one year follow-up. The evidence base for initial nonoperative treatment of acute uncomplicated appendicitis in children is by far insufficient. It suggests that the percentage of patients experiencing complications in the initial nonoperative treatment group is comparable to the appendectomy group, and it may avoid an appendectomy in the large majority of children after one year follow-up. Systematic review. 1. Copyright © 2017 Elsevier Inc. All rights reserved.

The prevalence of periodontal disease in a Romano-British population c. 200-400 AD

PubMed Central

Raitapuro-Murray, T.; Molleson, T. I.; Hughes, F. J.

2014-01-01

Objective The aim of this study was to investigate the prevalence of moderate to severe periodontitis in an ancient British cohort c. 200-400 AD. Design Observational study to assess periodontal and other oral disease parameters. Setting Natural History Museum, London. Subjects and methods 303 skulls from a Romano-British burial site in Poundbury, Dorset were examined for evidence of dental disease. Main outcome measures The primary outcome measure was presence of moderate to severe periodontitis. Secondary outcomes included: amount of horizontal bone loss; prevalence of ante-mortem tooth loss; and presence of other dental pathologies. Results The overall prevalence of moderate to severe periodontitis was just greater than 5%. The prevalence rate remained nearly constant between ages 20 to 60, after which it rose to around 10%. The number of affected teeth increased with age. Horizontal bone loss was generally minor. Caries was seen in around 50% of the cohort, and evidence of pulpal and apical pathology was seen in around 25%. Conclusions The prevalence of moderate to severe periodontitis was markedly decreased when compared to the prevalence in modern populations, underlining the potential importance of risk factors such as smoking and diabetes in determining susceptibility to progressive periodontitis in modern populations. PMID:25342357

Twelve hour reproducibility of choroidal blood flow parameters in healthy subjects

PubMed Central

Polska, E; Polak, K; Luksch, A; Fuchsjager-Mayrl, G; Petternel, V; Findl, O; Schmetterer, L

2004-01-01

Aims/background: To investigate the reproducibility and potential diurnal variation of choroidal blood flow parameters in healthy subjects over a period of 12 hours. Methods: The choroidal blood flow parameters of 16 healthy non-smoking subjects were measured at five time points during the day (8:00, 11:00, 14:00, 17:00, and 20:00). Outcome parameters were pulsatile ocular blood flow as assessed by pneumotonometry, fundus pulsation amplitude as assessed by laser interferometry, blood velocities in the opthalmic and posterior ciliary arteries as assessed by colour Doppler imaging, and choroidal blood flow, volume, and velocity as assessed by fundus camera based laser Doppler flowmetry. The coefficient of variation and the maximum change from baseline in an individual were calculated for each outcome parameter. Results: None of the techniques used found a diurnal variation in choroidal blood flow. Coefficients of variation were within 2.9% and 13.6% for all outcome parameters. The maximum change from baseline in an individual was much higher, ranging from 11.2% to 58.8%. Conclusions: These data indicate that in healthy subjects the selected techniques provide adequate reproducibility to be used in clinical studies. Variability may, however, be considerably higher in older subjects or subjects with ocular disease. The higher individual differences in flow parameter readings limit the use of the techniques in clinical practice. To overcome problems with measurement validity, a clinical trial should include as many choroidal blood flow outcome parameters as possible to check for consistency. PMID:15031172

Twelve hour reproducibility of choroidal blood flow parameters in healthy subjects.

PubMed

Polska, E; Polak, K; Luksch, A; Fuchsjager-Mayrl, G; Petternel, V; Findl, O; Schmetterer, L

2004-04-01

To investigate the reproducibility and potential diurnal variation of choroidal blood flow parameters in healthy subjects over a period of 12 hours. The choroidal blood flow parameters of 16 healthy non-smoking subjects were measured at five time points during the day (8:00, 11:00, 14:00, 17:00, and 20:00). Outcome parameters were pulsatile ocular blood flow as assessed by pneumotonometry, fundus pulsation amplitude as assessed by laser interferometry, blood velocities in the opthalmic and posterior ciliary arteries as assessed by colour Doppler imaging, and choroidal blood flow, volume, and velocity as assessed by fundus camera based laser Doppler flowmetry. The coefficient of variation and the maximum change from baseline in an individual were calculated for each outcome parameter. None of the techniques used found a diurnal variation in choroidal blood flow. Coefficients of variation were within 2.9% and 13.6% for all outcome parameters. The maximum change from baseline in an individual was much higher, ranging from 11.2% to 58.8%. These data indicate that in healthy subjects the selected techniques provide adequate reproducibility to be used in clinical studies. Variability may, however, be considerably higher in older subjects or subjects with ocular disease. The higher individual differences in flow parameter readings limit the use of the techniques in clinical practice. To overcome problems with measurement validity, a clinical trial should include as many choroidal blood flow outcome parameters as possible to check for consistency.

Surgical Treatment of Metastatic Ovarian Tumors From Extragenital Primary Sites.

PubMed

Sal, Veysel; Demirkiran, Fuat; Topuz, Samet; Kahramanoglu, Ilker; Yalcin, Ibrahim; Bese, Tugan; Sozen, Hamdullah; Tokgozoglu, Nedim; Salihoglu, Yavuz; Turan, Hasan; Iyibozkurt, Cem; Kolomuc, Tugba; Sofiyeva, Nigar; Berkman, Sinan; Arvas, Macit

2016-05-01

The purpose of this study was to investigate the outcomes and prognostic factors of metastasectomy in patients with metastatic ovarian tumors from extragenital primary sites. All patients with pathologically confirmed metastatic ovarian tumors between January 1997 and June 2015 were included in this study. A total of 131 patients were identified. The data were obtained from the patients' medical records. Clinicopathological features were evaluated by both univariate and multivariate analyses. The primary sites were colorectal region (53.4%), stomach (26%), and breast (13%). Preoperative serum CA 125 and CA 19-9 levels were elevated in 29.4% and 39.8% of the patients, respectively. Cytoreductive surgery was performed in 41.2% of the patients. Seventy-three (55.7%) patients had no residual disease after surgery. Sixty-six (49.6%) patients had combined metastases at the time of the surgery to sites including the liver, pancreas, lung, bone, lymph nodes, bladder, or the intestine. With a median follow-up of 33 months, the median survival time was 22 months. The estimated 5-year survival probability is 0.26. On univariate analysis, primary cancer site, combined metastasis outside the ovaries, residual disease, preoperative serum CA 125 and CA 19-9 levels, and histologic type were significant parameters for overall survival. Furthermore, residual disease, preoperative serum CA 19-9 level, and primary cancer site were found to be independent prognostic factors on multivariate analysis. The most common primary sites for ovarian metastasis are gastrointestinal tract. Metastasectomy may have beneficial effects on survival, especially if the residual disease is less than 5 mm. Prospective studies warranted to evaluate the value of metastasectomy in patients with ovarian metastasis.

18F-Fluoride PET/CT tumor burden quantification predicts survival in breast cancer.

PubMed

Brito, Ana E; Santos, Allan; Sasse, André Deeke; Cabello, Cesar; Oliveira, Paulo; Mosci, Camila; Souza, Tiago; Amorim, Barbara; Lima, Mariana; Ramos, Celso D; Etchebehere, Elba

2017-05-30

In bone-metastatic breast cancer patients, there are no current imaging biomarkers to identify which patients have worst prognosis. The purpose of our study was to investigate if skeletal tumor burden determined by 18F-Fluoride PET/CT correlates with clinical outcomes and may help define prognosis throughout the course of the disease. Bone metastases were present in 49 patients. On multivariable analysis, skeletal tumor burden was significantly and independently associated with overall survival (p < 0.0001) and progression free-survival (p < 0.0001). The simple presence of bone metastases was associated with time to bone event (p = 0.0448). We quantified the skeletal tumor burden on 18F-Fluoride PET/CT images of 107 female breast cancer patients (40 for primary staging and the remainder for restaging after therapy). Clinical parameters, primary tumor characteristics and skeletal tumor burden were correlated to overall survival, progression free-survival and time to bone event. The median follow-up time was 19.5 months. 18F-Fluoride PET/CT skeletal tumor burden is a strong independent prognostic imaging biomarker in breast cancer patients.

Atherectomy offers no benefits over balloon angioplasty in tibial interventions for critical limb ischemia.

PubMed

Todd, Kevin E; Ahanchi, Sadaf S; Maurer, Christian A; Kim, Jung H; Chipman, Candice R; Panneton, Jean M

2013-10-01

Endovascular adjuncts, like atherectomy, were developed to improve outcomes of endovascular arterial interventions. The true impact of atherectomy on endovascular outcomes remains to be determined, and little data exist on the influence of atherectomy on tibial interventions. Our study compares early and late outcomes of tibial intervention with angioplasty vs atherectomy-assisted interventions. We completed a retrospective review of all tibial interventions between 2008 and 2010. Outcomes were analyzed using single and multivariate analysis, Cox regression, and Kaplan-Meier curves. Primary outcomes were primary, primary assisted, and secondary patency rates, as well as limb salvage and survival rates. Over a 2-year period, 480 tibial interventions were completed for 421 patients. Eighty-seven percent (n = 418) of interventions were performed for critical limb ischemia (CLI) and 13% (n = 62) for claudication. The CLI cohort of 418 interventions was analyzed. These patients had a mean age of 71 years with a mean follow-up time of 16 ± 15 months (range, 0-59 months). Of the 418 interventions, 339 underwent percutaneous transluminal angioplasty (PTA): 333 PTA alone, six PTA + stent. The remaining 79 interventions received atherectomy: 33 laser, 13 directional, and 33 orbital either alone or in conjunction with PTA (11 atherectomy only, 68 atherectomy + PTA). The groups did not differ significantly in terms of demographics, risk factors, or technical success. The atherectomy group had more TASC B lesions (54% vs 38%; P = .013), while the PTA-alone group had more TASC D lesions (25% vs 13%; P = .004). TASC A and C lesions did not differ significantly between the groups. No significant differences existed with respect to the early (30-day) outcomes of loss of patency (11% vs 13%; P = .699), complications (8% vs 13%; P = .292), or major amputation (17% vs 13%; P = .344) in the PTA-alone group vs the atherectomy-assisted group. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA alone vs the atherectomy-assisted group at 12 and 36 months: primary patency (69%, 55% vs 61%, 46%; P = .158), primary assisted patency (83%, 71% vs 85%, 67%; P = .801), secondary patency (94%, 89% vs 95%, 89%; P = .892), limb salvage (79%, 70% vs 81%, 77%; P = .485), or survival (77%, 56% vs 80%, 50%; P = .944). The adjunctive use of atherectomy offered no improvement in primary outcomes over PTA alone in either early or late outcomes in CLI patients who underwent endovascular tibial interventions. Considering the additional cost and increased procedural time, these findings put into question the routine use of adjunctive atherectomy. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Socioeconomic and psychological impact of treatment for unilateral intraocular retinoblastoma.

PubMed

Soliman, S E; Dimaras, H; Souka, A A; Ashry, M H; Gallie, B L

2015-06-01

To identify the socioeconomic and psychosocial impacts of clinical treatment decisions for advanced unilateral intraocular retinoblastoma. Retrospective observational case series. institutional study at Alexandria Main University Hospital. records of 66 unilateral retinoblastoma cases treated from May 2005 to May 2013 were retrospectively reviewed. Sixty cases were eligible (International Intraocular Retinoblastoma Classification [IIRC] group C, D or E). two treatment groups were compared: enucleation vs. salvage treatment. Salvage treatment eyes were further subdivided based on IIRC group. Six socioeconomic parameters (financial burden, financial impact, psychological, social, medical and tumor impacts) were scored. Parameter scores ranged from 0 to 3, for overall score range 0 (no adverse impact) to 18 (severe adverse impact). derived Socioeconomic scores were correlated with treatment and outcomes. The enucleation group (28 eyes) had a median overall Socioeconomic score of 4/18, significantly lower than the salvage treatment group (32 eyes), median score 11/18 (P<0.01). Socioeconomic score varied with IIRC group. Attempted eye salvage failed in 25 children, due to uncontrolled tumor (44%) and socioeconomic impact of cumulative therapies (56%). Treatment duration and Socioeconomic score were higher for the 5 children in the salvage treatment group who developed metastatic disease compared to those without metastasis (P<0.01). The socioeconomic and psychosocial impacts of attempted ocular salvage for unilateral intraocular retinoblastoma are severe, in comparison to primary enucleation. Primary enucleation is a good treatment for unilateral retinoblastoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Expression of MMP-9 decreases metastatic potential of Chondrosarcoma: an immunohistochemical study.

PubMed

Malcherczyk, Dominik; Heyse, Thomas J; El-Zayat, Bilal F; Kunzke, Vanessa; Moll, Roland; Fuchs-Winkelmann, Susanne; Paletta, Jürgen R J

2018-01-09

Chondrosarcoma is the second most common primary malignant bone tumor. Because of their heterogeneity, with differences in invasive and metastatic behavior, it is important to identify biological markers that will allow for a more accurate estimation of prognosis in patients with these tumors. Matrix metalloproteinases (MMP) play a crucial role in tumor progression, invasion and metastasis. The mechanism of tumor progression dependent of MMPs is complex and influences malignant transformation, angiogenesis and tumor growth at the primary and metastatic sites. The purpose of this study was to investigate immunohistochemicaly the influence of MMP-1, MMP-3, MMP-9 and MMP-13 expression on prognostic parameter in chondrosarcoma. We investigated tissue samples of 28 patients with chondrosarcoma. Immunohistochemical staining to evaluate the expression of MMP-1, MMP-3, MMP-9 and MMP-13 was performed. Subsequently, the expression level was correlated with metastatic potential, histological grading and overall survival in patients with this neoplasm. In consideration of semi quantitative scoring 64% of chondrosarcoma were scored as positive for MMP-1, 46% for MMP-3, 61% for MMP-9. The specimens had shown no expression of MMP-13. High expression of MMP-9 was associated with better histological differentiation, decreased metastatic potential and favourable overall survival. No correlation was found for expression of MMP-1, MMP-3 or MMP-13. MMP-1, MMP-3 and MMP-9 are expressed in chondrosarcoma. Our findings suggest that the expression of MMP-9 is associated with clinical outcome parameters in chondrosarcoma.

Evaluation of the Effectiveness of a Primary Preventive Dental Health Education Programme Implemented Through School Teachers for Primary School Children in Mysore City

PubMed Central

Naidu, Jaya; Nandlal, B.

2017-01-01

Aims and Objectives: The present study was conducted with the aim of evaluating the effectiveness of a Primary Preventive Dental Health Education Programme conducted for 6–12-year-old primary school children in Mysore City. Materials and Methods: A total of 12 schools, one each in the category of Government, Aided, and Unaided, were randomly selected per zone viz., North, South, East, and West. These 12 schools constituted the study group where the Primary Preventive School Dental Health Education Programme (PPSDHEP) was implemented. Two additional schools were selected at random from the four zones to serve as the control. A total of 926 children participated in the study. The PPSDHEP involved the second-level transfer of preventive package wherein the oral health education was imparted to the school children by schoolteachers trained by the investigator. Among the parameters for evaluating the outcome of the programme were the pre and post-programme assessment (at the baseline and at follow-up, i.e., after 6 months) of knowledge, attitude, and practice (KAP), dental caries status, oral hygiene, and gingival health status. Results: The results suggest that the PPSDHEP resulted in bringing about an enhancement in the KAP towards oral health and also an improvement in dental caries, oral hygiene, and gingival health status of the school children in the study group. Conclusion: The present study supports the implementation of similar programmes in schools and the contention that schoolteachers are suitable personnel for imparting dental health education to school children on a regular basis. PMID:28462175

Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial.

PubMed

Berton, Linda; Bano, Giulia; Carraro, Sara; Veronese, Nicola; Pizzato, Simona; Bolzetta, Francesco; De Rui, Marina; Valmorbida, Elena; De Ronch, Irene; Perissinotto, Egle; Coin, Alessandra; Manzato, Enzo; Sergi, Giuseppe

2015-01-01

Although older people are particularly liable to sarcopenia, limited research is available on beta-hydroxy-beta-methylbutyrate (HMB) supplementation in this population, particularly in healthy subjects. In this parallel-group, randomized, controlled, open-label trial, we aimed to evaluate whether an oral supplement containing 1.5 g of calcium HMB for 8 weeks could improve physical performance and muscle strength parameters in a group of community-dwelling healthy older women. Eighty healthy women attending a twice-weekly mild fitness program were divided into two equal groups of 40, and 32 of the treated women and 33 control completed the study. We considered a change in the Short Physical Performance Battery (SPPB) score as the primary outcome and changes in the peak torque (PT) isometric and isokinetic strength of the lower limbs, 6-minute walking test (6MWT), handgrip strength and endurance as secondary outcomes. Body composition was assessed with dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computerized tomography (pQCT). The mean difference between the two groups on pre-post change were finally calculated (delta) for each outcome. After 8 weeks, there were no significant differences between the groups’ SPPB, handgrip strength or DXA parameters. The group treated with HMB scored significantly better than the control group for PT isokinetic flexion (delta = 1.56±1.56 Nm; p = 0.03) and extension (delta = 3.32±2.61 Nm; p = 0.03), PT isometric strength (delta = 9.74±3.90 Nm; p = 0.02), 6MWT (delta = 7.67±8.29 m; p = 0.04), handgrip endurance (delta = 21.41±16.28 s; p = 0.02), and muscle density assessed with pQCT. No serious adverse effects were reported in either group. In conclusion, a nutritional supplement containing 1.5 g of calcium HMB for 8 weeks in healthy elderly women had no significant effects on SPPB, but did significantly improve several muscle strength and physical performance parameters. ClinicalTrials.gov NCT02118181.

Randomized trial of primary PCI with or without routine manual thrombectomy.

PubMed

Jolly, Sanjit S; Cairns, John A; Yusuf, Salim; Meeks, Brandi; Pogue, Janice; Rokoss, Michael J; Kedev, Sasko; Thabane, Lehana; Stankovic, Goran; Moreno, Raul; Gershlick, Anthony; Chowdhary, Saqib; Lavi, Shahar; Niemelä, Kari; Steg, Philippe Gabriel; Bernat, Ivo; Xu, Yawei; Cantor, Warren J; Overgaard, Christopher B; Naber, Christoph K; Cheema, Asim N; Welsh, Robert C; Bertrand, Olivier F; Avezum, Alvaro; Bhindi, Ravinay; Pancholy, Samir; Rao, Sunil V; Natarajan, Madhu K; ten Berg, Jurriën M; Shestakovska, Olga; Gao, Peggy; Widimsky, Petr; Džavík, Vladimír

2015-04-09

During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02). In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

Brucella pinnipedialis hooded seal (Cystophora cristata) strain in the mouse model with concurrent exposure to PCB 153.

PubMed

Nymo, Ingebjørg H; das Neves, Carlos G; Tryland, Morten; Bårdsen, Bård-Jørgen; Santos, Renato Lima; Turchetti, Andreia Pereira; Janczak, Andrew M; Djønne, Berit; Lie, Elisabeth; Berg, Vidar; Godfroid, Jacques

2014-05-01

Brucellosis, a worldwide zoonosis, is linked to reproductive problems in primary hosts. A high proportion of Brucella-positive hooded seals (Cystophora cristata) have been detected in the declined Northeast Atlantic stock. High concentrations of polychlorinated biphenyls (PCBs) have also been discovered in top predators in the Arctic, including the hooded seal, PCB 153 being most abundant. The aim of this study was to assess the pathogenicity of Brucella pinnipedialis hooded seal strain in the mouse model and to evaluate the outcome of Brucella spp. infection after exposure of mice to PCB 153. BALB/c mice were infected with B. pinnipedialis hooded seal strain or Brucella suis 1330, and half from each group was exposed to PCB 153 through the diet. B. pinnipedialis showed a reduced pathogenicity in the mouse model as compared to B. suis 1330. Exposure to PCB 153 affected neither the immunological parameters, nor the outcome of the infection. Altogether this indicates that it is unlikely that B. pinnipedialis contribute to the decline of hooded seals in the Northeast Atlantic. Copyright © 2014 Elsevier Ltd. All rights reserved.

Ketogenic Diet in Refractory Childhood Epilepsy: Starting With a Liquid Formulation in an Outpatient Setting.

PubMed

Weijenberg, Amerins; van Rijn, Margreet; Callenbach, Petra M C; de Koning, Tom J; Brouwer, Oebele F

2018-01-01

Ketogenic diet in children with epilepsy has a considerable impact on daily life and is usually adopted for at least 3 months. Our aim was to evaluate whether the introduction of an all-liquid ketogenic diet in an outpatient setting is feasible, and if an earlier assessment of its efficacy can be achieved. The authors conducted a prospective, observational study in a consecutive group of children with refractory epilepsy aged 2 to 14 years indicated for ketogenic diet. Ketogenic diet was started as an all-liquid formulation of the classical ketogenic diet, KetoCal 4:1 LQ, taken orally or by tube. After 6 weeks, the liquid diet was converted into solid meals. The primary outcome parameter was time-to-response (>50% seizure reduction). Secondary outcome parameters were time to achieve stable ketosis, the number of children showing a positive response, and the retention rate at 26 weeks. Sixteen children were included. Four of them responded well with respect to seizure frequency, the median time-to-response was 14 days (range 7-28 days). The mean time to achieve stable ketosis was 7 days. The retention rate at 26 weeks was 50%. Of the 8 children who started this protocol orally fed, 6 completed it without requiring a nasogastric tube. Introduction of ketogenic diet with a liquid formulation can be accomplished in orally fed children without major complications. It allowed for fast and stable ketosis.

Microbial host interactions and impaired wound healing in mice and humans: defining a role for BD14 and NOD2.

PubMed

Williams, Helen; Campbell, Laura; Crompton, Rachel A; Singh, Gurdeep; McHugh, Brian J; Davidson, Donald J; McBain, Andrew J; Cruickshank, Sheena M; Hardman, Matthew J

2018-04-30

Chronic wounds cause significant patient morbidity and mortality. A key factor in their etiology is microbial infection, yet skin host-microbiota interactions during wound repair remain poorly understood. Microbiome profiles of non-infected human chronic wounds are associated with subsequent healing outcome. Furthermore, poor clinical healing outcome was associated with increased local expression of the pattern recognition receptor NOD2. To investigate NOD2 function in the context of cutaneous healing, we treated mice with the NOD2 ligand muramyl dipeptide (MDP) and analyzed wound repair parameters and expression of anti-microbial peptides. MDP treatment of littermate controls significantly delayed wound repair associated with reduced re-epithelialization, heightened inflammation and upregulation of murine β-Defensins (mBD) 1, 3 and particularly 14. We postulated that although BD14 might impact on local skin microbial communities it may further impact other healing parameters. Indeed, exogenously administered mBD14 directly delayed mouse primary keratinocyte scratch wound closure in vitro. To further explore the role of mBD14 in wound repair, we employed Defb14 -/- mice, and showed they had a global delay in healing in vivo, associated with alterations in wound microbiota. Taken together these studies suggest a key role for NOD2-mediated regulation of local skin microbiota which in turn impacts on chronic wound etiology. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Single implant supported mandibular overdenture: A literature review

PubMed Central

Mahoorkar, Sudhindra; Bhat, Srinidhi; Kant, Radhika

2016-01-01

Purpose: Rehabilitation of the edentulous mandible by implant-supported prosthesis is a successful and satisfying treatment as suggested by many clinical trials. However, the minimum number of implants required for this restoration is debatable. Single implant retained overdenture (SIROD) has gained popularity as a simple protocol. The purpose of this review is to systematically analyze the literature on SIROD. Materials and Methods: An electronic search was done in the PubMed and Medline databases using the key words “central single implant overdenture,” “implant overdenture retained by one implant,” “implant overdenture retained by single implant,” “mandibular single implant overdenture,” “mandibular SIRODs.” Articles from 1993 to November 2012 were included in the review. Out of 208 articles, only 18 had relevant data pertaining to mandibular single implant overdenture. Two more were hand-picked from journals that are non-PubMed indexed but from reputed publishing houses. Results: Majority of studies supported the concept of SIROD. Success outcome was addressed in relation to surgical, prosthetic, functional parameters, and patient satisfaction. 65% studies evaluated the primary stabilities of the placed implants, 50% of studies assessed the marginal bone loss quarterly across a 1-year period. Prosthesis outcome was a criterion for evaluation of success rate in 45% of studies. Conclusion: The SIROD is proved to be successful and an economic treatment protocol. However, the clinical parameters such as masticatory efficiency bite force, retention, and stability needs to be investigated. PMID:27134432

Viscoelastic blood coagulation measurement with Sonoclot predicts postoperative bleeding in cardiac surgery after heparin reversal.

PubMed

Bischof, Dominique B; Ganter, Michael T; Shore-Lesserson, Linda; Hartnack, Sonja; Klaghofer, Richard; Graves, Kirk; Genoni, Michele; Hofer, Christoph K

2015-01-01

The aim of the study was to determine if Sonoclot with its sensitive glass bead-activated, viscoelastic test can predict postoperative bleeding in patients undergoing cardiac surgery at predefined time points. A prospective, observational clinical study. A teaching hospital, single center. Consecutive patients undergoing cardiac surgery (N = 300). Besides routine laboratory coagulation studies and heparin management with standard (kaolin) activated clotting time, additional native blood samples were analyzed on a Sonoclot using glass bead-activated tests. Glass bead-activated clotting time, clot rate, and platelet function were recorded immediately before anesthesia induction and at the end of surgery after heparin reversal but before chest closure. Primary outcome was postoperative blood loss (chest tube drainage at 4, 8, and 12 hours postoperatively). Secondary outcome parameters were transfusion requirements, need for surgical re-exploration, time of mechanical ventilation, length of intensive care unit and hospital stay, and hospital morbidity and mortality. Patients were categorized into "bleeders" and "nonbleeders." Patient characteristics, operations, preoperative standard laboratory parameters, and procedural times were comparable between bleeders and nonbleeders except for sex and age. Bleeders had higher rates of transfusions, surgical re-explorations, and complications. Only glass bead measurements by Sonoclot after heparin reversal before chest closure but not preoperatively were predictive for increased postoperative bleeding. Sonoclot with its glass bead-activated tests may predict the risk for postoperative bleeding in patients undergoing cardiac surgery at the end of surgery after heparin reversal but before chest closure. Copyright © 2015 Elsevier Inc. All rights reserved.

IMPACT OF INTERNAL LIMITING MEMBRANE PEELING ON MACULAR HOLE REOPENING: A Systematic Review and Meta-Analysis.

PubMed

Rahimy, Ehsan; McCannel, Colin A

2016-04-01

To assess the literature regarding macular hole reopening rates stratified by whether the internal limiting membrane (ILM) was peeled during vitrectomy surgery. Systematic review and meta-analysis of studies reporting on macular hole reopenings among previously surgically closed idiopathic macular holes. A comprehensive literature search using the National Library of Medicine PubMed interface was used to identify potentially eligible publications in English. The minimum mean follow-up period for reports to be included in this study was 12 months. Analysis was divided into eyes that underwent vitrectomy with and without ILM peeling. The primary outcome parameter was the proportion of macular hole reopenings among previously closed holes between the two groups. Secondary outcome parameters included duration from initial surgery to hole reopening and preoperative and postoperative best-corrected correct visual acuities among the non-ILM peeling and ILM peeling groups. A total of 50 publications reporting on 5,480 eyes met inclusion criteria and were assessed in this meta-analysis. The reopening rate without ILM peeling was 7.12% (125 of 1,756 eyes), compared with 1.18% (44 of 3,724 eyes) with ILM peeling (odds ratio: 0.16; 95% confidence interval: 0.11-0.22; Fisher's exact test: P < 0.0001). There were no other identifiable associations or risk factors for reopening. The results of this meta-analysis support the concept that ILM peeling during macular hole surgery reduces the likelihood of macular hole reopening.

The Patient-Centered Medical Home (PCMH) Framing Typology for Understanding the Structure, Function, and Outcomes of PCMHs.

PubMed

Kieber-Emmons, Autumn M; Miller, William L

2017-01-01

Patient-centered medical homes (PCHMs) aspire to transform today's challenged primary care services. However, it is unclear which PCMH characteristics produce specific outcomes of interest for care delivery. This study tested a novel typology of PCMH practice transformation, the PCMH framing typology, and evaluated measurable outcomes by each type. Using the Patient-Centered Primary Care Collaborative 2012 to 2013 Annual Review, this secondary analysis of the published PCMH literature extracted data from publications of 59 PCMHs. Each of the 59 sites was categorized as 1 of 4 PCMH types: add-on, renovated, hybrid, or integrated. Six outcome measures (cost reductions, decreased emergency department/hospital utilization, improved quality, improved access, increased preventive services, and improved patient satisfaction) were independently coded for each site. Practices were combined based on type, and mean outcomes scores for each measure were displayed on radar graphs for comparison. While each type showed a characteristic pattern of success, only the integrated type improved in all 6 outcomes. No type achieved high success in all measures. There seem to be 4 types of PCMH, each of which shows a distinctive outcomes profile. Within the PCMH framing typology, direction is emerging for how best to transform primary care to achieve the greatest success. © Copyright 2017 by the American Board of Family Medicine.

Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.

PubMed

Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Romme Christensen, Jeppe; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn

2016-06-01

There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS. In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans. We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS. © The Author(s), 2015.

Systematic review of knowledge translation strategies in the allied health professions

PubMed Central

2012-01-01

Background Knowledge translation (KT) aims to close the research-practice gap in order to realize and maximize the benefits of research within the practice setting. Previous studies have investigated KT strategies in nursing and medicine; however, the present study is the first systematic review of the effectiveness of a variety of KT interventions in five allied health disciplines: dietetics, occupational therapy, pharmacy, physiotherapy, and speech-language pathology. Methods A health research librarian developed and implemented search strategies in eight electronic databases (MEDLINE, CINAHL, ERIC, PASCAL, EMBASE, IPA, Scopus, CENTRAL) using language (English) and date restrictions (1985 to March 2010). Other relevant sources were manually searched. Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Within each profession, evidence tables were created, grouping and analyzing data by research design, KT strategy, targeted behaviour, and primary outcome. The published descriptions of the KT interventions were compared to the Workgroup for Intervention Development and Evaluation Research (WIDER) Recommendations to Improve the Reporting of the Content of Behaviour Change Interventions. Results A total of 2,638 articles were located and the titles and abstracts were screened. Of those, 1,172 full-text articles were reviewed and subsequently 32 studies were included in the systematic review. A variety of single (n = 15) and multiple (n = 17) KT interventions were identified, with educational meetings being the predominant KT strategy (n = 11). The majority of primary outcomes were identified as professional/process outcomes (n = 25); however, patient outcomes (n = 4), economic outcomes (n = 2), and multiple primary outcomes (n = 1) were also represented. Generally, the studies were of low methodological quality. Outcome reporting bias was common and precluded clear determination of intervention effectiveness. In the majority of studies, the interventions demonstrated mixed effects on primary outcomes, and only four studies demonstrated statistically significant, positive effects on primary outcomes. None of the studies satisfied the four WIDER Recommendations. Conclusions Across five allied health professions, equivocal results, low methodological quality, and outcome reporting bias limited our ability to recommend one KT strategy over another. Further research employing the WIDER Recommendations is needed to inform the development and implementation of effective KT interventions in allied health. PMID:22831550

Early childhood neurodevelopment after intrauterine growth restriction: a systematic review.

PubMed

Levine, Terri A; Grunau, Ruth E; McAuliffe, Fionnuala M; Pinnamaneni, RagaMallika; Foran, Adrienne; Alderdice, Fiona A

2015-01-01

Children who experienced intrauterine growth restriction (IUGR) may be at increased risk for adverse developmental outcomes in early childhood. The objective of this study was to carry out a systematic review of neurodevelopmental outcomes from 6 months to 3 years after IUGR. PubMed, Embase, PsycINFO, Maternity and Infant Care, and CINAHL databases were searched by using the search terms intrauterine, fetal, growth restriction, child development, neurodevelopment, early childhood, cognitive, motor, speech, language. Studies were eligible for inclusion if participants met specified criteria for growth restriction, follow-up was conducted within 6 months to 3 years, methods were adequately described, non-IUGR comparison groups were included, and full English text of the article was available. A specifically designed data extraction form was used. The methodological quality of included studies was assessed using well-documented quality-appraisal guidelines. Of 731 studies reviewed, 16 were included. Poorer neurodevelopmental outcomes after IUGR were described in 11. Ten found motor, 8 cognitive, and 7 language delays. Other delays included social development, attention, and adaptive behavior. Only 8 included abnormal Doppler parameters in their definitions of IUGR. Evidence suggests that children are at risk for poorer neurodevelopmental outcomes following IUGR from 6 months to 3 years of age. The heterogeneity of primary outcomes, assessment measures, adjustment for confounding variables, and definitions of IUGR limits synthesis and interpretation. Sample sizes in most studies were small, and some examined preterm IUGR children without including term IUGR or AGA comparison groups, limiting the value of extant studies. Copyright © 2015 by the American Academy of Pediatrics.

Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial.

PubMed

Kiper, Pawel; Szczudlik, Andrzej; Agostini, Michela; Opara, Jozef; Nowobilski, Roman; Ventura, Laura; Tonin, Paolo; Turolla, Andrea

2018-05-01

To evaluate the effectiveness of reinforced feedback in virtual environment (RFVE) treatment combined with conventional rehabilitation (CR) in comparison with CR alone, and to study whether changes are related to stroke etiology (ie, ischemic, hemorrhagic). Randomized controlled trial. Hospital facility for intensive rehabilitation. Patients (N=136) within 1 year from onset of a single stroke (ischemic: n=78, hemorrhagic: n=58). The experimental treatment was based on the combination of RFVE with CR, whereas control treatment was based on the same amount of CR. Both treatments lasted 2 hours daily, 5d/wk, for 4 weeks. Fugl-Meyer upper extremity scale (F-M UE) (primary outcome), FIM, National Institutes of Health Stroke Scale (NIHSS), and Edmonton Symptom Assessment Scale (ESAS) (secondary outcomes). Kinematic parameters of requested movements included duration (time), mean linear velocity (speed), and number of submovements (peak) (secondary outcomes). Patients were randomized in 2 groups (RFVE with CR: n=68, CR: n=68) and stratified by stroke etiology (ischemic or hemorrhagic). Both groups improved after treatment, but the experimental group had better results than the control group (Mann-Whitney U test) for F-M UE (P<.001), FIM (P<.001), NIHSS (P≤.014), ESAS (P≤.022), time (P<.001), speed (P<.001), and peak (P<.001). Stroke etiology did not have significant effects on patient outcomes. The RFVE therapy combined with CR treatment promotes better outcomes for upper limb than the same amount of CR, regardless of stroke etiology. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A Comparison of Endothelial Cell Loss in Combined Cataract and MIGS (Hydrus) Procedure to Phacoemulsification Alone: 6-Month Results

PubMed Central

Fea, Antonio M.; Consolandi, Giulia; Pignata, Giulia; Cannizzo, Paola Maria Loredana; Lavia, Carlo; Billia, Filippo; Rolle, Teresa; Grignolo, Federico M.

2015-01-01

Purpose. To compare the corneal endothelial cell loss after phacoemulsification, alone or combined with microinvasive glaucoma surgery (MIGS), in nonglaucomatous versus primary open angle glaucoma (POAG) eyes affected by age-related cataract. Methods. 62 eyes of 62 patients were divided into group 1 (n = 25, affected by age-related cataract) and group 2 (n = 37, affected by age-related cataract and POAG). All patients underwent cataract surgery. Group 2 was divided into subgroups A (n = 19, cataract surgery alone) and B (n = 18, cataract surgery and MIGS). Prior to and 6 months after surgery the patients' endothelium was studied. Main outcomes were CD (cell density), SD (standard deviation), CV (coefficient of variation), and 6A (hexagonality coefficient) variations after surgeries. Results. There were no significant differences among the groups concerning preoperative endothelial parameters. The differences in CD before and after surgery were significant in all groups: 9.1% in group 1, 17.24% in group 2A, and 11.71% in group 2B. All endothelial parameters did not significantly change after surgery. Conclusions. Phacoemulsification determined a loss of endothelial cells in all groups. After surgery the change in endothelial parameters after MIGS was comparable to the ones of patients who underwent cataract surgery alone. PMID:26664740

RASSF1A protein expression and correlation with clinicopathological parameters in renal cell carcinoma

PubMed Central

Tezval, Hossein; Merseburger, Axel S; Matuschek, Ira; Machtens, Stefan; Kuczyk, Markus A; Serth, Jürgen

2008-01-01

Background Epigenetic silencing of RAS association family 1A (RASSF1A) tumor suppressor gene occurs in various histological subtypes of renal cell carcinoma (RCC) but RASSF1A protein expression in clear cell RCC as well as a possible correlation with clinicopathological parameters of patients has not been analyzed at yet. Methods 318 primary clear cell carcinomas were analyzed using tissue microarray analysis and immunohistochemistry. Survival analysis was carried out for 187 patients considering a follow-up period of 2–240 month. Results Expression of RASSF1A was found to be significantly decreased in tumoral cells when compared to normal tubular epithelial cells. RASSF1A immunopositivity was significantly associated with pT stage, group stage and histological grade of tumors and showed a tendency for impaired survival in Kaplan-Meier analysis. Conclusion While most tumors demonstrate a loss of RASSF1A protein, a subset of tumors was identified to exhibit substantial RASSF1A protein expression and show increased tumor progression. Thus RCC tumorigenesis without depletion of RASSF1A may be associated with an adverse clinical outcome. PMID:18822131

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

Patients with primary breast and primary female genital tract diffuse large B cell lymphoma have a high frequency of MYD88 and CD79B mutations.

PubMed

Cao, Xin-Xin; Li, Jian; Cai, Hao; Zhang, Wei; Duan, Ming-Hui; Zhou, Dao-Bin

2017-11-01

This study is to retrospectively evaluate the prevalence of MYD88 and CD79B mutations and the clinicopathologic characteristics of patients with primary diffuse large B cell lymphoma (DLBCL) of the female genital tract and breast. The characteristics, treatments, and outcomes of 19 patients diagnosed with primary DLBCL of the female genital tract and breast, who had formalin-fixed and paraffin-embedded tissues obtained from diagnostic samples diagnosed between January 2004 and June 2016, were analyzed retrospectively. Nineteen female patients (7 with primary breast and 12 with primary female genital tract DLBCL) were included in this retrospective study. Eleven patients (57.9%) carried a MYD88 mutation, including 10 with MYD8 L265P and 1 with the MYD88 L265S mutation. Seven patients (36.8%) harbored a CD79B mutation, which included two cases with CD79B Y196H, two cases with CD79B Y196N, one case with CD79B Y196D, one case with CD79B Y196F, and one case with CD79B Y196X. Four cases had both MYD88 and CD79B mutations. The clinicopathologic parameters, progression-free survival (PFS), and overall survival (OS) of the MYD88 mutation-carrying group were not significantly different from those of the MYD88 wild-type group except for higher LDH levels. Six patients received cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP), while 13 patients received rituximab plus CHOP, and 13 patients received central nervous system prophylaxis. The median OS and PFS were 73 and 56 months, respectively. Patients with primary breast and primary female genital tract DLBCL have a high frequency of MYD88 and CD79B mutations. The presence of these mutations does not affect survival but may offer additional therapeutic options.

The Comparison of the Outcomes between Primary PCI, Fibrinolysis, and No Reperfusion in Patients ≥ 75 Years Old with ST-Segment Elevation Myocardial Infarction: Results from the Chinese Acute Myocardial Infarction (CAMI) Registry.

PubMed

Peiyuan, He; Jingang, Yang; Haiyan, Xu; Xiaojin, Gao; Ying, Xian; Yuan, Wu; Wei, Li; Yang, Wang; Xinran, Tang; Ruohua, Yan; Chen, Jin; Lei, Song; Xuan, Zhang; Rui, Fu; Yunqing, Ye; Qiuting, Dong; Hui, Sun; Xinxin, Yan; Runlin, Gao; Yuejin, Yang

2016-01-01

Only a few randomized trials have analyzed the clinical outcomes of elderly ST-segment elevation myocardial infarction (STEMI) patients (≥ 75 years old). Therefore, the best reperfusion strategy has not been well established. An observational study focused on clinical outcomes was performed in this population. Based on the national registry on STEMI patients, the in-hospital outcomes of elderly patients with different reperfusion strategies were compared. The primary endpoint was defined as death. Secondary endpoints included recurrent myocardial infarction, ischemia driven revascularization, myocardial infarction related complications, and major bleeding. Multivariable regression analysis was performed to adjust for the baseline disparities between the groups. Patients who had primary percutaneous coronary intervention (PCI) or fibrinolysis were relatively younger. They came to hospital earlier, and had lower risk of death compared with patients who had no reperfusion. The guideline recommended medications were more frequently used in patients with primary PCI during the hospitalization and at discharge. The rates of death were 7.7%, 15.0%, and 19.9% respectively, with primary PCI, fibrinolysis, and no reperfusion (P < 0.001). Patients having primary PCI also had lower rates of heart failure, mechanical complications, and cardiac arrest compared with fibrinolysis and no reperfusion (P < 0.05). The rates of hemorrhage stroke (0.3%, 0.6%, and 0.1%) and other major bleeding (3.0%, 5.0%, and 3.1%) were similar in the primary PCI, fibrinolysis, and no reperfusion group (P > 0.05). In the multivariable regression analysis, primary PCI outweighs no reperfusion in predicting the in-hospital death in patients ≥ 75 years old. However, fibrinolysis does not. Early reperfusion, especially primary PCI was safe and effective with absolute reduction of mortality compared with no reperfusion. However, certain randomized trials were encouraged to support the conclusion.

Are dental researchers asking patient-important questions? A scoping review.

PubMed

Fleming, Padhraig S; Koletsi, Despina; O'Brien, Kevin; Tsichlaki, Aliki; Pandis, Nikolaos

2016-06-01

There is an increasing recognition that research outcomes should resonate with patients rather than fixating on technical aspects of interventions. We aimed to assess the nature of outcomes within a representative subset of clinical trials published in leading dental journals. Randomized controlled trials published over a 3-year period up to December 31st, 2015 were identified in eight leading general and specialty dental journals: Journal of Dental Research, Journal of Dentistry, American Journal of Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, International Journal of Prosthodontics, Journal of Endodontics, International Journal of Oral and Maxillofacial Surgery and Journal of Clinical Periodontology. The number and nature of outcomes considered within these trials were assessed. Overall 220 RCTs involving 409 outcomes (257 primary and 152 secondary) were identified. Measures of disease activity were most commonly assessed as both primary (n=91, 35%) and secondary outcomes (n=59, 39%). Quality of life and functional measures were rarely considered as primary outcome domains. Overall, 182 (44%) outcomes were primarily clinician-focused, 140 (34%) were patient-centered, while 22% (n=87) were both patient- and clinician- focused. There is an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of core outcome sets representing the minimum set of data that should be obtained within a dental clinical trial would assist in addressing this issue. There is an acceptance that research outcomes should ultimately be of relevance and benefit to patients rather than focusing on technical aspects of interventions. This study points to an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of agreed dental core outcome sets would help to remedy this. Copyright © 2016 Elsevier Ltd. All rights reserved.

Addressing the Challenges of Obtaining Functional Outcomes in Traumatic Brain Injury Research: Missing Data Patterns, Timing of Follow-Up, and Three Prognostic Models

PubMed Central

Morrison, Laurie J.; Devlin, Sean M.; Bulger, Eileen M.; Brasel, Karen J.; Sheehan, Kellie; Minei, Joseph P.; Kerby, Jeffrey D.; Tisherman, Samuel A.; Rizoli, Sandro; Karmy-Jones, Riyad; van Heest, Rardi; Newgard, Craig D.

2014-01-01

Abstract Traumatic brain injury (TBI) is common and debilitating. Randomized trials of interventions for TBI ideally assess effectiveness by using long-term functional neurological outcomes, but such outcomes are difficult to obtain and costly. If there is little change between functional status at hospital discharge versus 6 months, then shorter-term outcomes may be adequate for use in future clinical trials. Using data from a previously published multi-center, randomized, placebo-controlled TBI clinical trial, we evaluated patterns of missing outcome data, changes in functional status between hospital discharge and 6 months, and three prognostic models to predict long-term functional outcome from covariates available at hospital discharge (functional measures, demographics, and injury characteristics). The Resuscitation Outcomes Consortium Hypertonic Saline trial enrolled 1282 TBI patients, obtaining the primary outcome of 6-month Glasgow Outcome Score Extended (GOSE) for 85% of patients, but missing the primary outcome for the remaining 15%. Patients with missing outcomes had less-severe injuries, higher neurological function at discharge (GOSE), and shorter hospital stays than patients whose GOSE was obtained. Of 1066 (83%) patients whose GOSE was obtained both at hospital discharge and at 6-months, 71% of patients had the same dichotomized functional status (severe disability/death vs. moderate/no disability) after 6 months as at discharge, 28% had an improved functional status, and 1% had worsened. Performance was excellent (C-statistic between 0.88 and 0.91) for all three prognostic models and calibration adequate for two models (p values, 0.22 and 0.85). Our results suggest that multiple imputation of the standard 6-month GOSE may be reasonable in TBI research when the primary outcome cannot be obtained through other means. PMID:24552494

Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models.

PubMed

Zelnick, Leila R; Morrison, Laurie J; Devlin, Sean M; Bulger, Eileen M; Brasel, Karen J; Sheehan, Kellie; Minei, Joseph P; Kerby, Jeffrey D; Tisherman, Samuel A; Rizoli, Sandro; Karmy-Jones, Riyad; van Heest, Rardi; Newgard, Craig D

2014-06-01

Traumatic brain injury (TBI) is common and debilitating. Randomized trials of interventions for TBI ideally assess effectiveness by using long-term functional neurological outcomes, but such outcomes are difficult to obtain and costly. If there is little change between functional status at hospital discharge versus 6 months, then shorter-term outcomes may be adequate for use in future clinical trials. Using data from a previously published multi-center, randomized, placebo-controlled TBI clinical trial, we evaluated patterns of missing outcome data, changes in functional status between hospital discharge and 6 months, and three prognostic models to predict long-term functional outcome from covariates available at hospital discharge (functional measures, demographics, and injury characteristics). The Resuscitation Outcomes Consortium Hypertonic Saline trial enrolled 1282 TBI patients, obtaining the primary outcome of 6-month Glasgow Outcome Score Extended (GOSE) for 85% of patients, but missing the primary outcome for the remaining 15%. Patients with missing outcomes had less-severe injuries, higher neurological function at discharge (GOSE), and shorter hospital stays than patients whose GOSE was obtained. Of 1066 (83%) patients whose GOSE was obtained both at hospital discharge and at 6-months, 71% of patients had the same dichotomized functional status (severe disability/death vs. moderate/no disability) after 6 months as at discharge, 28% had an improved functional status, and 1% had worsened. Performance was excellent (C-statistic between 0.88 and 0.91) for all three prognostic models and calibration adequate for two models (p values, 0.22 and 0.85). Our results suggest that multiple imputation of the standard 6-month GOSE may be reasonable in TBI research when the primary outcome cannot be obtained through other means.

Outcome-based ventilation: A framework for assessing performance, health, and energy impacts to inform office building ventilation decisions.

PubMed

Rackes, A; Ben-David, T; Waring, M S

2018-07-01

This article presents an outcome-based ventilation (OBV) framework, which combines competing ventilation impacts into a monetized loss function ($/occ/h) used to inform ventilation rate decisions. The OBV framework, developed for U.S. offices, considers six outcomes of increasing ventilation: profitable outcomes realized from improvements in occupant work performance and sick leave absenteeism; health outcomes from occupant exposure to outdoor fine particles and ozone; and energy outcomes from electricity and natural gas usage. We used the literature to set low, medium, and high reference values for OBV loss function parameters, and evaluated the framework and outcome-based ventilation rates using a simulated U.S. office stock dataset and a case study in New York City. With parameters for all outcomes set at medium values derived from literature-based central estimates, higher ventilation rates' profitable benefits dominated negative health and energy impacts, and the OBV framework suggested ventilation should be ≥45 L/s/occ, much higher than the baseline ~8.5 L/s/occ rate prescribed by ASHRAE 62.1. Only when combining very low parameter estimates for profitable impacts with very high ones for health and energy impacts were all outcomes on the same order. Even then, however, outcome-based ventilation rates were often twice the baseline rate or more. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Nomogram for 30-day morbidity after primary cytoreductive surgery for advanced stage ovarian cancer.

PubMed

Nieuwenhuyzen-de Boer, G M; Gerestein, C G; Eijkemans, M J C; Burger, C W; Kooi, G S

2016-01-01

Extensive surgical procedures to achieve maximal cytoreduction in patients with advanced stage epithelial ovarian cancer (EOC) are inevitably associated with postoperative morbidity and mortality. This study aimed to identify preoperative predictors of 30-day morbidity after primary cytoreductive surgery for advanced stage EOC and to develop a nomogram for individual risk assessment. Patients in The Netherlands who underwent primary cytoreductive surgery for advanced stage EOC between January 2004 and December 2007. All peri- and postoperative complications within 30 days after surgery were registered and classified. To investigate predictors of 30-day morbidity, a Cox proportional hazard model with backward stepwise elimination was utilized. The identified predictors were entered into a nomogram. The main outcome was to identify parameters that predict operative risk. 293 patients entered the study protocol. Optimal cytoreduction was achieved in 136 (46%) patients. Thirty-day morbidity was seen in 99 (34%) patients. Morbidity could be predicted by age (p = 0.033; OR 1.024), preoperative hemoglobin (p = 0.194; OR 0.843), and WHO performance status (p = 0.015; OR 1.821) with a optimism-corrected c-statistic of 0.62. Determinants co-morbidity status, serum CA125 level, platelet count, and presence of ascites were comparable in both groups. Thirty-day morbidity after primary cytoreductive surgery for advanced stage EOC could be predicted by age, hemoglobin, and WHO performance status. The generated nomogram could be valuable for predicting operative risk in the individual patient.

Cost-effectiveness analysis reveals microsurgical varicocele repair is superior to percutaneous embolization in the treatment of male infertility.

PubMed

Kovac, Jason Ronald; Fantus, Jake; Lipshultz, Larry I; Fischer, Marc Anthony; Klinghoffer, Zachery

2014-09-01

Varicoceles are a common cause of male infertility; repair can be accomplished using either surgical or radiological means. We compare the cost-effectiveness of the gold standard, the microsurgical varicocele repair (MV), to the options of a nonmicrosurgical approach (NMV) and percutaneous embolization (PE) to manage varicocele-associated infertility. A Markov decision-analysis model was developed to estimate costs and pregnancy rates. Within the model, recurrences following MV and NMV were re-treated with PE and recurrences following PE were treated with repeat PE, MV or NMV. Pregnancy and recurrence rates were based on the literature, while costs were obtained from institutional and government supplied data. Univariate and probabilistic sensitivity-analyses were performed to determine the effects of the various parameters on model outcomes. Primary treatment with MV was the most cost-effective strategy at $5402 CAD (Canadian)/pregnancy. Primary treatment with NMV was the least costly approach, but it also yielded the fewest pregnancies. Primary treatment with PE was the least cost-effective strategy costing about $7300 CAD/pregnancy. Probabilistic sensitivity analysis reinforced MV as the most cost-effective strategy at a willingness-to-pay threshold of >$4100 CAD/pregnancy. MV yielded the most pregnancies at acceptable levels of incremental costs. As such, it is the preferred primary treatment strategy for varicocele-associated infertility. Treatment with PE was the least cost-effective approach and, as such, is best used only in cases of surgical failure.

Outcomes for Young Children's Social Status from Playing Group Games: Experiences from a Primary School in Hong Kong

ERIC Educational Resources Information Center

Liu, Sylvia; Yuen, Mantak; Rao, Nirmala

2015-01-01

This exploratory study involved a structured group-games intervention to develop first-grade students' social competence. The effects were evaluated by assessing possible outcomes for the children's social status. A sample of 119 first-grade, mixed-ability students from a Hong Kong primary school participated in the sessions (63 boys, 56 girls:…

Students Creating Digital Video in the Primary Classroom: Student Autonomy, Learning Outcomes, and Professional Learning Communities

ERIC Educational Resources Information Center

Henderson, Michael; Auld, Glenn; Holkner, Bernard; Russell, Glenn; Seah, Wee Tiong; Fernando, Anthony; Romeo, Geoff

2010-01-01

This research is a part of a national project to identify effective sustainable and embedded use of ICTs leading to improved educational outcomes. The project identified six schools and conducted a qualitative case study analysis out of which eleven successful strategies were reported. One of these strategies was observed at a primary school and…

Therapeutic alliance and obesity management in primary care - a cross-sectional pilot using the Working Alliance Inventory.

PubMed

Sturgiss, E A; Sargent, G M; Haesler, E; Rieger, E; Douglas, K

2016-12-01

Therapeutic alliance is a well-recognized predictor of patient outcomes within psychological therapy. It has not been applied to obesity interventions, and Bordin's theoretical framework shows particular relevance to the management of obesity in primary health care. This cross-sectional study of a weight management programme in general practice aimed to determine if therapeutic alliance was associated with patient outcomes. The Working Alliance Inventory short revised version (WAI-SR) was administered to 23 patients and 11 general practitioners (GPs) at the end of a 6-month weight management programme. Use of the WAI-SR indicated that the strength of therapeutic alliance varied between different patient-GP relationships in this pilot intervention. A robust therapeutic alliance was strongly associated with patient engagement in the weight management programme indicated by number of appointments. It was also associated with some general health and quality of life outcomes. These are promising results that require confirmation with larger studies in primary health care. The measurement of therapeutic alliance using the WAI-SR may predict patient attendance and outcomes in obesity interventions in primary healthcare settings. © 2016 World Obesity Federation.

Uncertainty in the Bayesian meta-analysis of normally distributed surrogate endpoints

PubMed Central

Thompson, John R; Spata, Enti; Abrams, Keith R

2015-01-01

We investigate the effect of the choice of parameterisation of meta-analytic models and related uncertainty on the validation of surrogate endpoints. Different meta-analytical approaches take into account different levels of uncertainty which may impact on the accuracy of the predictions of treatment effect on the target outcome from the treatment effect on a surrogate endpoint obtained from these models. A range of Bayesian as well as frequentist meta-analytical methods are implemented using illustrative examples in relapsing–remitting multiple sclerosis, where the treatment effect on disability worsening is the primary outcome of interest in healthcare evaluation, while the effect on relapse rate is considered as a potential surrogate to the effect on disability progression, and in gastric cancer, where the disease-free survival has been shown to be a good surrogate endpoint to the overall survival. Sensitivity analysis was carried out to assess the impact of distributional assumptions on the predictions. Also, sensitivity to modelling assumptions and performance of the models were investigated by simulation. Although different methods can predict mean true outcome almost equally well, inclusion of uncertainty around all relevant parameters of the model may lead to less certain and hence more conservative predictions. When investigating endpoints as candidate surrogate outcomes, a careful choice of the meta-analytical approach has to be made. Models underestimating the uncertainty of available evidence may lead to overoptimistic predictions which can then have an effect on decisions made based on such predictions. PMID:26271918

Uncertainty in the Bayesian meta-analysis of normally distributed surrogate endpoints.

PubMed

Bujkiewicz, Sylwia; Thompson, John R; Spata, Enti; Abrams, Keith R

2017-10-01

We investigate the effect of the choice of parameterisation of meta-analytic models and related uncertainty on the validation of surrogate endpoints. Different meta-analytical approaches take into account different levels of uncertainty which may impact on the accuracy of the predictions of treatment effect on the target outcome from the treatment effect on a surrogate endpoint obtained from these models. A range of Bayesian as well as frequentist meta-analytical methods are implemented using illustrative examples in relapsing-remitting multiple sclerosis, where the treatment effect on disability worsening is the primary outcome of interest in healthcare evaluation, while the effect on relapse rate is considered as a potential surrogate to the effect on disability progression, and in gastric cancer, where the disease-free survival has been shown to be a good surrogate endpoint to the overall survival. Sensitivity analysis was carried out to assess the impact of distributional assumptions on the predictions. Also, sensitivity to modelling assumptions and performance of the models were investigated by simulation. Although different methods can predict mean true outcome almost equally well, inclusion of uncertainty around all relevant parameters of the model may lead to less certain and hence more conservative predictions. When investigating endpoints as candidate surrogate outcomes, a careful choice of the meta-analytical approach has to be made. Models underestimating the uncertainty of available evidence may lead to overoptimistic predictions which can then have an effect on decisions made based on such predictions.

Amount of earnings during prize contingency management treatment is associated with posttreatment abstinence outcomes.

PubMed

Petry, Nancy M; Roll, John M

2011-12-01

Contingency management (CM) treatments that provide patients with the opportunity to earn chances of winning prizes of varying magnitudes are becoming increasingly popular. In the CM literature, magnitude of reinforcement is linked with effect sizes, such that CM treatments that provide larger magnitude reinforcement are more efficacious than those that provide lower magnitude reinforcement. With prize CM, even when magnitudes of overall expected prize earnings are constant, some patients win more prizes than others. Thus, patients who win larger overall amounts of prizes during treatment may have better outcomes than those who win fewer prizes. This study evaluated the impact of overall amounts of prizes won on long-term abstinence outcomes. The dollar amount of prizes won during prize CM treatments was determined from 78 cocaine-abusing methadone-maintenance patients who were randomized to prize CM treatments in three clinical trials. Abstinence three months following the end of the CM intervention was the primary dependent variable. The dollar amount of prizes won during CM treatment was a significant predictor of submission of cocaine-negative urine samples and self-reports of cocaine abstinence at the follow-up evaluation, even after controlling for other variables associated with long-term abstinence, such as pretreatment urinalysis results and longest duration of abstinence achieved during treatment. These results suggest that magnitudes of earnings during prize CM may impact outcomes and call for further experimentation of parameters related to the efficacy of prize CM.

Revision versus primary arthroscopic rotator cuff repair: a 2-year analysis of outcomes in 360 patients.

PubMed

Shamsudin, Aminudin; Lam, Patrick H; Peters, Karin; Rubenis, Imants; Hackett, Lisa; Murrell, George A C

2015-03-01

Symptomatic rotator cuff tears are often treated surgically. However, there is a paucity of information regarding the outcomes of revision arthroscopic rotator cuff repairs. To evaluate the outcome of revision arthroscopic rotator cuff surgery when compared with primary arthroscopic rotator cuff surgery in a large cohort of patients. Cohort study; Level of evidence, 3. A consecutive series of 50 revision arthroscopic rotator cuff repairs performed by a single surgeon, with minimum 2-year follow-up, were retrospectively reviewed using prospectively collected data. As a comparison, 3 primary arthroscopic rotator cuff repair cases (primary group; n = 310) were chosen immediately before each revision case, and 3 were chosen after. Standardized patient-ranked outcomes, examiner-determined assessments, and ultrasound-determined rotator cuff integrity were assessed preoperatively at 6 months and at a minimum of 2 years after surgery. The revision group was older (mean age, 63 years; range, 43-80 years) compared with the primary group (mean age, 60 years; range, 18-88 years) (P < .05) and had larger tear size (mean ± SEM) (4.1 ± 0.5 cm(2)) compared with the primary group (3.0 ± 0.2 cm(2)) (P < .05). Two years after surgery, the primary group reported less pain at rest (P < .02), during sleep (P < .05), and with overhead activity (P < .01) compared with the revision group. The primary group had better passive forward flexion (+13°; P < .05), abduction (+18°; P < .01), internal rotation (+2 vertebral levels; P < .001) and also significantly greater supraspinatus strength (+15 N; P < .001), lift-off strength (+9.3 N; P < .05), and adduction strength (+20 N; P < .01) compared with the revision group at 2 years. When compared with the primary group, the revision group was more satisfied with the overall shoulder function before surgery but was less satisfied with their shoulder function than the primary group at 2 years (P < .005). The retear rate for primary rotator cuff repair was 16% at 6 months and 21% at 2 years, while the retear rate for revision rotator cuff repair was 28% at 6 months and deteriorated to 40% at 2 years (P < .05). The short-term clinical outcomes of patients undergoing revision rotator cuff repair were similar to those after primary rotator cuff repair. However, these results did not persist, and by 2 years patients who had revision rotator cuff repair were twice as likely to have retorn compared with those undergoing primary repair. The increase in retear rate in the revision group at 2 years was associated with increased pain, impaired overhead function, less passive motion, weaker strength, and less overall satisfaction with shoulder function. © 2014 The Author(s).

Primary care physician assistant and advance practice nurses roles: Patient healthcare utilization, unmet need, and satisfaction.

PubMed

Everett, Christine M; Morgan, Perri; Jackson, George L

2016-12-01

Team-based care involving physician assistants (PAs) and advance practice nurses (APNs) is one strategy for improving access and quality of care. PA/APNs perform a variety of roles on primary care teams. However, limited research describes the relationship between PA/APN role and patient outcomes. We examined multiple outcomes associated with primary care PA/APN roles. In this cross-sectional survey analysis, we studied adult respondents to the 2010 Health Tracking Household Survey. Outcomes included primary care and emergency department visits, hospitalizations, unmet need, and satisfaction. PA/APN role was categorized as physician only (no PA/APN visits; reference), usual provider (PA/APN provide majority of primary care visits) or supplemental provider (physician as usual provider, PA/APN provide a subset of visits). Multivariable logistic and multinomial logistic regressions were performed. Compared to people with physician only care, patients with PA/APNs as usual providers [5-9 visits RRR=2.4 (CI 1.8-3.4), 10+ visits RRR=3.0 (CI 2.0-4.5): reference 2-4 visits] and supplemental providers had increased risk of having 5 or more primary care visits [5-9 visits RRR=1.3 (CI 1.0-1.6)]. Patients reporting PA/APN as supplemental providers had increased risk of emergency department utilization [2+ visits: RRR 1.8 (CI 1.3, 2.5)], and lower satisfaction [very dissatisfied: RRR 1.8 (CI 1.03-3.0)]. No differences were seen for hospitalizations or unmet need. Healthcare utilization patterns and satisfaction varied between adults with PA/APN in different roles, but reported unmet need did not. These findings suggest a wide range of outcomes should be considered when identifying the best PA/APN role on primary care teams. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of a Geriatric Care Model for frail older adults in primary care: Results from a stepped wedge cluster randomized trial.

PubMed

Hoogendijk, Emiel O; van der Horst, Henriëtte E; van de Ven, Peter M; Twisk, Jos W R; Deeg, Dorly J H; Frijters, Dinnus H M; van Leeuwen, Karen M; van Campen, Jos P C M; Nijpels, Giel; Jansen, Aaltje P D; van Hout, Hein P J

2016-03-01

Primary care-based comprehensive care programs have the potential to improve outcomes in frail older adults. We evaluated the impact of the Geriatric Care Model (GCM) on the quality of life of community-dwelling frail older adults. A 24-month stepped wedge cluster randomized controlled trial was conducted between May 2010 and March 2013 in 35 primary care practices in the Netherlands, and included 1147 frail older adults. The intervention consisted of a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Reassessment occurred every six months. Nurses worked together with primary care physicians and were supervised and trained by geriatric expert teams. Complex patients were reviewed in multidisciplinary consultations. The primary outcome was quality of life (SF-12). Secondary outcomes were health-related quality of life, functional limitations, self-rated health, psychological wellbeing, social functioning and hospitalizations. Intention-to-treat analyses based on multilevel modeling showed no significant differences between the intervention group and usual care regarding SF-12 and most secondary outcomes. Only for IADL limitations we found a small intervention effect in patients who received the intervention for 18months (B=-0.25, 95%CI=-0.43 to -0.06, p=0.007), but this effect was not statistically significant after correction for multiple comparisons. The GCM did not show beneficial effects on quality of life in frail older adults in primary care, compared to usual care. This study strengthens the idea that comprehensive care programs add very little to usual primary care for this population. The Netherlands National Trial Register NTR2160. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

The Chronic Care Model and Diabetes Management in US Primary Care Settings: A Systematic Review

PubMed Central

Stellefson, Michael; Stopka, Christine

2013-01-01

Introduction The Chronic Care Model (CCM) uses a systematic approach to restructuring medical care to create partnerships between health systems and communities. The objective of this study was to describe how researchers have applied CCM in US primary care settings to provide care for people who have diabetes and to describe outcomes of CCM implementation. Methods We conducted a literature review by using the Cochrane database of systematic reviews, CINAHL, and Health Source: Nursing/Academic Edition and the following search terms: “chronic care model” (and) “diabet*.” We included articles published between January 1999 and October 2011. We summarized details on CCM application and health outcomes for 16 studies. Results The 16 studies included various study designs, including 9 randomized controlled trials, and settings, including academic-affiliated primary care practices and private practices. We found evidence that CCM approaches have been effective in managing diabetes in US primary care settings. Organizational leaders in health care systems initiated system-level reorganizations that improved the coordination of diabetes care. Disease registries and electronic medical records were used to establish patient-centered goals, monitor patient progress, and identify lapses in care. Primary care physicians (PCPs) were trained to deliver evidence-based care, and PCP office–based diabetes self-management education improved patient outcomes. Only 7 studies described strategies for addressing community resources and policies. Conclusion CCM is being used for diabetes care in US primary care settings, and positive outcomes have been reported. Future research on integration of CCM into primary care settings for diabetes management should measure diabetes process indicators, such as self-efficacy for disease management and clinical decision making. PMID:23428085

Physician-patient communication in the primary care office: a systematic review.

PubMed

Beck, Rainer S; Daughtridge, Rebecca; Sloane, Philip D

2002-01-01

The physician-patient interview is the key component of all health care, particularly of primary medical care. This review sought to evaluate existing primary-care-based research studies to determine which verbal and nonverbal behaviors on the part of the physician during the medical encounter have been linked in empirical studies with favorable patient outcomes. We reviewed the literature from 1975 to 2000 for studies of office interactions between primary care physicians and patients that evaluated these interactions empirically using neutral observers who coded observed encounters, videotapes, or audiotapes. Each study was reviewed for the quality of the methods and to find statistically significant relations between specific physician behaviors and patient outcomes. In examining nonverbal behaviors, because of a paucity of clinical outcome studies, outcomes were expanded to include associations with patient characteristics or subjective ratings of the interaction by observers. We found 14 studies of verbal communication and 8 studies of nonverbal communication that met inclusion criteria. Verbal behaviors positively associated with health outcomes included empathy, reassurance and support, various patient-centered questioning techniques, encounter length, history taking, explanations, both dominant and passive physician styles, positive reinforcement, humor, psychosocial talk, time in health education and information sharing, friendliness, courtesy, orienting the patient during examination, and summarization and clarification. Nonverbal behaviors positively associated with outcomes included head nodding, forward lean, direct body orientation, uncrossed legs and arms, arm symmetry, and less mutual gaze. Existing research is limited because of lack of consensus of what to measure, conflicting findings, and relative lack of empirical studies (especially of nonverbal behavior). Nonetheless, medical educators should focus on teaching and reinforcing behaviors known to be facilitative, and to continue to understand further how physician behavior can enhance favorable patient outcomes, such as understanding and adherence to medical regimens and overall satisfaction.

FGF-23 as a Predictor of Renal Outcome in Diabetic Nephropathy

PubMed Central

Zatz, Roberto; Graciolli, Fabiana G.; dos Reis, Luciene M.; Barros, Rui T.; Jorgetti, Vanda; Moysés, Rosa M.A.

2011-01-01

Summary Background and objectives Fibroblast growth factor 23 (FGF-23) has emerged as a new factor in mineral metabolism in chronic kidney disease (CKD). An important regulator of phosphorus homeostasis, FGF-23 has been shown to independently predict CKD progression in nondiabetic renal disease. We analyzed the relation between FGF-23 and renal outcome in diabetic nephropathy (DN). Design, setting, participants, & measurements DN patients participating in a clinical trial (enalapril+placebo versus enalapril+losartan) had baseline data collected and were followed until June 2009 or until the primary outcome was reached. Four patients were lost to follow-up. The composite primary outcome was defined as death, doubling of serum creatinine, and/or dialysis need. Results At baseline, serum FGF-23 showed a significant association with serum creatinine, intact parathyroid hormone, proteinuria, urinary fractional excretion of phosphate, male sex, and race. Interestingly, FGF-23 was not related to calcium, phosphorus, 25OH-vitamin D, or 24-hour urinary phosphorus. Mean follow-up time was 30.7 ± 10 months. Cox regression showed that FGF-23 was an independent predictor of the primary outcome, even after adjustment for creatinine clearance and intact parathyroid hormone (10 pg/ml FGF-23 increase = hazard ratio, 1.09; 95% CI, 1.01 to 1.16, P = 0.02). Finally, Kaplan-Meier analysis showed a significantly higher risk of the primary outcome in patients with FGF-23 values of >70 pg/ml. Conclusions FGF-23 is a significant independent predictor of renal outcome in patients with macroalbuminuric DN. Further studies should clarify whether this relation is causal and whether FGF-23 should be a new therapeutic target for CKD prevention. PMID:20966122

Global measures of outcome in a controlled comparison of pharmacological and psychological treatment of panic disorder and agoraphobia in primary care.

PubMed Central

Sharp, D M; Power, K G; Simpson, R J; Swanson, V; Anstee, J A

1997-01-01

BACKGROUND: Panic disorder, with and without agoraphobia, is a prevalent condition which presents primarily in general practice. Previous clinical outcome studies have been conducted mainly in specialist university departments or hospital settings, and have tended to employ complex rating scales that are not well suited for use as outcome measures in primary care. AIM: To evaluate the outcome, in a primary care setting, of fluvoxamine versus cognitive behaviour therapy, each used alone and in combination in a double-blind placebo-controlled framework, balanced for therapist contact. METHOD: A total of 149 patients satisfying DSMIII-R criteria for panic disorder were randomly allocated to receive one of the following: fluvoxamine, placebo, fluvoxamine plus cognitive behaviour therapy, placebo plus cognitive behaviour therapy, and cognitive behaviour therapy alone. These five treatment groups represent the minimum number acceptable for such a comparison to be made. All patients received an identical schedule of contact over 13 weeks. Measures of symptom severity, general health and social disruption were taken at entry point and end point; measures of change in symptoms were taken at end point only. Outcome was reported in terms of brief global ratings of severity of illness and change in symptoms, and of ratings of general health and social disruption that are suitable for use in general practice. RESULTS: All active treatment groups showed statistically significant advantages over placebo over a range of outcome ratings. The groups employing cognitive behaviour therapy showed the most robust and consistent response. CONCLUSION: The brief global measures reported here proved adequate to the task of assessing treatment outcome. Results indicate that treatments including cognitive behaviour therapy can be effective in the treatment of panic disorder and agoraphobia in primary care. PMID:9167318

Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

PubMed

Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

2012-06-01

The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

Renal mass anatomic characteristics and perioperative outcomes of laparoscopic partial nephrectomy: a critical analysis.

PubMed

Tsivian, Matvey; Ulusoy, Said; Abern, Michael; Wandel, Ayelet; Sidi, A Ami; Tsivian, Alexander

2012-10-01

Anatomic parameters determining renal mass complexity have been used in a number of proposed scoring systems despite lack of a critical analysis of their independent contributions. We sought to assess the independent contribution of anatomic parameters on perioperative outcomes of laparoscopic partial nephrectomy (LPN). Preoperative imaging studies were reviewed for 147 consecutive patients undergoing LPN for a single renal mass. Renal mass anatomy was recorded: Size, growth pattern (endo-/meso-/exophytic), centrality (central/hilar/peripheral), anterior/posterior, lateral/medial, polar location. Multivariable models were used to determine associations of anatomic parameters with warm ischemia time (WIT), operative time (OT), estimated blood loss (EBL), intra- and postoperative complications, as well as renal function. All models were adjusted for the learning curve and relevant confounders. Median (range) tumor size was 3.3 cm (1.5-11 cm); 52% were central and 14% hilar. While 44% were exophytic, 23% and 33% were mesophytic and endophytic, respectively. Anatomic parameters did not uniformly predict perioperative outcomes. WIT was associated with tumor size (P=0.068), centrality (central, P=0.016; hilar, P=0.073), and endophytic growth pattern (P=0.017). OT was only associated with tumor size (P<0.001). No anatomic parameter predicted EBL. Tumor centrality increased the odds of overall and intraoperative complications, without reaching statistical significance. Postoperative renal function was not associated with any of the anatomic parameters considered after adjustment for baseline function and WIT. Learning curve, considered as a confounder, was independently associated with reduced WIT and OT as well as reduced odds of intraoperative complications. This study provides a detailed analysis of the independent impact of renal mass anatomic parameters on perioperative outcomes. Our findings suggest diverse independent contributions of the anatomic parameters to the different measures of outcomes (WIT, OT, EBL, complications, and renal function) emphasizing the importance of the learning curve.

Punishment induced behavioural and neurophysiological variability reveals dopamine-dependent selection of kinematic movement parameters

PubMed Central

Galea, Joseph M.; Ruge, Diane; Buijink, Arthur; Bestmann, Sven; Rothwell, John C.

2013-01-01

Action selection describes the high-level process which selects between competing movements. In animals, behavioural variability is critical for the motor exploration required to select the action which optimizes reward and minimizes cost/punishment, and is guided by dopamine (DA). The aim of this study was to test in humans whether low-level movement parameters are affected by punishment and reward in ways similar to high-level action selection. Moreover, we addressed the proposed dependence of behavioural and neurophysiological variability on DA, and whether this may underpin the exploration of kinematic parameters. Participants performed an out-and-back index finger movement and were instructed that monetary reward and punishment were based on its maximal acceleration (MA). In fact, the feedback was not contingent on the participant’s behaviour but pre-determined. Blocks highly-biased towards punishment were associated with increased MA variability relative to blocks with either reward or without feedback. This increase in behavioural variability was positively correlated with neurophysiological variability, as measured by changes in cortico-spinal excitability with transcranial magnetic stimulation over the primary motor cortex. Following the administration of a DA-antagonist, the variability associated with punishment diminished and the correlation between behavioural and neurophysiological variability no longer existed. Similar changes in variability were not observed when participants executed a pre-determined MA, nor did DA influence resting neurophysiological variability. Thus, under conditions of punishment, DA-dependent processes influence the selection of low-level movement parameters. We propose that the enhanced behavioural variability reflects the exploration of kinematic parameters for less punishing, or conversely more rewarding, outcomes. PMID:23447607

King’s College Hospital criteria for non-acetaminophen induced acute liver failure in an international cohort of children

PubMed Central

Sundaram, Vinay; Shneider, Benjamin L.; Dhawan, Anil; Ng, Vicky L.; Im, Kyungah; Belle, Steven; Squires, Robert H.

2012-01-01

Objective To validate King’s College Hospital criteria (KCHC) in children with non-acetaminophen (APAP) induced pediatric acute liver failure (PALF) and to determine whether re-optimizing the KCHC would improve predictive accuracy. Study design We utilized the PALF study group database. Primary outcomes were survival without liver transplantation (LT) versus death at 21 days following enrollment. Classification and Regression Tree (CART) analysis was used to determine if modification of KCHC parameters would improve classification of death versus survival. Results Among 163 patients who met KCHC, 54 patients (33.1%) died within 21 days. Sensitivity of KCHC in this cohort was significantly lower than in the original study (61% vs 91%, p=0.002), and specificity did not differ significantly. The positive predictive value (PPV) and negative predictive value (NPV) of KCHC for this cohort was 33% and 88% respectively. CART analysis yielded the following optimized parameters to predict death: grade 2–4 encephalopathy, international normalized ratio >4.02 and total bilirubin >2.02 mg/dL. These parameters did not improve PPV, but NPV was significantly better (88% vs. 92%, p<0.0001). Conclusions KCHC does not reliably predict death in PALF. With a PPV of 33%, twice as many participants who met KCHC recovered spontaneously than died, indicating that using KCHC may cause over utilization of LT. Re-optimized cutpoints for KCHC parameters improved NPV, but not PPV. Parameters beyond the KCHC should be evaluated to create a predictive model for PALF. PMID:22906509

The outcome of the seminal fluid parameters collected via coitus interruptus versus masturbation.

PubMed

Bahyah, M Kamarul; Murad, Z Ahmad; Ghazali, I; Roszaman, R; Noraziana, A W; Mokhtar, A; Omar, M H

2010-03-01

A one year study was carried out to determine the outcome of the seminal fluid parameters collected via masturbation and coitus interruptus in 151 patients who were undergoing intrauterine insemination (IUI) and patients who came for seminal analysis. There were no statistically significant differences in terms of volume, concentration, progressive motility and normal morphology from specimens collected via coitus interruptus compared to specimens collected via masturbation. Pregnancy outcomes were also comparable.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

PubMed

Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Method and system for assigning a confidence metric for automated determination of optic disc location

DOEpatents

Karnowski, Thomas P [Knoxville, TN; Tobin, Jr., Kenneth W.; Muthusamy Govindasamy, Vijaya Priya [Knoxville, TN; Chaum, Edward [Memphis, TN

2012-07-10

A method for assigning a confidence metric for automated determination of optic disc location that includes analyzing a retinal image and determining at least two sets of coordinates locating an optic disc in the retinal image. The sets of coordinates can be determined using first and second image analysis techniques that are different from one another. An accuracy parameter can be calculated and compared to a primary risk cut-off value. A high confidence level can be assigned to the retinal image if the accuracy parameter is less than the primary risk cut-off value and a low confidence level can be assigned to the retinal image if the accuracy parameter is greater than the primary risk cut-off value. The primary risk cut-off value being selected to represent an acceptable risk of misdiagnosis of a disease having retinal manifestations by the automated technique.

Immunocompromised patients with metastatic cutaneous nodal squamous cell carcinoma of the head and neck: Poor outcome unrelated to the index lesion.

PubMed

Lam, Johnson K S; Sundaresan, Puma; Gebski, Val; Veness, Michael J

2018-05-01

Immunocompromised patients with metastatic cutaneous nodal head and neck squamous cell carcinoma (HNSCC) have worse outcomes compared to the immunocompetent. The purpose of this study was to investigate the characteristics of the primary cutaneous squamous cell carcinoma (SCC), nodal pathology, and outcome between these 2 groups. Analysis of a prospective database was performed. A 2:1 pooled analysis selected 46 immunocompetent patients matched with 23 immunocompromised patients. Overall survival (OS) and relapse-free survival (RFS) were calculated using the Kaplan-Meier method. No significant difference was found in the primary tumor characteristics between the 2 groups. In the immunocompromised group, RFS (hazard ratio [HR] 2.70; P = .01) and OS (HR 2.32; P = .04) were significantly worse. Extracapsular spread was present in 100% of the immunocompromised patients. No significant difference was identified in the primary cutaneous SCC between the immunocompetent and immunocompromised patients. Immunosuppression predicted worse outcome. © 2018 Wiley Periodicals, Inc.

Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

PubMed

Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

2017-12-01

The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Cytoprotective Effect of Peptide Sedatin, an Agonist of μ/δ-Opioid Receptors, on Primary Culture of Pulmonary Fibroblasts of Albino Rats under Conditions of Oxidative Stress.

PubMed

Sazonova, E N; Samarina, E Yu; Lebed'ko, O A; Maltseva, I M; Timoshin, S S

2016-05-01

We studied the effects of a synthetic analogue of dermorphin peptide sedatin on DNA synthesis, nucleolar apparatus, and parameters of free radical oxidation in the primary culture of pulmonary fibroblasts under conditions of oxidative stress. Oxidative stress significantly enhanced production of superoxide anion radical in the culture, sufficiently inhibited DNA synthesis in fibroblasts, and reduced the size of cell nuclei and parameters of the nucleolar apparatus. Sedatin prevented accumulation of free radical oxidation products and changes in karyometry parameters induced by oxidative stress. The peptide completely eliminated changes in the parameters of fibroblast nucleolar apparatus and abolished the inhibitory effect of oxidative stress on the number of DNA-synthesizing cells. Pretreatment with non-selective opioid receptor antagonist naloxone hydrochloride partially abolished the effects of sedatin in the primary culture of pulmonary fibroblasts.

Defining the Scope of Prognosis: Primary Care Clinicians' Perspectives on Predicting the Future Health of Older Adults.

PubMed

Thomas, John M; Fried, Terri R

2018-05-01

Studies examining the attitudes of clinicians toward prognostication for older adults have focused on life expectancy prediction. Little is known about whether clinicians approach prognostication in other ways. To describe how clinicians approach prognostication for older adults, defined broadly as making projections about patients' future health. In five focus groups, 30 primary care clinicians from community-based, academic-affiliated, and Veterans Affairs primary care practices were given open-ended questions about how they make projections about their patients' future health and how this informs the approach to care. Content analysis was used to organize responses into themes. Clinicians spoke about future health in terms of a variety of health outcomes in addition to life expectancy, including independence in activities and decision making, quality of life, avoiding hospitalization, and symptom burden. They described approaches in predicting these health outcomes, including making observations about the overall trajectory of patients to predict health outcomes and recognizing increased risk for adverse health outcomes. Clinicians expressed reservations about using estimates of mortality risk and life expectancy to think about and communicate patients' future health. They discussed ways in which future research might help them in thinking about and discussing patients' future health to guide care decisions, including identifying when and whether interventions might impact future health. The perspectives of primary care clinicians in this study confirm that prognostic considerations can go beyond precise estimates of mortality risk and life expectancy to include a number of outcomes and approaches to predicting those outcomes. Published by Elsevier Inc.

Outcomes of Subsyndromal Depression in Older Primary Care Patients

PubMed Central

Grabovich, Andrew; Lu, Naiji; Tang, Wan; Tu, Xin; Lyness, Jeffrey M.

2010-01-01

Objectives Most older persons in primary care suffering clinically significant depressive symptoms do not meet criteria for major or minor depression. We tested the hypothesis that patients with subsyndromal depression (SSD) would have poorer psychiatric, medical, and functional outcomes at follow-up than non-depressed patients, but not as poor as those with minor or major depression. We also explored the relative outcomes of three definitions of SSD to determine their relative prognostic value. Design Prospective observational cohort study. Setting Primary care practices in Monroe County, NY. Participants 481 primary care patients age ≥65 years who completed research assessments at intake and at least one year of follow-up evaluation. Measurements Depression diagnoses and three definitions of SSD were determined by the Structured Clinical Interview for DSM-IV and the 24-item Hamilton Depression Rating Scale. Other validated measures assessed anxiety, cognition, medical burden, and functional status. Results Patients with SSD had poorer 1-year lagged outcomes than non-depressed subjects in terms of psychiatric symptoms and functional status, often not significantly different than major or minor depression. Two of the SSD definitions identified subjects with poorer psychiatric and functional outcomes than the third SSD definition. Conclusions Clinicians should be vigilant in caring for patients with SSD, monitoring for persistent or worsening depressive symptoms including suicidality, anxiety, cognitive impairment, and functional decline. Researchers may use particular SSD definitions to identify individuals at higher risk of poor outcomes, to better understand the relationships of SSD to functional disability and to test innovative preventive and therapeutic interventions. PMID:20173424

The effect of care pathways for hip fractures: a systematic review.

PubMed

Leigheb, Fabrizio; Vanhaecht, Kris; Sermeus, Walter; Lodewijckx, Cathy; Deneckere, Svin; Boonen, Steven; Boto, Paulo Alexandre Faria; Mendes, Rita Veloso; Panella, Massimiliano

2012-07-01

We performed a systematic review for primary studies on care pathways (CPs) for hip fracture (HF). The online databases MEDLINE-PubMed, Ovid-EMBASE, CINAHL-EBSCO host, and The Cochrane Library (Cochrane Central Register of Clinical Trials, Health Technology Assessment Database, NHS Economic Evaluation Database) were searched. Two researchers reviewed the literature independently. Primary studies that met predefined inclusion criteria were assessed for their methodological quality. A total of 15 publications were included: 15 primary studies corresponding with 12 main investigations. Primary studies were evaluated for clinical outcomes, process outcomes, and economic outcomes. The studies assessed a wide range of outcome measures. While a number of divergent clinical outcomes were reported, most studies showed positive results of process management and health-services utilization. In terms of mortality, the results provided evidence for a positive impact of CPs on in-hospital mortality. Most studies also showed a significantly reduced risk of complications, including medical complications, wound infections, and pressure sores. Moreover, time-span process measures showed that an improvement in the organization of care was achieved through the use of CPs. Conflicting results were observed with regard to functional recovery and mobility between patients treated with CPs compared to usual care. Although our review suggests that CPs can have positive effects in patients with HF, the available evidence is insufficient for formal recommendations. There is a need for more research on CPs with selected process and outcome indicators, for in-hospital and postdischarge management of HF, with an emphasis on well-designed randomized trials.

Prognostic indicators of poor short-term outcome of physiotherapy intervention in women with stress urinary incontinence.

PubMed

Hendriks, Erik J M; Kessels, Alfons G H; de Vet, Henrica C W; Bernards, Arnold T M; de Bie, Rob A

2010-03-01

To identify prognostic indicators independently associated with poor outcome of physiotherapy intervention in women with primary or recurrent stress urinary incontinence (stress UI). A prospective cohort study was performed in physiotherapy practices in primary care to identify prognostic indicators 12 weeks after initiation of physiotherapy intervention. Patients were referred by general practitioners or urogynecologists. Risk factors for stress UI were examined as potential prognostic indicators of poor outcome. The primary outcomes were defined as poor outcome on the binary Leakage Severity scale (LS scale) and the binary global perceived effectiveness (GPE) score. Two hundred sixty-seven women, with a mean age of 47.7 (SD = 8.3), with stress UI for at least 6 months were included. At 12 weeks, 43% and 59% of the women were considered recovered on the binary LS scale and the binary GPE score, respectively. Prognostic indicators associated with poor outcome included 11 indicators based on the binary LS scale and 8 based on the binary GPE score. The prognostic indicators shared by both models show that poor recovery was associated with women with severe stress UI, POP-Q stage > II, poor outcome of physiotherapy intervention for a previous UI episode, prolonged second stage of labor, BMI > 30, high psychological distress, and poor physical health. This study provides robust evidence of clinically meaningful prognostic indicators of poor short-term outcome. These findings need to be confirmed by replication studies. (c) 2009 Wiley-Liss, Inc.

Effects of Sand Harvesting on Environment and Educational Outcomes in Public Primary Schools in Kathiani Sub-County, Machakos County, Kenya

ERIC Educational Resources Information Center

Nthambi, Mutiso Veronicah; Orodho, John Aluko

2015-01-01

The purpose of this study was to examine the effects of sand harvesting on environment and educational outcomes in public primary schools in Kathiani Sub-County, Machakos County, Kenya. This study was premised on treadmill theory of production proposed by Schnaiberg (1980). The study adopted a survey design. Combinations of purposive and…

National socioeconomic indicators are associated with outcomes after aneurysmal subarachnoid hemorrhage: a hierarchical mixed-effects analysis.

PubMed

Guha, Daipayan; Ibrahim, George M; Kertzer, Joshua D; Macdonald, R Loch

2014-11-01

Although heterogeneity exists in patient outcomes following subarachnoid hemorrhage (SAH) across different centers and countries, it is unclear which factors contribute to such disparities. In this study, the authors performed a post hoc analysis of a large international database to evaluate the association between a country's socioeconomic indicators and patient outcome following aneurysmal SAH. An analysis was performed on a database of 3552 patients enrolled in studies of tirilazad mesylate for aneurysmal SAH from 1991 to 1997, which included 162 neurosurgical centers in North and Central America, Australia, Europe, and Africa. Two primary outcomes were assessed at 3 months after SAH: mortality and Glasgow Outcome Scale (GOS) score. The association between these outcomes, nation-level socioeconomic indicators (percapita gross domestic product [GDP], population-to-neurosurgeon ratio, and health care funding model), and patientlevel covariates were assessed using a hierarchical mixed-effects logistic regression analysis. Multiple previously identified patient-level covariates were significantly associated with increased mortality and worse neurological outcome, including age, intraventricular hemorrhage, and initial neurological grade. Among national-level covariates, higher per-capita GDP (p < 0.05) was associated with both reduced mortality and improved neurological outcome. A higher population-to-neurosurgeon ratio (p < 0.01), as well as fewer neurosurgical centers per population (p < 0.001), was also associated with better neurological outcome (p < 0.01). Health care funding model was not a significant predictor of either primary outcome. Higher per-capita gross GDP and population-to-neurosurgeon ratio were associated with improved outcome after aneurysmal SAH. The former result may speak to the availability of resources, while the latter may be a reflection of better outcomes with centralized care. Although patient clinical and radiographic phenotypes remain the primary predictors of outcome, this study shows that national socioeconomic disparities also explain heterogeneity in outcomes following SAH.

Hemoglobin A1c and short-term outcomes in patients with acute myocardial infarction undergoing primary angioplasty: an observational multicenter study.

PubMed

Tian, Li; Zhu, Jun; Liu, Lisheng; Liang, Yan; Li, Jiandong; Yang, Yanmin

2013-01-01

Several studies to date have examined whether admission levels of hemoglobin A1c (HbA1c) correlate with short-term and long-term outcomes in patients with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI). However, the results have been ambiguous. We speculated that admission levels of HbA1c correlate with short-term outcomes of patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. In this observational multicenter study, 608 patients with STEMI who underwent primary PCI between June 2001 and July 2004 were enrolled. Blood samples were collected upon admission to hospital for HbA1c measurement. Follow-up was carried out at 7 and 30 days after hospital admission. According to the new American Diabetes Association criteria, patients were stratified into three groups: I, HbA1c 5.6% or less (n=262); II, HbA1c 5.7-6.4% (n=182); and III, HbA1c at least 6.5% (n=164). The primary outcomes were all-cause mortality and major adverse cardiac events at follow-up. The 7-day mortality was similar (P=0.179) between groups I (1.9%), II (2.2%), and III (0.0%); the 30-day mortality was also similar (P=0.241) between groups I (3.8%), II (2.2%), and III (1.2%). MACE at the 7- day and 30-day follow-up were not significantly different between the three groups either (P>0.05). Rates of target vessel revascularization and rehospitalization, and MACE-free survival curves, at the 30-day follow-up were also similar among the three groups. After adjusting the baseline characteristics, HbA1c was not an independent predictor of short-term outcomes (hazards ratio: 0.431; 95% confidence interval: 0.175-1.061, P=0.067). Admission levels of HbA1c are not an independent prognostic marker for short-term outcomes in STEMI patients treated with primary PCI.

Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial.

PubMed

Schull, Michael J; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, Eric

2010-12-03

In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care. A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice. Controlled Clinical Trials ISRCTN47805230.

Primary closure versus non-closure of dog bite wounds. a randomised controlled trial.

PubMed

Paschos, Nikolaos K; Makris, Eleftherios A; Gantsos, Apostolos; Georgoulis, Anastasios D

2014-01-01

Dog bite wounds represent a major health problem. Despite their importance, their management and especially the role of primary closure remain controversial. In this randomised controlled trial, the outcome between primary suturing and non-closure was compared. 168 consecutive patients with dog bite injuries were included in this study. The wounds were allocated randomly in two treatment approaches: Group 1, consisting of eighty-two patients, had their wound sutured, whilst Group 2, consisting of eighty-six patients, did not have their wounds sutured. All wounds were cleansed using high-pressure irrigation and povidone iodine. All patients received the same type of antibiotic treatment. Our measured outcomes included presence of infection and cosmetic appearance. Cosmetic outcome was evaluated using the Vancouver Scar Scale (VSS). Wound and patient characteristics, such as time of management, wound location and size, and patient age, were recorded and analysed for their potential role in the resulting outcome. The overall infection rate was 8.3%. No difference in the infection rate between primary suturing and non-suturing group was detected in the present study. The cosmetic appearance of the sutured wounds was significantly better (mean score 1.74) compared to the wounds that were left open (mean score 3.05) (p=0.0001). The infection rate was comparable among all age groups. Wounds treated within 8h of injury demonstrated an infection rate of 4.5%, which is lower compared to the 22.2% rate observed in wounds treated later than 8h. The wounds located at the head and neck exhibited better results in both infection rate and cosmetic outcome. Additionally, wounds >3 cm negatively affected the cosmetic appearance of the outcome. Primary suturing of wounds caused by dog bites resulted in similar infection rate compared to non-suturing. However, primary suturing exhibited improved cosmetic appearance. Time of management appeared to be critical, as early treatment resulted in lower infection rate and improved cosmetic appearance regardless suturing or not. Furthermore, wounds located at the head and face demonstrated better results. Copyright © 2013 Elsevier Ltd. All rights reserved.

Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized Trial.

PubMed

Cusi, Kenneth; Orsak, Beverly; Bril, Fernando; Lomonaco, Romina; Hecht, Joan; Ortiz-Lopez, Carolina; Tio, Fermin; Hardies, Jean; Darland, Celia; Musi, Nicolas; Webb, Amy; Portillo-Sanchez, Paola

2016-09-06

The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682). University hospital. Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. All patients were prescribed a hypocaloric diet (500-kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score in 2 histologic categories without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, -0.5 [CI, -0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, -7 percentage points [CI, -10 to -4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of therapy. The overall rate of adverse events did not differ between groups, although weight gain was greater with pioglitazone (2.5 kg vs. placebo). Single-center study. Long-term pioglitazone treatment is safe and effective in patients with prediabetes or T2DM and NASH. Burroughs Wellcome Fund and American Diabetes Association.

Cancer and central nervous system disorders: protocol for an umbrella review of systematic reviews and updated meta-analyses of observational studies.

PubMed

Catalá-López, Ferrán; Hutton, Brian; Driver, Jane A; Page, Matthew J; Ridao, Manuel; Valderas, José M; Alonso-Arroyo, Adolfo; Forés-Martos, Jaume; Martínez, Salvador; Gènova-Maleras, Ricard; Macías-Saint-Gerons, Diego; Crespo-Facorro, Benedicto; Vieta, Eduard; Valencia, Alfonso; Tabarés-Seisdedos, Rafael

2017-04-04

The objective of this study will be to synthesize the epidemiological evidence and evaluate the validity of the associations between central nervous system disorders and the risk of developing or dying from cancer. We will perform an umbrella review of systematic reviews and conduct updated meta-analyses of observational studies (cohort and case-control) investigating the association between central nervous system disorders and the risk of developing or dying from any cancer or specific types of cancer. Searches involving PubMed/MEDLINE, EMBASE, SCOPUS and Web of Science will be used to identify systematic reviews and meta-analyses of observational studies. In addition, online databases will be checked for observational studies published outside the time frames of previous reviews. Eligible central nervous system disorders will be Alzheimer's disease, anorexia nervosa, amyotrophic lateral sclerosis, autism spectrum disorders, bipolar disorder, depression, Down's syndrome, epilepsy, Huntington's disease, multiple sclerosis, Parkinson's disease and schizophrenia. The primary outcomes will be cancer incidence and cancer mortality in association with a central nervous system disorder. Secondary outcome measures will be site-specific cancer incidence and mortality, respectively. Two reviewers will independently screen references identified by the literature search, as well as potentially relevant full-text articles. Data will be abstracted, and study quality/risk of bias will be appraised by two reviewers independently. Conflicts at all levels of screening and abstraction will be resolved through discussion. Random-effects meta-analyses of primary observational studies will be conducted where appropriate. Parameters for exploring statistical heterogeneity are pre-specified. The World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) criteria and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used for determining the quality of evidence for cancer outcomes. Our study will establish the extent of the epidemiological evidence underlying the associations between central nervous system disorders and cancer and will provide a rigorous and updated synthesis of a range of important site-specific cancer outcomes. PROSPERO CRD42016052762.

Outcome-Reporting Bias in Education Research

ERIC Educational Resources Information Center

Pigott, Therese D.; Valentine, Jeffrey C.; Polanin, Joshua R.; Williams, Ryan T.; Canada, Dericka D.

2013-01-01

Outcome-reporting bias occurs when primary studies do not include information about all outcomes measured in a study. When studies omit findings on important measures, efforts to synthesize the research using systematic review techniques will be biased and interpretations of individual studies will be incomplete. Outcome-reporting bias has been…

Working toward financial sustainability of integrated behavioral health services in a public health care system.

PubMed

Monson, Samantha Pelican; Sheldon, J Christopher; Ivey, Laurie C; Kinman, Carissa R; Beacham, Abbie O

2012-06-01

The need, benefit, and desirability of behavioral health integration in primary care is generally accepted and has acquired widespread positive regard. However, in many health care settings the economics, business aspects, and financial sustainability of practice in integrated care settings remains an unsolved puzzle. Organizational administrators may be reluctant to expand behavioral health services without evidence that such programs offer clear financial benefits and financial sustainability. The tendency among mental health professionals is to consider positive clinical outcomes (e.g., reduced depression) as being globally valued indicators of program success. Although such outcomes may be highly valued by primary care providers and patients, administrative decision makers may require demonstration of more tangible financial outcomes. These differing views require program developers and evaluators to consider multiple outcome domains including clinical/psychological symptom reduction, potential cost benefit, and cost offset. The authors describe a process by which a pilot demonstration project is being implemented to demonstrate programmatic outcomes with a focus on the following: 1) clinician efficiency, 2) improved health outcomes, and 3) direct revenue generation associated with the inclusion of integrated primary care in a public health care system. The authors subsequently offer specific future directions and commentary regarding financial evaluation in each of these domains.

Quality of registration for clinical trials published in emergency medicine journals.

PubMed

Jones, Christopher W; Platts-Mills, Timothy F

2012-10-01

In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

Association of the Magnitude of Weight Loss and Physical Fitness Change on Long-term CVD outcomes: The Look AHEAD Study

PubMed Central

2016-01-01

Background The Look AHEAD Study found no significant reduction in cardiovascular disease (CVD) incidence among adults with diabetes enrolled in an intensive weight loss intervention (ILI) compared to those randomized to diabetes support and education (DSE). We examined whether CVD incidence in Look AHEAD varied by weight or fitness change. Methods Among overweight or obese adults people aged 45–76 with type 2 diabetes in the Look AHEAD study, this observational analysis examined the association of magnitude of weight loss (N=4834) and fitness change (N=4406) over the first year with CVD incidence over a median 10.2 years of follow-up. The primary outcome was a composite of CVD death, myocardial infarction, stroke, or angina hospitalization; the secondary outcome included the same indices plus coronary–artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalization for congestive heart failure, peripheral vascular disease, or total mortality. Analyses adjusted for baseline differences in weight or fitness, demographics and CVD risk factors. Findings In analyses of the full cohort combining ILI and DSE, persons who lost > 10% body weight in the first year had 21% lower risk of the primary outcome (HR=0.79, 95% CI, 0.64 to 0.98) and a 24% reduced risk of the secondary outcome (HR=0.76, 95% CI, 0.63 to 0.91) relative to those with stable weight/weight gain. Achieving a > 2 MET fitness change was associated with a significant reduction in the secondary outcome (HR=0.77, 95% CI, 0.61 – 0.96) but not the primary outcome (HR=0.78, 0.60 – 1.03). In analyses treating the DSE as the referent group, ILI participants with > 10% weight losses had a 20% lower risk of the primary outcome (HR=0.80 (95% CI, 0.65 – 0.99) and a 21% reduced risk of the secondary outcome (0.79 (95% CI, 0.66 – 0.95); fitness change was not significantly associated with either outcome. Interpretation This secondary analysis of Look AHEAD suggests an association between the magnitude of intentional weight loss and CVD incidence. PMID:27595918

Implementation of a Care Pathway for Primary Palliative Care in 5 research clusters in Belgium: quasi-experimental study protocol and innovations in data collection (pro-SPINOZA).

PubMed

Leysen, Bert; Van den Eynden, Bart; Gielen, Birgit; Bastiaens, Hilde; Wens, Johan

2015-09-28

Starting with early identification of palliative care patients by general practitioners (GPs), the Care Pathway for Primary Palliative Care (CPPPC) is believed to help primary health care workers to deliver patient- and family-centered care in the last year of life. The care pathway has been pilot-tested, and will now be implemented in 5 Belgian regions: 2 Dutch-speaking regions, 2 French-speaking regions and the bilingual capital region of Brussels. The overall aim of the CPPPC is to provide better quality of primary palliative care, and in the end to reduce the hospital death rate. The aim of this article is to describe the quantitative design and innovative data collection strategy used in the evaluation of this complex intervention. A quasi-experimental stepped wedge cluster design is set up with the 5 regions being 5 non-randomized clusters. The primary outcome is reduced hospital death rate per GPs' patient population. Secondary outcomes are increased death at home and health care consumption patterns suggesting high quality palliative care. Per research cluster, GPs will be recruited via convenience sampling. These GPs -volunteering to be involved will recruit people with reduced life expectancy and their informal care givers. Health care consumption data in the last year of life, available for all deceased people having lived in the research clusters in the study period, will be used for comparison between patient populations of participating GPs and patient populations of non-participating GPs. Description of baseline characteristics of participating GPs and patients and monitoring of the level of involvement by GPs, patients and informal care givers will happen through regular, privacy-secured web-surveys. Web-survey data and health consumption data are linked in a secure way, respecting Belgian privacy laws. To evaluate this complex intervention, a quasi-experimental stepped wedge cluster design has been set up. Context characteristics and involvement level of participants are important parameters in evaluating complex interventions. It is possible to securely link survey data with health consumption data. By appealing to IT solutions we hope to be able to partly reduce respondent burden, a known problem in palliative care research. ClinicalTrials.gov Identifier: NCT02266069.

Statistical analysis and handling of missing data in cluster randomized trials: a systematic review.

PubMed

Fiero, Mallorie H; Huang, Shuang; Oren, Eyal; Bell, Melanie L

2016-02-09

Cluster randomized trials (CRTs) randomize participants in groups, rather than as individuals and are key tools used to assess interventions in health research where treatment contamination is likely or if individual randomization is not feasible. Two potential major pitfalls exist regarding CRTs, namely handling missing data and not accounting for clustering in the primary analysis. The aim of this review was to evaluate approaches for handling missing data and statistical analysis with respect to the primary outcome in CRTs. We systematically searched for CRTs published between August 2013 and July 2014 using PubMed, Web of Science, and PsycINFO. For each trial, two independent reviewers assessed the extent of the missing data and method(s) used for handling missing data in the primary and sensitivity analyses. We evaluated the primary analysis and determined whether it was at the cluster or individual level. Of the 86 included CRTs, 80 (93%) trials reported some missing outcome data. Of those reporting missing data, the median percent of individuals with a missing outcome was 19% (range 0.5 to 90%). The most common way to handle missing data in the primary analysis was complete case analysis (44, 55%), whereas 18 (22%) used mixed models, six (8%) used single imputation, four (5%) used unweighted generalized estimating equations, and two (2%) used multiple imputation. Fourteen (16%) trials reported a sensitivity analysis for missing data, but most assumed the same missing data mechanism as in the primary analysis. Overall, 67 (78%) trials accounted for clustering in the primary analysis. High rates of missing outcome data are present in the majority of CRTs, yet handling missing data in practice remains suboptimal. Researchers and applied statisticians should carry out appropriate missing data methods, which are valid under plausible assumptions in order to increase statistical power in trials and reduce the possibility of bias. Sensitivity analysis should be performed, with weakened assumptions regarding the missing data mechanism to explore the robustness of results reported in the primary analysis.

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

PubMed

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

2016-11-14

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

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

PubMed Central

Kasch, Helge; Kongsted, Alice; Qerama, Erisela; Bach, Flemming W; Bendix, Tom; Jensen, Troels Staehelin

2013-01-01

Objectives An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. Design The design was an observational prospective study of risk factors embedded in a randomised controlled study. Setting Acute whiplash patients from units, general practitioners in four Danish counties were referred to two research centres. Participants During a 2-year inclusion period, acute consecutive whiplash-injured (age 18–70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I–III, symptoms within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. Results The risk score and number of sick-listing days were related (Kruskal-Wallis, p<0.0001). In stratum 1, less than 4%, but in stratum 7, 68% were work-disabled after 1 year. Early work assessment (p<0.0001), impact of the event questionnaire (p<0.0006), psychophysical pain measures being McGill pain questionnaire parameters (p<0.0001), pressure pain algometry (p<0.0001) and palpation (p<0.0001) showed a significant relationship with risk stratification. Analysis Findings confirm previous studies reporting intense neck pain/headache and distress as predictors for work disability after whiplash. Neck-mobility was a strong predictor in this study; however, it was a more inconsistent predictor in other studies. Conclusions Application of the risk assessment score and use of the risk strata system may be beneficial in future studies and may be considered as a valuable tool to assess return-to-work following injuries; however, further studies are needed. PMID:23370009

Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

PubMed

Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

2014-11-01

Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may suggest new methods for enhancing outcomes. Australia and New Zealand Clinical Trial Registry: ACTRN12611000136909. Copyright © 2014. Published by Elsevier Ltd.

Clinical outcomes of HIV care delivery models in the US: a systematic review.

PubMed

Kimmel, April D; Martin, Erika G; Galadima, Hadiza; Bono, Rose S; Tehrani, Ali Bonakdar; Cyrus, John W; Henderson, Margaret; Freedberg, Kenneth A; Krist, Alexander H

2016-10-01

With over 1 million people living with HIV, the US faces national challenges in HIV care delivery due to an inadequate HIV specialist workforce and the increasing role of non-communicable chronic diseases in driving morbidity and mortality in HIV-infected patients. Alternative HIV care delivery models, which include substantial roles for advanced practitioners and/or coordination between specialty and primary care settings in managing HIV-infected patients, may address these needs. We aimed to systematically review the evidence on patient-level HIV-specific and primary care health outcomes for HIV-infected adults receiving outpatient care across HIV care delivery models. We identified randomized trials and observational studies from bibliographic and other databases through March 2016. Eligible studies met pre-specified eligibility criteria including on care delivery models and patient-level health outcomes. We considered all available evidence, including non-experimental studies, and evaluated studies for risk of bias. We identified 3605 studies, of which 13 met eligibility criteria. Of the 13 eligible studies, the majority evaluated specialty-based care (9 studies). Across all studies and care delivery models, eligible studies primarily reported mortality and antiretroviral use, with specialty-based care associated with mortality reductions at the clinician and practice levels and with increased antiretroviral initiation or use at the clinician level but not the practice level. Limited and heterogeneous outcomes were reported for other patient-level HIV-specific outcomes (e.g., viral suppression) as well as for primary care health outcomes across all care delivery models. No studies addressed chronic care outcomes related to aging. Limited evidence was available across geographic settings and key populations. As re-design of care delivery in the US continues to evolve, better understanding of patient-level HIV-related and primary care health outcomes, especially across different staffing models and among different patient populations and geographic locations, is urgently needed to improve HIV disease management.

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

PubMed

Zinman, Bernard; Wanner, Christoph; Lachin, John M; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Mattheus, Michaela; Devins, Theresa; Johansen, Odd Erik; Woerle, Hans J; Broedl, Uli C; Inzucchi, Silvio E

2015-11-26

The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

Safety and Efficacy of a Pharmacoinvasive Strategy in ST-Segment Elevation Myocardial Infarction: A Patient Population Study Comparing a Pharmacoinvasive Strategy With a Primary Percutaneous Coronary Intervention Strategy Within a Regional System.

PubMed

Rashid, Mohammed K; Guron, Nita; Bernick, Jordan; Wells, George A; Blondeau, Melissa; Chong, Aun-Yeong; Dick, Alexander; Froeschl, Michael P V; Glover, Chris A; Hibbert, Benjamin; Labinaz, Marino; Marquis, Jean-François; Osborne, Christina; So, Derek Y; Le May, Michel R

2016-10-10

This study investigated the safety and efficacy of a pharmacoinvasive strategy compared with a primary percutaneous coronary intervention (PCI) strategy for ST-segment elevation myocardial infarction (STEMI) in the context of a real-world system. Primary PCI continues to be the optimal reperfusion therapy; however, in areas where PCI centers are not readily available, a pharmacoinvasive strategy has been proposed. The University of Ottawa Heart Institute regional STEMI system provides a primary PCI strategy for patients presenting within a 90-km radius from the PCI center, and a pharmacoinvasive strategy for patients outside this limit. We included all confirmed STEMI patients between April 2009 and May 2011. The primary efficacy outcome was a composite of mortality, reinfarction, or stroke and the primary safety outcome was major bleeding. We identified 236 and 980 consecutive patients enrolled in pharmacoinvasive and primary PCI strategies, respectively. The median door-to-needle time was 31 min in the pharmacoinvasive group and the median door-to-balloon time was 95 min in the primary PCI group. In a multivariable model, there was no significant difference in the primary efficacy outcome (odds ratio: 1.54; p = 0.21); however, the propensity for more bleeding with a pharmacoinvasive strategy approached statistical significance (odds ratio: 2.02; p = 0.08). Within the context of a STEMI system, a pharmacoinvasive strategy was associated with similar rates of the composite of mortality, reinfarction, or stroke as compared with a primary PCI strategy; however, there was a propensity for more bleeding with a pharmacoinvasive strategy. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Innovations in primary mental healthcare.

PubMed

Reifels, Lennart; Bassilios, Bridget; King, Kylie E; Fletcher, Justine R; Blashki, Grant; Pirkis, Jane E

2013-06-01

We review the evidence on innovations in Tier 2 of the Access to Allied Psychological Services (ATAPS) program, which is designed to facilitate the provision of primary mental healthcare to hard-to-reach and at-risk population groups (including women with perinatal depression, people at risk of self-harm or suicide, people experiencing or at risk of homelessness, people affected by the 2009 Victorian bushfires, people in remote locations, Aboriginal and Torres Strait Islanders and children with mental disorders) and the trialling of new modalities of service delivery (e.g. telephone-based or web-based CBT). The primary focus is on the uptake, outcomes and issues associated with the provision of ATAPS Tier 2. Drawing on data from an ongoing national ATAPS evaluation, including a national minimum dataset, key informant interviews and surveys, the impact of ATAPS innovations is analysed and illustrated through program examples. ATAPS Tier 2 facilitates access to, uptake of and positive clinical outcomes from primary mental healthcare for population groups with particular needs, although it requires periods of time to implement locally. Relatively simple innovations in mental health program design can have important practical ramifications for service provision, extending program reach and improving mental health outcomes for target populations. What is known about the topic? It is recognised that innovative approaches are required to tailor mental health programs for hard-to-reach and at-risk population groups. Divisions of General Practice have implemented innovations in the Access to Allied Psychological Services (ATAPS) program for several years. What does this paper add? Drawing on data from an ongoing national ATAPS evaluation, this paper presents a systematic analysis of the uptake, outcomes and issues associated with provision of the innovative ATAPS program. What are the implications for practitioners? The findings highlight the benefits of introducing innovations in primary mental healthcare in terms of increased access to care and positive consumer outcomes. They also identify challenges to and facilitators of the implementation process, which can inform innovation efforts in other primary care contexts.

Nurse versus physician-led care for the management of asthma.

PubMed

Kuethe, Maarten C; Vaessen-Verberne, Anja A P H; Elbers, Roy G; Van Aalderen, Wim M C

2013-02-28

Asthma is the most common chronic disease in childhood and prevalence is also high in adulthood, thereby placing a considerable burden on healthcare resources. Therefore, effective asthma management is important to reduce morbidity and to optimise utilisation of healthcare facilities. To review the effectiveness of nurse-led asthma care provided by a specialised asthma nurse, a nurse practitioner, a physician assistant or an otherwise specifically trained nursing professional, working relatively independently from a physician, compared to traditional care provided by a physician. Our scope included all outpatient care for asthma, both in primary care and in hospital settings. We carried out a comprehensive search of databases including The Cochrane Library, MEDLINE and EMBASE to identify trials up to August 2012. Bibliographies of relevant papers were searched, and handsearching of relevant publications was undertaken to identify additional trials. Randomised controlled trials comparing nurse-led care versus physician-led care in asthma for the same aspect of asthma care. We used standard methodological procedures expected by The Cochrane Collaboration. Five studies on 588 adults and children were included concerning nurse-led care versus physician-led care. One study included 154 patients with uncontrolled asthma, while the other four studies including 434 patients with controlled or partly controlled asthma. The studies were of good methodological quality (although it is not possible to blind people giving or receiving the intervention to which group they are in). There was no statistically significant difference in the number of asthma exacerbations and asthma severity after treatment (duration of follow-up from six months to two years). Only one study had healthcare costs as an outcome parameter, no statistical differences were found. Although not a primary outcome, quality of life is a patient-important outcome and in the three trials on 380 subjects that reported on this outcome, there was no statistically significant difference (standardised mean difference (SMD) -0.03; 95% confidence interval (CI) -0.23 to 0.17). We found no significant difference between nurse-led care for patients with asthma compared to physician-led care for the outcomes assessed. Based on the relatively small number of studies in this review, nurse-led care may be appropriate in patients with well-controlled asthma. More studies in varied settings and among people with varying levels of asthma control are needed with data on adverse events and health-care costs.

Prognostic factors for extracorporeal cardiopulmonary resuscitation recipients following out-of-hospital refractory cardiac arrest. A systematic review and meta-analysis.

PubMed

Debaty, Guillaume; Babaz, Valentin; Durand, Michel; Gaide-Chevronnay, Lucie; Fournel, Emmanuel; Blancher, Marc; Bouvaist, Hélène; Chavanon, Olivier; Maignan, Maxime; Bouzat, Pierre; Albaladejo, Pierre; Labarère, José

2017-03-01

Association estimates between baseline characteristics and outcomes are imprecise and inconsistent among extracorporeal cardiopulmonary resuscitation (ECPR) recipients following refractory out-of-hospital cardiac arrest (OHCA). This systematic review and meta-analysis aimed to investigate the prognostic significance of pre-specified characteristics for OHCA treated with ECPR. The Medline electronic database was searched via PubMed for articles published from January 2000 to September 2016. The electronic search was supplemented by scanning the reference lists of retrieved articles and contacting field experts. Eligible studies were historical and prospective cohort studies of adult patients undergoing ECPR following OHCA. Fifteen primary studies were included, totaling 841 participants. The median prevalence of the primary outcome (i.e., short- or long-term survival for five studies and cerebral performance for ten studies) was 15% (range, 0-50%). The primary outcome was associated with an increased odds ratio of initial shockable cardiac rhythm (2.20; 95% confidence interval [CI], 1.30-3.72; P=0.003), shorter low-flow duration (geometric mean ratio, 0.90; 95% CI, 0.81-0.99; P=0.04), higher arterial pH value (difference, 0.12; 95% CI, 0.03-0.22; P=0.01) and lower serum lactate concentration (difference, -3.52mmol/L; 95% CI, -5.05 to -1.99; P<0.001). No significant association was found between the primary outcome and patient age (the odds of female gender and bystander CPR attempt. Observational evidence from published primary studies indicates that shorter low-flow duration, shockable cardiac rhythm, higher arterial pH value and lower serum lactate concentration on hospital admission are associated with better outcomes for ECPR recipients after OHCA. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Early Outcomes of Primary Total Hip Arthroplasty After Prior Lumbar Spinal Fusion.

PubMed

Barry, Jeffrey J; Sing, David C; Vail, Thomas P; Hansen, Erik N

2017-02-01

The coexistence of degenerative hip disease and spinal pathology is not uncommon with the number of surgical treatments performed for each condition increasing annually. The limited research available suggests spinal pathology portends less pain relief and worse outcomes after total hip arthroplasty (THA). We hypothesize that primary THA patients with preexisting lumbar spinal fusions (LSF) experience worse early postoperative outcomes. This study is a retrospective matched cohort study. Primary THA patients at 1 institution who had undergone prior LSF (spine arthrodesis-hip arthroplasty [SAHA]) were identified and matched to controls of primary THA without LSF. Early outcomes (<90 days) were compared. From 2012 to 2014, 35 SAHA patients were compared to 70 matched controls. Patients were similar in age, sex, American Society of Anesthesiologist score, body mass index, and Charlson Comorbidity Index. SAHA patients had higher rates of complications (31.4% vs 8.6%, P = .008), reoperation (14.3% vs 2.9%, P = .040), and general anesthesia (54.3% vs 5.7%, P = .0001). Bivariate analysis demonstrated SAHA to predict reoperation (odds ratio, 5.67; P = .045) and complications (odds ratio, 4.89; P = .005). With the numbers available, dislocations (0% vs 2.8%), infections (0% vs 8.6%), readmissions, postoperative walking distance, and disposition only trended to favor controls (P > .05). Comparing controls to SAHA patients with <3 or ≥3 levels fused, longer fusions had increased cumulative postoperative narcotic consumption (mean morphine equivalents, 44.3 vs 46.9 vs 169.4; P = .001). Patients with preexisting LSF experience worse early outcomes after primary THA including higher rates of complications and reoperation. Lower rates of neuraxial anesthesia and increased narcotic usage represent potential contributors. The complex interplay between the lumbar spine and hip warrants attention and further investigation. Copyright © 2016 Elsevier Inc. All rights reserved.

Do patients׳ illness beliefs predict depression measures at six months in primary care; a longitudinal study.

PubMed

Lynch, Jeannette; Moore, Michael; Moss-Morris, Rona; Kendrick, Tony

2015-03-15

Depressive disorders are prevalent and costly but there is a lack of evidence on how best to select treatments for mild to moderate depression in primary care. Illness beliefs have been shown to affect the outcome from physical illness, but there is limited information on the beliefs of patients who are depressed. To measure patients׳ beliefs about depression at baseline and determine whether these relate to depression severity at six months. Primary care patients with a recently diagnosed episode of depression completed the Beliefs about Depression Questionnaire and depression severity scores at baseline. The primary outcome was the change in depression severity score on the Hospital Anxiety and Depression Scale after six months. 227/292 (78%) participants completed follow-up questionnaires. Initial severity of depression at baseline, and particular beliefs about the causes, consequences and timeline of depression predicted poorer outcomes, whereas a belief in using exercise or keeping busy to treat depression predicted improved outcomes. Prescription of antidepressants did not appear to mediate these relationships. This was an initial study using a new validated questionnaire and it cannot be predicted whether these results are representative or would be reproduced in other populations. Although participants were primary care patients whose GP (General Practitioner) had coded as having a new incident episode of depression in the preceding six months, 43% of participants stated they had been depressed for more than a year. Sufficient participants were recruited to ensure the study was adequately powered but participation rate was 30%, raising the possibility of response bias. Illness beliefs may help to predict outcomes in depression and therefore assessing and addressing patients׳ beliefs about their depression may enhance treatment. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Reduced Myocardial Flow Reserve by Positron Emission Tomography Predicts Cardiovascular Events After Cardiac Transplantation.

PubMed

Konerman, Matthew C; Lazarus, John J; Weinberg, Richard L; Shah, Ravi V; Ghannam, Michael; Hummel, Scott L; Corbett, James R; Ficaro, Edward P; Aaronson, Keith D; Colvin, Monica M; Koelling, Todd M; Murthy, Venkatesh L

2018-06-01

We evaluated the diagnostic and prognostic value of quantification of myocardial flow reserve (MFR) with positron emission tomography (PET) in orthotopic heart transplant patients. We retrospectively identified orthotopic heart transplant patients who underwent rubidium-82 cardiac PET imaging. The primary outcome was the composite of cardiovascular death, acute coronary syndrome, coronary revascularization, and heart failure hospitalization. Cox regression was used to evaluate the association of MFR with the primary outcome. The relationship of MFR and cardiac allograft vasculopathy severity in patients with angiography within 1 year of PET imaging was assessed using Spearman rank correlation and logistic regression. A total of 117 patients (median age, 60 years; 71% men) were identified. Twenty-one of 62 patients (34%) who underwent angiography before PET had cardiac allograft vasculopathy. The median time from orthotopic heart transplant to PET imaging was 6.4 years (median global MFR, 2.31). After a median of 1.4 years, 22 patients (19%) experienced the primary outcome. On an unadjusted basis, global MFR (hazard ratio, 0.22 per unit increase; 95% confidence interval, 0.09-0.50; P <0.001) and stress myocardial blood flow (hazard ratio, 0.48 per unit increase; 95% confidence interval, 0.29-0.79; P =0.004) were associated with the primary outcome. Decreased MFR independently predicted the primary outcome after adjustment for other variables. In 42 patients who underwent angiography within 12 months of PET, MFR and stress myocardial blood flow were associated with moderate-severe cardiac allograft vasculopathy (International Society of Heart and Lung Transplantation grade 2-3). MFR assessed by cardiac rubidium-82 PET imaging is a predictor of cardiovascular events after orthotopic heart transplant and is associated with cardiac allograft vasculopathy severity. © 2018 American Heart Association, Inc.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

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

PubMed

Jakobsen, Lars; Niemann, Troels; Thorsgaard, Niels; Thuesen, Leif; Lassen, Jens F; Jensen, Lisette O; Thayssen, Per; Ravkilde, Jan; Tilsted, Hans H; Mehnert, Frank; Johnsen, Søren P

2012-10-01

The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood. We studied 7385 patients treated with primary percutaneous coronary intervention. Participants were divided into high-SES and low-SES groups according to income, education, and employment status. The primary outcome was major adverse cardiac events (cardiac death, recurrent myocardial infarction, and target vessel revascularization) at maximum follow-up (mean, 3.7 years). Low-SES patients had more adverse baseline risk profiles than high-SES patients. The cumulative risk of major adverse cardiac events after maximum follow-up was higher among low-income patients and unemployed patients compared with their counterparts (income: hazard ratio, 1.68; 95% CI, 1.47-1.92; employment status: hazard ratio, 1.75; 95% CI, 1.46-2.10). After adjustment for patient characteristics, these differences were substantially attenuated (income: hazard ratio, 1.12; 95% CI, 0.93-1.33; employment status: hazard ratio, 1.27; 95% CI, 1.03-1.56). Further adjustment for admission findings, procedure-related data, and medical treatment during follow-up did not significantly affect the associations. With education as the SES indicator, no between-group differences were observed in the risk of the composite end point. Even in a tax-financed healthcare system, low-SES patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be largely explained by differences in baseline patient characteristics. Employment status and income (but not education level) were associated with clinical outcomes.

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.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

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

Lipid Profiles, Inflammatory Markers, and Insulin Therapy in Youth with Type 2 Diabetes.

PubMed

Levitt Katz, Lorraine E; Bacha, Fida; Gidding, Samuel S; Weinstock, Ruth S; El Ghormli, Laure; Libman, Ingrid; Nadeau, Kristen J; Porter, Kristin; Marcovina, Santica

2018-05-01

Data regarding atherogenic dyslipidemia and the inflammation profile in youth with type 2 diabetes is limited and the effect of insulin therapy on these variables has not previously been studied in youth. We determined the impact of insulin therapy on lipid and inflammatory markers in youth with poorly controlled type 2 diabetes. In the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) multicenter trial, 285 participants failed to sustain glycemic control on randomized treatment (primary outcome, glycated hemoglobin A1c [HbA1c] at ≥8% for 6 months); 363 maintained glycemic control (never reached primary outcome). Statins were used for a low-density lipoprotein cholesterol of ≥130 mg/dL. Upon reaching the primary outcome, insulin was started. Changes in lipids and inflammatory markers (slopes over time) were examined. Progression of dyslipidemia was related to glycemic control. In those with the primary outcome, insulin therapy impacted HbA1c modestly, and dampened the increase in total cholesterol, low-density lipoprotein cholesterol, and total apolipoprotein B, although statin use increased from 8.6% to 22% year after the primary outcome. The increase in triglycerides and plasma nonesterified fatty acids stabilized after insulin was started, independent of HbA1c. There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight. Worsening dyslipidemia and inflammation over time raise concern regarding premature development of atherosclerosis in youth with type 2 diabetes. Insulin therapy has a limited benefit in the absence of glycemic control. Strategies to achieve better glycemic control are needed. ClinicalTrials.gov: NCT00081328. Copyright © 2017 Elsevier Inc. All rights reserved.

Robust estimation of the proportion of treatment effect explained by surrogate marker information.

PubMed

Parast, Layla; McDermott, Mary M; Tian, Lu

2016-05-10

In randomized treatment studies where the primary outcome requires long follow-up of patients and/or expensive or invasive obtainment procedures, the availability of a surrogate marker that could be used to estimate the treatment effect and could potentially be observed earlier than the primary outcome would allow researchers to make conclusions regarding the treatment effect with less required follow-up time and resources. The Prentice criterion for a valid surrogate marker requires that a test for treatment effect on the surrogate marker also be a valid test for treatment effect on the primary outcome of interest. Based on this criterion, methods have been developed to define and estimate the proportion of treatment effect on the primary outcome that is explained by the treatment effect on the surrogate marker. These methods aim to identify useful statistical surrogates that capture a large proportion of the treatment effect. However, current methods to estimate this proportion usually require restrictive model assumptions that may not hold in practice and thus may lead to biased estimates of this quantity. In this paper, we propose a nonparametric procedure to estimate the proportion of treatment effect on the primary outcome that is explained by the treatment effect on a potential surrogate marker and extend this procedure to a setting with multiple surrogate markers. We compare our approach with previously proposed model-based approaches and propose a variance estimation procedure based on a perturbation-resampling method. Simulation studies demonstrate that the procedure performs well in finite samples and outperforms model-based procedures when the specified models are not correct. We illustrate our proposed procedure using a data set from a randomized study investigating a group-mediated cognitive behavioral intervention for peripheral artery disease participants. Copyright © 2015 John Wiley & Sons, Ltd.

Improved outcomes in the non-operative management of liver injuries

PubMed Central

Saltzherr, Teun Peter; van der Vlies, Cees H; van Lienden, Krijn P; Beenen, Ludo F M; Ponsen, Kees Jan; van Gulik, Thomas M; Goslings, J Carel

2011-01-01

Objectives Non-operative management has become the treatment of choice in the majority of liver injuries. The aim of this study was to assess the changes in primary treatment and outcomes in a single Dutch Level 1 trauma centre with wide experience in angio-embolisation (AE). Methods The prospective trauma registry was retrospectively analysed for 7-year periods before (Period 1) and after (Period 2) the introduction of AE. The primary outcome was the failure rate of primary treatment defined as liver injury-related death or re-bleeding requiring radiologic or operative (re)interventions. Secondary outcomes were liver injury-related intra-abdominal complications. Results Despite an increase in high-grade liver injuries, the incidence of primary non-operative management more than doubled over the two periods, from 33% (20 of 61 cases) in Period 1 to 72% (84 of 116 cases) in Period 2 (P < 0.001). The failure rate of primary treatment in Period 1 was 18% (11/61), compared with 11% (13/116) in Period 2 (P = 0.21). Complication rates were 23% (14/61) and 16% (18/116) in Periods 1 and 2, respectively (P = 0.22). Liver-related mortality rates were 10% (6/61) and 3% (4/116) in Periods 1 and 2, respectively (P = 0.095). The increase in the frequency of non-operative management was even higher in high-grade injuries, in which outcomes were improved. In high-grade injuries in Periods 1 and 2, failure rates decreased from 45% (9/20) to 20% (11/55) (P = 0.041), liver-related mortality decreased from 30% (6/20) to 7% (4/55) (P = 0.019) and complication rates fell from 60% (12/20) to 27% (15/55) (P = 0.014). Liver infarction or necrosis and abscess formation seemed to occur more frequently with AE. Conclusions Overall, liver-related mortality, treatment failure and complication rates remained constant despite an increase in non-operative management. However, in high-grade injuries outcomes improved after the introduction of AE. PMID:21492335

Design and rationale of the MICHELANGELO Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS)-5 trial program evaluating fondaparinux, a synthetic factor Xa inhibitor, in patients with non-ST-segment elevation acute coronary syndromes.

PubMed

Mehta, Shamir R; Yusuf, Salim; Granger, Christopher B; Wallentin, Lars; Peters, Ron J G; Bassand, Jean-Pierre; Budaj, Andrzej; Joyner, Campbell; Chrolavicius, Susan; Fox, Keith A A

2005-12-01

Factor Xa plays a central role in the generation of thrombin, making it a novel target for treatment of arterial thrombosis. Fondaparinux, a synthetic pentasaccharide, is a factor Xa inhibitor, which has been shown to be superior to enoxaparin for the prevention of venous thrombosis. We designed a large, phase III, randomized trial to evaluate the efficacy and safety of fondaparinux compared with enoxaparin in acute coronary syndromes. The OASIS-5 trial is a randomized, double-blind trial of fondaparinux versus enoxaparin in 20,000 patients with unstable angina or non-ST-segment elevation myocardial infarction. The primary objective is to determine whether fondaparinux is noninferior to enoxaparin in preventing the composite of death, new myocardial infarction, and refractory ischemia at 9 days (primary outcome) and at 30 days (secondary outcome) after randomization. There will be additional follow-up of all patients for 3 to 6 months after randomization. If noninferiority is established at 9 days, superiority will be tested. The primary safety outcome is to evaluate the rates of major bleeds in the 2 groups with the balance of benefit and risk assessed by comparing the impact on the composite of the primary and safety outcomes. Secondary outcomes are each component of the composite primary outcome separately at days 9, 30, and up to 6 months. The TIMACS, a major substudy using a partial 2x2 factorial design evaluating whether early angiography and intervention (within 24 hours) are superior to a more delayed approach (after 36 hours) in reducing major ischemic events at 6 months after randomization. The MICHELANGELO OASIS 5 program will provide a comprehensive and reliable evaluation of fondaparinux in a broad spectrum of patients with ACS.