Primary Outcome For Analysis Research Articles

Access to routine care and risks for 30-day readmission in patients with cardiovascular disease

Studies have shown that access to routine medical care is associated with the prevention, diagnosis, and treatment of chronic diseases. However, studies have not examined whether patient-reported difficulties in access to care are associated with rehospitalization in patients with cardiovascular disease. Electronic medical records and a standardized survey were used to examine cardiovascular patients admitted to a large medical center from January 1, 2015 through January 10, 2017 (n=520). All-cause readmission within 30 days of discharge was the primary outcome for analysis. Logistic regression models were used to examine the association between access to care and 30-day readmission while adjusting for patient demographics, socioeconomic status, healthcare utilization, and health status. Nearly 1-in-6 patients (15.7%) reported difficulty in accessing routine medical care; and those who were younger, male, non-white, uninsured, with heart failure, and had low social support were significantly more likely to report difficulty. Patients who reported difficulty in accessing care had significantly higher rates of 30-day readmission than patients who did not report difficulty (33.3% vs. 17.9%; P=.001); and the risks remained largely unchanged after accounting for nearly two dozen covariates (unadjusted odds ratio [OR]=2.29; 95% CI, 1.46-3.60 vs. adjusted OR=2.17; 95% CI, 1.29-3.66). Risks for readmission were especially high for patients who reported issues with transportation (OR=3.24; 95% CI, 1.28-8.16) and scheduling appointments (OR=3.56; 95% CI, 1.43-8.84), but not for other reasons (OR=1.47; 95% CI, 0.61-3.54). Cardiovascular patients who reported difficulty in accessing routine care had substantial risks of readmission within 30 days after discharge. These findings have important implications for identifying high-risk patients and developing interventions to improve access to routine medical care.

9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: Results of the phase III multicentric Italian study Short-HER.

501 Background: 1-year trastuzumab with chemotherapy is the standard adjuvant treatment for HER2+ breast cancer patients (pts). The efficacy of less extended trastuzumab exposure is still under investigation. The Short-HER study is an independent, non-profit study aimed to test the non-inferiority of 9 weeks vs 1 year of adjuvant trastuzumab. Methods: This is a phase III, multicenter, Italian trial where pts with HER2+ breast cancer were randomly assigned to: Arm A (Long) AC or ECx4 followed by 4 courses of 3-weekly docetaxel in combination with trastuzumab, followed by 14 additional courses of 3-weekly trastuzumab; or Arm B (Short) 3 courses of 3-weekly docetaxel plus weekly trastuzumab for 9 doses followed by FEC x3. When indicated, radiation therapy was administered after the completion of chemotherapy. Hormonal therapy started at the completion of chemotherapy for pts with hormone receptor positive tumors. This is a non-inferiority trial with disease-free survival (DFS) as primary end-point.Overall survival (OS) is evaluated as second primary analysis outcome. The sample size of 1250 pts has been estimated based on a hazard ratio <1.29 for the short arm to be non-inferior. The definitive analysis will take place after 198 DFS events. Secondary aims include 2-yrs failure rate, cardiac toxicity, correlative biomarkers analyses. Hazard ratio for DFS and OS (90% CI) will be estimated according to the Cox model. Data will also be analyzed by the Bayesian approach. Results: from Dec-2007 to Oct-2013, 1254 pts from 82 centers have been randomized. Pts characteristics are the following: median age 55 yrs (25-78), stage I 37.3%, IIA 40%, IIB 20.6%, III 2.1%. 30% of the pts had 1-3 positive nodes, 16% >=4. Sixty-eight% of the pts had ER+ tumors. Characteristics were balanced between the two arms. At the time of this writing, 95% of the planned DFS events have been reported. 105 Grade ≥2 cardiac events have been reported, 78 in arm A (long) and 27 in arm B (short). Grade 3-4 cardiac events were 20 in arm A and 11 in arm B. Conclusions: Shorter trastuzumab administration almost halves the rate of severe cardiac toxicity. Final DFS data will be available at the time of the meeting. Clinical trial information: NCT00629278.

Real-world effectiveness of palonosetron within a three-drug regimen to prevent chemotherapy induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC).

e18231Background: CINV is among the most debilitating and feared consequences of cancer treatment. It is therefore imperative to determine if patients are achieving similar response rates in practice as demonstrated in trials. This study evaluated the real world effectiveness of palonosetron, an NK-1 inhibitor, and dexamethasone in patients receiving HEC for prevention of CINV according to international antiemetic guidelines (ASCO, MASCC, NCCN). Methods: A phase IV prospective, multi-center observational study was conducted in which 107 patients were enrolled and treated in accordance with standard of care. All medications were commercially available and the decision to treat was made by the primary physician prior to and independent of participation in the study. The primary outcome for analysis was complete response (CR) defined as no emetic episodes and no use of rescue medication for CINV. CR was classified as acute- (0-24 hours), delayed-phase ( > 24-120 hours), and overall (0-120 hours). Nausea, vom...

Pneumatic Compression Improves Quality of Life in Patients with Lower-Extremity Lymphedema

Lymphedema is an incurable and disfiguring disease secondary to excessive fluid and protein in the interstitium as a result of lymphatic obstruction. Pneumatic compression (PC) offers a novel modality for treatment of lymphatic obstruction through targeting lymphatic beds and mimicking a functional drainage system. The objective of this study is to demonstrate improved quality of life in patients with lower-extremity lymphedema. Consecutive patients presenting to a single institution for treatment of lymphedema were all treated with PC for at least 3 months. All patients underwent a pre- and post-PC assessment of episodes of cellulitis, number of ulcers, and venous insufficiency. Post-PC symptom questionnaires were administered. Symptom improvement was the primary outcome for analysis. A total of 100 patients met inclusion criteria. At presentation, 70% were female with a mean age of 57.5 years. Secondary lymphedema was present in 78%. Mean length of PC use was 12.7 months with a mean of 5.3 treatments per week. Ankle and calf limb girth decreased after PC use, (28.3 vs. 27.5 cm, P = 0.01) and (44.7 vs. 43.8 cm, P = 0.018), respectively. The number of episodes of cellulitis and ulcers pre- and post-PC decreased from mean of 0.26-0.05 episodes (P = 0.002) and 0.12-0.02 ulcers (P = 0.007), respectively. Fourteen percent had concomitant superficial venous insufficiency, all of whom underwent venous ablation. Overall 100% of patients reported symptomatic improvement post-PC with 54% greatly improved. 90% would recommend the treatment to others. PC improves symptom relief and reduces episodes of cellulitis and ulceration in lower-extremity lymphedema. It is well tolerated by patients and should be recommended as an adjunct to standard lymphedema therapy. Screening for venous insufficiency is recommended.

Head Position in Stroke Trial (HeadPoST) – sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial

BackgroundPositioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.Methods/DesignWe plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥30°) head position as a ‘business as usual’ stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period.DiscussionHeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.Trial registrationClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0767-1) contains supplementary material, which is available to authorized users.

Aetiology and outcome of generalized convulsive status epilepticus in elderly

PurposeConvulsive status epilepticus (CSE) is a common neurologic emergency in elderly people. The current study elaborates the clinical characteristics and outcome of CSE in elderly patients. MethodsAnalysis of data of generalized CSE patients, aged 60 years and above admitted at the neurointensive care unit (NICU) was performed. The primary outcome for analysis was in-hospital mortality. The study population was divided into groups based on progression of CSE and mortality to analyze difference in study variables. Mortality of the group was analyzed using life tables. ResultsA total of 33 patients satisfied the inclusion criteria from medical records of 212 patients with CSE. Mean age of the study population was 67.0±6.8 years; 69.7% were men. Acute symptomatic aetiology was the commonest cause of CSE (60.6%); nine (27.3%) patients progressed to refractory status epilepticus (RSE) of which five patients had prolonged RSE. The overall mortality was 18.2%. Complications of mechanical ventilation and mean age were higher in patients who died. Though vascular aetiology was the leading cause of CSE (39.3%), it was not associated with progression to RSE or mortality. Acute symptomatic aetiology accounted for five out of the six deaths in the entire cohort. ConclusionLess than one-third of elderly patients with CSE progressed to RSE. Vascular aetiology, the leading cause of generalized CSE in elderly, was not associated with progression to RSE and mortality. Acute symptomatic aetiology was associated with high mortality.

Determinants and predictors of outcome in super refractory status epilepticus—A developing country perspective

Super refractory status epilepticus (SRSE) is a recent entity. There is limited information about the etiology and outcome of SRSE from developing countries. We evaluated determinants and predictors of outcome in patients with convulsive SRSE in Indian population. In this open cohort study, data of patients with convulsive SE admitted in neurointensive care unit (NICU) from 2005 to 2013 was retrospectively analyzed. Regression and survival analysis was done for outcome of patients divided into non refractory SE (NRSE), refractory SE (RSE), and SRSE groups. The primary outcome for analysis was in hospital mortality. Also functional outcome at 6 months was graded according to the Glasgow outcome scale (GOS), and classified as good (GOS 4 and 5) and poor (GOS 1, 2 and 3) outcome groups. Out of 177 patients with SE, 105 (59.3%) had NRSE; 72 (40.7%) had RSE of which 30 (16.9% of 177) were sub-classified as SRSE. SRSE was frequent (39%) in children (p<0.01), elderly (21.7%; p<0.003), and in incident SE (82.1%, p=0.05). Encephalitis was the commonest etiology in RSE (30.9%, p=0.015), SRSE (66.7%, p<0.001) than NRSE (12.3%). Encephalitis (β=8.250 (1.8-37.82); p=0.007) was the determinant of the progression of SE to SRSE. Overall mortality was 19.2%, highest in SRSE (40.0%) followed by RSE (35.7%), both significantly (p<0.001) higher than NRSE (6.7%). Mortality was high in patients with encephalitis than other etiologies (39.1% vs. 12.1%; p=0.001). Acidosis predicted mortality in the entire cohort (β=7.313 (1.6-32.58); p=0.009); however none of the variables predicted mortality in SRSE patients. At 6 months follow up only 33.3% of patients with SRSE were in GOS good outcome group when compared to RSE (33.3% vs. 57.1%; p=0.055), and NRSE (33.3% vs. 79.1%; p<0.0001). SRSE is common in children, elderly, and incident SE. Encephalitis was the determinant of progression of SE to SRSE. None of the variables predicted mortality in SRSE patients. Sixty percent of patients with SRSE survived and one third had good outcome. Therefore one should continue the care inspite of weeks of SE.

Pharmacoeconomic Analysis of the Diabetes Initiative Program

Diabetes treatment cost increased 41% from 2007 to 2011. Pharmacists have provided collaborative diabetes management for decades with improvement in disease-related end points. Few have reported economic benefits of pharmacist management of type 2 diabetes. The purpose was to determine if cost savings associated with hemoglobin A1c (A1C) and systolic blood pressure (SBP) change outweighed programmatic pharmacist-physician collaborative care model costs. This cost analysis of a 12 month, prospective, multicenter, observational study included English-speaking adults, 18 years or older, with type 2 diabetes mellitus, a life expectancy >1 year, and either a A1C >7%, SBP >130 mm Hg, diastolic blood pressure >80 mm Hg, or low-density lipoprotein concentration >100 mg/dL. Pregnant patients were excluded. Primary analysis outcome was average cost per outcome, ratio of net cost (numerator) and percentage achieving outcomes (denominator). Assessment outcomes included A1C reduction by at least 1% and SBP reduction by at least 5.6 mm Hg. 206 patients were seen by pharmacists during 1612 encounters (mean = 7.8 encounters/patient). Pharmacists spent 983 hours caring for type 2 diabetes patients (mean 3.8 hours/patient). Base case net labor and program costs per patient were -$66.77 and $106.81, respectively. Improvement in A1C and SBP yielded $421.01 in cost savings per patient. Labor and program average costs per patient for each outcome achieved were -$100.40 and $160.61, respectively. This multisite pharmacist-physician collaboration in diabetes management showed cost savings when assessing pharmacist labor costs alone. Total program costs, including overhead, slightly increased cost of care.

Agreement in the Scoring of Respiratory Events and Sleep Among International Sleep Centers

The American Academy of Sleep Medicine (AASM) guidelines for polysomnography (PSG) scoring are increasingly being adopted worldwide, but the agreement among international centers in scoring respiratory events and sleep stages using these guidelines is unknown. We sought to determine the interrater agreement of PSG scoring among international sleep centers. Prospective study of interrater agreement of PSG scoring. Nine center-members of the Sleep Apnea Genetics International Consortium (SAGIC). Fifteen previously recorded deidentified PSGs, in European Data Format, were scored by an experienced technologist at each site after they were imported into the locally used analysis software. Each 30-sec epoch was manually scored for sleep stage, arousals, apneas, and hypopneas using the AASM recommended criteria. The computer-derived oxygen desaturation index (ODI) was also recorded. The primary outcome for analysis was the intraclass correlation coefficient (ICC) of the apnea-hypopnea index (AHI). The ICCs of the respiratory variables were: AHI = 0.95 (95% confidence interval: 0.91-0.98), total apneas = 0.77 (0.56-0.87), total hypopneas = 0.80 (0.66-0.91), and ODI = 0.97 (0.93-0.99). The kappa statistics for sleep stages were: wake = 0.78 (0.77-0.79), nonrapid eye movement = 0.77 (0.76-0.78), N1 = 0.31 (0.30-0.32), N2 = 0.60 (0.59-0.61), N3 = 0.67 (0.65-0.69), and rapid eye movement = 0.78 (0.77-0.79). The ICC of the arousal index was 0.68 (0.50-0.85). There is strong agreement in the scoring of respiratory events among the SAGIC centers. There is also substantial epoch-by-epoch agreement in scoring sleep variables. Our results suggest that centralized scoring of PSGs may not be necessary in future research collaboration among international sites where experienced, well-trained scorers are involved.

Effectiveness of Maternal Counseling in Reducing Caries in Cree Children

This cluster-randomized pragmatic (effectiveness) trial tested maternal counseling based on Motivational Interviewing (MI) as an approach to control caries in indigenous children. Nine Cree communities in Quebec, Canada were randomly allocated to test or control. MI-style counseling was delivered in test communities to mothers during pregnancy and at well-baby visits. Data on outcomes were collected when children were 30 months old. Two hundred seventy-two mothers were recruited from the 5 test and 4 control communities. Baseline characteristics were comparable but not equivalent for both groups. At trial’s end, 241 children had follow-up. The primary analysis outcome was enamel caries with substance loss (d2); no statistically significant treatment effect was detected. Prevalence of treated and untreated caries at the d2 level was 76% in controls vs. 65% in test (p = 0.17). Exploratory analyses suggested a substantial preventive effect for untreated decay at or beyond the level of the dentin, d3 (prevalences: 60% controls vs. 35% test), and a particularly large treatment effect when mothers had 4 or more MI-style sessions. Overall, these results provide preliminary evidence that, for these young, indigenous children, an MI-style intervention has an impact on severity of caries (clinical trial registration ISRCTN41467632).

Paliperidone Extended-Release in Schizoaffective Disorder

This 6-week, double-blind, placebo-controlled study evaluated paliperidone extended-release (ER) as both monotherapy and adjunctive therapy to mood stabilizers and/or antidepressants (MS/ADs) for schizoaffective disorder. Included subjects had a schizoaffective disorder diagnosis; a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher; a score of 4 or higher on 2 or more of the PANSS items for hostility, excitement, tension, uncooperativeness, or poor impulse control; and prominent mood symptoms (≥16 on the Young Mania Rating Scale and/or the 21-item Hamilton Rating Scale for Depression). Subjects were randomized to 6 mg/d paliperidone ER or placebo with flexible dosing (3-12 mg/d) until day 15. Randomization was stratified by use of MS/AD and study site. The primary analysis outcome was change in PANSS total score at week 6 last observation carried forward end point. A total of 311 subjects received paliperidone ER (n = 216) or placebo (n = 95); 52.0% received MS/AD. The mean (SD) modal dose of paliperidone ER was 8.6 (2.5) mg/d. Greater improvement was observed with paliperidone ER than placebo on mean (SE) PANSS total scores: -20.0 (1.3) and -10.8 (1.9), respectively. Subjects with prominent manic or depressive symptoms showed greater improvement with paliperidone ER versus placebo: mean (SE) Young Mania Rating Scale (-10.6 [0.9] vs -5.7 [1.2], respectively) and 21-item Hamilton Rating Scale for Depression (-10.2 [0.7] vs -6.2 [1.1], respectively). The most common adverse events with paliperidone ER were headache, akathisia, dizziness, insomnia, and dyspepsia. Paliperidone ER improved psychotic and affective symptoms both as monotherapy and as an adjunct to MS/AD. No new safety findings were observed in this population.

Cutaneous Cysts of the Head and Neck

A retrospective study on the features of cutaneous cysts of the head and neck as seen in a North Jordanian population. The records of the Department of Pathology at Jordan University of Science and Technology were reviewed for patients with cutaneous cysts of the head and neck during the 12-year period extending between 1991 and 2002. Applicable records were retrieved, reviewed, and analyzed. Primary analysis outcome measures included patient age, gender, location of the cyst, type, clinical presentation, and treatment. The records of 488 patients were available for analysis. Epidermoid cyst was the most frequent lesion (49%) followed by pilar cysts (27%), and dermoid cysts (22%). The site affected most frequently was the scalp (34%), predominantly with pilar cysts (96%). Epidermoid cyst was the most frequent lesion in the neck (68%), cheeks (77%), periauricular area (70%), and the nasal area (55%). Dermoid cyst was the most frequent lesion in the periorbital area (52%). Females represented 51% of the patients and males accounted for 49%. The peak of age distribution for patients with dermoid cysts was at the first decade, and both of epidermoid and pilar cysts peaked at the third decade. Infection presented in 2.5% of cases. All cysts were enucleated surgically. Maxillofacial surgeons often encounter cutaneous cysts of the head and neck, and they must be familiar with the clinicopathologic characteristics of these lesions.

ORIGINAL RESEARCH—PHARMACOTHERAPY: Efficacy of Sildenafil Citrate in Men with Erectile Dysfunction Following Radical Prostatectomy: A Systematic Review of Clinical Data

Radical prostatectomy is a frequently used treatment option for prostate cancer; however, prostatectomy is often associated with significant morbidity, including erectile dysfunction (ED).To analyze the efficacy of sildenafil citrate in treating ED after radical prostatectomy.MEDLINE and CANCERLIT (1998 to January 2004) were searched for English language articles using the key words prostatectomy, sildenafil, and phosphodiesterase inhibitors. Eleven studies fulfilled the inclusion criteria: primary, discrete data sets of postprostatectomy patients with ED treated with sildenafil monotherapy.Sample sizes ranged from 13 to 198 (mean age, 61 +/- 3 years). Treatment durations were 4 weeks (or more than four doses) to 1 year, and sildenafil dosing was in the recommended range (25-100 mg). Seven studies reported a response rate (range, 14%-53%) for an end point consistent with the primary analysis outcome (erection sufficient for vaginal intercourse); the combined estimate of probability of response was 35% (95% confidence interval [CI], 24%-48%). There was strong evidence for a lower response rate after non-nerve-sparing (range, 0%-15%) versus nerve-sparing surgery (range, 35%-75%; combined odds ratio [OR] = 12.1; 95% CI, 5.5-26.6) but not after unilateral (range, 10%-80%) versus bilateral nerve-sparing surgery (range, 46%-72%; combined OR = 2.21; 95% CI, 0.75-6.54).The results of these studies demonstrate that with sildenafil, more than one third of patients with postprostatectomy ED achieved erection sufficient for intercourse. The odds of responding improved 12-fold with preservation of at least one neurovascular bundle. Early treatment failure does not necessarily imply lack of efficacy in the future, and patients should be encouraged to continue trying sildenafil, titrating up to 100 mg as needed.