Application of a token economy with a non-compliant closed head-injured male

This study examined the application of several principles and procedures of operant conditioning in the rehabilitation of a closed head-injured 18-year-old male. The patient exhibited frequent and extreme verbal outbursts during therapy sessions, and he did not comply with rehabilitation exercises. After a goal-setting plus extinction procedure failed to improve compliance or to decrease disruptive vocalizations a contingent token reinforcement intervention was implemented to increase compliance with therapeutic activities. Frequency of disruptive vocalizations was measured as a covarying behaviour. The intervention was evaluated using a single-case experimental design. Results showed that both compliance with therapeutic activities and frequency of disruptive vocalizations changed as a function of contingent token reinforcement. The effect was replicated across three settings. This study demonstrates the generality of behavioural principles and procedures with closed head-injured populations in an acute rehabilitation setting. The functional equivalence of topographically dissimilar behaviours and the situation-specific control of behaviour is discussed.     

Nominal size in six bileaflet mechanical aortic valves: a comparison of orifice size and biologic equivalence

OBJECTIVES: Nominal size remains the standard by which valves are compared, but its relationship with orifice area and the patient tissue annulus diameter may differ according to valve design. The aims of this study were to measure the orifice size and compare biologic equivalence in six bileaflet mechanical heart valve designs. METHODS: The inflow aspect of each of 29 valves was photographed then digitized, and the maximum internal diameter and orifice area were calculated. Biologic equivalence was assessed with a series of machined polypropylene blocks. RESULTS: The orifice area ranged between 159 and 222 mm(2) for the six size 19 valves. The internal diameter ranged from 1.6 to 4.6 mm less than the manufacturer's nominal size. Biologic equivalence assessed from an estimate of tissue annulus diameter with machined blocks ranged from 1.0 and 3.5 mm larger than nominal size for the intra-annular valves. This diameter ranged from 3.5 mm smaller to 1.5 mm larger than nominal size for the supra-annular valves. CONCLUSION: There are major differences between nominal size and biologic equivalence. This may lead to confusion when attempting to make comparisons between different valve designs with the same nominal size. A clearer sizing nomenclature is required and could be based on in vitro assessment of tissue annulus diameter or an alphanumeric code.     

Prophylactic drainage after thyroidectomy: a randomized trial]

A randomized clinical trial of surgical drainage in thyroid surgery was performed with 97 patients. Using equivalence testing it is reported that morbidity was not significantly different between the two groups and the length of hospital stay was shorter in the undrained group. It is possible to perform thyroidectomy without drainage in a selected population.     

Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients

BACKGROUND: Although an erythropoiesis-stimulating agent (ESA) is most frequently administered intravenously for treatment of anemia in patients with chronic kidney disease who are on dialysis, few studies have compared the efficacy of different intravenous (i.v.) dosing schedules. METHODS: This multicenter, phase IIIb, open-label, controlled study randomized 289 stable hemodialysis patients to continue with conventional dosing of i.v. epoetin alfa or darbepoetin, or to switch to once-weekly i.v. epoetin alfa at the same cumulative weekly starting dose, to maintain hemoglobin levels at 11.0-13.0 g/dL, and within 1.0 g/dL of the baseline value. Hemoglobin levels and ESA doses were recorded every 4 weeks for 28 weeks. RESULTS: Hemoglobin levels fell significantly and ESA doses increased significantly between baseline and week 28 (mean of week 16-28 values) in the once-weekly epoetin alfa group, compared with the conventional treatment group (p< 0.001). The adjusted difference in mean hemoglobin levels between the groups was 0.73 g/dL (greater than the threshold for therapeutic equivalence of 0.5 g/dL). The changes between groups from baseline was significant at all time points for hemoglobin levels (0.36, 0.46, 0.81, 0.87, 0.78, 0.62 and 0.49 g/dL) and from week 12 for ESA dose (718.5, 1,326.5, 1,732.0, 1,839.7 and 1,959.1 IU/week; p=0.005). Hemoglobin was maintained at the target level in 78% and 84% of patients on conventional dosing, and 67% and 64% of those on once-weekly epoetin alfa in the intention-to-treat (p=0.1) and per protocol (p=0.016) populations, respectively. CONCLUSIONS: This study did not show therapeutic equivalence of once-weekly i.v. epoetin alfa with conventional dosing regimens.     

Towards a Unified Macroscopic Description of Exciton Diffusion in Organic Semiconductors

We study the exciton diffusion in organic semiconductors from a macroscopic viewpoint. In a unified way, we conduct the equivalence analysis between Monte-Carlo method and diffusion equation model for photoluminescence quenching and photocurrent spectrum measurements, in both the presence and the absence of Förster energy transfer effect. Connections of these two models to Stern-Volmer method and exciton-exciton annihilation method are also specified for the photoluminescence quenching measurement.     

Study design in osteoporosis: a European perspective.

The advent of effective agents for the treatment of osteoporosis has led to the view that placebo-controlled trials to test new agents for efficacy are no longer appropriate. Rather, studies of superiority, equivalence, or non-inferiority have been recommended. Such studies require very large sample sizes, and the burden of osteoporotic fracture in a trial setting is substantially increased. Studies of equivalence cannot be unambiguously interpreted because the variance in effect of active comparator agents is too large in osteoporosis. If fracture studies are required by regulatory agencies, there is still a requirement for placebo-controlled studies, although perhaps of shorter duration than demanded at present.     

Results of a pilot trial comparing prolonged intravenous antibiotics with sequential intravenous/oral antibiotics for children with perforated appendicitis.

HYPOTHESIS: For children with perforated appendicitis, the use of a prolonged course of intravenous (i.v.) antibiotics is equivalent to a short course of i.v. antibiotics followed by sequential conversion to oral (PO) antibiotics. DESIGN: Prospective, randomized, clinical trial. SETTING: Multicenter study in tertiary children's hospitals. PATIENTS: Children (aged 5-18 years) with perforated appendicitis found at laparotomy. INTERVENTION: Children were randomized after appendectomy either to a 10-day course of a combination of i.v. ampicillin, gentamicin sulfate, and clindamycin (n = 10); or to a short course of a combination of i.v. ampicillin, gentamicin, and clindamycin, followed by conversion to a combination of p.o. amoxicillin and clavulanate potassium plus metronidazole (n = 16). MAIN OUTCOME MEASURES: The primary outcome measure was clinical success, which was rated as complete, partial, or failure. Secondary outcome measures included return of oral intake, duration of fever, return of normal white blood cell count, and patient charges. Treatment equivalence was determined using confidence interval analysis. RESULTS: We found treatment equivalence between the i.v. and i.v./p.o. groups, with 6 (60%) complete and 4 (40%) partial successes for the 10 patients in the i.v. group and 15 (94%) complete and 1 (6%) partial successes for the 16 patients in the i.v./p.o. group (P< or =.05). There was no difference in return of oral intake, duration of fever, or return of normal white blood cell count between the groups. Conversion to oral therapy results in savings of approximately $1500 per case. CONCLUSION: There is treatment equivalence between prolonged i.v. therapy and i.v. therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis.     

Speed rather than distance: a novel graded treadmill test to assess claudication.

OBJECTIVE: To evaluate a new treadmill test, determining pain threshold speed (PTS) for use in assessment and measuring rehabilitation of patients with intermittent claudication. METHODS AND DESIGN: Twenty-nine patients with claudication were evaluated, and the ankle-brachial index (ABI) was assessed. PTS was determined with a treadmill protocol based on level walking, low starting speed, and progressive increments at a predetermined distance up to the onset of pain. Repeatability and equivalence with a time-based protocol were verified. PTS was compared to pain-free walking distance, 6-minute walking distance, and ABI. RESULTS: PTS was measured in all patients (3.6+/-1.1 km/h). Repeatability and equivalence between established tests were demonstrated. PTS showed a significant correlation with pain-free walking distance (r=0.833; P=0.0001), with 6-minute walking distance (r=0.724; P=0.005), and with ABI in the more ischemic limb (r=0.641; P=0.0001). CONCLUSIONS: PTS is a reliable parameter that correlates well with other established measures. It is useful for determining the degree of functional handicap and for designing and guiding rehabilitation protocols.     

Oblique intradermal suture as a faster choice for intradermal closure: a randomized equivalence trial

Performing interrupted intradermal suture during bi-layered skin closure is time consuming. The oblique intradermal suture is hypothesized to be a faster choice for intradermal closure while yielding similar wound cosmetic outcomes. This study aims to demonstrate the equivalence of wound outcomes between the interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture (IS) methods. This prospective, multicenter, double-blind randomized equivalence trial included patients scheduled to undergo elective surgery with a linear incision wound. A split-wound model was used. One half of the wound was sutured using IS method and the other using OIS method. Wounds were evaluated at 1 week and 2 months after surgery. Of the 120 patients, OIS was found to be equivalent to IS for all clinical outcome parameters. OIS was associated with 50% reduction in suture time and the number of stitches required, and a 40% reduction in suture material used (p?Trial registration: ClinicalTrials.gov identifier: NCT03001856.

Meeting presentation: 7th Bozner Symposium of Plastic Surgery, Bozen, Italy, January 2017.     

Equivalence and noninferiority testing in regression models and repeated-measures designs

Equivalence and noninferiority designs are useful when the superiority of one intervention over another is neither expected nor required. Equivalence trials test whether a difference between groups falls within a prespecified equivalence region, whereas noninferiority trials test whether a preferred intervention is either better or at least not worse than the comparator, with worse being defined a priori. Special designs and analyses are needed because neither of these conclusions can be reached from a nonsignificant test for superiority. Using the data from a companion article, we demonstrate analyses of basic equivalence and noninferiority designs, along with more complex model-based methods. We first give an overview of methods for design and analysis of data from superiority, equivalence, and noninferiority trials, including how to analyze each type of design using linear regression models. We then show how the analogous hypotheses can be tested in a repeated-measures setting in which there are multiple outcomes per subject. We especially address interactions between the repeated factor, usually time, and treatment. Although we focus on the analysis of continuous outcomes, extensions to other data types as well as sample size consideration are discussed.     

A necessary and sufficient condition of optimality for a class of multidimensional control problems

In this paper, we introduce a necessary and sufficient condition of optimality for a new class of multidimensional optimal control problems governed by path-independent curvilinear integral functionals and mixed constraints involving first-order partial differential equations (PDEs) of m-flow type. Furthermore, as a consequence, we establish the equivalence between the class of (strongly) b-invex functionals and the class of (strongly) b-pseudoinvex functionals. The mathematical development in the paper is supported by illustrative examples, as well.     

Increased Pancreatitis in Allografts Flushed with Histidine-Tryptophan-Ketoglutarate Solution: A Cautionary Tale

We reviewed pancreas transplantation outcomes after Histidine-Tryptophan-Ketoglutarate (HTK) and University of Wisconsin (UW) preservation solution use between 2001 and 2007 at two transplant centers. While equivalence has been claimed for kidney and liver transplant outcomes after the use of HTK or UW preservation solution, consensus has not been reached on equivalence when flushing pancreata. Others have reported comparable patient and graft survival rates, but found an association between the use of HTK and an increase in the incidence of acute rejection and pancreatitis. In reviewing our experiences, we found in pancreata flushed with HTK a higher incidence of postoperative complications including graft pancreatitis, use of octreotide and a decreased rate of insulin-independence at hospital discharge. These findings prompted us to critically review our centers' experience to determine if there is a basis for suspecting a causal relationship.     

Levobupivacaine for axillary brachial plexus block: a pharmacokinetic and clinical comparison in patients with normal renal function or renal disease

We compared the pharmacokinetics and clinical characteristics of 0.5% levobupivacaine for axillary block in patients with normal renal function versus patients with end-stage renal disease (ESRD). Twenty patients with normal renal function and eight patients with ESRD received an axillary block with 50-60 mL of 0.5% levobupivacaine. Patients were evaluated for onset and duration of sensory/motor block. Eleven patients with normal renal function and eight patients with ESRD underwent pharmacokinetic analysis. No differences between groups were found in the onset, duration, or quality of block. The median time to sensory block was 12.5 min and 12.9 min, and mean duration of the block was 19 h and 22 h in normal versus ESRD patients, respectively. No significant differences in noncompartmental pharmacokinetic variables (median) were found between normal and ESRD patients with an AUC(0-t) (microg. h(-1). mL(-1)) of 11 and 13, peak concentration (C(max)) (microg/mL) of 1.2 and 1.6, and a time to peak concentration (T(max)) (min) of 55 and 48, respectively. This study demonstrates the clinical efficacy and equivalence of the pharmacokinetic characteristics of 0.5% levobupivacaine for axillary brachial plexus block in patients with ESRD and normal renal function. IMPLICATIONS: This study demonstrates the clinical efficacy and equivalence of the pharmacokinetic characteristics of 0.5% levobupivacaine for axillary brachial plexus block in patients with renal disease and normal renal function.     

The revised civilian mississippi scale for PTSD: Reliability,validity, and cross-language stability

Examined in two studies the psychometric properties of a revised 30-item version of the civilian form of the Mississippi Scale for Combat-Related Posttraumatic Stress Disorder (PTSD) developed by Keane, Caddell, and Taylor (1988). Study 1, whose sample was composed of 37 bilingual adults who had experienced a variety of traumatic events, was undertaken primarily to examine the linguistic equivalence of a Spanish translation of the scale. High cross-language stability was demonstrated, and both English and Spanish versions showed high internal consistency. Study 2, which used a sample of 404 victims of Hurricane Andrew, provided additional evidence of scale reliability and also showed that the scale correlates in meaningful ways with known traumatic stressors. Together the results indicate that the scale is applicable to different populations and events and constitutes a valid and reliable self-report measure of PTSD.     

Confidence intervals: why use them?

We analyze the reasons why the use of confidence intervals is highly advisable. Among these reasons, confidence intervals provide an approach to knowledge of the real importance of a result, independently of statistical significance, as well as equivalence assessment between two variables.     

Making ends meet: a cost comparison of laparoscopic and open radical retropubic prostatectomy

PURPOSE: We compared the perioperative costs of laparoscopic radical prostatectomy (LRP) and open radical retropubic prostatectomy (RRP) at a metropolitan hospital by developing a detailed computer model. MATERIALS AND METHODS: Our predictive model incorporates institutional cost centers for operative time, operating room consumables, professional fees, hospital room and board, oral analgesics, autologous blood banking, blood transfusion and cystography. Versions with and without pelvic lymphadenectomy (PLND) were evaluated using 1 and 2-way sensitivity analyses. Operative times, lengths of stay and transfusion rates were derived from published series. We also reviewed individual hospital charges for 172 consecutive prostatectomy cases for comparison and validation of model predictions. RESULTS: The model predicted cost premiums for LRP of 14.4% (without PLND) and 17.5% (with PLND). The actual hospital charge premium for LRP and PLND was 18.4%, which differed from the predicted cost premium by less than 1%. The most significant cost centers in order of importance were operative time, length of stay and consumables. To achieve cost equivalence with RRP, operative times would need to average 159 minutes (LRP and PLND) and 174 minutes (LRP alone) holding other factors constant. Cost equivalence could not be achieved by shortening hospital stay alone unless LRP were performed as an outpatient procedure. CONCLUSIONS: Our model predicts the perioperative costs of LRP to be greater than RRP by a factor of less than 1.2x. If disposable instruments and trocars are eliminated, and patients undergoing LRP and PLND are discharged on postoperative day 2, cost equivalence with RRP and PLND can be achieved with operative times of 3.4 hours.     

DESNOS in three postconflict settings: assessing cross-cultural construct equivalence

This study examined the cross-cultural construct equivalence of the Structured Interview for Disorders of Extreme Stress (SIDES), an instrument designed to assess symptoms of Disorders of Extreme Stress Not Otherwise Specified (DESNOS). Participants completed the SIDES as a part of an epidemiological survey conducted between 1997 and 1999 among survivors of war or mass violence in Algeria (n = 652), Ethiopia (n = 1,200), and Gaza (n = 585). Findings indicated that the factor structure of the SIDES across samples was not stable; thus construct equivalence was not shown. A multistep interdisciplinary method is proposed to improve the cross-cultural construct validity of a psychiatric concept. This method accommodates universal chronic sequelae of extreme stress and accommodates culture-specific symptoms across a variety of cultures.     

An exact l1 penalty function method for a multitime control optimization problem with data uncertainty

In this article, we study the robust solution set of a multitime first-order PDE constrained control optimization problem with data uncertainty (MCOPU) and an unconstrained multitime control optimization problem (MCOPU)_ρ . We establish the equivalence between a robust optimal solution of (MCOPU) and a robust minimizer of (MCOPU)_ρ under the appropriate assumptions. Furthermore, we define the uncertain Lagrange functional for (MCOPU) and show the relationship between the robust solution set of (MCOPU) and (MCOPU)_ρ under the convexity hypothesis of uncertain Lagrange functional. Moreover, we present some nontrivial examples to illustrate the established results.     

Association of angiotensinogen gene M235T polymorphism with the risk of IgA nephropathy: a meta-analysis

The association between angiotensinogen (AGT) M235T gene polymorphism and IgA nephropathy (IgAN) risk remains elusive. Our aim was to evaluate the association between AGT M235T gene polymorphism and IgAN susceptibility by performing a meta-analysis. Eligible studies were searched according to predefined criteria using electronic databases. Eight studies were identified for the analysis of the association between AGT M235T gene polymorphism and IgAN risk. M allele/MM genotype were not associated with IgAN risk in overall populations, Caucasians and Asians (overall populations: p?=?0.448 and 0.861, Caucasians: p?=?0.618 and 0.886, Asians: p?=?0.566 and 0.652). TT/MT genotype were not associated with IgAN risk in overall populations, Caucasians and Asians (overall populations: p?=?0.703 and 0.454, Caucasians: p?=?0.975 and 0.946, Asians: p?=?0.697 and 0.353). No evidence of publication bias was observed. In conclusion, AGT M235T gene polymorphism may not be correlated with IgAN susceptibility in overall populations, Caucasians and Asians. However, more studies should be performed in the future.     

Treatment of carotid stenosis: angioplasty, a reasoned choice

MASTERING THE SURGICAL ACT: Over the last decade, the technique of carotid angioplasty has progressed and it can now be considered as mastered thanks to the combination of platelet antiaggregants, miniaturisation of the material, stenting and the use of cerebral protection devices. POTENTIAL COMPLICATIONS: Notably the occurrence of cerebral embolism despite protection. Haemorrhagic complications are also possible. After a delay of 6 months, the re-stenosis rate is of around 10%. RESULTS OF RANDOMISED STUDIES: These globally demonstrate the equivalence between endoluminal treatment and surgery, notably in patients at high surgical risk. IN PRACTICE: Carotid angioplasty can be proposed in cases of severe non-atheromatous stenosis localised away from the bifurcation. It is contraindicated in the case of asymptomatic atheromatous stenosis without surgical comorbidity and when the particular anatomic conditions complicate catheterism of the carotid axis.