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Outcome Parameters (outcome + parameter)
Selected AbstractsA Comparative Pharmacokinetic Study in Healthy Volunteers of the Effect of Carbamazepine and Oxcarbazepine on Cyp3a4EPILEPSIA, Issue 3 2007Astrid-Helene Andreasen Summary:,Purpose: Carbamazepine (CBZ) and oxcarbazepine (OXCZ) are well-known inducers of drug metabolism via CYP3A4. Indirect interaction studies and clinical experience suggest that CBZ has a stronger potential in this regard than OXCZ. However this has never been subject to a direct comparative study. We performed a study in healthy volunteers to investigate the relative inductive effect of CBZ and OXCZ on CYP3A4 activity using the metabolism of quinidine as a biomarker reaction. Methods: Ten healthy, male volunteers participated in an open, randomized crossover study consisting of two periods separated by a 4-week wash-out period. The subjects received 1200 mg oral OXCZ daily for 17 days and 800 mg oral CBZ for 17 days. A single 200 mg oral dose of quinidine was administered at baseline and following administration of CBZ and OXCZ. Outcome parameters were the formation clearance of 3-hydroxyquinidine dose and the ratio of the AUCs of 3-hydroxyquinidine to quinidine. Results: Formation clearance of 3-hydroxyquinidine was increased by means of 89% (CI: 36,164; p = 0.0022) and 181% (CI: 120,260, p < 0.0001) after treatment with OXCZ and CBZ, respectively, compared to baseline. The relative inductive effect of CBZ was 46% higher than for OXCZ. AUC ratio increased by means of 161% (CI: 139,187, p < 0.0001) (OXCZ) and 222% (CI: 192,257, p < 0.0001) (CBZ). Quinidine Cmax decreased by means of 29% (CI: 16,40, p = 0.0018) (OXCZ) and 33% (CI: 18,45, p = 0.0020) (CBZ). T½ decreased by means of 12% (CI: 6,17, p < 0.0014) (OXCZ) and 32% (CI: 25,38, p < 0.0001) (CBZ). tmax was not changed in either period. Conclusion: We confirm a clinically significant inductive effect of both OXCZ and CBZ. The inductive effect of CBZ was about 46% higher than that of OXCZ, a difference that may be of clinical relevance. [source] The Aachen Miniaturized Heart-Lung Machine,First Results in a Small Animal ModelARTIFICIAL ORGANS, Issue 11 2009Heike Schnoering Abstract Congenital heart surgery most often incorporates extracorporeal circulation. Due to foreign surface contact and the administration of foreign blood in many children, inflammatory response and hemolysis are important matters of debate. This is particularly an issue in premature and low birth-weight newborns. Taking these considerations into account, the Aachen miniaturized heart-lung machine (MiniHLM) with a total static priming volume of 102 mL (including tubing) was developed and tested in a small animal model. Fourteen female Chinchilla Bastard rabbits were operated on using two different kinds of circuits. In eight animals, a conventional HLM with Dideco Kids oxygenator and Stöckert roller pump (Sorin group, Milan, Italy) was used, and the Aachen MiniHLM was employed in six animals. Outcome parameters were hemolysis and blood gas analysis including lactate. The rabbits were anesthetized, and a standard median sternotomy was performed. The ascending aorta and the right atrium were cannulated. After initiating cardiopulmonary bypass, the aorta was cross-clamped, and cardiac arrest was induced by blood cardioplegia. Blood samples for hemolysis and blood gas analysis were drawn before, during, and after cardiopulmonary bypass. After 1 h aortic clamp time, all animals were weaned from cardiopulmonary bypass. Blood gas analysis revealed adequate oxygenation and perfusion during cardiopulmonary bypass, irrespective of the employed perfusion system. The use of the Aachen MiniHLM resulted in a statistically significant reduced decrease in fibrinogen during cardiopulmonary bypass. A trend revealing a reduced increase in free hemoglobin during bypass in the MiniHLM group could also be observed. This newly developed Aachen MiniHLM with low priming volume, reduced hemolysis, and excellent gas transfer (O2 and CO2) may reduce circuit-induced complications during heart surgery in neonates. [source] Combined thrombolysis with abciximab and rtPA in patients with middle cerebral artery occlusionACTA NEUROLOGICA SCANDINAVICA, Issue 1 2010G. Gahn Background,,, In patients with acute middle cerebral artery (MCA) occlusion, recanalization rates with intravenous (IV) recombinant tissue plasminogen activator (rtPA) are limited. Aim, We evaluated the feasibility and safety of combined IV thrombolysis with abciximab and reduced dose rtPA in a 3- to 6-h time window. Methods,,, We prospectively (March 2002 to February 2005) studied patients with symptomatic MCA occlusion on computed tomography (CT) angiography and absence of major early ischemic changes (EIC) on non-contrast CT (NCCT) within 3,6 h from symptom onset. Patients were treated with IV abciximab and half-standard dose rtPA. Outcome parameters were symptomatic intracerebral hemorrhage (sICH), early clinical improvement and functional independence at discharge (modified Rankin Scale score , 2). Results,,, Of 13 patients, mean age was 62 ± 11 years, onset-to-treatment time 4.8 ± 0.9 h and median baseline National Institutes of Health Stroke Scale score 11 (interquartile range 6.5,13.5). sICH occurred in one patient (8%). We observed early clinical improvement in four patients (31%). Six patients (46%) were functionally independent at discharge. Conclusions,,, In patients with acute symptomatic MCA occlusion and absence of major EIC on NCCT, combined IV thrombolysis with abciximab and half-standard dose rtPA was feasible and seemed to be safe if applied within 3,6 h from symptom onset. [source] Twelve-hour reproducibility of retinal and optic nerve blood flow parameters in healthy individualsACTA OPHTHALMOLOGICA, Issue 8 2009Alexandra Luksch Abstract. Purpose:, The aim of the present study was to investigate the reproducibility and potential diurnal variation of optic nerve head and retinal blood flow parameters in healthy individuals over a period of 12 hr. Methods:, We measured optic nerve head and retinal blood flow parameters in 16 healthy male non-smoking individuals at five time-points during the day (08:00, 11:00, 14:00, 17:00 and 20:00 hr). Outcome parameters were perimacular white blood cell flux (as assessed with the blue field entoptic technique), blood velocities in retinal veins (as assessed with bi-directional laser Doppler velocimetry), retinal arterial and venous diameters (as assessed with the retinal vessel analyser), optic nerve head blood flow, volume and velocity (as assessed with single point and scanning laser Doppler flowmetry) and blood velocities in the central retinal artery (as assessed with colour Doppler imaging). The coefficient of variation and the maximum change from baseline in an individual were calculated for each outcome parameter. Results:, No diurnal variation in optic nerve head or retinal blood flow was observed with any of the techniques employed. Coefficients of variation were between 1.6% and 18.5% for all outcome parameters. The maximum change from baseline in an individual was much higher, ranging from 3.7% to 78.2%. Conclusion:, Our data indicate that in healthy individuals the selected techniques provide adequate reproducibility to be used in clinical studies. However, in patients with eye diseases and reduced vision the reproducibility may be considerably worse. [source] End-to-side caval anastomosis in adult piggyback liver transplantationCLINICAL TRANSPLANTATION, Issue 5 2006Wojciech G. Polak Abstract:, No consensus exists regarding the optimal reconstruction of the cavo-caval anastomosis in piggyback orthotopic liver transplantation (PB-LT). The aim of this study was to analyze our experience with end-to-side (ES) cavo-cavostomy. Outcome parameters were patient and graft survival and surgical complications. During the period 1995,2002 146 full-size PB-LT in 137 adult patients were performed with ES cavo-cavostomy without the routine use of temporary portocaval shunt (TPCS). In 12 patients (8%) this technique was used for implantation of second or third grafts. Veno-venous bypass was not used in any case and TPCS was performed only in eight patients (6%). One-, three- and five-yr patient and graft survival were 84%, 79% and 75%, and 81%, 74% and 69%, respectively. The median number of intraoperative transfusion of packed red blood cells (RBC) was 2.0 (range 0,33) and 30% of the patients (n = 43) did not require any RBC transfusion. Surgical complications of various types were observed after 49 LT (34%) and none of the complications was specifically related to the technique of ES cavo-cavostomy. Our experience indicates that PB-LT with ES cavo-cavostomy is a safe procedure, can safely be performed without the routine use of a TPCS, has a very low risk of venous outflow obstruction and can also be used effectively during retransplantations. [source] Comparison of clinical outcome parameters, the Patient Benefit Index (PBI-k) and patient satisfaction after ablative fractional laser treatment of peri-orbital rhytides,LASERS IN SURGERY AND MEDICINE, Issue 3 2010Syrus Karsai MD Abstract Background Laser treatment of facial rhytides has evolved as a major modality of aesthetic surgery. Published results, while generally encouraging, feature highly diverse evaluation methods, which makes an evidence-based assessment of treatment efficacy and safety all but impossible. Objective To compare the results of different instruments of measurement. Patients/Methods Twenty-eight patients were enrolled and completed the entire study. They received a single ablative fractional treatment of the peri-orbital region. The evaluation included the Fitzpatrick wrinkle score, the profilometric measurement of wrinkle depth and the Patient Benefit Index (both before and 3 months after treatment) as well as the assessment of patient satisfaction (1, 3, 6 days and 3 months after treatment). Results All assessment instruments showed a significant, albeit moderate, improvement. The agreement between assessment methods was poor. Despite claiming to assess basically the same parameter, the Fitzpatrick wrinkle score and profilometry differed significantly, and neither assessment instrument showed any appreciable correlation with any other. Conclusions The outcome assessment of rhytide therapy,regardless of the method used,shows substantial room for improvement. Strict methodological precautions ought to be applied for ,objective' evaluation methods like photographic scoring and profilometry. Subjective methods of assessment are essential and might serve as a main outcome parameter. Finally, critical reappraisal of published treatment results seems warranted to review the quality of their methodology. Lasers Surg. Med. 42:215,223, 2010. © 2010 Wiley-Liss, Inc. [source] Effect of medical and surgical interventions on health-related quality of life in Parkinson's diseaseMOVEMENT DISORDERS, Issue 6 2007Pablo Martinez-Martin MD Abstract Motor-related parameters are the standard outcome parameters for treatment interventions. Nonetheless, subjective appraisals about the consequences of treatment on health-related quality of life (HRQoL) are meanwhile established and may uncover important aspects of interventions. We have reviewed the literature with a defined search strategy and collected 61 clinical trials, which have used HRQoL as a planned outcome parameter. The articles were rated similarly as for the Task Force report of the Movement Disorder Society on interventions for Parkinson's disease (PD), but the relevant outcome parameter was HRQoL. We found that unilateral pallidotomy, deep brain stimulation of the subthalamic nucleus, and rasagiline are efficacious to improve the HRQoL of PD patients. For many other interventions, the efficacy to improve HRQoL in the PD setting cannot be considered to be proven so far. HRQoL should be part of future trial designs and more research is necessary to understand the determinants of QoL in PD. © 2007 Movement Disorder Society [source] Twelve-hour reproducibility of retinal and optic nerve blood flow parameters in healthy individualsACTA OPHTHALMOLOGICA, Issue 8 2009Alexandra Luksch Abstract. Purpose:, The aim of the present study was to investigate the reproducibility and potential diurnal variation of optic nerve head and retinal blood flow parameters in healthy individuals over a period of 12 hr. Methods:, We measured optic nerve head and retinal blood flow parameters in 16 healthy male non-smoking individuals at five time-points during the day (08:00, 11:00, 14:00, 17:00 and 20:00 hr). Outcome parameters were perimacular white blood cell flux (as assessed with the blue field entoptic technique), blood velocities in retinal veins (as assessed with bi-directional laser Doppler velocimetry), retinal arterial and venous diameters (as assessed with the retinal vessel analyser), optic nerve head blood flow, volume and velocity (as assessed with single point and scanning laser Doppler flowmetry) and blood velocities in the central retinal artery (as assessed with colour Doppler imaging). The coefficient of variation and the maximum change from baseline in an individual were calculated for each outcome parameter. Results:, No diurnal variation in optic nerve head or retinal blood flow was observed with any of the techniques employed. Coefficients of variation were between 1.6% and 18.5% for all outcome parameters. The maximum change from baseline in an individual was much higher, ranging from 3.7% to 78.2%. Conclusion:, Our data indicate that in healthy individuals the selected techniques provide adequate reproducibility to be used in clinical studies. However, in patients with eye diseases and reduced vision the reproducibility may be considerably worse. [source] End-to-end jejuno-ileal anastomosis following resection of strangulated small intestine in horses: a comparative studyEQUINE VETERINARY JOURNAL, Issue 4 2005D. I. RENDLE Summary Reasons for performing study: Small intestinal resection and anastomosis is a relatively common procedure in equine surgical practice. This study was designed to test objectively the subjective opinions of surgeons at the Liphook Equine Hospital that an end-to-end jejuno-ileal anastomosis (JIA) is an effective and clinically justifiable procedure, contrary to conventional recommendations. Hypothesis: An end-to-end JIA carries no greater risk of morbidity and mortality than an end-to-end jejunojejunal anastomosis (JJA). Methods: A retrospective observational study was performed on a population of 100 horses that had undergone small intestinal resection and end-to-end anastomosis. Two groups were identified; Group 1 (n = 30) had undergone an end-to-end JIA and Group 2 (n = 70) an end-to-end JJA. The 2 populations were tested for pre- and intraoperative comparability and for their equivalence of outcomes. Results: The 2 populations were comparable in terms of their distributions of preoperative parameters and type of lesion present. The observations used as outcome parameters (incidence risk of post operative colic, incidence risk of post operative ileus, duration of post operative ileus, rates of functioning original anastomoses at the time of discharge and at 12 months, survival rates at 6 months and 12 months) were equivalent between the 2 groups. Conclusion: End-to-end JIA carries no greater risk of morbidity and mortality than an end-to-end JJA. Potential relevance: Surgeons faced with strangulating obstructions involving the jejuno-ileal junction in which there remains an accessible length of viable terminal ileum may reasonably perform an end-to-end JIA. This has the potentially significant advantage over a jejunocaecal anastomosis of preserving more anatomical and physiological normality to the intestinal tract. The study was, however, relatively small for an equivalence study and greater confidence would be gained with higher numbers. [source] Free fatty acids exert a greater effect on ocular and skin blood flow than triglycerides in healthy subjectsEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 8 2004M. Bayerle-Eder Abstract Background, Free fatty acids (FFAs) and triglycerides (TGs) can cause vascular dysfunction and arteriosclerosis. Acute elevation of plasma FFA and TG concentration strongly increase ocular and skin blood flow. This study was designed to discriminate whether FFA or TG independently induce hyperperfusion by measuring regional and systemic haemodynamics. Methods, In a balanced, randomized, placebo-controlled, double-blind, three-way, crossover study nine healthy subjects received either Intralipid® (Pharmacia and Upjohn, Vienna, Austria) with heparin, Intralipid® alone or placebo control. Pulsatile choroidal blood flow was measured with laser interferometry, retinal blood flow and retinal red blood cell velocity with laser Doppler velocimetry, and skin blood flow with laser Doppler flowmetry during an euglycaemic insulin clamp. Results, A sevenfold increase of FFA during Intralipid®/heparin infusion was paralleled by enhanced choriodal, retinal, and skin blood flow by 17 ± 4%, 26 ± 5% (P < 0·001), and 47 ± 19% (P = 0·03) from baseline, respectively. In contrast, a mere threefold increase of FFA by infusion of Intralipid® alone did not affect outcome parameters, despite the presence of plasma TG levels of 250,700 mg dL,1; similar to those obtained during combined Intralipid®/heparin infusion. Systemic haemodynamics were not affected by drug infusion. Conclusions, Present findings demonstrate a concentration-dependent increase in ocular and skin blood flow by FFA independently of elevated TG plasma concentrations. As vasodilation of resistance vessels occur rapidly, FFA may play a role in the development of continued regional hyperperfusion and deteriorate microvascular function. [source] New once-daily formulation for trospium in overactive bladderINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 11 2010C. Chapple Summary Aims:, We examined the relative efficacy and safety of trospium 20 mg bid and 60 mg extended release formulations and position this drug against other antimuscarinic agents. Methods:, Data were identified on the pharmacology and pharmacokinetics of trospium chloride. Key publications on trospium 20-mg and 60-mg clinical studies in patients with overactive bladder (OAB) were identified and efficacy and safety compared between these formulations as well as other antimuscarinic agents. Results:, Trospium offers the principal advantage over other antimuscarinic agents that, as it is a quaternary amine, it does not cross the blood,brain barrier and is therefore less likely to cause central nervous system effects observed with several other agents. Moreover, with its minimal liver metabolisation, independent of the main cytochrome pathways, trospium has a low risk of drug,drug interaction in patients taking multiple pharmacological agents. Trospium 60 mg ER is as effective as trospium 20 mg bid in improving the key outcome parameters associated with OAB, but with a lower rate of dry mouth, the most common side effect of these agents. Trospium has comparable efficacy and safety to the other antimuscarinic agents currently marketed. Discussion:, Good patient persistence with treatment has been reported with trospium. There are currently a large number of antimuscarinic drugs on the market without clear evidence to distinguish one agent from another in terms of efficacy, provided that an adequate dose is used in the clinical setting. Conclusion:, The new formulation of trospium is certainly worth considering as a pharmacological treatment of patients with OAB, particularly in the elderly, in whom one wants to avoid the potential for cognitive dysfunction. [source] Early predictors of morbidity and mortality in trauma patients treated in the intensive care unitACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2010O. BRATTSTRÖM Background: We investigated the incidence and severity of post-injury morbidity and mortality in intensive care unit (ICU)-treated trauma patients. We also identified risk factors in the early phase after injury that predicted the later development of complications. Methods: A prospective observational cohort study design was used. One hundred and sixty-four adult patients admitted to the ICU for more than 24 h were included during a 21-month period. The incidence and severity of morbidity such as multiple organ failure (MOF), acute lung injury (ALI), severe sepsis and 30-day post-injury mortality were calculated and risk factors were analyzed with uni- and multivariable logistic regression analysis. Results: The median age was 40 years, the injury severity score was 24, the new injury severity score was 29, the acute physiology and chronic health evaluation II score was 15, sequential organ failure assessment maximum was 7 and ICU length of stay was 3.1 days. The incidences of post-injury MOF were 40.2%, ALI 25.6%, severe sepsis 31.1% and 30-day mortality 10.4%. The independent risk factors differed to some extent between the outcome parameters. Age, severity of injury, significant head injury and massive transfusion were independent risk factors for several outcome parameters. Positive blood alcohol was only a predictor of MOF, whereas prolonged rescue time only predicted death. Unexpectedly, injury severity was not an independent risk factor for mortality. Conclusions: Although the incidence of morbidity was considerable, mortality was relatively low. Early post-injury risk factors that predicted later development of complications differed between morbidity and mortality. [source] A systematic review of hand-assisted laparoscopic live donor nephrectomyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 5 2004P. Dasgupta Summary We provide a systematic review of hand-assisted laparoscopic live donor nephrectomy (HALDN), a relatively new procedure. Medline search of HALDN between 1995 and 2002 was conducted. Published studies were scored by two independent assessors using a modified form of 11 generic questions. All questions required one of three responses: 0 , criterion not reported, 1 , criterion reported but inadequate, 2 , criterion reported and adequate. The studies were placed according to their scoRes in category A (score 20,22), category B (17,19) and category C (16 or less). Higher scores indicate better quality of studies. Where possible, statistical analysis of comparative data was performed. Most reports of HALDN are expert series, some comparative and a few prospective. There was good correlation between the assessors (r = 0.91), and of the seven published series on HALDN, two fell into category B and five into category C. At present, there is only one published randomised-controlled trial of HALDN vs. open donor nephrectomy; this is the only such trial in laparoscopic urology. HALDN allows kidneys to be harvested with short operating and warm ischaemia times and fewer ureteric complications. HALDN is a relatively new and effective technique, designed to make kidney donation more attractive and minimally invasive without affecting recipient outcomes. More prospective data of this technique is needed, and wide variation in reported outcome parameters need to be standardised to allow meaningful comparison. [source] Radical prostatectomy in obese patients: Improved surgical outcomes in recent yearsINTERNATIONAL JOURNAL OF UROLOGY, Issue 8 2010Uri Lindner Objectives: Obesity has been proposed as a risk factor for reduced disease-specific survival, increased positive surgical margin (PSM) and biochemical recurrence (BCR) after radical prostatectomy (RP) in patients with prostate cancer. The aim of this study was to clarify the relationship between obesity and surgical outcomes in patients undergoing RP. Methods: Medical records of 491 patients who underwent RP from 2004 to 2007 were retrieved from our institutional database. Patients were divided into three groups based on their body mass index (BMI): <25, 25,30 (overweight) and >30 kg/m (obese). Outcomes after RP were compared between the groups in terms of length of stay, perioperative complications, BCR, PSM and Gleason scores. Results: Age, stage and preoperative prostate-specific antigen were similar between BMI categories. Operating time was prolonged in obese patients (146 vs 135 min, P = 0.01) and blood loss was greater (mean estimated blood loss 640 vs 504 mL, P = 0.02), but did not translate into higher transfusion rates. Early complication rates, PSM rates and Gleason scores were not statistically different between the groups. Significant differences in late outcomes, such as the need for adjunct procedures or BCR (hazard ratio 0.44, 95% CI 0.18,1.09), were not shown. Conclusion: As surgical experience with high BMI patients has developed, RP appears to be a well tolerated procedure in contemporary series, irrespective of BMI. In particular, early outcome parameters, such as PSM and BCR rates, are similar. [source] ,Liberal' vs. ,restrictive' perioperative fluid therapy , a critical assessment of the evidenceACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 7 2009M. BUNDGAARD-NIELSEN Background: Several studies have assessed the effect of a ,liberal' vs. a ,restrictive' perioperative fluid regimen on post-operative outcome. The literature was reviewed in order to provide recommendations regarding perioperative fluid regimens. Methods: A PubMed search identified randomized clinical trials and cited studies, comparing two different fixed fluid volumes on post-operative clinical outcome in major surgery. Studies were assessed for the type of surgery, primary and secondary outcome endpoints, the type and volume of administered fluid and the definition of the perioperative period. Also, information regarding perioperative care and type of anaesthesia was assessed. Results: In the seven randomized studies identified, the range of the liberal intraoperative fluid regimen was from 2750 to 5388 ml compared with 998 to 2740 ml for the restrictive fluid regimen. The period for fluid therapy and outcome endpoints were inconsistently defined and only two studies reported perioperative care principles and discharge criteria. Three studies found an improved outcome (morbidity/hospital stay) with a restrictive fluid regimen whereas two studies found no difference and two studies found differences in the selected outcome parameters. Conclusion: Liberal vs. restrictive fixed-volume regimens are not well defined in the literature regarding the definition, methodology and results, and lack the use of or information on evidence-based standardized perioperative care-principles (fast-track surgery), thereby precluding evidence-based guidelines for procedure-specific perioperative fixed-volume regimens. Optimization of perioperative fluid management may include a combination of fixed crystalloid administration to replace extra-vascular losses and avoiding fluid excess, together with individualized goal-directed colloid administration to maintain a maximal stroke volume. [source] Diode laser hair removal does not interfere with botulinum toxin A treatment against axillary hyperhidrosisLASERS IN SURGERY AND MEDICINE, Issue 3 2010Anna Paul MD Abstract Background and Objective The possible interference of combined laser hair removal and Botulinum toxin A (BoNT/A) injections in the treatment of axillary hyperhidrosis has not previously been explored. In order to examine this potential interference, we assessed the effect of BoNT/A on axillary hyperhidrosis with and without concomitant diode laser axillary hair removal. Study Design/Materials and Methods In a prospective, double blind, randomized cross over trial, nine patients suffering from primary axillary hyperhidrosis were laser-treated on one randomly assigned axilla. One week later, both axillas were injected intradermally with BoNT/A (100,MU per axilla). During the same session, the previously untreated axilla was lasered. Axillary sweat rates (in g/5,minutes.) were determined by gravimetry and compared at rest, during mental exercise, and during physical exercise. Additionally, subjective outcome measures were assessed by a visual analogue scale, Dermatology Life Quality Index, and Global Clinical Impression score. Results No differences were found regarding the effect of BoNT/A on previously laser-treated and laser co-treated sides over time course for any of the outcome parameters. Sweat production was reduced 3 weeks after BoNT/A treatment by 93.5% at rest, 96.5% during mental exercise, and 67% during physical exercise. Conclusions Concomitant laser hair removal does not interfere with BoNT/A treatment on axillary hyperhidrosis. Lasers Surg. Med. 42:211,214, 2010. © 2010 Wiley-Liss, Inc. [source] Comparison of clinical outcome parameters, the Patient Benefit Index (PBI-k) and patient satisfaction after ablative fractional laser treatment of peri-orbital rhytides,LASERS IN SURGERY AND MEDICINE, Issue 3 2010Syrus Karsai MD Abstract Background Laser treatment of facial rhytides has evolved as a major modality of aesthetic surgery. Published results, while generally encouraging, feature highly diverse evaluation methods, which makes an evidence-based assessment of treatment efficacy and safety all but impossible. Objective To compare the results of different instruments of measurement. Patients/Methods Twenty-eight patients were enrolled and completed the entire study. They received a single ablative fractional treatment of the peri-orbital region. The evaluation included the Fitzpatrick wrinkle score, the profilometric measurement of wrinkle depth and the Patient Benefit Index (both before and 3 months after treatment) as well as the assessment of patient satisfaction (1, 3, 6 days and 3 months after treatment). Results All assessment instruments showed a significant, albeit moderate, improvement. The agreement between assessment methods was poor. Despite claiming to assess basically the same parameter, the Fitzpatrick wrinkle score and profilometry differed significantly, and neither assessment instrument showed any appreciable correlation with any other. Conclusions The outcome assessment of rhytide therapy,regardless of the method used,shows substantial room for improvement. Strict methodological precautions ought to be applied for ,objective' evaluation methods like photographic scoring and profilometry. Subjective methods of assessment are essential and might serve as a main outcome parameter. Finally, critical reappraisal of published treatment results seems warranted to review the quality of their methodology. Lasers Surg. Med. 42:215,223, 2010. © 2010 Wiley-Liss, Inc. [source] Effect of medical and surgical interventions on health-related quality of life in Parkinson's diseaseMOVEMENT DISORDERS, Issue 6 2007Pablo Martinez-Martin MD Abstract Motor-related parameters are the standard outcome parameters for treatment interventions. Nonetheless, subjective appraisals about the consequences of treatment on health-related quality of life (HRQoL) are meanwhile established and may uncover important aspects of interventions. We have reviewed the literature with a defined search strategy and collected 61 clinical trials, which have used HRQoL as a planned outcome parameter. The articles were rated similarly as for the Task Force report of the Movement Disorder Society on interventions for Parkinson's disease (PD), but the relevant outcome parameter was HRQoL. We found that unilateral pallidotomy, deep brain stimulation of the subthalamic nucleus, and rasagiline are efficacious to improve the HRQoL of PD patients. For many other interventions, the efficacy to improve HRQoL in the PD setting cannot be considered to be proven so far. HRQoL should be part of future trial designs and more research is necessary to understand the determinants of QoL in PD. © 2007 Movement Disorder Society [source] Periradicular infiltration for sciatica: a randomized controlled trial. (University Hospital of Oulu, Helsinki, Finland).PAIN PRACTICE, Issue 4 2001Spine. In this study, 160 consecutive, eligible patients with sciatica who had unilateral symptoms of 1 to 6 months duration, and who never underwent surgery were randomized for a double-blinded injection with methylprednisolone bupivacaine combination or saline. Objective and self-reported outcome parameters and costs were recorded at baseline, at 2 and 4 weeks, at 3 and 6 months, and at 1 year. Recovery was better in the steroid group at 2 weeks for leg pain, straight leg raising, lumbar flexion, and patient satisfaction. Back pain was significantly lower in the saline group at 3 and 6 months. Sick leave and medical costs were similar for both treatments, except for cost of therapy visits and drugs at 4 weeks, which were in favor of the steroid injection. By 1 year, 18 patients in the steroid group and 15 in the saline group underwent surgery. Conclude improvement during the follow-up was found in both the methylprednisolone and saline groups. The combination of methylprednisolone and bupivacaine seems to have a short-term effect, but at 3 and 6 months, the steroid group seems to experience a "re-bound" phenomenon. [source] The Yale University Experience of Early-Stage Invasive Lobular Carcinoma (ILC) and Invasive Ductal Carcinoma (IDC) Treated with Breast Conservation Treatment (BCT): Analysis of Clinical-Pathologic Features, Long-Term Outcomes, and Molecular Expression of COX-2, Bcl-2, and p53 as a Function of HistologyTHE BREAST JOURNAL, Issue 6 2009Meena S. Moran MD Abstract:, To evaluate our experience of the clinical-pathologic features and outcomes of early-stage Invasive Lobular (ILC) versus Invasive Ductal (IDC) carcinoma treated with breast conservation treatment (BCT). 142 ILC and 1,760 IDC patients were treated with BCT at our institution. All patients underwent breast conserving surgery and radiation therapy (median total dose: 64 Gy). Clinical-pathologic and outcome parameters were analyzed to detect differences between the two cohorts. In addition, COX-2, Bcl-2, and p-53 expression was analyzed from our existing tissue micro-array database. Median follow-up was 6.8 years. A higher percentage of ILC patients presented at >40 years of age (94% ILC versus 89% IDC, p = 0.0353) and had more mammographically occult tumors (p < 0.002). There were no significant differences in T stage, nodal status, family history, final margin, ER/PR/HER-2 status or triple negative tumors (all p-values >0.05). From the immuno-histochemical analysis, expression of p53, COX-2, and Bcl-2 did not differ significantly (all p-values >0.05) between the two cohorts. At 10 years, there was no difference in breast relapse (20% versus 13%, p = 0.25), distant relapse (26% versus 20%, p = 0.28), cause-specific survival (72% versus 84%, p = 0.09) and OS (68% versus 78%, p = 0.08). Patients with ILC had higher contralateral breast relapses (26% versus 12%, p = 0.0006). Patients with early-stage ILC have comparable outcomes to IDC when treated with BCT. Because of the higher risk of contralateral breast cancers for ILC patients, careful evaluation of the contralateral breast will be important in the follow-up of these patients. Future investigations of chemo-preventive strategies to decrease contralateral breast cancers are warranted. [source] Planned Postradiotherapy Neck Dissection: Rationale and Clinical OutcomesTHE LARYNGOSCOPE, Issue 1 2007Gregory K. Sewall MD Abstract Objectives: In this study, we examine pathology results and clinical outcome for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) who present with advanced neck disease and undergo planned postradiotherapy neck dissection. Study Design: Review of all patients with SCCHN treated with primary radiation (or chemoradiation) and postradiotherapy neck dissection at the University of Wisconsin between 1992 to 2005 was performed. One hundred seven neck dissections were identified in 93 patients, 79 unilateral and 14 bilateral. All major treatment and outcome parameters were examined with particular emphasis on the postradiotherapy neck dissection. Results: Thirty of 107 neck dissection specimens (28%) showed evidence of residual carcinoma on pathologic review. The mean number of lymph nodes identified at neck dissection for the entire cohort was 21 per specimen (range, 1,60) with 1.3 nodes per positive neck dissection demonstrating residual carcinoma. No correlation was found between the type of neck dissection performed and the presence of residual nodal disease. Eighty-two evaluated patients (93%) remain free of regional disease recurrence, whereas six patients have subsequently manifested neck recurrence. Four of the six patients who developed regional recurrence showed residual carcinoma in their neck dissection specimen. Five of these patients underwent comprehensive neck dissection (levels I,V); one underwent selective neck dissection ( Preoperative prediction of long-term outcome following laparoscopic fundoplicationANZ JOURNAL OF SURGERY, Issue 7 2002Colm J. O'Boyle Background: Although long-term outcomes following laparoscopic fundoplication for gastro-oesophageal disease have now been reported as very satisfactory, a small, but important, minority of patients are unhappy with the outcome, often due to recurrent reflux symptoms or new-onset dysphagia. In this study, we sought to establish whether various parameters that can be determined before surgery, can predict the long-term outcome of surgery. Methods: Data collected prospectively were evaluated to determine factors that were associated with outcome at 5 years following laparoscopic fundoplication. Inclusion criteria were complete preoperative assessment data and 5-year follow-up data. Data examined included information on preoperative age, sex, weight, home address, health insurance status, duration of reflux symptoms, previous surgery, operating surgeon, endoscopy and 24-h pH monitoring. In addition, lower oesophageal sphincter resting and residual relaxation pressures were evaluated before and after surgery. The postoperative symptoms of heartburn and dysphagia, as well as overall satisfaction 5 years following surgery was determined using a 0,10 visual analogue scale. The association of the pre- and perioperative factors and outcome at 5 years was determined by univariate and linear regression analysis. Results: Two hundred and sixty-two patients from an overall experience of over 1000 laparoscopic anti-reflux procedures met the entry criteria. There was no association between patient address, age, weight, duration of symptoms, the presence of endoscopically proven oesophagitis, operating surgeon, the necessity for conversion to an open procedure, change in lower oesophageal sphincter residual relaxation pressure and the outcome parameters. Using univariate analysis, a higher heartburn score was associated with previous abdominal surgery, female sex, no private health insurance, and a normal preoperative 24-h pH study. A higher dysphagia score was associated with a normal preoperative pH study, a postoperative increase in lower oesophageal sphincter resting pressure of more than 6 mmHg, and previous abdominal surgery. Overall satisfaction with the outcome at 5 years was higher among male patients, private patients, patients who had a hiatus hernia, and patients who had an abnormal preoperative pH study. Linear regression analysis confirmed that private insurance, male sex, and the absence of previous abdominal surgery, were the strongest predictors of an improved heartburn score, whereas male sex and private health insurance were the strongest predictors of greater satisfaction with the overall outcome. Conclusions: There are parameters that can be assessed before or during laparoscopic Nissen fundoplication that correlate with late outcome parameters. In particular, male patients and those from higher socioeconomic groups appear to have a better long-term outcome. [source] Applying Concepts of Generalizability Theory on Data from Experimental Pain Studies to Investigate ReliabilityBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 2 2009Assam Pryseley This can be used to help optimizing outcome parameters from existing data sets. [source] The International Prognostic Index determines the outcome of patients with nodal mature T-cell lymphomasBRITISH JOURNAL OF HAEMATOLOGY, Issue 3 2005Ruth Sonnen Summary The World Health Organization (WHO) lymphoma classification recognises anaplastic large cell lymphoma (ALCL), angioimmunoblastic lymphoma (AIL) and peripheral T-cell lymphoma, unspecified (PTCU) as nodal mature T-cell lymphomas. Little is known about long-term outcome and prognostic factors of these diseases. A retrospective analysis on 125 patients with ALCL, AIL or PTCU was performed to evaluate outcome parameters, taking into account histological subtype and the International Prognostic Index (IPI). Median age was 54 years (range 17,90 years). Complete remission (CR) was achieved in 51% of patients. Five-year overall survival (OS) was 43%, and 5-year relapse-free survival was 69%. Five-year OS was 61% for ALCL, 45% for PTCU and 28% for AIL. With regard to the IPI, 5-year OS was 74%, 49%, 21% and 6% for the low, low-intermediate, high-intermediate and high risk groups, respectively. In the multivariate analysis, the IPI but not the histological subtype significantly predicted survival. To a large extent, the IPI score explains the differences in survival between histological subtypes of nodal mature T-cell lymphomas. The IPI may therefore be used for risk stratification in clinical trials to identify patients who would benefit most from new treatment strategies, such as high-dose chemotherapy followed by stem cell or bone marrow transplantation. [source] Psychosocial interventions for bipolar disorderACTA NEUROPSYCHIATRICA, Issue 6 2009David J. Castle Aim: To provide a selected overview of the literature on psychosocial treatments for bipolar disorder Method: Selective literature review Results: Randomised controlled trials of psychosocial interventions in bipolar disorder fall largely into five categories, namely: psychoeducation, integrated treatments, family based therapy, cognitive behavioural therapy and interpersonal social rhythm therapy. Most studies have shown some benefit in terms of relapse prevention, but have tended to be effective for either the depressed or the manic pole, and not both. Broader outcome parameters such as quality of life have not been reported consistently. The mechanisms whereby treatments might exert their effects have not been clearly delineated. Many studies have excluded patients with bipolar II and other variants, and those with psychiatric and substance use comorbidities, reducing their generalisability. Discussion: Whilst psychosocial treatments show promise in the area of bipolar disorder, more work is required to delineate the effective elements of such interventions, and to ensure generalisability to individuals with bipolar II and other forms of bipolar disorder, as well as those with psychiatric and substance use comorbidities. Other forms of delivery, such as via the internet, deserve further exploration. [source] Twelve-hour reproducibility of retinal and optic nerve blood flow parameters in healthy individualsACTA OPHTHALMOLOGICA, Issue 8 2009Alexandra Luksch Abstract. Purpose:, The aim of the present study was to investigate the reproducibility and potential diurnal variation of optic nerve head and retinal blood flow parameters in healthy individuals over a period of 12 hr. Methods:, We measured optic nerve head and retinal blood flow parameters in 16 healthy male non-smoking individuals at five time-points during the day (08:00, 11:00, 14:00, 17:00 and 20:00 hr). Outcome parameters were perimacular white blood cell flux (as assessed with the blue field entoptic technique), blood velocities in retinal veins (as assessed with bi-directional laser Doppler velocimetry), retinal arterial and venous diameters (as assessed with the retinal vessel analyser), optic nerve head blood flow, volume and velocity (as assessed with single point and scanning laser Doppler flowmetry) and blood velocities in the central retinal artery (as assessed with colour Doppler imaging). The coefficient of variation and the maximum change from baseline in an individual were calculated for each outcome parameter. Results:, No diurnal variation in optic nerve head or retinal blood flow was observed with any of the techniques employed. Coefficients of variation were between 1.6% and 18.5% for all outcome parameters. The maximum change from baseline in an individual was much higher, ranging from 3.7% to 78.2%. Conclusion:, Our data indicate that in healthy individuals the selected techniques provide adequate reproducibility to be used in clinical studies. However, in patients with eye diseases and reduced vision the reproducibility may be considerably worse. [source] Computer-assisted training system for pars plana vitrectomyACTA OPHTHALMOLOGICA, Issue 6 2003Jost B. Jonas Abstract. Purpose:,To evaluate whether microsurgical steps in vitreoretinal surgery can be taught by a computer-assisted training system. Methods:,This prospective, randomized experimental study included 14 ophthalmic residents and medical students who were completely inexperienced in microsurgery. They were randomized into two groups. The study group underwent training programmes in a computer-assisted training system for simulation of pars plana vitrectomy. The control group did not participate in any in vitro training. In the second phase of the study, participants of both groups performed a pars plana vitrectomy in three pig eyes, which included picking a metallic foreign body from the retinal surface. Results:,The amount of retinal detachment and the number of retinal defects at the end of the vitrectomies were smaller, the time needed to remove the foreign body was shorter, the number of retinal lesions associated with the foreign body removal was lower, and the mark given was better in the trained study group than in the untrained group. The relatively small number of study participants did not allow the differences between the study and control groups to reach the 5% level of error probability. Conclusions:,In an animal model, training by a computer-based medical work station for simulation of pars plana vitrectomy showed better outcome measures for trained study participants compared with untrained study participants. Future studies may show whether further refinements of such training programmes will result in statistically significantly better results in surgical outcome parameters. [source] Total serum bilirubin levels during cyclooxygenase inhibitor treatment for patent ductus arteriosus in preterm infantsACTA PAEDIATRICA, Issue 1 2009C Rheinlaender Abstract Aim: To determine whether ibuprofen use in VLBW infants is associated with increased serum bilirubin levels and impaired neurodevelopmental outcome at 2 years of age compared to indomethacin. Methods: We retrospectively evaluated bilirubin data and outcome parameters of 178 VLBW infants treated with COX inhibitors for a haemodynamically relevant patent ductus arteriosus (PDA) between 1998 and 2003 in a single institution. In our department ibuprofen replaced indomethacin for PDA treatment in 2001, while clinical and echocardiagraphic criteria for the indication of PDA invention have remained unchanged. Results: Ibuprofen and indomethacin therapy groups did not differ in their baseline clinical profile. Peak serum bilirubin concentration was 10.2 mg/dL in the ibuprofen group and 8.6 mg/dL in the indomethacin group (p < 0.01), while phototherapy duration did not differ. At 2 years of age neurodevelopmental outcome was similar in both groups. In a single case analysis, four cases of adverse neurodevelopmental outcome despite inconspicuous clinical course were identified in the ibuprofen group. Conclusion: In VLBW infants with PDA, ibuprofen treatment was associated with higher bilirubin levels than indomethacin. [source]
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