Time to hemostasis: a comparison of manual versus mechanical compression of the femoral artery

1995 ◽  
Vol 4 (2) ◽  
pp. 149-156 ◽  
Author(s):  
MA Bogart
Keyword(s):  
Femoral Artery ◽  
Demographic Data ◽  
Mechanical Compression ◽  
Manual Compression ◽  
Special Equipment ◽  
Group 2 ◽  
A Prospective Study ◽  
The Cost ◽  
Mean Time ◽  
Pressure Dressing

BACKGROUND: Compression of the femoral artery to achieve hemostasis is necessary following angiographic and interventional cardiovascular procedures. OBJECTIVES: To evaluate length of time to hemostasis with manual versus mechanical compression of the femoral artery. METHODS: In a prospective study of 503 patients randomized into one of three groups, manual compression with a pressure dressing or vascular stasis button was used on groups 1 and 3, respectively. Mechanical compression with a pressure dressing was used on group 2. The length of time to hemostasis was measured in minutes. Demographic data, current medications, risk factors, laboratory values, and procedural data were analyzed. RESULTS: Mean time to hemostasis was 22 minutes with manual compression and 31 minutes with mechanical compression. Crossover from mechanical to manual compression to achieve hemostasis occurred in 21 of 168 patients (13%). CONCLUSIONS: Results of this study show that advantages of manual compression include shorter time to hemostasis, no requirement for special equipment, and the ability to remove arterial and venous sheaths simultaneously. Disadvantages include upper extremity fatigue and human resource considerations. If the operator is a nurse, the cost of compression increases and the ability to meet patient needs may be restricted. Although mechanical compression is a "hands free" approach, arterial hemostasis is prolonged, special equipment is required, and the total cost per procedure is higher.

Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization

1998 ◽  
Vol 7 (4) ◽  
pp. 308-313 ◽  
Author(s):  
A Simon ◽  
B Bumgarner ◽  
K Clark ◽  
S Israel
Keyword(s):  
Cardiac Catheterization ◽  
Femoral Artery ◽  
Vascular Complications ◽  
Control Group ◽  
Mechanical Compression ◽  
Success Rates ◽  
Manual Compression ◽  
Diagnostic Cardiac Catheterization ◽  
Compression Time ◽  
Catheterization Procedure

BACKGROUND: Most cardiac catheterizations are performed via femoral artery access. Reported rates of both peripheral vascular complications and success rates for the use of manual and mechanical compression techniques to achieve femoral artery hemostasis after cardiac catheterization vary. OBJECTIVE: To determine is use of a mechanical clamp is as effective as standard manual pressure for femoral artery hemostasis after cardiac catheterization. METHODS: Subjects consisted of 720 patients from 2 community hospitals who had elective diagnostic cardiac catheterization via the femoral artery. The control group (n=343) received manual compression for hemostasis; the study group (n=377) received mechanical compression. Standard protocols were used for the 2 compression techniques. Pressure was applied for a minimum of 10 minutes for 5F and 6F sheaths and catheters and for a minimum of 15 minutes for 7F and 8F sheaths and catheters. Prospective data were collected and analyzed for each patients, including sheath or catheter size, blood pressure, height, weight, age, time from administration of local anesthetic to successful cannulation of the femoral artery, anticoagulation status, total compression time, physician performing the catheterization procedure, nurse or technician who obtained hemostasis, and complications. In follow-up, patients were asked site-specific and functional status questions 1 to 2 days after the catheterization procedure and again 3 days after the catheterization procedure. RESULTS: Data were analyzed by using frequency distributions, measures of central tendency, and measures of variability. Only 1 difference between the 2 groups was significant: manual compression time was 14.93 +/- minutes, whereas mechanical compression time was 17.13 +/- minutes. CONCLUSION: Mechanical compression is as effective as manual compression for femoral artery hemostasis after cardiac catheterization.

scholarly journals Effect of Timing of Ondansetron Administration on Incidence of Postoperative Vomiting in Paediatric Strabismus Surgery

2000 ◽  
Vol 28 (1) ◽  
pp. 27-30 ◽  
Author(s):  
R. Madan ◽  
T. Perumal ◽  
K. Subramaniam ◽  
D. Shende ◽  
S. Sadashivam ◽  
...  
Keyword(s):  
Muscle Relaxation ◽  
Demographic Data ◽  
Median Number ◽  
Strabismus Surgery ◽  
First Episode ◽  
Antiemetic Efficacy ◽  
Number Of Patients ◽  
Group 2 ◽  
Mean Time ◽  
Group 1

This prospective, randomized, double-blinded study evaluated the effect of the timing of ondansetron administration on its antiemetic efficacy in children undergoing elective strabismus surgery. One hundred and twenty children aged one to 15 years, ASA physical status 1 or 2, were randomly allocated to receive intravenous ondansetron 100 μg/kg either at induction (Group 1) or at the end of the surgery (Group 2). All patients had general anaesthesia induced and maintained with nitrous oxide and halothane, muscle relaxation with vecuronium, endotracheal intubation, reversal with neostigmine and glycopyrrolate, and pethidine 0.5 mg/kg analgesia. Episodes of nausea and vomiting were evaluated at 0 to 2, 2 to 6 and 6 to 24 hour intervals by a blinded observer. Demographic data, duration of anaesthesia, type of surgery, incidence of previous postoperative nausea or vomiting and motion sickness and number of patients who developed oculocardiac reflex requiring atropine treatment were similar in both groups. The incidence of emesis in the first 24 hours following surgery was similar in both groups (35% Group 1, 33.3% Group 2, P=1.00). Severity of emesis (median number of emetic episodes, rescue antiemetic requirement and mean time to the onset of first episode of emesis) and mean time to discharge from the post anaesthesia care unit were also similar in the two groups. We conclude that the timing of ondansetron administration either before or after the surgical manipulation of extraocular muscles had similar antiemetic efficacy following strabismus surgery in children.

Mechanical compression versus haemostatic wound dressing after femoral artery sheath removal: A prospective, randomized study

VASA ◽  
2009 ◽  
Vol 38 (1) ◽  
pp. 53-59 ◽  
Author(s):  
Schwarz ◽  
Rastan ◽  
Pochert ◽  
Sixt ◽  
Schwarzwälder ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Calcium Ion ◽  
Wound Dressing ◽  
Patient Comfort ◽  
Bleeding Complications ◽  
Compression Bandage ◽  
Mechanical Compression ◽  
Manual Compression ◽  
Major Hemorrhage ◽  
Group 1

Background: Bleeding complications in the groin are one of the major disadvantages of femoral catheter procedures. The immobilisation of the patient and the compression bandages can jeopardize the patients’ comfort. Aim of the study was a randomized comparison of safety and patient comfort of mechanical pressure followed by pressure bandage overnight using two different haemostatic pads after femoral artery sheath removal. Patients and methods: Nine hundred and eight consecutive patients undergoing diagnostic or therapeutic procedures via a 5 or 6 F femoral sheath were randomly selected either for mechanical compression therapy followed by a compression bandage (302 patients, group 1), or manual compression with application of a calcium ion releasing device (compression bandage only after application of > 5000 IU of heparin; 303 patients; group 2), or manual compression with a thrombin covered PAD without compression bandage (303 patients, group 3). Results: No major hemorrhage or death occurred. A false aneurysm was found in 10 (3.3%), 13 (4.3%), and 10 patients (3.3%) of group 1, 2, and 3, respectively (p = 0.38). Three patients (0.3%) needed surgical treatment. 69 (22.7%) patients in thrombin covered PAD-group required a compression bandage overnight due to seeping hemorrhage after 15 minutes. In the calcium ion releasing PAD-group 124 (40.9%) patients had continued bandaging, 46 (15.2%) due to seeping hemorrhage after 15 min, and 78 (25.7%) due to application of heparin > 5000 IU. Conclusions: The use of mechanical compression combined with a pressure bandage, and the use of haemostatic wound dressing assisted sheath removal technique offer a comparable level of safety. Patient comfort is improved with the usage of PAD devices, however the technical failure rate of the PAD should be taken into account.

Clinical and Radiological Changes after use of Alpha-1 Blocker Therapy in Patients of Posterior Urethral Valve with Bladder Neck Hypertrophy

JMS SKIMS ◽  
2009 ◽  
Vol 12 (1) ◽  
pp. 3-7
Author(s):  
Aejaz A Baba ◽  
Bajpai Minu
Keyword(s):  
Bladder Neck ◽  
Posterior Urethral Valve ◽  
Posterior Urethral Valves ◽  
Blocker Therapy ◽  
Urethral Valve ◽  
Novel Method ◽  
Radiological Changes ◽  
Group 2 ◽  
Mean Time ◽  
Group 1

Background: We evaluated the effects of alpha-1 blocker therapy on clinical and radiological abnormalities in patients of posterior urethral valve with bladder neck hypertrophy. Materials and Methods: A total of 74 patients with posterior urethral valves were seen at our department between 2003 and 2007. Out of these 24 had radiological evidence of bladder neck hypertrophy. Those patients with bladder neck hypertrophy who were seen before June 2006 and did not receive alpha-1 blocker (prazocin) therapy after valve ablation were assigned to group 1 (n=10). Group 2 consisted of 14 age matched patients with bladder neck hypertrophy and comparable prognostic factors who received alpha-1 blocker therapy after valve ablation (n=14). Micturating cystourethrography (MCU) was done periodically and a novel method used to calculate bladder neck hypertrophy. Trends in symptoms and radiological changes were evaluated throughout follow-up. Results: Mean patient age at presentation was 3.02±2.68 years in group 1 and 3.12±3.4 years in group 2. Bladder neck hypertrophy decreased from 2.3±1.0 to 2.0±0.5 in a mean time of 52.0 (34-52) weeks in group 1 where as it decreased from 2.2±0.5 to 1.6±0.3 in a mean time of 32.0 (22-52) weeks. Symptomatically patients in group 2 who received alpha-1 blocker therapy after valve ablation were better and had quick resolution of bladder neck hypertrophy. Conclusions: Use of alpha-1 blocker therapy in patients of posterior urethral valve with bladder neck hypertrophy helps in quick resolution of bladder neck hypertrophy. J Med Sci 2009;12(1):3-7.

RISKS OF ANEMIA DEVELOPMENT IN DONORS ACCORDING TO INHERITED PREDISPOSITION AND REGULARITY OF BLOOD DONATION

2020 ◽  
pp. 72-83
Author(s):  
I.M. Vorotnikov ◽  
V.A. Razin ◽  
I.M. Lamzin ◽  
M.N. Sokolova ◽  
M.E. Khapman ◽  
...  
Keyword(s):  
Blood Donors ◽  
Blood Donation ◽  
Hla Antigens ◽  
Hla Typing ◽  
Main Role ◽  
Inherited Predisposition ◽  
Group 2 ◽  
Student’S T ◽  
A Prospective Study ◽  
Group 1

Anemia is one of the most common complications of blood donation. Thus, the objective of the paper was to assess the risks of anemia development in donors according to the regularity of donation and inherited predisposition. Materials and Methods. The authors carried out a prospective study, which included 241 blood donors, using random sampling and case-control techniques. Depending on blood donation frequency, the donors were divided into 2 groups: Group 1 consisted of 122 people (51.5 %) frequently donating blood; Group 2 included 119 people (48. 5 %) rarely donating blood. We studied the initial indicators of a general blood test and the same indicators a year after the first blood donation. Additionally, we performed HLA typing of donors. Statistica v. 8.0 software package (Stat Soft Inc., USA) was used for statistical analysis. To compare two independent samples, we used a nonparametric Mann-Whitney U-test and a parametric Student’s t-test (depending on the type of distribution). To assess anemia risks, the odds ratio was calculated. Results. One year after the first blood donation, anemia was diagnosed in 13 people (10.6 %) in Group 1 and in 7 people (5.9 %) in Group 2 (p=0.179). A11 and B7 HLA antigens did not increase anemia risks in group 1 (OS=1.257 (95 % CI 0.318–4.973) and OS=0.240 (95 % CI 0.051–1.134, respectively). HLA-antigens A11 and B7 did not increase anemia risks in Group 1 (OR=1.257 (95 % CI 0.318-4.973) and OR=0.240 (95 % CI 0.051–1.134), respectively). In group 2, antigen-A11 was also an insignificant factor (OS=2.902 (95 % CI 0.606-13.889)) for anemia development. Whereas, antigen-B7 increased anemia risks by 14 times (OS=14.364 (95 % CI 1.644-124.011)). Conclusion. In rare blood donors, it is the genetic factor that plays the main role in anemia development. High prevalence rates of anemia in frequent blood donors are probably determined by other factors. Keywords: anemia, blood donors, HLA typing. Механизмы развития анемий и факторы, их индуцирующие, остаются до конца не изученными. Целью исследования стало изучение риска развития анемии у доноров крови в зависимости от частоты донации и наличия наследственной предрасположенности к развитию анемии. Материалы и методы. Проведено проспективное исследование, выполненное методами случайной выборки и «случай-контроль», в которое вошел 241 донор крови. В зависимости от частоты сдачи доноры были поделены на 2 группы: группу 1 составили 122 чел. (51,5 %), часто сдающие кровь; группу 2 – 119 чел. (48,5 %), редко сдающих кровь. Изучались исходные показатели общего анализа крови и через год от начала донации. Дополнительно проводилось HLA-типирование доноров. Статистический анализ осуществлялся с применением программы Statistica v. 8.0 (Stat Soft Inc., США). Для сравнения двух независимых выборок использовался непараметрический U-критерий Манна–Уитни и параметрический t-критерий Стьюдента (в зависимости от типа распределения). Для оценки риска возникновения анемии рассчитывалось отношение шансов. Результаты. Через год с момента первой сдачи крови в группе 1 выявлено 13 чел. (10,6 %) с анемией, в группе 2 – 7 чел. (5,9 %) (р=0,179). Наличие HLA-антигенов А11 и B7 не повышало риск развития анемии в группе 1 (ОШ=1,257 (95 % ДИ 0,318–4,973) и ОШ=0,240 (95 % ДИ 0,051–1,134 соответственно). В группе 2 наличие гена А11 также являлось незначимым фактором (ОШ=2,902 (95 % ДИ 0,606–13,889), присутствие гена В7 в 14 раз повышало риск развития анемии (ОШ=14,364 (95 % ДИ 1,664–124,011). Выводы. Высокий риск развития анемии у редко сдающих кровь доноров обусловливается генетическими факторами. Высокая распространённость анемии у часто сдающих кровь доноров, вероятно, определяется другими факторами. Ключевые слова: анемия, доноры крови, HLA-типирование.

447 Cost-Effectiveness of a 3-Year Tele-OSA Intervention

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A177-A177
Author(s):  
Jaejin An ◽  
Dennis Hwang ◽  
Jiaxiao Shi ◽  
Amy Sawyer ◽  
Aiyu Chen ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Incremental Cost ◽  
Economic Benefits ◽  
Small Sample ◽  
Apnea Hypopnea Index ◽  
Obstructive Sleep ◽  
Group 2 ◽  
The Cost

Abstract Introduction Trial-based tele-obstructive sleep apnea (OSA) cost-effectiveness analyses have often been inconclusive due to small sample sizes and short follow-up. In this study, we report the cost-effectiveness of Tele-OSA using a larger sample from a 3-month trial that was augmented with 2.75 additional years of epidemiologic follow-up. Methods The Tele-OSA study was a 3-month randomized trial conducted in Kaiser Permanente Southern California that demonstrated improved adherence in patients receiving automated feedback messaging regarding their positive airway pressure (PAP) use when compared to usual care. At the end of the 3 months, participants in the intervention group pseudo-randomly either stopped or continued receiving messaging. This analysis included those participants who had moderate-severe OSA (Apnea Hypopnea Index >=15) and compared the cost-effectiveness of 3 groups: 1) no messaging, 2) messaging for 3 months only, and 3) messaging for 3 years. Costs were derived by multiplying medical service use from electronic medical records times costs from Federal fee schedules. Effects were average nightly hours of PAP use. We report the incremental cost per incremental hour of PAP use as well as the fraction acceptable. Results We included 256 patients with moderate-severe OSA (Group 1, n=132; Group 2, n=79; Group 3, n=45). Group 2, which received the intervention for 3 months only, had the highest costs and fewest hours of use and was dominated by the other two groups. Average 1-year costs for groups 1 and 3 were $6035 (SE, $477) and $6154 (SE, $575), respectively; average nightly hours of PAP use were 3.07 (SE, 0.23) and 4.09 (SE, 0.42). Compared to no messaging, messaging for 3 years had an incremental cost ($119, p=0.86) per incremental hour of use (1.02, p=0.03) of $117. For a willingness-to-pay (WTP) of $500 per year ($1.37/night), 3-year messaging has a 70% chance of being acceptable. Conclusion Long-term Tele-OSA messaging was more effective than no messaging for PAP use outcomes but also highly likely cost-effective with an acceptable willingness-to-pay threshold. Epidemiologic evidence suggests that this greater use will yield both clinical and additional economic benefits. Support (if any) Tele-OSA study was supported by the AASM Foundation SRA Grant #: 104-SR-13

scholarly journals 109 Game Changing Magnetic Experience in Rural and Urban Wirral Peninsula - Our Experience with Magseed Localisation of Impalpable Breast Tumours and Axillary Nodes

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
T Arif ◽  
R Vinayagam ◽  
J M Lund ◽  
S Poonawala
Keyword(s):  
Incidental Finding ◽  
Breast Tumour ◽  
Axillary Node ◽  
Reliable Technique ◽  
Breast Tumours ◽  
Rural And Urban ◽  
Mean Size ◽  
The Right ◽  
A Prospective Study ◽  
Mean Time

Abstract Introduction Magseed is a novel localization technology in which a tiny seed is inserted to accurately mark the site of breast tumour. These can be detected intra-operatively by sentimag localization system. It aids localization of impalpable breast lesions improving margin clearance rates. Method A prospective study of first fifty Magseed localised breast tumour and axillary node excisions in Clatterbridge General Hospital. Results A total of 50 patients had 52 Magseed inserted. n = 14 was symptomatic, n = 35 was screen detected and n = 1 was an incidental finding on surveillance mammogram for a B3 lesion. 30 seeds were inserted on the right and 22 were inserted on the left (two were bilateral). 44 seeds were inserted under ultrasound guidance and the rest were targeted under stereo guidance (n = 8). Deployment of two resulted in malposition requiring wire localization. Mean age of subjects was 59.76 (range 31-81) years. Mean time to surgery after magseed insertion was 8.04 (range 1-27) days. Mean weight of the specimen was 48.57(range 10-264) gm. Mean size of the lesions was 20.32 (range 8-65) mm. Redo surgery for margin clearance was performed bringing the re-excision rate to 15.38% (n = 8). Conclusions We conclude that Magseed localization of breast tumours is a safe and reliable technique

scholarly journals SAT0140 SAFETY OF TOFACITINIB THERAPY IN HBSAG CARRIERS WITH RHEUMATOID ARTHRITIS: A PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1008.2-1008
Author(s):  
L. Fang ◽  
Z. Lin ◽  
Z. Liao ◽  
O. Jin ◽  
Y. Pan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Viral Load ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Infection ◽  
Hbsag Carriers ◽  
B Virus ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

Background:Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent rheumatoid arthritis (RA) and HBV infection were available by now.Objectives:To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with RA.Methods:In this 52 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARDs were enrolled. Patients must have normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily) and concomitant MTX (10-12.5mg/w). Entecavir was prescribed preventively for patients who had a baseline HBV load >2000 copy/ml (group 1), and Lamivudin for patients with HBV load ≤ 2000 copy/ml (group 2). Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion.Results:Thirteen patients (10 female) were recruited. Nine patients had a baseline viral load >2000 copy/ml (group 1, with preventive Entecavir), and the other 4 patients had a viral load ≤ 2000 copy/ml (group 2, with preventive Lamivudin). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib.No reactivation of hepatitis B was observed in patients from group 1. One patients (female, 54 years old) from group 2 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16. An elevated viral load (4.9e6 copies/ml, baseline 1.4e3) and a HBV YMDD mutant was also found. The tofacitinib treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal throughout the study.Conclusion:An aggressive Tofacitinib + MTX therapy may be a safe option for HBsAg carriers with cs-DMARDs refractory RA. More active and effective prophylaxis strategy may be recommended to reduce the risk of HBV reactivation during the treatment.References:[1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2.Disclosure of Interests: :None declared

scholarly journals STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bastiaan C. ter Meulen ◽  
Johanna M. van Dongen ◽  
Marinus van der Vegt ◽  
Henry C. Weinstein ◽  
Raymond W. J. G. Ostelo
Keyword(s):  
Statistical Analysis ◽  
Cost Effectiveness ◽  
Intervention Group ◽  
Statistical Analysis Plan ◽  
Pain Medication ◽  
Oral Pain ◽  
Oral Pain Medication ◽  
Group 2 ◽  
The Cost ◽  
Star Trial

Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)

Ultra-resistant schizophrenia and potentiation strategies

2017 ◽  
Vol 41 (S1) ◽  
pp. s834-s834 ◽  
Author(s):  
S. Khouadja ◽  
R. Ben Soussia ◽  
S. Younes ◽  
A. Bouallagui ◽  
I. Marrag ◽  
...  
Keyword(s):  
Treatment Resistance ◽  
Cost Benefit ◽  
Clinical Excellence ◽  
University Hospital ◽  
Dsm Iv ◽  
Competing Interest ◽  
A Prospective Study ◽  
Psychiatric Department ◽  
The Cost ◽  
The University

IntroductionTreatment resistance to clozapine is estimated at 40–70% of the treated population. Several clozapine potentiation strategies have come into clinical practice although often without evidence-based support.ObjectiveThe aim of our work was to identify the potentiation strategies in ultra-resistant schizophrenia depending on the subtype of schizophrenia.MethodologyThis is a prospective study conducted on patients with the diagnosis of schizophrenia, based on DSM-IV-TR criteria, and hospitalized in the psychiatric department of the university hospital in Mahdia, Tunisia. The study sample consisted of patients meeting the resistant schizophrenia criteria as defined by national institute for clinical excellence (NICE), and the prescription of clozapine for 6 to 8 weeks was shown without significant improvement.Resultswe have collected 10 patients. The mean serum level of clozapine was 462.25 mg/L. The potentiation strategies were different depending on the subtype of schizophrenia. For the undifferentiated schizophrenia, we have chosen ECT sessions. For the disorganized schizophrenia, we opted for amisulpiride and aripiprazole. For the paranoid forms, we have chosen the association of risperidone and ECT. A psychometric improvement was noted in BPRS ranging from 34 to 40%.ConclusionEvery potentiation strategy entails a cost, whether it is an additional monetary cost, adverse effects or greater stress to caregivers. The cost/benefit equation should be thoroughly evaluated and discussed before commencing a strategy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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