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Treatment Alternative (treatment + alternative)
Selected AbstractsThe Milled Bar-Retained Removable Bridge Implant-Supported Prosthesis: A Treatment Alternative for the Edentulous MaxillaJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 4 2002DGDP(UK), PAUL A. TIPTON BDS ABSTRACT Restoration of the edentulous jaw with dental implants can be achieved using either an implant-supported prosthesis, such as a fixed bridge, or an implant-retained prosthesis, such as a traditional overdenture. The implant-retained prostheses use edentulous ridges as primary stress-bearing regions, and through stress-breaking mechanisms, the implants are not loaded during function. However, the success rates of maxillary overdentures do not appear to be as good as for mandibular overdentures; this may be attributable to the adverse loading conditions, short implant length, poor quality of bone, number of implants used, flexible bar design, or poor treatment planning. Many articles have also described the numerous problems and multiple visits required in maintaining a traditional bar-retained overdenture restoration, often making it more expensive in the long term than a fixed restoration. The milled bar implant-supported prosthesis offers the benefits of both fixed and removable restorations. Its infrastructure provides the same rigidity as the fixed restoration, owing to the precise fit to the superstructure, which is removable, to promote adequate access for hygiene, yet it still provides lip support and maintains close contact with the soft tissues. These advantages enhance phonetics, esthetics, correct lip support, maintenance, and patient comfort. CLINICAL SIGNIFICANCE Restoring esthetics and function for the edentulous patient requires a multidiscipline approach for success. This article discusses the techniques for restoring function and esthetics for these patients, using a milled bar restoration supported and retained by dental implants. [source] Irritability is associated with anxiety and greater severity, but not bipolar spectrum features, in major depressive disorderACTA PSYCHIATRICA SCANDINAVICA, Issue 4 2009R. H. Perlis Objective:, Irritability is common during major depressive episodes, but its clinical significance and overlap with symptoms of anxiety or bipolar disorder remains unclear. We examined clinical correlates of irritability in a confirmatory cohort of Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study participants with major depressive disorder (MDD). Method:, Logistic regression was used to identify features associated with presence of irritability on the clinician-rated Inventory of Depressive Symptomatology. Results:, Of 2307 study participants, 1067(46%) reported irritability at least half the time during the preceding week; they were more likely to be female, to be younger, to experience greater depression severity and anxiety, and to report poorer quality of life, prior suicide attempts and suicidal ideation. Bipolar spectrum features were not more common among those with irritability. Conclusion:, Irritable depression is not a distinct subtype of MDD, but irritability is associated with greater overall severity, anxiety comorbidity and suicidality. [source] Substance Use Disorder Comorbidity in Major Depressive Disorder: A Confirmatory Analysis of the STAR*D CohortTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 4 2006Lori L. Davis MD The demographics and clinical features were compared between those with (29.4%) and without concurrent substance use disorder (SUD) in 2541 outpatients with major depression (MDD) enrolled in the Sequenced Treatment Alternatives to Relieve Depression study. Compared to those without SUD, MDD patients with concurrent SUD were more likely to be younger, male, divorced or never married, and at greater current suicide risk, and have an earlier age of onset of depression, greater depressive symptomatology, more previous suicide attempts, more frequent concurrent anxiety disorders, and greater functional impairment (p = 0.048 to < 0.0001). They were also less likely to be Hispanic and endorse general medical comorbidities (p = 0.006 and 0.002, respectively). [source] A Simple, Pain-Free Treatment for Ingrown Toenails Complicated with Granulation TissueDERMATOLOGIC SURGERY, Issue 11 2006F. GÜLRU ERDOGAN MD BACKGROUND The treatment of ingrown toenail complicated with granulation tissue is usually partial or total nail avulsion with or without matricectomy. It costs loss of occupational power, however, because most patients cannot go to work or school for some time after surgery, and it is a costly and uncomfortable procedure for most patients. OBJECTIVE This study aimed to find an easy, painless, and inexpensive alternative. MATERIALS AND METHODS Seven patients with ingrown toenails complicated with granulation tissue are included. A small apparatus was applied on the nails, granulation tissue was chemically cauterized, and a foot bath was recommended twice daily. They were followed on a weekly basis or every other week until recovery. None of the patients received systemic treatment. RESULTS All seven patients were completely cured without requiring surgery and/or systemic treatment. The procedure did not have any effect on their daily life. The follow-up examination of the patients at 6 months revealed that they were totally cured, and there were no recurrences. CONCLUSION Patients with ingrown toenails complicated by granulation tissue might have an inexpensive and pain-free treatment alternative, although new studies with more patients are required. [source] TIPS is a useful long-term derivative therapy for patients with Budd-Chiari syndrome uncontrolled by medical therapyHEPATOLOGY, Issue 1 2002Antonia Perelló Patients with Budd-Chiari syndrome (BCS) may require treatment with portal decompressive surgery or liver transplantation. Transjugular intrahepatic portosystemic shunt (TIPS) represents a new treatment alternative, but its long-term effect on BCS outcome has not been evaluated. Twenty-one patients with BCS consecutively admitted to our unit were evaluated. The mean follow-up was 4 ± 3 years. Seven patients had nonprogressive forms and were successfully controlled with medical therapy; 1 case, with a short-length hepatic vein stenosis was successfully treated by angioplasty. All 8 patients are alive and asymptomatic. The remaining 13 patients, had a TIPS because of clinical deterioration (in one of them, because early TIPS thrombosis a successful side-to-side portacaval shunt [SSPCS] was performed) followed by an improvement in clinical condition. However, a patient with fulminant liver failure before TIPS insertion, died 4 months later and another patient with cirrhosis at diagnosis had liver transplantation 2 years later. The remaining 11 patients are alive and free of ascites. In 3 of these patients TIPS is patent after 3, 6, and 12 months. The remaining 8 patients developed late TIPS dysfunction. In two of these cases, after angioplasty and restenting, TIPS is patent after a follow-up of 9 and 80 months. In 5 other patients, recurring TIPS occlusion was not further corrected because no signs of portal hypertension were present. In conclusion, in patients with BCS uncontrolled with medical therapy, TIPS is a highly effective technique that is associated with long-term survival. [source] Evaluation of spontaneous space closure and development of permanent dentition after extraction of hypomineralized permanent first molarsINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 5 2007BIRGITTA JÄLEVIK Aim., ,The aim of this study was to evaluate spontaneous space closure, development of the permanent dentition, and need for orthodontic treatment after extraction of permanent first molars due to severe molar,incisor hypomineralization (MIH). Subjects., ,Twenty-seven children aged 5.6,12.7 (median 8.2) years had one to four permanent first molars extracted due to severe MIH. Each case was followed up on individual indications 3.8,8.3 (median 5.7) years after extractions. The eruption of the permanent dentition, and space closure were documented by orthopantomograms, casts, photographs, and/or bitewings. Results. ,Fifteen children were judged to have a favourable spontaneous development of their permanent dentition without any orthodontic intervention. Seven children were or should be subjected to orthodontic treatment for other reasons registered prior to the extraction. Five children were judged to have a treatment at least caused by the extractions, but three of them abstained because of no subjective treatment need. Conclusion. Extraction of permanent first molars severely affected by MIH is a good treatment alternative. Favourable spontaneous space reduction and development of the permanent dentition positioning can be expected without any intervention in the majority of cases extracted prior to the eruption of the second molar. [source] Stones in anomalous kidneys: Results of treatment by shock wave lithotripsy in 150 patientsINTERNATIONAL JOURNAL OF UROLOGY, Issue 10 2004LUTFI TUNC Abstract Objective:, To determine the efficacy of shock wave lithotripsy (SWL) in anomalous kidneys. Methods:, From October 1990 to October 2002, 150 patients (93 men and 57 women) with anomalous urinary tracts, including 45 horseshoe kidneys, 57 duplex kidneys, 30 malrotated kidneys, 14 pelvic and four crossed ectopic kidneys were treated with SWL for urolithiasis at the Gazi University Faculty of Medicine. Shock wave lithotripsy was performed with Siemens Lithostar plus (Siemans, Erlanger, Germany) device and all procedures were carried under fluoroscopic control. Results:, The mean shock wave number and intensity received by the patients was 3770 (range, 1380,4100) shocks and 18.4 (range, 16.1,19) kV per session, respectively. The minimum success rate was obtained in patients with lower calyceal (50%) followed by middle calyceal (60%) calculi. The stone-free rate decreased and the number of sessions per patient increased with increasing stone diameter (dm). In patients with a stone dm > 30 mm, only 34% could be stone-free, compared to a rate of 92% for calculi dm < 10 mm. The overall stone free rate at the third month was 68%. The best stone-free rates were obtained in patients with ureteral duplication (80.7%). The stone-free rates in horseshoe, malrotated, pelvic and crossed ectopic kidneys were found to be 66.7%, 56.7%, 57.2% and 25%, respectively. Conclusion:, Shock wave lithotripsy might be an effective and minimally invasive treatment alternative in stone-bearing anomalous kidneys. The type of anomaly, stone burden and localization seem to be the main parameters effecting the treatment success. [source] Photocatalytic degradation of methyl tert -butyl ether (MTBE) in contaminated water by ZnO nanoparticlesJOURNAL OF CHEMICAL TECHNOLOGY & BIOTECHNOLOGY, Issue 11 2008Akbar Eslami Abstract BACKGROUND: Over the past several decades methyl tert -butyl ether (MTBE) as additive to gasoline, intended to either boost ratings of fuel or to reduce air pollution, has been accepted worldwide. Since MTBE has high water solubility, the occurrence of fuel spills or leaks from underground storage tanks or transferring pipeline has led to the contamination of natural waters. In this study the degradation of aqueous MTBE at relatively high concentrations was investigated by a UV-visible/ZnO/H2O2 photocatalytic process. The effects of important operational parameters such as pH, amount of H2O2, catalyst loading and irradiation time were also investigated. Concentration of MTBE and intermediates such as tert -butyl formate and tert -butyl alcohol were measured. RESULTS: Time required for complete degradation increased from 20 to 150 min when the initial concentration was increased from 10 to 500 mg L,1. The first-order rate constants for degradation of MTBE were estimated to be 0.183,0.022 min,1 as the concentration increased from 10 to 500 mg L,1. Study of the overall mineralization monitored by total organic carbon analysis showed that at an initial concentration of 100 mg L,1 MTBE complete mineralization was obtained after 100 min under UV-visible/ZnO/H2O2 photocatalysis. CONCLUSION: The data presented in this paper clearly indicated that UV-visible/ZnO/O2 as an advanced oxidation process provides an efficient treatment alternative for the remediation of MTBE-contaminated waters. Copyright © 2008 Society of Chemical Industry [source] Mandibular and maxillary furcation tunnel preparations , literature review and a case reportJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 1 2001Stefan G. Rüdiger Abstract Aim: The objective of this literature review and subsequent case report is to discuss and illustrate the tunnel preparation procedure as a treatment alternative for furcation-involved molars. Review of the literature: Furcation tunnel preparation, i.e., the creation of access for plaque control between periodontally diseased roots, has not been discussed in the literature as comprehensively as root resective therapy, though success rates appear to fall within the same range. A short root trunk and a wide furcation entrance diameter are prerequisites for the indication of the tunnel preparation procedure. Although accessory canals in the furcation area are frequent findings on extracted teeth, endodontic complications have not been reported to be major complications after tunnel preparation. Caries developed at tunneled teeth even under proper maintenance, but did not necessarily lead to the loss of an affected tooth. Case report: In the case presented to illustrate the indication for the tunnel preparation procedure, periodontal disease was almost entirely restricted to the furcation sites of molar teeth. Affected teeth were either extracted or left intact and subjected to tunneling procedures. Periodontal health could be established and maintained at both single and double tunnels over a period of 2 years of periodontal supportive therapy. [source] Percutaneous radiofrequency ablation of renal tumours: Case series of 11 tumours and review of published workJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 5 2007TW Watkins Summary Detection of renal cell carcinoma (RCC) is increasing with the greater use of cross-sectional imaging and up to two-thirds of RCCs are discovered incidentally in asymptomatic patients. The traditional option of nephrectomy or partial nephrectomy may not always be appropriate. A minimally invasive treatment alternative is radiofrequency ablation (RFA). We retrospectively reviewed the RFA cases for renal tumours at our institution between January 2004 and June 2006. Thirteen RFA treatment sessions were conducted for 11 neoplasms in 11 patients. Mean patient age was 74.4 years (61,88 years). Imaging was carried out after ablation with a mean follow up of 8.0 months (2,26 months). No residual tumour was observed after the first RFA treatment in 82% of patients (nine of 11). Two patients required a second RFA treatment for residual (one) or recurrent tumour (one). RFA is emerging as a useful technique for treatment of small renal tumour. A number of short-term studies reflect this, however, long-term findings are still lacking. [source] Improved efficacy and tolerability of retinoic acid in acne vulgaris: a new topical formulation with cyclodextrin complex ,JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2004RY Anadolu ABSTRACT Objectives, Retinoic acid (RA) has long been used, both topically and systemically, for disorders of keratinization, acne and related disorders. In the present study, the efficacy and tolerability of topical RA prepared as a cyclodextrin beta complex (,-CD) is investigated in 66 acne vulgaris patients. Methods, This randomized, double-blind, placebo-controlled study compares nightly topical application of RA/,-CD complex hydrogel formulation (0.025%), RA/,-CD complex in moisturizing base (0.025%), hydrogel base, moisturizer base or a commercial RA gel (0.05%) in acne vulgaris patients. Improvement of acne was assessed using a 5-point improvement scale and by measuring sebum and moisture content of the skin using an SM 810 sebumeter/corneometer. Results, After 3 months of treatment, mean scores of acne improvement on the 5-point scale were 4 with the RA/,-CD complex hydrogel formulation, 4.1 with the RA/,-CD complex in moisturizing base, 1.2 with hydrogel placebo base, 1.1 with moisturizer placebo base and 3 with the commercial RA product. All patients treated with the commercial product experienced local side-effects. One patient discontinued due to severe irritation. None of the patients treated with the RA/,-CD complex in the moisturizing base and hydrogel formulation experienced significant local irritation, although the sebum content of the skin decreased after application of the RA/,-CD preparations. This change was not significant compared to controls. The moisture content of the skin was better preserved in the group treated with the RA/,-CD complex in the moisturizing base. Conclusion, The topical RA/,-CD complex, in hydrogel and moisturizing base, was more effective than the twice concentrated commercial RA product. There were few topical side-effects with this new formulation, which increases patient compliance. Topical RA/,-CD (0.025% RA) did not significantly reduce sebum secretion but may help to preserve optimum epidermal moisture content with the proper base formulation. This is the first study in the literature reporting efficacy and tolerability of the topical RA/,-CD complex in acne vulgaris. We conclude that the topical RA/,-CD complex displays an improved efficacy and tolerability profile and is an effective treatment alternative for acne vulgaris. [source] Optimization of treatment parameters for Foscan®-PDT of basal cell carcinomasLASERS IN SURGERY AND MEDICINE, Issue 5 2008Christian S. Betz MD Abstract Background and Objective Basal cell carcinomas (BCCs) are the most common form of skin cancers with high and increasing incidence rates. Photodynamic therapy (PDT) with mTHPC (Foscan®) has shown to be a promising treatment alternative with good cosmetic results. The current study was aimed to determine optimal treatment parameters for this indication. Study Design/Materials and Methods mTHPC-PDT was performed in 117 patients with a total of 460 BCCs with diagnosis confirmed by scratch cytology. Treatment parameters were altered as follows: Foscan® dose 0.03,0.15 mg/kg, drug-light interval (DLI) 1,96 hours, total energy density 20,120 J/cm2. Outcomes were assessed 8 weeks post-PDT following WHO guidelines. Results The overall rate of complete remissions (CR) was 96.7% and the cosmetic outcome was very good. In the largest subgroup (n,=,80) where low-dose Foscan® was applied (0.05 mg/kg mTHPC; 48 hours DLI; 50 J/cm2 total energy density), a CR rate of 100% with a high and narrow 95% Confidence Interval of 0.955,1.000 was achieved. Smaller variations of the treatment parameters (i.e., reducing the photosensitizer dose to 0.04 mg/kg or shortening the DLI to 24 hours) yielded similarly good results. Side effects were encountered in 52 out of 133 PDT sessions. They were more common in patients who had received high drug doses (0.06,0.15 mg/kg) and comprised mostly pain and phototoxic reactions. Three patients developed severe sunburns with subsequent scarring at the injection site following bright sunlight exposure 15,19 days after photosensitizer administration. Conclusions The presented data suggest that mTHPC-PDT with the treatment parameters mentioned above seems to be an effective treatment option for BCCs. If sensibly applied, it is well tolerated and provides mostly excellent cosmetic results. Long-term results are yet to be evaluated. Lesers Surg. Med. 40:300,311, 2008. © 2008 Wiley-Liss, Inc. [source] Combination of Er:YAG laser and photodynamic therapy in the treatment of nodular basal cell carcinomaLASERS IN SURGERY AND MEDICINE, Issue 2 2008Roman, mucler PhD Abstract Backgrounds and Objectives Photodynamic therapy (PDT), via topical aminolevulinic acid (ALA) is an effective treatment for basal cell carcinomas not exceeding a depth of 2 mm. This limits the treatment of basal cell carcinoma (non-melanoma skin cancer) to superficial forms and nodular therapy (only in aesthetically desired locations). This paper addresses the effectiveness of reducing tumor mass via initial Er:YAG laser ablation to depths that are therapeutically responsive to PDT with ALA. Study Design/Materials and Methods This study compared three methods for the treatment of recurring nodular basal cell carcinomas (r nBCC). Method A utilized PDT with topical application of ALA methyl ester, method B with solitary Er:YAG laser ablation, and method C combined Er:YAG laser ablation reducing tumor size below 2 mm (method B) with subsequent ALA methyl ester PDT (method A). All three methods were used to treat to each patient, all subjects presenting with three or more basal cell carcinomas in order to eliminate differences in patient responsiveness to treatment. Patients were monitored and interviewed at 3, 6, and 12 month intervals to examine the progress of tumor elimination, aesthetic results as well as the patient's preference of treatment method. In all, 286 patients were treated, of whom 194 were checked at the prescribed intervals and then evaluated. Results Statistically, the combination therapy demonstrated the most effective treatment at all time intervals, with a final efficacy of 98.97% versus 94.85% (PDT only) and 91.75% (Er:YAG laser only). The combined method also provided the best aesthetic results (scale: 1,best; 4,worst) of 1.23±1.23, compared to 1.67±0.76 (PDT only) and 1.83±0.95 (Er:YAG laser only). Conclusions Although 67% patients preferred solitary Er:YAG laser treatment over the PDT method (20%) and the combined treatment (13%), because of the simplicity of the treatment, the combination therapy has proven to be both clinically and aesthetically superior. Solitary Er:YAG laser ablation will remain however a fast, effective, and economical treatment alternative for simple manifestations of superficial basal cell carcinoma and has replaced PDT for uncomplicated cases at our facility. The combination of Er:YAG laser ablation and ALA,PDT aspires to be therapy of choice for BCC. Lesers Surg. Med. 40:153,158, 2008. © 2008 Wiley-Liss, Inc. [source] Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases. (University of Pennsylvania Health System, School of Medicine, Pennsylvania, PA).PAIN PRACTICE, Issue 4 2001Arch Phys Med Rehabil. Failed back surgery syndrome (FBSS) is a long-lasting often disabling, and relatively frequent (5% to 10%) complication of lumdosacral spine surgery. Epidural fibrosis is among the most common causes of FBSS, and it is often recalcitrant to treatment. Repeated surgery for fibrosis has only a 30% to 35% success rate, whereas 15% to 20% of patients report worsening of their symptoms. Long-term outcome studies focusing on pharmacologic management of chronic back pain secondary to epidural fibrosis are lacking in the literature. This report presented 2 cases of severe epidural fibrosis managed successfully with gabapentin monotherapy. In both cases, functional status improved markedly and pain was significantly diminished. Gabapentin has an established, favorable safety profile and has been shown to be effective in various animal models and human studies of chronic neuropathic pain. Conclude clinicians should consider gabapentin as a pharmacological treatment alternative in the management of FBSS caused by epidural fibrosis. [source] Ability of preschool children to use dry powder inhalers as evaluated by In-Check MeterPEDIATRICS INTERNATIONAL, Issue 1 2006YOKO S ADACHI Abstract Background: Although current guidelines recommend the pressurized metered-dose inhaler with a spacer for preschool children with asthma, dry powder inhalers (DPI) may be a valuable treatment alternative. Methods: To evaluate the ability of preschool children to inhale through DPI, peak inspiratory flow rates (PIFR) of 57 healthy children aged 3,6 years were measured with In-Check Meter after practising with an instructor. Two different calibrated resistances were attached to the Meter to mimic the internal resistance of each inhaler; Diskus and Turbuhaler. Results: The ability of children to generate adequate inspiratory flow increased with age. The percentages of the 3-, 4-, 5-, and 6-year-old children who were able to inhale reliably through the devices were 30% (3/10), 79.0% (15/19), 100% (16/16), and 100% (12/12), respectively. In these children, 100%, 93.3%, 100%, and 100% achieved an adequate PIFR for the Diskus (30 L/min). In contrast, 66.7%, 66.7%, 62.5%, and 91.7% generated an adequate PIFR for the Turbuhaler (60 L/min). Conclusions: The In-Check Meter is a useful device to assess the ability of preschool children to generate adequate PIFR for each inhaler. Most children aged ,5 years could use DPI. [source] Safety, Efficacy, and Pharmacokinetic Overview of Low-Dose Daily Administration of TadalafilTHE JOURNAL OF SEXUAL MEDICINE, Issue 7 2009Rebecca Wrishko PhD ABSTRACT Introduction., Several phosphodiesterase type 5 (PDE5) inhibitors are commercially available for the treatment of erectile dysfunction (ED). Development of the first once-daily alternative dosing regimen with a PDE5 inhibitor was motivated by the behavioral complexities associated with sexual intimacy. Aim., To provide an alternative dosing option for certain men who may benefit from the removal of the temporal linkage between administration of an ED therapy and sexual intimacy or for men and their partners who anticipate at least twice-weekly sexual activity. Methods., Pharmacokinetic predictions of tadalafil plasma concentrations were generated based upon empirical data following 20-mg, single-dose administration coupled with tadalafil usage patterns from as-needed clinical trials. To support the pharmacokinetic simulations and pharmacodynamic assumptions, clinical trials were conducted to demonstrate the efficacy and safety of once-daily, low-dose tadalafil 2.5 and 5 mg. Main Outcome Measures., Simulated tadalafil plasma concentrations and comparison with safety and efficacy measures from clinical trials. Results., Based upon pharmacodynamic and pharmacokinetic data, once-daily doses of tadalafil 5 mg were predicted to provide therapeutic concentrations that would be maintained throughout the 24-hour dosing interval. Additionally, for a subgroup of men who anticipate at least twice-weekly sexual activity and are currently taking tadalafil 20 mg, a reduction in daily tadalafil exposure was predicted. To support the hypothesis that low-dose, once-daily tadalafil may be a safe and effective treatment alternative, clinical trials were conducted to demonstrate the safety and efficacy of once-daily tadalafil 2.5 and 5 mg. These results were similar to those of historical as-needed studies evaluating tadalafil 10 and 20 mg. Conclusions., Consistent with pharmacokinetic predictions, data from clinical trials indicate that once-daily use of low-dose tadalafil is a safe and effective treatment for men with ED. Wrishko R, Sorsaburu S, Wong D, Strawbridge A, and McGill J. Safety, efficacy, and pharmacokinetic overview of low-dose daily administration of tadalafil. J Sex Med 2009;6:2039,2048. [source] Middle ear aneurysm treated with an innovative, vessel-preserving, aneurysm-occluding stent,THE LARYNGOSCOPE, Issue 4 2010Elisa Fuller BSc Abstract Middle ear aneurysms are rare and difficult to treat. An innovative, parent vessel-preserving, aneurysm occlusion stent is a treatment alternative. It redirects blood flow away from the aneurysm, resulting in stasis within, and ultimate aneurysm thrombosis. Concurrent coiling is not needed with this stent, eliminating the risk of coils extruding or migrating, or acting as a nidus for infection in the middle ear. We review a successful treatment using this device. Laryngoscope, 2010 [source] Microdissection or Microspot CO2 Laser for Limited Vocal Fold Benign Lesions: A Prospective Randomized Trial,THE LARYNGOSCOPE, Issue S92 2000Michael S. Benninger MD CO2 lasers have become an important technological advance and an integral tool for the laryngeal surgeon since the 1960s. Surgeons have used lasers for a variety of benign and malignant lesions in the larynx with good success. With better understanding of the microarchitecture of the vocal folds and the recognition of heat distribution into surrounding tissues that occurs with the use of standard CO2 lasers, questions and concerns have been raised regarding the use of the CO2 laser for benign lesions of the vocal folds. With the advent of the microspot CO2 laser with a spot size of less than 250 ,m, the potential heat distribution to the deeper layers of the lamina propria has been reduced. The microspot CO2 laser has been suggested to be an appropriate tool for the excision of superficial benign lesions of the vocal fold and may be considered as an appropriate treatment alternative to microdissection. Only a limited number of studies have compared the efficacy of microdissection versus microspot CO2 laser surgery in the larynx, and no prospective, randomized trials have been performed. Objective This study was designed to compare microspot CO2 laser excision and microdissection for superficial benign lesions confined to the free margin of the vocal fold. Study Design: A randomized, prospective trial comparing microspot CO2 laser excision and microdissection in the removal of nodules, polyps, and mucous retention cysts of the vocal fold. Methods Acoustic and aerodynamic measures and videostroboscopic and perceptual audio recordings evaluated by a panel of blinded viewers and listeners were studied preoperatively and 2 to 3 weeks and 5 to 12 weeks postoperatively. Surgical and recovery times were compared between the two groups. Results Thirty-seven patients met selection criteria and were enrolled, 21 in the microdissection group and 16 in the laser excision group. Significant improvements in videostroboscopic parameters were found over time in both groups. Significant improvements were noted for perceptual analysis over time for the laser excision group with nonsignificant improvements over time for the microdissection group. There was no difference in any measure between laser excision and microdissection at the two postoperative visits. There was no difference in surgical or recovery time between laser excision and microdissection. Acoustic and aerodynamic parameters were noncontributory in evaluating outcomes of treatment, since most values were normal before surgery. Conclusion No differences in clinical outcomes are identified when comparing microdissection with laser excision of nodules, polyps, and mucous retention cysts of the vocal folds. [source] Inflammation assessment after selective laser trabeculoplasty (SLT) treatmentACTA OPHTHALMOLOGICA, Issue 2009M AYALA Purpose Glaucoma is a progressive neuropathy, reducing intraocular pressure (IOP) seems to be the only treatment to stop progression in glaucoma. There are several methods to reduce IOP: medical treatment, laser and surgery. Selective Laser Trabeculoplasty (SLT) is a new treatment alternative. SLT selectively targets the pigmented cells of the trabecular meshwork without causing thermal or collateral damage to the surroundings structures. The aim of the present study was to assess inflammation after SLT treatment. Methods 40 patients (80 eyes) were included in the study. Inclusion criteria: Glaucoma (POAG, pigmentary and pseudoexfoliative glaucoma)/ OHT patients that will be treated with SLT in just one eye, both with and without eye-drops. Exclusion criteria: patients suffering from ocular or systemic inflammatory diseases or treated with cortisone or immunosuppressive drugs. Inflammation was measured in 2 different ways: 1) clinically with a slit lamp and classified 0-4; 2) with a "Laser flare meter (Kowa FM 500)". Measurements were done before, 2 hours after, 1 week and 1 month after SLT treatement, both eyes were evaluated. IOP was also checked in the same way. SLT treatment was performed in 90° with the SLT Solo Ellex laser. Results inflammation before and after SLT showed no significant difference measured both clinically with slit lamp and objectively with the laser flare meter. No inflammation was found in the untreated eyes. No IOP peaks after SLT treatment were found. Conclusion SLT treatment seems not to induce inflammation in the anterior chamber when 90° were treated. SLT treatment might be considered as a first choice treatment against high intraocular pressure. [source] Oral implant restoration for enhanced oral functionCLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 1-2 2005Patrick J Henry SUMMARY 1.,The present paper reviews the clinical applications of implant-anchored restorations replacing teeth and defects of the craniofacial skeleton resultant from congenital, traumatic and surgical tissue loss. 2.,Different categories of tooth and tissue loss were treated in controlled multicentre prospective clinical trials. More recent developments have been the subject of limited pilot studies. 3.,Long-term results and meta-analysis reviews have shown that osseointegrated implant-supported restorations were at least equal to, and in some applications superior to, traditional treatment methods. 4.,Based on the outcome of a 30 year research and development programme and validation in numerous clinical trials, osseointegrated implant dental rehabilitation has become a viable treatment alternative for missing teeth and, for some applications, is considered to be a standard of care. [source] Systemic tetracycline delays degradation of three different collagen membranes in rat calvariaCLINICAL ORAL IMPLANTS RESEARCH, Issue 2 2009Ofer Moses Abstract Objectives: The aim of this study was to quantitatively evaluate the effect of systemic tetracycline (TTC) on the degradation of three different collagen membranes. Materials and methods: Collagen membranes were cut into 5 mm diameter membrane discs and labeled with aminohexanoyl-biotin- N -hydroxy-succinimide ester. One membrane disc each of a non-cross-linked [BioGide® (BG)], glutaraldehyde cross-linked [BioMend Extend® (BM)], and ribose cross-linked [OssixÔ (OS)] was implanted on the calvaria of 40 Wistar rats. Another 10 biotinylated collagen membrane discs from each membrane type were processed for histologic observation and served as baseline; half of them (five from each group) were also treated with formic acid to inspect possible interference with biotinilazation of collagen by formic acid used during the decalcification process. A 10 mg/kg dose of TTC (50% of the minimal recommended antibacterial dose) to the experimental (20 animals) and saline to the control (20 animals) group was administered intramuscularly every 3 days. From each group, block sections were retrieved in half of the animals after 14 days and in the remaining after 28 days. Decalcified tissue histology was stained with streptavidin horseradish peroxidase. A computer-assisted program measured the membranes' collagen contents. Statistical analysis consisted of analysis of variance (ANOVA) with repeated measures. Results: No statistically significant differences in collagen contents were appreciated between biotinylated non-implanted membranes treated or not treated by formic acid. Systemic TTC had a different effect on the bio-degradation of the membranes: while it significantly decreased the resorption of two of the membranes (BG and BM), it had minimal influence on the ribose cross-linked membrane (OS). ANOVA with repeated measures, tests of within-subjects effects, showed a statistically significant difference between the membranes (P<0.001), within the membranes at the different time-points (P<0.001), a significant interaction between membranes and time and between the membranes and administered TTC (P<0.001). Test of between-subject effects revealed a statistically significant interaction with time and with TTC (P<0.001). Conclusions: Systemically administered TTC in sub-antibacterial doses may offer a possible treatment alternative to reduce bio-degradation and enhance bio-durability of certain collagen membranes. The findings of the present study could have clinical application in large non-self-contained bone defects, where prolonged membrane barrier functions are desirable. [source] Immediate functional loading of implants in single tooth replacement: a prospective clinical multicenter studyCLINICAL ORAL IMPLANTS RESEARCH, Issue 8 2008Mauro Donati Abstract Objectives: The aim of the present study was to evaluate the outcome of immediate functional loading of implants in single-tooth replacement using two different installation procedures. Material and Methods: One hundred and fifty-one subjects, who required single-tooth rehabilitation in the area of 15,25 and 35,45, were enrolled in eight private clinics in Italy. The implant sites were randomly allocated to one of the following treatment groups. In the control group, in which a standard preparation procedure for implant placement and submerged healing of the implant was used, abutment connection and loading of the implants were performed 3 months after installation. In the test group 1, a standard preparation procedure for the implant placement and immediate functional loading of implant was carried out. In the test 2 group, however, a modified implant installation procedure (osteotome technique) was used followed by immediate functional loading of the implant. Clinical and radiographic examinations were performed at 3 and 12 months of follow-up at all sites. Results: Three implants (5.5%) from the test 2 group (osteotome preparation) and one (2%) from the test 1 group (conventional drill preparation) failed to integrate and were removed one and three months after implant installation. The mean marginal bone loss assessed at 12 months was 0.31 mm (test 1), 0.25 mm (test 2) and 0.38 mm (control) (no statistically significant differences were found between the three treatment groups.) Conclusion: It is suggested that immediate functional loading of implants that are placed with a conventional installation technique and with sufficient primary stability may be considered as a valid treatment alternative in a single-tooth replacement. [source] Implant-supported fixed prostheses in the edentulous maxillaCLINICAL ORAL IMPLANTS RESEARCH, Issue 3 2004A 2-year clinical, radiological follow-up of treatment with non-submerged ITI implants Abstract Objectives: To evaluate the survival rate of non-submerged solid-screw ITI dental implants with a rough (titanium plasma sprayed, TPS) surface in the edentulous maxilla after 1 and 2 years of loading. Material and method:, Twenty-five patients (mean age 64 years) with edentulous upper jaws received five,seven implants and, after a mean healing time of 6.9 months, screw-retained implant-supported fixed prostheses. A total of 146 ITI solid screw TPS implants were inserted. The diameter of 56% of the implants was smaller (3.3 mm) than the standard (4.1 mm) and the diameter of the rest (44%) was standard. The bone quantity of the majority of the patients was low and the bone quality poor. Clinical parameters were registered at baseline and at two annual follow-ups. Radiological examinations and assessments were also made at these times. Results: Mean marginal bone level at baseline was measured at a point 4.52 mm (range 1.45,7.70, SD 1.2) apical of the reference point. Mean bone loss from baseline to 1 year of loading was 0.24 mm (SD 0.9, P=0.002) and from 1 year to 2 years of loading 0.15 mm (SD 0.4, P<0.001). Five implants failed, four of which were early failures prior to loading. One implant failed shortly after bridge installation. The cumulative survival rate was 96.6% after 1 and 2 years. Conclusion: ITI TPS solid-screw implants in combination with fixed prostheses had successful survival rates and were found to be a viable treatment alternative in the edentulous maxilla. Résumé Le but de cette étude a été d'évaluer le taux de survie d'implants dentaires ITI vis solides non-enfouis avec une surface TPS (titane plasma-spray) au niveau du maxillaire édenté après une ou deux années de mise en charge. Vingt-cinq patients d'un âge moyen de 64 ans avec des mâchoires supérieures édentées ont reçu de cinq à sept implants et, après un temps de guérison moyen de 6,9 mois, des prothèses fixées vissées à ces implants (ISFP). Un total de 146 implants TPS ITI vis pleines ont été insérés. Le diamètre de 56% des implants étaient plus petits (3,3 mm) que le reste des implants qui avaient un diamètre standard (4,1 mm). La longueur des implants variait de 6 à 16 mm. La quantité osseuse de la majorité des patients était faible et la qualité osseuse pauvre. Des paramètres cliniques ont été enregistrés lors de l'examen initial et après deux années. Des examens radiographiques ont également été effectués à ces moments. Le niveau osseux marginal moyen lors de l'examen initial a été mesuréà un point 4,52 mm (de 1,45 à 7,70 mm : SD 1,2 mm) en apical du point de référence. La perte osseuse moyenne entre l'examen de départ et un an après la mise en charge était de 0,24 mm (SD 0,9; p=0,0002) et entre la première et la deuxième année de 0,15 mm (SD 0,4; p<0,001). Cinq implants ont échoué, dont quatre avant la mise en charge. Un implant a échoué peu de temps après le placement du bridge. Le taux de survie cumulatif après une ou deux années était de 96,6%. Les implants ITI TPS vis pleines avec des prothèses fixées avaient des taux de survie excellents et représentaient un traitement alternatif de qualité pour les patients édentés du maxillaire supérieur. Zusammenfassung Ziele: Die Ueberlebensrate von transmukosalen dentalen ITI-Vollschraubenimplantaten mit einer rauen Oberfläche (titanplasmabeschichtet, TPS) im zahnlosen Oberkiefer nach 1 und 2 Jahren Belastung auszuwerten. Material und Methoden: Fünfundzwanzig Patienten (mittleres Alter 64 Jahre) mit zahnlosen Oberkiefern erhielten 5,7 Implantate und nach einer mittleren Einheilzeit von 6.9 Monaten wurden verschraubte festsitzende implantatgetragene Rekonstruktionen (ISFPs) eingesetzt. Insgesamt wurden 146 ITI-Vollschraubenimplantate eingesetzt. Der Durchmesser von 56% dieser Implantate war kleiner (3.3 mm) als der Standard (4.1 mm) und der Durchmesser der restlichen 44% war Standard. Bei der Mehrzahl der Patienten war die Knochenmenge gering und die Knochenqualität schlecht. Die klinischen Parameter wurden bei der Ausgangsuntersuchung und bei den zwei Nachuntersuchungen in jährlichen Abständen aufgenommen. Bei diesen Untersuchungen wurden auch radiologische Auswertungen durchgeführt. Resultate: Das marginale Knochenniveau zum Zeitpunkt der Ausgangsuntersuchung wurde an einem Punkt 4.52 mm (Bandbreite 1.45,7.70, SD 1.2) apikal des Referenzpunktes gemessen. Der mittlere Knochenverlust von der Ausgangsuntersuchung bis 1 Jahr nach Belastung betrug 0.24 mm (SD 0.9, P=0.002) und zwischen 1 und 2 Jahren nach Belastung betrug er 0.15 mm (SD 0.4, P>0.001). Fünf Implantate zeigten Misserfolge, vier davon waren Frühmisserfolge vor Belastung. Ein Implantat versagte kurz nach der Eingliederung der Brücke. Die kummulative Ueberlebensrate nach 1 und 2 Jahren betrug 96.6%. Schlussfolgerung: ITI TPS Vollschraubenimplantate in Kombination mit festsitzenden Rekonstruktion zeigten erfolgreiche Ueberlebensraten und scheinen eine überlebensfähige Behandlungsalternative im zahnlosen Oberkiefer darzustellen. Resumen Objetivos: Evaluar el índice de supervivencia de implantes ITI roscados macizos no sumergidos con una superficie rugosa (pulverizada con plasma de titanio, TPS) en el maxilar edéntulo tras 1 o 2 años de carga. Material y Métodos: Veinticinco pacientes (edad media 64 años) con maxilares superiores edéntulos recibieron 5,7 implantes y, tras un periodo de cicatrización medio de 6.9 meses, una prótesis fija atornillada implantosoportada (ISFPs). Se insertaron un total de 146 implantes ITI roscados macizos. El diámetro del 56% de los implantes fue menor (3.3 mm) que el estándar (4.1 mm) y el diámetro del resto (44%) fue estándar. La cantidad de hueso de la mayoría de los pacientes fue baja y la calidad de hueso baja. Los parámetros clínicos se registraron al inicio y en los exámenes anuales de seguimiento. También se realizaron exámenes radiológicos y valoraciones en estos momentos. Resultados: El nivel medio de hueso marginal al inicio se midió en un punto 4.52 (rango 1.45,7.70, SD 1.2) apical al punto de referencia. La pérdida de hueso desde el inicio hasta 1 año de carga fue de 0.24 mm (SD 0.9, P=0.002) y de 1 año a 2 años de carga fue de 0.15 mm (SD 0.4, P<0.001). Cinco implantes fracasaron al poco de instalar los puentes. El índice acumulativo de supervivencia fue del 95%. Conclusión: Los implantes roscados macizos ITI TPS en combinación con prótesis fijas tuvieron unos índices de supervivencia exitosos y se encontró que eran una alternativa de tratamiento viable en el maxilar edéntulo. [source] Rapid-cycling bipolar disorder: effects of long-term treatmentsACTA PSYCHIATRICA SCANDINAVICA, Issue 1 2003L. Tondo Objective: To compare responses to long-term treatment of rapid-cycling (RC) vs. non-RC bipolar disorder patients and assess relative effectiveness of specific agents in RC patients. Method: Studies identified by literature searching were analyzed for effects of RC status and treatment-type on clinical outcome (recurrence or non-improvement per exposure-time), using random-effects methods to estimate pooled rates and their 95% CI for quantitative meta-analytic modeling. Results: Data were obtained from 16 reports with 25 trial-arms involving 1856 (905 RC and 951 non-RC) patients treated with carbamazepine, lamotrigine, lithium, topiramate, or valproate, alone or with other agents over an average of 47.5 months (7347 total patient-years). Estimated RC prevalence was 15.4%. Crude rates (%/month) of recurrence (2.31/1.20) and clinical non-improvement (1.93/0.49) averaged 2.9-fold greater in RC vs. non-RC subjects. The pooled RC/non-RC risk ratio (RR) for inferior treatment-response (in 13 direct comparisons) was 1.40 (CI 1.26,1.56; P < 0.0001). Pooled crude recurrence and non-improvement rates suggested no clear advantage for any treatment, nor superiority for anticonvulsants over lithium. However, only lithium vs. carbamazepine could be directly compared (in four treatment-arms) meta-analytically in RC patients (RR = 0.93, CI 0.74,1.18, indicating no difference in effectiveness). Conclusion: As expected, RC was associated with lower effectiveness of all treatments evaluated. Direct comparisons of specific treatment alternatives for RC patients were rare, and provided no secure evidence of superiority of any treatment. Additional long-term studies comparing RC/non-RC patients randomized to specific treatments are required. [source] Navigating toward Fetal and Maternal Health: The Challenge of Treating Epilepsy in PregnancyEPILEPSIA, Issue 10 2004Torbjörn Tomson Summary:, A rational approach to the treatment of women of childbearing potential with epilepsy has been hampered by the lack of conclusive data on the comparative teratogenic potential of different antiepileptic drugs (AEDs). Although, several cohort studies on birth defects associated with AED use during pregnancy have been published, these have generally failed to demonstrate differences in malformation rates between AEDs, probably mainly due to insufficient power. In particular, pregnancies with new generation AEDs have been too few. In recent years, pregnancy registries have been introduced to overcome this problem,EURAP (an international collaboration), the North American, and the U.K. AED and pregnancy registries are observational studies that prospectively assess pregnancy outcome after AED exposure using slightly different methods. Each has enlisted 3,5,000 pregnancies in women with epilepsy, and the North American and the U.K. have released preliminary observations. Thus the U.K. registry reported a higher malformation rate with valproate, 5.9% (4.3,8.2%; 95% CI), than with carbamazepine, 2.3% (1.4,3.7%), and lamotrigine, 2.1% (1.0,4.0%). Most of the more recent cohort studies have also identified a nonsignificant trend toward a higher teratogenicity with valproate. These signals need to be interpreted with some caution since none of the studies to date have fully assessed the impact of possible confounders, such as type of epilepsy, family history of birth defects, etc. However, with increasing number of pregnancies it should be possible in the near future for the pregnancy registries to take such confounding factors into account and thus make more reliable assessments of the causal relationship between exposure to specific AEDs and teratogenic risks. While awaiting more conclusive results, it appears reasonable to be cautious in prescribing valproate to women considering to become pregnant if other suitable treatment alternatives, and with less teratogenic potential, are available. Any attempt to change treatment should, however, be accomplished well before conception. The importance of maintained seizure control must also be kept in mind, and the woman who needs valproate to control her seizures should not be discouraged from pregnancy, provided that counseling at the best of available knowledge is given. [source] A cost evaluation of treatment alternatives for mild-to-moderate bleeding episodes in patients with haemophilia and inhibitors in BrazilHAEMOPHILIA, Issue 5 2007M. C OZELO Summary., The first-line treatment for mild-to-moderate bleeding episodes in patients with haemophilia and inhibitors in Brazil is currently activated prothrombin complex concentrate (aPCC), with recombinant activated factor VII (rFVIIa) used as second-line therapy or as a last resort. The aim of this study was to determine the cost and effectiveness of these treatments from the perspective of the Brazilian National Health Service. A decision analysis model was constructed to assess total direct medical costs (including drug costs, costs of outpatient or inpatient care, ambulance transportation and cost of concomitant medications) of first-line treatment with aPCC or rFVIIa. Clinical outcome and resource utilization data were obtained both retrospectively and prospectively and validated by the consensus of an expert panel of Brazilian haematologists. A total of 103 bleeds in 25 patients were included in the analysis. rFVIIa resolved bleeds more quickly (4.4 h) than aPCC (62.6 h) and was more effective (100% vs. 56.7% respectively). Mean total direct medical costs (from initiation to cessation of bleed) were estimated to be US$13 500 (aPCC) and US$7590 (rFVIIa). Extensive sensitivity analyses confirmed the cost-effectiveness of rFVIIa. Compared with aPCC, rFVIIa was more effective and less expensive when used as first-line treatment for mild-to-moderate bleeding episodes in patients with haemophilia and inhibitors in Brazil. rFVIIa should be considered a first-line treatment for the management of these patients. [source] End-of-Life Decision-Making, Decisional Conflict, and Enhanced Information: Race EffectsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2008Rebecca S. Allen PhD OBJECTIVES: To examine the effect of enhanced information regarding the risks, benefits, and life-sustaining treatment alternatives on hypothetical medical decisions and decisional conflict in older, community-dwelling Caucasian and African-American adults. DESIGN: Two-group (enhanced information; no information) between-subjects design. SETTING: Community-based dwellings, two assisted living facilities, and one senior citizen center. PARTICIPANTS: Seventy-eight adults (aged 74.5±7.18) with a mean Telephone Interview for Cognitive Status,Modified (TICS-m) score of 31.5±4.7 were recruited through personal contacts and informational talks held at the recruitment sites. MEASUREMENTS: Measures included the Life Support Preferences/Predictions Questionnaire,modified (LSPQ-m); the Decisional Conflict Scale; and enhanced information, including detailed descriptions of life-sustaining treatment options for each LSPQ-m illness scenario, risks of the treatment, benefits of the treatment, and alternatives for each treatment (called medical information stimuli). RESULTS: Enhanced information (e.g., medical information stimuli) reduced decisional conflict (P=.049, d=0.47) for hypothetical life-sustaining treatment decisions. A mixed analysis of variance with group and race as between-subjects variables and illness and treatment as within-subjects variables revealed significant main effects of race, illness, and treatment, as well as a significant race-by-illness-by-group interaction (Wilk's lambda=0.923, F(2, 73)=3.05, P=.05, partial ,2=0.08). Enhanced information produced different patterns of desire for life-sustaining treatments in African Americans and Caucasians. CONCLUSION: Physicians and other healthcare professionals can reduce decisional conflict in patients by providing enhanced information regarding treatment risks, benefits, and alternatives. Such decision aids may provide new information or knowledge and thus reduce desire for treatment in African Americans. [source] Managing Congenitally Missing Lateral Incisors.JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 4 2005Part III: Single-Tooth Implants ABSTRACT Three treatment options exist for the replacement of congenitally missing lateral incisors. They include canine substitution, a tooth-supported restoration, and a single-tooth implant. Selecting the appropriate treatment option depends on the malocclusion, anterior relationship, specific space requirements, and condition of the adjacent teeth. The ideal treatment is the most conservative option that satisfies individual esthetic and functional requirements. Today, the single-tooth implant has become one of the most common treatment alternatives for the replacement of missing teeth. This article closely examines the many interdisciplinary issues that arise when treatment planning the placement of single-tooth implants in patients with congenitally missing lateral incisors. The specific criteria that must be evaluated illustrate the importance of an interdisciplinary treatment approach to achieve optimal esthetics and long-term predictability. This is the final article of a three-part series discussing the three treatment alternatives for replacing congenitally missing lateral incisors. [source] Managing Congenitally Missing Lateral Incisors.JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 1 2005Part I: Canine Substitution ABSTRACT Dentists often encounter patients with missing or malformed teeth. The maxillary lateral incisor is the second most common congenitally absent tooth. There are three treatment options that exist for replacing missing lateral incisors. They include canine substitution, a tooth-supported restoration, or a single-tooth implant. Selecting the appropriate option depends on the mal-occlusion, specific space requirements, tooth-size relationship, and size and shape of the canine. The ideal treatment is the most conservative option that satisfies individual esthetic and functional requirements. Often the ideal option is canine substitution. Although the orthodontist positions the canine in the most esthetic and functional location, the restorative dentist often needs to place a porcelain veneer or crown to re-create normal lateral incisor shape and color. This article closely examines patient selection and illustrates the importance of interdisciplinary treatment planning to achieve optimal esthetics. It is the first in a three-part series discussing the three treatment alternatives for replacing missing lateral incisors. [source] At what degree of belief in a research hypothesis is a trial in humans justified?JOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 2 2002Benjamin Djulbegovic MD Abstract Rationale, aims and objectives,Randomized controlled trials (RCTs) have emerged as the most reliable method of assessing the effects of health care interventions in clinical medicine. However, RCTs should be undertaken only if there is substantial uncertainty about which of the trial treatments would benefit a patient most. The purpose of this study is to determine the degree of uncertainty in a research hypothesis before it can empirically be tested in an RCT. Methods,We integrated arguments from three independent lines of research , on ethics, principles of the design and conduct of clinical trials, and medical decision making , to develop a decision model to help solve the dilemma of under which circumstances innovative treatments should be tested in an RCT. Results,We showed that RCTs are the preferable option to resolve uncertainties about competing treatment alternatives whenever we desire reliable, undisputed, high-quality evidence with a low likelihood of false-positive or false-negative results. Conclusions When the expected benefit : risk ratio of a new treatment is small, an RCT is justified to resolve uncertainties over a wide range of prior belief (e.g. 10,90%) in the accuracy of the research hypothesis. Randomized controlled trials represent the best means for resolving uncertainties about health care interventions. [source] | ||||||||||||||||||||||||||||