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Subjective Outcomes (subjective + outcome)

Distribution by Scientific Domains

Medical Sciences	100%

Selected Abstracts

Early Clinical Results: SOUNDTEC Implantable Hearing Device Phase II Study,

THE LARYNGOSCOPE, Issue 1 2001
J. V. D. Hough MD
Abstract Objective To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTECÔ Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented. Study Design The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial. Methods For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured. Results When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250,6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception. Conclusion Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures. [source]

Study of Botulinum Toxin A in Neurogenic Bladder Due to Spina Bifida in Children

ANZ JOURNAL OF SURGERY, Issue 4 2010
Aniruddh V. Deshpande
Abstract Background:, We report results of a pilot study investigating the safety and efficacy of Botulinum A toxin on urinary incontinence and bladder function in children with neurogenic bladder. Methods:, This was a prospective, non-randomized clinical trial. Seven children with median age of 16 years with spina bifida who had high storage pressures, poor bladder compliance and had failed treatment with anticholinergic medications were offered a single intra-detrusor injection of Botulinum A toxin. All subjects were on clean intermittent catheterization before and during the study. Follow-up videourodynamic studies were performed at 1 month, between 3 and 6 months, and at 9 months. Data were collected on safety and on subjective outcomes through validated questionnaires filled out by patients at each visit. Results:, In majority of the patients (5/7), the injection produced an increase in bladder compliance (P < 0.05) and an improvement in incontinence (P < 0.05) at 1-month follow-up. However, in two patients whose baseline bladder capacity was markedly reduced (<200 mL), the improvement was very minimal. The beneficial effects in bladder compliance and incontinence dissipated by 9 months. The changes in subjective outcomes (incontinence and satisfaction scores) did not parallel the changes in urodynamics through the study period. No side effects of Botulinum toxin were seen. Conclusion:, Botulinum A toxin injection produces beneficial urodynamics and clinical effects. These beneficial effects last for approximately 9 months. There is a poor correlation between improvement in the urodynamics and the subjective outcomes. Botulinum A toxin injection is a safe alternative treatment for patients with spina bifida and a neurogenic bladder. [source]

Suburethral slingplasty evaluation study in North Queensland, Australia: The SUSPEND trial

AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2005
Yik Nyok LIM
Abstract Objective:, To compare the safety and efficacy of three types of suburethral slings for the treatment of urodynamic stress incontinence. Methods:, Following ethics approval, 195 (3 × 65) patients with urodynamic stress incontinence were randomly assigned to undergo suburethral slingplasty with the Tension-free Vaginal Tape (TVT; Gynecare, Ethicon, Somerville, NJ, USA), Intravaginal Sling (IVS; Tyco Healthcare, Mansfield, MA, USA), or Suprapubic Arc Sling (SPARC; American Medical Systems, Minnetonka, MN, USA). The patients were blinded to the type of sling implanted. Main outcome measures were:, (1) operative and short-term complications; (2) pre- and postoperative symptomatology; and (3) pre- and postoperative urodynamic findings. Results:, There was a statistically significant increased rate of sling protrusion (13.1% vs. 3.3% and 1.7%; P = 0.04) in the SPARC group when compared to TVT and IVS. Otherwise, there were no significant differences between the groups with respect to the incidences of other operative complications, patients' main subjective outcomes, satisfaction rates, or postoperative urodynamic findings. The overall objective stress incontinence cure rates were 87.9%, 81.5% and 72.4% for the TVT, IVS, SPARC groups respectively (P = 0.11). Conclusions:, All three slings appear quite successful for the treatment of stress incontinence. The SPARC tapes showed more sling protrusion complications and a trend towards lower objective cure rates; probably as a result of the insertion method used in this study which favoured a loose SPARC sling placement. The authors recommend that the SPARC slings be left tighter than TVT, or for the cough test to be carried out. [source]

Long-term outcome and risk of oesophageal cancer after surgery for achalasia

BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 12 2008
G. Zaninotto
Background: Few studies have reported very long-term results after surgery for oesophageal achalasia. The aim of the present study was to assess long-term subjective outcomes after cardiomyotomy and partial fundoplication, focusing specifically on the risk of oesophageal cancer. Methods: Clinical and demographic information from 228 consecutive patients who had surgery between 1980 and 1992 was extracted from hospital files. Survival status and dates of death were obtained from census offices. Causes of death were obtained from public registries and compared with those of the general population. Symptoms were assessed by means of a questionnaire and endoscopy results were scrutinized. Results: Among 226 patients who could be traced, 182 of 184 survivors were contacted and the cause of death established for 41 of 42 patients. At a median follow-up of 18·3 years, almost 90 per cent of patients were satisfied with the treatment. Four had developed squamous cell oesophageal carcinoma 2, 8, 13 and 18 years after surgery, one of whom was still alive. The standardized mortality ratio for oesophageal carcinoma was significantly higher than expected in men. Conclusion: Cardiomyotomy and partial fundoplication is an excellent long-term treatment for achalasia. Men with achalasia have an increased risk of developing oesophageal cancer. Copyright © 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source]