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Outcome Assessment (outcome + assessment)
Selected AbstractsORIGINAL RESEARCH,OUTCOMES ASSESSMENT: Validation of the Female Sexual Distress Scale-Revised for Assessing Distress in Women with Hypoactive Sexual Desire DisorderTHE JOURNAL OF SEXUAL MEDICINE, Issue 2 2008Leonard DeRogatis PhD ABSTRACT Introduction., The concept of sexually related personal distress is currently central to the diagnosis of all female sexual dysfunctions (FSD). In the current study, we have focused on validating a slightly revised version of the Female Sexual Distress Scale (FSDS), the FSDS-Revised (FSDS-R), to enhance the sensitivity of the instrument with patients suffering from hypoactive sexual desire disorder (HSDD). In addition, we have attempted to extend the validation generalizability of the scale by demonstrating that both instruments possess reliability and discriminative validity in premenopausal women with HSDD. Aim., To assess the validity of the revised version of the FSDS, the FSDS-R, for measuring sexual distress in women with HSDD. Methods., A prospective methodological study carried out at 27 centers in North America enrolled 296 women aged 18,50 years with HSDD, another female sexual dysfunction (FSD), or no FSD. The subjects completed the FSDS-R at baseline, day 7, and day 28, with a 30-day recall at baseline and with a 7-day recall on days 7 and 28. Main Outcome Measures., Receiver operating characteristic (ROC) analyses of FSDS, FSDS-R, and FSDS-R item 13 were used for the differentiation of HSDD from no FSD, while intraclass correlation coefficient (ICC) was used to estimate test,retest reliability. Cronbach's coefficient alpha was used to measure the internal consistency of the FSDS-R and Pearson's correlation coefficient to assess FSDS, FSDS-R, and FSDS-R item 13 with different recall periods (7 and 30 days). Results., Mean total FSDS, FSDS-R, and FSDS-R item 13 scores with either recall period were significantly higher (P < 0.0001) in women with FSD or HSDD than in women with no FSD, showing both tests had discriminant validity. ROC analysis confirmed these findings, while an ICC of >0.74 showed the test,retest reliability of both scales, including FSDS-R item 13 alone, and Cronbach's coefficient alpha of >0.86 confirmed the internal consistency of both tests. Conclusions., Consistent with the FSDS, the FSDS-R demonstrated good discriminant validity, high test,retest reliability, and a high degree of internal consistency in measuring sexually related personal distress in women with HSDD. FSDS-R item 13 alone also demonstrated good discriminant validity and test,retest reliability. DeRogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, and Fu Y. Validation of the female sexual distress scale revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med 2008;5:357,364. [source] Web-based Health Survey Systems in Outcome Assessment and Management of PainPAIN MEDICINE, Issue 2007Vinod K. Podichetty MD ABSTRACT Pain is a complex phenomenon lacking a well-defined paradigm for diagnosis and management across medical disciplines. This is due in part to inconsistencies in the assessment of pain as well as in the measurement of related social and psychological states. Efforts to evaluate and measure pain through objective tests have been hindered by challenges such as methodological differences in data acquisition, and the lack of common, universally accepted information systems. Physicians and hospital administrators have expressed mixed reactions to the costs that inevitably accompany advances in medical technology. Nonetheless, computer systems are currently being developed for use in the quantitative assessment and management of pain, which can advance our understanding of the public health impact of pain, improve the care individual patients receive, and educate providers. The description of an interdisciplinary, integrated, health survey system illustrates the approach and highlights the advantages of using information technology in pain evaluation and management. [source] ORIGINAL RESEARCH,SURGERY: Surgical Treatment of Vulvar Vestibulitis Syndrome: Outcome Assessment Derived from a Postoperative QuestionnaireTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2006Andrew T. Goldstein MD ABSTRACT Introduction., Vulvar vestibulitis syndrome (VVS) is the most common pathology in women with sexual pain. Surgery for VVS was first described in 1981. Despite apparently high surgical success rates, most review articles suggest that surgery should be used only "as a last resort." Risks of complications such as bleeding, scarring, and recurrence of symptoms are often used to justify these cautionary statements. However, there are little data in the peer-reviewed literature to justify this cautionary statement. Aims., To determine patient satisfaction with vulvar vestibulectomy for VVS and the rate of complications with this procedure. Methods., Women who underwent a complete vulvar vestibulectomy with vaginal advancement by one of three different surgeons were contacted via telephone by an independent researcher between 12 and 72 months after surgery. Main Outcome Measures., The primary outcome measurement of surgical success was overall patient satisfaction with surgery. Additional secondary outcome measurements included improvement in dyspareunia, changes in coital frequency, and occurrence of surgical complications. Results., In total, 134 women underwent surgery in a 5-year period. An independent research assistant was able to contact 106 women, and 104 agreed to participate in the study. Mean duration since surgery was 26 months. A total of 97 women (93%) were satisfied, or very satisfied, with the outcome of their surgery. Only three patients (3%) reported persistently worse symptoms after surgery and only seven (7%) reported permanent recurrence of any symptoms after surgery. Prior to surgery, 72% of the women were completely apareunic; however, after surgery, only 11% were unable to have intercourse. Discussion., In this cohort of patients, there was a high degree of satisfaction with surgery for VVS. In addition, the risks of complications with this procedure were low, and most complications were transient and the risk of recurrence after surgery was also found to be low. Goldstein AT, Klingman D, Christopher K, Johnson C, and Marinoff SC. Surgical treatment of vulvar vestibulitis syndrome: Outcome assessment derived from a postoperative questionnaire. J Sex Med 2006;3:923,931. [source] Outcome Assessment in Emergency Medicine,A Beginning: Results of the Council of Emergency Medicine Residency Directors (CORD) Emergency Medicine Consensus Workgroup on Outcome AssessmentACADEMIC EMERGENCY MEDICINE, Issue 3 2008Cherri Hobgood MD Abstract This article is designed to serve as a guide for emergency medicine (EM) educators seeking to comply with the measurement and reporting requirements for Phase 3 of the Accreditation Council for Graduate Medical Education (ACGME) Outcome Project. A consensus workshop held during the 2006 Council of Emergency Medicine Residency Directors (CORD) "Best Practices" conference identified specific measures for five of the six EM competencies,interpersonal communication skills, patient care, practice-based learning, professionalism, and systems-based practice (medical knowledge was excluded). The suggested measures described herein should allow for ease in data collection and applicability to multiple core competencies as program directors incorporate core competency outcome measurement into their EM residency training programs. [source] ORIGINAL RESEARCH,SURGERY: Surgical Treatment of Vulvar Vestibulitis Syndrome: Outcome Assessment Derived from a Postoperative QuestionnaireTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2006Andrew T. Goldstein MD ABSTRACT Introduction., Vulvar vestibulitis syndrome (VVS) is the most common pathology in women with sexual pain. Surgery for VVS was first described in 1981. Despite apparently high surgical success rates, most review articles suggest that surgery should be used only "as a last resort." Risks of complications such as bleeding, scarring, and recurrence of symptoms are often used to justify these cautionary statements. However, there are little data in the peer-reviewed literature to justify this cautionary statement. Aims., To determine patient satisfaction with vulvar vestibulectomy for VVS and the rate of complications with this procedure. Methods., Women who underwent a complete vulvar vestibulectomy with vaginal advancement by one of three different surgeons were contacted via telephone by an independent researcher between 12 and 72 months after surgery. Main Outcome Measures., The primary outcome measurement of surgical success was overall patient satisfaction with surgery. Additional secondary outcome measurements included improvement in dyspareunia, changes in coital frequency, and occurrence of surgical complications. Results., In total, 134 women underwent surgery in a 5-year period. An independent research assistant was able to contact 106 women, and 104 agreed to participate in the study. Mean duration since surgery was 26 months. A total of 97 women (93%) were satisfied, or very satisfied, with the outcome of their surgery. Only three patients (3%) reported persistently worse symptoms after surgery and only seven (7%) reported permanent recurrence of any symptoms after surgery. Prior to surgery, 72% of the women were completely apareunic; however, after surgery, only 11% were unable to have intercourse. Discussion., In this cohort of patients, there was a high degree of satisfaction with surgery for VVS. In addition, the risks of complications with this procedure were low, and most complications were transient and the risk of recurrence after surgery was also found to be low. Goldstein AT, Klingman D, Christopher K, Johnson C, and Marinoff SC. Surgical treatment of vulvar vestibulitis syndrome: Outcome assessment derived from a postoperative questionnaire. J Sex Med 2006;3:923,931. [source] Approach to treatment of mental illness and substance dependence in remote Indigenous communities: Results of a mixed methods studyAUSTRALIAN JOURNAL OF RURAL HEALTH, Issue 4 2009Tricia Nagel Abstract Objective:,To develop and evaluate a culturally adapted brief intervention for Indigenous people with chronic mental illness. Design:,A mixed methods design in which an exploratory phase of qualitative research was followed by a nested randomised controlled trial. Setting:,Psycho-education resources and a brief intervention, motivational care planning (MCP), were developed and tested in collaboration with aboriginal mental health workers in three remote communities in northern Australia. Participants:,A total of 49 patients with mental illness and 37 carers were recruited to a randomised controlled trial that compared MCP (n = 24) with a clinical control condition (treatment as usual, n = 25). Intervention:,The early treatment group received MCP at baseline and the late treatment group received delayed treatment at six months. Main outcome measures:,The primary outcome was mental health problem severity as measured by the health of the nation outcome scales. Secondary measures of well-being (Kessler 10), life skills, self-management and substance dependence were chosen. Outcome assessments were performed at baseline, six-month, 12-month and 18-month follow up. Results:,Random effects regression analyses showed significant advantage for the treatment condition in terms of well-being with changes in health of the nation outcome scales (P < 0.001) and Kessler 10 (P = 0.001), which were sustained over time. There was also significant advantage for treatment for alcohol dependence (P = 0.05), with response also evident in cannabis dependence (P = 0.064) and with changes in substance dependence sustained over time. Conclusions:,These results suggest that MCP is an effective treatment for Indigenous people with mental illness and provide insight into the experience of mental illness in remote communities. [source] Addressing the Systems-based Practice Core Competency: A Simulation-based CurriculumACADEMIC EMERGENCY MEDICINE, Issue 12 2005Ernest E. Wang MD Systems-based practice is one of the six core competencies implemented by the Accreditation Council for Graduate Medical Education to direct residency educational outcome assessment and accreditation. Emergency medicine,specific systems-based practice criteria have been described to define the expected knowledge and skill sets pertinent to emergency medicine practitioners. High-fidelity patient simulation is increasingly used in graduate medical education to augment case-based learning. The authors describe a simulation-based curriculum to address the emergency medicine,specific systems-based practice core competency. [source] Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gumADDICTION, Issue 9 2009Ned L. Cooney ABSTRACT Aims The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes. Design Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment. Setting Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions. Participants Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day. Intervention All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions. Findings Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions. Conclusions Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation. [source] Quantitative evaluation of automated skull-stripping methods applied to contemporary and legacy images: Effects of diagnosis, bias correction, and slice locationHUMAN BRAIN MAPPING, Issue 2 2006Christine Fennema-Notestine Abstract Performance of automated methods to isolate brain from nonbrain tissues in magnetic resonance (MR) structural images may be influenced by MR signal inhomogeneities, type of MR image set, regional anatomy, and age and diagnosis of subjects studied. The present study compared the performance of four methods: Brain Extraction Tool (BET; Smith [2002]: Hum Brain Mapp 17:143,155); 3dIntracranial (Ward [1999] Milwaukee: Biophysics Research Institute, Medical College of Wisconsin; in AFNI); a Hybrid Watershed algorithm (HWA, Segonne et al. [2004] Neuroimage 22:1060,1075; in FreeSurfer); and Brain Surface Extractor (BSE, Sandor and Leahy [1997] IEEE Trans Med Imag 16:41,54; Shattuck et al. [2001] Neuroimage 13:856,876) to manually stripped images. The methods were applied to uncorrected and bias-corrected datasets; Legacy and Contemporary T1 -weighted image sets; and four diagnostic groups (depressed, Alzheimer's, young and elderly control). To provide a criterion for outcome assessment, two experts manually stripped six sagittal sections for each dataset in locations where brain and nonbrain tissue are difficult to distinguish. Methods were compared on Jaccard similarity coefficients, Hausdorff distances, and an Expectation-Maximization algorithm. Methods tended to perform better on contemporary datasets; bias correction did not significantly improve method performance. Mesial sections were most difficult for all methods. Although AD image sets were most difficult to strip, HWA and BSE were more robust across diagnostic groups compared with 3dIntracranial and BET. With respect to specificity, BSE tended to perform best across all groups, whereas HWA was more sensitive than other methods. The results of this study may direct users towards a method appropriate to their T1 -weighted datasets and improve the efficiency of processing for large, multisite neuroimaging studies. Hum. Brain Mapping, 2005. © 2005 Wiley-Liss, Inc. [source] The effects of physical exercise on depressive symptoms among the aged: a systematic reviewINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 5 2006Noora Sjösten Abstract Objective To determine the effects of physical exercise on depression or depressive symptoms among the aged. Method A literature search covering various medical databases was conducted to identify randomised controlled trials (RCT's) about the effects of exercise treatments on depression or depressive symptoms among the aged. The studies were classified according to the baseline depression status of participants and assessed in relation to allocation concealment, blinding at outcome assessment, follow-up and whether intention to treat analysis was used. Studies meeting the inclusion criteria were accepted. Results Exercise was effective in treating depression among those suffering from minor or major depression and in reducing depressive symptoms among those with a high amount of depressive symptoms at baseline. However, both the allocation concealment and the blinding method were adequately described in only four studies. Furthermore, intention-to-treat analysis was conducted in half of the studies and some follow-up information after the intervention has been published for five studies. Conclusions Physical exercise may be efficient in reducing clinical depression and depressive symptoms in the short-term among the aged suffering from depression or a high amount of depressive symptoms. More well controlled studies are needed. Copyright © 2006 John Wiley & Sons, Ltd. [source] Randomization in psychiatric intervention research in the general practice settingINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2000CM Van Der Feltz-Cornelis Faculty of Medicine Abstract Most studies of psychiatric interventions in general practice settings conform only in part to the requirements of randomization, placebo control and blinding as formulated by the Cochrane Collaboration. It is possible, nonetheless, to develop experimental research designs that are sufficiently near to this standard. These must deal with certain methodological issues specific to psychiatric research. This article discusses scientific standards of psychiatric research with special consideration of interventions in general practice settings. These issues are accompanied by concrete examples and suggestions on how to confront the problems. In psychiatric intervention research, equivalence studies with single-blind outcome assessment, a tested and ethically justified method, are generally used in place of placebo-controlled studies. The article also examines randomization procedures in greater depth. Randomization can be applied across trial subjects or across doctors' practices. Practical consequences of randomizing across subjects, and specific implementations of it such as crossover and pre-post designs in general practice settings, are clarified. Overall, a research design using randomization across doctors' practices is judged preferable to one that randomizes across trial subjects. One potential problem is that the control group may become too small, especially when considerable effects are expected from the intervention being studied. One might consider making the control condition smaller in the first place, or, if indicated on ethical grounds, performing an intermediate analysis and then breaking off the study as soon as a statistically significant effect has been demonstrated. Multilevel statistical techniques offer new opportunities for analysis within such designs. Copyright © 2000 Whurr Publishers Ltd. [source] Direct versus Indirect Veneer Restorations for Intrinsic Dental StainsJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 2 2006Article first published online: 25 APR 200 abstract Objective:, The purpose of this study was to examine the effectiveness of indirect and direct veneer restorations, particularly with regard to longevity and patient satisfaction. Materials and Methods:, This study evaluated the literature on randomized clinical trials comparing direct and indirect veneers on anterior teeth. The search strategy involved Medline and other databases and was followed by contacting authors to determine whether any additional published or unpublished studies were available. Relevant studies were assessed for factors such as quality of randomization, outcome assessment, and completeness of recall evaluation. Data from the studies were extracted by three independent reviewers using special forms. Authors were contacted for clarification and missing data. Study details such as dates, demographics of the sample, and outcomes were recorded. Results:, The electronic searches identified 29 clinical trials and 1 systematic review. Six of those were screened as potentially relevant to the review, but following a more detailed screening, only one study (Meijering and colleagues, 1998) met all of the inclusion criteria. In the 2-year recall of that study, the overall survival rates were 94% for porcelain, 90% for indirect composite, and 74% for direct composite veneers. The survival rate was higher when the incisal edge was reduced. Patient satisfaction rates were 93% for porcelain, 82% for indirect composite, and 67% for direct composite. Conclusion:, Very little reliable evidence compares the effectiveness of indirect versus indirect veneers. For an individual patient, the choice between the two options should take into account patient preference and the clinician's experience. [source] Measurement of Whole-Brain Atrophy in Multiple SclerosisJOURNAL OF NEUROIMAGING, Issue 2004Daniel Pelletier MD ABSTRACT Brain atrophy reflects the net result of irreversible and destructive pathological processes in multiple sclerosis (MS). The gross morphological changes can be accurately quantified using standard magnetic resonance imaging (MRI) acquisitions and various image analysis tools. The current methods used to assess whole-brain atrophy in patients with MS can be classified into 2 groups based on their reliance on segmentation and registration. Segmentation-based methods employed to measure whole-brain atrophy in MS include the brain parenchymal fraction, the index of brain atrophy, the whole-brain ratio, the brain to intracranial capacity ratio, fuzzy connectedness/Udupa's method, 3DVIEWNIX, the Alfano method, and SIENAX. Current registration-based methods used to measure whole-brain atrophy in MS include the brain boundary shift integral, SIENA, statistical parametric mapping, template-driven seg mentation, and voxel-based morphometry. Most of the methods presented here are sensitive to subtle changes in brain structures and have been successfully applied to MS as measures of whole-brain atrophy. Yet comparative studies of these methods are limited and are complicated by the lack of a gold standard for image acquisition, a segmentation algorithm, an image analysis method, or a reproducibility measure. Overall, the measure of whole-brain atrophy from MRI contributes to an appreciation of the dynamics of MS pathology and its relationship to the clinical course of MS. Determination of the relative reproducibility, precision, sensitivity, and validity of these methods will promote the use of whole-brain atrophy measures as components of comprehensive MRI-based outcome assessment in MS clinical trials. [source] Induction of a neoarthrosis by precisely controlled motion in an experimental mid-femoral defectJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 3 2002Dennis M. Cullinane Bone regeneration during fracture healing has been demonstrated repeatedly, yet the regeneration of articular cartilage and joints has not yet been achieved. It has been recognized however that the mechanical environment during fracture healing can be correlated to the contributions of either the endochondral or intramembranous processes of bone formation, and to resultant tissue architecture. Using this information, the goal of this study was to test the hypothesis that induced motion can directly regulate osteogenic and chondrogenic tissue formation in a rat mid-femoral bone defect and thereby influence the anatomical result. Sixteen male Sprague Dawley rats (400 ± 20 g) underwent production of a mid-diaphyseal, non-critical sized 3.0 mm segmental femoral defect with rigid external fixation using a custom designed four pin fixator. One group of eight animals represented the controls and underwent surgery and constant rigid fixation. In the treatment group the custom external fixator was used to introduce daily interfragmentary bending strain in the eight treatment animals (12°s angular excursion), with a hypothetical symmetrical bending load centered within the gap. The eight animals in the treatment group received motion at 1.0 Hz, for 10 min a day, with a 3 days on, one day off loading protocol for the first two weeks, and 2 days on, one day off for the remaining three weeks. Data collection included histological and immunohistological identification of tissue types, and mean collagen fiber angles and angular conformity between individual fibers in superficial, intermediate, and deep zones within the cartilage. These parameters were compared between the treatment group, rat knee articular cartilage, and the control group as a structural outcome assessment. After 35 days the control animals demonstrated varying degrees of osseous union of the defect with some animals showing partial union. In every individual within the mechanical treatment group the defect completely failed to unite. Bony arcades developed in the experimental group, capping the termini of the bone segments on both sides of the defect in four out of six animals completing the study. These new structures were typically covered with cartilage, as identified by specific histological staining for Type II collagen and proteoglycans. The distribution of collagen within analogous superficial, intermediate, and deep zones of the newly formed cartilage tissue demonstrated preferred fiber angles consistent with those seen in articular cartilage. Although not resulting in complete joint development, these neoarthroses show that the induced motion selectively controlled the formation of cartilage and bone during fracture repair, and that it can be specifically directed. They further demonstrate that the spatial organization of molecular components within the newly formed tissue, at both microanatomical and gross levels, are influenced by their local mechanical environment, confirming previous theoretical models. © 2002 Orthopaedic Research Society. Published by Elsevier Science Ltd. All rights reserved. [source] Advances in paediatric rheumatology: Beyond NSAIDs and joint replacementJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 4 2004JE Munro Over the previous three decades there have been a number of dramatic changes in our understanding of both the pathogenesis and epidemiology of the rheumatic diseases of childhood. Improvements in the classification of paediatric-onset arthritides and international collaboration in terms of multicentre research have led to the development of new therapeutic agents and better methods of outcome assessment for these chronic and often disabling conditions. Fortunately for children with paediatric rheumatic diseases treatment regimes are now available that provide excellent disease control for many and remission induction for some. Challenges include clearer definition of the genetics and pathogenesis of the diseases, delineation of reliable biological markers for diagnosis and monitoring of disease activity. The future should also herald early identification of those with a poorer prognosis, together with the design of more powerful, safer and cheaper remission-inducing agents, given to the right patients at the right time. [source] Outcome Variables and Their Assessment in Alcohol Treatment Studies: 1968-1998ALCOHOLISM, Issue 10 2003John W. Finney Background: This article provides a historical overview of the assessment of outcome variables in alcohol treatment studies that were first published between 1968 and 1998. The review focuses on changes over time in (1) the number of outcome variables and the number of different types of outcome variables assessed, (2) the likelihood of assessing specific types of outcome variables, (3) the methods used to assess outcome variables, and (4) the status of outcome assessment in more recent studies first published between 1990 and 1998. Methods: Reports of 357 alcohol treatment trials with two or more treatment/control groups were coded with respect to the number and types of outcome variables assessed, sources of outcome data, and methodological aspects of outcome assessment. Results: Although the number of outcome variables assessed in studies, on average, did not increase significantly over time, the number of different types of outcome variables did increase. An expected decrease in the assessment of categorical abstinence was not found, but another categorical variable, global ratings of drinking improvement, did decrease over time. More recent studies were more likely to assess such continuous variables as time abstinent, alcohol consumption, time drinking, dependence symptoms, and drinking-related problems. Physiological markers of drinking/alcohol misuse also were assessed more frequently in later years. Some aspects of outcome assessment methods exhibited improvement over time; validity data were more likely to be provided or cited, and self-reports of drinking behaviors were more likely to be corroborated in studies first published in more recent years. However, the percentages of studies that provided/cited reliability data for outcome measures, indicated that follow-up data collectors were not affiliated with treatment and were unaware of respondents' treatment conditions, and reported that respondents were alcohol-free at follow-up did not rise significantly over time. Conclusions: Although the methods of outcome assessment improved between 1968 and 1998, much room for improvement remains. [source] Abstracts of the 8th Meeting of the Italian Peripheral Nerve Study Group: 46JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 1 2003L Padua Traditional outcome assessment in neurological diseases has always been based on physician-derived and instrumental findings. Over the last two decades, clinical and public health researchers emphasized the need for a thorough evaluation of concepts such as Health Related Quality of Life (HRQoL) to study the impact of chronic illnesses and their treatments on the patient's life. The most frequent inherited neuropathy is Charcot-Marie-Tooth disease (CMT). CMT Patients develop progressive weakness and sensory disturbances, becoming sometimes severely disabled even at very young age. In CMT clinic, neurophysiologic, pathologic and genetic evaluation, are considered fundamental to assess nerve involvement and diagnose, but how these findings are related to HRQoL and disability is not assessed. We propose a prospective follow-up (24,30 months) of CMT patients with multiple measurements of CMT. Besides conventional clinic, pathologic, neurophysiologic and genetic measurements we adopt validated patient-oriented measurements to assess HRQoL and disability. Aims of the study are: 1) to assess HRQoL and disability of CMT patients in a wide and well-represented sample and to evaluate the relationships between conventional parameters and the patient's perception of his own HRQoL and disability; 2) to evaluate natural history of HRQoL and disability in CMT, and to evaluate the predictive value of phenotype, genetic picture, neurophysiological and pathological pattern 3) to develop a national network and a database on CMT disease (this aim includes the standardization, based on a consensus validation process, of the most used terms and measurements in CMT and the development of a database software). In a preliminary reunion, the authors developed a dedicated database for patients affected by CMT. Details about this database will be presented. [source] Statistical issues in the assessment of health outcomes in children: a methodological reviewJOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES A (STATISTICS IN SOCIETY), Issue 4 2009Gillian A. Lancaster Summary., The lack of outcome measures that are validated for use on children limits the effectiveness and generalizability of paediatric health care interventions. Statistical epidemiology is a broad concept encompassing a wide range of useful techniques for use in child health outcome assessment and development. However, the range of techniques that are available is often confusing and prohibits their adoption. In the paper an overview of methodology is provided within the paediatric context. It is demonstrated that in many cases assessment can be performed relatively straightforwardly by using standard statistical techniques, although sometimes more sophisticated techniques are required. Examples of both physiological and questionnaire-based outcomes are given. The usefulness of these techniques is highlighted for achieving specific objectives and ultimately for achieving methodological rigour in clinical outcome studies that are performed in the paediatric population. [source] Microvascularly augmented transverse rectus abdominis myocutaneous flap for breast reconstruction,Reappraisal of its value through clinical outcome assessment and intraoperative blood gas analysisMICROSURGERY, Issue 8 2008Jing-Wei Lee M.D. Our experience with 73 transverse rectus abdominis myocutaneous (TRAM) flap transfers was reviewed to see the variance in the incidence of complications among three groups of patients undergoing different types of surgical techniques. The TRAM flap was transferred as a free flap in 26 patients, a unipedicled flap in 25 patients, and a microvascularly augmented pedicled flap in 22 patients. Our data demonstrated that the incidence of partial flap loss and fat necrosis in the microvascularly augmented group was significantly lower than that in the unipedicled flap group (P < 0.01), and also lower than that in the free flap group with a statistically marginal significance (P = 0.055). Supplemental surgery is less often required in the microvascularly augmented group than in the conventional TRAM group (P = 0.002). Substantial increase in venous O2 concentration (P = 0.03), O2 saturation level (P = 0.007), and pH value (P = 0.002) was noticed following supercharge, and this very fact testifies to the perfusion-promoting effect of the microvascular augmentation maneuver. © 2008 Wiley-Liss, Inc. Microsurgery, 2008. [source] Assessing Negative Consequences in Patients with Substance Use and Bipolar Disorders: Psychometric Properties of the Short Inventory of Problems (SIP)THE AMERICAN JOURNAL ON ADDICTIONS, Issue 6 2007Rachel E. Bender BA The Short Inventory of Problems (SIP), a questionnaire that measures negative consequences of alcohol use, has not been validated among substance users with co-occurring psychiatric illness. This study examined the psychometric properties of the SIP in 57 outpatients diagnosed with substance use disorder and bipolar disorder. We modified the items to assess drugs in addition to alcohol and, further, we added corresponding items to assess consequences of bipolar disorder. This modified version of the SIP was psychometrically sound, and may be useful in patients with both disorders. A greater understanding of perceived negative consequences may enhance outcome assessment in dually diagnosed populations. [source] Nifedipine trials: effectiveness and safety aspectsBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2005Herman P. van Geijn Nifedipine (Adalat) is marketed as an anti-hypertensive agent. Nifedipine inhibits voltage-dependent L-type calcium channels, which leads to vascular (and other) smooth muscle relaxation and negative inotropic and chronotropic effects on the heart. Vasodilation, followed by a baroreceptor-mediated increase in sympathetic tone then results in indirect cardiostimulation. Nifedipine was introduced as a tocolytic agent at a time when ,-agonists and magnesium sulphate dominated the arena for the prevention of preterm birth. The oral administration route, the availability of immediate and slow-release preparations, the low incidence of (mild) side effects, and its limited costs explain the attraction to this medication from the obstetric field and its rapid and widespread distribution. Currently, over 40 studies have been published on nifedipine's tocolytic effectiveness, including seven meta-analyses. The quality of the studies suffers particularly from performance bias because the majority of them failed to ensure adequate blinding to treatment both for providers and patients. Concerns about other methodological flaws include measurements, outcome assessment and attrition bias. In particular, the safety aspects of nifedipine for tocolysis have been underassessed. Conclusions from the meta-analyses, favouring the use of nifedipine as a tocolytic agent, are not supported by close examination of the data. The tocolytic effectiveness and ,safety' of nifedipine has been studied primarily in normal pregnancies. Based on its pharmacological properties, one should be cautious to administer nifedipine when the maternal cardiovascular condition is compromised, such as with intrauterine infection, twin pregnancy, maternal hypertension, cardiac disease, etc. Life-threatening pulmonary oedema and/or cardiac failure are definite risks and have been reported. Under such circumstances, the baroreceptor-mediated increase in sympathetic tone may not balance the cardiac-depressant activity of nifedipine. [source] Knowledge of Treatment Group Does Not Bias Assessment of Time to Seizure in an Animal Model of Cocaine PoisoningACADEMIC EMERGENCY MEDICINE, Issue 7 2010Kennon J. Heard MD ACADEMIC EMERGENCY MEDICINE 2010; 17:E75,E77 © 2010 by the Society for Academic Emergency Medicine Abstract Objectives:, Blinded outcome assessment decreases bias in human clinical trials. The necessity of blinded outcome assessment on animal studies is unknown. The authors determined the effect of knowledge of treatment group on assessment of time to seizure in an animal model of cocaine poisoning. Methods:, Four subjects observed 20 animal experiments where all animals were administered a high dose of cocaine and placebo. For each experiment, two of the observers were told the animal had been treated with placebo and two were told the animal had been treated with a medication expected to delay the onset of seizures. Each observer recorded the time from cocaine administration to onset of seizure. The median time to seizure was compared between observers told the animal received placebo and those told the animal received active treatment. Results:, Seizures were reported by all subjects in 12 animals and by no subjects in five animals, and there was disagreement in three animals. The reported median time to seizure was similar for observers told that the animals were treated with placebo and those told they were treated with study medication. Conclusions:, It is feasible to determine whether unblinded assessments are biased in an animal study. Knowledge of treatment group did not bias the assessment of time to seizure in this animal model. [source] Longitudinal analysis when the experimenter does not determine when treatment ends: what is dose,response?CLINICAL PSYCHOLOGY AND PSYCHOTHERAPY (AN INTERNATIONAL JOURNAL OF THEORY & PRACTICE), Issue 6 2003Daniel J. Feaster The most appropriate amount of psychotherapy to address a particular problem is of interest to clinicians, consumers and those responsible for funding of care. The dose,response relationship has been examined within the context of randomized clinical trials, meta-analysis as well as naturalistic studies; however, each of these approaches has limits. Many of these approaches have conceptually blurred two distinct concepts: do participants with different characteristics need different amounts of therapy and do otherwise equal participants show different outcomes when given different levels of (a particular type of) therapy? For any study design, if the experimenter does not determine the duration of therapy, then the length of therapy is said to be endogenous. This endogeneity can bias any attempt to untangle the answer to these two questions. An extension of the biasing effect of this endogeneity involves the choice of times to assess outcome; if outcome assessment depends on when therapy is terminated (rather than exogenously chosen) then estimates of the trajectory of outcome may be biased. Design considerations to minimize this effect are discussed.,Copyright © 2003 John Wiley & Sons, Ltd. [source] Guidelines for assessment of bone microstructure in rodents using micro,computed tomographyJOURNAL OF BONE AND MINERAL RESEARCH, Issue 7 2010Mary L Bouxsein Abstract Use of high-resolution micro,computed tomography (µCT) imaging to assess trabecular and cortical bone morphology has grown immensely. There are several commercially available µCT systems, each with different approaches to image acquisition, evaluation, and reporting of outcomes. This lack of consistency makes it difficult to interpret reported results and to compare findings across different studies. This article addresses this critical need for standardized terminology and consistent reporting of parameters related to image acquisition and analysis, and key outcome assessments, particularly with respect to ex vivo analysis of rodent specimens. Thus the guidelines herein provide recommendations regarding (1) standardized terminology and units, (2) information to be included in describing the methods for a given experiment, and (3) a minimal set of outcome variables that should be reported. Whereas the specific research objective will determine the experimental design, these guidelines are intended to ensure accurate and consistent reporting of µCT-derived bone morphometry and density measurements. In particular, the methods section for papers that present µCT-based outcomes must include details of the following scan aspects: (1) image acquisition, including the scanning medium, X-ray tube potential, and voxel size, as well as clear descriptions of the size and location of the volume of interest and the method used to delineate trabecular and cortical bone regions, and (2) image processing, including the algorithms used for image filtration and the approach used for image segmentation. Morphometric analyses should be based on 3D algorithms that do not rely on assumptions about the underlying structure whenever possible. When reporting µCT results, the minimal set of variables that should be used to describe trabecular bone morphometry includes bone volume fraction and trabecular number, thickness, and separation. The minimal set of variables that should be used to describe cortical bone morphometry includes total cross-sectional area, cortical bone area, cortical bone area fraction, and cortical thickness. Other variables also may be appropriate depending on the research question and technical quality of the scan. Standard nomenclature, outlined in this article, should be followed for reporting of results. © 2010 American Society for Bone and Mineral Research [source] Relationship between various clinical outcome assessments in patients with blepharospasm,MOVEMENT DISORDERS, Issue 3 2009Joseph Jankovic MD Abstract The objective was to analyze the metric properties of the Jankovic Rating Scale (JRS) and a self-rating patient response outcome scale, the Blepharospasm Disability Index (BSDI©), in blepharospasm patients. Data from a randomized, double-blind, active-control clinical trial in 300 patients with blepharospasm treated with either botulinum toxin type A (Botox®) or NT201 (Xeomin®) were used to evaluate the metric properties of the JRS and the BSDI compared with the Patient Evaluation of Global Response (PEGR) and Global Assessment Scale (GAS). The internal consistency of the BSDI was high, Cronbach's Alpha = 0.88, and the retest reliability of the BSDI single items was adequate, Spearman's rank coefficient = 0.453 < r < 0.595. The correlation between JRS sum score and BSDI weighted mean score was r = 0.487 (baseline) and r = 0.737 (control visit), respectively. Using the GAS and PEGR, the results suggest that a change of 2 points in the JRS and of 0.7 points in the BSDI are clinically meaningful. JRS and BSDI are objective indicators of clinical efficacy as suggested by their good validity when compared with physicians' and patients' rating scales. Both, JRS and BSDI, can be used to reliably assess blepharospasm in treatment trials. © 2008 Movement Disorder Society [source] Goal attainment for spasticity management using botulinum toxinPHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 1 2006Stephen Ashford Abstract Background and Purpose. To determine whether goal attainment scaling (GAS) can demonstrate functional gains following injection of botulinum toxin (BTX) for spasticity in severely disabled patients. Method. Subjects were categorized as ,responder' (positive clinical outcome) and ,non-responder' (non-significant clinical outcome) on the basis of their overall clinical response. GAS scores for functional goals were calculated retrospectively and compared with standard outcome assessments undertaken at the time of intervention. Integrated care pathway (ICP) proformas were interrogated for 18 patients with acquired brain injuries. Mean age was 44.4 (SD 13.4) years. Results. Baseline GAS and Barthel scores were similar for the responder and non-responder groups. The outcome GAS score was significantly greater in the responder than in the non-responder group (Mann,Whitney U = 11.0; p = 0.011) as was the change in GAS score (Mann,Whitney U = 8.0; p = 0.004). GAS scores reflected change recorded in focal outcome measures. However, the Barthel Index measured change in only one case. Conclusions. This exploratory retrospective study provides preliminary support for the hypothesis that GAS provides a useful measure of functional gains in response to treatment with BTX, and is more sensitive than global measures such as the Barthel Index. Copyright © 2006 John Wiley & Sons, Ltd. [source] The Significance of Insecure Attachment and Disorganization in the Development of Children's Externalizing Behavior: A Meta-Analytic StudyCHILD DEVELOPMENT, Issue 2 2010R. Pasco Fearon This study addresses the extent to which insecure and disorganized attachments increase risk for externalizing problems using meta-analysis. From 69 samples (N = 5,947), the association between insecurity and externalizing problems was significant, d = 0.31 (95% CI: 0.23, 0.40). Larger effects were found for boys (d = 0.35), clinical samples (d = 0.49), and from observation-based outcome assessments (d = 0.58). Larger effects were found for attachment assessments other than the Strange Situation. Overall, disorganized children appeared at elevated risk (d = 0.34, 95% CI: 0.18, 0.50), with weaker effects for avoidance (d = 0.12, 95% CI: 0.03, 0.21) and resistance (d = 0.11, 95% CI: ,0.04, 0.26). The results are discussed in terms of the potential significance of attachment for mental health. [source] 360-degree Feedback: Possibilities for Assessment of the ACGME Core Competencies for Emergency Medicine ResidentsACADEMIC EMERGENCY MEDICINE, Issue 11 2002Kevin G. Rodgers MD The Accreditation Council for Graduate Medical Education (ACGME) has challenged residency programs to provide documentation via outcomes assessment that all residents have successfully mastered the six core competencies. A variety of assessment "tools" has been identified by the ACGME for outcomes assessment determination. Although rarely cited in the medical literature, 360-degree feedback is currently in widespread use in the business sector. This tool provides timely, consolidated feedback from sources in the resident's sphere of influence (emergency medicine faculty, emergency medicine residents, off-service residents and faculty, nurses, ancillary personnel, patients, out-of-hospital care providers, and a self-assessment). This is a significant deviation from both the peer review process and the resident review process that almost exclusively use physicians as raters. Because of its relative lack of development, utilization, and validation as a method of resident assessment in graduate medical education, a great opportunity exists to develop the 360-degree feedback tool for resident assessment. [source] Classification System for the Completely Dentate PatientJOURNAL OF PROSTHODONTICS, Issue 2 2004Thomas J. McGarry DDS The American College of Prosthodontists (ACP) has developed a classification system designed for use by dental professionals in the diagnosis and treatment of completely dentate patients. This classification is the third in a series and is similar to the Classifications for Complete Edentulism and Partial Edentulism previously developed by the ACP. These guidelines are intended to aid practitioners in the systematic diagnosis of each patient which, in turn, should lead to an appropriate treatment. Four categories of a completely dentate situation are defined (Class I,IV), differentiated by specific diagnostic criteria, with Class I representing an uncomplicated clinical situation and Class IV representing the most complex clinical situation. Potential benefits of the system include (1) improved intraoperator consistency, (2) improved professional communication, (3) insurance reimbursement commensurate with complexity of care, (4) an improved screening tool for dental school admission clinics, (5) standardized criteria for outcomes assessment and research, (6) enhanced diagnostic consistency, and (7) a simplified aid in the decision-making process associated with referral. [source] The talking touchscreen: A new approach to outcomes assessment in low literacyPSYCHO-ONCOLOGY, Issue 2 2004Elizabeth A. Hahn Purpose. Cancer patients who are deficient in literacy skills are particularly vulnerable to experiencing different outcomes due to disparities in care or barriers to care. Outcomes measurement in low literacy patients may provide new insight into problems previously undetected due to the challenges of completing paper-and-pencil forms. Description of study. A multimedia program was developed to provide a quality of life assessment platform that would be acceptable to patients with varying literacy skills and computer experience. One item at a time is presented on the computer touchscreen, accompanied by a recorded reading of the question. Various colors, fonts and graphic images are used to enhance visibility, and a small picture icon appears near each text element allowing patients to replay the sound as many times as they wish. Evaluation questions are presented to assess patient burden and preferences. Results. An ethnically diverse group of 126 cancer patients with a range of literacy skills and computer experience reported that the ,talking touchscreen' (TT) was easy to use, and commented on the usefulness of the multimedia approach. Clinical implications. The TT is a practical, user-friendly data acquisition method that provides greater opportunities to measure self-reported outcomes in patients with a range of literacy skills. 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