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Eligibility Criteria (eligibility + criterion)
Selected AbstractsSetting Eligibility Criteria for a Care-Coordination BenefitJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2005Christine T. Cigolle MD Objectives: To examine different clinically relevant eligibility criteria sets to determine how they differ in numbers and characteristics of individuals served. Design: Cross-sectional analysis of the 2000 wave of the Health and Retirement Study (HRS), a nationally representative longitudinal health interview survey of adults aged 50 and older. Setting: Population-based cohort of community-dwelling older adults, subset of an ongoing longitudinal health interview survey. Participants: Adults aged 65 and older who were respondents in the 2000 wave of the HRS (n=10,640, representing approximately 33.6 million Medicare beneficiaries). Measurements: Three clinical criteria sets were examined that included different combinations of medical conditions, cognitive impairment, and activity of daily living/instrumental activity of daily living (ADL/IADL) dependency. Results: A small portion of Medicare beneficiaries (1.3,5.8%) would be eligible for care coordination, depending on the criteria set chosen. A criteria set recently proposed by Congress (at least four severe complex medical conditions and one ADL or IADL dependency) would apply to 427,000 adults aged 65 and older in the United States. Criteria emphasizing cognitive impairment would serve an older population. Conclusion: Several criteria sets for a Medicare care-coordination benefit are clinically reasonable, but different definitions of eligibility would serve different numbers and population groups of older adults. [source] The Relationship between Eligibility Criteria for Participation in Alcohol Brief Intervention Trials and Other Alcohol and Health-Related VariablesTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 3 2001Stephen A. Maisto Ph.D. In clinical trials of brief interventions for alcohol use, individuals typically are defined as eligible for the research through meeting quantity- frequency (QF) of alcohol consumption criteria, alcohol-related problems criteria, or both. The purpose of this study was to evaluate preintervention and posttreatment differences among three groups of research participants eligible for participation in a brief intervention clinical trial by meeting the AUDIT total score criterion only, the QF criterion only, or both. The participants were 301 men and women 21 years of age or older who presented for medical treatment at one of twelve primary care clinics and were screened for participation in the clinical trial. Participants completed an assessment protocol at preintervention and 1, 3, 6, 9, and 12 months postintervention. The analyses showed statistical differences among the three subgroups on three outcome dimensions of alcohol consumption, related consequences and behaviors, and medical complications; for both consumption and complications, the AUDIT + QF participants showed greater severity than participants in either of the other two groups. For consequences, AU DIT + QF participants scored higher than the QF participants on one variable constituting this dimension. The overall subgroup differences were maintained at six months in the consumption and consequences data. The implications of these findings for sensitivity of brief intervention trial design, the discovery of patient moderators of intervention effectiveness, and clinical practice are discussed. [source] Prevention of wound complications following salvage laryngectomy using free vascularized tissueHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2007FRCS(C), Kevin Fung MD Abstract Background. Total laryngectomy following radiation therapy or concurrent chemoradiation therapy is associated with unacceptably high complication rates because of wound healing difficulties. With an ever increasing reliance on organ preservation protocols as primary treatment for advanced laryngeal cancer, the surgeon must develop techniques to minimize postoperative complications in salvage laryngectomy surgery. We have developed an approach using free tissue transfer in an effort to improve tissue vascularity, reinforce the pharyngeal suture line, and minimize complications in this difficult patient population. The purpose of this study was to outline our technique and determine the effectiveness of this new approach. Methods. We conducted a retrospective review of a prospective cohort and compared it with a historical group (surgical patients of Radiation Therapy Oncology Group (RTOG)-91-11 trial). Eligibility criteria for this study included patients undergoing salvage total laryngectomy following failed attempts at organ preservation with either high-dose radiotherapy or concurrent chemo/radiation therapy regimen. Patients were excluded if the surgical defect required a skin paddle for pharyngeal closure. The prospective cohort consisted of 14 consecutive patients (10 males, 4 females; mean age, 58 years) who underwent free tissue reinforcement of the pharyngeal suture line following total laryngectomy. The historical comparison group consisted of 27 patients in the concomitant chemoradiotherapy arm of the RTOG-91-11 trial who met the same eligibility criteria (26 males, 1 female; mean age, 57 years) but did not undergo free tissue transfer or other form of suture line reinforcement. Minimum follow-up in both groups was 12 months. Results. The overall pharyngocutaneous fistula rate was similar between groups,4/14 (29%) in the flap group, compared with 8/27 (30%) in the RTOG-91-11 group. There were no major wound complications in the flap group, compared with 4 (4/27, 14.8%) in the RTOG-91-11 group. There were no major fistulas in the flap group, compared with 3/27 (11.1%) in the RTOG-91-11 group. The rate of pharyngeal stricture requiring dilation was 6/14 (42%) in the flap group, compared with 7/27 (25.9%) in the RTOG-91-11 group. In our patients, the rate of tracheoesophageal speech was 14/14 (100%), and complete oral intake was achieved in 13/14 (93%) patients. Voice-Related Quality of Life Measure (V-RQOL) and Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) scores suggest that speech and swallowing functions are reasonable following free flap reinforcement. Conclusions. Free vascularized tissue reinforcement of primary pharyngeal closure in salvage laryngectomy following failed organ preservation is effective in preventing major wound complications but did not reduce the overall fistula rate. Fistulas that developed following this technique were relatively small, did not result in exposed major vessels, and were effectively treated with outpatient wound care rather than readmission to the hospital or return to operating room. Speech and swallowing results following this technique were comparable to those following total laryngectomy alone. © 2007 Wiley Periodicals, Inc. Head Neck 2007 [source] Excellent outcome following down-staging of hepatocellular carcinoma prior to liver transplantation: An intention-to-treat analysis,,HEPATOLOGY, Issue 3 2008Francis Y. Yao We previously reported encouraging results of down-staging of hepatocellular carcinoma (HCC) to meet conventional T2 criteria (one lesion 2,5 cm or two to three lesions <3 cm) for orthotopic liver transplantation (OLT) in 30 patients as a test of concept. In this ongoing prospective study, we analyzed longer-term outcome data on HCC down-staging in a larger cohort of 61 patients with tumor stage exceeding T2 criteria who were enrolled between June 2002 and January 2007. Eligibility criteria for down-staging included: (1) one lesion >5 cm and up to 8 cm; (2) two to three lesions with at least one lesion >3 cm and not exceeding 5 cm, with total tumor diameter up to 8 cm; or (3) four to five lesions with none >3 cm, with total tumor diameter up to 8 cm. A minimum observation period of 3 months after down-staging was required before OLT. Tumor down-staging was successful in 43 patients (70.5%). Thirty-five patients (57.4%) had received OLT, including two who had undergone live-donor liver transplantation. Treatment failure was observed in 18 patients (29.5%), primarily due to tumor progression. In the explant of 35 patients who underwent OLT, 13 had complete tumor necrosis, 17 met T2 criteria, and five exceeded T2 criteria. The Kaplan-Meier intention-to-treat survival at 1 and 4 years after down-staging were 87.5% and 69.3%, respectively. The 1-year and 4-year posttransplantation survival rates were 96.2% and 92.1%, respectively. No patient had HCC recurrence after a median posttransplantation follow-up of 25 months. The only factor predicting treatment failure was pretreatment alpha-fetoprotein >1,000 ng/mL. Conclusion: Successful down-staging of HCC can be achieved in the majority of carefully selected patients and is associated with excellent posttransplantation outcome. (HEPATOLOGY 2008.) [source] Adverse Outcomes of Osteoporotic Fractures in the General Population,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 6 2003L Joseph Melton III MD Abstract Osteoporotic fractures exact a terrible toll on the population with respect to morbidity and cost, and to a lesser extent mortality, which will increase dramatically with the growing elderly population. Attention has focused on the 12-20% excess deaths after hip fracture, but most are caused by underlying medical conditions unrelated to osteoporosis. More important is fracture-related morbidity. An estimated 10% of patients are disabled by hip fracture, and 19% require institutionalization, accounting for almost 140,000 nursing home admissions annually in this country. Distal forearm and vertebral fractures less commonly result in nursing home placement, but about 10% of postmenopausal women have vertebral deformities that cause chronic pain, and a substantial minority have poor function after forearm fracture. These fractures interfere greatly with the activities of daily living, and all of them can have a substantial negative impact on quality of life. Annual expenditures for osteoporotic fracture care in the United States ($17.5 million in 2002 dollars) are dominated by hip fracture treatment, but vertebral fractures, distal forearm fractures, and importantly, the other fractures related to osteoporosis contribute one-third of the total. Although all fracture patients are at increased risk of future fractures, few of them are currently treated for osteoporosis, and only a subset (i.e., those with vertebral fractures) are considered candidates for many clinical trials. Eligibility criteria should be expanded and fracture end-points generalized to acknowledge the overall burden of osteoporotic fractures. [source] Early steroid withdrawal after liver transplantation: The canadian tacrolimus versus microemulsion cyclosporin a trial: 1-year follow-upLIVER TRANSPLANTATION, Issue 6 2003Paul Greig Corticosteroid therapy contributes significant toxicity to liver transplantation. The safety and efficacy of early steroid withdrawal were determined in patients treated with either tacrolimus or microemulsion cyclosporin A (micro-CsA). The primary outcome was the proportion of patients who were steroid-free 1 year posttransplantation. From the seven Canadian adult liver transplant centers, 143 patients were randomly allocated oral treatment with either tacrolimus (n = 71) or micro-CsA (n = 72), together with corticosteroids and azathioprine. Eligibility criteria for steroid withdrawal included freedom from acute rejection for a minimum of 3 months, and prednisone ,0.15 mg/kg/d. In eligible patients, the daily steroid dose was reduced by 2.5 mg each month until complete discontinuation was achieved. At 1 year after transplantation, 75% of the tacrolimus patients and 63% of the micro-CsA patients were steroid-free (P = .20). Of all of the patients who became eligible for steroid withdrawal, steroid discontinuation was achieved in over 80%. One-year patient survival was 97% with tacrolimus and 89% with micro-CsA (P = .052). Graft survival was 97% and 86%, respectively (P = .017). The overall incidence of acute rejection during the first year was 35% with tacrolimus and 43% with micro-CsA (P = .26). There was no difference in survival, acute rejection, or rate of steroid withdrawal when adjusting for hepatitis C. All acute rejection episodes experienced during steroid withdrawal were steroid-responsive. Steroid-resistant rejection occurred in 5.6% of the tacrolimus and 9.7% of the micro-CsA patients. One patient, in the micro-CsA group, experienced refractory rejection. Chronic rejection was not observed in either group. The toxicity profiles were similar. Postoperative serum creatinine levels were similar, and dialysis was required in less than 10% of patients in each group. Infectious complications were similar in both groups. Neurotoxicity was a serious adverse event in 13% and 10% of patients receiving tacrolimus and micro-CsA, respectively. Early steroid withdrawal is safe and effective after liver transplantation using either tacrolimus plus azathioprine or micro-CsA plus azathioprine immunoprophylaxis. [source] Nested case-control analysis of high pesticide exposure events from the Agricultural Health StudyAMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 6 2001Michael C. R. Alavanja Abstract Background A nested case-control analysis of high pesticide exposure events (HPEEs) was conducted using the Iowa farmers enrolled in the Agricultural Health Study (AHS). Methods In the 12 months of the study, 36 of the 5,970 farmer applicators randomly chosen from the AHS cohort (six per 1,000 farmer applicators per year) met our definition of an HPEE, by reporting "an incident with fertilizers, weed killers, or other pesticides that caused an unusually high personal exposure" resulting in physical symptoms or a visit to a health care provider or hospital. Eligibility criteria were met by 25 HPEE cases and 603 randomly selected controls. Results Significant risk factors for an HPEE included: poor financial condition of the farm which limited the purchase of rollover protective structures OR,=,4.6 (1.5,16.6), and having a high score on a risk acceptance scale OR,=,3.8 (1.4,11.2). Other non-significant factors were also identified. Conclusions The limited statistical power of this study necessitates replication of these analyses with a larger sample. Nonetheless, the observed elevated odds ratios of an HPEE provide hypotheses for future studies that may lead to preventive action. Am. J. Ind. Med. 39:557,563, 2001. © 2001 Wiley-Liss, Inc. [source] AL03 ADVERSE EVENTS: OUR RESPONSIBILITY FOR REPORTING, REVIEWING AND RESPONDINGANZ JOURNAL OF SURGERY, Issue 2009J. Collins The sustained production of competent surgeons in sufficient numbers to meet the increasing needs of society commences with recruitment and selection of the most able medical graduates. As the process begins through self-selection, accurate information must be readily available to enable these graduates make an informed judgement on their career choice. Each surgical discipline aspires to use best practice selection in order to identify those who have the potential to acquire the necessary standard of technical and non technical skills and attributes required to practice as a surgeon. A selection system must rank applicants effectively and be reliable, valid, fair, defensible, cost effective and feasible. Best practice selection commences with an analysis of the relevant knowledge, skills, abilities and attitudes associated with successful performance in the particular target job. This information is used to construct a person specification in order to identify selection criteria at a level appropriate for entry to training. Selection methods are then chosen which will best elicit measurable applicant behaviour related to these selection criteria. A number of selection methods are used which include structured references, curriculum vitae and interviews. Other methods available although rarely used include tests of mental ability, aptitude tests and personality inventories. More recently selection or assessment centres (a selection method, not a place) involving a combination of selection techniques such as written exercises, interviews and work simulations have been shown to be highly effective. Eligibility criteria for application (long listing), shortlising for interview, scoring of items within each selection method and overall % weighting for each method are important variables in the selection process. [source] Equitable access to dental care for an at-risk group: a review of services for Australian refugeesAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 1 2007Natasha Davidson Objective: Despite the poor dental health of refugees, few specific services are available. This review maps public dental services for refugees across Australian jurisdictions, identifies gaps in provision, identifies barriers to accessing dental care, and provides recommendations for improving access and oral health promotion for this group. Methods: Data were sought from the State and Territory services for: a) the survivors of torture; b) oral health care units; and c) auditors-general reports of dental services. Eligibility criteria and estimated waiting times for general dental services, criteria for access to emergency care and availability of interpreter services were reviewed. Results: Marked variation exists across Australian jurisdictions in available dental services and criteria for access to public dental care for refugees. There is limited priority access to general dental services for refugees. Waiting times for public dental treatment in most, if not all, jurisdictions are unacceptably long (range 13,58 months). Few interpreter services exist for refugees seeking to access dental services. Conclusions: Access to dental services for refugees across Australia remains fragmented and limited, particularly in rural and regional areas. Refugees are not using services because of several barriers, including long waiting times, variation in assessment criteria, different eligibility criteria and limited interpreter services. Consequently, their pattern of service use does not accurately reflect their needs. Implications: Australia needs better co-ordinated, more extensive dental services that are easily accessible for this very high risk group. Identification of refugees as a special needs group and provision of targeted interventions addressing barriers to care are needed to establish adequate dental care. [source] Empiric validation of the Rural Australian Medical Undergraduate Scholarship ,rural background' criterionAUSTRALIAN JOURNAL OF RURAL HEALTH, Issue 3 2005Gillian A. Laven Abstract Objective:,Rural Australian Medical Undergraduate Scholarships (RAMUS) provide $10 000 per annum to selected medical students with a rural background. Eligibility criteria include having lived in a rural community for five consecutive or eight cumulative years. We sought to validate the above-specified criterion using data from the Australian National Rural Background Study. Design:,National case control study stratified by jurisdiction. Participants:,Two thousand four hundred and fourteen Australian-trained rural and urban general practitioners (GPs). Main outcome measure:,Whether the RAMUS rural background criterion was met or not. Results:,Doctors who met the RAMUS rural background criterion were more likely to be in rural practice (odds ratio = 2.50; 95% confidence interval, 1.97,3.18) than those who did not. This was true for all jurisdictions (except for the Northern Territory) and ranged from 1.95 for South Australia to 3.57 for Victoria. Conclusion:,Rural GPs are more likely to fulfil the RAMUS rural background criterion, supporting the existence of the RAMUS scheme. [source] Race, Ethnicity, and Management of Pain from Long-bone Fractures: A Prospective Study of Two Academic Urban Emergency DepartmentsACADEMIC EMERGENCY MEDICINE, Issue 7 2008Polly Bijur PhD Abstract Objectives:, The objective was to test the hypothesis that African American and Hispanic patients are less likely to receive analgesics than white patients in two academic urban emergency departments (EDs). Methods:, This was a prospective observational study of a convenience sample of patients with long-bone fractures from April 2002 to November 2006 in two academic urban EDs. Eligibility criteria were age 18,55 years, isolated long-bone fracture, and race and ethnicity (Hispanic, African American, and white). The primary outcome was receipt of analgesics; secondary outcomes included receipt of opioids, dose, route, time to first analgesic, and change in pain. Logistic regression was used to adjust the risk of receiving analgesics for patients' initial rating of pain and demographic characteristics. Results:, Of 1,239 patients with suspected long-bone fractures, 345 patients were eligible: 177 (51%) were Hispanic, 98 (28%) were African American, and 70 (20%) were white. Administration of analgesics was not associated with race or ethnicity. Sixteen percent (95% confidence interval [CI] = 11% to 22%) of Hispanic, 15% (95% CI = 10% to 24%) of African American, and 14% (95% CI = 8% to 24%) of white patients did not receive any analgesics. Seventy-four percent of Hispanic (95% CI = 67% to 80%), 66% of African American (95% CI = 57% to 75%), and 69% (95% CI = 57% to 78%) of white patients received opioid analgesics. After adjustment for covariates, there was no evidence of an association between receipt of analgesics or opioid analgesics and the race or ethnicity of the patients. There were no significant differences in time to treatment, dose, route, or change in pain. Conclusions:, Receipt of analgesics for pain from long-bone fractures was not associated with patient race or ethnicity in two academic urban EDs. [source] Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced nonsmall cell lung cancerCANCER, Issue 11 2005Ralph G. Zinner M.D. Abstract BACKGROUND The primary objectives of this study were to determine the efficacy and tolerability of a pemetrexed-carboplatin combination as first-line therapy in patients with advanced nonsmall cell lung cancer. METHODS Eligibility criteria included Zubrod performance status of 0 or 1, Stage IIIB (malignant effusion) or IV disease, and no prior chemotherapy. Treatment was pemetrexed 500 mg/m2 given intravenously and carboplatin area under the serum concentration,time curve = 6 given intravenously on Day 1 every 3 weeks for six cycles; patients could receive additional cycles at the discretion of the treating physician and patient. All patients received folic acid, vitamin B12, and dexamethasone prophylaxis. RESULTS Fifty patients (31 men and 19 women) were treated. The median age was 62 years. Ninety-six percent of patients had Stage IV disease, and 88% had a performance status of 1. The median number of cycles was 6; 15 patients received 8 or more cycles. There was Grade 3/4 neutropenia in 11 (22%) and 2 (4%) patients, respectively; Grade 3/4 thrombocytopenia in 1 (2%) and 0 patients, respectively. Three patients (6%) experienced Grade 3 nonhematologic side effects (diarrhea, neutropenic pneumonia, and fatigue). No patients had sensory neuropathy or alopecia >Grade 1. The partial response rate was 24%, median time to progression 5.4 months, 1-year survival 56.0%, and median survival 13.5 months. CONCLUSIONS This is an active, very well-tolerated regimen. Trials focused on how to integrate this doublet with novel agents are warranted. Cancer 2005. © 2005 American Cancer Society. [source] Long-acting insulin analogues vs.DIABETES OBESITY & METABOLISM, Issue 4 2009NPH human insulin in type 1 diabetes. Aim:, Basal insulin in type 1 diabetes can be provided using either NPH (Neutral Protamine Hagedorn) human insulin or long-acting insulin analogues, which are supposed to warrant a better metabolic control with reduced hypoglycaemic risk. Aim of this meta-analysis is the assessment of differences with respect to HbA1c (Glycated hemoglobin), incidence of hypoglycaemia, and weight gain, between NPH human insulin and each long-acting analogue. Methods:, Of 285 randomized controlled trials with a duration > 12 weeks comparing long-acting insulin analogues (detemir or glargine) with NPH insulin in type 1 diabetic patients identified through Medline search and searches on www.clinicaltrials.gov, 20 met eligibility criteria (enrolling 3693 and 2485 in the long-acting analogues and NPH group respectively). Data on HbA1c and body mass index at endpoint, and incidence of any, nocturnal and severe hypoglycaemia, were extracted and meta-analysed. Results:, Long-acting analogues had a small, but significant effect on HbA1c [-0.07 (,0.13; ,0.01)%; p = 0.026], in comparison with NPH human insulin. When analysing the effect of long-acting analogues on body weight, detemir was associated with a significantly smaller weight gain than human insulin [by 0.26 (0.06;0.47) kg/m2; p = 0.012]. Long-acting analogues were associated with a reduced risk for nocturnal and severe hypoglycaemia [OR (Odd Ratio, 95% Confidence Intervals) 0.69 (0.55; 0.86), and OR 0.73 (0.60; 0.89) respectively; all p < 0.01]. Conclusions:, The switch from NPH to long-acting analogues as basal insulin replacement in type 1 diabetic patients had a small effect on HbA1c, and also reduced the risk of nocturnal and severe hypoglycaemia. [source] A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetesDIABETIC MEDICINE, Issue 12 2006V. L. Franklin Abstract Aims To assess Sweet Talk, a text-messaging support system designed to enhance self-efficacy, facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes. Methods One hundred and twenty-six patients fulfilled the eligibility criteria; Type 1 diabetes for > 1 year, on conventional insulin therapy, aged 8,18 years. Ninety-two patients were randomized to conventional insulin therapy (n = 28), conventional therapy and Sweet Talk (n = 33) or intensive insulin therapy and Sweet Talk (n = 31). Goal-setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system, containing personalized goal-specific prompts and messages tailored to patients' age, sex and insulin regimen. Results HbA1c did not change in patients on conventional therapy without or with Sweet Talk (10.3 ± 1.7 vs. 10.1 ± 1.7%), but improved in patients randomized to intensive therapy and Sweet Talk (9.2 ± 2.2%, 95% CI ,1.9, ,0.5, P < 0.001). Sweet Talk was associated with improvement in diabetes self-efficacy (conventional therapy 56.0 ± 13.7, conventional therapy plus Sweet Talk 62.1 ± 6.6, 95% CI +2.6, +7.5, P = 0.003) and self-reported adherence (conventional therapy 70.4 ± 20.0, conventional therapy plus Sweet Talk 77.2 ± 16.1, 95% CI +0.4, +17.4, P = 0.042). When surveyed, 82% of patients felt that Sweet Talk had improved their diabetes self-management and 90% wanted to continue receiving messages. Conclusions Sweet Talk was associated with improved self-efficacy and adherence; engaging a classically difficult to reach group of young people. While Sweet Talk alone did not improve glycaemic control, it may have had a role in supporting the introduction of intensive insulin therapy. Scheduled, tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care settings and chronic diseases. [source] Treatment of symptomatic diabetic polyneuropathy with the antioxidant ,-lipoic acid: a meta-analysisDIABETIC MEDICINE, Issue 2 2004D. Ziegler Abstract Aims To determine the efficacy and safety of 600 mg of ,-lipoic acid given intravenously over 3 weeks in diabetic patients with symptomatic polyneuropathy. Methods We searched the database of VIATRIS GmbH, Frankfurt, Germany, for clinical trials of ,-lipoic acid according to the following prerequisites: randomized, double-masked, placebo-controlled, parallel-group trial using ,-lipoic acid infusions of 600 mg i.v. per day for 3 weeks, except for weekends, in diabetic patients with positive sensory symptoms of polyneuropathy which were scored by the Total Symptom Score (TSS) in the feet on a daily basis. Four trials (ALADIN I, ALADIN III, SYDNEY, NATHAN II) comprised n = 1258 patients (,-lipoic acid n = 716; placebo n = 542) met these eligibility criteria and were included in a meta-analysis based on the intention-to-treat principle. Primary analysis involved a comparison of the differences in TSS from baseline to the end of i.v. Treatment between the groups treated with ,-lipoic acid or placebo. Secondary analyses included daily changes in TSS, responder rates (, 50% improvement in TSS), individual TSS components, Neuropathy Impairment Score (NIS), NIS of the lower limbs (NIS-LL), individual NIS-LL components, and the rates of adverse events. Results After 3 weeks the relative difference in favour of ,-lipoic acid vs. placebo was 24.1% (13.5, 33.4) (geometric mean with 95% confidence interval) for TSS and 16.0% (5.7, 25.2) for NIS-LL. The responder rates were 52.7% in patients treated with ,-lipoic acid and 36.9% in those on placebo (P < 0.05). On a daily basis there was a continuous increase in the magnitude of TSS improvement in favour of ,-lipoic acid vs. placebo which was noted first after 8 days of treatment. Among the individual components of the TSS, pain, burning, and numbness decreased in favour of ,-lipoic acid compared with placebo, while among the NIS-LL components pin-prick and touch-pressure sensation as well as ankle reflexes were improved in favour of ,-lipoic acid after 3 weeks. The rates of adverse events did not differ between the groups. Conclusions The results of this meta-analysis provide evidence that treatment with ,-lipoic acid (600 mg/day i.v.) over 3 weeks is safe and significantly improves both positive neuropathic symptoms and neuropathic deficits to a clinically meaningful degree in diabetic patients with symptomatic polyneuropathy. Diabet. Med. 21, 114,121 (2004) [source] Placebo-corrected efficacy of modern antiepileptic drugs for refractory epilepsy: Systematic review and meta-analysisEPILEPSIA, Issue 1 2010Stefan Beyenburg Summary Although adjunctive treatment with modern antiepileptic drugs (AEDs) is standard care in refractory epilepsy, it is unclear how much of the effect can be attributed directly to the AEDs and how much to the beneficial changes seen with placebo. Therefore, we performed a systematic review and meta-analysis of the evidence to determine the placebo-corrected net efficacy of adjunctive treatment with modern AEDs on the market for refractory epilepsy. Of 317 potentially eligible articles reviewed in full text, 124 (39%) fulfilled eligibility criteria. After excluding 69 publications, 55 publications of 54 studies in 11,106 adults and children with refractory epilepsy form the basis of evidence. The overall weighted pooled-risk difference in favor of AEDs over placebo for seizure-freedom in the total sample of adults and children was 6% [95% confidence interval (CI) 4,8, z = 6.47, p < 0.001] and 21% (95% CI 19,24, z = 17.13, p < 0.001) for 50% seizure reduction. Although the presence of moderate heterogeneity may reduce the validity of the results and limit generalizations from the findings, we conclude that the placebo-corrected efficacy of adjunctive treatment with modern AEDs is disappointingly small and suggest that better strategies of finding drugs are needed for refractory epilepsy, which is a major public health problem. [source] Long-term seizure outcome of surgery versus no surgery for drug-resistant partial epilepsy: A review of controlled studiesEPILEPSIA, Issue 6 2009Dieter Schmidt Summary A majority of patients with formerly drug-resistant temporal lobe epilepsy become seizure-free after surgery. However, apart from one 12-month randomized trial, it is unclear how many become seizure-free because of surgery. To determine the net benefit of surgery, we performed a systematic review and meta-analysis of the published evidence of how many patients in similar studies become seizure-free without surgery. Of 155 potentially eligible articles reviewed in full text, 29 (19%) fulfilled eligibility criteria. After excluding 9 publications, 20 studies form the base of evidence. Overall, 719 of 1,621 (44%) of patients with mostly temporal lobe surgery were seizure-free compared to 139 of 1113 (12%) of nonoperated controls [pooled random effects relative risk (RR) 4.26, 95% confidence interval (CI) 3.03,5.98]. The pooled risk difference in favor of surgery was 42% (95% CI 32,51%). We found no comparative outcome data in patients with extratemporal lobe epilepsy only. The available evidence from mostly nonrandomized observational studies indicates that in appropriately selected patients with drug-resistant temporal lobe epilepsy, the combination of surgery with medical treatment is 4 times as likely as medical treatment alone to achieve freedom from seizures. [source] The Multicenter Study of Epilepsy Surgery: Recruitment and Selection for SurgeryEPILEPSIA, Issue 11 2003Anne T. Berg Summary:,Purpose: Multiple studies have examined predictors of seizure outcomes after epilepsy surgery. Most are single-center series with limited sample size. Little information is available about the selection process for surgery and, in particular, the proportion of patients who ultimately have surgery and the characteristics that identify those who do versus those who do not. Such information is necessary for providing the epidemiologic and clinical context in which epilepsy surgery is currently performed in the United States and in other developed countries. Methods: An observational cohort of 565 surgical candidates was prospectively recruited from June 1996 through January 2001 at six Northeastern and one Midwestern surgical centers. Standardized eligibility criteria and protocol for presurgical evaluations were used at all seven sites. Results: Three hundred ninety-six (70%) study subjects had resective surgery. Clinical factors such as a well-localized magnetic resonance imaging (MRI) abnormality and consistently localized EEG findings were most strongly associated with having surgery. Of those who underwent intracranial monitoring (189, 34%), 85% went on to have surgery. Race/ethnicity and marital status were marginally associated with having surgery. Age, education, and employment status were not. Demographic factors had little influence over the surgical decision. More than half of the patients had intractable epilepsy for ,10 years and five or more drugs had failed by the time they initiated their surgical evaluation. During the recruitment period, eight new antiepileptic drugs were approved by the Food and Drug Administration for use in the United States and came into increasing use in this study's surgical candidates. Despite the increased availability of new therapeutic options, the proportion that had surgery each year did not fluctuate significantly from year to year. This suggests that, in this group of patients, the new drugs did not provide a substantial therapeutic benefit. Conclusions: Up to 30% of patients who undergo presurgical evaluations for resective epilepsy surgery ultimately do not have this form of surgery. This is a group whose needs are not currently met by available therapies and procedures. Lack of clear localizing evidence appears to be the main reason for not having surgery. To the extent that these data can address the question, they suggest that repeated attempts to control intractable epilepsy with new drugs will not result in sustained seizure control, and eligible patients will proceed to surgery eventually. This is consistent with recent arguments to consider surgery earlier rather than later in the course of epilepsy. Postsurgical follow-up of this group will permit a detailed analysis of presurgical factors that predict the best and worst seizure outcomes. [source] Prevention of wound complications following salvage laryngectomy using free vascularized tissueHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2007FRCS(C), Kevin Fung MD Abstract Background. Total laryngectomy following radiation therapy or concurrent chemoradiation therapy is associated with unacceptably high complication rates because of wound healing difficulties. With an ever increasing reliance on organ preservation protocols as primary treatment for advanced laryngeal cancer, the surgeon must develop techniques to minimize postoperative complications in salvage laryngectomy surgery. We have developed an approach using free tissue transfer in an effort to improve tissue vascularity, reinforce the pharyngeal suture line, and minimize complications in this difficult patient population. The purpose of this study was to outline our technique and determine the effectiveness of this new approach. Methods. We conducted a retrospective review of a prospective cohort and compared it with a historical group (surgical patients of Radiation Therapy Oncology Group (RTOG)-91-11 trial). Eligibility criteria for this study included patients undergoing salvage total laryngectomy following failed attempts at organ preservation with either high-dose radiotherapy or concurrent chemo/radiation therapy regimen. Patients were excluded if the surgical defect required a skin paddle for pharyngeal closure. The prospective cohort consisted of 14 consecutive patients (10 males, 4 females; mean age, 58 years) who underwent free tissue reinforcement of the pharyngeal suture line following total laryngectomy. The historical comparison group consisted of 27 patients in the concomitant chemoradiotherapy arm of the RTOG-91-11 trial who met the same eligibility criteria (26 males, 1 female; mean age, 57 years) but did not undergo free tissue transfer or other form of suture line reinforcement. Minimum follow-up in both groups was 12 months. Results. The overall pharyngocutaneous fistula rate was similar between groups,4/14 (29%) in the flap group, compared with 8/27 (30%) in the RTOG-91-11 group. There were no major wound complications in the flap group, compared with 4 (4/27, 14.8%) in the RTOG-91-11 group. There were no major fistulas in the flap group, compared with 3/27 (11.1%) in the RTOG-91-11 group. The rate of pharyngeal stricture requiring dilation was 6/14 (42%) in the flap group, compared with 7/27 (25.9%) in the RTOG-91-11 group. In our patients, the rate of tracheoesophageal speech was 14/14 (100%), and complete oral intake was achieved in 13/14 (93%) patients. Voice-Related Quality of Life Measure (V-RQOL) and Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) scores suggest that speech and swallowing functions are reasonable following free flap reinforcement. Conclusions. Free vascularized tissue reinforcement of primary pharyngeal closure in salvage laryngectomy following failed organ preservation is effective in preventing major wound complications but did not reduce the overall fistula rate. Fistulas that developed following this technique were relatively small, did not result in exposed major vessels, and were effectively treated with outpatient wound care rather than readmission to the hospital or return to operating room. Speech and swallowing results following this technique were comparable to those following total laryngectomy alone. © 2007 Wiley Periodicals, Inc. Head Neck 2007 [source] The Impact of Welfare Reform on Insurance Coverage before Pregnancy and the Timing of Prenatal Care InitiationHEALTH SERVICES RESEARCH, Issue 4 2007Norma I. Gavin Objective. This study investigates the impact of welfare reform on insurance coverage before pregnancy and on first-trimester initiation of prenatal care (PNC) among pregnant women eligible for Medicaid under welfare-related eligibility criteria. Data Sources. We used pooled data from the Pregnancy Risk Assessment Monitoring System for eight states (AL, FL, ME, NY, OK, SC, WA, and WV) from 1996 through 1999. Study Design. We estimated a two-part logistic model of insurance coverage before pregnancy and first-trimester PNC initiation. The impact of welfare reform on insurance coverage before pregnancy was measured by marginal effects computed from coefficients of an interaction term for the postreform period and welfare-related eligibility and on PNC initiation by the same interaction term and the coefficients of insurance coverage adjusted for potential simultaneous equation bias. We compared the estimates from this model with results from simple logistic, ordinary least squares, and two-stage least squares models. Principal Findings. Welfare reform had a significant negative impact on Medicaid coverage before pregnancy among welfare-related Medicaid eligibles. This drop resulted in a small decline in their first-trimester PNC initiation. Enrollment in Medicaid before pregnancy was independent of the decision to initiate PNC, and estimates of the effect of a reduction in Medicaid coverage before pregnancy on PNC initiation were consistent over the single- and two-stage models. Effects of private coverage were mixed. Welfare reform had no impact on first-trimester PNC beyond that from reduced Medicaid coverage in the pooled regression but separate state-specific regressions suggest additional effects from time and income constraints induced by welfare reform may have occurred in some states. Conclusions. Welfare reform had significant adverse effects on insurance coverage and first-trimester PNC initiation among our nation's poorest women of childbearing age. Improved outreach and insurance options for these women are needed to meet national health goals. [source] Impact of reproductive factors and lactation on breast carcinoma in situ riskINTERNATIONAL JOURNAL OF CANCER, Issue 1 2004Kathleen Meeske Abstract Incidence rates for breast carcinoma in situ (CIS) have increased markedly over the past 20 years. Breast CIS, detected primarily on mammography, now represents 30,45% of all screened detected breast cancers. We conducted a large population-based case-control study to evaluate the impact of reproductive factors and lactation on breast CIS risk. Case subjects were newly diagnosed with breast CIS at ages 35,64 years between March 1, 1995 and May 31, 1998 (n = 567), resided in Los Angeles County and were born in the United States. Control subjects (n = 614), identified through random digit dialing, fulfilled the same eligibility criteria and were required to have had at least one screening mammogram in the 2-year period before their interview. Women with a positive family history of breast cancer had a 2-fold increase in breast CIS risk. Parous women were at reduced risk relative to nulligravid women (odds ratio [OR] = 0.67, 95% confidence interval [CI] = 0.46,1.00). Among nulliparous women, pregnancy was unrelated to breast CIS risk. Among parous women, risk declined with each additional term pregnancy (p -trend = 0.003). No associations were found with age at first term pregnancy, induced abortion or miscarriage. Long duration of breast-feeding (,24 months) was associated with increased risk (OR = 2.00, 95% CI = 1.11,3.60). The observed effects of family history and pregnancy on breast CIS risk are consistent with those observed for invasive breast cancer. The results for breast-feeding are contrary to what has been observed in studies of invasive breast cancer. © 2004 Wiley-Liss, Inc. [source] The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic reviewINTERNATIONAL JOURNAL OF DENTAL HYGIENE, Issue 4 2008DE Slot Abstract:, Aim:, The aim of the study was to asses the effect of the use of interdental brushes (IDB) in patients as an adjunct to toothbrushing compared with toothbrushing alone or other interdental oral hygiene devices on plaque and the clinical parameters of periodontal inflammation. Material and methods:, MEDLINE,PubMed and the Cochrane Central register of controlled trials (CENTRAL) were searched through November 2007 to identify appropriate studies. Clinical parameters of periodontal inflammation such as plaque, gingivitis, bleeding and pockets were selected as outcome variables. Results:, Independent screening of the titles and abstracts of 218 MEDLINE,PubMed and 116 Cochrane papers resulted in nine publications that met the eligibility criteria. Mean values and standard deviations were collected by data extraction. Descriptive comparisons are presented for brushing alone or brushing and woodsticks; meta-analyses were also performed for the floss comparison. Conclusion:, As an adjunct to brushing, the IDB removes more dental plaque than brushing alone. Studies showed a positive significant difference using IDB with respect to the plaque scores, bleeding scores and probing pocket depth. The majority of the studies presented a positive significant difference in the plaque index when using the IDB compared with floss. [source] Lack of evidence of the effectiveness of primary brachial plexus surgery for infants (under the age of two years) diagnosed with obstetric brachial plexus palsyINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2006Andrea Bialocerkowski PhD M App Sc (Physio) M App Sc (Physio) Grad Dip Public Health Abstract Background, Obstetric brachial plexus palsy, which occurs in 1,3 per 1000 live births, results from traction and/or compression of the brachial plexus in utero, during descent through the birth canal or during delivery. This results in a spectrum of injuries that range in extent of damage and severity and can lead to a lifelong impairment and functional difficulties associated with the use of the affected upper limb. Most infants diagnosed with obstetric brachial plexus palsy receive treatment, such as surgery to the brachial plexus, physiotherapy or occupational therapy, within the first months of life. However, there is controversy regarding the most effective form of management. This review follows on from our previous systematic review which investigated the effectiveness of primary conservative management in infants with obstetric brachial plexus palsy. This systematic review focuses on the effects of primary surgery. Objectives, The objective of this review was to systematically assess and collate all available evidence on effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy. Search strategy, A systematic literature search was performed using 13 databases: TRIP, MEDLINE, CINAHL, Web of Science, Proquest 5000, Evidence Based Medicine Reviews, Expanded Academic ASAP, Meditext, Science Direct, the Physiotherapy Evidence Database, Proquest Digital Dissertations, Open Archives Initiative Search Engine, the Australian Digital Thesis program. Those studies that were reported in English and published between July 1992 to June 2004 were included in this review. Selection criteria, Quantitative studies that investigated the effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy were eligible for inclusion into this review. This excluded studies where infants were solely managed conservatively or with pharmacological agents, or underwent surgery for the management of secondary deformities. Data collection and analysis, Two independent reviewers assessed the eligibility of each study for inclusion into the review, the study design used and its methodological quality. Where any disagreement occurred, consensus was reached by discussion. Studies were also assessed for clinical homogeneity by considering populations, interventions and outcomes. Where heterogeneity was present, synthesis was undertaken in a narrative format. Results, Twenty-one studies were included in the review. Most were ranked low on the hierarchy of evidence (no randomised controlled trials were found), and most had only fair methodological quality. Surgical intervention was variable, as were the eligibility criteria for surgery, the timing of surgery and the outcome instruments used to evaluate the effect of surgery. Therefore, it is difficult to draw conclusions regarding the effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy. Conclusions, Although there is a wealth of information regarding the outcome following primary brachial plexus surgery it was not possible to determine whether this treatment is effective in increasing functional recovery in infants with obstetric brachial plexus palsy. Further research is required to develop standardised surgical criteria, and standardised outcome measures should be used at specific points in time during the recovery process to facilitate comparison between studies. Moreover, comparison groups are required to determine the relative effectiveness of surgery compared with other forms of management. [source] Acetylcholinesterase treatment,modelling potential demand and auditing practiceINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 12 2001Simon Lovestone Abstract Background Acetylcholinesterase inhibitors represent an entirely novel treatment option for patients with Alzheimer's disease (AD). As such they represent a significant change in practice and a significant cost pressure on funding bodies. Objectives To assess the impact of cholinesterase inhibitors on routine clinical practice. Methods We estimated potential demand for the compounds taking into account eligibility criteria and prescribing practice agreed between clinicians and funders. We then audited actual prescribing practice assessing whether the estimated demand matched actual demand and whether practice and prescribing criteria were adhered to. Results Over a two-year period we estimated the demand for treatment at a total of 89 patient years for the population of the audit unit. In practice only 24.5 patient years of therapy were received, the short fall apparently being due to low referral rates for treatment. Prescribing by clinicians matched practice guidelines and a high proportion of three monthly assessments using scales for cognition, function and global state were performed. Using these assessment procedures treatment successes could be differentiated from primary and secondary treatment failures and, where apparently appropriate, treatment could be stopped. Conclusion In the real world of clinical practice demand for treatment in AD is modest but likely to grow and assessment with an aim to identifying those receiving benefit from treatment can be achieved. Copyright © 2001 John Wiley & Sons, Ltd. [source] Disability benefits and workers with HIV/AIDS: Coverage issues and challenges in the United Republic of TanzaniaINTERNATIONAL SOCIAL SECURITY REVIEW, Issue 4 2008Tulia Ackson Abstract This paper explores the effective non-availability of disability/invalidity benefits to formal sector employees with HIV/AIDS in the United Republic of Tanzania. The legal difficulty of establishing a direct connection between HIV/AIDS and employment injury and occupational diseases present a challenge to social security institutions and schemes which are simultaneously trying to come to grips with the mounting problems of the shrinkage of the formal sector and low coverage. Remedial policy responses are proposed. These identify the statutory and legal adjustments needed both to ensure convergence of eligibility criteria for invalidity benefit claims among the concerned institutions, and to ensure that qualifying conditions are both consistent and in line with contemporary approaches to disbility. The suggested adjustments would simplify and clarify eligibility criteria in cases of invalidity involving existing scheme members, potentially also allowing for a future expansion of benefit coverage better to reflect labour market realities. [source] Flu: Effect of Vaccine in Elderly Care Home Residents: A Randomized TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2007Fiona Gaughran MD OBJECTIVES: To determine whether assessing seroprotection after influenza vaccine and administering booster vaccination where not achieved reduces hospitalization and death. To estimate the overall seroprotection rate of influenza vaccine. DESIGN: A two-arm, partially blind, randomized, multicenter, parallel-group, controlled trial. SETTING: Twenty-six care homes in three South London boroughs in fall 2004. PARTICIPANTS: Two hundred seventy-seven elderly permanent care home residents meeting eligibility criteria. INTERVENTION: Postvaccination blood samples were randomized to booster evaluation or no booster evaluation (control). If evaluation revealed inadequate seroprotection, a booster vaccine was administered. MEASUREMENTS: Primary outcome was hospitalization to end April 2005; secondary outcomes were death, antibiotic use, and seroprotection. RESULTS: Sixty percent of the controls and 41% of the booster evaluation group responded to routine vaccination. Booster vaccination where indicated increased seroprotection rates in the booster evaluation group to 66%. Treatment groups did not differ in any outcome measures in the intention-to-treat analysis (hospitalization odds ratio=1.02, 95% confidence interval=0.55,1.87). There was a tendency towards greater differences between groups in the per-protocol analysis than in the intention-to-treat analysis, particularly regarding seroprotection rates. The same effect was observed in the a priori exploratory analysis of residents not seroprotected after routine vaccination alone. CONCLUSION: In a year without circulating influenza, there is no clinical benefit of administering a booster vaccine if routine trivalent vaccination fails to result in seroprotection. Hemagglutination titers rose in two strains postbooster vaccination but fell against the novel strain, Wyoming. The benefit of such a booster strategy when influenza is prevalent thus remains unc ertain. [source] Osteoporosis-Related Kyphosis and Impairments in Pulmonary Function: A Systematic Review,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 3 2007Robyn A Harrison Abstract We conducted a systematic review to examine the relationship between osteoporotic vertebral fractures, kyphosis, and pulmonary function. Findings suggest modest but predictable declines in vital capacity related to the degree of kyphosis. However, there were only four studies, and all had significant methodologic limitations. Further high-quality research is needed. Introduction: Our objective was to systematically review the extent to which osteoporosis-related vertebral fractures and kyphosis affect pulmonary function. Materials and Methods: We used a literature search from 1966 to 2006 (using Medline, EMBASE, and hand searches of references) for studies examining pulmonary function in patients without known lung disease who had vertebral fractures or kyphosis secondary to osteoporosis. Two reviewers independently abstracted data. Heterogeneity precluded formal meta-analysis. Results: Initial searches yielded 453 articles. After applying eligibility criteria, only four case-control studies of limited quality (e.g., only one study was blinded) remained. Since 1966, only 109 patients (6 men) have been studied. All four studies reported reductions in vital capacity (VC), with values ranging from 68% to 94% of predicted values. This was quantified as a 9% reduction in predicted VC per vertebral fracture in one study. The degree of kyphosis clinically (one study) or radiographically (three studies) correlated with declines in VC; impairments were most notable at kyphotic angles >55°. Statistically significant differences in percent predicted VC were obtained only when arm span or recalled height, rather than measured height, was used (two studies). Conclusions: Despite conventional teaching, the evidence relating osteoporotic vertebral fractures or kyphosis to pulmonary function is limited. On the basis of available studies, declines in VC secondary to kyphosis seem modest and directly related to the number of vertebral fractures or degree of kyphosis. Future studies need longitudinal follow-up of larger numbers of men and women, appropriate proxies for height, standardized measures for pulmonary function and kyphosis, and efforts to blind outcomes ascertainment. [source] Preoperative Intra-Aortic Balloon Pump in Patients Undergoing Coronary Bypass Surgery: A Systematic Review and Meta-AnalysisJOURNAL OF CARDIAC SURGERY, Issue 1 2008Adel M. Dyub M.D., M.Sc. The primary outcome was hospital mortality and secondary outcomes were IABP-related complications (bleeding, leg ischemia, aortic dissection). Methods: MEDLINE, EMBASE, Cochrane registry of Controlled Trials, and reference lists of relevant articles were searched. We included randomized controlled trials (RCTs), and cohort studies that fulfilled our a priori inclusion criteria. Eligibility decisions, relevance, study validity, and data extraction were performed in duplicate using pre-specified criteria. Meta-analysis was conducted using a random effects model. Results: Ten publications fulfilled our eligibility criteria, of which four were RCTs and six were cohort studies with controls. There were statistical as well as clinical heterogeneity among included studies. A total of 1034 patients received preoperative IABP and 1329 did not receive preoperative IABP. The pooled odds ratio (OR) for hospital mortality in patients treated with preoperative IABP was 0.41 (95% CI, 0.21,0.82, p = 0.01). The number needed to treat was 17. The pooled OR for hospital mortality from randomized trials was 0.18 (95% CI, 0.06,0.57, p = 0.003) and from cohort studies was 0.54 (95% CI, 0.24,1.2, p = 0.13). Overall, 3.7% (13 of 349) of patients who received preoperative IABP developed either limb ischemia or haematoma at the IABP insertion site, and most of these complications improved after discontinuation of IABP. Conclusion: Evidence from this meta-analysis support the use of preoperative IABP in high-risk patients to reduce hospital mortality. [source] Patients' preference for radiotherapy fractionation schedule in the palliation of symptomatic unresectable lung cancer,JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 5 2008JI Tang Summary The palliative radiotherapeutic management of unresectable non-small-cell lung cancer is controversial, with various fractionation (Fx) schedules available. We aimed to determine patient's choice of Fx schedule after involvement in a decision-making process using a decision board. A decision board outlining the various advantages and disadvantages apparent in the Medical Research Council study of Fx schedules (17 Gy in two fractions vs 39 Gy in 13 fractions) was discussed with patients who met Medical Research Council eligibility criteria. Patients were then asked to indicate their preferred Fx schedules, reasons and their level of satisfaction with being involved in the decision-making process. Radiation oncologists (RO) could prescribe radiotherapy schedules irrespective of patients' preferences. Of 92 patients enrolled, 55% chose the longer schedule. English-speaking patients were significantly more likely to choose the longer schedule (P = 0.02, 95% confidence interval: 1.2,7.6). Longer Fx was chosen because of longer survival (90%) and better local control (12%). Shorter Fx was chosen for shorter overall treatment duration (80%), cost (61%) and better symptom control (20%). In all, 56% of patients choosing the shorter schedule had their treatment altered by the treating RO, whereas only 4% of patients choosing longer Fx had their treatment altered (P < 0.001). Despite this, all (100%) patients were satisfied with being involved in the decision-making process. The decision board was useful in aiding decision-making, with both Fx schedules being acceptable to patients. Interestingly, despite the longer average survival associated with longer Fx, nearly half of the patients believed that this was not as important as a shorter duration of treatment and lower cost. Despite patients' preferences, there were significant alterations of preferred schedules because of RO's own biases. [source] Emergency department attendances associated with drug-related problems in paediatricsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 2 2003KL Easton-Carter Objectives: To determine the frequency and characteristics of paediatric emergency department attendances associated with drug-related problems (DRP) at three Victorian hospitals. Methods: All paediatric medical patients attending the emergency department of the Royal Children's Hospital, Geelong Hospital or Box Hill Hospital were considered for inclusion. The investigator and attending medical practitioners screened eligible patients. A multidisciplinary panel reviewed collated data. Causality, preventability and clinical significance classifications were established by the panel. Results: Combining data from the three hospitals, over 18 weeks of data collection, a total of 8601 patients met the eligibility criteria. Of these, 280 (3.3%, 95% CI 2.9,3.7%) were determined to have emergency department attendances associated with DRP. Of the 187 cases assessed for preventability, 51.3% were judged to be preventable. Conclusions: Emergency department attendances are associated with DRP in paediatrics. Given that the need to prevent DRP in adults is recognized, it is now time to act to reduce the consequences of DRP in paediatrics. [source] |