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PubMed2005

Usefulness of electrodiagnostic techniques in the evaluation of suspected tarsal tunnel syndrome: an evidence-based review.

This evidence-based review was performed to evaluate the utility of nerve conduction studies (NCSs) and needle electromyography (EMG) in the diagnosis of tibial neuropathy at the ankle (tarsal tunnel syndrome, TTS). A total of 317 articles on TTS were identified that were published in English from 1965 through April 2002, from the National Library of Medicine MEDLINE database. All articles were reviewed on the basis of six selection criteria. The results of this search revealed that four articles met five or more criteria. All four articles examined the use of electrodiagnostic (EDX) techniques for the evaluation of patients with clinically suspected TTS, and were included in this practice parameter. Each of these four studies was considered to meet Class III level of evidence. NCSs were abnormal in some patients with suspected TTS. Sensory NCSs were more likely to be abnormal than motor NCSs but the actual sensitivity and specificity could not be determined. The sensitivity of needle EMG abnormalities could not be determined. NCSs may be useful for confirming the diagnosis of tibial neuropathy at the ankle, recommendation Level C. Well-designed studies are needed to evaluate more definitively EDX techniques in TTS.

Action Potentials↗

PubMed2003

Update on Cochrane data on paediatric respiratory diseases.

INTRODUCTION: Systematic reviews seek to describe and summarise the best evidence for a given intervention by pooling data from relevant quality clinical trials. The Cochrane Collaboration has fostered the development and dissemination of systematic reviews throughout the world. We have identified and summarised The Cochrane systematic reviews of relevance to the paediatric pulmonologist. METHODS: We performed an expert search of the Cochrane Database of Systematic Reviews using a combination of medical subject headings and free text terms relating to paediatric respiratory disease. RESULTS: The search identified 120 systematic reviews with interventions specific to children with some relevance to pulmonary disease, and 327 reviews with interventions relating to pulmonary disease in adults and children. After pragmatic exclusions, 81 reviews were sorted by disease and 59 of these are discussed in detail. CONCLUSIONS: There are now many systematic reviews that make a positive contribution to paediatric pulmonology. The majority of reviews (69%) found evidence that either confirmed or refuted an accepted practice. The remaining reviews concluded that the evidence for an accepted practice is poor and sometimes wholly absent. Clinicians must be aware that lack of evidence of effect is not the same as evidence of lack of effect. Caution must be exercised before applying the conclusions of systematic reviews based upon adult data to childhood disease.

Adolescent↗

PubMed1997

The safety of ranitidine in over a decade of use.

BACKGROUND: Ranitidine hydrochloride (Zantac) is one of the most extensively studied and widely used drugs of all time. This has provided an excellent opportunity to define its safety profile. METHODS: Data from 189 controlled clinical trials in which more than 26,000 patients received daily doses of ranitidine for 4 weeks or more were reviewed. More than 80% of patients were treated with up to 300 mg ranitidine daily; the remaining patients received doses of up to 1200 mg daily. Eighty-seven trials were placebo controlled. Analyses of post-marketing surveillance and a database of all spontaneously reported adverse events were also evaluated. RESULTS: Overall in the clinical trial programme adverse events were reported by 20% of those receiving ranitidine compared with 27% of those receiving placebo. The pattern of events was similar in all treatment groups with no evidence of dose-related toxicity in regimens encompassing an eightfold range of therapeutic doses. Similarly in a programme of studies designed to evaluate a dose of ranitidine of 75 mg for non-prescription (over-the-counter) use in the treatment of heartburn, ranitidine was not associated with an adverse event profile distinct from that of placebo. Analysis of spontaneously reported adverse event data allowed identification of rare idiosyncratic events. CONCLUSIONS: Review of data from a large population of controlled clinical trials with analyses of postmarketing surveillance studies and spontaneously reported adverse events confirmed the excellent safety profile of ranitidine.

Anti-Ulcer Agents↗

PubMed2000

Do mucosal defensive agents improve the cure rate when used with dual or triple therapy regimens for eradicating Helicobacter pylori infection?

BACKGROUND: Some of mucosal defensive agents have anti-Helicobacter pylori activities. However, their effectiveness in eradicating H. pylori infection has not been evaluated. AIM: To assess the additive effect of mucosal defensive agents in eradication regimens using statistical analysis. METHODS: Pertinent studies were retrieved using the Medline and the Igaku-chuo-zasshi databases in Japan, reference and congress abstract lists. Studies in which regimens consisted of dual or triple therapy with mucosal defensive agents and without them, were selected from the retrieved studies. Eradication rates were extracted from studies according to intention-to-treat analysis. We evaluated the efficacies of mucosal defensive agents by pooled relative risk of eradication rates and its 95% confidence intervals (95% CI), which were calculated by Mantel-Haenszel method. Heterogeneity among the studies in treatment effect was evaluated by a chi2-test. RESULTS: In dual therapy regimens, mucosal defensive agents demonstrated significant additive effects (pooled relative risk 1.41; 95% CI: 1.24-1.61). In triple therapy regimens, these agents did not provide significant additive effect. The clinical usefulness of specific agents could not be established, when each agent was analysed independently. CONCLUSIONS: Mucosal defensive agents improve the cure rate when used with existing dual therapy regimens for eradicating H. pylori infection.

Anti-Ulcer Agents↗

PubMed2006

Mycophenolate mofetil treatment of myasthenia gravis.

OBJECTIVE: To review published literature evaluating the effectiveness of mycophenolate mofetil for the treatment of myasthenia gravis (MG). DATA SOURCES: Searches of MEDLINE (1966-August 2005) and Cochrane Database (1993-August 2005) were conducted. Studies conducted in humans and published in English were retrieved. Additional data were identified through subsequent bibliographic reviews. DATA SYNTHESIS: Interruption of T- and B-lymphocyte proliferation in various autoimmune diseases has been investigated. Mycophenolate is known to inhibit lymphocyte proliferation and has shown improved clinical responses in several autoimmune diseases including lupus erythematosus, rheumatoid arthritis, and systemic vasculitis. Data suggesting similar benefits in MG treatment have been reported in case reports, retrospective analyses, an open-label trial, and a randomized, double-blind trial. CONCLUSIONS: Limited evidence from retrospective analyses and clinical trials suggests that mycophenolate is a possible treatment option for patients with MG. Improvement in clinical symptoms and a steroid-sparing effect have been reported when mycophenolate is used in this patient population. Larger, randomized, controlled, and comparative trials are needed to establish optimal dose, time to effect, specific therapeutic role, and long-term safety for mycophenolate when used for treating MG.

Clinical Trials as Topic↗

PubMed2005

Simplified search strategies were effective in identifying clinical trials of pharmaceuticals and physical modalities.

BACKGROUND AND OBJECTIVES: Assess the efficacy of simplified search strategies and identify the best electronic bibliographic database for clinical trials in the field of musculoskeletal disorders and pain. METHODS: Clinical trials within selected reviews from the Cochrane Back, Musculoskeletal, and PaPaS Review Groups were searched using MEDLINE, EMBASE, CINAHL, and CENTRAL to identify which database included the highest percentage of trials. Simplified search strategies for each review were devised and compared to the original, more complex strategy for sensitivity, specificity and precision. RESULTS: Individually, MEDLINE, and EMBASE included 90 and 89% of the relevant studies respectively, and 94% when combined. CENTRAL contained 87% and CINAHL 31%. Generally, simplified search strategies (two to four lines) had higher specificity than the original strategies (approximately 27 lines). Sensitivity was also high, but varied according to intervention. Super simple search strategies (one to two lines) proved as sensitive, but were slightly less specific, depending on the intervention. Both simple and super simple search strategies were often more precise than the original. CONCLUSION: Simplified search strategies are an effective, efficient way to search for clinical trials. They work best when the intervention is a pharmaceutical or a well-defined physical treatment. Their sensitivity, however, is not adequate for conducting systematic reviews.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2002

Suicide risk in patients with anxiety disorders: a meta-analysis of the FDA database.

BACKGROUND: Previous reports of suicide risk in patients with anxiety disorders have been inconsistent. METHODS: Using the FDA database, we assessed suicide and suicide attempt risk among patients, participating in recent clinical trials evaluating new anti-anxiety medications, with diagnosis of panic disorder (PD), social anxiety disorder or social phobia (SP), generalized anxiety disorder (GAD), post traumatic stress disorder (PTSD), and obsessive compulsive disorder (OCD). RESULTS: Overall, among 20076 participating anxious patients, 12 committed suicide and 28 attempted suicide. The annual suicide risk rate was 193/100000 patients and annual suicide attempt risk was 1350/100000 patients. LIMITATIONS: Clinical trial data have limited applicability to clinical practice. Participants in clinical trials are a highly selected, nonrepresentative sample of the clinical population. A number of patients never complete clinical trials and thus data are based on a limited sub-sample. These trials were not primarily designed to assess suicide risk. CONCLUSIONS: Suicide risk in patients with anxiety disorders is higher than previously thought. Patients with anxiety disorders warrant explicit evaluation for suicide risk.

Adolescent↗

PubMed2003

Trends in prescribing for heart failure in Dutch primary care from 1996 to 2000.

PURPOSE: The aim of this study is to explore trends in primary care prescribing for chronic heart failure (CHF) over a 5-year period (1996-2000). METHODS: This study consisted of repeated cross-sectional surveys in a dynamic cohort from the Integrated Primary Care Information (IPCI) primary care database. The cohort comprised all patients aged > or = 55 years with a CHF diagnosis and prescribed a cardiovascular medication during the study period. The point prevalence per calendar year was determined for each of the main drug groups used to treat CHF. RESULTS: The study population consisted of 3121 CHF patients. Small increases were seen in the percentage of CHF patients prescribed spironolactone (4.6%, 95% CI: 2.3-6.9%), beta-blockers (6.1%, 95% CI: 2.6-9.5%) and angiotensin II antagonists (6.8%, 95% CI: 5.1-8.6%) during the study period, while the prescribing of digoxin decreased (-4.4%, 95% CI: -8.2 to -0.7). Prescribing of diuretics (difference: -0.7% 95% CI: -2.7-4.2) and ACE inhibitors (difference: 4.0% 95% CI: -0.1-8.2%) remained unchanged. CONCLUSIONS: Prescription of some drug groups for CHF increased. However, given the new scientific evidence that has emerged in past 15 years regarding CHF pharmacotherapy, the changes observed were less than expected.

Aged↗

PubMed1999

The publication rates of presentations at major Spine Specialty Society meetings (NASS, SRS, ISSLS).

STUDY DESIGN: A review of all the presentations at three major spine specialty meetings held over a 3-year period. OBJECTIVES: To determine the rate of publication in peer-reviewed journals after presentations at major spine meetings conducted annually by the following three organizations: North American Spine Society (NASS), Scoliosis Research Society (SRS), and International Society for the Study of the Lumbar Spine (ISSLS). SUMMARY OF BACKGROUND DATA: The rate of publication for presentations at national and international meetings has been determined for medical and surgical subspecialties. This rate has been used to judge the quality of the content of the meetings and to determine the validity of the research presentations. METHODS: All presentations either in poster or oral presentation form were entered into a database covering a 3-year period for spine specialty meetings conducted annually by the following three organizations: NASS 1990 to 1992, SRS 1991 to 1993, and ISSLS 1991 to 1993. A computer search for each abstract was performed with the Melvyl Medline Plus database to determine if the abstract had been published in a peer-reviewed journal from 1990 to the end of 1997. Publication rates for presentations at these three meetings were determined over a 3-year period. RESULTS: A total of 1186 abstracts were listed over a 3-year period in the final programs of these three meetings for the years 1991 to 1993 (SRS, ISSLS) and 1990 to 1992 (NASS). Of these 1186 abstracts, 516 were published in peer-reviewed journals, giving an overall publication rate of 43.5%. The publication rates for the three different meetings (NASS, SRS, ISSLS) were similar, with values of 40%, 47%, and 45% respectively. More than 90% of the publications resulting from these meetings were published within a period of 4 years from the data of the meeting. CONCLUSIONS: The publication rates of presentations at three major spine specialty meetings are high and quite comparable with the publication rates of meetings in other medical subspecialties. This reflects the high quality of the meeting programs and validates their selection process.

Congresses as Topic↗

PubMed2006

Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee.

BACKGROUND: Disparities in cancer outcome among different subsets of the American population related to ethnic background have been well documented. Clinical trials represent the most powerful strategy for improving cancer treatments, but racial and ethnic minority patients are frequently underrepresented among patients accrued to these protocols. Proof of comparable efficacy for a promising cancer therapy in different groups of patients requires diversity in the clinical trial populations so that study results will be generalizable. Appropriate targets for accrual of minority ethnicity patients have not previously been defined. METHODS: The National Cancer Database (NCDB) is maintained jointly by the American Cancer Society and the American College of Surgeons. Information submitted by tumor registries throughout the United States represents an estimated 70% of newly diagnosed cancer cases. The authors analyzed NCDB reports on ethnic distribution of patients with breast, prostate, nonsmall cell lung, and colorectal cancer, stratified by stage of disease at diagnosis. RESULTS: African Americans with cancer of the breast and prostate had the most notable patterns of disproportionate representation among populations with advanced-stage disease. The authors compiled a table of suggested accrual targets for selected solid-organ cancers based on NCDB stage-specific reports. CONCLUSIONS: Clinical trial results will be more meaningful if participating patients reflect the site- and stage-specific populations that are under study. The authors recommended that clinical trial investigators incorporate accrual targets for minority ethnicity populations into the study design.

American Cancer Society↗

PubMed2004

Autologous transfusion techniques: a systematic review of their efficacy.

Shortages of donor blood and fears of transmitted infections have prompted the use of a range of blood-sparing techniques in the peri-operative period. We conducted a systematic review of three techniques that involve the re-infusion of a patient's blood--pre-operative autologous blood deposit (PAD), acute normovolaemic haemodilution (ANH), and cell salvage (CS). We examined the effects of these interventions on the need for peri-operative allogeneic red blood cell transfusion and on clinical outcomes. Controlled clinical studies were identified by computer searches of comprehensive electronic databases and bibliographic searches of published articles. The literature search retrieved a total of 68 randomized trials (RCTs) and 81 controlled observational studies that included data from over 34 000 individuals. In summary, the RCTs found that autologous transfusion techniques consistently reduced the frequency of allogeneic transfusions, with intervention effect sizes ranging from a relative 63% reduction (95% CI 46-74%) with PAD, to 42% (27-53%) with CS and to 31% (16-44%) with ANH. Non-randomized studies reported larger effect sizes than RCTs. PAD increased overall transfusion rates by 30% (95% CI 12-48%) and reduced pre-operative haemoglobin levels by an average of 1.23 g dL(-1). Intervention effects were substantially reduced when these techniques were performed under transfusion protocols. Interpretation of the studies was hampered by serious methodological weaknesses, particularly inadequate randomization techniques, unblinded measurements and the subjective nature of the outcome variables. The studies reported few clinical outcome and adverse event data. Previous claims regarding reduced rates of mortality and infection with autologous transfusions were not confirmed.

Blood Transfusion, Autologous↗

PubMed2001

Selection of clinical, patient-reported, and economic end points in acute exacerbation of chronic bronchitis.

BACKGROUND: Acute exacerbation of chronic bronchitis (AECB) places tremendous burden on patients, providers, employers, and health care systems. OBJECTIVE: The purpose of this paper is to (1) review the clinical, patient-reported, and economic measures used to evaluate disease burden and treatment effectiveness in AECB in clinical trials and (2) propose a guide for selecting study end points in AECB that will help capture all the relevant disease outcomes. METHODS: Two literature searches of the PubMed database were conducted to identify studies of clinical trials in bronchitis and evaluate the clinical, patient-reported, and economic end points used in these studies. RESULTS: Previous studies have focused primarily on clinician-assessed outcomes, which do not capture the full impact of AECB on patients' lives. Reporting mechanisms for most end points have been inconsistent, limiting the ability to compare information or interpret differences. Previous studies have given limited attention to patient-reported outcomes and the economic implications of AECB. Patient-reported outcomes such as speed of symptom relief and work productivity are important parameters for assessing treatment effectiveness and provide practical information for treatment evaluation. CONCLUSIONS: Additional research is needed to develop, examine, and validate patient-reported outcomes and the indirect costs of AECB. Measuring the relevant clinical, economic, and patient-reported outcomes in AECB patients using standardized methods may lead to a clearer understanding of the disease burden and the role, effectiveness, and cost-effectiveness of antibiotic treatment.

Acute Disease↗

PubMedDate not supplied

Managing attribute--value clinical trials data using the ACT/DB client-server database system.

ACT/DB is a client-server database application for storing clinical trials and outcomes data, which is currently undergoing initial pilot use. It stores most of its data in entity-attribute-value form. Such data are segregated according to data type to allow indexing by value when possible, and binary large object data are managed in the same way as other data. ACT/DB lets an investigator design a study rapidly by defining the parameters (or attributes) that are to be gathered, as well as their logical grouping for purposes of display and data entry. ACT/DB generates customizable data entry. The data can be viewed through several standard reports as well as exported as text to external analysis programs. ACT/DB is designed to encourage reuse of parameters across multiple studies and has facilities for dictionary search and maintenance. It uses a Microsoft Access client running on Windows 95 machines, which communicates with an Oracle server running on a UNIX platform. ACT/DB is being used to manage the data for seven studies in its initial deployment.

Clinical Trials as Topic↗

PubMed2006

Increased morbidity and mortality in acute human organophosphate-poisoned patients treated by oximes: a meta-analysis of clinical trials.

Organophosphates are one of the most common causes of poisoning, especially in the Third world, with high morbidity and mortality. The treatment of this type of poisoning involves the use of atropine and oximes. Atropine has been used successfully in large doses to counteract the muscarinic effects of organophosphate poisoning, but the efficacy of oximes in the management of this poisoning remains under question. In this study, we undertook a meta-analysis by reviewing all clinical trials to evaluate the efficacy of oximes in the management of organophosphate poisoning. The databases of PUBMED, EMBASE, Cochrane, SCOPUS, and the search engine of Google were searched for all clinical trials on the use of oximes in organophosphate poisoning. The inclusion criteria were death, development of intermediate syndrome, and need for ventilation. Six clinical trials met the inclusion criteria and were included in the metaanalysis. The chi2 tests for heterogeneity (P = 0.25, 0.16, and 0.33, respectively) indicated that the included studies were not significantly heterogeneous and could be combined. A significant relative risk (P = 0.0017) for death among oxime-exposed was 2.17 (95% CI of 1.34-3.51). The 'need for ventilation' in patients who received oxime was higher (P = 0.03) than those who did not receive oxime with a relative risk of 1.53 (1.16-2.02). The incidence of 'intermediate syndrome' for oxime-exposed patients was significantly higher (P = 0.01) than oxime non-exposed patients with a relative risk of 1.57 (95% CI 1.11-2.11). It can be concluded that oximes are not effective in the management of organophosphate-poisoned patients and, surprisingly, they can be dangerous and worsen the patient's clinical situation.

Antidotes↗

PubMed2002

High-dose versus conventional-dose chemotherapy as first-salvage treatment in patients with non-seminomatous germ-cell tumors: a matched-pair analysis.

BACKGROUND: The purpose of this study was to compare high-dose chemotherapy (HDCT) with conventional-dose chemotherapy (CDCT) as first-salvage treatment in patients with relapsed or refractory non-seminomatous germ-cell tumors (NSGCT). PATIENTS AND METHODS: One hundred and ninety-three patients with relapsed or refractory NSGCT, between 1981 and 1995, were identified from two large databases. In 74 of these, intensification of first-salvage treatment by HDCT was planned. Patients were matched based on primary tumor location, response to first-line treatment, duration of this response and serum levels of the tumor markers, human chorionic gonadotrophin (HCG) and alpha-fetoprotein (AFP). Multivariate analyses were performed using event-free survival and overall survival as primary endpoints. RESULTS: Full matches on all five factors were found for 38 pairs of patients; for a further 17 pairs, matches on at least four factors could be identified. Hazard ratios in favor of HDCT were obtained between 0.72 and 0.84 [confidence interval (CI) 0.59-1.01] for event-free survival and between 0.77 and 0.83 (CI 0.60-0.99) for overall survival, depending on the type of analysis. CONCLUSIONS: The current analysis suggests a benefit from HDCT, with an estimated absolute improvement in event-free survival of between 6 and 12% and in overall survival of between 9 and 11% at 2 years. This benefit is lower than expected from previous phase I/II studies.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2006

Risperidone treatment of bipolar mania.

OBJECTIVE: To review clinical trial evidence regarding the efficacy and safety of risperidone for the treatment of bipolar mania. DATA SOURCES: Articles were identified through searches of PubMed (1950-August 2005), EMBASE (1988-August 2005 week 37), and International Pharmaceutical Abstracts (1970-August 2005) databases using the key words risperidone, atypical antipsychotics, and bipolar mania. Additional references were found through review of bibliographies of identified articles. PubMed searches for efficacy and safety were limited to clinical trials. STUDY SELECTION AND DATA EXTRACTION: Six randomized trials and 6 observational studies of risperidone monotherapy or combination therapy for bipolar mania in adults were selected. DATA SYNTHESIS: Randomized, placebo-controlled and observational trials reported that risperidone monotherapy decreases manic symptoms in patients with a moderate severity of mania, as determined by change in Young Mania Rating Scale (YMRS) scores. Adverse effects observed in monotherapy trials included somnolence, extrapyramidal symptoms (EPS), and weight gain. Clinical trials of risperidone in combination with other mood stabilizers (ie, lithium, valproate, carbamazepine, topiramate) also reported decreases in YMRS scores in patients with moderate and severe manic symptoms. CONCLUSIONS: Risperidone monotherapy or adjunctive therapy with other first-line mood stabilizers may be effective for the treatment of acute bipolar mania in adults with moderate severity of mania. The use of risperidone as monotherapy in severe mania or in maintenance treatment remains to be elucidated.

Antipsychotic Agents↗

PubMed2003

Outcome of follicular lymphoma grade 3: is anthracycline necessary as front-line therapy?

A grading system (grades 1-3) for follicular lymphoma (FL) is used in the WHO classification for lymphoid malignancies based on the absolute number of centroblasts in the neoplastic follicles. Grade 3 FL is further subdivided into 3a and 3b depending on the presence or absence of centrocytes. A total of 231 patients with FL, referred from 1970 to 2001, were identified from our prospectively maintained database. Original diagnostic materials were available for review on 215 patients and these were reclassified according to the WHO grading system. Follicular lymphoma grades 1, 2 and 3 accounted for 92, 68 and 55 patients, respectively. No significant overall survival (OS) differences were observed among FL grades 1-3 (log rank P=0.25) or between grades 3a and 3b (log rank P=0.20). No significant failure-free survival (FFS) differences were observed among FL grades 1-3 (log rank P=0.72) or between grades 3a and 3b (log rank P=0.11). First-line anthracyclines did not influence OS or FFS (log rank P=0.86, P=0.58, respectively) in patients with FL grade 3. There are long-term survivors among patients with FL grade 3 with a continuing risk of relapse. Anthracyclines did not appear to influence survival or disease relapses when given as front-line therapy in our series. The role of anthracyclines should be further evaluated in large randomised studies.

Adolescent↗

PubMed2003

The phase III trial in the era of targeted therapy: unraveling the "go or no go" decision.

PURPOSE: To review characteristics of contemporary phase III oncology trials and create an explicit framework to help clinical researchers prioritize novel therapies for phase III testing. METHODS: We searched the MEDLINE and EMBASE databases for all reviews of phase III trials; cataloged all phase III trials in two national clinical trial databases; and reviewed approval criteria of recently approved oncology drugs from public data provided by the US Food and Drug Administration. Industry data not available elsewhere in the medical literature were obtained from a sourcebook published by a large contract research organization. RESULTS: Phase III oncology trials are the most expensive and time-consuming aspect of the drug development process. The results of these trials continue to exert the greatest influence on the treatment decision of oncologists and remain pivotal to the granting of drug approval. Making optimal decisions about which agents to advance to phase III testing may decrease the overall cost of cancer drug development and limit the number of patients exposed to ineffective drugs. A conceptual decision model for prioritizing novel therapies for phase III testing is presented. CONCLUSION: Cancer drug development has become more complex and expensive, whereas overall clinical progress remains slow. The transition from phase II to phase III requires a strategic decision that is based on new considerations. A greater investment in phase I and II drug trials may be required to provide the information necessary for phase III planning.

Antineoplastic Agents↗