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Design and implementation of a portal for the medical equipment market: MEDICOM.

BACKGROUND: The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers Web sites with itself. The network of the Portal and the connected manufacturers sites is called the MEDICOM system. OBJECTIVES: To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). METHODS: The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system s databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM s functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. RESULTS: The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. CONCLUSIONS: The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support.

Advertising↗

Redundant surgical publications: tip of the iceberg?

BACKGROUND: A redundant publication is one which duplicates previous, simultaneous, or future publications by the same author or group or, alternatively, could have been combined with the latter into one paper. As there is no information about the extent of this problem in the surgical literature, we set out to assess the incidence, spectrum, and salient characteristics of redundant publications in 3 leading surgical journals. METHODS: Original articles (excluding reviews, editorials, abstracts, and letters) published during 1998 in the journals Surgery, The British Journal of Surgery, and Archives of Surgery were searched by using the on-line search engine PUBMED. Each original article was scrutinized to identify redundancy by combining the names of the first, second, and last authors with a few key words from the title. Papers were defined as "suspected" redundant publications if they were found to address the same topic as the "index" article and shared some or most of the elements of methodology, results, or conclusions. The full versions of all suspected papers were retrieved and compared with the index articles. A grading system was developed to define several types of redundant publications: A. "dual"; B. "potentially dual"; C. "salami-slicing." RESULTS: A total of 660 articles were screened. There were 92 index articles (14%) leading to 147 suspected papers found in other journals, representing some potential form of a redundant publication. The vast majority of suspected papers were published within approximately a year of the index paper and were not cited by the latter. Most (69%) of the suspected papers were also published in surgical journals. Only 12 (8.1%) appeared in, or originated from, a "local-foreign" journal. Twenty (13.6%) of the suspected papers met the criteria for dual publications, 50 (34%) for potentially dual publications, and 77 (52.4%) were considered products of salami-slicing. CONCLUSIONS: Almost 1 in every 6 original articles published in leading surgical journals represents some form of redundancy. Current on-line search technology provides an effective tool for identifying and tracing such publications, but it is not used routinely as part of the peer review process. Redundancies occur in several well-defined patterns; the phenomenon is widespread, and it cuts across the entire spectrum of surgeons in the United States and abroad. Redundant publications must be recognized not as a mere nuisance but as a real threat to the quality and intellectual impact of surgical publishing.

General Surgery↗

Patient Safety and Quality Improvement Act of 2005.

OBJECTIVE: To review Public Law (PL) 109-41-the Patient Safety and Quality Improvement Act of 2005 (PSQIA)-and summarize key medication error research that contributed to congressional recognition of the need for this legislation. DATA SOURCES: Relevant publications related to medication error research, patient safety programs, and the legislative history of and commentary on PL 109-41, published in English, were identified by MEDLINE, PREMEDLINE, Thomas (Library of Congress), and Internet search engine-assisted searches using the terms healthcare quality, medication error, patient safety, PL 109-41, and quality improvement. Additional citations were identified from references cited in related publications. STUDY SELECTION AND DATA EXTRACTION: All relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis. DATA SYNTHESIS: PL 109-41 provides privilege and confidentiality for patient safety work product (PSWP) developed for reporting to patient safety organizations (PSOs). It does not establish federal mandatory reporting of significant errors; rather, it relies on existing state reporting systems. The Act does not preempt stronger state protections for PSWP. The Agency for Healthcare Research and Quality is directed to certify PSOs and promote the establishment of a national network of patient safety databases. Whistleblower protection and penalties for unauthorized disclosure of PSWP are among its enforcement mechanisms. CONCLUSIONS: The Act protects clinicians who report minor errors to PSOs and protects the information from disclosure, but providers must increasingly embrace a culture of interdisciplinary concern for patient safety if this protection is to have real impact on patient care.

Databases, Factual↗

Pramipexole is a possible effective treatment for primary orthostatic tremor (shaky leg syndrome).

OBJECTIVE: To report the successful treatment of primary orthostatic tremor in a 76-year-old man. BACKGROUND: Primary orthostatic tremor is a rare condition, with few reports describing therapies. Established therapies had previously failed in our patient. METHODS: Using an evidence-based evaluation of treatments via MEDLINE's GRATEFUL MED search engine, a therapeutic option was determined during the first consultation with the patient, and pramipexole therapy was initiated. RESULTS: The therapy proved effective, and the patient had relief from his symptoms for the first time in 6 years. CONCLUSION: Pramipexole is a potential therapy for primary orthostatic tremor. Arch Neurol. 2000;57:1519-1520

Aged↗

The spectrum of pneumatosis intestinalis.

HYPOTHESIS: A review of the spectrum of illness associated with pneumatosis intestinalis enables us to identify the probable causes of, the best diagnostic approaches to, and the most appropriate treatments for this condition. DATA SOURCES: A review of all published material in the English language regarding pneumatosis intestinalis was conducted using the PubMed and MEDLINE databases. Any relevant work referenced in those articles and not previously found or published before the limit of the search engine was also retrieved and reviewed. STUDY SELECTION: There were no exclusion criteria for published information relevant to the topic. All of the studies cited in the present review make a point that contributes to the portrayal of this condition. In circumstances in which the same point was made in several different studies, not all were cited herein. DATA EXTRACTION: All published material on pneumatosis intestinalis was considered. Information was extracted for preferentially selected ideas and theories supported in multiple studies. DATA SYNTHESIS: The collected information was organized by theory. CONCLUSIONS: Mucosal integrity, intraluminal pressure, bacterial flora, and intraluminal gas all interact in the formation of pneumatosis intestinalis. Radiography and computed tomography are the best diagnostic tests. Nonoperative management should be pursued in most patients, and underlying illnesses should be treated. When acute complications appear, such as perforation, peritonitis, and necrotic bowel, surgery is indicated.

Adult↗

Laparoscopic surgery: an excellent approach in elderly patients.

HYPOTHESIS: A review of the literature will show that laparoscopy is safe and effective for the treatment of surgical diseases in elderly patients. DATA SOURCES: An electronic search using the PubMed and MEDLINE databases was performed using the term laparoscopy in elderly patients. Literature published in the English language in the past decade was reviewed. Pertinent references from articles and books not identified by the search engines were also retrieved. Relevant surgical textbooks were also reviewed. STUDY SELECTION: All relevant studies that could be obtained regardless of the study design were included. DATA EXTRACTION: All studies that contained material applicable to the topic were considered. Data on patient characteristics and surgical outcomes were abstracted. DATA SYNTHESIS: Sixteen studies evaluated laparoscopic cholecystectomy in the elderly. Compared with open cholecystectomy, elderly patients undergoing the laparoscopic procedure had a lower incidence of complications and a shorter hospitalization. In the 4 studies reporting the results of laparoscopic antireflux surgery in the elderly, the morbidity, mortality, and length of hospital stay were similar to those of younger patients. The elderly had equally good postoperative symptom relief. Ten reports of laparoscopic colon resection in the elderly demonstrated earlier return of bowel function, shorter hospitalization, and less cardiopulmonary morbidity. CONCLUSIONS: Despite underlying comorbidities, individuals older than 65 years tolerate laparoscopic procedures extremely well. Complications and hospitalization are lower than in open procedures. Surgeons need to inform primary care physicians of the excellent result of laparoscopic procedures in the elderly to encourage earlier referrals.

Aged↗

Rating health information on the Internet: navigating to knowledge or to Babel?

CONTEXT: The rapid growth of the Internet has triggered an information revolution of unprecedented magnitude. Despite its obvious benefits, the increase in the availability of information could also result in many potentially harmful effects on both consumers and health professionals who do not use it appropriately. OBJECTIVES: To identify instruments used to rate Web sites providing health information on the Internet, rate criteria used by them, establish the degree of validation of the instruments, and provide future directions for research in this area. DATA SOURCES: MEDLINE (1966-1997), CINAHL (1982-1997), HEALTH (1975-1997), Information Science Abstracts (1966 to September 1995), Library and Information Science Abstracts (1969-1995), and Library Literature (1984-1996); the search engines Lycos, Excite, Open Text, Yahoo, HotBot, Infoseek, and Magellan; Internet discussion lists; meeting proceedings; multiple Web pages; and reference lists. INSTRUMENT SELECTION: Instruments used at least once to rate the quality of Web sites providing health information with their rating criteria available on the Internet. DATA EXTRACTION: The name of the developing organization, Internet address, rating criteria, information on the development of the instrument, number and background of people generating the assessments, and data on the validity and reliability of the measurements. DATA SYNTHESIS: A total of 47 rating instruments were identified. Fourteen provided a description of the criteria used to produce the ratings, and 5 of these provided instructions for their use. None of the instruments identified provided information on the interobserver reliability and construct validity of the measurements. CONCLUSIONS: Many incompletely developed instruments to evaluate health information exist on the Internet. It is unclear, however, whether they should exist in the first place, whether they measure what they claim to measure, or whether they lead to more good than harm.

Computer Communication Networks↗

Content and design attributes of antivaccination web sites.

CONTEXT: Individuals searching the Internet for vaccine information may find antivaccination Web sites. Few published studies have systematically evaluated these sites. OBJECTIVES: To examine antivaccination Web site attributes and to delineate the specific claims and concerns expressed by antivaccination groups. DESIGN AND SETTING: In late 2000, using a metasearch program that incorporates 10 other search engines, we reviewed and analyzed 772 links to find 12 Web sites that promulgated antivaccination information. Analyzing links from these 12 sites yielded another 10 sites, producing a total of 22 sites for study. Using a standardized form, 2 authors (R.M.W., L.K.S.) systematically evaluated these sites based on specific content and design attributes. MAIN OUTCOME MEASURES: Presence or absence of 11 Web site content attributes (antivaccination claims) and 10 Web site design attributes. RESULTS: The most commonly found content claims were that vaccines cause idiopathic illness (100% of sites), vaccines erode immunity (95%), adverse vaccine reactions are underreported (95%), and vaccination policy is motivated by profit (91%). The most common design attributes were the presence of links to other antivaccination sites (100%of sites), information for legally avoiding immunizations (64%), and the use of emotionally charged stories of children who had allegedly been killed or harmed by vaccines (55%). CONCLUSION: Antivaccination Web sites express a range of concerns related to vaccine safety and varying levels of distrust in medicine. The sites rely heavily on emotional appeal to convey their message.

Health Education↗

The ContiNet of the International Continence Society.

This is an account of the International Continence Society's ContiNet--the web server linking up continence organisations worldwide with provision to upload or download vast data stores of information on continence via e-mail, FTP, mailing lists, and special tools to seek information using "search engines." Special communication devices using internet voice/phone mail and real-time "text" or "voice" chats permit conversation globally over normal phone lines linked to the Net at local telephone rates. Special features of ContiNet include announcements of upcoming conventions, information for professionals and laypeople, and the capability to conduct research via the net and conduct consultations and discussions via newsgroups. In-built devices requiring special IDs and passwords permit privacy and security for users. Simple instructions are provided on how to get your PC up and running and get connected to fellow members of ICS, link up with national continence societies, or simply surf for professional enrichment and leisure. With the advent of advanced multimedia capabilities, the current poor quality videoconferencing on the Net will be replaced by excellent videophones by 1998.

Computer Communication Networks↗

Two-dimensional electrophoresis resources available from ExPASy.

This paper describes the set of two-dimensional electrophoresis (2-DE) resources currently available from the ExPASy proteomics Web server. These resources include the SWISS-2DPAGE database, 2-DE software packages, 2-DE technical and educational services, as well as indexes and search engines for 2-DE related sites over the Internet.

Databases, Factual↗

Memantine for dementia.

BACKGROUND: Memantine, a low affinity antagonist to glutamate NMDA receptors, may prevent excitatory neurotoxicity in dementia. OBJECTIVES: To determine efficacy and safety of memantine for people with Alzheimer's disease (AD), vascular (VD) and mixed dementia. SEARCH STRATEGY: The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched on 28 October 2004. This register contains references from all major healthcare databases and many ongoing trial databases and is updated regularly. In addition the search engines Copernic and Google were used to identify unpublished trials through inspection of the websites of licensing bodies like the FDA , EMEA an Nice and of companies' websites (Lundbeck, Merz, Forest, Suntori etc). SELECTION CRITERIA: Double-blind, parallel group, placebo-controlled, randomized trials of memantine in people with dementia. DATA COLLECTION AND ANALYSIS: Data were pooled where possible. Intention-to-treat (ITT) and observed case (OC) analyses are reported. MAIN RESULTS: 1. Moderate to severe AD. A major study (MD-01) is unpublished. Published data from two six month studies show a small beneficial effect of memantine at six months on cognition (4.12 SIB points, 95% Confidence Interval (CI) 2.14 to 5.74, P < 0.00001), activities of daily living (1.70 ADCS-ADLsev19 points, 95% CI 0.63 to 2.76, p = 0.002) and behaviour (3.64 NPI points, 95% CI 1.38 to 5.90, p = 0.002), supported by clinical impression of change (0.27 CIBIC+ points, 95% CI 0.10 to 0.43, p = 0.002). The unpublished study would need to have found a detrimental effect of memantine to overturn the statistical significance of the benefits apparent in the two published studies. 2. Mild to moderate AD. In a single six month trial, memantine had a beneficial effect on ITT analysis of cognition, (1.9 ADAS-Cog points, 95% CI 0.35 to 3.43, p = 0.02) and behaviour (3.50 NPI points 95% CI 0.15 to 6.85, p = 0.04) supported by clinical global impression of change (0.30 CIBIC+ points, 95% CI 0.09 to 0.51, p = 0.005), but no effect on activities of daily living or OC analysis of cognition. The statistical significance of these benefits could be overturned by data from two unpublished studies which are known to show no significant effect. 3. Mild to moderate vascular dementia. In two six month studies, memantine improved cognition (1.85 ADAS-Cog points, 95% CI 0.88 to 2.83, p = 0.0002), and behaviour (Weighted Mean Difference (WMD) 0.84 95% CI 0.06 to 0.91, p = 0.03) but this was not supported by clinical global measures.4. Patients taking memantine were less likely to develop agitation (Odds Ratio (OR): 0.65, 95% CI 0.48 to 0.89, p = 0.007). The effect on agitation which is already present is unknown.5. Memantine is well tolerated. AUTHORS' CONCLUSIONS: Published data suggest a small beneficial effect of memantine at six months in moderate to severe AD. The beneficial effect on cognition in patients with mild to moderate vascular dementia was not clinically discernible at six months. Whether memantine has any effect in mild to moderate AD is unknown.

Activities of Daily Living↗

Memantine for dementia.

BACKGROUND: Memantine, a low affinity antagonist to glutamate NMDA receptors, may prevent excitatory neurotoxicity in dementia. OBJECTIVES: To determine efficacy and safety of memantine for people with Alzheimer's disease (AD), vascular (VD) and mixed dementia. SEARCH STRATEGY: The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched on 20 May 2005. This register contains references from all major healthcare databases and many ongoing trial databases and is updated regularly. In addition the search engines Copernic and Google were used to identify unpublished trials through inspection of the websites of licensing bodies like the FDA , EMEA and NICE and of companies' websites (Lundbeck, Merz, Forest, Suntori etc) and clinical trials registries. SELECTION CRITERIA: Double-blind, parallel group, placebo-controlled, randomized trials of memantine in people with dementia. DATA COLLECTION AND ANALYSIS: Data were pooled where possible. Intention-to-treat (ITT) and observed case (OC) analyses are reported. MAIN RESULTS: 1. Moderate to severe AD. Two out of three six month studies show a small beneficial effect of memantine. Pooled data indicate a beneficial effect at six months on cognition (4.12 points on the 100 point SIB , 95% CI 2.14 to 5.74, P < 0.00001), activities of daily living (1.27 points on the 54 point ADCS-ADLsev, 95% CI 0.44 to 2.09, P = 0.003) and behaviour (2.76 points on the 144 NPI, 95% CI 0.88 to 4.63, P = 0.004), supported by clinical impression of change (0.28 points on the 7 point CIBIC+, 95% CI 0.15 to 0.41, P < 0.0001).2. Mild to moderate AD. In a single six month trial, memantine had a beneficial effect on ITT analysis of cognition, (1.9 ADAS-Cog points, 95% CI 0.35 to 3.45, P = 0.02) and behaviour (3.50 NPI points 95% CI 0.15 to 6.85, P = 0.04) supported by clinical global impression of change (0.30 CIBIC+ points, 95% CI 0.09 to 0.51, P = 0.005), but no effect on activities of daily living or OC analysis of cognition. The statistical significance of these benefits could be overturned by data from two unpublished studies which are known to show no significant effect. 3. Mild to moderate vascular dementia. In two six month studies, memantine improved cognition (1.85 ADAS-Cog points, 95% CI 0.88 to 2.83, P = 0.0002), and behaviour (0.84 95% CI 0.06 to 0.91, P = 0.03) but this was not supported by clinical global measures.4. Patients taking memantine appeared to be less likely to develop agitation (93/1167 [8%] versus 134/1141 [12%] (Peto odds ratio (OR): 0.65, 95% CI 0.49 to 0.86, P = 0.002). This was consistently seen in moderate to severe dementia. There were no data which suggested an effect on agitation which is already present.5. Memantine is well tolerated. AUTHORS' CONCLUSIONS: Published data suggest a small beneficial effect of memantine at six months in moderate to severe AD. The beneficial effect on cognition in patients with mild to moderate vascular dementia was not detectable on global assessment at six months. Whether memantine has any effect in mild to moderate AD is unknown.

Activities of Daily Living↗

Memantine for dementia.

BACKGROUND: Memantine, a low affinity antagonist to glutamate NMDA receptors, may prevent excitatory neurotoxicity in dementia. OBJECTIVES: To determine efficacy and safety of memantine for people with Alzheimer's disease (AD), vascular (VD) and mixed dementia. SEARCH STRATEGY: The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched on 8th February 2006. This register contains references from all major healthcare databases and many ongoing trial databases and is updated regularly. In addition, the search engines Copernic and Google were used to identify unpublished trials through inspection of the websites of licensing bodies like the FDA , EMEA and NICE and of companies' websites (Lundbeck, Merz, Forest, Suntori etc) and clinical trials registries. SELECTION CRITERIA: Double-blind, parallel group, placebo-controlled, randomized trials of memantine in people with dementia. DATA COLLECTION AND ANALYSIS: Data were pooled where possible. Intention-to-treat (ITT) and observed case (OC) analyses are reported. MAIN RESULTS: 1. Moderate to severe AD. Two out of three six month studies show a small beneficial effect of memantine. Pooled data indicate a beneficial effect at six months on cognition (2.97 points on the 100 point SIB, 95% CI 1.68 to 4.26, P < 0.00001), activities of daily living (1.27 points on the 54 point ADCS-ADLsev, 95% CI 0.44 to 2.09, P = 0.003) and behaviour (2.76 points on the 144 point NPI, 95% CI 0.88 to 4.63, P=0.004), supported by clinical impression of change (0.28 points on the 7 point CIBIC+, 95% CI 0.15 to 0.41, P < 0.0001).2. Mild to moderate AD. Pooled data from three unpublished studies indicate a marginal beneficial effect at six months on ITT cognition (0.99 points on the 70 point ADAS-Cog, 95% CI 0.21 to 1.78, P = 0.01) which was barely detectable clinically (0.13 CIBIC+ points, 95% CI 0.01 to 0.25, P = 0.03) but no effect on behaviour, activities of daily living or OC analysis of cognition.3. Mild to moderate vascular dementia. Pooled data from two six month studies indicated a small beneficial effect of memantine on cognition (1.85 ADAS-Cog points, 95% CI 0.88 to 2.83, P = 0.0002), and behaviour (0.84 95% CI 0.06 to 0.91, P = 0.03) but this was not supported by clinical global measures.4. Patients taking memantine were slightly less likely to develop agitation (134/1739, 7.7% versus 175/1873, 9.3% OR 0.78, 95% CI 0.61 to 0.99, P = 0.04). This effect was slightly larger, but still small, in moderate to severe AD (58/506 [12%] vs 88/499 [18%]; OR = 0.6, 95% CI 0.42 to 0.86, P = 0.005). There is no evidence either way about whether it has an effect on agitation which is already present.5. Memantine is well tolerated. AUTHORS' CONCLUSIONS: Memantine has a small beneficial effect at six months in moderate to severe AD. In patients with mild to moderate dementia, the small beneficial effect on cognition was not clinically detectable in those with vascular dementia and was detectable in those with AD. Memantine is well tolerated.

Activities of Daily Living↗

Dopamine versus no treatment to prevent renal dysfunction in indomethacin-treated preterm newborn infants.

BACKGROUND: Indomethacin therapy for closure of patent ductus arteriosus frequently causes oliguria, and occasionally more serious renal dysfunction. Low dose dopamine has been suggested as a means for preventing this side effect. OBJECTIVES PRIMARY OBJECTIVE: To determine whether dopamine therapy may prevent indomethacin-mediated deterioration in renal function in the preterm newborn infant without serious adverse effects. SECONDARY OBJECTIVE: To assess the effects of dopamine on the above variables in two subgroups: (1) patients given indomethacin as prophylaxis of intraventricular hemorrhage, and (2) patients given indomethacin as treatment of patent ductus arteriosus SEARCH STRATEGY: Standard methods of the Cochrane Neonatal Review Group (CNRG) were used. We searched MEDLINE (1966-2001) using PubMed as the search engine, EMBASE (1974-2001) and the Cochrane Controlled Trials Register (CCTR) from the Cochrane Library (Issue 3, 2001). In addition we contacted the principal investigators if necessary to ascertain the required information. SELECTION CRITERIA: Randomized or quasi-randomized studies of the effects of dopamine on urine output, glomerular filtration rate, fluid balance or incidence of renal failure, in preterm newborn infants receiving indomethacin. The comparison group should have received no dopamine. DATA COLLECTION AND ANALYSIS: We used the standard methods of the Cochrane Collaboration and those of the CNRG. The primary outcomes of interest were: mortality before discharge; intraventricular hemorrhage, grade three or four; cystic periventricular leukomalacia; renal failure (either oliguria, defined as a urine output less than 1 ml/kg/hour or an elevation in creatinine by more than 40 micromoles/L); failure to close the ductus arteriosus; need for surgical PDA ligation. For categorical outcomes, we calculated typical estimates for relative risk and risk difference. For continuous outcomes the weighted mean difference (WMD) was calculated. Fixed effect models were assumed for meta-analysis. MAIN RESULTS: Three studies were found (total number randomized patients, 75) which fulfilled the entry criteria for this review. All were single center trials which enrolled NICU patients receiving indomethacin for symptomatic patent ductus arteriosus. There are no (or only partial) results for effects of dopamine on several of the primary outcomes, including death before discharge, serious intraventricular hemorrhage, cystic periventricular leukomalacia, or renal failure. There has been inadequate investigation of the effects of dopamine on cerebral perfusion or cardiac output, or GI complications, or endocrine toxicity. Dopamine improved urine output [WMD 0.68 ml/kg/hour (95% CI 0.22, 1.44)], but there was no evidence of effect on serum creatinine (WMD 2.04 micromoles/liter, CI -17.90, 21.97) or the incidence of oliguria (urine output < 1 ml/kg/hour) (RR 0.73, CI 0.35, 1.54). There was no evidence of effect of dopamine on the frequency of failure to close the ductus arteriosus (RR 1.11, CI 0.56, 2.19). REVIEWER'S CONCLUSIONS: There is no evidence from randomized trials to support the use of dopamine to prevent renal dysfunction in indomethacin-treated preterm infants.

Cardiovascular Agents↗

Combined vitamin B6-magnesium treatment in autism spectrum disorder.

BACKGROUND: The use of mega-vitamin intervention began in the early 1950's with the treatment of schizophrenic patients. Pyroxidine (vitamin B6) was first used with children diagnosed with "autism syndrome" when speech and language improvement was observed in some children as a result of large doses of B6. A number of published studies attempted to assess the effects of vitamin B6-Mg (Mg was found to reduce undesirable side effects from B6) on a variety of characteristics such as verbal communication, non-verbal communication, interpersonal skills, and physiological function, in individuals with autism. OBJECTIVES: To determine the efficacy of vitamin B6 and magnesium (B6-Mg) for treating social, communication and behavioural responses of children and adults with autism. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2002), MEDLINE (1966- January 2002), EMBASE (1980-January 2002), PsychINFO (1887 - January 2002), Dissertation Abstracts International (1861 - January 2002). The search engine FirstSearch was also used (January 2002). Reference lists for all the obtained studies and other review articles were examined for additional studies. SELECTION CRITERIA: All studies in which the participants were randomly allocated prior to intervention and in which outcomes were compared to either a placebo or non-treated group were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated all potential studies identified as indicated above for inclusion. MAIN RESULTS: Two trials were included in the review. Both studies used a double-blind crossover design. One study (Tolbert 1993) provided insufficient data to conduct an analysis. The senior author was contacted for supporting data but was unable to provide the needed information. The remaining study (Findling, 1997) yielded no significant differences between treatment and placebo group performances following the B6 intervention on measures of social interaction, communication, compulsivity, impulsivity, or hyperactivity. REVIEWER'S CONCLUSIONS: Due to the small number of studies, the methodological quality of studies, and small sample sizes, no recommendation can be advanced regarding the use of B6-Mg as a treatment for autism.

Adult↗

Botulinum toxin injections for the treatment of spasmodic dysphonia.

BACKGROUND: The use of botulinum toxin for the treatment of spasmodic dysphonia is currently the treatment of choice for management of this neurological voice disorder. Over the past 20 years, botulinum toxin has been used to treat both adductor and abductor forms of the disorder, with vocal improvement noted after treatment for both. A large number of studies have attempted to document the efficacy of botulinum toxin for improvement of vocal symptoms in individuals with spasmodic dysphonia. OBJECTIVES: To determine the effectiveness of botulinum toxin for treating spasmodic dysphonia. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to July 2003), EMBASE (1974 to July 2003 ), CINAHL (through July 2003), Dissertation Abstracts International (1975 to July 2003) and PsycINFO (1975 to July 2003). The search engine FirstSearch was also used (July 2003). Reference lists for all the obtained studies and other review articles were examined for additional studies. SELECTION CRITERIA: All studies in which the participants were randomly allocated prior to intervention and in which botulinum toxin was compared to either an alternative treatment, placebo or non-treated control group were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated all potential studies meeting the selection criteria noted above for inclusion. One study met the inclusion criteria and was included in the final analysis. MAIN RESULTS: Only one study in the literature met the inclusion criteria. This was the only study identified which reported a treatment/no treatment comparison. It reported significant beneficial effects for fundamental frequency (Fo), Fo Range, spectrographic analysis, independent ratings of voice severity and patient ratings of voice improvement. REVIEWERS' CONCLUSIONS: The evidence from randomized controlled trials does not allow firm conclusions to be drawn about the effectiveness of botulinum toxin for all types of spasmodic dysphonia, or for patients with different behavioral or clinical characteristics.

Botulinum Toxins↗

Intramuscular arteether for treating severe malaria.

BACKGROUND: Quinine and artemisinin drugs are used in severe malaria, but quinine resistance is increasing. Arteether is a recently developed artemisinin derivative that is oil soluble, has a long elimination half life, and is more stable than other derivatives. OBJECTIVES: To compare intramuscular arteether with other antimalarial drugs to treat severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (August 2004), CENTRAL (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to August 2004), EMBASE (1980 to August 2004), U.S. National Library of Medicine (NLM) Gateway (1953 to 1965), Web Science Citation (1981 to August 2004), LILACS (August 2004), Google search engine (August 2004), conference proceedings, and reference lists. We also contacted researchers, organizations, and pharmaceutical companies to help identify trials. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials of intramuscular arteether in adults and children with severe malaria. DATA COLLECTION AND ANALYSIS: We independently assessed the methodological quality of the trials and extracted data, and analysed data using Review Manager 4.2. MAIN RESULTS: Two small trials (n = 194) met the inclusion criteria. Both trials compared arteether with quinine in children with cerebral malaria and reported on similar outcomes. There was no statistically significant difference in the number of deaths (relative risk 0.75, 95% confidence interval 0.43 to 1.30; n = 194, 2 trials), neurological complications (relative risk 1.18, 95% confidence interval 0.31 to 4.46; n = 58, 1 trial), or other outcomes including time to regain consciousness, parasite clearance time, and fever clearance time. The meta-analyses lack statistical power to detect important differences. REVIEWERS' CONCLUSIONS: More trials with a larger number of participants are needed before a firm conclusion about the efficacy and safety of arteether can be reached.

Adult↗

Error tolerant searching of uninterpreted tandem mass spectrometry data.

An error tolerant mode for database matching of uninterpreted tandem mass spectrometry data is described. Selected database entries are searched without enzyme specificity, using a comprehensive list of chemical and post-translational modifications, together with a residue substitution matrix. The modifications are tested serially, to avoid the catastrophic loss of discrimination that would occur if all the permutations of large numbers of modifications in combination were possible. The new mode has been coded as an extension to the Mascot search engine, and tested against a number of Liquid chromatography-tandem mass spectrometry datasets. The results show a number of additional peptide matches, but require careful interpretation. The most significant limitation of this approach is that it can only reveal new matches to proteins that already have at least one significant peptide match.

Animals↗