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Allergy to latex rubber.

OBJECTIVE: To summarize the clinical symptoms of latex rubber allergy and provide guidelines for the management of this allergy. DATA SOURCES: The English-language literature was searched from 1979 through 1994 manually and using MEDLINE. Conference proceedings and reference lists of relevant articles were reviewed. DATA EXTRACTION: Studies clinically relevant to latex allergy were selected. RESULTS: The most common clinical presentation of latex allergy is a nonimmunologic, irritant dermatitis of the hand. Contact dermatitis (type IV delayed hypersensitivity reactions to rubber additives) is the most common immunologic manifestation of latex rubber allergy. Type I allergic responses are less common and include contact urticaria, rhinoconjunctivitis, asthma, and anaphylaxis. Seven percent to 10% of health care workers regularly exposed to latex and 28% to 67% of children with spina bifida have a positive skin test result to latex proteins indicating increased blood levels of IgE antibody. About one third of patients with positive skin test results, however, do not yet have symptoms of latex allergy. Systemic (life-threatening) anaphylactic shock can occur intraoperatively in highly sensitive patients because of mucosal absorption of latex protein allergens from the surgeon's gloves. The present treatment for latex allergy is careful avoidance of latex materials. In addition, the use of powder-free latex gloves can eliminate airborne latex exposure and can allow health care workers with inhalant allergic reactions to return to work. CONCLUSION: Latex allergy currently affects thousands of people. These persons have IgE-mediated cutaneous, respiratory, and systemic allergic reactions. A reduction of the total protein level on latex rubber devices may prevent further sensitization and eliminate latex allergic reactions.

Algorithms↗

Polymerase chain reaction for the diagnosis of HIV infection in adults. A meta-analysis with recommendations for clinical practice and study design.

PURPOSE: To do a meta-analysis of studies that have evaluated the sensitivity and specificity of polymerase chain reaction (PCR) assay for the diagnosis of human immunodeficiency virus (HIV) infection in adults. Evaluating the performance of PCR is difficult because in certain clinical situations, the sensitivity or specificity of PCR may exceed those of the current reference standard tests (enzyme immunoassay followed by confirmatory Western blot analysis). Therefore, an additional goal was to develop recommendations for 1) the design of future evaluative studies of PCR and 2) the use of PCR in persons with suspected HIV infection. DATA SOURCES: Studies published between 1988 and 1994 that were identified in a search of 17 computer databases, including MEDLINE, and abstracts identified from conference proceedings. STUDY SELECTION: Studies were included if DNA amplification by PCR was done on peripheral blood mononuclear cells from adults. Ninety-six studies met the inclusion criteria. DATA EXTRACTION: Data were extracted independently by two reviewers. Study design was assessed independently by two investigators blinded to study results. RESULTS: Reported sensitivities for PCR range from 10% to 100%, and specificities range from 40% to 100%. A summary receiver-operating characteristic curve based on all 96 studies has a maximum joint sensitivity and specificity (upper left point on the curve, where sensitivity equals specificity) of 97.0% to 98.1%. If the threshold value that defines a positive PCR result is chosen so that sensitivity is higher than 98.1%, specificity will decrease to less than 98.1%. Conversely, if the threshold value that defines a positive PCR result is chosen so that specificity is greater than 98.1%, sensitivity will decrease to less than 98.1%. If sensitivity and specificity are chosen to be equal, the corresponding false-positive rate is 1.9% to 3.0%. At the maximum joint sensitivity and specificity, the positive predictive value of PCR ranges from 34% to 85% as the prevalence of HIV increases from 1.0% to 10%. We identified seven areas in which study design could be modified to 1) reduce susceptibility to bias in estimates of the sensitivity and specificity of PCR and 2) to increase the generalizability of the study results. These modifications will also help to overcome methodologic problems created by the lack of a reference standard test. CONCLUSIONS: The PCR assay is not sufficiently accurate to be used for the diagnosis of HIV infection without confirmation. Use of PCR for the diagnosis of HIV in adults should be limited to situations in which antibody tests are known to be insufficient. Future studies of PCR performance should be sufficiently large and should use adequate reference standard tests and standardized methods for the performance of PCR. Specimens should be evaluated by persons blinded to clinical status and to the results of other diagnostic tests for HIV infection.

Adult↗

Formulating questions and locating primary studies for inclusion in systematic reviews.

Much time and effort are spent on designing primary research studies. Similar care must be given to planning systematic reviews. The review should be based on an important, well-focused question that is relevant to patient care. By formulating the question properly, the criteria that primary studies must meet to be included in the review become clear. These criteria, which comprise the types of persons involved, exposure, control group, outcomes, and study designs of interest, can then be refined so that they are clinically relevant, sensible, and workable. Inclusion criteria that are too narrow will limit the amount of data in the review, thereby increasing the risk for chance results and making the review less useful for the reader. Reviews should include studies whose designs offer the least biased answer to the question being asked. To maximize available data and reduce the risk for bias, as many relevant studies as possible need to be identified, regardless of publication status or language. Multiple overlapping search strategies should therefore be used and must be carefully planned. Strategies include searching the many electronic databases available (after careful consideration of which terms to enter), manually searching journals and conference proceedings, searching bibliographies of articles, searching existing registers of studies, and contacting companies or researchers. The time taken to formulate the question adequately and develop appropriate searches will increase the chance of producing a high-quality, meaningful review.

Clinical Trials as Topic↗

Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis. A meta-analysis of randomized, controlled trials.

BACKGROUND: Low-molecular-weight heparins may simplify the management of deep venous thrombosis. A critical clinical issue is whether this more convenient therapy is as safe and effective as treatment with unfractionated heparin. PURPOSE: To compare the safety and efficacy of low-molecular-weight heparins with those of unfractionated heparin for treatment of acute deep venous thrombosis. DATA SOURCES: Reviewers identified studies by searching MEDLINE, reviewing references from retrieved articles, scanning abstracts from conference proceedings, and contacting investigators and pharmaceutical companies. STUDY SELECTION: Randomized, controlled trials that compared a low-molecular-weight heparin preparation with unfractionated heparin for treatment of acute deep venous thrombosis. DATA EXTRACTION: Two reviewers extracted data independently. Reviewers evaluated study quality using a validated four-item instrument. DATA SYNTHESIS: Eleven of 37 studies met inclusion criteria for three major outcomes. Most studies used proper randomization procedures, but only one was double-blinded. Compared with unfractionated heparin, low-molecular-weight heparins reduced mortality rates over 3 to 6 months of patient follow-up (odds ratio, 0.71 [95% CI, 0.53 to 0.94]; P = 0.02). For major bleeding complications, the odds ratio favored low-molecular-weight heparins (0.57 [CI, 0.33 to 0.99]; P = 0.047), but the absolute risk reduction was small and not statistically significant (0.61% [CI, -0.04% to 1.26%]; P = 0.07). For preventing thromboembolic recurrences, low-molecular-weight heparins seemed as effective as unfractionated heparin (odds ratio, 0.85 [CI, 0.63 to 1.14]; P > 0.2). CONCLUSIONS: Low-molecular-weight heparin treatment reduces mortality rates after acute deep venous thrombosis. These drugs seem to be as safe as unfractionated heparin with respect to major bleeding complications and appear to be as effective in preventing thromboembolic recurrences.

Analysis of Variance↗

Prevention of intravascular catheter-related infections.

PURPOSE: To review the literature on prevention of intravascular catheter-related infections. DATA SOURCES: The MEDLINE database, conference proceedings, and bibliographies of review articles and book chapters were searched for relevant articles. Primary authors were contacted directly if data were incomplete. STUDY SELECTION: Studies met the following criteria unless otherwise stated: Trials were prospective and randomized; catheters were inserted into new sites, not into old sites over guidewires; catheter cultures were done by using semi-quantitative or quantitative methods; and, for prospective studies, catheter-related bloodstream infection was confirmed by microbial growth from percutaneously drawn blood cultures that matched catheter cultures. DATA EXTRACTION: Data on population, methods, preventive strategy, and outcome (measured as catheter-related bloodstream infections) were gathered. The quality of the data was graded by using preestablished criteria. DATA SYNTHESIS: The recommended preventive strategies with the strongest supportive evidence are full barrier precautions during central venous catheter insertion; subcutaneous tunneling short-term catheters inserted in the internal jugular or femoral veins when catheters are not used for drawing blood; contamination shields for pulmonary artery catheters; povidone-iodine ointment applied to insertion sites of hemodialysis catheters; specialized nursing teams caring for patients with short-term peripheral venous catheters, especially at institutions with a high incidence of catheter-related infection; no routine replacement of central venous catheters; antiseptic chamberfilled hub or hub-protective antiseptic sponge for central venous catheters; and use of chlorhexidine-silver sulfadiazine-impregnated or minocycline-rifampin-impregnated short-term central venous catheters if the rate of infection is high despite adherence to other strategies that do not incorporate antimicrobial agents (for example, maximal barrier precautions). CONCLUSIONS: Simple interventions can reduce the risk for serious catheter-related infection. Adequately powered randomized trials are needed.

Anti-Infective Agents↗

Extended out-of-hospital low-molecular-weight heparin prophylaxis against deep venous thrombosis in patients after elective hip arthroplasty: a systematic review.

PURPOSE: Evidence-based medicine guidelines based on venographic end points recommend in-hospital prophylaxis with low-molecular-weight heparin (LMWH) in patients having elective hip surgery. Emerging data suggest that out-of-hospital use may offer additional protection; however, uncertainty remains about the risk-benefit ratio. To provide clinicians with a practical pathway for translating clinical research into practice, we systematically reviewed trials comparing extended out-of-hospital LMWH prophylaxis versus placebo. DATA SOURCES: Studies were identified by 1) searching PubMed, MEDLINE, and the Cochrane Library Database for reports published from January 1976 to May 2001; 2) reviewing references from retrieved articles; 3) scanning abstracts from conference proceedings; and 4) contacting pharmaceutical companies and investigators of the original reports. STUDY SELECTION: Randomized, controlled trials comparing extended out-of-hospital prophylaxis with LMWH versus placebo in patients having elective hip arthroplasty. DATA EXTRACTION: Two reviewers extracted data independently. Reviewers evaluated study quality by using a validated four-item instrument. DATA SYNTHESIS: Six of seven original articles met the defined inclusion criteria. The included studies were double-blind trials that used proper randomization procedures. Compared with placebo, extended out-of-hospital prophylaxis decreased the frequency of all episodes of deep venous thrombosis (placebo rate, 150 of 666 patients [22.5%]; relative risk, 0.41 [95% CI, 0.32 to 0.54; P < 0.001]), proximal venous thrombosis (placebo rate, 76 of 678 patients [11.2%]; relative risk, 0.31 [CI, 0.20 to 0.47; P < 0.001]), and symptomatic venous thromboembolism (placebo rate, 36 of 862 patients [4.2%]; relative risk, 0.36 [CI, 0.20 to 0.67; P = 0.001]). Major bleeding was rare, occurring in only one patient in the placebo group. CONCLUSIONS: Extended LMWH prophylaxis showed consistent effectiveness and safety in the trials (regardless of study variations in clinical practice and length of hospital stay) for venographic deep venous thrombosis and symptomatic venous thromboembolism. The aggregate findings support the need for extended out-of-hospital prophylaxis in patients undergoing hip arthroplasty surgery.

Aftercare↗

Implantable cardioverter defibrillators in primary and secondary prevention: a systematic review of randomized, controlled trials.

BACKGROUND: Sudden cardiac death is common in persons with cardiovascular disease. PURPOSE: To assess the efficacy of implantable cardioverter defibrillators (ICDs) in persons at increased risk for sudden cardiac death. DATA SOURCES: MEDLINE (1980-2002), EMBASE (1980-2002), Cochrane Controlled Clinical Trial Registry (2002, Volume 3), other databases, and conference proceedings. Primary study authors and device manufacturers were contacted, and bibliographies of relevant papers were hand searched. STUDY SELECTION: Randomized, controlled clinical trials evaluating ICDs versus usual care were selected. DATA EXTRACTION: Two reviewers extracted data independently. DATA SYNTHESIS: Eight trials were included in the final analysis (4909 patients, 1154 deaths). Compared with usual care (most commonly amiodarone therapy), ICDs significantly reduced sudden cardiac death (relative risk [RR], 0.43 [95% CI, 0.35 to 0.53]) and all-cause mortality (RR, 0.74 [CI, 0.67 to 0.82]). The included trials were divided a priori into two categories: secondary prevention (involving patients resuscitated after cardiac arrest or unstable ventricular tachycardia or ventricular fibrillation [ n = 1963]) and primary prevention (involving patients at increased risk for sudden cardiac death but without documented cardiac arrest, ventricular fibrillation, or ventricular tachycardia [ n = 2946]). Regardless of baseline risk, ICDs were equally efficacious in preventing sudden cardiac death in both types of trials (RR, 0.50 [CI, 0.38 to 0.66] for secondary prevention vs. 0.37 [CI, 0.27 to 0.50] for primary prevention). However, the magnitude of benefit in total mortality varied within the primary prevention trials depending on baseline risk for sudden cardiac death. CONCLUSIONS: Implantable cardioverter defibrillators prevent sudden cardiac death regardless of baseline risk. However, their impact on total mortality is sensitive to baseline risk for arrhythmic death. Decisions about resource allocation for ICDs depend on accurate stratification of patients according to risk.

Arrhythmias, Cardiac↗

Systematic review: cardiac resynchronization in patients with symptomatic heart failure.

BACKGROUND: Even with optimal pharmacotherapy, symptomatic heart failure is associated with substantial morbidity and mortality. PURPOSE: To determine the efficacy and safety of cardiac resynchronization therapy in adults with advanced systolic heart failure. DATA SOURCES: The Cochrane Central Register of Controlled Trials (2002, volume 4), MEDLINE (1980-2003), EMBASE (1980-2003), other electronic databases, and U.S. Food and Drug Administration reports. We contacted primary study authors and device manufacturers, and we hand searched bibliographies of relevant papers and conference proceedings. STUDY SELECTION: Randomized, controlled clinical trials for efficacy and controlled trials plus prospective cohort studies for safety. DATA EXTRACTION: Two reviewers chose studies and extracted data independently; random-effects models were used for analyses. DATA SYNTHESIS: Nine trials were included in the efficacy review (3216 patients). All trial participants had reduced ejection fraction and prolonged QRS duration, and 85% had New York Heart Association (NYHA) class III or IV symptoms. Cardiac resynchronization therapy improved ejection fraction (weighted mean difference, 0.035 [95% CI, 0.015 to 0.055]), quality of life (weighted mean reduction in score on the Minnesota Living with Heart Failure Questionnaire, 7.6 points [CI, 3.8 to 11.5 points]), and function (58% vs. 37% of patients improved by at least 1 NYHA class). Heart failure hospitalizations were reduced by 32% (relative risk [RR], 0.68 [CI, 0.41 to 1.12]), with benefits most marked in patients with NYHA class III or IV symptoms at baseline (RR, 0.65 [CI, 0.48 to 0.88]; number needed to treat for benefit [NNT(B)], 12). All-cause mortality was reduced by 21% (RR, 0.79 [CI, 0.66 to 0.96]; NNT(B), 24), driven largely by reductions in death from progressive heart failure (RR, 0.60 [CI, 0.36 to 1.01]). Eighteen studies (total of 3701 patients with cardiac resynchronization devices) were included in the safety review. Implant success rate was 90% (CI, 89% to 91%), and 0.4% of patients died during implantation (CI, 0.2% to 0.7%). Over a median 6-month follow-up, leads dislodged in 9% of patients (CI, 7% to 10%) and mechanical malfunctions occurred in 7% (CI, 5% to 8%). LIMITATIONS: These trials enrolled only patients with heart failure with NYHA class III or IV symptoms despite medical therapy, a prolonged QRS duration, and reduced ejection fraction; in addition, experienced providers implanted the devices. Because all but one of these trials randomly assigned patients after device implantation, their results may overestimate the potential benefits of cardiac resynchronization. Finally, since few patients in these trials had bradyarrhythmias or atrial fibrillation, the role of cardiac resynchronization in such patients is uncertain. CONCLUSIONS: In selected patients with heart failure, cardiac resynchronization therapy improves functional and hemodynamic status, reduces heart failure hospitalizations, and reduces all-cause mortality.

Cardiac Pacing, Artificial↗

Meta-analysis: accuracy of rapid tests for malaria in travelers returning from endemic areas.

BACKGROUND: Microscopic diagnosis of malaria is unreliable outside specialized centers. Rapid tests have become available in recent years, but their accuracy has not been assessed systematically. PURPOSE: To determine the accuracy of rapid diagnostic tests for ruling out malaria in nonimmune travelers returning from malaria-endemic areas. DATA SOURCES: The authors searched MEDLINE, EMBASE, CAB Health, and CINAHL (1988 to September 2004); hand-searched conference proceedings; checked reference lists; and contacted experts and manufacturers. STUDY SELECTION: Diagnostic accuracy studies in nonimmune individuals with suspected malaria were included if they compared rapid tests with expert microscopic examination or polymerase chain reaction tests. DATA EXTRACTION: Data on study and patient characteristics and results were extracted in duplicate. The main outcome was the likelihood ratio for a negative test result (negative likelihood ratio) for Plasmodium falciparum malaria. Likelihood ratios were combined by using random-effects meta-analysis, stratified by the antigen targeted (histidine-rich protein-2 [HRP-2] or parasite lactate dehydrogenase [LDH]) and by test generation. Nomograms of post-test probabilities were constructed. DATA SYNTHESIS: The authors included 21 studies and 5747 individuals. For P. falciparum, HRP-2-based tests were more accurate than parasite LDH-based tests: Negative likelihood ratios were 0.08 and 0.13, respectively (P = 0.019 for difference). Three-band HRP-2 tests had similar negative likelihood ratios but higher positive likelihood ratios compared with 2-band tests (34.7 vs. 98.5; P = 0.003). For P. vivax, negative likelihood ratios tended to be closer to 1.0 for HRP-2-based tests than for parasite LDH-based tests (0.24 vs. 0.13; P = 0.22), but analyses were based on a few heterogeneous studies. Negative likelihood ratios for the diagnosis of P. malariae or P. ovale were close to 1.0 for both types of tests. In febrile travelers returning from sub-Saharan Africa, the typical probability of P. falciparum malaria is estimated at 1.1% (95% CI, 0.6% to 1.9%) after a negative 3-band HRP-2 test result and 97% (CI, 92% to 99%) after a positive test result. LIMITATIONS: Few studies evaluated 3-band HRP-2 tests. The evidence is also limited for species other than P. falciparum because of the few available studies and their more heterogeneous results. Further studies are needed to determine whether the use of rapid diagnostic tests improves outcomes in returning travelers with suspected malaria. CONCLUSIONS: Rapid malaria tests may be a useful diagnostic adjunct to microscopy in centers without major expertise in tropical medicine. Initial decisions on treatment initiation and choice of antimalarial drugs can be based on travel history and post-test probabilities after rapid testing. Expert microscopy is still required for species identification and confirmation.

Aldehyde-Lyases↗

Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients.

BACKGROUND: The efficacy of antimicrobial urinary catheters in hospitalized patients is poorly defined. PURPOSE: To assess currently marketed antimicrobial urinary catheters for preventing catheter-associated urinary tract infection (UTI). DATA SOURCES: Electronic databases, conference proceedings, bibliographies, trialists, and catheter manufacturers (search dates, 1966 to June 2005). STUDY SELECTION: Randomized and quasi-randomized trials of nitrofurazone-coated or silver alloy-coated antimicrobial urinary catheter use for less than 30 days; no language restriction. DATA EXTRACTION: Study design, study sample, inclusion and exclusion criteria, allocation, blinding, UTI definition, ascertainment methods, and proportion developing symptomatic UTI (primary end point) or bacteriuria (secondary end point) were extracted by using a structured data collection instrument. DATA SYNTHESIS: Twelve qualifying trials (13,392 total participants or catheters) were identified. They compared nitrofurazone-coated silicone (n = 3) or silver-coated latex (n = 9) catheters with silicone or latex catheters. No study addressed symptomatic UTI. All trials suggested protection against bacteriuria with test catheter use. However, effect size varied considerably and postrandomization exclusions were very common. Effect size was greatest in trials of nitrofurazone-coated catheters (all post-1995) and in pre-1995 silver alloy-coated catheter trials and was smallest in post-1995 silver alloy-coated catheter trials. Control group bacteriuria rate, control catheter type (latex vs. silicone), and patient sample (urology vs. other) also predicted effect size. Few studies addressed secondary bloodstream infection, mortality, costs, or microbial resistance. Short-term adverse effects were minimal. LIMITATIONS: The study was limited by the number, size, and quality of studies and by lack of the following: intention-to-treat analyses, data on clinical end points, and trials comparing nitrofurazone-coated with silver alloy-coated catheters. CONCLUSIONS: According to fair-quality evidence, antimicrobial urinary catheters can prevent bacteriuria in hospitalized patients during short-term catheterization, depending on antimicrobial coating and several other variables. Older data probably lack current relevance. Cost implications and effect on infectious complications remain undefined.

Anti-Infective Agents, Urinary↗

Databases, websites, and the Internet.

By the end of the year 2000, an estimated 100 to 500 million computers may be linked to the Internet, representing an enormous level of information exchange. Even today, a broad Internet search of a term such as "breast cancer" can produce an overwhelming list of web pages, most of which will not be of interest to the typical Internet user. A more sophisticated user such as the oncology professional will more likely refine the search by adding other terms, producing a more manageable and useful list of websites. Information on cancer can be readily accessed from thousands of websites developed by the government, medical organizations, other institutions, medical journals, patient support groups, and pharmaceutical companies, as well as through medical web directories. The Cancer Information Network (CIN), an independent website geared to the oncology community, provides access to Medline, PDQ, and hundreds of cancer-related resources on the World Wide Web. CIN also offers the complete NCCN conference proceedings and practice guidelines; full text of several medical journals, textbooks, and handbooks; a daily oncology news service; a clinically oriented drug reference guide; and an extensive calendar of medical meetings and CME courses.

Databases as Topic↗

Influencing satisfaction for dental services.

A strong concern about consumer satisfaction characterizes the health care industry, reflecting, perhaps, the introduction of the marketing culture into this service industry. Consequently, consumer satisfaction with dental services has become the focus of several studies published in recent years. Past research has focused on two major issues: the initial choice of a dentist and continuity in dentist-patient relationships. The authors propose that consumer satisfaction with dental care is influenced by the variables waiting time, availability/convenience of care, pain management by dentists, costs, and continuity of care. They also hypothesize that demographic characteristics such as gender and age also influence consumer satisfaction. Implications for the management of dental practitioners are discussed. An abstract of this article was published in the 1992 AAAHCR Conference Proceedings.

Adult↗

Saliva testing--a nontraditional diagnostic tool.

OBJECTIVE: To demonstrate the advantages of saliva testing over more common methods of determining concentrations of hormones, drugs, and viral antibodies in blood. DATA SOURCES: Recent professional journals, product literature, bibliographies, and conference proceedings. STUDY SELECTION: Not applicable. DATA EXTRACTION: Survey of literature. DATA SYNTHESIS: In the past 10 years, saliva has been used increasingly to determine concentrations of steroid hormones, HIV antibodies, drugs of abuse, and therapeutic drugs in blood. Benefits of using saliva rather than blood or urine for diagnostic testing include convenience and economy of specimen collection, ease of multiple sampling, and low risk of exposing laboratorians to hazardous samples. CONCLUSION: Saliva testing is possible with currently available laboratory technologies. If benefits of saliva testing are to be fully realized, laboratorians must provide physicians with data showing correlations of analyte concentrations in saliva, blood, and urine.

Clinical Laboratory Techniques↗