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PubMed2005

Mood disorders in the medically ill: scientific review and recommendations.

OBJECTIVE: The purpose of this review is to assess the relationship between mood disorders and development, course, and associated morbidity and mortality of selected medical illnesses, review evidence for treatment, and determine needs in clinical practice and research. DATA SOURCES: Data were culled from the 2002 Depression and Bipolar Support Alliance Conference proceedings and a literature review addressing prevalence, risk factors, diagnosis, and treatment. This review also considered the experience of primary and specialty care providers, policy analysts, and patient advocates. The review and recommendations reflect the expert opinion of the authors. STUDY SELECTION/DATA EXTRACTION: Reviews of epidemiology and mechanistic studies were included, as were open-label and randomized, controlled trials on treatment of depression in patients with medical comorbidities. Data on study design, population, and results were extracted for review of evidence that includes tables of prevalence and pharmacological treatment. The effect of depression and bipolar disorder on selected medical comorbidities was assessed, and recommendations for practice, research, and policy were developed. CONCLUSIONS: A growing body of evidence suggests that biological mechanisms underlie a bidirectional link between mood disorders and many medical illnesses. In addition, there is evidence to suggest that mood disorders affect the course of medical illnesses. Further prospective studies are warranted.

Acquired Immunodeficiency Syndrome↗
PubMed2005

Anesthesia and analgesia during and after surgery in neonates.

BACKGROUND: Historically, the use of anesthetics and analgesics in neonates and infants has been based on extrapolations from studies performed in adults and older children. Over the past 20 years, there has been a growing body of research on the clinical pharmacology and clinical outcomes of these agents in neonates and infants. OBJECTIVE: This article summarizes clinical pharmacology and clinical outcomes studies of opioids, opioid antagonists, sedative-hypnotics, nonsteroidal anti-inflammatory drugs and acetaminophen, and local anesthetics in neonates and infants to highlight gaps in the available knowledge, review some concerns about study design, and identify drugs that should receive high priority for future study. METHODS: Relevant studies were identified through a search of MEDLINE and a review of textbooks, conference proceedings, and abstracts. The available literature was subjected to expert committee-based review. CONCLUSIONS: There is a growing body of information on analgesic and anesthetic pharmacokinetics, pharmacodynamics, and clinical outcomes in neonates and infants, permitting safe and effective use in some clinical settings. Major gaps in knowledge persist, however. Future research may involve a combination of clinical trials and preclinical studies in suitable infant animal surrogate models.

Analgesia↗
PubMed2005

Efficacy of biphasic insulin aspart in patients with type 2 diabetes.

BACKGROUND: It is estimated that 39% of people with diabetes worldwide who use insulin are prescribed premixes, largely because of the practical advantages of addressing both prandial and basal insulin needs with a single product. Rapid-acting premixed insulin analogues such as biphasic insulin aspart 30 (BIAsp 30 [30% soluble insulin aspart and 70% protamine-crystallized insulin aspart], NovoLog Mix 70/30, Novo Nordisk, Bagsvaerd, Denmark) have been developed recently to overcome the pharmacokinetic limitations of regular human insulin used in the most commonly prescribed premix, biphasic human insulin 30 (BHI 30, 30% human insulin and 70% neutral protamine Hagedorn [NPH] insulin). It would be expected that these pharmacokinetic improvements would enhance clinical performance. However, the efficacy of BIAsp 30 compared with other common treatment regimens has not yet been systematically reviewed. OBJECTIVE: The aim of this paper is to review current data on the efficacy of BIAsp 30 in comparison with other treatment strategies in type 2 diabetes, including oral antidiabetic drugs (eg, metformin, sulfonylureas, meglitinides, thiazolidinediones), conventional insulins (eg, BHI 30, NPH insulin), and other analogue insulins (eg, insulin glargine, biphasic insulin lispro 25 [Mix 25, 25% biphasic insulin lispro and 75% protaminated lispro]). The focus will be on comparative efficacy (ie, postprandial glucose [PPG], blood glucose profiles, and glycosylated hemoglobin [HbA1c]). METHODS: We identified human clinical studies published through February 2005 involving BIAsp 30 in patients with type 2 diabetes by performing a MEDLINE search (key words: biphasic insulin aspart, BIAsp 30, biphasic insulin, and premixed insulin). Additional papers were identified by assessing (1) the reference lists in these studies, (2) published conference proceedings, and (3) our reference files. A total of 21 relevant papers were retrieved: 13 were published as full manuscripts, 1 as a short communication, 5 as abstracts, and 1 as a poster. One paper is currently in press. Novo Nordisk supplied data from an unpublished trial (Study 1536, 2004), as well as data from a trial published in abstract form only (Study 1269, 2002). RESULTS: A regimen of BIAsp 30 BID, at breakfast and dinner, provides improved PPG control compared with BHI 30 BID, NPH BID, and insulin glargine OD for patients with type 2 diabetes. Fasting plasma glucose (FPG) with BIAsp 30 was not significantly different from FPG with insulin glargine; however, FPG was higher with BIAsp 30 than with NPH. BIAsp 30 prevented excessive PPG excursions whether it was injected at the beginning of a meal or < or =15 minutes after starting a meal. BIAsp 30 was not associated with an increased risk of major hypoglycemia compared with other insulin regimens used in the studies reviewed. The incidence of minor hypoglycemic events with BIAsp 30 varied across studies but occurred with frequency or risk similar to BHI 30, Mix 25, or NPH. Treat-to-target trials reported that BIAsp 30 can be used to intensify insulin therapy and to reach the glycemic target recommended by the American Diabetes Association (ie, HbA1c <7.0%). One study reported a greater lowering of postprandial triglyceride levels with BIAsp 30 than with BHI 30. CONCLUSIONS: BIAsp 30 BID can reduce PPG levels to a greater extent than other common treatment regimens, including basal insulin OD. Using BIAsp 30, even once daily, may allow some patients to reach glycemic targets with a degree of convenience and tolerability that may not be achievable with other treatment regimens.

Biphasic Insulins↗
PubMed2005

Biphasic insulin aspart 30: literature review of adverse events associated with treatment.

BACKGROUND: Biphasic insulin aspart 30 (BIAsp 30 [30% soluble, rapid-acting insulin aspart and 70% protamine-bound insulin aspart], NovoLog Mix 70/30, Novo Nordisk, Bagsvaerd, Denmark), a premixed insulin analogue, addresses both the prandial and basal aspects of glucose regulation when used once or twice daily in patients with type 1 or type 2 diabetes. It provides overall glycemic control similar to biphasic human insulin 30 (BHI 30, 30% human insulin and 70% neutral protamine Hagedorn [NPH] insulin) in patients with type 1 or type 2 diabetes. OBJECTIVE: The aim of this review was to evaluate the safety profile associated with BIAsp 30 in patients with type 1 or type 2 diabetes versus that of comparator insulin products, including BHI 30 and biphasic insulin lispro 25 (Mix 25 [25% biphasic insulin lispro and 75% protaminated lispro], Humalog Mix 75/25, Eli Lilly and Company, Indianapolis, Indiana), together with the basal insulins, including NPH insulin and insulin glargine (Lantus, Sanofi-Aventis Pharmaceuticals, Paris, France). METHODS: Data from human clinical studies published in peer-reviewed journals or as conference proceedings that reported safety results in patients with type 1 or type 2 diabetes who were treated with BIAsp 30 versus comparator insulins were evaluated. To locate the appropriate articles, a MEDLINE search was performed for all years up to February 2005, using the following key words: biphasic insulin aspart, BIAsp 30, biphasic insulin, and premixed insulin. Additional papers were identified by examining the reference lists in these papers as well as our own personal reference files. Results from 17 publications were analyzed. The analysis included >2600 patients with type 2 diabetes (mean [range] age, 58 [36-70] years; duration of diabetes, 11.8 [9-17] years; and baseline glycosylated hemoglobin [HbA1c], 8.6% [7.5%-9.9%]). It also included 104 patients with type 1 diabetes (mean [range] age, 44.5 [30-58] years; duration of diabetes, 16 [2-30] years; and baseline HbA1c, 8.4% [7.2%-10.4%]). RESULTS: Hypoglycemia occurred in 43% to 57% of patients receiving BIAsp 30 versus 32% to 57% of patients receiving BHI 30 and 28% of patients receiving NPH insulin. Major hypoglycemic events were uncommon in most studies; but when they did occur, they were reported less frequently in patients receiving BIAsp 30 (2%-8% of patients) than in patients receiving BHI 30 (2%-14% of patients). Furthermore, patients treated with BIAsp 30 were at lower risk of experiencing minor nocturnal hypoglycemia than patients receiving comparator insulin; in 1 study, the relative risk (BIAsp 30 vs BHI 30) was calculated to be 0.63 (95% CI, 0.37 to 1.09). The adverse event (AE) profile, weight gain during treatment, and formation of cross-reactive antibodies were not different between BIAsp 30 and BHI 30. AEs were reported in 36% to 90% of patients receiving BIAsp 30, 38% to 88% of patients receiving BHI 30, and 51% of patients receiving Mix 25. The use of oral antidiabetic drugs in combination with BIAsp 30 did not alter the safety profile of BIAsp 30. CONCLUSION: The flexible and convenient treatment regimen offered by BIAsp 30, together with its ability to improve postprandial glucose control, is associated with a safety profile comparable to that of BHI 30 and NPH insulin, with a lower risk of major and nocturnal hypoglycemic events.

Adult↗
PubMed2006

Single-agent purine analogues for the treatment of chronic lymphocytic leukaemia: a systematic review and meta-analysis.

BACKGROUND: Recent trials suggest improved response rates for purine analogues compared to alkylator-based regimens in the treatment of B-CLL. However, none was able to show a survival advantage. Thus, a systematic Cochrane review may be able to further define the role of purine analogues in the first-line treatment of B-CLL. METHODS: Randomized controlled trials comparing single-agent purine analogues with alkylator-based regimens were included. Medical databases (Cochrane Library, MEDLINE, EMBASE), conference proceedings and trial registers were searched. We included full-text and abstract publications as well as unpublished data. Relative risks (RR) and hazard ratios (HR) were calculated under a fixed-effects model, clinical and statistical heterogeneity was examined with sensitivity analyses and meta-regression. If applicable, numbers needed to treat or harm (NNT, NNH) were also determined. FINDINGS: Five trials with 1838 randomized patients were included. Importantly, four trials had a cross-over design. There was a trend for improved overall survival for patients receiving purine analogues as initial therapy but statistical significance was just not reached (HR 0.89 [95% CI 0.78-1.01]). The RR for achieving an overall (RR 1.22 [95% CI 1.13-1.31]; NNT 8 [95% CI 6-13]) and complete response (RR 1.94 [95% CI 1.65-2.28]; NNT 6 [5-8]) was significantly improved, resulting in a longer progression-free survival (HR 0.70 [95% CI 0.61-0.82]). Incidence of grade III/IV infections (RR 1.83 [95% CI 1.30-2.58]; NNH 20 [95% CI 12.5-50]) and haemolytic anaemia (RR 3.36 [95% CI 1.27-8.91]; NNH 21 [95% CI 6-185]) was significantly higher in patients receiving purine analogues. INTERPRETATION: Despite significantly increased response rates and longer progression-free survival with purine analogues as first-line therapy, we were not able to detect a statistically significant improvement of overall survival compared to alkylator-based regimens. Furthermore, the use of purine analogues augments the risk for grade III/IV infections and haemolytic anaemia.

Anemia, Hemolytic↗
PubMed2006

Malignant distal biliary obstruction: a systematic review and meta-analysis of endoscopic and surgical bypass results.

BACKGROUND: Surgical bypass and endoscopic stents are available for palliative bypass of malignant distal biliary obstruction. AIM: Comparison of reported outcomes in randomized controlled trials (RCTs) which included surgery, endoscopic plastic stents or endoscopic metal stents in palliative relief of malignant distal biliary obstruction. METHODS: Systematic review and meta-analysis of published literature and conference proceedings review to June 2006. RESULTS: We found 24 studies, containing 2436 patients, which met our inclusion criteria. Endoscopic stenting with plastic stents (three studies) is associated with a lower risk of complications (RR 0.60, 95% CI 0.45-0.81), but a higher risk of recurrent biliary obstruction (RR 18.59, 95% CI 5.33 -64.86) than traditional surgical bypass. Self-expanding metal stents (seven studies) are associated with a significantly reduced risk of recurrent biliary obstruction at 4 months (RR 0.44, 95% CI 0.3, 0.63), or prior to death or end of study (RR 0.52, 95% CI 0.39-0.69), but are not superior to plastic stents in terms of technical success, therapeutic success, mortality or complications. Cost-effectiveness outcomes were not suitable for meta-analysis. No other plastic stent designs have been demonstrated to be superior to polyethylene stents (12 studies). CONCLUSIONS: Endoscopic metal stents are the intervention of choice in patients with malignant distal biliary obstruction, producing similar outcomes to plastic stents, but with improved patency rates.

Biliary Tract Diseases↗
PubMed2026

Associations between smart infusion pump-electronic health record interoperability and healthcare outcomes: A systematic review.

OBJECTIVE: This study synthesized available evidence on the associations between smart infusion pump-electronic health record (EHR) interoperability and healthcare outcomes. METHODS: A systematic review of PubMed, CINAHL, Embase, and Scopus databases identified 901 records, which were imported into Rayyan&#xae; for duplicate removal, independent screening by three reviewers, and resolution of discrepancies. Eligible studies were peer-reviewed, data-driven, and reported associations between smart infusion pump-EHR interoperability and healthcare outcomes. Studies focused solely on technical validation or interoperability prototypes were excluded. A backward citation search identified additional studies. Two reviewers independently extracted and cross-validated study characteristics using standardized templates. Methodological quality was assessed with the Joanna Briggs Institute Critical Appraisal Tools. RESULTS: Twenty records of 14 full-text studies and 6 conference proceedings were included. Most records reported positive associations between smart infusion pump-EHR interoperability and outcomes related to safety (e.g., medication administration errors, safety-reported events, pump alerts, and compliance with interoperability and drug library), operational efficiency (e.g., programming and documentation time and technical issues), financial performance (e.g., charges captured, and cost avoided), and user experience domains. Most studies used observational designs, reflecting real-world interoperability implementations, where controlling confounding factors is challenging. Limited reporting of baseline characteristics, pump type, and sample sizes limited comparability across studies. CONCLUSIONS: Smart infusion pump-EHR interoperability was associated with improvements in patient safety, efficiency, charge capture, and user experience, with variable findings across studies. Future research should use rigorous methodologies and standardized measures, examine relationships across outcome domains, assess limitations of pump-EHR interoperability, and evaluate underexplored outcomes, including team communication, cognitive workload, and AI-enabled pumps. IMPLICATIONS FOR CLINICAL PRACTICE: Interoperability should be viewed as a component of a broader sociotechnical system, in which technology, user, workflow, clinical content, and organizational practices collectively determine overall effectiveness.

Humans↗
PubMed2004

Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials.

OBJECTIVES: We sought to compare, through a meta-analytic process, the transradial and transfemoral approaches for coronary procedures in terms of clinical and procedural outcomes. BACKGROUND: The radial approach has been increasingly used as an alternative to femoral access. Several trials have compared these two approaches, with inconclusive results. METHODS: The MEDLINE, CENTRAL, and conference proceedings from major cardiologic associations were searched. Random-effect odds ratios (ORs) for failure of the procedure (crossover to different entry site or impossibility to perform the planned procedure), entry site complications (major hematoma, vascular surgery, or arteriovenous fistula), and major adverse cardiovascular events (MACE), defined as death, myocardial infarction, emergency revascularization, or stroke, were computed. RESULTS: Twelve randomized trials (n = 3,224) were included in the analysis. The risk of MACE was similar for the radial versus femoral approach (OR 0.92, 95% confidence interval [CI] 0.57 to 1.48; p = 0.7). Instead, radial access was associated with a significantly lower rate of entry site complications (OR 0.20, 95% CI 0.09 to 0.42; p < 0.0001), even if at the price of a higher rate of procedural failure (OR 3.30, 95% CI 1.63 to 6.71; p < 0.001). CONCLUSIONS: The radial approach for coronary procedures appears as a safe alternative to femoral access. Moreover, radial access virtually eliminates local vascular complications, thanks to a time-sparing hemostasis technique. However, gaining radial access requires higher technical skills, thus yielding an overall lower success rate. Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic progress of materials and increased operator experience.

Angioplasty, Balloon, Coronary↗
PubMed2006

Laboratory parameter profiles among patients with cystic fibrosis.

BACKGROUND: Clinical trials in cystic fibrosis (CF) currently use laboratory-specific reference ranges to evaluate chemistry and hematology measurements. Laboratory-specific normal reference ranges may not accurately reflect what is abnormal but clinically insignificant among CF patients. METHODS: To address this concern, data from the Phase III trial of inhaled tobramycin in CF patients was used to describe the distribution and variability of laboratory parameters. The laboratory specimens were analyzed at a central laboratory after being obtained at baseline and throughout the 24-week trial. RESULTS: At the time of entry into the clinical trial, 91% (463 of 508) of patients had at least a single value outside the normal range. Liver function tests (AST, ALT) were above the normal range in 16% and 12% of the patients respectively, with 2.4% of patients having an AST>2.0 times the upper limit of normal. Of the 243 patients on placebo, 242 (99.6%) had at least one laboratory parameter that changed from normal to abnormal during the 24-week follow-up period. Of those same placebo patients, 11.5% (N=28) had a laboratory parameter change from a Common Toxicity Criteria (CTC) grade 0 to grade 2 or higher during follow-up. CONCLUSIONS: Patients with CF frequently have laboratory values outside the normal range and have significant longitudinal variability of laboratory values. Interpretation of adverse events in the clinical trial setting may be complicated by the underlying high rates of some laboratory abnormalities in the CF population. This data was presented in poster format at the American Thoracic Society International Conference, Atlanta, USA, 2002, appearing subsequently in the Conference proceedings [Goss CH, Mayer-Hamblett N, Yunker A, Waltz DA, Kronmal RA, Ramsey BW. Laboratory parameter profiles among patients with cystic fibrosis. Am J Rep Crit Care Med 2002;165(8):A283].

Adolescent↗
PubMed2006

Reporting of trials presented in conference abstracts needs to be improved.

OBJECTIVES: To assess how trial information reported in conference abstracts differs to their subsequent full publication. METHODS: Randomized trials reported at the American Society of Clinical Oncology conference (1992) were identified. CENTRAL and PubMed (December 2002) were searched to identify corresponding full publications. A checklist (based on CONSORT) was used to compare abstracts for 37 trials with their full publication. RESULTS: Some aspects were well reported. Ninety-five percent of study objectives, 92% of participant eligibility, 100% of trial interventions, and 84% of primary outcomes were the same in both abstract and full publication. Other areas were more discrepant. Forty-six percent reported the same number of participants randomized in the abstract and full publication; only 22% reported the same number analyzed (median number analyzed per trial was 96 for abstracts and 117 for full publications). Eighty-two percent of trials were closed to follow-up in the full publication compared to 19% of abstracts. Lack of information was a major problem in assessing trial quality: no abstracts reported on allocation concealment, 16% reported on blinding and 14% reported intention to treat analysis. These figures were 49, 19, and 46%, respectively, for full publications. CONCLUSION: The information given for trials in conference proceedings can be unstable, especially for trials presenting early or preliminary results, and needs to be improved.

Abstracting and Indexing↗
PubMed2005

Influence of pH environment on polymer based dental material properties.

OBJECTIVE: This study aims to analyze the influence of different pH environments causing degradation to the properties of polymer based materials. DATA AND SOURCES: Studies were identified by searching published material in medical and dental literature using general and specialist databases, hand searching key dental journals and searching abstracts from conference proceedings. STUDY SELECTION: Evaluation of published laboratory studies regarding the effects of different pH mediums on resin-based material properties. CONCLUSION: For laboratory studies, slightly low pH mediums are the ones of choice to best mimic some in vivo conditions, but the effect seems to be slow acting. If the purpose is to accelerate dental composite hydrolysis and produce quick micro-structural damage to evaluate in vitro mechanical performances, suitable alternatives would be the use of high alkaline or very low acidic mediums.

Acids↗
PubMed2004

Developments in dental plaque pH modelling.

OBJECTIVES: The objectives of this review were to give a comprehensive account of the methods used to determine dental plaque pH over the last 50 years, to review how these methods have been used in dental cariology research and to give an update as to how dental plaque pH studies might be developed in the future. DATA: Published, referred papers and abstracts of conference proceedings in the literature were reviewed. SOURCES: A comprehensive search of the electronic databases PubMed and Medline, was undertaken. In addition, a hand search of the Index Denticus was done to identify relevant citations before 1966. STUDY SELECTION: Relevant published literature in peer-reviewed publications was reviewed. No additional inclusion criteria were applied. CONCLUSIONS: This comprehensive review gives an account of the background to, history of, relative merits and demerits of, applications of and future of dental plaque pH technologies.

Animals↗