Biomedical subjects

Gerald Gartlehner

Publications and source records attributed to Gerald Gartlehner.

10 recordsLinked to original sources

PubMed2006

A simple and valid tool distinguished efficacy from effectiveness studies.

OBJECTIVE: To propose and test a simple instrument based on seven criteria of study design to distinguish effectiveness (pragmatic) from efficacy (explanatory) trials. STUDY DESIGN: Currently no validated definition of effectiveness studies exists. We asked the directors of 12 Evidence-based Practice Centers to select six studies each: four that they considered to be examples of effectiveness trials and two considered efficacy studies. We then applied our proposed criteria to test the construct validity using the selected studies as if they had been identified by a gold standard. RESULTS: Based on the rationale to identify effectiveness studies reliably with minimal false positives (i.e., a high specificity), a cutoff of six criteria produced the most desirable balance between sensitivity and specificity. This setting produced a specificity of 0.83 and a sensitivity of 0.72. CONCLUSION: When applied in a standardized manner, our proposed criteria can provide a valid and simple tool to distinguish effectiveness from efficacy studies. The applicability of systematic reviews can improve when analysts place more emphasis on the generalizability of included studies. In addition, clinicians can also use our criteria to determine the external validity of individual studies, given an appropriate population of interest.

Drug Therapy↗

PubMed2006

Cesarean delivery on maternal request: maternal and neonatal outcomes.

OBJECTIVE: To review systematically the evidence about maternal and infant outcomes of cesarean delivery on maternal request and planned vaginal delivery. DATA SOURCES: We searched MEDLINE, Cochrane Collaboration resources, and Embase and identified 1,406 articles through dual review using a priori inclusion criteria. METHODS OF STUDY SELECTION: We included English language studies published from 1990 to June 2005 that compared the key reference group (cesarean delivery on maternal request or proxies) and planned vaginal delivery. TABULATION, INTEGRATION, AND RESULTS: We identified 54 articles for maternal and infant outcomes. Virtually no studies exist on cesarean delivery on maternal request, so the knowledge base rests on indirect evidence from proxies with unique and significant limitations. Most studies compared outcomes by actual routes of delivery, resulting in variable relevance to planned routes of delivery. Primary cesarean delivery on maternal request and planned vaginal delivery likely differ with respect to individual outcomes; for instance, risks of urinary incontinence and maternal hemorrhage were lower with planned cesarean, whereas the risk of neonatal respiratory morbidity was higher and maternal length of stay was longer with planned cesarean delivery. However, our comprehensive assessment, across many outcomes, suggests no major differences between primary cesarean delivery on maternal request and planned vaginal delivery, but the evidence is too weak to conclude definitively that differences are completely absent. If a woman chooses to have a cesarean delivery in her first delivery, she is more likely to have subsequent deliveries by cesarean. With increasing numbers of cesarean delivery, risks occur with increasing frequency. CONCLUSION: The evidence is significantly limited by its minimal relevance to primary cesarean delivery on maternal request. Future research requires developing consensus about terminology, creating a minimum data set for cesarean delivery on maternal request, improving study design and statistical analyses, attending to major outcomes and their special measurement issues, assessing both short- and long-term outcomes with better measurement strategies, dealing better with confounders, and considering the value or utility of different outcomes.

Cesarean Section↗

PubMed2006

The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis.

OBJECTIVE: Biologics are an important therapeutic option for treating patients with rheumatoid arthritis (RA). However, they are associated with rare but severe adverse events such as serious infections, lymphoma, or chronic heart failure. In addition, dosing regimens and routes of administration differ substantially among biologics. In a systematic review, we assessed the comparative efficacy and safety of biologic agents for RA. METHODS: We searched electronic databases up to May 2006. We limited evidence to controlled trials for efficacy but included observational evidence for safety. Outcomes of interest were clinical response, radiographic progression, and quality of life. Given the paucity of head-to-head evidence, we conducted adjusted, indirect comparisons of placebo-controlled trials. RESULTS: Twenty-six controlled trials provided efficacy data; 18 additional studies assessed safety. The only evidence directly comparing 2 biologic agents was a nonrandomized, open-label trial that found no differences in effectiveness and safety between etanercept and infliximab. Adjusted indirect comparisons indicate no significant differences in efficacy between anti-tumor necrosis factor (TNF) drugs. However, anti-TNF drugs appear to be more efficacious than anakinra, although not all comparisons reached statistical significance. Because of the lack of sound longterm safety data, evidence is insufficient to draw firm conclusions about the comparative safety of biologics. CONCLUSION: Anti-TNF drugs appear to be more efficacious than anakinra but do not differ significantly among each other. Clinical considerations such as comorbidities, route of administration, dosing regimens, and specific side effect profiles may guide the choice of an anti-TNF drug.

Antirheumatic Agents↗

PubMed2005

Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder.

BACKGROUND: Reviews have compared the efficacy and tolerability of newer second-generation antidepressants with those of placebo or older treatments, but comparative evidence for use of second-generation antidepressants to treat major depressive disorder has not been evaluated. PURPOSE: To systematically evaluate comparative data on the efficacy, effectiveness, and tolerability of commonly prescribed second-generation antidepressants (selective serotonin reuptake inhibitors, bupropion, duloxetine, mirtazapine, and venlafaxine) in the treatment of major depressive disorder. DATA SOURCES: MEDLINE, EMBASE, and PsychLit; the Cochrane Library; and the International Pharmaceutical Abstracts were searched from January 1980 through February 2005 for reviews; randomized, controlled trials; meta-analyses; and observational studies. STUDY SELECTION: The authors reviewed 46 head-to-head randomized, controlled trials comparing one second-generation antidepressant with another. Twenty-four observational studies and placebo-controlled trials were also included for assessment of safety and tolerability. DATA EXTRACTION: Two researchers independently reviewed titles and abstracts. Trained reviewers abstracted data from each study and assigned an initial quality rating. A second reviewer verified the data extraction and quality rating. DATA SYNTHESIS: According to fair to good evidence, the second-generation antidepressants that were compared had only minimal differences in efficacy, and 88% of comparative efficacy studies reported no statistically significant difference in any outcome measure at the end of the study. One effectiveness trial rated good and 2 effectiveness trials rated fair reported no statistically significant differences in primary outcome measures for compared drugs. Meta-analyses showed a modest but statistically significant additional treatment effect for sertraline and venlafaxine compared with fluoxetine. About 96% of comparative trials were sponsored by or had at least 1 author affiliated with a pharmaceutical company; the remaining trials did not report funding sources. Adverse event profiles differed among drugs; however, the degree and quality of adverse event assessment varied and only 13% of trials used a standardized scale to assess adverse events. LIMITATIONS: Quantitative analyses could not be done for many drug comparisons because the quantity and quality of the evidence were inadequate. Most published evidence was from trials sponsored by pharmaceutical companies, and publication bias may have occurred. CONCLUSIONS: Overall, second-generation antidepressants probably do not differ substantially for treatment of major depressive disorder. Choosing the agent that is most appropriate for a given patient is difficult.

Antidepressive Agents, Second-Generation↗

PubMed2005

Outcomes of routine episiotomy: a systematic review.

CONTEXT: Episiotomy at the time of vaginal birth is common. Practice patterns vary widely, as do professional opinions about maternal risks and benefits associated with routine use. OBJECTIVE: To systematically review the best evidence available about maternal outcomes of routine vs restrictive use of episiotomy. EVIDENCE ACQUISITION: We searched MEDLINE, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Collaboration resources and performed a hand search for English-language articles from 1950 to 2004. We included randomized controlled trials of routine episiotomy or type of episiotomy that assessed outcomes in the first 3 postpartum months, along with trials and prospective studies that assessed longer-term outcomes. Twenty-six of 986 screened articles provided relevant data. We entered data into abstraction forms and conducted a second review for accuracy. Each article was also scored for research quality. EVIDENCE SYNTHESIS: Fair to good evidence from clinical trials suggests that immediate maternal outcomes of routine episiotomy, including severity of perineal laceration, pain, and pain medication use, are not better than those with restrictive use. Evidence is insufficient to provide guidance on choice of midline vs mediolateral episiotomy. Evidence regarding long-term sequelae is fair to poor. Incontinence and pelvic floor outcomes have not been followed up into the age range in which women are most likely to have sequelae. With this caveat, relevant studies are consistent in demonstrating no benefit from episiotomy for prevention of fecal and urinary incontinence or pelvic floor relaxation. Likewise, no evidence suggests that episiotomy reduces impaired sexual function--pain with intercourse was more common among women with episiotomy. CONCLUSIONS: Evidence does not support maternal benefits traditionally ascribed to routine episiotomy. In fact, outcomes with episiotomy can be considered worse since some proportion of women who would have had lesser injury instead had a surgical incision.

Episiotomy↗

PubMed2005

Discontinuation rates for selective serotonin reuptake inhibitors and other second-generation antidepressants in outpatients with major depressive disorder: a systematic review and meta-analysis.

The present study aimed to systematically compare overall loss to follow-up, discontinuation rates because of adverse events and discontinuation rates because of a lack of efficacy in published studies assessing the efficacy and tolerability of selective serotonin reuptake inhibitors (SSRIs) compared to other second-generation antidepressants in treating outpatients with major depressive disorder (MDD). We searched MEDLINE, Embase, The Cochrane Library, PsychLit and the International Pharmaceutical Abstracts from 1980 to 2004 (April). Twenty double-blinded, randomized controlled trials met our eligibility criteria and compared SSRIs to other second-generation antidepressants in adult outpatients with MDD. Pooled relative risks of discontinuation rates because of (i) any reason (overall loss to follow-up), (ii) adverse events and (iii) a lack of efficacy did not differ substantially between SSRIs as a class and other second-generation antidepressants. Taking the similar efficacy of second-generation antidepressant into account, our findings suggest that clinicians can focus on other practically or clinically relevant considerations such as costs, differences in side-effect profiles, onset of action or aspects of health-related quality of life to tailor a treatment to an individual patient's needs.

Antidepressive Agents, Second-Generation↗

PubMed2005

Perinatal depression: a systematic review of prevalence and incidence.

OBJECTIVE: We systematically review evidence on the prevalence and incidence of perinatal depression and compare these rates with those of depression in women at non-childbearing times. DATA SOURCES: We searched MEDLINE, CINAHL, PsycINFO, and Sociofile for English-language articles published from 1980 through March 2004, conducted hand searches of bibliographies, and consulted with experts. METHODS OF STUDY SELECTION: We included cross-sectional, cohort, and case-control studies from developed countries that assessed women for depression during pregnancy or the first year postpartum with a structured clinical interview. TABULATION, INTEGRATION, AND RESULTS: Of the 109 articles reviewed, 28 met our inclusion criteria. For major and minor depression (major depression alone), the combined point prevalence estimates from meta-analyses ranged from 6.5% to 12.9% (1.0-5.6%) at different trimesters of pregnancy and months in the first postpartum year. The combined period prevalence shows that as many as 19.2% (7.1%) of women have a depressive episode (major depressive episode) during the first 3 months postpartum; most of these episodes have onset following delivery. All estimates have wide 95% confidence intervals, showing significant uncertainty in their true levels. No conclusions could be made regarding the relative incidence of depression among pregnant and postpartum women compared with women at non-childbearing times. CONCLUSION: To better delineate periods of peak prevalence and incidence for perinatal depression and identify high risk subpopulations, we need studies with larger and more representative samples.

Depression, Postpartum↗

PubMed2004

Evidence-based medicine breaking the borders--a working model for the European Union to facilitate evidence-based health care.

The promotion of evidence-based health care to improve quality of care has become an important political agenda worldwide. In April 2003 the European Commission acknowledged the lack of evidence-based health care in the European Union. Nevertheless, neither the new eHealth 2005 Action Plan nor the Public Health Program 2003 explicitly state the facilitation of evidence-based health care as a goal. This article proposes a working model for a network of institutions and databases within the European Union to facilitate evidence-based health care. The model strives to adapt existing U.S. examples of institutions in the field of evidence-based medicine, like Evidence-based Practice Centers, and the National Guideline Clearinghouse to the heterogeneous and legally restrictive environment of the European Union, particularly Article 152 of the European Union Treaty. In addition to increasing efficiency and decreasing redundancy, coordinating national efforts in best practice will also facilitate information sharing and knowledge transfer. The establishment of databases in native languages could also break down one of the main barriers existing between care providers and evidence-based medicine while adhering to the overall concepts of eHealth 2005.

Databases as Topic↗

PubMed2004

Assessing the need to update prevention guidelines: a comparison of two methods.

BACKGROUND: An important concern for developers of clinical practice guidelines is how best to determine when guidelines require updating to ensure they remain current and evidence based. Because of the high costs associated with updating guidelines, recent attention has focused on approaches that can reliably assess the extent of updating required. Recently, Shekelle and colleagues proposed a model of limited literature searches with modest expert involvement as a way to reduce the cost and time requirements for assessing whether a guideline needs updating. METHODS: The main objective of this study was to compare the Shekelle et al. assessment model (review approach) and a conventional process using typical systematic review methods (traditional approach) in terms of comprehensiveness and effort. We modeled the review approach on that by Shekelle and colleagues but refined it iteratively over three phases to achieve greater efficiency. Using both methods independently, we assessed the need to update six topics from the 1996 Guide to Clinical Preventive Services from the US Preventive Services Task Force. Main outcomes included completeness of study identification, importance of missed studies and the effort involved. RESULTS: Although the review approach identified fewer eligible studies than the traditional approach, none of the studies missed was rated as important by task force members acting as liaisons to the project with respect to whether the topic required an update. On average, the review approach produced substantially fewer citations to review than the traditional approach. The effort involved and potential time saving depended largely on the scope of the topic. CONCLUSIONS: The revised review approach provides an efficient and acceptable method for judging whether a guideline requires updating.

Bacteriuria↗

PubMedDate not supplied

Efficacy and safety of inhaled corticosteroids in patients with COPD: a systematic review and meta-analysis of health outcomes.

PURPOSE: We wanted to review systematically the efficacy, effectiveness, and safety of inhaled corticosteroids with respect to health outcomes in patients with chronic obstructive pulmonary disease (COPD). METHODS: We searched MEDLINE, EMBASE, The Cochrane Library, and the International Pharmaceutical Abstracts to identify relevant articles. We limited evidence to double-blinded randomized controlled trials (RCTs) for efficacy, but we also reviewed observational evidence for safety. Outcomes of interest were overall mortality, exacerbations, quality of life, functional capacity, and respiratory tract symptoms. When possible, we pooled data to estimate summary effects for each outcome. RESULTS: Thirteen double-blinded RCTs determined the efficacy of an inhaled corticosteroid compared with placebo; 11 additional studies assessed the safety of inhaled corticosteroid treatment in patients with asthma or COPD. Overall, COPD patients treated with inhaled corticosteroids experienced significantly fewer exacerbations than patients taking placebo (relative risk [RR] = 0.67; 95% CI, 0.59-0.77). No significant difference could be detected for overall mortality (RR = 0.81; 95% CI, 0.60-1.08). Evidence on quality of life, functional capacity, and respiratory tract symptoms is mixed. Adverse events were generally tolerable; pooled discontinuation rates did not differ significantly between inhaled corticosteroid and placebo treatment groups (RR = 0.92; 95% CI, 0.74-1.14). Observational evidence, however, indicates a dose-related risk of cataract and open-angle glaucoma. Severe adverse events, such as osteoporotic fractures, are rare; the clinical importance of the additional risk is questionable. CONCLUSIONS: Overall, the risk-benefit ratio appears to favor inhaled corticosteroid treatment in patients with moderate to severe COPD. Existing evidence does not indicate a treatment benefit for patients with mild COPD.

Administration, Inhalation↗