Donna F. Stroup

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with <<trial flow>>, study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement. Copyright 2000 S. Karger GmbH, Freiburg

The Impact of Stretching on Sports Injury Risk: A Systematic Review of the Literature

PURPOSE We conducted a systematic review to assess the evidence for the effectiveness of stretching as a tool to prevent injuries in sports and to make recommendations for research and prevention. METHODS Without language limitations, we searched electronic data bases, including MEDLINE (1966-2002), Current Contents (1997-2002), Biomedical Collection (1993-1999), the Cochrane Library, and SPORTDiscus, and then identified citations from papers retrieved and contacted experts in the field. Meta-analysis was limited to randomized trials or cohort studies for interventions that included stretching. Studies were excluded that lacked controls, in which stretching could not be assessed independently, or where studies did not include subjects in sporting or fitness activities. All articles were screened initially by one author. Six of 361 identified articles compared stretching with other methods to prevent injury. Data were abstracted by one author and then reviewed independently by three others. Data quality was assessed independently by three authors using a previously standardized instrument, and reviewers met to reconcile substantive differences in interpretation. We calculated weighted pooled odds ratios based on an intention-to-treat analysis as well as subgroup analyses by quality score and study design. RESULTS Stretching was not significantly associated with a reduction in total injuries (OR = 0.93, CI 0.78-1.11) and similar findings were seen in the subgroup analyses. CONCLUSION There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes. Further research, especially well-conducted randomized controlled trials, is urgently needed to determine the proper role of stretching in sports.

The Prevention of Ankle Sprains in Sports A Systematic Review of the Literature

To assess the published evidence on the effectiveness of various approaches to the prevention of ankle sprains in athletes, we used textbooks, journals, and experts in the field of sports medicine to identify citations. We identified 113 studies reporting the risk of ankle sprains in sports, methods to provide support, the effect of these interventions on performance, and comparison of prevention efforts. The most common risk factor for ankle sprain in sports is history of a previous sprain. Ten citations of studies involving athletes in basketball, football, soccer, or volleyball compared alternative methods of prevention. Methods tested included wrapping the ankle with tape or cloth, orthoses, high-top shoes, or some combination of these methods. Most studies indicate that appropriately applied braces, tape, or orthoses do not adversely affect performance. Based on our review, we recommend that athletes with a sprained ankle complete supervised rehabilitation before returning to practice or competition, and those athletes suffering a moderate or severe sprain should wear an appropriate orthosis for at least 6 months. Both coaches and players must assume responsibility for prevention of injuries in sports. Methodologic limitations of published studies suggested several areas for future research.

Efficacy and safety of intrapartum electronic fetal monitoring: an update

Objective To compare the efficacy and safety of routine electronic fetal monitoring (EFM) of labor with intermittent auscultation, using the results of published randomized controlled trials (RCTs). Data Sources We identified RCTs by searching the MEDLINE data base for the period 1966–1994, contacting experts, and reviewing published references. Methods of Study Selection Our search identified 12 published RCTs addressing the efficacy and safety of EFM; no unpublished studies were found. The studies included 58, 855 pregnant women and their 59, 324 infants in both high- and low-risk pregnancies from ten clinical centers in the United States, Europe, Australia, and Africa. Data Extraction and Synthesis Data were abstracted, and their accuracy was confirmed independently. A single reviewer assessed study quality based on criteria developed by others for RCTs. Data reported from similar studies were used to calculate a combined risk estimate for each of nine outcomes. Overall, a statistically significant decrease was associated with routine EFM for a i-minute Apgar score less than 4 (relative risk [RR] 0.82, 955 confidence interval [CI] 0.65–0.98) and neonatal seizures (RR 0.5, 9599 CI 0.30–0.82). The protective effect of EFM for a 1-minute Apgar score less than 4 was apparent only in the non-United States studies, and the protective effect for neonatal seizures was evident only in studies with high-quality scores. No significant differences were observed in 1-minute Apgar scores less than 7, rate of admissions to neonatal intensive care units, and perinatal death. An increase associated with the use of EFM was observed in the rate of cesarean delivery (RR 1.33, 95% CI 1.08–1.59) and total operative delivery (RR 1.23, 95% Cl 1.15–1.31). Risk of cesarean delivery was greatest in low-risk pregnancies. Conclusion The only clinically significant benefit from the use of routine EFM was in the reduction of neonatal seizures. Because of the increase in cesarean and operative vaginal deliveries, the long-term benefit of this reduction must be evaluated in the decision reached jointly by the pregnant woman and her clinician to use EFM or intermittent auscultation during labor.

Worsening Trends in Adult Health-Related Quality of Life and Self-Rated Health— United States, 1993-2001

Objectives. Health-related quality of life and self-rated health complement mortality and morbidity as measures used in tracking changes and disparities in population health. The objectives of this study were to determine whether and how health-related quality of life and self-rated health changed overall in U.S. adults and in specific sociodemographic and geographic groups from 1993 through 2001. Methods. The authors analyzed data from annual cross-sectional Behavioral Risk Factor Surveillance System surveys of 1.2 million adults from randomly selected households with telephones in the 50 states and the District of Columbia. Results. Mean physically and mentally unhealthy days and activity limitation days remained constant early in the study period but increased later on. Mean unhealthy days increased about 14% during the study period. The percentage with fair or poor self-rated health increased from 13.4% in 1993 to 15.5% in 2001. Health-related quality of life and self-rated health worsened in most demographic groups, especially adults 45–54 years old, high school graduates without further education, and those with annual household incomes less than

Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement

50,000. However, adults 65 years old or older and people identified as non-Hispanic Asian/Pacific Islander reported stable or improving health-related quality of life and self-rated health. In 18 of the states and the District of Columbia, mean unhealthy days increased, while only North Dakota reported a decrease. Conclusion. Population tracking of adult health-related quality of life and self-rated health identified worsening trends overall and for many groups, suggesting that the nations overall health goals as identified in the Healthy People planning process are not being met.

Breast cancer risk and duration of estrogen use: the role of study design in meta-analysis.

Background: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). Methods: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. Findings: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with «trial flow», study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. Interpretation: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

The Science of Public Health Surveillance

Recent meta-analyses of studies of the risk of breast cancer associated with hormone replacement therapy agree that little risk is associated with ever-use or short-term use of estrogen replacement. These analyses disagree, however, about the effect of long-duration estrogen use. To understand differences in the findings among the meta-analyses of the effect of long-term use, we investigated the source of heterogeneity among the included studies. We analyzed subgroups by source of controls (community vs hospital), study design (case-control vs follow-up), and types of estrogen. We also examined the effect of modeling assumptions: that before women began estrogen use, those who chose to use estrogen replacement (1) were, or (2) were not, at substantially different risk from those who chose not to use estrogen. We found a small increase in risk in all subgroups of studies except those that used hospital controls. From a homogeneous group of case-control studies using community controls that analyzed the effect of conjugated equine estrogens, we estimated that the risk of breast cancer after 10 years of estrogen use increased by at least 15% and up to 29%.

The prevention of shin splints in sports: a systematic review of literature.

Improved public health surveillance can lead to earlier implementation of prevention and control measures. Better surveillance data lead to a more rational establishment of priorities. More timely and accurate data facilitate earlier epidemic detection and control. With better surveillance data, the impact of intervention activities and other public health programs can be evaluated more accurately. In this paper we describe how to improve the science of surveillance in terms of data collection, analysis, and dissemination and its application to public health practice. We then discuss the potential benefits and costs of such efforts and suggest methods for evaluating alternative approaches.The argument for science in surveillance, on the other hand, may be subject to excess. Surveillance is not an end unto itself, but rather a tool. This tool should be refined and modified to adapt to the goals of a particular public health program. It is the development of methods to apply creative ideas to surveillance, and the rigorous assessment of the process, that will benefit from the application of scientific principles.

Occupational Risk of Lyme Disease in Endemic Areas of New York State

PURPOSE To review the published and unpublished evidence regarding risk factors associated with shin splints, assess the effectiveness of prevention strategies, and offer evidence-based recommendations to coaches, athletes, and researchers. METHODS We searched electronic data bases without language restriction, identified citations from reference sections of research papers retrieved, contacted experts in the field, and searched the Cochrane Collaboration. Of the 199 citations identified, we emphasized results of the four reports that compared methods to prevent shin splints. We assessed the methodologic quality of these reports by using a standardized instrument. RESULTS The use of shock-absorbent insoles, foam heel pads, heel cord stretching, alternative footwear, as well as graduated running programs among military recruits have undergone assessment in controlled trials. There is no strong support for any of these interventions, and each of the four controlled trials is limited methodologically. Median quality scores in these four studies ranged from 29 to 47, and serious flaws in study design, control of bias, and statistical methods were identified. CONCLUSION Our review yielded little objective evidence to support widespread use of any existing interventions to prevent shin splints. The most encouraging evidence for effective prevention of shin splints involves the use of shock-absorbing insoles. However, serious flaws in study design and implementation constrain the work in this field thus far. A rigorously implemented research program is critically needed to address this common sports medicine problem.