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At least 793 records · Page 44Linked to original sources
PubMed2000

Outcomes after abdominal aortic aneurysm repair: comparison of mortality defined by centralized VA Patient Treatment File data versus hospital-based chart review.

BACKGROUND: Outcomes after abdominal aortic aneurysm (AAA) repair have been reported by individual Veterans Affairs medical centers (VAMCs) and for the entire VA patient population. PURPOSE: This study was done to determine whether outcomes defined using VA Patient Treatment File (PTF) data were comparable to those defined by direct chart review in those undergoing repair of intact AAA. METHODS: Focused chart review was performed in all veterans undergoing such AAA repair in a sample of VAMCs (n = 5) for separate 1-year periods during fiscal years (FY) 1991-1993. A previous report of outcomes after AAA repair for all veterans in DRGs 110 and 111 during FY 1991-1993 was based on PTF data that were further analyzed by Patient Management Category (PMC) software. Outcomes after AAA repair were defined in a similar fashion using PTF data and PMC analysis in the same sample VAMCs for which direct chart review data were available. Outcomes defined by chart review were then compared to those based on PTF data. RESULTS: Three of the 69 patients undergoing repair of intact AAA for which chart review data were available were assigned to DRGs other than 110 and 111 and, by definition, were not included in the PTF-derived database. Nine of 10 additional patients undergoing chart review were not identified as having undergone AAA repair by PMC software: 7 had procedure codes 39.25 instead of more standard AAA repair codes 38.34 or 38.44. Two additional patients with codes 38.64 or 38.66 were not identified as having undergone AAA repair by PMC software. The 10th patient not included in the PTF-derived database underwent additional operative procedures. Of the 13 patients missed by the combined PTF and PMC outcome analyses but identified by chart review, none died or had cardiac complications. One of these 13 patients had pulmonary complications based on chart review and PTF but was excluded by PMC analysis. There remained a total of 56 patients at the five sample VAMCs common to the PTF-derived and chart-derived databases identified as having undergone repair of intact AAA. There were two in-hospital deaths in these patients, and both were identified by each approach to outcome assessment. Four of these 56 patients had postoperative cardiac complications (ICD-9-CM code 997. 10) which were identified by both PTF and chart review. Postoperative pulmonary complications (ICD-9-CM code 997.30) were present in 4 of the 56 cases and were also identified by both PTF-based and chart-based outcome analyses. CONCLUSIONS: All deaths as well as cardiac or respiratory complications identified by chart review at the study hospitals were also affirmed by the PTF. Due to study methodologies (which restricted analysis to those in DRGs 110 and 111 and which included secondary analyses of PTF data by PMC software), 19% of patients who underwent repair of intact AAA identified by hospital-based chart review were excluded from the PTF-based outcome analysis. Outcomes defined using large databases such as the VA PTF may be comparable to those defined by chart review if study methodologies permit. Discrepancies in outcome assessment between direct chart review and large database analysis in the present study were due to methodologies used, not to deficiencies, per se, in PTF data.

Aged↗
PubMed2002

The typical Cochrane review. How many trials? How many participants?

OBJECTIVES: To describe the number of trials and participants in a typical systematic review from The Cochrane Database of Systematic Reviews. METHODS: The number of trials in 1,000 Cochrane systematic reviews in issue 1, 2001 of The Cochrane Database of Systematic Reviews was counted for three categories of trial: included trials, ongoing trials, and trials awaiting assessment for inclusion. (The term trial is used in this paper, although a small number of Cochrane reviews include studies that are not trials.) The total number of participants in included trials was extracted from a sample of reviews. RESULTS: A total of 9,778 trials were included in the Cochrane reviews. There were a further 356 ongoing trials and 1,138 trials awaiting assessment for inclusion. A typical review contained six included trials. Forty percent of the reviews listed ongoing trials and/or trials awaiting assessment for inclusion. Based on a sample of 258 reviews, the median number of participants per review was 945 (interquartile range, 313 to 2,511) per review and 118 (interquartile range, 60 to 241) per trial. CONCLUSION: This report is a descriptive study of the number of trials and participants in a typical Cochrane review from The Cochrane Library, issue 1, 2001.

Databases, Bibliographic↗
PubMed2006

Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols.

Gene transfer clinical trial protocols are reviewed by the Recombinant DNA Advisory Committee (RAC). Identifying the design concerns and suggestions commonly raised during RAC review may help investigators and sponsors shorten the process of protocol development and improve the quality of gene transfer trials. We therefore examined 53 full public reviews of gene transfer clinical trial protocols performed by the RAC between December 2000 and June 2004 to determine what trial design concerns or suggestions RAC members raised during written review or public discussion or in the formal letter to investigators after the review was completed. We also determined how frequently these concerns were raised. We found that RAC members raised issues regarding selection of subjects in 89% of reviews, dose escalation in 77%, selection of safety end points in 76%, biological activity measures in 66%, and overall design in 60% of reviews. The most common issue raised by RAC reviewers was the need to exclude subjects at increased risk for adverse events. Furthermore, in 89% of reviews, at least one design issue pertaining to safety of participants was raised. In 91% of reviews, at least one design concern was presented as a written RAC recommendation or concern to the investigator after the public review. When submitting protocols for RAC review, investigators and sponsors might devote more attention to issues that RAC reviewers commonly raise. Such attention might help strengthen clinical trial protocols, shorten the protocol development process, and enhance the protection of research participants.

Clinical Protocols↗
PubMed2000

Radiological review of incidence breast cancers.

OBJECTIVES: To examine the rate of incidence cancers detectable on review of previous screening mammograms using two reviewing methods. To compare the results with a previous study of interval cancers using the same reviewing methods. SETTING: Almost 50000 women are regularly invited for service screening at Stockholm Söder Hospital. From 1989 to 1993, 119 women were identified with breast cancer detected at screening and the previous round attendance (incidence cancer). METHODS: Screening mammograms, obtained before detection of the incidence cancers, were reviewed first mixed with other screening images (ratio 1:8) and then non-mixed. Reviewers from the screening unit responsible for the mammograms as well as reviewers from other units interpreted all images by both single and double reading. RESULTS: The proportion detected on retrospective review varied between 5% and 50% depending on the review method used and the number of reviewers included to classify a case as truly identified. Generally more cancers were detected when non-mixed samples of mammograms were reviewed than when mixed samples were reviewed (mean increase 23%) and when interpreted by double reading compared with single reading (mean increase 14%). CONCLUSIONS: In an experimental retrospective set up, fewer incidence cancers were identified in mixed than in non-mixed review. Generally more incidence cancers were identified on review (22%) than previously reported for interval cancers (14%), probably reflecting differences in tumour biology and growth. How many women with potentially visible incidence cancers would have benefited from earlier tumour detection still needs to be evaluated.

Breast Neoplasms↗
PubMed2005

Minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide.

BACKGROUND: Federal regulations allow waiver of informed consent for minimal-risk research (waiver). More than minimal-risk emergency research is allowed with an exception from informed consent (EFIC) under specific guidelines called the Final Rule. Performance of research without consent is controversial; however, chances for public health improvements are significant. OBJECTIVES: 1) To describe the number and demographics of academic medical institutions that have reviewed and approved minimal-risk waiver and EFIC studies; 2) to describe associations between National Institutes of Health (NIH) funding percentile and whether an academic medical institution reviews EFIC studies; and 3) to describe associations between geographic region and review of EFIC studies, and the interaction of region and NIH funding percentile with review of EFIC studies. The hypothesis was that schools with a higher NIH funding percentile (more funding) reviewed more EFIC studies research, and that this effect did not vary based on region. METHODS: This was an e-mail and telephone survey of all 122 MD-degree-granting medical schools in the continental United States. Descriptive data were collected on the number of schools reviewing and approving EFIC research. Sites were split into those that have reviewed EFIC studies and those that have not. A multivariable logistic regression examined the effects of 1) funding percentile and 2) region (Northeast, North Central, Southeast, and West) on the likelihood of EFIC study reviews at the sites. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were determined. RESULTS: Ninety-eight of 118 eligible institutional review boards (IRBs) (83%) responded. Ninety-nine percent (97/98) approved waiver studies; 51% (50/98) had reviewed and approved EFIC studies. Academic medical institutions with higher funding percentile were significantly more likely to have reviewed/approved EFIC studies (interaction p = 0.01) in all regions except the Northeast, where higher funding percentile was associated with IRBs significantly less likely to have reviewed/approved EFIC studies (OR 0.25; 95% CI = 0.08 to 0.81). CONCLUSIONS: Almost all medical school IRBs review minimal-risk waiver studies. About half of IRBs at medical schools have reviewed and approved an EFIC study. The higher the NIH funding percentile (more NIH funding), the more likely a site has reviewed EFIC studies, except in the Northeast region.

Academic Medical Centers↗
PubMed2000

Vaccines for preventing influenza in people with asthma.

BACKGROUND: Influenza vaccination is recommended for asthmatic patients in many countries as observational studies have shown that influenza infection can be associated with asthma exacerbations, but influenza vaccination itself has the potential to adversely affect pulmonary function. A recent overview concluded that there was no clear benefit of influenza vaccination in patients with asthma but this conclusions was not based on a systematic search of the literature. OBJECTIVES: Whilst influenza may cause asthma exacerbations, there is controversy about the use of influenza vaccinations, since they may precipitate an asthma attack in some people. The objective of this review was to assess the effects of influenza vaccination in children and adults with asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register and checked reference lists of articles. SELECTION CRITERIA: Randomised trials of influenza vaccination in children (over two years of age) and adults with asthma. Studies involving people with chronic obstructive pulmonary disease were excluded. DATA COLLECTION AND ANALYSIS: Inclusion criteria and assessment of trial quality were applied by two reviewers independently. Data extraction was done by two reviewers independently. Study authors were contacted for missing information. MAIN RESULTS: Nine trials were included. Four of these trials were of high quality. One further article has been included since the previous version of this review. Inclusion of the new trial has not altered the conclusions of this review. The included studies covered a wide diversity of people, settings and types of influenza vaccination, so data from the different trials were not pooled. In one trial, no protective effect of influenza vaccination against asthma exacerbation was demonstrated, but the incidence of influenza was low during the study period. A higher number of asthma exacerbations following killed influenza vaccination was found in one trial (risk difference 3 1%, 95% confidence interval 0.3% to 5.8%). When people with upper respiratory tract infections were excluded, this difference was no longer significant. A small trial using recombinant vaccine found no significant difference in asthma exacerbations between the vaccinated and placebo groups. REVIEWER'S CONCLUSIONS: There is not enough evidence to assess the benefits and risks of influenza vaccination for people with asthma.

Adult↗
PubMed2005

High prevalence but low impact of data extraction and reporting errors were found in Cochrane systematic reviews.

BACKGROUND AND OBJECTIVE: Extracting data from primary articles is an essential component in conducting systematic reviews. Incorrect data extraction can lead to false conclusions. The objective of this study was to retrospectively repeat the data extraction in all systematic reviews conducted by the Cochrane Cystic Fibrosis and Genetic Disorders Group. STUDY DESIGN AND SETTING: For each review, data extraction was conducted, by an experienced statistician, for the same publications used by the reviewers. Results were compared with those obtained by the reviewers. RESULTS: Errors were found in 20 of 34 reviews, including incorrect calculations made when converting data in primary articles into data required for the review (2 reviews) and misinterpretation of data that were reported in the primary article (7 reviews). All data-handling errors led to changes in the summary results, but none of these affected the review conclusions. CONCLUSIONS: Important errors were identified in a high proportion of reviews. A variety of problems relating to the reporting of results within a review were identified, but these did not lead to substantial changes in any conclusion.

Cystic Fibrosis↗
PubMedDate not supplied

Peer review in toxicologic pathology.

Peer review of histopathology findings in safety assessment studies involving rodents and other animals is a relatively recent procedure in toxicologic pathology. It serves to ensure the integrity of the pathology evaluation in safety studies, encourages consistency of diagnostic criteria and use of common terminology, and provides a method of continuing education for participants. The use of a standardized system of pathology nomenclature and diagnostic criteria, such as the Society of Toxicologic Pathologist's Guides for Toxicologic Pathology, is of great value in the procedure. Pathology reviews may involve government-sponsored bioassay programs, in-house industrial corporations, or individual peer reviews suggested or required by government regulatory agencies. Pathology Working Groups can be an integral part of the review process. The extent of the peer review is primarily dependent on the study results; however, other variables such as confidence of the data, study size and duration, complexity, and purpose are also important considerations. Essential components of any peer review, however, include selection of tissues/lesions for review, by a reviewing pathologist, discrepancy resolution, data modification, and documentation of all aspects of the review process. Specific procedures for pathology peer review are discussed. Disagreements among pathologists discovered in peer reviews can be resolved by several methods and examples will be presented. The entire pathology peer review process should be a learning experience for all involved and can help ensure the integrity of animal toxicology studies used for important regulatory decisions involving the use of chemicals in our society.

Animals↗
PubMedDate not supplied

Setting up interdepartmental peer review. The British Thoracic Society's scheme.

In 1992 the British Thoracic Society arranged a series of voluntary interdepartmental peer reviews. Their prime objective was to help to improve services by enabling clinicians to share experiences and ideas on the organisational aspects of the service and training provided. This paper outlines the planning and implementation of the scheme and some of the key results, and discusses the benefits and difficulties of such 'peer reviews'. Much of the benefit comes from the free exchange of ideas at the time of the reviews and 82% of the participants felt that they had picked up new ideas during the review. In their reports, reviewers outlined the strengths and weaknesses of the units and put forward a list of their key recommendations for change. Importantly, in half of the reviews the reviewers identified factors requiring change that had not been anticipated by the reviewed units. In most cases, the reports were subsequently shown to the managers concerned. One year after the review, 53% of 144 major recommendations had been achieved or were imminent. This form of voluntary peer review benefits both the reviewers and the reviewed and could well be adopted by other specialties.

Humans↗
PubMed2005

Nurse editors' views on the peer review process.

A growing body of research challenges the inter-rater reliability of peer reviewers and the value of reviewer training or blinding in improving the quality of manuscript reviews, but double-blinded peer review of papers remains a relatively unexamined standard for nursing journals. Using data from a larger emailed survey, the views of 88 nurse editors on peer review were analyzed using content analysis. The majority of nurse editors reported that blinding was important in peer review, to maintain objectivity and avoid negative personal or professional consequences. The minority who saw potential benefits of open review valued increased transparency in the reviewing and editorial decision-making process. An excellent review was viewed as containing specific instructions on how the deficits in a manuscript might be remedied. Common weaknesses of reviews were lack of specificity and inappropriate focus. Virtually all editors provided some form of preparation or guidance to reviewers. Peer review has an impact on nurses' workload and careers, and training in writing and critique should be included in nursing education.

Attitude↗
PubMed2005

Identifying studies for systematic reviews of diagnostic tests was difficult due to the poor sensitivity and precision of methodologic filters and the lack of information in the abstract.

BACKGROUND AND OBJECTIVES: Methods to identify studies for systematic reviews of diagnostic accuracy are less well developed than for reviews of intervention studies. This study assessed (1) the sensitivity and precision of five published search strategies and (2) the reliability and accuracy of reviewers screening the results of the search strategy. METHODS: We compared the results of the search filters with the studies included in two systematic reviews, and assessed the interobserver reliability of two reviewers screening the list of articles generated by a search strategy. RESULTS: In the first review, the search strategy published by van der Weijden had the greatest sensitivity, and in the second, four search strategies had 100% sensitivity. There was "substantial" agreement between two reviewers, but in the first review each reviewer working on their own would have missed one paper eligible for inclusion in the review. Ascertainment intersection techniques indicate that it is unlikely that further papers have been missed in the screening process. CONCLUSION: Published search strategies may miss papers for reviews of diagnostic test accuracy. Papers are not easily identified as studies of diagnostic test accuracy, and the lack of information in the abstract makes it difficult to assess the eligibility for inclusion in a systematic review.

Abstracting and Indexing↗
PubMed1994

A computerized system for reviewing medical records from physicians' offices.

BACKGROUND: Review of clinical performance in office-based care is increasing in importance as more medical care shifts to outpatient settings. Decisions made in primary care settings can save lives and limit disability through prevention and early intervention in disease. Information is needed to assess quality of care by answering such questions as whether drugs are prescribed and monitored appropriately, follow-up on serious health threats is carried out promptly, or procedures are performed for appropriate indications. Moreover, data from medical records are essential to provide important clinical information not found in the more widely used administrative data sets. Managed care organizations, too, face the need to respond to requests for objective information about the quality of primary care that they provide. Those organizations now planning assessments of primary care will need to consider the cost of obtaining information from medical record review. METHODS: The DEMPAQ Record Review System (DRRS) is a tool for peer review organizations (PROs) to use to review ambulatory care given to Medicare beneficiaries in physicians' offices. The system is described in terms of functions (activities commonly performed in the course of an office visit, such as drug prescribing), indicators (summary measures of quality for each key function of clinical care), and clinical items (for example, specific drugs or tests for each function and indicator)--a total of 263 indicators in all. A framework is provided for measuring the operational costs of a review system based on medical records. RESULTS: The costs directly associated with a fully operational review system were less than $48 per case in Iowa and Alabama and $72 per case in Maryland. On average, reviewers spent about an hour per case signed on to DRRS; average review times declined over time with practice. About half the cost of the review process is accounted for by administrative costs. Therefore, once the effort has been made to obtain records, the additional cost of abstracting more data items is relatively low. Since samples of 300-500 records suffice to measure average performance for a region or state, costs per region/state approximate $15,000 to $25,000 per measurement cycle for assessment of a wide array of clinical areas. SUMMARY: The cost of collecting information on quality of care from medical records using the review system falls within current budgets for PRO review. However, organizations planning to implement a quality improvement campaign should also consider the costs of analyzing the data, reporting information to physicians, and continuing to monitor changes in performance.

Aged↗
PubMed2003

Impartial judgment by the "gatekeepers" of science: fallibility and accountability in the peer review process.

High publication demands and the low acceptance rate of peer review journals place the journal editors and their reviewers in a powerful position. Journal reviewers have a vital role not only in influencing the journal editor's publication decisions, but also in the very nature and direction of scientific research. Because of their influence in peer review outcomes, journal reviewers are aptly described as the "gatekeepers of science." In this article we describe several pitfalls that can impede reviewers' impartial judgement. These include such issues as confirmatory bias, the negative results bias (the file drawer problem), the Matthew effect, the Doctor Fox effect, and gender, race, theoretical orientation, and "political correctness." We argue that procedures currently used by many professional journals, such as blind or masked review, may not completely alleviate the effects of these pitfalls. Instead, we suggest that increasing reviewers' awareness of the pitfalls, accountability, and vigilance can improve fairness in the peer review process. The ultimate responsibilities belong to the journal editors who are confronted with the difficult task of satisfying journal readers, contributors, reviewers, and owners. We recommend that the journal editors conduct periodic internal and external evaluations of their journals' peer review process and outcomes, with participation of reviewers, contributors, readers and owners.

Judgment↗
PubMed2001

Peer review of classroom teaching: an interim report.

This paper provides interim findings from the implementation of peer review of classroom teaching in a large UK University School of Nursing, Midwifery and Health Visiting. A total of 258 classroom teaching sessions, involving 129 teaching staff (n=129) were included over a period of 7 months. Teachers had two teaching sessions reviewed by a colleague. One reviewer was self-nominated and the Dean of School allocated the other. The paper is in two parts. Part one includes a short literature review followed by a descriptive account of how peer review was implemented. Part two focuses upon individual experiences from a small scale study with data obtained from 14 teachers (n=14) who took part in qualitative interviews based on their experiences of being both reviewer and reviewee. The larger study gathered data from several sources. This paper presents the initial findings from interview data with nurse teachers. Their perceptions form the basis of a discussion, which raises issues related to the experience of both implementing and being involved in, peer review of classroom teaching. Four themes emerged from the interview transcriptions; peer review was initially perceived as a threat; the experience of peer review was a positive one; teachers felt that being a reviewer was an interesting and worthwhile experience and perceived peer review positively when good relations existed between them and their reviewer.

Attitude↗
PubMed2004

Effects of training on quality of peer review: randomised controlled trial.

OBJECTIVE: To determine the effects of training on the quality of peer review. DESIGN: Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group. SETTING AND PARTICIPANTS: Reviewers at a general medical journal. Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials. MAIN OUTCOME MEASURES: Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts. RESULTS: Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002). CONCLUSIONS: Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

Education, Professional↗
PubMed2004

Profiling quality of care: Is there a role for peer review?

BACKGROUND: We sought to develop a more reliable structured implicit chart review instrument for use in assessing the quality of care for chronic disease and to examine if ratings are more reliable for conditions in which the evidence base for practice is more developed. METHODS: We conducted a reliability study in a cohort with patient records including both outpatient and inpatient care as the objects of measurement. We developed a structured implicit review instrument to assess the quality of care over one year of treatment. 12 reviewers conducted a total of 496 reviews of 70 patient records selected from 26 VA clinical sites in two regions of the country. Each patient had between one and four conditions specified as having a highly developed evidence base (diabetes and hypertension) or a less developed evidence base (chronic obstructive pulmonary disease or a collection of acute conditions). Multilevel analysis that accounts for the nested and cross-classified structure of the data was used to estimate the signal and noise components of the measurement of quality and the reliability of implicit review. RESULTS: For COPD and a collection of acute conditions the reliability of a single physician review was quite low (intra-class correlation = 0.16-0.26) but comparable to most previously published estimates for the use of this method in inpatient settings. However, for diabetes and hypertension the reliability is significantly higher at 0.46. The higher reliability is a result of the reviewers collectively being able to distinguish more differences in the quality of care between patients (p < 0.007) and not due to less random noise or individual reviewer bias in the measurement. For these conditions the level of true quality (i.e. the rating of quality of care that would result from the full population of physician reviewers reviewing a record) varied from poor to good across patients. CONCLUSIONS: For conditions with a well-developed quality of care evidence base, such as hypertension and diabetes, a single structured implicit review to assess the quality of care over a period of time is moderately reliable. This method could be a reasonable complement or alternative to explicit indicator approaches for assessing and comparing quality of care. Structured implicit review, like explicit quality measures, must be used more cautiously for illnesses for which the evidence base is less well developed, such as COPD and acute, short-course illnesses.

Acute Disease↗
PubMed2000

Open peer review: a randomised controlled trial.

BACKGROUND: Most scientific journals practise anonymous peer review. There is no evidence, however, that this is any better than an open system. AIMS: To evaluate the feasibility of an open peer review system. METHOD: Reviewers for the British Journal of Psychiatry were asked whether they would agree to have their name revealed to the authors whose papers they review; 408 manuscripts assigned to reviewers who agreed were randomised to signed or unsigned groups. We measured review quality, tone, recommendation for publication and time taken to complete each review. RESULTS: A total of 245 reviewers (76%) agreed to sign. Signed reviews were of higher quality, were more courteous and took longer to complete than unsigned reviews. Reviewers who signed were more likely to recommend publication. CONCLUSIONS: This study supports the feasibility of an open peer review system and identifies such a system's potential drawbacks.

Feasibility Studies↗
PubMed2004

The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence.

OBJECTIVE: A review of the evidence concerning the effect of chronic or intermittent hypoxia on cognition in childhood was performed by using both a systematic review of the literature and critical appraisal criteria of causality. Because of the significant impact of behavioral disorders such as attention-deficit/hyperactivity disorder on certain cognitive functions as well as academic achievement, the review also included articles that addressed behavioral outcomes. METHODS: Both direct and indirect evidence were collected. A structured Medline search was conducted from the years 1966-2000 by using the OVID interface. Both English- and non-English-language citations were included. Significant articles identified by the reviewers up to 2003 were also included. To be included as direct evidence, an article needed to be an original report in a peer-reviewed journal with data on cognitive, behavioral, or academic outcomes in children up to 14 years old, with clinical conditions likely to be associated with exposure to chronic or intermittent hypoxia. Indirect evidence from other reviews and publications in closely related fields, including experimental studies in adults, was used to help formulate conclusions. Two reviewers screened abstracts and titles. Each article included as direct evidence received a structured evaluation by 2 reviewers. Adjudication of differences was performed by a group of 2 reviewers and a research consultant. After this review, tables of evidence were constructed that were used as the basis for group discussion and consensus development. Indirect evidence assigned by topic to specific reviewers was also presented as part of this process. A formal procedure was used to rank the studies by design strength. The critical appraisal criteria for causation described in Evidence Based Pediatrics and Child Health (Moyer V, Elliott E, Davis R, et al, eds. London, United Kingdom: BMJ Books; 2000:46-55) were used to develop consensus on causality. RESULTS: A total of 788 literature citations were screened. For the final analysis, 55 articles met the criteria for inclusion in the direct evidence. Of these, 43 (78.2%) reported an adverse effect. Of the 37 controlled studies, 31 (83.8%) reported an adverse effect. Adverse effects were noted at every level of arterial oxygen saturation and for exposure at every age level except for premature newborns. The studies were classified into 5 clinical categories: congenital heart disease (CHD), sleep-disordered breathing (SDB), asthma, chronic ventilatory impairment, and respiratory instability in infants. Two of these categories, CHD and SDB, which accounted for 42 (76.4%) of the included articles, fulfilled the Evidence Based Pediatrics and Child Health criteria for causation. The indirect evidence included 8 reviews, 1 meta-analysis, and 10 original reports covering the fields of adult anoxia, animal research, SDB in adults, natural and experimental high-altitude studies, perinatal hypoxic-ischemic encephalopathy, anemia, and carbon-monoxide poisoning. The studies of high-altitude and carbon-monoxide poisoning provided evidence for causality. CONCLUSIONS: Adverse impacts of chronic or intermittent hypoxia on development, behavior, and academic achievement have been reported in many well-designed and controlled studies in children with CHD and SDB as well as in a variety of experimental studies in adults. This should be taken into account in any situation that may expose children to hypoxia. Because adverse effects have been noted at even mild levels of oxygen desaturation, future research should include precisely defined data on exposure to all levels of desaturation.

Adolescent↗