OBJECTIVES: To consider methods and related evidence for evaluating bias in non-randomised intervention studies. DATA SOURCES: Systematic reviews and methodological papers were identified from a search of electronic databases; handsearches of key medical journals and contact with experts working in the field. New empirical studies were conducted using data from two large randomised clinical trials. METHODS: Three systematic reviews and new empirical investigations were conducted. The reviews considered, in regard to non-randomised studies, (1) the existing evidence of bias, (2) the content of quality assessment tools, (3) the ways that study quality has been assessed and addressed. (4) The empirical investigations were conducted generating non-randomised studies from two large, multicentre randomised controlled trials (RCTs) and selectively resampling trial participants according to allocated treatment, centre and period. RESULTS: In the systematic reviews, eight studies compared results of randomised and non-randomised studies across multiple interventions using meta-epidemiological techniques. A total of 194 tools were identified that could be or had been used to assess non-randomised studies. Sixty tools covered at least five of six pre-specified internal validity domains. Fourteen tools covered three of four core items of particular importance for non-randomised studies. Six tools were thought suitable for use in systematic reviews. Of 511 systematic reviews that included non-randomised studies, only 169 (33%) assessed study quality. Sixty-nine reviews investigated the impact of quality on study results in a quantitative manner. The new empirical studies estimated the bias associated with non-random allocation and found that the bias could lead to consistent over- or underestimations of treatment effects, also the bias increased variation in results for both historical and concurrent controls, owing to haphazard differences in case-mix between groups. The biases were large enough to lead studies falsely to conclude significant findings of benefit or harm. Four strategies for case-mix adjustment were evaluated: none adequately adjusted for bias in historically and concurrently controlled studies. Logistic regression on average increased bias. Propensity score methods performed better, but were not satisfactory in most situations. Detailed investigation revealed that adequate adjustment can only be achieved in the unrealistic situation when selection depends on a single factor. CONCLUSIONS: Results of non-randomised studies sometimes, but not always, differ from results of randomised studies of the same intervention. Non-randomised studies may still give seriously misleading results when treated and control groups appear similar in key prognostic factors. Standard methods of case-mix adjustment do not guarantee removal of bias. Residual confounding may be high even when good prognostic data are available, and in some situations adjusted results may appear more biased than unadjusted results. Although many quality assessment tools exist and have been used for appraising non-randomised studies, most omit key quality domains. Healthcare policies based upon non-randomised studies or systematic reviews of non-randomised studies may need re-evaluation if the uncertainty in the true evidence base was not fully appreciated when policies were made. The inability of case-mix adjustment methods to compensate for selection bias and our inability to identify non-randomised studies that are free of selection bias indicate that non-randomised studies should only be undertaken when RCTs are infeasible or unethical. Recommendations for further research include: applying the resampling methodology in other clinical areas to ascertain whether the biases described are typical; developing or refining existing quality assessment tools for non-randomised studies; investigating how quality assessments of non-randomised studies can be incorporated into reviews and the implications of individual quality features for interpretation of a review's results; examination of the reasons for the apparent failure of case-mix adjustment methods; and further evaluation of the role of the propensity score.

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Evaluating non-randomised intervention studies.

OBJECTIVE: To revise the American Academy of Pediatrics practice parameter regarding the diagnosis and management of initial urinary tract infections (UTIs) in febrile infants and young children. METHODS: Analysis of the medical literature published since the last version of the guideline was supplemented by analysis of data provided by authors of recent publications. The strength of evidence supporting each recommendation and the strength of the recommendation were assessed and graded. RESULTS: Diagnosis is made on the basis of the presence of both pyuria and at least 50 000 colonies per mL of a single uropathogenic organism in an appropriately collected specimen of urine. After 7 to 14 days of antimicrobial treatment, close clinical follow-up monitoring should be maintained to permit prompt diagnosis and treatment of recurrent infections. Ultrasonography of the kidneys and bladder should be performed to detect anatomic abnormalities. Data from the most recent 6 studies do not support the use of antimicrobial prophylaxis to prevent febrile recurrent UTI in infants without vesicoureteral reflux (VUR) or with grade I to IV VUR. Therefore, a voiding cystourethrography (VCUG) is not recommended routinely after the first UTI; VCUG is indicated if renal and bladder ultrasonography reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy and in other atypical or complex clinical circumstances. VCUG should also be performed if there is a recurrence of a febrile UTI. The recommendations in this guideline do not indicate an exclusive course of treatment or serve as a standard of care; variations may be appropriate. Recommendations about antimicrobial prophylaxis and implications for performance of VCUG are based on currently available evidence. As with all American Academy of Pediatrics clinical guidelines, the recommendations will be reviewed routinely and incorporate new evidence, such as data from the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study. CONCLUSIONS: Changes in this revision include criteria for the diagnosis of UTI and recommendations for imaging.

Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months.

Background: Preparing healthcare professionals for teaching is regarded as essential to enhancing teaching effectiveness. Although many reports describe various faculty development interventions, there is a paucity of research demonstrating their effectiveness.Objective: To synthesize the existing evidence that addresses the question: “What are the effects of faculty development interventions on the knowledge, attitudes and skills of teachers in medical education, and on the institutions in which they work?”Methods: The search, covering the period 1980–2002, included three databases (Medline, ERIC and EMBASE) and used the keywords: staff development; in-service training; medical faculty; faculty training/development; continuing medical education. Manual searches were also conducted.Articles with a focus on faculty development to improve teaching effectiveness, targeting basic and clinical scientists, were reviewed. All study designs that included outcome data beyond participant satisfaction were accepted....

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A systematic review of faculty development initiatives designed to improve teaching effectiveness in medical education: BEME Guide No. 8.

A systematic review of faculty development initiatives designed to improve teaching effectiveness in medical education: BEME Guide No. 8

Objective. This study examined the process of health care transition (HCT) posing the following questions: What are the transition experiences of youths and young adults with disabilities and special health care needs, family members, and health care providers? What are promising practices that facilitate successful HCT? What are obstacles that inhibit HCT? Methods. A qualitative approach was used to investigate these questions. Focus group interviews were conducted. Content and narrative analyses of interview transcripts were completed using ATLAS.ti. Results. Thirty-four focus groups and interviews were conducted with 143 young adults with disabilities and special health care needs, family members, and health care providers. Content analysis yielded 3 content domains: transition services, which presents a chronological understanding of the transition process; health care systems, which presents differences between pediatric and adult-oriented medicine and how these differences inhibit transition; and transition narratives, which discusses transition experience in the broader context of relationships between patients and health care providers. Conclusion. This study demonstrated the presence of important reciprocal relationships that are based on mutual trust between providers and families and are developed as part of the care of chronically ill children. Evidence supports the need for appropriate termination of pediatric relationships as part of the transition process. Evidence further supports the idea that pediatric and adult-oriented medicines represent 2 different medical subcultures. Young adults’ and family members’ lack of preparation for successful participation in the adult health care system contributes to problems with HCT.

Health care transition: youth, family, and provider perspectives.

Objective. To formulate recommendations for health care professionals about the diagnosis, treatment, and evaluation of an initial urinary tract infection (UTI) in febrile infants and young children (ages 2 months to 2 years). Design. Comprehensive search and analysis of the medical literature, supplemented with consensus opinion of Subcommittee members. Participants. The American Academy of Pediatrics (AAP) Committee on Quality Improvement selected a Subcommittee composed of pediatricians with expertise in the fields of epidemiology and informatics, infectious diseases, nephrology, pediatric practice, radiology, and urology to draft the parameter. The Subcommittee, the AAP Committee on Quality Improvement, a review panel of office-based practitioners, and other groups within and outside the AAP reviewed and revised the parameter. Methods. The Subcommittee identified the population at highest risk of incurring renal damage from UTI—infants and young children with UTI and fever. A comprehensive bibliography on UTI in infants and young children was compiled. Literature was abstracted in a formal manner, and evidence tables were constructed. Decision analysis and cost-effectiveness analyses were performed to assess various strategies for diagnosis, treatment, and evaluation. Technical Report. The overall problem of managing UTI in children between 2 months and 2 years of age was conceptualized as an evidence model. The model depicts the relationship between the steps in diagnosis and management of UTI. The steps are divided into the following four phases: 1) recognizing the child at risk for UTI, 2) making the diagnosis of UTI, 3) short-term treatment of UTI, and 4) evaluation of the child with UTI for possible urinary tract abnormality. Phase 1 represents the recognition of the child at risk for UTI. Age and other clinical features define a prevalence or a prior probability of UTI, determining whether the diagnosis should be pursued. Phase 2 depicts the diagnosis of UTI. Alternative diagnostic strategies may be characterized by their cost, sensitivity, and specificity. The result of testing is the division of patients into groups according to a relatively higher or lower probability of having a UTI. The probability of UTI in each of these groups depends not only on the sensitivity and specificity of the test, but also on the prior probability of the UTI among the children being tested. In this way, the usefulness of a diagnostic test depends on the prior probability of UTI established in Phase 1. Phase 3 represents the short-term treatment of UTI. Alternatives for treatment of UTI may be compared, based on their likelihood of clearing the initial UTI. Phase 4 depicts the imaging evaluation of infants with the diagnosis of UTI to identify those with urinary tract abnormalities such as vesicoureteral reflux (VUR). Children with VUR are believed to be at risk for ongoing renal damage with subsequent infections, resulting in hypertension and renal failure. Prophylactic antibiotic therapy or surgical procedures such as ureteral reimplantation may prevent progressive renal damage. Therefore, identifying urinary abnormalities may offer the benefit of preventing hypertension and renal failure. Because the consequences of detection and early management of UTI are affected by subsequent evaluation and long-term management and, likewise, long-term management of patients with UTI depends on how they are detected at the outset, the Subcommittee elected to analyze the entire process from detection of UTI to the evaluation for, and consequences of, urinary tract abnormalities. The full analysis of these data can be found in the technical report. History of the literature review along with evidence-tables and a comprehensive bibliography also are available in the report. This report is published in Pediatrics electronic pages and can be accessed at the following URL:http://www.pediatrics.org/cgi/content/full/103/4/e54. Results. Eleven recommendations are proposed for the diagnosis, management, and follow-up evaluation of infants and young children with unexplained fever who are later found to have a diagnosed UTI. Infants and young children are of particular concern because UTI in this age group (approximately 5%) may cause few recognizable signs or symptoms other than fever and has a higher potential for renal damage than in older children. Strategies for diagnosis and treatment depend on the clinician's assessment of the illness in the infant or young child. Diagnosis is based on the culture of a properly collected specimen of urine; urinalysis can only suggest the diagnosis. A sonogram should be performed on all infants and young children with fever and their first documented UTI; voiding cystourethrography or radionuclide cystography should be strongly considered.

Practice Parameter: The Diagnosis, Treatment, and Evaluation of the Initial Urinary Tract Infection in Febrile Infants and Young Children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee on Urinary Tract Infection.

OBJECTIVES. The American Academy of Pediatrics (AAP) believes that health education, through office-based counseling, can contribute to childhood injury prevention. This report presents the results of a critical review of the scientific literature on the effectiveness of primary care-based counseling to prevent childhood unintentional injury. METHODS. A panel selected from the AAP Committee and the AAP Section on Injury and Poison Prevention searched the English-language scientific literature for all articles about childhood unintentional injury prevention counseling. A standardized format was developed to record data on each study. Two members of the panel independently reviewed each article. Articles that were original reports and in which unintentional injury prevention counseling took place in a primary care setting were included. Articles were encoded and analyzed by computer and then grouped by quality of evidence using the US Preventive Services Task Force (USPSTF) method of categorizing results of medical care evaluation. Articles were rated by strength of study design in order to compare studies within each USPSTF group. RESULTS. Twenty articles met the criteria for inclusion. Of these, 18 showed positive effects of injury prevention counseling including five randomized/controlled, 10 non-randomized/controlled, two multiple time series, and one descriptive study. In 15 of the positive studies, physicians performed the counseling. Positive outcomes as measured by increased knowledge, improved behavior, or decreased injury occurrence were reported for both motor vehicle and non-motor vehicle injuries. CONCLUSIONS. The literature review supports the recommendation of the AAP to include injury prevention counseling as part of routine health supervision. This recommendation has implications for health care reimbursement and care content.

Childhood Injury Prevention Counseling in Primary Care Settings: A Critical Review of the Literature

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Reaffirmation of AAP Clinical Practice Guideline: The Diagnosis and Management of the Initial Urinary Tract Infection in Febrile Infants and Young Children 2–24 Months of Age

Each year, 5,000 Americans die and 300,000 are hospitalized as a result of 2.8 million residential fires. Almost all house fires allow time for safe exit if an early warning is given. Smoke detectors are an effective, reliable, and inexpensive method of providing such warning. After an upsurge of deaths related to fires in 1982, Baltimore City gave away 3,720 smoke detectors to households that requested them. This study addressed two questions: (1) Did the households that received the smoke detectors install them? (2) Was the population reached by this giveaway program a population at high risk from fire? A survey of 231 randomly selected households among those requesting smoke detectors was conducted 8 to 10 months after the giveaway program. At that time, smoke detectors were installed in 92% (212/231) of the homes and 88% (187/212) of the installed smoke detectors were operational. Households requesting smoke detectors were in census tracts at higher risk from fire. The correlation coefficient between the rate of requesting a smoke detector and the risk of death or injury related to fires was r = .90, P less than .001. The 231 surveyed households had more personal fire risk factors than the general population. The success of this smoke detector giveaway program is notable in that it required the active participation of a high-risk population.

Kenneth B. Roberts

Papers

Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months.

Practice Parameter: The Diagnosis, Treatment, and Evaluation of the Initial Urinary Tract Infection in Febrile Infants and Young Children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee on Urinary Tract Infection.

Childhood Injury Prevention Counseling in Primary Care Settings: A Critical Review of the Literature

Reaffirmation of AAP Clinical Practice Guideline: The Diagnosis and Management of the Initial Urinary Tract Infection in Febrile Infants and Young Children 2–24 Months of Age

A successful city-wide smoke detector giveaway program.