Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations.

This is the third and last article in the series about the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to grading the quality of evidence and the strength of recommendations in clinical practice guidelines and its application in the field of allergy. We describe the factors that influence the strength of recommendations about the use of diagnostic, preventive and therapeutic interventions: the balance of desirable and undesirable consequences, the quality of a body of evidence related to a decision, patients' values and preferences, and considerations of resource use. We provide examples from two recently developed guidelines in the field of allergy that applied the GRADE approach. The main advantages of this approach are the focus on patient important outcomes, explicit consideration of patients' values and preferences, the systematic approach to collecting the evidence, the clear separation of the concepts of quality of evidence and strength of recommendations, and transparent reporting of the decision process. The focus on transparency facilitates understanding and implementation and should empower patients, clinicians and other health care professionals to make informed choices.

Grading quality of evidence and strength of recommendations in clinical practice guidelines: Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies.

The GRADE approach to grading the quality of evidence and strength of recommendations provides a comprehensive and transparent approach for developing clinical recommendations about using diagnostic tests or diagnostic strategies. Although grading the quality of evidence and strength of recommendations about using tests shares the logic of grading recommendations for treatment, it presents unique challenges. Guideline panels and clinicians should be alert to these special challenges when using the evidence about the accuracy of tests as the basis for clinical decisions. In the GRADE system, valid diagnostic accuracy studies can provide high quality evidence of test accuracy. However, such studies often provide only low quality evidence for the development of recommendations about diagnostic testing, as test accuracy is a surrogate for patient-important outcomes at best. Inferring from data on accuracy that using a test improves outcomes that are important to patients requires availability of an effective treatment, improved patients' wellbeing through prognostic information, or - by excluding an ominous diagnosis - reduction of anxiety and the opportunity for earlier search for an alternative diagnosis for which beneficial treatment can be available. Assessing the directness of evidence supporting the use of a diagnostic test requires judgments about the relationship between test results and patient-important consequences. Well-designed and conducted studies of allergy tests in parallel with efforts to evaluate allergy treatments critically will encourage improved guideline development for allergic diseases.

Effectiveness of Helicobacter pylori therapies in a clinical practice setting.

BACKGROUND: Whether eradication rates for Helicobacter pylori treatment regimens obtained in controlled clinical trials (efficacy) can also be obtained in clinical practice (effectiveness) is unknown because no such trials have been reported in the United States. OBJECTIVES: To determine the eradication rates of H pylori in a community practice setting and the effects of practice variation in the choice of treatment regimen on patient outcome (H pylori infection cure) and cost. METHODS: Between February 1 and December 30, 1996, 38 community-based gastroenterologists in the Portland, Ore, metropolitan area enrolled a total of 250 patients infected with H pylori, as determined by endoscopic or noninvasive methods. Various therapeutic regimens aimed at eradicating H pylori were used by the gastroenterologists, and a posttreatment urea breath test was used to determine H pylori infection cure. Compliance and incidental effects were also measured and decision analysis was used to estimate the cost of treatment. RESULTS: The regimens used varied considerably. Patients receiving a 2- or 3-times-a-day treatment regimen were significantly more compliant (P=.01) than those receiving a 4-times-a-day regimen. Proton pump inhibitor-based triple-therapy regimens were significantly more effective than all other treatment regimens combined (87% vs 70%; P = .001) in eradicating H pylori. These proton pump inhibitor-based triple-therapy regimens were also more cost-effective by decision analysis for a hypothetical cohort of patients with duodenal ulcer disease. CONCLUSIONS: The considerable variation in the choice of treatment regimens affects the clinical and economic outcomes of patients undergoing therapy for H pylori infection. Whether these data reflect the outcome in other communities is unknown but should be determined. It will be necessary to determine if the dissemination of these data results in a reduction of practice variation and improvement in clinical and economic outcomes of patients being treated for H pylori infection in clinical practice.

Screening for chlamydial infection.

OBJECTIVES: To examine data on the effectiveness of screening for chlamydial infection by a physician or other health care professional. Specifically, we examine the evidence that early treatment of chlamydial infection improves health outcomes, as well as evidence of the effectiveness of screening strategies in nonpregnant women, pregnant women, and men, and the accuracy of tests used for screening. This review updates the literature since the last recommendation of the U.S. Preventive Services Task Force published in 1996. SEARCH STRATEGY: We searched the topic of chlamydia in the MEDLINE, HealthSTAR, and Cochrane Library databases from January 1994 to July 2000, supplemented by reference lists of relevant articles and from experts in the field. Articles published prior to 1994 and research abstracts were cited if particularly important to the key questions or to the interpretation of included articles. SELECTION CRITERIA: A single reader reviewed all English abstracts. Articles were selected for full review if they were about Chlamydia trachomatis genitourinary infections in nonpregnant women, pregnant women, or men and were relevant to key questions in the analytic framework. Investigators read the full-text version of the retrieved articles and applied additional eligibility criteria. For all topics, we excluded articles if they did not provide sufficient information to determine the methods for selecting subjects and for analyzing data. DATA COLLECTION AND ANALYSIS: We systematically reviewed three types of studies about screening in nonpregnant women that relate to three key questions: (1) studies about the effectiveness of screening programs in reducing prevalence rates of infection, (2) studies about risk factors for chlamydial infection in women, and (3) studies about chlamydial screening tests in women. Our search found too few studies on pregnant women to systematically review, although pertinent studies are described. We systematically reviewed two types of studies about screening in men: (1) studies about prevalence rates and risk factors for chlamydial infection in men and (2) studies about chlamydial screening tests in men. MAIN RESULTS: Nonpregnant women. The results of a randomized controlled trial conducted in a large health maintenance organization indicate that screening women selected by a set of risk factors reduces the incidence of pelvic inflammatory disease (PID) over a 1-year period. Changes in population prevalence rates have not been well documented because few studies have employed a representative population sample. Age continues to be the best predictor of chlamydial infection in women, with most studies evaluating cut-offs at age younger than 25 years. Other risk factors may be useful predictors, but these are likely to be population specific. To determine the accuracy of screening tests for women, we retrieved and critically reviewed 34 articles on test performance. Results indicate that endocervical swab specimens and first-void urine specimens have similar performance when using DNA amplification tests and have better sensitivity than endocervical culture. Recurrent chlamydial infections in women have been associated with increased risks for PID and ectopic pregnancies. Pregnant women. The Second Task Force recommendations for screening pregnant women were based on two major studies demonstrating improved pregnancy outcomes following treatment of chlamydial infection. We identified no recent studies on this topic in our literature search. Very few studies describe risk factors for chlamydial infection in pregnant women. Nonculture testing techniques appear to perform well in pregnant women, although studies are limited. Men. No studies described the effectiveness of screening or early treatment for men in reducing transmission to women or in preventing acute infections or complications in men. Studies of prevalence rates and risk factors for chlamydial infection in men are limited. Age lower than 25 years is the strongest known risk factor cited so far. Results of urethral swab specimens compared to first-void urine specimens were similar for DNA amplification tests. DNA amplification techniques are more sensitive than culture. CONCLUSIONS: Screening women for Chlamydia trachomatis reduces the incidence of PID, and it is associated with reductions in prevalence of infection in uncontrolled studies. No studies were found to determine whether screening asymptomatic men would reduce transmission or prevent acute infections or complications. Age is the strongest risk factor for men and women. A variety of tests can detect chlamydial infection with acceptable sensitivity and specificity, including new DNA amplification tests that use either endocervical swabs in women, urethral swabs in men, or first-void urine specimens from men and women.

The art and science of incorporating cost effectiveness into evidence-based recommendations for clinical preventive services.

As medical technology continues to expand and the cost of using all effective clinical services exceeds available resources, decisions about health care delivery may increasingly rely on assessing the cost-effectiveness of medical services. Cost-effectiveness is particularly relevant for decisions about how to implement preventive services, because these decisions typically represent major investments in the future health of large populations. As such, decisions regarding the implementation of preventive services frequently involve, implicitly if not explicitly, consideration of costs. Cost-effectiveness analysis summarizes the expected benefits, harms, and costs of alternative strategies to improve health and has become an important tool for explicitly incorporating economic considerations into clinical decision making. Acknowledging the usefulness of this tool, the third U.S. Preventive Services Task Force (USPSTF) has initiated a process for systematically reviewing cost-effectiveness analyses as an aid in making recommendations about clinical preventive services. In this paper, we provide an overview and examples of roles for using cost-effectiveness analyses to inform preventive services recommendations, discuss limitations of cost-effectiveness data in shaping evidence-based preventive health care policies, outline the USPSTF approach to using cost-effectiveness analyses, and discuss the methods the USPSTF is developing to assess the quality and results of cost-effectiveness studies. While this paper focuses on clinical preventive services (i.e., screening, counseling, immunizations, and chemoprevention), the framework we have developed should be broadly portable to other health care services.

Screening for skin cancer.

CONTEXT: Malignant melanoma is often lethal, and its incidence in the United States has increased rapidly over the past 2 decades. Nonmelanoma skin cancer is seldom lethal, but, if advanced, can cause severe disfigurement and morbidity. Early detection and treatment of melanoma might reduce mortality, while early detection and treatment of nonmelanoma skin cancer might prevent major disfigurement and to a lesser extent prevent mortality. Current recommendations from professional societies regarding screening for skin cancer vary. OBJECTIVE: To examine published data on the effectiveness of routine screening for skin cancer by a primary care provider, as part of an assessment for the U.S. Preventive Services Task Force. DATA SOURCES: We searched the MEDLINE database for papers published between 1994 and June 1999, using search terms for screening, physical examination, morbidity, and skin neoplasms. For information on accuracy of screening tests, we used the search terms sensitivity and specificity. We identified the most important studies from before 1994 from the Guide to Clinical Preventive Services, second edition, and from high-quality reviews. We used reference lists and expert recommendations to locate additional articles. STUDY SELECTION: Two reviewers independently reviewed a subset of 500 abstracts. Once consistency was established, the remainder were reviewed by one reviewer. We included studies if they contained data on yield of screening, screening tests, risk factors, risk assessment, effectiveness of early detection, or cost effectiveness. DATA EXTRACTION: We abstracted the following descriptive information from full-text published studies of screening and recorded it in an electronic database: type of screening study, study design, setting, population, patient recruitment, screening test description, examiner, advertising targeted at high-risk groups or not targeted, reported risk factors of participants, and procedure for referrals. We also abstracted the yield of screening data including probabilities and numbers of referrals, types of suspected skin cancers, biopsies, confirmed skin cancers, and stages and thickness of skin cancers. For studies that reported test performance, we recorded the definition of a suspicious lesion, the "gold-standard" determination of disease, and the number of true positive, false positive, true negative, and false negative test results. When possible, positive predictive values, likelihood ratios, sensitivity, and specificity were recorded. DATA SYNTHESIS: No randomized or case-control studies have been done that demonstrate that routine screening for melanoma by primary care providers reduces morbidity or mortality. Basal cell carcinoma and squamous cell carcinoma are very common, but detection and treatment in the absence of formal screening are almost always curative. No controlled studies have shown that formal screening programs will improve this already high cure rate. While the efficacy of screening has not been established, the screening procedures themselves are noninvasive, and the follow-up test, skin biopsy, has low morbidity. Five studies from mass screening programs reported the accuracy of skin examination as a screening test. One of these, a prospective study, tracked patients with negative results to determine the number of patients with false-negative results. In this study, the sensitivity of screening for skin cancer was 94% and specificity was 98%. Several recent case-control studies confirm earlier evidence that risk of melanoma rises with the presence of atypical moles and/or many common moles. One well-done prospective study demonstrated that risk assessment by limited physical exam identified a relatively small (<10%) group of primary care patients for more thorough evaluation. CONCLUSIONS: The quality of the evidence addressing the accuracy of routine screening by primary care providers for early detection of melanoma or nonmelanoma skin cancer ranged from poor to fair. We found no studies that assessed the effectiveness of periodic skin examination by a clinician in reducing melanoma mortality. Both self-assessment of risk factors or clinician examination can classify a small proportion of patients as at highest risk for melanoma. Skin cancer screening, perhaps using a risk-assessment technique to identify high-risk patients who are seeing a physician for other reasons, merits additional study as a strategy to address the excess burden of disease in older adults.

Screening for bacterial vaginosis in pregnancy.

CONTEXT: Bacterial vaginosis (BV) is a strong independent risk factor for adverse pregnancy outcomes. BV is found in 9% to 23% of pregnant women. Symptoms include vaginal discharge, pruritus, or malodor, but often women with BV are asymptomatic. OBJECTIVES: To determine whether screening and treating pregnant women for BV reduces adverse pregnancy outcomes, as part of an assessment for the U.S. Preventive Services Task Force. DATA SOURCES: Randomized clinical trials of BV treatment in pregnancy that measured pregnancy outcomes were identified from multiple searches in MEDLINE from 1966 to 1999, the Cochrane Controlled Trials Register and Library, and national experts. STUDY SELECTION: All randomized controlled trials of BV treatment in pregnancy that specifically measured pregnancy outcomes. DATA EXTRACTION: The following information was abstracted: study design and blinding, diagnostic methods, antibiotic interventions, timing of antibiotic treatment in pregnancy, criteria for treatment, comorbidities, demographic details, risk factors for preterm delivery such as previous preterm delivery, compliance, rates of spontaneous and total preterm delivery less than 37 weeks and less than 34 weeks, preterm premature rupture of membranes, low birth weight less than 2500 grams, spontaneous abortion, postpartum endometritis, and neonatal sepsis. For each study, we measured the effect of treatment by calculating the difference in the rate of a given pregnancy outcome in the control group minus the treatment group (the absolute risk reduction [ARR]). A stepwise procedure based on the profile likelihood was applied to assess heterogeneity, to pool studies when appropriate, and to calculate the mean and 90% confidence intervals (CIs) for the effect of treatment. DATA SYNTHESIS: Seven randomized controlled trials met inclusion criteria for the meta-analysis. We found no benefit to BV treatment in average-risk women for any pregnancy outcome. Results of studies of high-risk populations, women with previous preterm delivery, were statistically heterogeneous. They clustered into two groups; one showed no benefit (ARR=-0.08, 90% CI=-0.19 to 0.04), whereas the three homogeneous studies showed potential benefit of BV treatment (pooled ARR=0.22; 90% CI=0.13 to 0.31) for preterm delivery before 37 weeks. Four high-risk studies reported results for preterm delivery less than 34 weeks. The pooled estimate showed no benefit (ARR=0.04; 90% CI=-0.02 to 0.09), but variation was noted among individual studies. Two trials of high-risk women found an increase in preterm delivery less than 34 weeks in women who did not have BV but received BV treatment. Comparisons of patient populations, treatment regimens, and study designs did not explain the heterogeneity among studies. CONCLUSIONS: We found no benefit to routine BV screening and treatment. A subgroup of high-risk women may benefit from BV screening and treatment; however, there may be a subgroup for whom BV treatment could increase the occurrence of preterm delivery.

Current methods of the US Preventive Services Task Force: a review of the process.

The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Low birthweight in a public prenatal care program: behavioral and psychosocial risk factors and psychosocial intervention.

A retrospective, observational study of 3073 low income African American, Latina, and White women receiving comprehensive prenatal care at 26 provider sites was completed. The purpose of the study was to test three hypotheses. First, after adjustment for biomedical complications, the presence of maternal behavioral and psychosocial factors would be associated with an increased rate of low birthweight infants. Second, increased time spent in psychosocial services would negate the relationship between maternal psychosocial factors and low birthweight. Third, after adjusting for biomedical, behavioral, and psychosocial factors, rates of low birthweight would no longer differ by race. Maternal smoking (over five cigarettes per week), maternal low weight for height and/or weight gain, negative mood (depression, anxiety, and/or hostility) and rejection of the pregnancy were found to be related to an increased rate of low birthweight birth (< 2500 g). Receiving more than 45 min of psychosocial services was related to a reduced rate of low birthweight birth for all women regardless of risk profile. The rate of low birthweight remained higher in African American women after adjusting for all significant maternal biomedical, behavioral, and psychosocial risk and intervention factors. Further analyses revealed that the strength and direction of the relationship between time spent in psychosocial services and low birthweight remained after controlling for the number of prenatal care visits, the time spent in nutrition or health educational services, and gestational age. Also, the time spent in psychosocial services was related to a reduced rate of low birthweight even after excluding time spent in psychosocial services in the third trimester of pregnancy or excluding women who received their first psychosocial assessment in the third trimester from the analysis. Although definitive evidence from randomized trials of psychosocial services is lacking, receiving over 45 min of psychosocial services was related to a reduced risk of low birthweight for all women in this study. Therefore, general psychosocial services appears to be an important component of prenatal care for all low income women.

Information seeking in primary care: how physicians choose which clinical questions to pursue and which to leave unanswered.

Primary care physicians have many questions about optimal care while they are seeing patients, but they pursue only about 30% of their questions. The authors designed a study to determine the factors that motivate physicians to pursue answers to some of their questions, while leaving the majority of their questions unanswered. They interviewed 49 non-academic primary care physicians during office hours to record clinical questions as they arose in the course of patient care. The physicians then recorded their perceptions of each question with respect to 12 factors expected to motivate information seeking. Two to five days after the interview, each physician was telephoned to determine which questions had been pursued. In a multiple logistic-regression model only two factors were significant predictors of pursuit of new information: the physician's belief that a definitive answer existed, and the urgency of the patient's problem. Other factors, including the difficulty of finding the answer, potential malpractice liability, potential help or harm to the patient, and self-perceived knowledge of the problem, were not significant in the model. Primary care physicians are significantly more likely to pursue answers to their clinical questions when they believe that definitive answers to those questions exist, and when they perceive the patient's problem to be urgent. Medical information systems must be shown to have direct and immediate benefits to solving the problems of patient care if they are to be more widely used by practitioners.

Community-based research--a framework for problem formulation: the case of upper endoscopy for gastroesophageal reflux disease.

OBJECTIVE: To identify clinical hypotheses and information gaps underlying disagreement about the use of upper gastrointestinal endoscopy (EGD) for the diagnosis of gastroesophageal reflux disease (GERD), and to design a registry study to test these hypotheses. DESIGN AND SETTING: Structured group discussions with community-based practicing gastroenterologists. RESULTS: Thirty-three gastroenterologists from 17 sites discussed a set of clinical scenarios concerning the use of EGD in GERD patients with different clinical histories. Clinicians identified patient characteristics and outcome variables missing from the original problem formulation. Using decision tables, the combinations of patient characteristics that provoked disagreement among clinicians were determined. The resulting decision tables specified which characteristics and outcome variables should be measured to test competing clinical theories of when to use EGD in patients with GERD. Subsequently, the clinicians conducted a practice-based study measuring uncertain variables associated with disagreement about the need for EGD in specific clinical situations. CONCLUSION: A structured, but flexible, approach to group discussion may help identify factors that are important in decision making and the hypotheses that should be addressed in resolving variations in practice styles. Technology assessors can use these methods to identify variables underlying clinicians' concerns about the clinical validity of recommendations about practice. This experience with eliciting patient characteristics and uncertain variables underscores the importance of involving practicing clinicians in the process and could be a useful model for problem formulation in guideline development and in community-based research.

Oregon trauma system: change in initial admission site and post- admission transfer of injured patients.

OBJECTIVE: Associate statewide trauma system development with a change in the percentage of injured patients initially hospitalized at Levels I and II categorized trauma hospitals and a change in the length of stay (LOS) prior to arrival at a Level I or II hospital (PRE-LOS) and total LOS (T-LOS) for post-admission transfer patients. METHODS: A retrospective analysis was performed using a hospital discharge database of 235,395 discharges with codes for acute injury managed at 74 acute care hospitals in Oregon State from 1983 to 1991. Primary outcome measures were admission site and transfer patient PRE-LOS and T-LOS. Predicator variables included category of initial hospital admission site, injury severity scale (ISS) score, head injury, age, and status of trauma system (pre-system, 1983 to 1987; transitional, 1988 to 1989; and post-system, 1991 to 1992). RESULTS: There was a significant increase in the percentage of initial admissions to hospitals with Level I and II categorization (17.6%, 26.2%, and 27.6% for the three periods of development, respectively; p < 0.00001). The percentage of patients with ISS scores greater than 15 admitted initially to Level I or II hospitals increased from 33.4% to 52.6% and 57.3%; p < 0.00001). Only 1,059 0.57%) of 185,321 patients initially admitted to Level III, Level IV, or noncategorized hospitals were transferred to a Level I or II hospital. Mean PRE-LOS for 1.059 transferred patients showed a significant decrease with system development (2.3, 1.9, and 1.8 days, respectively; p < 0.02). When adjusted for age, ISS score, and head injury effects, mean T-LOS was significantly reduced for the transitional and post-system periods (p < 0.05). CONCLUSIONS: In Oregon, development of a statewide trauma system was associated with increased initial admissions to Level I and II trauma hospitals. For those patients transferred to higher levels of care post- admission, hospital LOSs were decreased with trauma system development.

Rural hospital transfer patterns before and after implementation of a statewide trauma system. OHSU Rural Trauma Research Group.

OBJECTIVE: To evaluate trauma transfer practices in rural Oregon before and after implementation of a statewide trauma system. METHODS: A pre- vs post-system implementation (historical control) analysis of trauma transfer practices was performed using a sample of rural ED trauma patients from 4 Level-3 and 5 Level-4 trauma hospitals. Medical records of patients with specific index injury diagnoses in 4 anatomic regions (head, chest, liver/ spleen, and femur/open-tibia) were reviewed for a 3-year period before statewide trauma system implementation and 3 years after hospital trauma designation. RESULTS: Of 1,057 patients entered into the database, 532 were evaluated during the pre-system period and 525 were evaluated during the post-system period. Overall, 47% had head injuries, 34% had chest injuries, 23% had femur/open-tibia injuries, and 12% had spleen/liver injuries. There were 142 (13%) patients with an injury in > 1 index area. After trauma system implementation, there was a significant increase in the proportion of ED trauma patients transferred from Level-4 trauma hospitals (32% vs 68%, p < 0.001), with a corresponding decrease in the number of hospital admissions to these facilities (63% to 29%, p < 0.001). Significant increases in the proportion transferred from Level-4 trauma hospital EDs were noted for all index injury categories (p < 0.001). Trauma patients presenting to Level-4 EDs were significantly more likely to be transferred to Level-2 facilities (66% vs 82%, p = 0.030), while patients at Level-3 facilities were significantly more likely to be transferred to Level-1 centers (2% vs 14%, p = 0.002) following trauma system implementation. Multiple logistic regression modeling indicated that implementation of the statewide trauma system was an independent predictor of rural trauma patient transfer from Level-4 hospitals, while transfers from Level-3 facilities were dependent on type of injury. CONCLUSION: Implementation of the Oregon statewide trauma system was associated with a redistribution of rural trauma patients to trauma hospitals with greater therapeutic resources.

Clinical outcomes resulting from telemedicine interventions: a systematic review.

BACKGROUND: The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. METHODS: Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis). All included articles were abstracted and graded for quality and direction of the evidence. RESULTS: A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. CONCLUSIONS: Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective.

Telemedicine for the Medicare population: pediatric, obstetric, and clinician-indirect home interventions.

BACKGROUND: This report is a supplement to an earlier evidence report, Telemedicine for the Medicare Population, which was intended to help policymakers weigh the evidence relevant to coverage of telemedicine services under Medicare. That report focused on telemedicine programs and clinical settings that had been used with or were likely to be applied to Medicare beneficiaries. While we prepared that report, it became apparent that there are also telemedicine studies among non-Medicare beneficiaries--e.g., children and pregnant women--that could inform policymakers and provide more comprehensive evidence of the state of the science regarding telemedicine applications. In addition, the first evidence report only partially included a class of telemedicine applications (called self-monitoring/testing telemedicine) in which the beneficiary used a home computer or modern-driven telephone system to either report information or access information and support from Internet resources and indirectly interact with a clinician. Self-monitoring/testing applications in the first report required direct interaction with a clinician. The goal of this report is to systematically review the evidence in the clinical areas of pediatric and obstetric telemedicine as well as home-based telemedicine where there is indirect involvement of the health care professional. (In this report, we will refer to the latter as clinician-indirect home telemedicine.) Specifically, the report summarizes scientific evidence on the diagnostic accuracy, access, clinical outcomes, satisfaction, and cost-effectiveness of services provided by telemedicine technologies for these patient groups. It also identifies gaps in the evidence and makes recommendations for evaluating telemedicine services for these populations in the future. The evidence is clustered according to three categories of telemedicine service defined in our original report: store-and-forward, self-monitoring/testing, and clinician-interactive services. The three clinical practice areas reviewed in this report are defined as follows. The term pediatric applies to any telemedicine study in which the sample consisted wholly or partially of persons aged 18 or younger, including studies with neonatal samples. The term obstetric applies to any telemedicine study in which the sample consisted entirely of women seeking pregnancy-related care. The term clinician-indirect home telemedicine applies to home-based telemedicine (called self-monitoring/testing in our original report) where a telemedicine application used in the home has only indirect involvement by the health care professional. Interactive home telemedicine was applied in this report to all patient populations. KEY QUESTIONS: The key questions that served as a guide for reviewing the literature in the evaluation of pediatric, obstetric, and clinician-indirect home telemedicine applications were derived by consensus among the evidence-review team based on the analytic framework established for the original evidence report. For the current report, the questions were applied to studies in all three practice areas as a whole group within each of the three categories of telemedicine services: store-and-forward; self-monitoring/testing; and clinician-interactive. The specific key questions were: 1. Does telemedicine result in comparable diagnosis and appropriateness of recommendations for management? 2. Does the availability of telemedicine provide comparable access to care? 3. Does telemedicine result in comparable health outcomes? 4. Does telemedicine result in comparable patient or clinician satisfaction with care? 5. Does telemedicine result in comparable costs of care and/or cost-effectiveness? METHODS: We searched for peer-reviewed literature using several bibliographic databases. In addition, we conducted hand searches of leading telemedicine journals and identified key papers from the reference lists of journal articles. For our original evidence report on telemedicine for the Medicare population, we designed a search to find any publications about telemedicine and used it to search the MEDLINE, CINAHL, and HealthSTAR databases for all years the databases were available. Through this process, we captured studies of pediatric, obstetric, and clinician-indirect home telemedicine; however, they were excluded from the original report since they were outside its scope. For this supplemental report, we reviewed our original search results and identified studies relevant to this report. We identified additional studies from the reference lists of included papers and from hand searching two peer-reviewed telemedicine publications, the Journal of Telemedicine and Telecare and Telemedicine Journal. We critically appraised the included studies for each study area and key question and discussed the strengths and limitations of the most important studies at weekly meetings of the research team. We also developed recommendations for research to address telemedicine knowledge gaps. To match these gaps with the capabilities of specific research methods, we classified the telemedicine services according to the type of evidence that would be needed to determine whether the specific goals of covering such services had been met. We emphasized the relationship between the type and level of evidence found in the systematic review of effectiveness and the types of studies that might be funded to address the gaps in knowledge in this growing field of research. FINDINGS: We identified a total of 28 eligible studies. In the new clinical areas, we found few studies in store-and-forward telemedicine. There is some evidence of comparable diagnosis and management decisions made using store-and-forward telemedicine from the areas of pediatric dental screening, pediatric ophthalmology, and neonatalogy. In self-monitoring/testing telemedicine for the areas of pediatrics, obstetrics, and clinician-indirect home telemedicine, there is evidence that access to care can be improved when patients and families have the opportunity to receive telehealth care at home rather than in-person care in a clinic or hospital. Access is particularly enhanced when the telehealth system enables timely communication between patients or families and care providers that allows self-management and necessary adjustments that may prevent hospitalization. There is some evidence that this form of telemedicine improves health outcomes, but the study sample sizes are usually small, and even when they are not, the treatment effects are small. There is also some evidence for the efficacy of clinician-interactive telemedicine, but the studies do not clearly define which technologies provide benefit or cost-efficiency. Some promising areas for diagnosis include emergency medicine, psychiatry, and cardiology. Most of the studies measuring access to care provide evidence that it is improved. Although none of these studies were randomized controlled trials, they provide some evidence of access improvement over prior conditions. Clinician-interactive telemedicine was the only area for which any cost studies were found. The three cost studies did not adequately demonstrate that telemedicine reduces costs of care (except comparing only selected costs). No study addressed cost-effectiveness. CONCLUSIONS: This supplemental report covering the areas of pediatrics, obstetrics, and indirect-clinician home telemedicine echoes the findings of our initial report for the Medicare domain, which is that while the use of telemedicine is small but growing, the evidence for its efficacy is incomplete. Many of the studies are small and/or methodologically limited, so it cannot be determined whether telemedicine is efficacious. Future studies should focus on the use of telemedicine in conditions where burden of illness and/or barriers to access for care are significant. Use of recent innovations in the design of randomized controlled trials for emerging technologies would lead to higher quality studies. Journals publishing telemedicine evaluation studies must set high standards for methodologic quality so that evidence reports need not rely on studies with marginal methodologies.

Evidence of case management effect on traumatic-brain-injured adults in rehabilitation.

The purpose of this study was to evaluate the evidence for effectiveness of case management during recovery from traumatic brain injury (TBI) in adults. After an overview of TBI incidence, prevalence, and problems, and a brief explanation of case management, the study methods are described, the findings are discussed and recommendations are made for future research. Medline, HealthSTAR, CINAHL, PsychINFO, and the Cochrane Library databases were searched and 83 articles met the criteria for review. The strongest studies (n = 3) were critically appraised and their design features and data were placed in two evidence tables. Due to methodological limitations, there was neither clear evidence of effectiveness nor of ineffectiveness. For future research, we recommend controlled research designs, standardization of measures, adequate statistical analysis and specification of health outcomes of importance to persons with TBI and their families.