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Expert review of the diagnosis and histologic classification of Hodgkin disease in a population-based cancer registry: interobserver reliability and impact on incidence and survival rates.

BACKGROUND: The reliability of Hodgkin disease (HD) diagnosis and histologic classification is an ongoing concern but has not been evaluated in a population-based case series in 20 years. Yet, diagnostic error in cancer registry data used in surveying HD occurrence may produce statistics that misrepresent incidence, mortality, or survival. METHODS: Uniform pathology review was attempted for all 395 women ages 19--79 years with incident HD reported to a population-based cancer registry in 1988--94. Agreement between original registry and review diagnoses was measured with positive predictive values and kappa statistics. Incidence rates and survival probabilities were computed based on registry and review diagnoses. RESULTS: Registry and review diagnosis agreed for 245 of the 362 reviewed cases. Positive predictive values varied by histologic subtype (nodular sclerosis, 95%; lymphocyte predominance, 69%; mixed cellularity, 58%; lymphocyte depletion, 0%; not otherwise specified, 40%), but agreement was good overall (kappa, 0.66, 95% confidence interval, 0.56--0.76). Eleven patients were determined not to have HD; all were older than age 44 years. Hodgkin disease incidence rates differed for original and review diagnoses only in older women, for whom registry rates slightly overestimated incidence. Five-year survival rates did not differ for registry and review data overall or by age group. CONCLUSIONS: For most adult women patients, the diagnosis of HD was confirmed on review, reflecting the very good agreement between registry and review diagnoses for nodular sclerosis, the most common subtype. Thus, cancer registry statistics for this time period can provide accurate estimates of disease patterns for HD overall and for the nodular sclerosis variant. For other histologic subtypes, rates may be unreliable, and HD occurrence overall may be less dependable in populations with larger proportions of these subtypes.

Adult↗

Sources of bias in reviews of spinal manipulation for back pain.

The effectiveness of spinal manipulation as a treatment for back pain remains uncertain and controversial. This is because of methodological weakness in many of the published clinical trials and also because of markedly opposing interpretations of the primary data by different reviewers. We have systematically assessed a representative sample of recent reviews on this topic. Reviews were included in the analysis if they were published between 1993 and March 2004, were listed in PubMed with an abstract and categorised as a review or meta-analysis, and were written in English. They were also required to present the evidence from at least two referenced clinical trials of spinal manipulation for back pain and to reach a conclusion about the effectiveness of the intervention. Each review was evaluated for methodological quality. Twenty-nine reviews met the inclusion criteria. Sixteen reached an overall positive conclusion, 7 a negative conclusion and 6 a neutral conclusion regarding therapeutic effectiveness. There were statistically significant pairwise correlations between each of the three factors: direction of conclusion, methodological quality and authorship by osteopaths or chiropracters. This indicates an association between authorship by osteopaths or chiropractors and low methodological quality and positive conclusion. We conclude that the outcomes of reviews of this subject are strongly influenced by both scientific rigour and profession of authors. The effectiveness of spinal manipulation for back pain is less certain than many reviews suggest; most high quality reviews reach negative conclusions.

Authorship↗

Pathology review for paediatric non-Hodgkin's lymphoma patients in Japan; a report from the Japan association of childhood leukaemia study (JACLS).

A central pathology review system with an immunophenotyping laboratory was established in Japan to support the clinical trial, the Japan Association of Childhood Leukaemia Study (JACLS) NHL-98, for patients with paediatric non-Hodgkin's lymphoma (NHL). Pathology samples from 155 clinically-suspected NHL cases were evaluated centrally initially using the Revised European-American Lymphoma (REAL) classification in a rapid review (within 2 weeks after surgery/biopsy) and then later at the consensus review (once a year). The samples were subsequently re-classified according to the new World Health Organisation (WHO) classification. After the pathology review, 96 (62%) patients were eligible for the study, and 58 of them (60%) had extra-nodal primaries. These NHL cases included B-cell lymphomas (precursor B-cell, 11; Burkitt, 18; diffuse large B-cell, 18; not otherwise specified, 3) and T/Natural Killer (NK)-cell lymphomas (precursor T-cell, 23; anaplastic large cell, 20; others, 3). There was excellent concordance in making the diagnoses (95/96, 99%) and typing (93/96, 97%) of NHL between the rapid and consensus reviews. Five cases, initially diagnosed as diffuse large B-cell lymphoma by the review, were re-classified as Burkitt lymphoma according to the immunocytochemical criteria by the WHO classification. A total of 59 (38%) cases were excluded from the study: they were Hodgkin lymphoma (7), leukaemias (11), reactive lymphoid hyperplasia (20), necrotizing lymphadenitis (7), no consensus diagnosis (1), insufficient materials (2), and others (11). This is the first report of the central pathology review from the paediatric NHL group study in Japan. Because various diseases, either neoplastic or reactive, mimicked NHL, clinically and histopathologically, the central pathology review system was critical and essential for patient enrollment and protocol assignment in our clinical trial. Through the two-step review system, highly reliable data were generated to support this study.

Adolescent↗

The value of specialist oncological radiology review of cross-sectional imaging.

AIM: To determine whether specialist oncological radiology review of outside cross-sectional imaging affects patient management. MATERIALS AND METHODS: Five hundred and twenty-six patients attending a regional oncology centre had review of outside cross-sectional imaging over a 1-year period. The number of examinations per patient, time interval between examination and review request, and examination technical adequacy were recorded in each case. More detailed evaluation of 124 patients included comparison of outside and review reports for major differences in interpretation by a medical oncologist who also evaluated the effect of the review on patient management. Examinations resulting in major report discrepancies were subjected to independent radiological adjudication. RESULTS: Eighty-one percent of examinations were reviewed within 3 months of being performed and 94% were considered technically adequate. The hard copy images provided were incomplete in 33% of cases and a calibration rule was absent in 9%. There was a major difference in interpretation in 34% of examinations, the most common cause being differences in interpretation of lymphadenopathy (52%), particularly in the mediastinum (19%). Other problems identified were the failure to record disease dimensions and absence of specific information on key organs in the outside reports. Specialist radiology review changed radiological staging in 19% of patients, affected management in 7% of patients and resulted in a change in treatment in 4%. There was no correlation between management change and any particular tumour type. In 27% of cases, treatment decisions had been made before the review was requested. CONCLUSION: Specialist oncological radiology review of outside cross-sectional imaging changed radiological staging in 19% of cases but had little impact on patient management. Oncological cross-sectional imaging techniques in the North West of England are of high quality, probably helped by recent RCR guidelines.

Adolescent↗

[Effect of statistical review on manuscript quality in Medicina Clínica (Barcelona): a randomized study].

BACKGROUND AND OBJECTIVE: The statistical review of biomedical articles should result in an improved quality. The objective of this study was to compare the effects of clinical review and joint clinical and statistical review on manuscript quality, in articles submitted to Medicina Clínica (Barcelona), a Spanish weekly journal of internal medicine. METHOD: Original papers arriving between May 2000 and February 2001 were randomized either to a clinical review group or a clinical and statistical review group. Two evaluators, blinded to the paper's group, assessed the quality improvement in both groups, from submission to publication using a modified version ot the Goodman et al. scale. The protocol required that final versions arrived before the end of May 2001. RESULTS: Final sample size was 43 manuscripts, evaluated before and after peer review. On the intention to treat analysis, the estimated effect of statistical review was 1.35 (95% CI: -0.45 to 3.16) positive, but not statistically significant. The analysis of the reviewers' comments revealed some protocol deviations. Taking into account the spontaneous inclusion of statistical experts in the clinical group, the estimated effect was statistically significant, with a confidence interval of 0.3 to 3.7. CONCLUSION: The inclusion of a statistical expert in the peer review process improves manuscript quality, although in the intention to treat analysis the improvement was not statistically significant.

Humans↗

The art and science of chart review.

BACKGROUND: Explicit chart review was an integral part of an ongoing national cooperative project, "Using Achievable Benchmarks of Care to Improve Quality of Care for Outpatients with Depression," conducted by a large managed care organization (MCO) and an academic medical center. Many investigators overlook the complexities involved in obtaining high-quality data. Given a scarcity of advice in the quality improvement (QI) literature on how to conduct chart review, the process of chart review was examined and specific techniques for improving data quality were proposed. METHODS: The abstraction tool was developed and tested in a prepilot phase; perhaps the greatest problem detected was abstractor assumption and interpretation. The need for a clear distinction between symptoms of depression or anxiety and physician diagnosis of major depression or anxiety disorder also became apparent. In designing the variables for the chart review module, four key aspects were considered: classification, format, definition, and presentation. For example, issues in format include use of free-text versus numeric variables, categoric variables, and medication variables (which can be especially challenging for abstraction projects). Quantitative measures of reliability and validity were used to improve and maintain the quality of chart review data. Measuring reliability and validity offers assistance with development of the chart review tool, continuous maintenance of data quality throughout the production phase of chart review, and final documentation of data quality. For projects that require ongoing abstraction of large numbers of clinical records, data quality may be monitored with control charts and the principles of statistical process control. RESULTS: The chart review module, which contained 140 variables, was built using MedQuest software, a suite of tools designed for customized data collection. The overall interrater reliability increased from 80% in the prepilot phase to greater than 96% in the final phase (which included three abstractors and 465 unique charts). The mean time per chart was calculated for each abstractor, and the maximum value was 13.7 +/- 13 minutes. CONCLUSIONS: In general, chart review is more difficult than it appears on the surface. It is also project specific, making a "cookbook" approach difficult. Many factors, such as imprecisely worded research questions, vague specification of variables, poorly designed abstraction tools, inappropriate interpretation by abstractors, and poor or missing recording of data in the chart, may compromise data quality.

Data Collection↗

Assessment of the consistency of medicinal chemists in reviewing sets of compounds.

Medicinal chemists are frequently asked to review lists of compounds to assess their drug- or leadlike nature and to evaluate the suitability of lead compounds based on their "attractiveness" and/or synthetic feasibility as a basis for launching a drug-discovery campaign. It is often felt that one medicinal chemist's opinion is as good as any other, but is it? In an attempt to answer this question, an experiment was performed in conjunction with a recent compound acquisition program (CAP) conducted at Pharmacia. Historically, the CAP included a review of many thousands of compounds by medicinal chemists who eliminate anything deemed undesirable for any reason. In a review conducted in 2002, about 22 000 compounds requiring review by medicinal chemists were broken down into 11 lists of approximately 2000 compounds each. Unknown to the medicinal chemists, a subset of 250 compounds, previously rejected by a very experienced senior medicinal chemist, was added to each of the lists. Most of the 13 medicinal chemists who participated in this process reviewed two lists, although some only reviewed a single list and one reviewed three lists. Those compounds that were deemed unacceptable were recorded and tabulated in various ways to assess the consistency of the reviews. It was found that medicinal chemists were not very consistent in the compounds they rejected as being undesirable. The inconsistency arises from the subjective analysis that all humans utilize when considering "data sets" of any kind. This has important implications for pharmaceutical project teams where individual medicinal chemists review lists of primary screening hits to identify those compounds suitable for follow-up. Once a compound is removed from a list, it and other structurally similar compounds are effectively removed from further consideration. This can also have an impact on computational chemists who are developing models for assessing the desirability or attractiveness of different classes of compounds for lead discovery.

Chemistry, Pharmaceutical↗

Multidisciplinary case conference reviews: improving outcomes for nursing home residents, carers and health professionals.

AIM OF STUDY: This study sought to determine whether multidisciplinary case conference reviews improved outcomes for nursing home residents, and the effects of this team approach to resident care on carers, including the hands-on carers employed by the nursing home, and health professionals. METHOD: 245 residents of three Canberra nursing homes were enrolled in this non-randomised controlled trial. The intervention consisted of sessions of three case conference reviews held between 10/4/96 and 4/12/96. These sessions were attended by the General Practitioners (GPs) of the residents discussed, the GP project officer from the ACT Division of General Practice, a clinical pharmacist, senior nursing staff, other health professionals e.g. physiotherapist, and occasionally the resident concerned or their representative. At each review, a case presentation by the resident's GP was followed by a multidisciplinary discussion of all aspects, medical and non-medical, of the resident's care. The review concluded with a management plan for the resident. In total 75 residents were reviewed. MAIN OUTCOME MEASURES: Medication use and cost, and mortality. RESULTS: One month after the reviews were completed comparisons between those who were reviewed and those who were not showed non-significant reductions in medication orders, medication cost, and mortality in the reviewed group. Many of the 92 recommendations in the management plans that were carried out benefited the residents (n = 37) and/or carers (n = 24). The responses of the GPs and the Directors of Nursing to the reviews were overwhelmingly positive. CONCLUSION: Recommendations arising from multidisciplinary case conferences were carried out to the benefit of patients and carers. Given the support shown by key stakeholders, multidisciplinary conferences should be used more.

Aged↗

Quality of systematic reviews used in guidelines for oncology practice.

BACKGROUND: Systematic reviews are an important tool for developing clinical recommendations. Those of high quality assure a good level of confidence on the strength of the recommendations. METHODS: A QUOROM-based checklist was applied to the reviews cited in a sample of guidelines on breast and colon cancer prevention and therapy. The checklist provided a weight for each criterion and a total quality score. Each review was independently evaluated by two reviewers; disagreements were solved by consensus. RESULTS: Eighty reviews (96%) were retrieved and evaluated; 36 focused on breast, and 44 on colorectal cancer. Twenty-three reviews (29%) did not match the definition of systematic review. In 17 (21%) the searching methods were unclear or described elsewhere. Forty (50%) were systematic. Not systematic, low and very low quality reviews accounted for 70% of the total. No review obtained the A+ class score; only 5 (6%) the A- and 7 (9%) the B+. CONCLUSIONS: The results of this assessment provide a sober picture of the quality of the sources used to build guidelines. Oncologists should be aware that they could be relying on poor underlying documents. Writing groups should be aware of methodological problems, and should consult the existing manuals for the preparation of guidelines.

Evidence-Based Medicine↗

Prevalence of inter-institutional anatomic pathology slide review: a survey of current practice.

Multiple studies have demonstrated discrepancy rates between original and review histopathologic diagnoses of up to 30% with a mean of approximately 10%. In view of these rates of discrepancy, several authorities, including the Association of Directors of Anatomic and Surgical Pathology, have recommended in-house review of all outside materials before commencement of therapy. We used a mail survey to determine the degree of compliance with these recommendations among pathology groups in the United States. Mail surveys were sent to six randomly selected hospitals from each state (300 total). The survey included demographic questions, including surgical pathology caseload, size of hospital (beds), and type of hospital (community-general, non-academic-tertiary care, or academic-tertiary care). The survey asked whether the hospital required review of all outside slides before the performance of surgery. If not, was such a policy encouraged but not required. The survey also asked whether in-house review of outside cases had disclosed any significant differences in pathologic diagnoses. Finally, the survey questioned whether any discrepancies between an internal and external surgical pathology diagnosis had been discovered following radical surgery. One hundred twenty-six usable responses were obtained. Fifty-five of these were from hospitals self-described as community-general, seven were from hospitals describing themselves as non-academic-tertiary care, and the remaining 61 hospitals described themselves as academic-tertiary care institutions. Sixty-three institutions stated they had a requirement for in-house review of outside material, with 46 of 61 academic-tertiary centers having such a requirement. Thirty-seven of 55 community-general hospitals did not require in-house review of outside material before surgery could be performed. One hundred ten of the 126 institutions returning surveys either encouraged or required review of outside material. Ninety-five institutions reported that they had at least one outside case in which their diagnosis was significantly discordant with that rendered by the referring pathologist. Sixty (48%) of the 126 institutions reported at least one case in which a discrepancy was found between the outside biopsy diagnosis and the internal diagnosis rendered on material obtained by radical surgery. Approximately half of all responding institutions have a requirement for in-house review of outside material prior to surgery. A majority of institutions requiring such review have found discrepancies between the in-house diagnoses and those rendered by referring laboratories.

Diagnostic Errors↗

Analysis of US Food and Drug Administration review intervals for drugs approved during the period 1997-2002.

This research investigates US Food and Drug Administration review intervals in the United States from 1997 through 2002 for three main categories new drugs applications: new drug application (NDA), the supplemental new drug application (SNDA), and the abbreviated new drug application (ANDA). Review interval for each application was the basis for evaluation and was calculated based on the difference between approval date and the application date. The median review time for all applications was 13.5 months (1.1 years). The median review intervals for ANDAs, NDAs, and SNDAs were 19.1, 12.0, and 10.0 months (1.6, 1.0, and 0.8 years), respectively, during the period. It was found that the median review period for an ANDA was significantly longer than that for an NDA and SNDA. Comparison of application class medians revealed significant differences for all 3 pairwise comparisons (all P < 0.001, Tukey HSD). Within each application category, we compared differences between years. The year effect was not statistically significant for ANDAs or NDAs. NDA median review times were 13.7, 12.0, 12.0, 10.8, 12.5, and 11.7 months (1.14, 1.00, 1.00, 0.90, 1.04, and 0.98 years), while ANDA median review times were 20.4, 19.1, 19.9, 18.6, 18.4, and 21.5 months (1.70, 1.59, 1.66, 1.55, 1.53, and 1.79 years) for 1997, 1998, 1999, 2000, 2001, and 2002, respectively. Year differences were significant for SNDAs (P < 0.001). The primary source of this difference was a lower median review time during 1997, but there was little difference in median review times for the remaining years.

Humans↗

Preventive care in the emergency department, Part II: Clinical preventive services--an emergency medicine evidence-based review. Society for Academic Emergency Medicine Public Health and Education Task Force Preventive Services Work Group.

INTRODUCTION: Emergency departments (EDs) provide an opportunity to initiate preventive services for millions of Americans who have no other source for these services. OBJECTIVES: To identify primary and secondary preventive interventions appropriate for inclusion in routine emergency care and, secondarily, to recommend areas in which research into the efficacy and cost-effectiveness of interventions is needed. METHODS: Systematic reviews were performed on 17 candidate preventive interventions with potential applicability in the ED. All but one was selected from those reviewed by the U.S. Preventive Services Task Force (USPSTF). Each two-person review team followed a template that provided a uniform approach to search strategy, selection criteria, methodology appraisal, and analysis of the results of primary studies bearing on ED cost-effectiveness. Assigned proctors provided methodological guidance to the review teams throughout the review process. A grading scheme was developed that took into account the evidence and recommendations of the USPSTF supporting primary efficacy of the intervention and the level of evidence supporting ED application identified by the Society for Academic Emergency Medicine Public Health and Education Task Force (PHTF) review teams. RESULTS: Seventeen reviews were completed. The following interventions received an alpha rating, indicating that evidence is sufficient to support offering these services in the ED setting, assuming sufficient resources are available: alcohol screening and intervention, HIV screening and referral (in high-risk, high-prevalence populations), hypertension screening and referral, adult pneumococcal immunizations (age >/=65 years), referral of children without primary care physicians to a continuing source of care, and smoking cessation counseling. Interventions receiving a beta or gamma rating, indicating that existing research is not sufficient to recommend for or against instituting them routinely in the ED, include: identification and counseling of geriatric patients at risk of falls, Pap tests in women having a pelvic exam in the ED, counseling for smoke detector use, routine social service screening, depression screening, domestic violence screening, safe firearm storage counseling, motorcycle helmet use counseling, and youth violence counseling programs in the ED. Interventions not recommended for ED implementation (omega rating) include Pap test screening for women not having a routine pelvic exam, diabetes screening, and pediatric immunizations. CONCLUSIONS: A set of recommendations for prevention, screening, and counseling activities in the ED based on systematic reviews of selected interventions is presented. The applicability of these primary and secondary preventive services will vary with the different clinical environments and resources available in EDs. The PHTF recommendations should not be used as the basis of curtailing currently available services. This review makes clear the need for further research in this important area.

Counseling↗

Medical radiologic technologist review: effects on a population-based breast cancer screening program.

PURPOSE: To evaluate the effects of medical radiologic technologist review of mammograms in a population-based breast cancer screening program. MATERIALS AND METHODS: A technologist review pilot project was incorporated into the Regina, Saskatchewan, Canada, reading center. Technologists received special training in mammographic interpretation. They reviewed all 27,863 mammograms obtained at the center from July 1995 to September 1996 that were reviewed by a radiologist and selected cases for second blind reading by another radiologist. When the two radiologists' readings were in agreement, the report was sent. When the readings differed, a third opinion was obtained from the program's consulting radiologist. Changes in the number of mammograms interpreted as abnormal and the number of cancers detected were assessed. RESULTS: The technologist review was responsible for the detection of nine cancers missed at the first radiologist's interpretation. Technologists were very discriminating; only 391 cases (1.4%) were sent for double reading. The positive predictive value of screening did not change significantly (7.5% without review, 8.1% with review; P > .20). CONCLUSION: A substantial number of cancers were found with the technologist review. The number of mammograms interpreted as abnormal was reduced slightly. The technologist review proved to be a cost-effective alternative to double reading by two radiologists.

Breast Neoplasms↗

Towards systematic reviews that inform health care management and policy-making.

OBJECTIVES: To identify ways to improve the usefulness of systematic reviews for health care managers and policy-makers that could then be evaluated prospectively. METHODS: We systematically reviewed studies of decision-making by health care managers and policy-makers, conducted interviews with a purposive sample of them in Canada and the United Kingdom (n = 29), and reviewed the websites of research funders, producers/purveyors of research, and journals that include them among their target audiences (n = 45). RESULTS: Our systematic review identified that factors such as interactions between researchers and health care policy-makers and timing/timeliness appear to increase the prospects for research use among policy-makers. Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them (e.g. contextual factors that affect a review's local applicability and information about the benefits, harms/risks and costs of interventions) and having reviews presented in a way that allows for rapid scanning for relevance and then graded entry (such as one page of take-home messages, a three-page executive summary and a 25-page report). Managers and policy-makers have mixed views about the helpfulness of recommendations. Our analysis of websites found that contextual factors were rarely highlighted, recommendations were often provided and graded entry formats were rarely used. CONCLUSIONS: Researchers could help to ensure that the future flow of systematic reviews will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions. Research funders could help to ensure that the global stock of systematic reviews will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly 'front ends' for potentially relevant systematic reviews.

Canada↗

Meta-analyses of clinical drug trials--gold standard reviews or statistical alchemy?

Renewed emphasis on the critical appraisal of published evidence has in turn led to critical appraisal of the way clinical studies have been reviewed. Reviews perform the vital function of summarising a wealth of research information in an efficient and trustworthy manner, but traditional narrative reviews have fallen short in this area, not because they are narrative, but because they have allowed reviewer and publication bias to creep in under the guise of expert authority. Meta-analysis or systematic review emphasises the use of a review protocol based on logical principles to minimise bias, together with qualitative and appropriate quantitative summaries of the data. Like any review, the perceived impact of a meta-analysis is dependent on the quality of the reviewed studies, therefore randomised clinical trials are the favoured substrate for the meta-analysis of drug efficacy because of their potentially high internal validity. The importance of meta-analysis as a tool for clinical drug evaluation has prompted this selective account of its nature, theory, practice and interpretation, with particular emphasis on meta-analysis as a review methodology rather than a statistical methodology, the critical distinction between design and result homogeneity and the need to explore issues of heterogeneity rather than gloss over them by using some statistical shortcut.

Clinical Trials as Topic↗

Inconsistent grading of evidence across countries: a review of low back pain guidelines.

OBJECTIVE: The aim of this study was to report clinical treatment recommendations for low back pain (LBP) based on 5 international guidelines and best evidence from the Cochrane database of systematic reviews. METHODS: Five LBP guidelines available in English language were appraised, including 4 studies published since the seminal work by Koes et al (Spine 2001;26:2504-5213). The guidelines were examined for treatment recommendations concerning nonspecific LBP and guideline quality with application of the Appraisal of Guidelines for Research and Evaluation instrument. Secondly, a systematic literature search for reviews and randomized controlled trials was conducted using a modified version of the search strategy recommended by the Cochrane Back Review Group. Two systematic reviews were identified. RESULTS: According to best evidence from review of the Cochrane database of systematic reviews, there remains a lack of consensus regarding reported efficacy of spinal manipulative therapy for the treatment of nonspecific LBP. Furthermore, the guidelines reviewed in the present study have not changed significantly with respect to treatment recommendations for nonspecific LBP since the original review, and there is inconsistency between the guidelines regarding optimal time to introduce spinal manipulation to treat nonspecific LBP. CONCLUSION: Treatment recommendations for nonspecific LBP, particularly spinal manipulation, remain inconclusive. Guideline developers need to consider guidelines in neighboring countries and reach consensus on how evidence is graded and incorporated into guidelines. Guidelines should continue to be regularly updated to incorporate new evidence and methods of grading the evidence.

Evidence-Based Medicine↗

The process of systematic review and its application in agri-food public-health.

Foodborne illness is an important public-health concern. Livestock operations represent the original source of many foodborne pathogens. Policy- and decision-makers in the area of agri-food public-health need dependable information on interventions to reduce foodborne diseases. While individual studies might be weak or reach contradictory conclusions, the body of information contained in all studies might reveal a clearer picture of the state of knowledge. A formal process has been developed for conducting systematic reviews of the human healthcare literature. Systematic reviews differ from traditional narrative reviews in that systematic reviews follow a structured research protocol to reduce sources of bias at all stages of the review. This includes the objective, the literature search, the identification of relevant literature, quality assessment of relevant studies, summarization or statistical analysis of data, and conclusions. To date, systematic reviews have not been widely used in agri-food public-health. Existing systematic reviews on agri-food public-health topics revealed a scarcity of rigorously conducted intervention research, indicating a need for additional high quality primary studies. The specific protocols used to conduct systematic reviews in agri-food public-health need to accommodate the use of challenge studies and observational studies, the lack of randomized controlled trials, and the clustering of animal populations.

Animals↗

Peer review.

Peer review is essential for ensuring quality medical care. In the 1980s a physician-plaintiff prevailed in lawsuit filed against peer reviewers who excluded the physician from a hospital's medical staff. The peer reviewers had acted to preserve their own economic interests. A multimillion-dollar verdict against the peer reviewers destroyed the community's only multispecialty practice and received national attention. Congress reacted by passing the Health Care Quality Improvement Act that granted sweeping, legal immunity for peer reviewers but also created the National Practitioner's Data Bank. The combination of the establishment of a public repository for physicians malpractice and medical staff privileging activity in combination with the near complete legal protection of peer reviewers has converted peer review from an evaluative to a punitive process. The peer review process and the laws that govern it should be reformed to regain its ability to improve and assure quality without being a threat to physicians.

Humans↗