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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.

ABSTRACT: BACKGROUND:This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS:One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry. RESULTS:Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct clinical questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence to manufacturer instructions, and proactive and timely reactions to information derived from both internal QC and proficiency-testing specimens. Highly desirable procedures include those designed to minimize the risk of the reporting of erroneous results attributable to interferences such as heterophilic antibodies or hook effects, to facilitate the provision of informative clinical reports (e.g., cumulative and/or graphical reports, appropriately derived reference intervals, and interpretative comments), and when possible to integrate these reports with other patient information through electronic health records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical and laboratory users, and regulatory agencies. CONCLUSIONS:Implementation of these recommendations, adapted to local practice, should encourage optimization of the clinical use of tumor markers.

SUBMITTER: Sturgeon CM

PROVIDER: S-EPMC5564312 | biostudies-literature | 2008 Aug

REPOSITORIES: biostudies-literature

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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.

Sturgeon Catharine M CM Hoffman Barry R BR Chan Daniel W DW Ch'ng Soo-Ling SL Hammond Elizabeth E Hayes Daniel F DF Liotta Lance A LA Petricoin Emmanuel F EF Schmitt Manfred M Semmes O John OJ Söletormos Györg G van der Merwe Elena E Diamandis Eleftherios P EP

Clinical chemistry 20080707 8

<h4>Background</h4>This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers.<h4>Methods</h4>One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry.<h4>Results ...[more]

PMID: 18606634

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Project description:IntroductionThis guideline establishes clinical practice recommendations for the diagnosis of obstructive sleep apnea (OSA) in adults and is intended for use in conjunction with other American Academy of Sleep Medicine (AASM) guidelines on the evaluation and treatment of sleep-disordered breathing in adults.MethodsThe AASM commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use. In addition, the task force adopted foundational recommendations from prior guidelines as "good practice statements", that establish the basis for appropriate and effective diagnosis of OSA. The AASM Board of Directors approved the final recommendations.RecommendationsThe following recommendations are intended as a guide for clinicians diagnosing OSA in adults. Under GRADE, a STRONG recommendation is one that clinicians should follow under most circumstances. A WEAK recommendation reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources. Good Practice Statements: Diagnostic testing for OSA should be performed in conjunction with a comprehensive sleep evaluation and adequate follow-up. Polysomnography is the standard diagnostic test for the diagnosis of OSA in adult patients in whom there is a concern for OSA based on a comprehensive sleep evaluation.Recommendations: We recommend that clinical tools, questionnaires and prediction algorithms not be used to diagnose OSA in adults, in the absence of polysomnography or home sleep apnea testing. (STRONG). We recommend that polysomnography, or home sleep apnea testing with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. (STRONG). We recommend that if a single home sleep apnea test is negative, inconclusive, or technically inadequate, polysomnography be performed for the diagnosis of OSA. (STRONG). We recommend that polysomnography, rather than home sleep apnea testing, be used for the diagnosis of OSA in patients with significant cardiorespiratory disease, potential respiratory muscle weakness due to neuromuscular condition, awake hypoventilation or suspicion of sleep related hypoventilation, chronic opioid medication use, history of stroke or severe insomnia. (STRONG). We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for polysomnography be used for the diagnosis of OSA. (WEAK). We suggest that when the initial polysomnogram is negative and clinical suspicion for OSA remains, a second polysomnogram be considered for the diagnosis of OSA. (WEAK).

Project description:ImportanceRecommendations of clinical guidelines affect physicians' care delivery. Potential bias and undeclared conflicts of interests (COIs) among guideline authors can impact clinical practice decisions.ObjectiveTo assess financial disclosures reported by physician authors of the American Academy of Ophthalmology (AAO) Practice Pattern Guidelines compared with those reported by industry to evaluate the disclosures' accuracy.Design, setting, and participantsIn this cross-sectional study, all clinical guidelines in the AAO Preferred Practice Patterns (PPP) since 2013 (first year with publicly available industry payment reports) were reviewed on May 1, 2022. Guideline physician authors' name and their reported COI disclosure were extracted from the guideline publication. Payments to physician authors reported by industry were retrieved from the US Centers for Medicare & Medicaid Open Payments database. Physician authors serving on the AAO guideline committee were included.Main outcomes and measuresThe primary outcome measure was the accuracy of authors' COIs disclosure. Secondary outcome measures were payments to physician authors reported by industry, the types of payments, and authors' gender.ResultsA total of 24 AAO guidelines released between 2016 and 2020 were included. Per guideline, there was a mean (SD) of 7.83 (2.24) physician authors. After removing 14 nonphysician authors, 188 physician author names remained, including 83 names assigned as women (44.1%) and 105 names assigned as men (55.9%). Authors could be counted multiple times in these 188 names. According to the Open Payments database, industry reported that 112 of 188 physician authors (59.6%) had at least received 1 payment while serving on the guideline committee, with a payment mean (SD) of $29 849.35 ($54 131.56). According to AAO guidelines, 149 authors (79.3%) had no financial disclosures while serving on the guideline committee. Among these 149 authors, most authors (81 [54.4%]) had payments reported by industry on the Open Payments database not disclosed within the guideline reports. Women physicians were paid significantly more than men for total payments (median [IQR] payments, $15 265 [$598.47-$41 104.67] vs $301.48 [$218.85-$14 615.09]; difference, $14 963.52; P = .003).Conclusions and relevanceIndustry reported physician guideline authors to have received significant industry payments, some of which were not disclosed within information of the guidelines. To strengthen author transparency regarding these reported disclosures, the authors may want to review and resolve such potential discrepancies during the review and subsequent publication of guidelines.

Project description:BACKGROUND:Clinical practice guidelines (CPGs) have been published by the American College of Emergency Physicians (ACEP) since 1990 to advance evidence-based emergency care. ACEP clinical policies have drawn anecdotal criticism for bias, yet the overall quality of these guidelines has not previously been quantified. We sought to examine ACEP clinical policies using a recognised, validated appraisal instrument: Appraisal of Guidelines for Research & Evaluation (AGREE II). METHODS:Systematic assessment of current ACEP clinical policies was conducted using the AGREE II instrument, which contains 23 appraisal items (scored on a 1-7 scale) in six domains and two overall assessments. Each policy was independently appraised by five trained appraisers. Primary outcomes were AGREE II ratings for each item, domain and "Overall Assessment," and scores were reported as standardised percentages from all five appraisers. Secondary analyses examined associations between AGREE II ratings and policy publication date, strength of underlying evidence and strength of recommendations. Additional analysis examined relationships between domain and "Overall Assessment" ratings. RESULTS:Twenty guidelines published from April 2007 to November 2017 were included. Of the six domains, "Scope and Purpose" scored highest (mean 90%) and "Applicability" scored lowest (mean 35%). The four remaining domains ("Stakeholder Involvement," "Rigor of Development," "Clarity of Presentation" and "Editorial Independence") had mean scores of 53%-78%. The mean "Overall Assessment" rating was 69% and was not associated with policy publication date, strength of underlying evidence or strength of recommendations. We found positive associations between "Overall Assessment" ratings and two domains: "Rigor of Development" (r = 0.70) and "Clarity of Presentation" (r = 0.70). CONCLUSIONS:Based on validated AGREE II criteria, ACEP clinical policies can be most improved by addressing their application in practice. ACEP clinical policies' overall quality did not improve over the assessed time period and is not explained by the quality of underlying evidence.

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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.

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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.

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