Do clinical practice guidelines consider evidence about diagnostic test consequences on patient-relevant outcomes? A critical document analysis.

RATIONALE, AIMS AND OBJECTIVES: Supporting evidence for diagnostic test recommendations in clinical practice guidelines (CPGs) should not only include diagnostic accuracy, but also downstream consequences of the test result on patient-relevant outcomes. The aim of this study is to assess the extent to which evidence-based CPGs about diagnostic tests cover all relevant test-treatment pathway components. METHODS: We performed a systematic document analysis and quality assessment of publicly accessible CPGs about three common diagnostic tests: C-reactive protein, colonoscopy and fractional exhaled nitric oxide. Evaluation of the impact of the full test-treatment pathway (diagnostic accuracy, burden of the test, natural course of target condition, treatment effectiveness, and link between test result and administration of treatment) on patient relevant outcomes was considered best practice for developing medical test recommendations. RESULTS: We retrieved 15 recommendations in 15 CPGs. The methodological quality of the CPGs varied from poor to excellent. Ten recommendations considered diagnostic accuracy. Four of these were funded on a systematic review and rating of the certainty in the evidence. None of the CPGs evaluated all steps of the test-treatment pathway. Burden of the test was considered in three CPGs, but without systematically reviewing the evidence. Natural course was considered in two CPGs, without a systematic review of the evidence. In three recommendations, treatment effectiveness was considered, supported with a systematic review and rating of the certainty in the evidence in one CPG. The link between test result and treatment administration was not considered in any CPG. CONCLUSIONS: The included CPGs hardly seem to consider evidence about test consequences on patient-relevant outcomes. This might be explained by reporting issues and challenging methodology. Future research is needed to investigate how to facilitate guideline developers in explicit reliable consideration of all steps of a test-treatment pathway when developing diagnostic test recommendations.

Applying GRADE for diagnosis revealed methodological challenges: an illustrative example for guideline developers.

OBJECTIVE: To identify challenges in the application of GRADE for diagnosis when assessing the certainty of evidence in the test-treatment strategy (diagnostic accuracy, test burden, management effectiveness, natural course, linked evidence) in an illustrative example and to propose solutions to these challenges. STUDY DESIGN AND SETTING: A case study in applying GRADE for diagnosis that looked at the added value of IgE for diagnosing allergic rhinitis. RESULTS: Evaluation of the full test-treatment strategy showed a lack of (high-quality) evidence for all elements. In our example, we found a lack of evidence for test burden, natural course, and link between the test result and clinical management. Overall, systematically reviewing the evidence for all elements of a test-treatment strategy is more time-consuming than only considering test accuracy results and management effectiveness. For increasing efficiency, the guideline panel could determine critical elements of the test-treatment strategy that need a systematic review of the evidence. For less critical elements, a guideline panel can rely on gray literature and professional expertise. CONCLUSION: A lack of high-quality evidence and time investment if the full test-treatment strategy is assessed, creating challenges in applying GRADE for diagnosis. Discussion within guideline panels about critical elements that need to be reviewed might help.

[Chronic kidney damage guidelines revision]. / Herziening richtlijnen 'Chronische nierschade'.

Age has no effect on the diagnosis of 'chronic kidney damage'. Estimated glomerular filtration rate (eGFR) < 60 ml/min per 1.73 m2 is to be considered 'abnormal' for patients of all ages. Albuminuria is classified as 'not abnormal', 'moderately elevated' and 'severely elevated'. Decreased eGFR and elevated albuminuria are independent risk factors for and predictors of cardiovascular and total mortality, progression of chronic kidney damage and end-stage kidney failure. Blood pressure target value is ≤ 130/80 mmHg. In case of an indication for blood pressure-lowering treatment for patients with chronic kidney damage and elevated albuminuria, an ACE inhibitor or angiotensin II receptor blocker is preferred. The general practitioner refers patients with chronic kidney damage and a highly elevated risk of mortality, cardiovascular disease, progression of kidney damage and end-stage kidney failure to the internist-nephrologist. Inform patients about drugs that can cause kidney damage and about the importance of dosage adjustments. When prescribing drugs to patients with eGFR < 50 ml/min per 1.73 m2, the pharmacist should, with the patient's approval, be informed of the eGFR.

Applicability of evidence from previous systematic reviews on immunotherapy in current practice of childhood asthma treatment: a GRADE (Grading of Recommendations Assessment, Development and Evaluation) systematic review.

OBJECTIVE: Because most children with asthma now use inhaled corticosteroids (ICS), the added benefit of immunotherapy in asthmatic children needs to be examined. We re-assessed the effectiveness of subcutaneous (SCIT) and sublingual immunotherapy (SLIT) in childhood asthma treatment focusing on studies with patient-relevant outcome measures and children using ICS. METHODS: We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to systematically search and appraise the evidence using predefined critical patient-relevant outcomes (asthma symptoms, asthma control and exacerbations). We searched to retrieve systematic reviews and randomised controlled trials on immunotherapy for asthma in children (1960-2017). We assessed the quality of the body of evidence with GRADE criteria. RESULTS: The quality of the evidence for SCIT was very low due to a large risk of bias and indirectness (dated studies in children not using ICS). No effect of SCIT was found for asthma symptoms; no studies reported on asthma control. For asthma exacerbations, studies favoured SCIT. We have little confidence in this effect estimate, due to the very low quality of evidence. For SLIT, quality of the evidence was very low due to a large risk of bias, indirectness and imprecision. The outcome 'asthma symptoms' could not be calculated due to lack of standardisation and large clinical heterogeneity. Other predefined outcomes were not reported. CONCLUSION: The beneficial effects of immunotherapy in childhood asthma found in earlier reviews are no longer considered applicable, because of indirectness (studies performed in children not being treated according to current asthma guidelines with ICS). There was absence of evidence to properly determine the effectiveness or lack thereof of immunotherapy in asthma treatment in children with ICS.

[The NHG guidelines 'Adult asthma' and 'COPD']. / NHG-standaarden 'Astma bij volwassenen' en 'COPD'.

The Dutch College of General Practitioners (NHG) guidelines 'Adult asthma' and 'COPD' have been revised. New spirometry reference values from the Global Lung Function Initiative are recommended. Airway obstruction is defined as a FEV1/FVC ratio below the 5th percentile for the reference population. Spirometry for diagnosis takes place without use of patients' inhaled medication and consists of measurements before and after standardized bronchodilation. In monitoring spirometry, patients continue using inhaled medication and standardized bronchodilation is not indicated. The goal of asthma management is optimal asthma control, tailored to individual goals. The most important non-drug intervention in asthma and COPD is to recommend stopping smoking. The goal of COPD management is to limit symptoms, improve exercise capacity and quality of life, and reduce the burden of disease. Inhaled corticosteroids are usually not indicated in COPD treatment. Patients with comorbid asthma and COPD are treated with non-drug interventions according to the COPD guideline and with medication according to the asthma guideline.

[Dutch College of General Practitioners' practice guideline 'Asthma in children']. / NHG-standaard 'Astma bij kinderen'.

In children < 6 years characteristic asthma patterns are often lacking and the diagnosis cannot be objectified. For this reason 'episodic expiratory wheezing' is the preferred diagnosis. In children ≥ 6 years asthma is diagnosed on the basis of symptoms; if there is doubt spirometry may be helpful. The treatment goal is complete asthma control, i.e. daytime symptoms < 2/week, no nocturnal symptoms, no limitation of activities, rescue treatment ≤ 2/week, normal spirometry. Smoking by children or relatives is strongly discouraged. In children < 1 year, a monitored trial with short-acting beta-agonist (SABA) is recommended. Controller medication (inhaled corticosteroids (ICS)) is not recommended. In children aged 1 to 6 years, a SABA is recommended, with additional ICS if symptoms persist. Incompletely controlled asthma is an indication for referral. In children ≥ 6 years ICS are recommended in incomplete asthma control. If the normal daily dosage of ICS and adequate coping fail to achieve complete control of the asthma, then referral is recommended. Patients on ICS should be monitored regularly.

Prospective comparison of three guideline development methods for treatment of actinic keratosis.

OBJECTIVE: To compare three methods of guideline development, to see whether using alternative evidence-based methods resulted in variation of recommendations for treating actinic keratosis. METHODS: Method 1 followed a standard multiple session evidence-based approach with a working group. In method 2 recommendations were formulated by a working group during a 2-day conference. Method 3 used one epidemiologist to summarise the evidence and one dermatologist to make clinical recommendations afterwards. Graded recommendations and levels of evidence were compared per therapy across three draft guidelines. The primary outcome was the extent of accordance or discordance. Secondary outcomes were total costs and time period necessary to make a draft guideline. RESULTS: Therapeutic recommendations and levels of evidence differed in some occasions. However, intraclass correlations between levels of evidence were significant (method 1 vs 2: p = 0.003; method 1 vs 3: p < 0.001). Regarding recommendation variation method 1 and method 2 correlated significant at 0.755 (p = 0.001). Method 1 versus 3 and method 2 versus 3 also showed significant, but lower, correlation coefficients (respectively, 0.493 (p = 0.026) and 0.673 (p = 0.007)). Method 3 was the cheapest and quickest (24,770 euro and 4 months) and method 1 was the most expensive and slowest method (€48,100 euro and 14 months). CONCLUSIONS: The value of a guideline using alternative evidence-based methods seems to at least equal that of a guideline composed in multiple sessions, that is, for topics with a monodisciplinary character and a relatively small number of conducted trials. In addition, the presented alternatives were more time- and cost-efficient.

[Advice on guidelines: planning for guideline development in the Netherlands]. / Regie over richtlijnen: plannen voor richtlijnontwikkeling in Nederland.

There is a lack of shared responsibility and national steering in guideline development. The 'Regieraad' (advisory board on guideline development, established by the Dutch Health Secretary) hopes to facilitate the coordination of guideline development. Therefore, the board developed a shortlist of the 100 most important diseases and 25 important care processes, based on several accepted criteria. An inventory of already available guidelines and other instruments for quality improvement was also made. The board thinks that guidelines should become more uniform to improve accessibility and usefulness for daily practice. The board encourages the availability of guidelines for the most important topics. With the information available a long-term policy for guideline development and maintenance can be determined.

Quality of primary care guidelines for acute low back pain.

STUDY DESIGN: Systematic review of clinical guidelines. OBJECTIVES: To assess the methodologic quality of existing guidelines for the management of acute low back pain. SUMMARY OF BACKGROUND DATA: Guidelines are playing an increasingly important role in evidence-based practice. After publication of the Quebec Task Force in Canada in 1987 and the Agency for Health Care Policy and Research guidelines in the United States in 1994, guidelines for acute low back pain were developed in many other countries. However, little is known about the methodologic quality of these guidelines. METHODS: Guidelines were selected by electronically searching MEDLINE and the Internet and through personal communication with experts in the field of low back pain research in primary care. The methodologic quality of the guidelines was assessed by two authors independently using the AGREE instrument. RESULTS: A total of 17 guidelines were included. Overall, the quality of reporting of guidelines was disappointing. Most guidelines clearly described the aim of the guideline and its target population, and most guideline development committees were multiprofessional. However, many other methodologic flaws were identified. More than half of the guidelines did not take patients' preferences into account, did not perform a pilot test among target users, did not clearly describe the methods of study identification and selection, did not include an external review, did not provide a procedure for updating, were not supported with tools for application, did not consider potential organizational barriers and cost implications, did not provide criteria for monitoring and audit, did not include recommendations for implementation strategies, and did not adequately record editorial independence and conflict of interest of the members. The diagnostic and therapeutic recommendations of the guidelines were largely similar. CONCLUSIONS: The quality and transparency of the development process and the consistency in the reporting of primary care guidelines for low back pain need to be improved.