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INTRODUCTION: The involvement of the public in the collection and selection of topics for health technology assessments (HTAs) is an important prerequisite for producing HTA reports on questions actually relevant to patients. In §139b (5) Social Code Book (SGB V), the legislator established the requirements for health insurance members and other interested individuals to propose topics for HTA reports to the Institute for Quality and Efficiency in Health Care (IQWiG). OBJECTIVES: How is the legal remit implemented with regard to the involvement of patients and consumers in topic collection and selection for HTA reports in IQWiG's Topic Check Medicine? TOPIC COLLECTION AND SELECTION: Topic proposals for HTA reports can be submitted by any interested individual via a simple submission form on the "ThemenCheck Medizin" website. If the HTA question is unclear, IQWiG consults the person submitting the proposal. On the basis of topic processing, a Selection Committee comprising members of the public and patient representatives nominates 15 patient-relevant topics suitable for the production of an HTA report. IQWiG then chooses 4-6 topics from which HTA reports are produced. EXPERIENCE WITH TOPIC COLLECTION AND SELECTION: In the first 2 selection cycles (July 2016 to July 2017), 57 topic proposals for HTA reports were submitted from a wide range of topics. At the end of 2016 and 2017, the Selection Committee nominated 15 patient-relevant topics suitable for HTA reports. At the beginning of 2017, IQWiG selected 5, at the beginning of 2018 4 topics for HTA reports. The processing of topics and the selection process were largely judged positively by the Selection Committee. CONCLUSION: A high degree of involvement in topic collection for "ThemenCheck Medizin" is achieved through the simple submission form and the nomination of topics by the Selection Committee. Furthermore, important factors for successful implementation were political support from the legislator, choice of suitable members for the Selection Committee, and support of topic selection by this Committee. How the demand for greater involvement of patients and public can be implemented needs investigation in the future.

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BACKGROUND: The AGREE II instrument is the most commonly used guideline appraisal tool. It includes 23 appraisal criteria (items) organized within six domains. AGREE II also includes two overall assessments (overall guideline quality, recommendation for use). Our aim was to investigate how strongly the 23 AGREE II items influence the two overall assessments. METHODS: An online survey of authors of publications on guideline appraisals with AGREE II and guideline users from a German scientific network was conducted between 10th February 2015 and 30th March 2015. Participants were asked to rate the influence of the AGREE II items on a Likert scale (0 = no influence to 5 = very strong influence). The frequencies of responses and their dispersion were presented descriptively. RESULTS: Fifty-eight of the 376 persons contacted (15.4%) participated in the survey and the data of the 51 respondents with prior knowledge of AGREE II were analysed. Items 7-12 of Domain 3 (rigour of development) and both items of Domain 6 (editorial independence) had the strongest influence on the two overall assessments. In addition, Items 15-17 (clarity of presentation) had a strong influence on the recommendation for use. Great variations were shown for the other items. The main limitation of the survey is the low response rate. CONCLUSIONS: In guideline appraisals using AGREE II, items representing rigour of guideline development and editorial independence seem to have the strongest influence on the two overall assessments. In order to ensure a transparent approach to reaching the overall assessments, we suggest the inclusion of a recommendation in the AGREE II user manual on how to consider item and domain scores. For instance, the manual could include an a-priori weighting of those items and domains that should have the strongest influence on the two overall assessments. The relevance of these assessments within AGREE II could thereby be further specified.

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OBJECTIVES: To investigate whether Appraisal of Guidelines for Research & Evaluation (AGREE) II users apply a cut-off based on standardized domain scores or overall guideline quality to distinguish between high- and low-quality guidelines, as well as to investigate which criteria they use to generate this cut-off and which type of cut-off they apply. STUDY DESIGN AND SETTING: We conducted a systematic search in MEDLINE, EMBASE, DARE, and the HTA-database for German- and English-language studies appraising guidelines with AGREE II. Information on cut-offs was extracted and analyzed descriptively. RESULTS: We identified 118 relevant publications. Thirty-nine (33%) used a cut-off, of which 24 (62%) used a 2-step and 13 (33%) used a 3-step approach. The cut-off for high quality lay between 50% and 70% (2-step) and 60% and 83% (3-step) of the highest possible rating. Twenty-four (62%) publications applied a cut-off based on standardized domain scores and 7 (18%) based on overall guideline quality. Eleven (28%) applied cut-offs to derive the recommendation for guideline use. CONCLUSION: A third of AGREE II users apply a cut-off to distinguish between high- and low-quality guidelines, often without clearly describing how the cut-off is generated. Many users might welcome a clear distinction between high- and low-quality guidelines; specifying a cut-off for this purpose might be useful.

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INTRODUCTION: The Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument is the most commonly used guideline appraisal tool. It includes 23 appraisal criteria (items) organized within 6 domains and 2 overall assessments (1. overall guideline quality; 2. recommendation for use). The aim of this systematic review was twofold. Firstly, to investigate how often AGREE II users conduct the 2 overall assessments. Secondly, to investigate the influence of the 6 domain scores on each of the 2 overall assessments. MATERIALS AND METHODS: A systematic bibliographic search was conducted for publications reporting guideline appraisals with AGREE II. The impact of the 6 domain scores on the overall assessment of guideline quality was examined using a multiple linear regression model. Their impact on the recommendation for use (possible answers: "yes", "yes, with modifications", "no") was examined using a multinomial regression model. RESULTS: 118 relevant publications including 1453 guidelines were identified. 77.1% of the publications reported results for at least one overall assessment, but only 32.2% reported results for both overall assessments. The results of the regression analyses showed a statistically significant influence of all domains on overall guideline quality, with Domain 3 (rigour of development) having the strongest influence. For the recommendation for use, the results showed a significant influence of Domains 3 to 5 ("yes" vs. "no") and Domains 3 and 5 ("yes, with modifications" vs. "no"). CONCLUSIONS: The 2 overall assessments of AGREE II are underreported by guideline assessors. Domains 3 and 5 have the strongest influence on the results of the 2 overall assessments, while the other domains have a varying influence. Within a normative approach, our findings could be used as guidance for weighting individual domains in AGREE II to make the overall assessments more objective. Alternatively, a stronger content analysis of the individual domains could clarify their importance in terms of guideline quality. Moreover, AGREE II should require users to transparently present how they conducted the assessments.

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BACKGROUND: The use of comprehensive instruments for guideline appraisal is time-consuming and requires highly qualified personnel. Since practicing physicians are generally busy, the rapid-assessment Mini-Checklist (MiChe) tool was developed to help them evaluate the quality and utility of guidelines quickly. The aim of this study was to validate the MiChe in comparison to the AGREE II instrument and to determine its reliability as a tool for guideline appraisal. METHODS: Ten guidelines that are relevant to general practice and had been evaluated by 2 independent reviewers using AGREE II were assessed by 12 GPs using the MiChe. The strength of the correlation between average MiChe ratings and AGREE II total scores was estimated using Pearson's correlation coefficient. Inter-rater reliability for MiChe overall quality ratings and endorsements was determined using intra-class correlations (ICC) and Kendall's W for ordinal recommendations. To determine the GPs' satisfaction with the MiChe, mean scores for the ratings on five questions were computed using a six-point Likert scale. RESULTS: The study showed a high level of agreement between MiChe and AGREE II in the quality rating of guidelines (Pearson's r = 0.872; P < 0.001). Inter-rater-reliability for overall MiChe ratings (ICC = 0.755; P < 0.001) and endorsements (Kendall's W = 0.73; P < 0.001) were high. The mean time required for guideline assessment was less than 15 min und user satisfaction was generally high. CONCLUSIONS: The MiChe performed well in comparison to AGREE II and is suitable for the rapid evaluation of guideline quality and utility in practice. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00007480.

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BACKGROUND: Guidelines of high methodological quality make an essential contribution to the quality assurance of medical knowledge. The detailed evaluation of guideline quality is a complex and time-consuming task. The answers to a few key questions generally suffice for an initial, rapid assessment of the quality and utility of a guideline. METHOD: We selectively searched the pertinent literature for guideline-assessing instruments and analyzed selected ones with respect to their target group, purpose, orientation, and comprehensiveness. We identified key questions from brief instruments that can be used to assess guideline quality rapidly. RESULTS: A comparison of ten instruments revealed that most were designed to provide a highly detailed assessment of guideline quality. Four recently developed instruments enable a rough and rapid assessment. They focus, in essence, on four key questions: Was the evidence analyzed systematically? Does the evidence support the recommendations? Is the goal of the guideline formulated, and are the authors named? Is the organization of the guideline easy to follow, and are the recommendations clearly signposted? CONCLUSION: Alongside the comprehensive instruments for assessing guidelines, such as DELBI and AGREE II, rapid-assessment instruments are a convenient tool for gaining a quick impression of the value of a guideline.

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UNLABELLED: Guideline synopses, i.e. the systematic synthesis of clinical practice guidelines, are used as a basis for Disease Management Programmes (DMPs) in Germany. One of the responsibilities of the German Institute for Quality and Efficiency in Health Care (IQWiG) is the preparation of guideline synopses for DMPs. The article describes the experiences with this methodology. METHODS: For the preparation of guideline synopses, a systematic search for evidence-based guidelines is conducted, and their recommendations are extracted and synthesised. In parallel, the quality of the guidelines is assessed using the AGREE instrument. The need for updating or supplementing a DMP is justified by means of the Grade of Recommendation (GoR) or, alternatively, the Level of Evidence (LoE). EXPERIENCES: Since 2006 IQWiG has synthesised recommendations from 256 evidence-based guidelines in 12 guideline synopses for DMPs. The results are then used by the Federal Joint Committee (G-BA) to update DMPs. Using the example of the 12 synopses, several analyses were conducted. It was determined that a search for guidelines in guideline databases is sufficient and that a search in bibliographic databases can be dispensed with. Furthermore, the analyses showed that a large proportion of recommendations in evidence-based guidelines are not clearly linked to a GoR or LoE. If GoR and LoE are provided, only about 42% of recommendations with a strong GoR also refer to a strong LoE. It was also shown that only 21 % of the analysed guideline providers supplied information on the handling of unpublished data. With consistent average to high values, the assessment of the methodological quality across all of the prepared synopses allows for the conclusion of a basically acceptable guideline quality, but with a need for improvement. OUTLOOK: A guideline synopsis is an established tool for identifying health care standards as a basis for developing and updating DMPs. Further methodological development, particularly in collaboration with guideline providers, appears to be reasonable. It should be examined whether guideline synopses are suitable not only for guideline and DMP development, but also for other health care issues.

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BACKGROUND: To ensure that clinical practice guidelines (CPGs) form a sound basis for decision-making in health care, it is necessary to be able to reliably assess and ensure their quality. This results in the need to assess the content of guidelines systematically, particularly with regard to the validity of their recommendations.The aim of the present analysis was to determine the suitability and applicability of frequently used assessment tools for evidence syntheses with regard to the assessment of guideline content. METHODS: We conducted a systematic comparison and analysis of established tools for the assessment of evidence syntheses (guidelines, systematic reviews, health technology assessments). The tools analyzed were: ADAPTE, AGREE II, AMSTAR, GLIA and the INAHTA checklist. We analyzed methodological steps related to the assessment of the reliability and validity of guideline recommendations. Data were extracted and analyzed by two persons independently of one another. RESULTS: Widely used tools for the methodological assessment of evidence syntheses are not suitable for a comprehensive content-related assessment. They remain mostly at the level of assessment of the documentation of processes. Some tools assess selected content-related aspects, but operationalization is either unspecific or lacking. CONCLUSION: None of the tools analyzed enables the structured and comprehensive assessment of the content of guideline recommendations with special regard to their reliability and validity. All tools contribute towards the judicious use of evidence syntheses by supporting their systematic development or assessment. However, further progress is needed, particularly with regard to the assessment of content quality. This includes comprehensive operationalization and documentation of the assessment process to ensure reliability and validity, and therefore to enable the effective use of trustworthy guidelines in the health care system.

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INTRODUCTION: Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools. METHODS: Among others we searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from 1995 to May 2011 for relevant primary and secondary publications. We also handsearched the reference lists of relevant publications. On the basis of the available literature we firstly generated 34 items to be used in the comparison of appraisal tools and grouped them into thirteen quality dimensions. We then extracted formal characteristics as well as questions and statements of the appraisal tools and assigned them to the items. RESULTS: We identified 40 different appraisal tools. They covered between three and thirteen of the thirteen possible quality dimensions and between three and 29 of the possible 34 items. The main focus of the appraisal tools were the quality dimensions "evaluation of evidence" (mentioned in 35 tools; 88%), "presentation of guideline content" (34 tools; 85%), "transferability" (33 tools; 83%), "independence" (32 tools; 80%), "scope" (30 tools; 75%), and "information retrieval" (29 tools; 73%). The quality dimensions "consideration of different perspectives" and "dissemination, implementation and evaluation of the guideline" were covered by only twenty (50%) and eighteen tools (45%) respectively. CONCLUSIONS: Most guideline appraisal tools assess whether the literature search and the evaluation, synthesis and presentation of the evidence in guidelines follow the principles of evidence-based medicine. Although conflicts of interest and norms and values of guideline developers, as well as patient involvement, affect the trustworthiness of guidelines, they are currently insufficiently considered. Greater focus should be placed on these issues in the further development of guideline appraisal tools.

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BACKGROUND: All major guidelines for antihypertensive therapy recommend weight loss; anti-obesity drugs might be a helpful option. PRIMARY OBJECTIVES: To assess the long-term effects of pharmacologically induced reduction in body weight with orlistat, sibutramine or rimonabant on:- all cause mortality - cardiovascular morbidity - adverse events SECONDARY OBJECTIVES: - changes in systolic and/or diastolic blood pressure - body weight reduction even though sibutramine and rimonabant have been withdrawn from the market. SEARCH METHODS: Studies were obtained from computerised searches of Ovid MEDLINE, EMBASE, CENTRAL and from hand searches in reference lists and systematic reviews (status as of 17(th) August, 2012). SELECTION CRITERIA: Randomized controlled trials in adult hypertensive patients with a study duration of at least 24 weeks comparing pharmacologic interventions (orlistat, sibutramine, rimonabant) for weight loss with placebo. DATA COLLECTION AND ANALYSIS: Two authors independently assessed risk of bias and extracted data. Studies were pooled using fixed-effect meta-analysis in the absence of significant heterogeneity between studies (p>0.1). Otherwise, we used the random effects method and investigated the cause of heterogeneity. MAIN RESULTS: After the updated literature search, the number of studies remained the same, with eight studies comparing orlistat or sibutramine to placebo fulfilling our inclusion criteria. No relevant studies investigating rimonabant for weight loss were identified. No study included mortality and cardiovascular morbidity as a pre-defined outcome. Incidence of gastrointestinal side effects was consistently higher in orlistat treated vs. placebo treated patients. Most frequent side effects with sibutramine were dry mouth, constipation and headache. Patients assigned to weight loss diets, orlistat or sibutramine reduced their body weight more effectively than patients in the usual care/placebo groups. Blood pressure reduction in patients treated with orlistat was for systolic blood pressure (SBP): weighted mean difference (WMD): -2.5 mm Hg; 95% CI, -4.0 to -0.9 mm Hg and for diastolic blood pressure (DBP): WMD -1.9 mm Hg; 95% CI, -3.0 to -0.9 mm Hg. Meta-analysis showed DBP increase under therapy with sibutramine: WMD +3.2 mm Hg; 95%CI +1.4 to +4.9 mm Hg. AUTHORS' CONCLUSIONS: In patients with elevated blood pressure, orlistat and sibutramine reduced body weight to a similar degree. In the same trials, orlistat reduced blood pressure and sibutramine increased blood pressure. No trials investigating rimonabant in people with elevated blood pressure could be included. Long-term trials assessing the effect of orlistat, sibutramine and rimonabant on mortality and morbidity are lacking. Rimonabant and sibutramine have been withdrawn from the market for the time being.

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BACKGROUND: All major guidelines for antihypertensive therapy recommend weight loss; anti-obesity drugs might be a helpful option. PRIMARY OBJECTIVES: To assess the long-term effects of pharmacologically induced reduction in body weight with orlistat, sibutramine or rimonabant on:- all cause mortality - cardiovascular morbidity - adverse events SECONDARY OBJECTIVES: - changes in systolic and/or diastolic blood pressure - body weight reduction SEARCH STRATEGY: Studies were obtained from computerised searches of Ovid MEDLINE, EMBASE, CENTRAL and from hand searches in reference lists and systematic reviews. SELECTION CRITERIA: Randomized controlled trials in adult hypertensive patients with a study duration of at least 24 weeks comparing pharmacologic interventions (orlistat, sibutramine, rimonabant) for weight loss with placebo. DATA COLLECTION AND ANALYSIS: Two authors independently assessed risk of bias and extracted data. Studies were pooled using fixed-effect meta-analysis in the absence of significant heterogeneity between studies (p>0.1). Otherwise, we used the random effects method and investigated the cause of heterogeneity. MAIN RESULTS: Eight studies comparing orlistat or sibutramine to placebo fulfilled our inclusion criteria. No relevant studies investigating rimonabant for weight loss were identified. No study included mortality and cardiovascular morbidity as a pre-defined outcome. Incidence of gastrointestinal side effects was consistently higher in orlistat treated vs. placebo treated patients. Most frequent side effects with sibutramine were dry mouth, constipation and headache. Patients assigned to weight loss diets, orlistat or sibutramine reduced their body weight more effectively than patients in the usual care/placebo groups. Blood pressure reduction in patients treated with orlistat was for systolic blood pressure (SBP): weighted mean difference (WMD): -2.5 mm Hg; 95% CI, -4.0 to -0.9 mm Hg and for diastolic blood pressure (DBP): WMD -1.9 mm Hg; 95% CI, -3.0 to -0.9 mm Hg. Meta-analysis showed DBP increase under therapy with sibutramine: WMD +3.2 mm Hg; 95%CI +1.4 to +4.9 mm Hg. AUTHORS' CONCLUSIONS: In patients with elevated blood pressure, orlistat and sibutramine reduced body weight to a similar degree. In the same trials, orlistat reduced blood pressure and sibutramine increased blood pressure. No trials investigating rimonabant in people with elevated blood pressure could be included. Long-term trials assessing the effect of orlistat, sibutramine and rimonabant on mortality and morbidity are needed.

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Weight loss is recommended in all major guidelines for antihypertensive therapy. We searched for randomized controlled trials investigating the effects of weight-reducing diets, pharmacologic substances, and invasive interventions for weight reduction on patient-relevant end points and blood pressure (BP) in patients with essential hypertension. No information on the effects on patient-relevant end points was available. Patients assigned to weight loss diets, orlistat, or sibutramine reduced their body weight more effectively than did patients in the usual care/placebo groups. Reduction of BP was higher in patients treated with weight loss diets (systolic BP [SBP]: weighted mean difference [WMD], -6.3 mm Hg; diastolic BP [DBP]: WMD, -3.4 mm Hg) or orlistat (SBP: WMD, -2.5 mm Hg; DBP: WMD, -2.0 mm Hg). Systolic BP increased with sibutramine treatment (WMD, 3.2 mm Hg). In patients with essential hypertension, therapy with a weight loss diet or orlistat resulted in reductions in body weight and BP. Although sibutramine treatment reduced body weight, it did not lower BP.

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