Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers.

BACKGROUND: People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers' perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers' perspective in Germany. METHODS: Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring's qualitative content analysis with MAXQDA software was utilised to analyse the data. RESULTS: A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants' trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients' knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician-patient talks. Healthcare provider's unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. CONCLUSION: Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician-patient communication.

Barriers and facilitators in developing patient versions of clinical practice guidelines - qualitative interviews on experiences of international guideline producers.

BACKGROUND: Several guideline organizations produce patient versions of clinical practice guidelines (PVGs) which translate recommendations into simple language. A former study of our working group revealed that few guideline organizations publish their methods used to develop PVGs. Clear definitions of PVGs do not prevail and their purposes often remain unclear. We aimed to explore experts' perspectives on developing, disseminating and implementing PVGs to discuss and incorporate these experiences when consenting on methodological guidance and further improving PVGs. METHODS: We conducted 17 semi-structured telephone interviews with international experts working with PVGs from September 2021 through January 2022. We conducted the interviews in English or German, they were recorded and transcribed verbatim. We utilized Mayring's qualitative content analysis with MAXQDA software to analyze the data. RESULTS: In two interviews two participants were interviewed at the same time. This resulted in a total of 19 participants from 16 different organizations and eight different countries participated. Most were female (16/19) and their experience in working with PVGs ranged from 1 to 20 years. All follow methodological standards when developing PVGs, but the extent of these standards and their public accessibility differs. Aims and target groups of PVGs vary between organizations. Facilitators for developing PVGs are working with a multidisciplinary team, financial resources, consultation processes and a high-quality underlying CPG. Facilitators for disseminating and implementing PVGs are using various strategies. Barriers, on the other hand, are the lack of these factors. All participants mentioned patient involvement as a key aspect in PVG development. CONCLUSION: The steps in the PVG development process are largely similar across the countries. Focus is placed on the involvement of patients in the development process, although the extent of participation varies. The experts collectively attribute great importance to PVGs overall, but in order to constantly adapt to medical progress and changing conditions, the focus in the future may be more on formats like living guidelines. Although there are different views on the mandatory development of PVGs, there is a consistent call for more transparency regarding the methodology used for PVGs.

[Are the assessments of individual out-of-pocket health services of the IGeL-Monitor in line with clinical guidelines?] / Stehen die Bewertungen von Individuellen Gesundheitsleistungen (IGeL) des IGeL-Monitors im Einklang mit Leitlinien?

OBJECTIVES: The IGeL-Monitor of the Federal Medical Advisory Service in Germany evaluates the benefits and harms of individual out-of-pocket health services (in German: Individuelle Gesundheitsleistungen / IGeL). The aim of the analysis was to systematically compare IGeL-assessements with the recommendations from evidence-based guidelines. METHOD: To identify guidelines, we conducted searches in guidelines databases (AWMF, Guidelines International Network and Trip database) and the websites of guideline organisations (February/March 2022). We included guidelines that were not older than 5 years. The methodological quality of the guidelines was assessed using the AGREE II instrument. We compared the recommendations with the IGeL-assessments in terms of content and grade of recommendation. RESULTS: We identified 41 guidelines covering 24 IGeL-assessements. 19 (79%) assessments (nearly) were in agreement with the guideline recommendations. No comparison was possible for 5 IGeL-assessements, because, for example, the recommendations were more specific. Ten of the 13 IGeL that were rated (tendentially) negatively were also not recommended in the guidelines. CONCLUSION: Overall, the IGeL-assessments were consistent with the recommendations of current guidelines. Accordingly, guideline groups seem to assess the evidence similarly to the IGeL-Monitor team. Insured persons should be informed honestly about the evidence, particularly for the (tendentially) negatively evaluated IGeL that are not recommended even in guidelines.

Heterogeneous methodology in the development of patient versions of clinical practice guidelines: a scoping review.

OBJECTIVES: We aimed to gain an overview of the methods and approaches used to develop, disseminate, and implement patient versions of clinical practice guidelines (PVGs). METHODS: We searched PubMed and MEDLINE through Ovid for articles reporting on the development, dissemination, or implementation of PVGs until March 2022. We searched the homepages of guideline organizations, screened the reference lists of the included documents, and asked experts to complement the publications. We narratively synthesized the findings. RESULTS: Of 3,941 publications screened, 27 were included in the study. The identified method reports focused on patient involvement and peer-review processes. The other included publications highlighted the relevance of broad dissemination strategies and emphasized the importance of patient involvement and improving the readability of PVGs by using lay terms and shorter sentences. CONCLUSION: The terminology used for PVGs varies widely. The extent to which the methods were described was heterogeneous. Organizations developing PVGs should make their methods publicly available and use uniform labeling for PVGs in English to improve their use and recognition, not only for other PVG producers but also for patients and the public. A consensus regarding a minimum reporting standard for developing PVGs internationally and developing guiding principles is desirable.

An adapted 'Ottawa' method allowed assessing the need to update topic areas within clinical practice guidelines.

OBJECTIVES: To adapt and evaluate a method for assessing the need to update guideline topic areas involving multiple recommendations. STUDY DESIGN AND SETTING: The 'Ottawa method' uses literature signals to determine changes in evidence that trigger a need to update individual guideline questions. We adapted the Ottawa method to include a process for aggregating updating signals by topic area (e.g., resuscitation) and tested this method using the German guideline on the treatment of patients with severe/multiple injuries. This involved a focused systematic evaluation of current evidence to identify updating signals and classifying the need to update for each topic area. Then, we surveyed the guideline group online about the modified method. RESULTS: We conducted focused literature searches for 37 topic areas and screened a mean of 97 abstracts per topic area in 2021. The need to update was high for eight (21.6%), intermediate for eight (21.6%), and low for 21 topic areas (56.8%) based on updating signals. The survey response rate was 56% (24/43). Most guideline group members (94%, 16/17 responders) would use the Ottawa method again but their comments identified some weaknesses. CONCLUSION: The modified Ottawa method is a suitable, efficient tool to generate evidence-based updating signals for guideline topic areas involving multiple recommendations. Further fine-tuning is recommended.

Investigating the role and applicability of patient versions of guidelines in oncology and deriving recommendations for the development, dissemination and implementation of patient versions in Germany: protocol for multiphase study.

INTRODUCTION: The German Guideline Program in Oncology (GGPO) has published patient versions of clinical practice guidelines for more than 10 years. However, a systematic evaluation of these is lacking. The project aims to investigate the role and applicability of patient versions by considering the perspectives of experts, patients and healthcare providers to derive recommendations for the development, dissemination and implementation of patient versions in Germany. METHODS AND ANALYSIS: The project comprises two main modules. In module 1, we will first obtain information on methods and approaches for the development, dissemination and implementation of patient versions by conducting systematic searches in Medline and screening the websites of guideline organisations. We will include any articles, such as methodological or empirical reports, published in German or English since 2000, that address methodological aspects related to patient versions. Further, we will conduct 20 interviews with experts from international and German organisations who are involved in the development of patient versions. In module 2, we will first conduct interviews to explore patients and healthcare providers' perceptions of patient versions of the GGPO. For the group of patients and the group of healthcare providers, we aim to conduct 25 interviews each. Second, we will conduct focus groups, separately for breast, prostate and colon cancer. The recruitment of participants for the interviews and focus groups will primarily be done through a previous survey about patient versions in oncology. The results will be used to derive recommendations for enhancing the development, dissemination and implementation of patient versions by involving the relevant stakeholder groups. ETHICS AND DISSEMINATION: Ethical approval for the qualitative parts of the project was given by the Ethics Committee of Witten/Herdecke University (number 160/2021). Participants will be required to provide informed consent. The project findings will be published in peer-reviewed journals and presented at scientific conferences.

[German-language translation of the PANELVIEW instrument to evaluate the guideline development process from the perspective of the guideline group]. / Deutschsprachige Übersetzung des PANELVIEW Instruments zur Evaluierung des Prozesses der Leitlinienentwicklung aus der Perspektive der Leitliniengruppe.

INTRODUCTION: The development process for clinical guidelines is influenced by factors that are relevant to the validity of a guideline but often are not captured sufficiently in the final guideline documents. PANELVIEW is an English-language tool that can be used to explore the guideline development process from the perspective of guideline group members. Our aim was to translate the PANELVIEW tool into German, taking into account national contexts and linguistic differences. METHODS: The PANELVIEW tool was initially translated by a core team, then refined and approved by a group of experts in a consensus-based Delphi process. The experts were selected on the basis of their experience in guideline development covering different fields (clinical, methodological, organisational, health professional, patient perspective) and geographical regions (Germany, Austria, Switzerland). A representative of the original PANELVIEW team was also involved. The Delphi steps included an online survey, an online consensus conference and final approval by circulating the results via email. Individual items were seen as generally agreed upon if the level of agreement in the respective steps was 75 % or more. RESULTS: The expert group consisted of 12 persons. Of these, 11 (92 %) participated in the online survey and 10 (83 %) in the subsequent consensus conference. After the first Delphi step, sufficient agreement was achieved for 19 of 34 items (56 %). The remaining 15 items were discussed in the consensus conference and finally obtained 100 % agreement. The discussion focused on clarifying and adapting terms whose meaning was ambiguous or inadequate in the German context, which led to a deviation from the original wording in some instances. DISCUSSION: The PANELVIEW tool was translated into German by means of a Delphi process. PANELVIEW complements existing instruments for assessing the methodological quality of guidelines by capturing the perspective of the guideline group. This will enable guideline developers and organisations to identify problems in the drafting process and avoid them in future projects. User testing and validation of the German-language PANELVIEW tool are planned for the future. CONCLUSION: The German-language translation of PANELVIEW will enable guideline developers in German-speaking countries to continuously evaluate and, where necessary, improve the process and methods of guideline development.

International experiences in the development and implementation of guideline-based quality indicators: a qualitative study.

OBJECTIVES: Evidence-based clinical guidelines play an important role in healthcare and can be a valuable source for quality indicators (QIs). However, the link between guidelines and QI is often neglected and methodological standards for the development of guideline-based QI are still lacking. The aim of this qualitative study was to get insights into experiences of international authors with developing and implementing guideline-based QI. SETTING: We conducted semistructured interviews via phone or skype (September 2017-February 2018) with guideline authors developing guideline-based QI. PARTICIPANTS: 15 interview participants from eight organisations in six European and North American countries. METHODS: Organisations were selected using purposive sampling with a maximum variation of healthcare settings. From each organisation a clinician and a methodologist were asked to participate. An interview guide was developed based on the QI development steps according to the 'Reporting standards for guideline-based performance measures' by the Guidelines International Network. Interviews were analysed using qualitative content analysis with deductive and inductive categories. RESULTS: Interviewees deemed a programmatic approach, involvement of representative stakeholders with clinical and methodological knowledge and the connection to existing quality improvement strategies important factors for developing QI parallel to or after guideline development. Methodological training of the developing team and a shared understanding of the QI purpose were further seen conducive. Patient participation and direct patient relevance were inconsistently considered important, whereas a strong evidence base was seen essential. To assess measurement characteristics interviewees favoured piloting, but often missed implementation. Lack of measurability is still experienced a serious limitation, especially for qualitative aspects and individualised care. CONCLUSION: Our results suggest that developing guideline-based QI can succeed either parallel to or following the guideline process with careful planning and instruction. Strategic partnerships seem key for implementation. Patient participation and relevance, measurement of qualitative aspects and piloting are areas for further development. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00013006).

[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

Correction to: Guideline-based quality indicators-a systematic comparison of German and international clinical practice guidelines.

An amendment to this paper has been published and can be accessed via the original article.

Quality and risk of bias appraisals of systematic reviews are inconsistent across reviewers and centers.

OBJECTIVE: The objective of the study was to evaluate the inter-rater and intercenter reliability, usability, and utility of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS). STUDY DESIGN AND SETTING: This is a prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centers. RESULTS: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (interquartile range) 15.7 (11.3), 19.7 (12.1), and 28.7 (17.4) minutes and reached consensus in 2.6 (3.2), 4.6 (5.3), and 10.9 (10.8) minutes, respectively. Across all centers, inter-rater reliability was substantial to almost perfect for 8/11 AMSTAR, 9/16 AMSTAR 2, and 12/24 ROBIS items. Intercenter reliability was substantial to almost perfect for 6/11 AMSTAR, 12/16 AMSTAR 2, and 7/24 ROBIS items. Intercenter reliability for confidence in the results of the review or overall risk of bias was moderate (Gwet's first-order agreement coefficient (AC1) 0.58, 95% confidence intervals [CI]: 0.30 to 0.85) to substantial (AC1 0.74, 95% CI: 0.30 to 0.85) for AMSTAR 2 and poor (AC1 -0.21, 95% CI: -0.55 to 0.13) to moderate (AC1 0.56, 95% CI: 0.30 to 0.83) for ROBIS. It is not clear whether using the appraisals of any tool as an inclusion criterion would alter an overview's findings. CONCLUSIONS: Improved guidance may be needed to facilitate the consistent interpretation and application of the newer tools (especially ROBIS).

Methodological Quality of Physical Therapy Guidelines and Their Suitability for Adaptation: A Scoping Review.

OBJECTIVE: Clinical practice guidelines (CPGs) can be characterized to the extent that they specifically address physical therapists and mainly contain recommendations for physical therapist interventions. The primary aim of this study was to identify existing physical therapy CPGs regardless of medical condition, with a secondary aim of assessing their methodological quality to determine whether they are potentially suitable for adaptation. METHODS: Systematic searches of the Medline and Physiotherapy Evidence Database were performed (August 2019), and the websites of World Confederation for Physical Therapy members were screened (September 2019). Only CPGs published in German or English were included. Two independent reviewers screened records according to previously defined inclusion criteria. Information was extracted regarding country of origin, year of publication, and clinical subject area addressed. Four independent reviewers assessed the quality of physical therapy CPGs using the Appraisal of Guidelines Research and Evaluation instrument. A descriptive data analysis was performed. RESULTS: Thirty-five CPGs met the inclusion criteria; 46% (16/35) of the included CPGs were from the United States, and 31% (11/35) were from the Netherlands. Assessment using the Appraisal of Guidelines Research and Evaluation tool resulted in the following domain scores, presented as median percentage (interquartile range): domain 1 (scope and purpose), 76 (63-92); domain 2 (stakeholder involvement), 63 (55-76); domain 3 (rigor of development), 67 (53-75); domain 4 (clarity of presentation), 74 (67-77); domain 5 (applicability), 44 (30-57); and domain 6 (editorial independence), 52 (35-66). CONCLUSIONS: In general, the methodological quality of the included CPGs was moderate to good. Possibilities of adapting recommendations from existing CPGs should be considered with the development of new physical therapy CPGs. IMPACT STATEMENT: This study can raise awareness of existing physical therapy CPGs and can support their application by physical therapists. Further, the study can support decisions on adapting existing CPGs with the planning of new physical therapy CPGs.

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials.

RATIONALE & OBJECTIVE: The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. STUDY DESIGN: Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. SETTING & STUDY POPULATIONS: Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. SELECTION CRITERIA FOR STUDIES: Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. DATA EXTRACTION: 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. ANALYTIC APPROACH: Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. RESULTS: 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, -40.84 [95% CI, -48.09 to-33.59] g/long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (-0.50 [95% CI, -1.19 to 0.18] mmol/L; low certainty) and hemoglobin A1c levels (-0.14% [95% CI, -0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. LIMITATIONS: Trial quality was variable. The follow-up period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. CONCLUSIONS: Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and cost-effectiveness associated with icodextrin is needed.

[(How) Are quality indicators for measuring and appraising the quality of healthcare derived from evidence-based clinical practice guidelines? A review]. / (Wie) Erfolgt die Ableitung von Qualitätsindikatoren zur Messung und Bewertung der Versorgungsqualität im Rahmen von S3-Leitlinien? Eine Übersichtsarbeit.

BACKGROUND: Evidence-based and formally consensus-based clinical practice guidelines (CPGs) offer potential for the development of quality indicators (QIs). Although QIs are recommended as part of some CPGs, there is no accepted gold standard for the specific development process of guideline-based QIs. The purpose of this review, which is embedded in a mixed-methods research project, was to analyze the current state of methodological approaches for QI development in German CPGs to derive insights for the development of a national evidence-guided and consensus-based standard for guideline-based development of QIs. METHODS: In order to identify valid CPGs containing recommendations for QIs, a search was carried out (July 31, 2016) via the guideline database of the German Association of the Scientific Medical Societies (AWMF). Based on a stratified random sample per guideline program (guidelines published by medical societies, National Program for Disease Management Guidelines (DMG), and the German Guideline Program in Oncology [GGPO]), 11 CPGs were selected. With regard to QIs, the specific development methodology, indications on their psychometric properties and how the quality of care should be examined by recommended QIs were extracted and compared by using the guideline documents. RESULTS: In 35 of the 109 (16/85 medical societies, 4/8 DMG, 15/16 GGPO) (32 %) valid CPGs, a total of 372 QIs were recommended. Based on 11 randomly selected guidelines (5 published by medical societies, 1 DMG, 5 GGPO; a total of 109 QIs), the QI development methodology was inconsistent in all five medical societies guidelines (including QI presentation, usage and selection of guideline recommendations for QI derivation) compared to DMG and GGPO. Based on all 109 QIs, 2 (2 %) were presented as a quantitative measure with a reference range, and quality objectives were formulated for 17 (16 %). There was no guideline explicitly reporting about the results of a pilot study or data-based analysis of the psychometric properties of the recommended QIs. The GGPO guideline documents were the only ones providing information on the assessment of the quality of care based on recommended QIs. DISCUSSION: The usage of the QI manuals of the DMG and GGPO leads to a largely standardized development of guideline-based QIs. In the CPGs of the medical societies - if at all - QIs are developed inconsistently and mostly unsystematically. Due to largely missing reference ranges and quality objectives, the identified QIs cannot yet be used to transparently identify potential quality deficits in health care. This requires results of pilot studies and further development of guideline-based QI. CONCLUSIONS: A standard for QI development is needed for German guideline authors to seize the opportunity and develop clinically relevant, widely accepted and evidence-based QIs in the guideline development process. In addition, it must be ensured that appropriate structures are used or set up in order to be able to apply the recommended QIs in the German healthcare system.

[Development of guideline-based quality indicators: a qualitative study on barriers and facilitating factors from the perspective of S3-guideline authors]. / Entwicklung leitlinienbasierter Qualitätsindikatoren: eine qualitative Studie zu Barrieren und förderlichen Faktoren aus der Sicht von S3-LeitlinienautorInnen.

BACKGROUND: Evidence-based and formally consensus-based clinical practice guidelines (S3-CPGs) are a valuable source for the development of quality indicators (QIs) in Germany. While deriving QIs from guideline recommendations is a mandatory part of the development of S3-CPGs within the National Program for Disease Management Guidelines (DMGP) and the German Guideline Program in Oncology (GGPO), there is no such obligation in the guideline program of the Association of the Scientific Medical Societies in Germany (AWMF) (MS program). Despite that, several S3-CPGs in the MS program have been published with QIs in the last years while some DMGP and one GGPO S3 guidelines have failed to meet this requirement. From the perspective of the guideline authors of all three mentioned programs, the present qualitative study examined why S3-CPGs do or do not contain QIs and explored the factors perceived by authors as either facilitating or hampering in the QI development process. METHODS: Semi-structured interviews were conducted with authors of 22 S3-CPGs, 11 of which represented guidelines containing QIs and 11 of which represented guidelines without QIs. Authors of guidelines containing QIs (n=11) were asked about the perceived decisive reasons for formulating QIs and about facilitators and barriers during the QI development process. Authors of guidelines without QIs (n=11) gave reasons for not formulating QIs. Interviews were analyzed using structuring qualitative content analysis. RESULTS: Within the MS program, not formulating QIs was mainly attributed to the lack of a mandatory requirement and to insufficient funding of guideline projects. Amongst DMGP authors, a low priority of QI development prevailed, which was, for example, due to already existing QIs or to their lacking implementation. In the GGPO guideline examined, not formulating QIs was due to the guideline topic (prevention) - for this topic, there was a lack of suitable evidence and data sources. If QIs were developed, the most important facilitating factor in the development process, across all programs, was the methodological support provided by the guideline program. Important hampering factors included the additional time required for QI development and concerns regarding the implementation of many potential QIs, especially due to a lack of data availability. DISCUSSION: For regular development of QIs within S3-CPG projects, the incorporation of such a requirement in the guideline program is a necessary, but not a sufficient, condition. Other pivotal factors include systematic methodological support, adequate financial and staff resources and the perceived meaningfulness and relevance of guideline-based QI development, measured in terms of the actual implementation of already existing QIs. CONCLUSION: The study reveals starting points for measures to strengthen the consideration of QI development in German S3-CPG projects, especially within the MS program. Without substantial structural changes, especially of the resources of guideline groups, and without an overall concept covering the entire process from QI development to QI implementation, guideline-based QI development will remain heavily dependent on the (self-)motivation of guideline groups.

[Increasing the efficiency of guideline production: a narrative review]. / Effizientere Leitlinienerstellung ­ eine narrative Übersichtsarbeit.

BACKGROUND: The development of high-quality clinical practice guidelines is laborious and time-consuming. New methods have become available to streamline this process. However, the awareness of these methods should be improved. METHODS: Selective literature search in PubMed/MEDLINE und Embase. RESULTS: Simple tools such as surveys or voting systems can facilitate the organization, planning and communication. Adequate methods should be used to prioritize all potential questions that should be addressed in the guideline. Published or ongoing international guidelines and systematic reviews can be used meaningfully for the planned guideline. In the case of guideline updates, it should be determined whether all parts of the guideline require an update of the evidence. The need for an update should be investigated. The concept of living guidelines has the biggest potential to provide gains in efficiency. Living guidelines are continuously updated based on new evidence instead of being regularly updated at a predefined time. CONCLUSIONS: New methods allowing for more efficient guideline production have been developed and, in part, already been introduced. Before starting with the production of a guideline (or its update), the potential advantages and disadvantages/risks of the corresponding methods should be balanced.

Guideline-based quality indicators-a systematic comparison of German and international clinical practice guidelines.

BACKGROUND: Evidence-based clinical practice guidelines (CPGs) are relevant sources for generating quality indicators (QIs). The objective of this study was to compare guideline-based QIs of German and international CPGs and their underlying methodological approaches. METHODS: We conducted systematic searches in the guideline databases of G-I-N (Guidelines International Network) and NGC (National Guideline Clearinghouse) between February and June 2017 to identify international CPGs matching the topics of German evidence-based CPGs (n = 35) that report QIs, which were identified in a preceding study. Additionally, we searched the websites of the particular CPG providers for separate documents with regard to QIs. We included evidence-based CPGs which report QIs. Reported QIs, the underlying guideline recommendations, and information on methods of development were extracted. The selection and extraction of CPGs were conducted by one reviewer and checked by another. For each matched pair of CPGs, we assessed whether the suggested QIs matched or were not directly comparable. RESULTS: Twenty-five international CPGs, originating from seven CPG providers in total, met the criteria for inclusion. They matched the topics of 18 German CPGs. This resulted in 30 CPG pairs for the comparison of QIs (some of the international CPGs matched the topic of more than one German CPG). We found 27 QI pairs with QIs "not different or slightly different", corresponding to 13% (27 of 212) of the QIs in German CPGs and 16% (27 of 166) in international CPGs. Only two QI pairs were judged to be "different/inconsistent". For 183 of 212 (86%) QIs from German CPGs and 137 of 166 (83%) QIs from international CPGs, no direct comparison could be made. An explicit link to one or more guideline recommendations was found for 136 of 152 (89%) QIs from German CPGs and 82 of 166 (49%) QIs from international CPGs. Some information on methods for the development of QIs existed for 12 of 18 (67%) German CPGs and 8 of 25 (32%) international CPGs. CONCLUSIONS: The majority of QIs in German and international CPGs were not comparable. Various reasons for this are conceivable. More transparent reporting of the underlying methods for generating guideline-based QIs is needed.

The role of icodextrin in peritoneal dialysis: protocol for a systematic review and meta-analysis.

BACKGROUND: Previous meta-analyses have found several advantages of icodextrin compared with glucose in the application of peritoneal dialysis (PD), such as an improvement of peritoneal ultrafiltration during the long dwell and a reduction in episodes of uncontrolled fluid overload. However, the effect of icodextrin on patient-relevant outcomes remains unclear. This review aims to evaluate the benefits and harms of icodextrin in comparison with conventional glucose PD solution in patients with end-stage kidney disease receiving PD. METHODS: Randomized controlled trials of icodextrin comparing with conventional glucose solution in patients with end-stage kidney disease who received PD will be deemed eligible. We will conduct systematic searches in MEDLINE, EMBASE, CENTRAL, Ichushi-Web, Chinese and Japanese databases, and in clinical trials registries (ClinicalTrials.gov, International Clinical Trials Registry Platform Search Portal (ICTRP), EU Clinical Trials Register, Japan Registries Network (JPRN), China's Clinical Trial Registry (ChiCTR)). Furthermore, we will check conference proceedings and search references from relevant studies manually. Relevant pharmaceutical companies, authors, and experts will be contacted in an effort to identify further studies. We will not apply any limitations regarding language, publication status, and publication date when searching for eligible studies. The selection of studies, data extraction, and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan 5 software with either a fixed effects model or random-effects model, depending on the presence of heterogeneity. For the assessment of statistical heterogeneity, I2 will be calculated. Sources of clinical heterogeneity will be evaluated through subgroup analyses. If there are ten or more studies included in the meta-analysis, we will investigate the publication bias using funnel plots and Egger's test. The quality of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. DISCUSSION: We assume that our systematic review will be more comprehensive compared to those published previously due to contacting the relevant pharmaceutical companies and a systematic search of published and unpublished non-English studies from China, Taiwan, and Japan. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096951.

Evaluation of the reliability, usability, and applicability of AMSTAR, AMSTAR 2, and ROBIS: protocol for a descriptive analytic study.

BACKGROUND: Systematic reviews (SRs) of randomised controlled trials (RCTs) can provide the best evidence to inform decision-making, but their methodological and reporting quality varies. Tools exist to guide the critical appraisal of quality and risk of bias in SRs, but evaluations of their measurement properties are limited. We will investigate the interrater reliability (IRR), usability, and applicability of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS) for SRs in the fields of biomedicine and public health. METHODS: An international team of researchers at three collaborating centres will undertake the study. We will use a random sample of 30 SRs of RCTs investigating therapeutic interventions indexed in MEDLINE in February 2014. Two reviewers at each centre will appraise the quality and risk of bias in each SR using AMSTAR, AMSTAR 2, and ROBIS. We will record the time to complete each assessment and for the two reviewers to reach consensus for each SR. We will extract the descriptive characteristics of each SR, the included studies, participants, interventions, and comparators. We will also extract the direction and strength of the results and conclusions for the primary outcome. We will summarise the descriptive characteristics of the SRs using means and standard deviations, or frequencies and proportions. To test for interrater reliability between reviewers and between the consensus agreements of reviewer pairs, we will use Gwet's AC1 statistic. For comparability to previous evaluations, we will also calculate weighted Cohen's kappa and Fleiss' kappa statistics. To estimate usability, we will calculate the mean time to complete the appraisal and to reach consensus for each tool. To inform applications of the tools, we will test for statistical associations between quality scores and risk of bias judgments, and the results and conclusions of the SRs. DISCUSSION: Appraising the methodological and reporting quality of SRs is necessary to determine the trustworthiness of their conclusions. Which tool may be most reliably applied and how the appraisals should be used is uncertain; the usability of newly developed tools is unknown. This investigation of common (AMSTAR) and newly developed (AMSTAR 2, ROBIS) tools will provide empiric data to inform their application, interpretation, and refinement.

A systematic decision-making process on the need for updating clinical practice guidelines proved to be feasible in a pilot study.

OBJECTIVES: The objective of this study was to test and evaluate a new decision-making process on the need for updating within the update of a German clinical practice guideline (CPG). STUDY DESIGN AND SETTING: The pilot study comprised (1) limited searches in Pubmed to identify new potentially relevant evidence, (2) an online survey among the members of the CPG group to assess the need for update, and (3) a consensus conference for determination and prioritization of guideline sections with a high need for update. Subsequently, we conducted a second online survey to evaluate the procedure. RESULTS: The searches resulted in 902 abstracts that were graded as new potentially relevant evidence. Twenty five of 39 members of the CPG group (64%) participated in the online survey. Seventy six percent of those took part in the second online survey. The evaluation study found on average a grade of support of the procedure regarding the determination of the need for update of 3.65 (standard deviation: 0.76) on a likert scale with 1 = "no support" to 5 = "very strong support." CONCLUSION: The conducted procedure presents a systematic approach for assessing whether and to what extent a CPG requires updating and enables setting priorities for which particular guideline section to update within a CPG.