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.

Prehospital management of chest injuries in severely injured patients-a systematic review and clinical practice guideline update.

PURPOSE: Our aim was to review and update the existing evidence-based and consensus-based recommendations for the management of chest injuries in patients with multiple and/or severe injuries in the prehospital setting. This guideline topic is part of the 2022 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries. METHODS: MEDLINE and Embase were systematically searched to May 2021. Further literature reports were obtained from clinical experts. Randomised controlled trials, prospective cohort studies, cross-sectional studies, and comparative registry studies were included if they compared interventions for the detection and management of chest injuries in severely injured patients in the prehospital setting. We considered patient-relevant clinical outcomes such as mortality and diagnostic test accuracy. Risk of bias was assessed using NICE 2012 checklists. The evidence was synthesised narratively, and expert consensus was used to develop recommendations and determine their strength. RESULTS: Two new studies were identified, both investigating the accuracy of in-flight ultrasound in the detection of pneumothorax. Two new recommendations were developed, one recommendation was modified. One of the two new recommendations and the modified recommendation address the use of ultrasound for detecting traumatic pneumothorax. One new good (clinical) practice point (GPP) recommends the use of an appropriate vented dressing in the management of open pneumothorax. Eleven recommendations were confirmed as unchanged because no new high-level evidence was found to support a change. CONCLUSION: Some evidence suggests that ultrasound should be considered to identify pneumothorax in the prehospital setting. Otherwise, the recommendations from 2016 remained unchanged.

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.

[Quality of life of ostomates in Germany]. / Lebensqualität von Menschen mit einem künstlichen Darmausgang in Deutschland.

BACKGROUND: The presence of an ostomy may have a serious impact on the quality of life (QoL). The aim of this study was to evaluate the QoL of ostomates in Germany. METHOD: An online survey was performed using the validated Gastrointestinal Quality of Life Index (GIQLI) by Eypasch et al. Ostomates ≥ 18 yrs. with an ostomy duration ≥ 3 months were eligible to participate. RESULTS: Completed questionnaires from 519 participants (79.3 % female) with a median age of 50 yrs. (range 19-83 yrs.) and a median ostomy duration of 3 yrs. (range 3 months-58 yrs.) were analyzed. The most common indications for an ostomy were Crohn's disease (36.5 %), colorectal cancer (19.8 %) and ulcerative colitis (18.2 %). The mean GIQLI-Score in the study population was 94.8 ± 24.6, with higher scores corresponding with better QoL and healthy individuals reach 125.8. Limitations were recorded with regard to sleep, tiredness, energy level, endurance, fitness and sexuality. Individuals with a stoma due to Colitis (103,0 ± 24,5), colorectal cancer (99,2 ± 21,7) and Crohn's (95,0 ± 22,8) had the highest mean GIQLI-scores amongst all ostomates. DISCUSSION: The findings of this study confirm that ostomates have a reduced QoL compared to the healthy population. Amongst all ostomates, those with colitis, colorectal cancer and Crohn's have a better QoL compared to ostomy carriers with other diagnoses.

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.

Information needs of patients undergoing bariatric surgery in Germany: a qualitative study.

BACKGROUND: Obesity is a worldwide problem with different treatment options. Bariatric surgery is an effective treatment for severe obesity; however, it leads to drastic changes (e.g., changes in everyday life and eating behavior) for patients, which may lead to information needs. Our aim was to identify the information needs of patients undergoing bariatric surgery and to explore the information provision within the healthcare process of bariatric surgery in Germany. METHODS: We conducted a qualitative study (n = 14 single, semi-structured telephone interviews) between April 2018 and April 2019. The interview guide was designed prior to the interviews and consisted of four main sections (demographic information, pre-/postoperative healthcare provision, information needs). The interviews were transcribed verbatim and analyzed using qualitative content analysis with MAXQDA software. RESULTS: There were unmet information needs with two factors (time: pre/postoperative and categories of information: general/specific) to be considered. Due to the patients' description of information, we categorized information into general (different surgical procedures, general nutritional information) and specific (occurring simultaneously with a problem) information. Most patients felt well informed concerning general information. However, it was pointed out that it was not possible to provide complete information preoperatively, as the need for information only arises when there are postoperative (specific) problems. In addition, there seems to be a high demand for specific postoperative information regarding nutrition and nutrition-related problems. However, patients stated that postoperative nutritional counseling is not reimbursed by health insurance funds. The information conveyed in support groups and the exchange of experiences are highly valued by patients. However, some patients describe the information provided within the support groups as unfiltered, frightening or exaggerated. CONCLUSION: Overall, there were unmet information needs. Reimbursement by health insurance funds could increase the use of postoperative nutritional counseling and thus serve existing information needs. Support groups enable an exchange of experiences and therefore offer low-barrier access to information. Cooperation between support groups and healthcare professionals in information provision could be an approach to improving existing information needs or to avoiding the development of information gaps. Furthermore, the development and implementation of a digital solution for (postoperative) information dissemination could be helpful.

The effect of preoperative stoma site marking on risk of stoma-related complications in patients with intestinal ostomy - A systematic review and meta-analysis.

AIM: This systematic review and meta-analysis aimed to investigate the effect of preoperative stoma site marking on stoma-related complications in patients with intestinal ostomy. METHODS: MEDLINE, Embase, CENTRAL, CINHAL, and Google Scholar were searched up to August 2021 for randomised controlled trials (RCTs) and nonrandomised studies of interventions (NRSI) that involved patients with intestinal ostomies comparing preoperative stoma site marking to no marking and which reported at least one patient-relevant outcome. Outcomes were prioritised by stakeholder involvement. Random-effects meta-analyses produced odds ratios (ORs) or standardised mean differences (SMD) and 95% confidence intervals (CIs). The ROBINS-I tool and the GRADE approach were used to assess the risk of bias and certainty of evidence, respectively. RESULTS: This review included two RCTs and 25 NRSI. The risk of bias was high in RCTs and serious to critical in NRSI. Although preoperative site marking reduced stoma-related complications (OR: 0.45, 95% CI: [0.31-0.65]), dependence on professional or unprofessional care (narrative synthesis), and increased health-related quality of life (SMD: 1.13 [0.38-1.88]), the evidence is very uncertain. Preoperative site marking may probably reduce leakage (OR: 0.14 [0.06-0.37]) and may decrease dermatological complications (OR: 0.38 [0.29-0.50]) and surgical revision (OR: 0.09 [0.02-0.49]). The confidence in the cumulative evidence was moderate to very low. CONCLUSION: Despite low quality evidence, preoperative stoma site marking can prevent stoma-related complications and should be performed in patients undergoing gastrointestinal surgery given that this intervention poses no harm to patients.

Communication strategies in the prevention of type 2 diabetes and gestational diabetes in vulnerable groups: a scoping review.

BACKGROUND: The global prevalence of diabetes is nearly 9%, with an upward trend in type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). Although evidence shows that vulnerable groups are affected disproportionally, these groups are difficult to reach in terms of preventive measures. Currently, there is no gold standard regarding communication strategies and/or public awareness campaigns. METHODS: We conducted a scoping review in September 2019. Two reviewers independently screened the results of the electronic literature search in several databases, including Medline, EMBASE, and PsycINFO. Extracted data were charted, categorized, and summarized. RESULTS: All of the included articles (n=24) targeted T2DM; none targeted GDM. We identified the following five different vulnerable groups within the identified studies: migrants (n=9), ethnic groups such as African Americans (n=8), people with low socioeconomic status (n=3), older people (n=1), and people in need of care (n=1). Three categories of communication strategies were identified as follows: adapted diabetes prevention programs (n=21), community health workers (n=5), and technical approaches (n=9). CONCLUSION: We found different approaches for preventive interventions for T2DM. Some of these approaches were already adapted to known barriers. Communication strategies should be adapted to barriers and facilitating factors to increase participation and motivation.

Healthcare delivery and information provision in bariatric surgery in Germany: qualitative interviews with bariatric surgeons.

BACKGROUND: There are several healthcare professionals involved in health information provision regarding bariatric surgery, such as bariatric surgeons, nutritionists, and medical doctors in outpatient settings. Trustworthy health information supports patients in understanding their diagnosis, treatment decisions, and possible prognosis. Therefore, it is necessary to provide health information on bariatric surgery. This study has two distinct objectives. The first is to outline the delivery of healthcare regarding bariatric surgery in Germany. The second is to describe the information provision within healthcare delivery. METHODS: We conducted 15 semi-structured telephone interviews with bariatric surgeons between April 2018 and February 2019. The interviews were audio recorded and transcribed verbatim. The interview guide consisted of four sections (information about the clinic/surgeon and surgical procedures, preoperative procedure, postoperative procedure, information needs). The transcribed interviews were analyzed using qualitative content analysis supported by MAXQDA software. RESULTS: The pre- and postoperative processes differed substantially between clinics. Additionally, every bariatric clinic had its own information provision concept. There were several cost-related issues the surgeons claimed to be relevant for patients, such as nutritional blood tests or postoperative psychotherapy. These issues were often caused by unclearness of responsibility within the medical disciplines involved. CONCLUSION: Healthcare delivery in bariatric surgery in Germany is heterogeneous in terms of pre- and postoperative care. Therefore, preoperative information provision between the clinics differs. The impact of this heterogeneous healthcare delivery and information provision on patients' information needs regarding bariatric surgery should be further investigated among patients and other healthcare professionals involved.

Perspective of potential patients on the hospital volume-outcome relationship and the minimum volume threshold for total knee arthroplasty: a qualitative focus group and interview study.

BACKGROUND: Total knee arthroplasty (TKA) is performed to treat end-stage knee osteoarthritis. In Germany, a minimum volume threshold of 50 TKAs/hospital/year was implemented to ensure outcome quality. This study, embedded within a systematic review, aimed to investigate the perspectives of potential TKA patients on the hospital volume-outcome relationship for TKA (higher volumes associated with better outcomes). METHODS: A convenience sample of adults with knee problems and heterogeneous demographic characteristics participated in the study. Qualitative data were collected during a focus group prior to the systematic review (n = 5) and during telephone interviews, in which preliminary results of the systematic review were discussed (n = 16). The data were synthesised using content analysis. RESULTS: All participants (n = 21) believed that a hospital volume-outcome relationship exists for TKA while recognising that patient behaviour or the surgeon could also influence outcomes. All participants would be willing to travel longer for better outcomes. Most interviewees would choose a hospital for TKA depending on reputation, recommendations, and service quality. However, some would also choose a hospital based on the results of the systematic review that showed slightly lower mortality/revision rates at higher-volume hospitals. Half of the interviewees supported raising the minimum volume threshold even if this were to increase travel time to receive TKA. CONCLUSIONS: Potential patients believe that a hospital volume-outcome relationship exists for TKA. Hospital preference is based mainly on subjective factors, although some potential patients would consider scientific evidence when making their choice. Policy makers and physicians should consider the patient perspectives when deciding on minimum volume thresholds or recommending hospitals for TKA, respectively.

The effect of preoperative stoma site marking on risk of stoma-related complications in patients with intestinal ostomy-protocol of a systematic review and meta-analysis.

BACKGROUND: An intestinal ostomy is an artificial bowel opening created on the skin. Procedure-related mortality is extremely rare. However, the presence of an ostomy may be associated with significant morbidity. Complications negatively affect the quality of life of ostomates. Preoperative stoma site marking can reduce stoma-related complications and is recommended by several guidelines. However, there is no consensus on the procedure and recommendations are based on low-quality evidence. The objective of the systematic review will be to investigate if preoperative stoma site marking compared to no preoperative marking in patients undergoing intestinal stoma surgery reduces or prevents the rate of stoma-related complications. METHODS: We will include (cluster-) randomised controlled trials and cohort studies that involve patients with intestinal ostomies comparing preoperative stoma site marking to no preoperative marking and report at least one patient-relevant outcome. For study identification, we will systematically search MEDLINE/PubMed, EMBASE, CENTRAL and CINHAL as well as Google Scholar, trial registries, conference proceedings and reference lists. Additionally, we will contact experts in the field. Two reviewers will independently perform study selection and data extraction. Outcomes will be prioritised based on findings from telephone interviews with five ostomates and five ostomy and wound nurses prior to conducting the review. Outcomes may include but are not limited to stoma-related complications (infection, parastomal abscess, hernia, mucocutaneous separation, dermatological complications, stoma necrosis, stenosis, retraction and prolapse) or other patient-relevant postoperative endpoints (quality of life, revision rate, dependence on professional care, mortality, length of stay and readmission). We will use the ROBINS-I or the Cochrane risk of bias tool to assess the risk of bias of the included studies. We will perform a meta-analysis and assess the certainty of evidence using the GRADE approach. DISCUSSION: With the results of the systematic review, we aim to provide information for future clinical guidelines and influence clinical routine with regard to preoperative stoma site marking in patients undergoing ostomy surgery. When the evidence of our systematic review is low, it would still be a useful basis for future clinical trials by identifying data gaps. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42021226647.

[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.

Barriers and facilitating factors in the prevention of diabetes type 2 and gestational diabetes in vulnerable groups: A scoping review.

AIMS: Type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM) are globally on the rise, accompanied by comorbidities and associated health costs. Increased physical activity, healthy nutrition, and weight loss have shown the potential to prevent T2DM/GDM. Despite this, reaching vulnerable groups remains a key challenge. The aim of this scoping review was to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. METHODS: We conducted a systematic literature search in May 2018, updated in September 2019, in several databases (e.g. PubMed, Embase) to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. Two reviewers independently screened the results. Extracted data was charted, categorized, and summarized. RESULTS: We included 125 articles. Ninety-eight studies were extracted, and eight categories of barriers and facilitating factors were formed. The most common categories of barriers were limited knowledge, family/friends, and economic factors, and the most common categories of facilitating factors were family/friends, social support, and knowledge. CONCLUSION: This scoping review identified various barriers and facilitating factors in vulnerable groups. Preventive interventions should consider these barriers and facilitating factors in developing preventive interventions or in adapting existing ones.

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.

Psychosocial Changes of Bariatric Surgery in Patients' Everyday Life: a Scoping Review.

PURPOSE: Although the post-bariatric clinical and physical changes are well-known, the psychosocial changes in patients' everyday life are less clear. Therefore, we tried to summarize comprehensively the currently available literature on the psychosocial changes of bariatric surgery (BS) by means of a scoping review. MATERIALS AND METHODS: The scoping review was conducted following the Arksey and O'Malley framework, the Joanna Briggs Institute Reviewer's Manual 2015, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. PubMed, EMBASE, and PsycINFO were searched for data dating from January 2008 through October 2019. Only gastric bypass and sleeve gastrectomy procedures were considered for this review. To explore and describe the essence of the experienced changes deeply, only qualitative studies were included. The synthesis was performed using the qualitative content analysis technique. RESULTS: The literature search yielded 1420 unique records, and 1371 articles were eliminated on the basis of irrelevant title and/or abstract. Forty-nine full-text articles were reviewed. Ultimately, eight articles were included in this scoping review. The qualitative content analysis emerged in 12 categories, which were further condensed into three major thematic areas, namely, "subjective self-image," "interpersonal relationships," and "it's not all gold that glitters," which reflect the post-operative psychosocial changes. CONCLUSION: A wide range of psychosocial changes occurs following bariatric surgery. To maintain the improvements and to prevent negative changes, long-term support by specially trained health professionals is crucial.

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.

Hospital volume-outcome relationship in total knee arthroplasty: protocol for a systematic review and non-linear dose-response meta-analysis.

BACKGROUND: Knee osteoarthritis is a common, chronic condition and main contributor to global disability. Total knee arthroplasty (TKA) is the most successful treatment for end-stage knee osteoarthritis. It is assumed that in the field of surgery, there is a relationship between hospital volume and health outcomes and that higher hospital volume results in better health outcomes. As a consequence, minimum volume thresholds have been implemented in Germany for various procedures, including TKA (50 procedures per year). To date, it is unclear whether minimum volume thresholds truly result in better outcomes. The objective of this study will be to quantify the relationship between hospital volume and patient-relevant outcomes in patients undergoing TKA. METHODS: We will include published or unpublished (cluster-) randomized controlled trials and prospective or retrospective cohort studies that involve patients with primary and/or revision TKA, report at least two different hospital volumes and report at least one patient-relevant outcome. To identify studies, we will systematically search (from inception onwards) PubMed/MEDLINE, Embase, CENTRAL, and CINAHL, as well as trial registers, conference proceedings, and reference lists. We will also contact experts in the field. Study selection and data extraction will be performed by two reviewers independently. The primary outcome will be rate of early revision. Secondary outcomes will include rate of revision > 1 year, mortality, length of stay, readmission rate, surgical complications, adverse events and health-related quality of life. We will assess the risk of bias of the included studies using ROBINS-I or the Cochrane risk of bias tool. Both a linear and a non-linear dose-response meta-analyses will be performed. We will use the GRADE approach to evaluate our confidence in the cumulative evidence. We will incorporate patients' needs, goals and preferences into our recommendations by consulting three focus groups, each consisting of eight participants. DISCUSSION: The findings of our systematic review will probably be limited by the design of the included studies. We do not expect to identify any (cluster-) randomized controlled trials that meet our inclusion criteria. Therefore, the best available evidence included in our systematic review will most likely consist of cohort studies only. We anticipate that the results of this study will inform future health policy decisions in Germany regarding the minimum volume threshold for TKA. Systematic review registration: PROSPERO CRD42019131209.

[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.

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.

Communication strategies in the prevention of type 2 and gestational diabetes in vulnerable groups: protocol for a scoping review.

BACKGROUND: The global prevalence of diabetes mellitus is nearly 9%, with an upward trend in type 2 and gestational diabetes mellitus (T2DM/GDM). Evidence shows that vulnerable groups are affected disproportionally. Therefore, there is an increasing need to implement policies to prevent risk factors for T2DM/GDM and to promote a healthy lifestyle. However, up to now, no gold standard in terms of communication strategies and/or public awareness campaigns is known. METHODS/DESIGN: We will conduct a systematic scoping review to evaluate communication strategies in the prevention of T2DM/GDM in vulnerable groups. Two reviewers will independently screen the results of the electronic literature search in PubMed, EMBASE, PsycINFO, PSYNDEX, Social Science Citation Index, and CINAHL. Extracted data will be charted, categorized, and summarized. DISCUSSION: The results will be used to inform the National education and communication strategy on diabetes mellitus in Germany. In particular, the results will be discussed in focus groups of experts to develop recommendations for communication strategies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO does not register scoping reviews.