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Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures.We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews.Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate andthere were contradictory findings for some outcomes. Providing patients with more informationin general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction.A lower readability level decreased anxiety and improved comprehension and knowledge.Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications.When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.

IntroductionThe 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 analysisThe 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 disseminationEthical 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.

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/24 h; 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.

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.

Registration: PROSPERO: CRD42020210645 Introduction: We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control. Methods: We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses. Results: We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89–1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01–1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75–1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas. Plain language summary Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes Introduction: We performed the review to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older type 2 diabetes patients with blood sugar outside the normal level. Methods: To answer the question, we searched various electronic databases. We included studies in older (⩾65 years) patients with type 2 diabetes that assessed the safety of DPP-4 inhibitors. The data from the different studies were quantitatively summarized using statistical methods. We assessed the quality of the data to judge the certainty of the findings. Results: We identified 16 studies that included 19,317 patients with a mean age greater than 70 years. The average blood sugar level of patients in the included studies was slightly or moderately increased. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia, but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas. DPP-4s probably reduce the risk of hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase the risk that blood sugar falls below normal. Adding DPP-4 inhibitorss to standard care in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case additional treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.

BackgroundWe aim to assess the safety of dipeptidylpeptidase-4 inhibitors (DPP4s) in older type 2 diabetes patients with inadequate glycaemic control. MethodsWe included RCTs in older (≥65 years) patients with type 2 diabetes. The intervention group was treated with any DPP4. A systematic search in MEDLINE and EMBASE was performed in December 2020. For assessing risk of bias, the RoB 2 tool was applied. The quality of evidence was assessed using GRADE. We pooled outcomes using random-effects meta-analyses. ResultsWe identified 16 RCTs that included 19,317 patients with a mean age >70 years. The mean HbA1c ranged between 7.1g/dl and 10.0g/dl.Adding DPP4s to standard alone care may increase mortality slightly (RR 1.04; 0.89-1.21). Adding DPP4s to standard care increases the risk for hypoglycaemia (RR 1.08; 95%CI 1.01-1.16), but difference in overall adverse events is negligible.DPP4s added to standard care likely reduce mortality compared to sulfonylureas (RR 0.88; 0.75-1.04). DPP4s probably reduce the risk for hypoglycaemia compared to sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible.There is insufficient evidence on hospitalizations, falls, fractures, renal impairment, and pancreatitis. Conclusion There is no evidence that DPP4s in addition to standard care decrease mortality but DPP4s increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously because even in drugs with a good safety profile like DPP4s. In the case second-line treatment is necessary, DPP4s appear to be superior to sulfonylureas. RegistrationPROSPERO: CRD42020210645

PurposeOur objective was to assess the safety of long-term intake of DOACs in older adults with atrial fibrillation (AF). MethodsWe included RCTs in elderly (≥65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 9/11/2020. For determination of risk of bias, the RoB-2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE.ResultsTen RCTs with a total of 61,948 patients were identified. Seven RCTs included patients with AF-only and three with AF who received PCI and additional antiplatelet-therapy. Two RCTs compared apixaban with either warfarin or aspirin, three edoxaban with either placebo, aspirin, or Vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF-only (HR 0.89 95%CI 0.78 to 1.02). We did not find any RCT that reported mortality in elderly AF-PCI patients. Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). High-dose edoxaban reduces major or clinically relevant bleeding (MCRB) compared to VKAs (HR 0.82 95%CI 0.73 to 0.93) but high-dose dabigatran or rivaroxaban increase MCRB (HR 1.15 95%CI 1.02 to 1.30).Conclusion We found that low-dose DOACs probably decrease mortality in AF-only patients. Moreover, apixaban and edoxaban are associated with fewer MCRB compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose.

Background There is evidence of a volume outcome relationship for liver transplantation. In Germany, there is a minimum volume threshold of 20 transplantations per year for each center. Thresholds potentially lead to centralization of the healthcare supply, generating longer travel times. Objective This study assessed whether patients are willing to travel longer times to transplantation centers for better outcomes (lower hospital mortality and higher 3-year survival) and identified patient characteristics influencing their choices. Methods Participants were recruited in hospitals and via random samples at registration offices. Discrete choice experiments were used to identify trade-offs in their choices between local and regional centers. Descriptive statistics and logistic regression models were used to measure patients’ preferences and quantify potentially influencing characteristics. Results Overall, 82.22% (in-hospital mortality) and 84.44% (3-year survival) of the participants opted to accept a longer travel time in order to receive a liver transplantation with better outcomes. Conclusion Most participants were willing to trade shorter travel times for lower mortality risks and higher 3-year survival in cases of liver transplantation.

Background: Caesarean sections often have no urgent indication and are electively planned. Research showed that elective caesarean section should not be performed until 39+(0-6) week of gestation to ensure best neonatal and maternal health if there are no contraindications. This was recommended by various guidelines published in the last two decades. With this systematic review we are looking for implementation strategies trying to implement these recommendations into clinical practice. Methods: We performed a systematic literature search in MEDLINE, EMBASE, CENTRAL and CINAHL in November 2019. We included studies that assessed implementation strategies aiming to postpone elective caesarean section to ≥39+(0-6) week of gestation. There were no restrictions regarding the type of implementation strategy or reasons for elective caesarean section. Our primary outcome was the rate of elective caesarean sections before 39+(0-6) week of gestation. We did a narrative analysis of the results.Results: We included 9 studies, of which were 2 interrupted time series and 7 before-after studies, covering 205.954 elective caesarean births. All studies included various types of implementation strategies. All implementation strategies showed success in decreasing the rate of elective caesarean sections performed Conclusion: This systematic review shows that all presented implementation strategies to reduce elective caesarean section before 39+(0-6) weeks of gestation are effective. Reduction rates differ widely and it remains unclear which strategy is most successful. Strategies used locally in one hospital seem a little more effective. For planning an implementation strategy to reduce elective caesarean section before 39+(0-6) weeks of gestation it is necessary to consider specific barriers and facilitators and take all obstetric personal into account.Systematic review registration: Registered in PROSPERO (CRD42017078231)

Background Caesarean sections often have no urgent indication and are electively planned. Research showed that elective caesarean section should not be performed until 39 + (0–6) weeks of gestation to ensure best neonatal and maternal health if there are no contraindications. This was recommended by various guidelines published in the last two decades. With this systematic review, we are looking for implementation strategies trying to implement these recommendations to reduce elective caesarean section before 39 + (0–6) weeks of gestation. Methods We performed a systematic literature search in MEDLINE, EMBASE, CENTRAL, and CINAHL on 3rd of March 2021. We included studies that assessed implementation strategies aiming to postpone elective caesarean section to ≥ 39 + (0–6) weeks of gestation. There were no restrictions regarding the type of implementation strategy or reasons for elective caesarean section. Our primary outcome was the rate of elective caesarean sections before 39 + (0–6) weeks of gestation. We used the ROBINS-I Tool for the assessment of risk of bias. We did a narrative analysis of the results. Results We included 10 studies, of which were 2 interrupted time series and 8 before-after studies, covering 205,954 elective caesarean births. All studies included various types of implementation strategies. All implementation strategies showed success in decreasing the rate of elective caesarean sections performed < 39 + (0–6) weeks of gestation. Risk difference differed from − 7 (95% CI − 8; − 7) to − 45 (95% CI − 51; − 31). Three studies reported the rate of neonatal intensive care unit admission and showed little reduction. Conclusion This systematic review shows that all presented implementation strategies to reduce elective caesarean section before 39 + (0–6) weeks of gestation are effective. Reduction rates differ widely and it remains unclear which strategy is most successful. Strategies used locally in one hospital seem a little more effective. Included studies are either before-after studies (8) or interrupted time series (2) and the overall quality of the evidence is rather low. However, most of the studies identified specific barriers in the implementation process. For planning an implementation strategy to reduce elective caesarean section before 39 + (0–6) weeks of gestation, it is necessary to consider specific barriers and facilitators and take all obstetric personal into account. Systematic review registration PROSPERO CRD42017078231

Background Distance to a hospital is an influencing factor for patients´ decision making when choosing a hospital for surgery. It is unclear whether patients prefer to travel further to regional instead of local hospitals if the risk associated with elective surgery is lower in the farther hospital. The aim of our systematic review was to investigate patient preferences for the location of care, taking into consideration surgical outcomes and hospital distance. Methods MEDLINE (PubMed), EconLit, PsycInfo and EMBASE were searched until November 2019. We included experimental choice studies in which participants were asked to make a hypothetical decision where to go for elective surgery when surgical risk and/or distance to the hospitals vary. There was no restriction on the type of intervention or study. Reviewers independently extracted data using a standardized form. The number and proportion of participants willing to accept additional risk to obtain surgery in the local hospital was recorded. We also extracted factors associated with the decision. Results Five studies exploring participants´ preferences for local care were included. In all studies, there were participants who, independently of a decreased mortality risk or a higher survival benefit in the regional hospital, adhered to the local hospital. The majority of the patients were willing to travel longer to lower their surgical risk. Older age and fewer years of formal education were associated with a higher risk tolerance in the local hospital. Conclusions Whether patients were willing to travel for a lower surgery-associated risk could not be answered in a straightforward manner. The studies we identified showed that decision making also relies on factors other than on rational information on risk or distance to hospital. Trial registration International prospective register of ongoing systematic reviews (PROSPERO): CRD42016033655. Registered 1 January 2016.

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.

Zusammenfassung Hintergrund Mono- (MSS) und bisegmentale Spondylodesen (BSS) sind in deutschen Krankenhäusern häufig durchgeführte Eingriffe. Trotz des hohen Fallvolumens gibt es kaum Daten über die Behandlungsabläufe und medizinischen Versorgungskonzepte während und nach dem Krankenhausaufenthalt. Ziel der Umfrage war es, einen detaillierten Einblick in die Behandlungsprozesse sowie medizinischen Ansätze in der elektiven MSS- und BSS-Versorgung in Deutschland zu erhalten. Auf Basis der erhobenen Daten sollen zudem Möglichkeiten für eine optimierte Patientenversorgung aufgezeigt werden. Materialien und Methoden Über einen Newsletter wurden Mitglieder der Deutschen Wirbelsäulengesellschaft (DWG) eingeladen, an der Befragung teilzunehmen. 209 leitende Ärzte wurden zu Themen wie Verweildauer, Behandlungsablauf und Ergebnismessung befragt. Ergebnisse Für die statistische Auswertung wurden Daten aus 142 Fragebögen berücksichtigt. In einigen Aspekten gibt es ein einheitliches Vorgehen, beispielsweise bei der präoperativen Information des Patienten über den Behandlungsablauf und der Entlassung auf Basis qualitativer Kriterien. Gleichzeitig existiert eine große Spannweite in der Verweildauer und eine starke Varianz im Vorgehen bei Rehabilitation, Restriktionen, prä- und postoperativer Ergebnismessung, radiologischer Kontrolle und interdisziplinärer Abstimmung. Schlussfolgerung Mehr als die Hälfte der befragten Ärzte gab an, einem strukturierten Behandlungsschema zu folgen. Gleichzeitig zeigen die Ergebnisse der Befragung ein sehr heterogenes Vorgehen im Rahmen der MSS- und BSS-Versorgung in Deutschland. Zudem wird deutlich, dass dies besonders ausgeprägt ist in den Teilaspekten der Behandlung, bei denen ein Mangel an Evidenz vorliegt. Die Ergebnisse geben erste wichtige Hinweise, in welchen Aspekten Behandlungsabläufe und Organisationsstrukturen standardisiert werden können, um die Patientenversorgung zu optimieren.

Background The rate of caesarean sections (CS) has increased in the last decades to about 30% of births in high income countries. Many CSs are electively planned without an urgent medical reason for mother or child. An early CS though may harm the newborn. Our aim was to evaluate the gestational time point after the 37 + 0 week of gestation (WG) (after prematurity = term) of performing an elective CS with the lowest morbidity for mother and child by assessing the time course from 37 + 0 to 42+ 6 WG. Methods We performed a systematic literature search in MEDLINE, EMBASE, CENTRAL and CINAHL in November 2018. We included studies that compared different time points of elective CS at term no matter the reason for elective CS. Our primary outcomes were the rate of admissions to the neonatal intensive care unit (NICU), neonatal death and maternal death in early versus late term elective CS. Various binary and dose response random effects meta-analyses were performed. Results We identified 35 studies including 982,749 women. Except one randomised controlled trial, all studies were cohort studies. We performed a linear time-response meta-analysis on the primary outcome NICU admission on 14 studies resulting in a decrease of the relative risk (RR) to 0.63 (95% CI 0.56, 0.71) from 37 + 0 to 39 + 6 WG. RR for neonatal death showed a decrease to 39 + (0–6) WG (RR 0.59 95% CI 0.43 to 0.83) and increase from then on (RR 2.09 95% CI 1.18 to 3.70) assuming a U-shape course and using a cubic spline model for meta-analysis of four studies. We only identified one study analyzing maternal death resulting in RR of 0.38 (95% CI 0.04 to 3.40) for 37 + 0 + 38 + 6 WG versus ≥39 + 0 WG. Conclusion Our systematic review showed that elective CS (primary and repeated) before the 39 + 0 WG lead to more NICU admissions and neonatal deaths, although death is rare and increases again after 39 + 6 WG. We did not find enough evidence on maternal outcomes. There is a need for more research, considering maternal outcomes to provide a balanced decision between neonatal and maternal health. Systematic review registration Registered in PROSPERO (CRD42017078231).

The aim of this study is to investigate, whether patients in Germany are willing to travel a longer time to a certain hospital in order to receive a better treatment (lower 90-days mortality, lower risk of revision) in elective total knee arthroplasty. In addition, we analyzed which characteristics determined patient preference.The participants were recruited via random samples of registration offices and hospitals. All have undergone discrete choice experiments for the outcomes mortality and revision. Descriptive statistics were used to analyze the patient's preference. Logistic regression models were applied to identify characteristics that influence decision making.71.7% (mortality) and 86.11% (revision) of the respondents are willing to travel a longer time in order to lower their surgical risk. The amount of people that are willing to do so is even larger in the subgroup recruited in the hospital (78.5% respectively 90.7%).The majority of the participants are willing to travel longer to lower their surgical risk for elective knee arthroplasty. It has to be considered, that the population under study might not be representative. Patient's preferences corresponds with the aim of introducing minimum volume thresholds. Future studies should focus on other indications and outcomes.ZIEL: Ziel dieser Analyse ist es, zu überprüfen, ob Patienten in Deutschland bereit sind, für einen elektiven Knie-TEP-Eingriff längere Fahrzeiten zu Krankenhäusern mit verbesserter Behandlungsqualität (niedrigere 90-Tage-Mortalitätswahrscheinlichkeit, geringeres Risiko einer Revision) in Kauf zu nehmen und zu analysieren, welche Charakteristika der Teilnehmer mit dem Entscheidungsverhalten assoziiert sind.Teilnehmer wurden in einer Klinik und über zufällige Stichproben von Einwohnermeldeämtern rekrutiert und im Rahmen eines Discrete-Choice-Experiments befragt. Als Outcomes wurde das 90-Tage-Mortalitäts- bzw. Revisionsrisiko verwendet. Anhand deskriptiver Statistik wurde das Entscheidungsverhalten ausgewertet. Logistische Regressionsmodelle wurden verwendet, um Merkmale zu identifizieren, die die Entscheidung beeinflussen.71,7% (Mortalität) bzw. 86,11% (Revision) der Teilnehmer sind bereit, für eine bessere Behandlungsqualität längere Fahrzeiten auf sich zu nehmen. In der Subgruppe derer, die in der Klinik rekrutiert wurden, waren die Raten etwas höher (78,5 bzw. 90,7%).Die Mehrheit der befragten Teilnehmer ist bereit, für eine verbesserte Behandlungsqualität im Falle eines elektiven Knie-TEP-Eingriffes eine längere Anfahrtszeit in Kauf zu nehmen. Die Studienpopulation ist jedoch nicht zwingend repräsentativ. Weiterhin muss überprüft werden, ob das auch für weitere Prozeduren und deren relevante Outcomes gültig ist.

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, I 2 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

Background Stringent requirements exist regarding the transparency of the study selection process and the reliability of results. A 2-step selection process is generally recommended; this is conducted by 2 reviewers independently of each other (conventional double-screening). However, the approach is resource intensive, which can be a problem, as systematic reviews generally need to be completed within a defined period with a limited budget. The aim of the following methodological systematic review was to analyse the evidence available on whether single screening is equivalent to double screening in the screening process conducted in systematic reviews. Methods We searched Medline, PubMed and the Cochrane Methodology Register (last search 10/2018). We also used supplementary search techniques and sources (“similar articles” function in PubMed, conference abstracts and reference lists). We included all evaluations comparing single with double screening. Data were summarized in a structured, narrative way. Results The 4 evaluations included investigated a total of 23 single screenings (12 sets for screening involving 9 reviewers). The median proportion of missed studies was 5% (range 0 to 58%). The median proportion of missed studies was 3% for the 6 experienced reviewers (range: 0 to 21%) and 13% for the 3 reviewers with less experience (range: 0 to 58%). The impact of missing studies on the findings of meta-analyses had been reported in 2 evaluations for 7 single screenings including a total of 18,148 references. In 3 of these 7 single screenings – all conducted by the same reviewer (with less experience) – the findings would have changed substantially. The remaining 4 of these 7 screenings were conducted by experienced reviewers and the missing studies had no impact or a negligible on the findings of the meta-analyses. Conclusions Single screening of the titles and abstracts of studies retrieved in bibliographic searches is not equivalent to double screening, as substantially more studies are missed. However, in our opinion such an approach could still represent an appropriate methodological shortcut in rapid reviews, as long as it is conducted by an experienced reviewer. Further research on single screening is required, for instance, regarding factors influencing the number of studies missed. Electronic supplementary material The online version of this article (10.1186/s12874-019-0782-0) contains supplementary material, which is available to authorized users.

Background The rate of caesarean sections increased in the last decades to about 30% of births in western populations. Many caesarean sections are electively planned without an urgent medical reason for mother or child. Especially in women with a foregoing caesarean section, the procedure is planned early. An early caesarean section though may harm the newborn. Our aim is to evaluate the gestational time point after the 37th gestational week (after prematurity = term) of performing an elective caesarean section with the lowest morbidity for mother and child. Methods This is an update of a systematic review previously carried out on behalf of the German Federal Ministry of Health. We will perform a systematic literature search in MEDLINE, EMBASE, CENTRAL and CINAHL. Our primary outcome is the rate of admissions to the neonatal intensive care unit in early versus late term neonates. We will include (quasi) randomized controlled trials and cohort studies. The studies should include pregnant women who have an elective caesarean section at term. We will screen titles and abstracts and the identified full texts of studies for eligibility. Risk of bias will be assessed with the Cochrane Risk of Bias Tool for Randomized Trials or with the Risk of Bias Tool for Non-Randomized Studies of Interventions (ROBINS-I). These tasks will be performed independently by two reviewers. Data will be extracted in beforehand piloted extraction tables. A dose-response meta-analysis will be performed. Discussion Our aim is to reach a higher validity in the assessment of the time point of elective caesarean sections by performing a meta-analysis to support recommendations for clinical practice. We assume to identify less randomized controlled trials but a large number of cohort studies analyzing the given question. We will discuss similarities and differences in included studies as well as methodological strengths and weaknesses. Systematic review registration PROSPERO CRD42017078231

Objectives: The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI.Methods: We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way.Results: Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague.Conclusions: The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

Objective There is a movement from generic quality checklists toward a more domain-based approach in critical appraisal tools. This study aimed to report on a first experience with the newly developed risk of bias in systematic reviews (ROBIS) tool and compare it with A Measurement Tool to Assess Systematic Reviews (AMSTAR), that is, the most common used tool to assess methodological quality of systematic reviews while assessing validity, reliability, and applicability. Study Design and Setting Validation study with four reviewers based on 16 systematic reviews in the field of occupational health. Results Interrater reliability (IRR) of all four raters was highest for domain 2 (Fleiss' kappa κ = 0.56) and lowest for domain 4 (κ = 0.04). For ROBIS, median IRR was κ = 0.52 (range 0.13–0.88) for the experienced pair of raters compared to κ = 0.32 (range 0.12–0.76) for the less experienced pair of raters. The percentage of “yes” scores of each review of ROBIS ratings was strongly correlated with the AMSTAR ratings (r s = 0.76; P = 0.01). Conclusion ROBIS has fair reliability and good construct validity to assess the risk of bias in systematic reviews. More validation studies are needed to investigate reliability and applicability, in particular.

Background: Biomarker tests are increasingly being offered by laboratories and clinicians as self-pay health services to screen asymptomatic individuals; however, sufficient evidence may not be available to support this practice. We investigated the benefit-harm tradeoffs associated with 11 biomarkers currently offered in Germany as self-pay tests to screen for cancer. Methods : We systematically searched bibliographic databases for health technology assessments, systematic reviews and randomized-controlled trials (RCTs) through September 2015. We included publications that analysed cancer screening biomarkers and reported patient-relevant outcomes (mortality, morbidity, quality of life), and potential harms of screening, among asymptomatic individuals in screening and non-screening arms. Language was restricted to English and German. Two reviewers independently screened references; data were extracted and quality of included studies was evaluated by a reviewer and validated by a second reviewer. Results: Six publications of secondary literature and four publications reporting results from two RCTs were included. For 10 cancer screening biomarkers, no direct evidence on patient-relevant outcomes was available. Only one trial, which simultaneously assessed cancer antigen 125 (CA125) and vaginal ultrasound for ovarian cancer screening, provided the outcome of interest. Screening compared with usual care did not reduce ovarian cancer mortality. Patient harms included overdiagnosis and false-positive results. Conclusion: Although ovarian cancer screening with CA125 showed no benefit, false-positive tests, overdiagnosis and overtreatment were reported. Physicians and laboratories should provide patients with comprehensive information about the lack of evidence and potential harms caused by biomarker screening tests offered as a self-pay health service.