Evidence-based health policy in Germany: lack of communication and coordination between academia and health authorities?

Health-care decision making should consider the best available evidence, often in the form of systematic reviews (SRs). The number of existing SRs and their overlap make their identification and use difficult. Decision makers often rely on de novo SRs instead of using existing SRs. We describe two cases of duplicate reviews (minimum volume threshold of total knee arthroplasties and lung cancer screening) and one case of duplicate primary data analysis (transcatheter aortic valve implantation). All cases have in common that unintended duplication of research occurred between health authorities and academia, demonstrating a lack of communication and coordination between them.It is important to note that academia and health authorities have different incentives. Academics are often measured by the number of peer-reviewed publications and grants awarded. In contrast, health authorities must comply with laws and are commissioned to deliver a specific report within a defined period of time. Most replication is currently unintended. A solution may be the collaboration of stakeholders commonly referred to as integrated knowledge translation (IKT). The IKT approach means that research is conducted in collaboration with the end users of the research. It requires active collaborations between researchers and decision-makers or knowledge users (clinicians, managers, policy makers) throughout the research process. Wherever cooperation is possible in spite of requirements for independence or confidentiality, legal regulations should facilitate and support collaborative approaches between academia and health authorities.

Protocol for the development of a core outcome set for studies on centralisation of healthcare services.

INTRODUCTION: Centralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while improving quality. Research on centralisation of healthcare services is thus essential to inform decision-makers. However, so far studies on centralisation report a variability of outcomes, often neglecting outcomes at the health system level. Therefore, this study aims at developing a core outcome set (COS) for studies on centralisation of hospital procedures, which is intended for use in observational as well as in experimental studies. METHODS AND ANALYSIS: We propose a five-stage study design: (1) systematic review, (2) focus group, (3) interview studies, (4) online survey, (5) Delphi survey. The study will be conducted from March 2022 to November 2023. First, an initial list of outcomes will be identified through a systematic review on reported outcomes in studies on minimum volume regulations. We will search MEDLINE, EMBASE, CENTRAL, CINHAL, EconLIT, PDQ-Evidence for Informed Health Policymaking, Health Systems Evidence, Open Grey and also trial registries. This will be supplemented with relevant outcomes from published studies on centralisation of hospital procedures. Second, we will conduct a focus group with representatives of patient advocacy groups for which minimum volume regulations are currently in effect in Germany or are likely to come into effect to identify outcomes important to patients. Furthermore, two interview studies, one with representatives of the German medical societies and one with representatives of statutory health insurance funds, as well as an online survey with health services researchers will be conducted. In our analyses of the suggested outcomes, we will largely follow the categorisation scheme developed by the Cochrane EPOC group. Finally, a two-round online Delphi survey with all stakeholder groups using predefined score criteria for consensus will be employed to first prioritise outcomes and then agree on the final COS. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committee at the Brandenburg Medical School Theodor Fontane (MHB). The final COS will be disseminated to all stakeholders involved and through peer-reviewed publications and conferences.

The effect of minimum volume standards in hospitals (MIVOS) - protocol of a systematic review.

BACKGROUND: The volume-outcome relationship, i.e., higher hospital volume results in better health outcomes, has been established for different surgical procedures as well as for certain nonsurgical medical interventions. Accordingly, many countries such as Germany, the USA, Canada, the UK, and Switzerland have established minimum volume standards. To date, there is a lack of systematically summarized evidence regarding the effects of such regulations. METHODS: To be included in the review, studies must measure any effects connected to minimum volume standards. Outcomes of interest include the following: (1) patient-related outcomes, (2) process-related outcomes, and (3) health system-related outcomes. We will include (cluster) randomized controlled trials ([C]RCTs), non-randomized controlled trials (nRCTs), controlled before-after studies (CBAs), and interrupted time-series studies (ITSs). We will apply no restrictions regarding language, publication date, and publication status. We will search MEDLINE (via PubMed), Embase (via Embase), CENTRAL (via Cochrane Library), CINHAL (via EBSCO), EconLit (via EBSCO), PDQ evidence for informed health policymaking, health systems evidence, OpenGrey, and also trial registries for relevant studies. We will further search manually for additional studies by cross-checking the reference lists of all included primary studies as well as cross-checking the reference lists of relevant systematic reviews. To evaluate the risk of bias, we will use the ROBINS-I and RoB 2 risk-of-bias tools for the corresponding study designs. For data synthesis and statistical analyses, we will follow the guidance published by the EPOC Cochrane group (Cochrane Effective Practice and Organisation of Care (EPOC), EPOC Resources for review authors, 2019). DISCUSSION: This systematic review focuses on minimum volume standards and the outcomes used to measure their effects. It is designed to provide thorough and encompassing evidence-based information on this topic. Thus, it will inform decision-makers and policymakers with respect to the effects of minimum volume standards and inform further studies in regard to research gaps. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022318883.

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.

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.