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

Investigation if preoperative stoma site marking compared to no preoperative marking in patients undergoing intestinal stoma surgery reduces the risk of stoma-related complication

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

Abstract 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

Utility of health-related data in the regional context for health service planning in the Federal State of Brandenburg, Germany. Study protocol of a qualitative study exploring needs of stakeholders (GeDa-BB)

Background: A spatial view on health and disease can be realised by cartographic processing of data on regional variation of health services utilisation and health outcomes using a health atlas. In several countries, health atlases have been developed for a long time, however several challenges with their usage have been identified, e.g. low usage by professionals working in health planning and difficulties with applicability. In Germany, several health atlases have been published, too. Brandenburg is a federal state in the north-east of Germany. It is a largely rural federal state with agglomeration areas especially close to the city of Berlin and is characterised by an aging population. Some maps of health-related data in Brandenburg exist, but there is no comprehensive health atlas as there is in other federal states of Germany, which cartographically process a wide range of data available on health, health services and population characteristics. The study aims to explore current data usage and needs of stakeholders working in regional health services planning. This shall serve as a starting point for future resources for health service planning. Methods: We will conduct semi-structured interviews with stakeholders of regional health planning in Brandenburg. Stakeholders will be identified primarily through the Federal State Committee according to § 90a SGB V (Paragraph 90a Social Code Volume Five) which was built to answer questions regarding cross-sectional health services. Interviews will be conducted by telephone, online-meeting tools or face-to-face meetings. They will be recorded, transcribed, anonymised, and then analysed according to qualitative content analysis. The results of the interviews will be presented and discussed during workshops with interviewed stakeholders. Discussion: The results of the study will help to develop and agree on next steps for appropriate resources for regional health planning in Brandenburg

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

Abstract 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 CRD4202231888

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.Federal Ministry of Education and Research of German

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