Structured lactation support and human donor milk for German NICUs-Protocol on an intervention design based on a multidimensional status quo and needs assessment (Neo-MILK).

INTRODUCTION: Mother's own milk is the best nutrition for every newborn and especially for vulnerable infants such as preterm infants with a very low birth weight below 1,500 grams (VLBW). If no MOM is available, human donor milk is the alternative of choice. Mothers of preterm born infants face challenging conditions that impair sufficient milk production. For this reason, it is particularly important to provide structural lactation support and, at the same time, to promote the establishment of human donor milk banks. METHODS AND ANALYSIS: Via a multidisciplinary approach the Neo-MILK study will develop an intervention for structured breastfeeding and lactation support. This will be based on a comprehensive status quo and needs assessment. In addition, the implementation of human donor milk banks (HDMB) will be supported by the development of standards. ETHICS AND DISSEMINATION: Intervention development is participatory, involving different disciplines and stakeholders. All surveys are subject to approval by the ethics committee. During the course of the project, the results will be communicated to the scientific community and the general public via publications, the project homepage and social media. TRIAL REGISTRATION NUMBER: DRKS00024799 (German Clinical Trials Register).

International comparison of minimum volume standards for hospitals.

INTRODUCTION: Minimum volume standards have been implemented in various countries for quality or safety policies. We present minimum volume standards in an international comparison, focusing on regulatory approaches, selected sets of procedures and thresholds as well as predetermined consequences of non-compliance. MATERIALS AND METHODS: We combined a comprehensive literature search in electronic databases in March 2016 with a hand-search of governmental and related organisations' webpages. We also contacted international experts to verify the information we found in the literature and to obtain additional data. RESULTS: Minimum volume standards have been introduced in different countries predominantly for highly specialized surgical procedures. The same evidence has led to different definitions and ways of implementation of minimum volume standards in Germany, Canada (Ontario), the Netherlands, Switzerland, and Austria. The regulatory approaches to minimum volume standards and the predetermined consequences of non-compliance differ across the countries. CONCLUSION: The sets of procedures for which minimum volume standards and corresponding thresholds have been introduced vary across countries, possibly due to different regulatory approaches. In addition, key attributes of the health care system might affect the development and implementation of minimum volume standards. Therefore, it is not feasible to formulate uniform recommendations that are applicable to all countries. Our results provide a comprehensive overview of international minimum volume standards and can be used to inform policy decisions.

Evidence-based decision-making for diagnostic and therapeutic methods: the changing landscape of assessment approaches in Germany.

This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic 'methods' in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears to be much more regulated than the inpatient sector (based on a strict separation of the two care settings), developments in Germany have led to a more tightened assessment framework, making the use of evidence a firm component in the decision-making process. Nevertheless, a comprehensive approach for a systematic assessment of diagnostic and therapeutic 'methods' still does not exist. Readjustments of current regulations in Germany, such as the existing 'Verbotsvorbehalt' (i.e. provision of a diagnostic and therapeutic 'method' possible unless actively delisted) in the inpatient care setting, as well as further developments at the European level are needed in order to create a system that ensures early access to innovation under controlled study conditions.

[GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence]. / GRADE-Leitlinien: 10. Den Ressourcenverbrauch berücksichtigen und die Qualität ökonomischer Evidenz bewerten.

In this article we describe how to include considerations about resource utilisation when making recommendations according to the GRADE approach. We focus on challenges with rating the confidence in effect estimates (quality of evidence) and incorporating resource use into evidence profiles and Summary of Findings (SoF) tables. GRADE recommends that important differences in resource use between alternative management strategies should be included along with other important outcomes in the evidence profile and SoF table. Key steps in considering resources in making recommendations with GRADE are the identification of items of resource use that may differ between alternative management strategies and that are potentially important to decision-makers, finding evidence for the differences in resource use, making judgements regarding confidence in effect estimates using the same criteria used for health outcomes, and valuing the resource use in terms of costs for the specific setting for which recommendations are being made.