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).

The major impact on healthcare through the ongoing digital transformation and new technologies results in opportunities for improving quality of care. Electronic patient records (EPR) are a substantial part in this transformation, even though their influence on documentation remains often unclear. This review aims to answer the question of which effect the introduction of the EPR has on the documentation proper in hospitals. To do this, studies are reviewed that analyze the documentation itself, rather than merely conducting interviews or surveys about it. Several databases were searched in this systematic review (PubMed including PubMed, PubMed Central and Medline; PDQ Evidence; Web of Science Core Collection; CINHAL). To be included, studies needed to analyze written documentation and empirical data, be in either German or English language, published between 2010 and 2020, conducted in a hospital setting, focused on transition from paper-based to electronic patient records, and peer reviewed. Quantitative, qualitative and mixed methods studies were included. Studies were independently screened for inclusion by two researchers in three stages (title, abstract, full text) and, in case of disagreement, discussed with a third person from the research team until consensus was reached. The main outcome assessed was whether the studies indicated a negative or positive effect on documentation (e.g. changing the completeness of documentation) by introducing an EPR. Mixed Methods Appraisal Tool was used to assess the individual risk of bias in the included studies. Overall, 264 studies were found. Of these, 17 met the inclusion criteria and were included in this review. Of all included studies, 11 of 17 proved a positive effect of the introduction of the EPR on documentation such as an improved completeness or guideline adherence of the documentation. Six of 17 showed a mixed effect with positive and negative or no changes. No study showed an exclusively negative effect. Most studies found a positive effect of EPR introduction on documentation. However, it is difficult to draw specific conclusions about how the EPR affects or does not affect documentation since the included studies examined a variety of outcomes. As a result, various scenarios are conceivable with higher or reduced burden for practitioners. Additionally, the impact on treatment remains unclear.

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BACKGROUND Electronic medical records (EMR) are considered a key component of the health care systems digital transformation. The implementation of an EMR promises various improvements e.g. in the availability of information, coordination of care, or patient safety and is required for big data analytics. To ensure those possibilities of an EMR, the included documentation must be of high quality. In this matter, the most frequently described dimension of data quality is the completeness of documentation. In this regard, little is known about how and why the completeness of documentation might change after the implementation of an EMR. OBJECTIVE The purpose of the presented study is to compare the completeness of documentation in paper-based medical records and electronic medical records and to discuss the possible impact of an EMR on the completeness of documentation. METHODS A retrospective document analysis was conducted, comparing the completeness in paper-based medical records and EMRs. Data were collected before and after implementation of an EMR on an orthopaedical ward in a German academic teaching hospital. The anonymized records represent all treated patients of a three-week period each. Unpaired, two tailed t-tests, χ²-tests and Odds Ratios were calculated to analyze and compare the mean completeness of the two record types in general and of ten specific items in detail (blood pressure, body temperature, diagnosis, diet, excretions, height, pain, pulse, reanimation status, weight). For this purpose, each of the ten items received a score of 1 if it was documented on the day of admission, otherwise it was scored as 0. RESULTS N=180 medical records became part of the analysis. The average completeness was 6.25 (SD 2.15) out of 10 in the paper-based medical record, significantly rising to an average of 7.13 (SD 2.01) in the EMR (t(178)=-2.469; P=.014; d=-0.428). When looking at the significant changes of the ten items in detail, the documentation of diet (P<.001), height (P<.001) and weight (P<.001) was more complete in the EMR, while the documentation of diagnosis (P<.001), excretions (P=.016), and pain (P=.008) was less complete in the EMR. The completeness remained significantly unchanged for the documentation of pulse (P=.276), blood pressure (P=.474), body temperature (P=.497) and reanimation status (P=.729). CONCLUSIONS Implementing EMRs can influence the completeness of documentation with a possible change to both, an increased or decreased completeness. However, the mechanisms that determine those changes are often neglected. There are mechanisms that might facilitate an improved completeness of documentation and could relieve or increase the staffs’ burden, caused by documentation tasks. Research is needed to take advantage of these mechanisms and use them for mutual profit in the interests of all stakeholders. CLINICALTRIAL The project is registered at the German clinical trials register (DRKS00023343).