Measuring Signs of Atopic Dermatitis in Clinical Practice: A HOME-CP Consensus Statement.

Importance: Outcome measurement is an essential component of value-based health care and can aid patient care, quality improvement, and clinical effectiveness evidence generation. The Harmonising Outcome Measures for Eczema Clinical Practice initiative aims to identify a list of validated, feasible, outcome measurement instruments recommended to measure atopic dermatitis (AD) in the clinical practice setting. The clinical practice set is a list of instruments that clinicians can pick and choose from to suit their needs in the context of clinical care. Objective: To recommend instruments to measure clinical signs of AD in clinical practice. Evidence Review: Following the predefined roadmap, a mixed methods design was implemented and incorporated systematic reviews and qualitative consensus methods. Previous systematic reviews identified few clinical signs instruments with sufficient validation for recommendation. An updated systematic review evaluating the validity of clinical signs instruments informed an international meeting to reach consensus on recommended instruments to measure AD clinical signs in clinical practice. Consensus was defined as less than 30% disagreement. An in-person consensus exercise was held in Montreal, Canada, on October 16, 2022. The 34 attendees included patient and patient advocate research partners, health care professionals, researchers, methodologists, and industry representatives. Findings: The updated systematic review found that the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis, and objective Scoring Atopic Dermatitis were the only instruments that demonstrated sufficient performance in all assessed measurement properties. The modified EASI and Signs Global Assessment × Body Surface Area instruments were also recommended. The EASI, Validated Investigator Global Assessment, and Investigator's Global Assessment multiplied by or measured concurrently with a body surface area measure achieved consensus in criteria and were adopted. Conclusions and Relevance: This consensus statement by the Harmonising Outcome Measures for Eczema initiative suggests that when assessing and documenting clinical signs of AD, there are several valid and feasible instruments that can best fit a clinician's specific practice needs. These instruments should improve and standardize the documentation of signs severity, help determine the effect of treatment, facilitate the generation of clinical effectiveness evidence, and enhance the implementation of value-based health care.

Evidence-based and Patient-centered Indication for Knee Arthroplasty - Update of the Guideline. / Evidenzbasierte und patientenorientierte Indikationsstellung zur Knieendoprothese ­ Update der Leitlinie.

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel. For practical use, the checklist has also been updated.For this guideline update, a systematic literature research was conducted in order to analyse (inter-)national guidelines and systematic reviews focusing on osteoarthritis of the knee and knee arthroplasty, to answer clinically relevant questions on diagnostic, predictors of outcome, risk factors and contraindications.Knee arthroplasty should solely be performed in patients with radiologically proven moderate or severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4), after previous non-surgical treatment for at least three months, in patients with high subjective burden with regard to knee-related complaints and after exclusion of possible contraindications (infection, comorbidities, BMI ≥ 40 kg/m2). Modifiable risk factors (such as smoking, diabetes mellitus, anaemia) should be addressed and optimised in advance. After meeting current guideline indications, a shared decision-making process between patients and surgeons is recommended, in order to maintain high quality surgical management of patients with osteoarthritis of the knee.The update of the S2k-guideline was expanded to include unicondylar knee arthroplasty, the preoperative optimisation of modifiable risk factors was added and the main indication criteria were specified.

[Follow-up outpatient clinics for patients with post COVID: a survey to assess and characterize aspects of care]. / Nachsorgeambulanzen für Patient*innen mit Post-COVID: eine Befragung zur Bestandsaufnahme und Charakterisierung von Versorgungsaspekten.

After acute infection with the SARS-CoV-2 virus, up to 10 % of affected individuals suffer from long-term health impairments, also referred to as "Post-COVID". In Germany, specialized outpatient clinics have been established to care for patients with Post-COVID. A structured survey of the care situation is not yet available, but essential for a demand-oriented care. The present study aimed to systematically assess and describe structural and process-related aspects of care, and to perform an inventory and needs analysis of Post-COVID outpatient clinics in Germany.An online survey was developed assessing the structure and organization of the outpatient clinics, service offerings and networking of care from the perspective of the outpatient clinic directors. A total of 95 outpatient clinics were identified, and an invitation to participate in the online survey was sent via e-mail to the directors of the outpatient clinics. Data were collected between February and May 2022. Descriptive data analysis was performed.A total of 28 outpatient clinic managers (29 %) took part in the survey. Participants were between 32 and 66 years old, and 61 % (n = 17) were male. The outpatient clinics were most frequently affiliated with the specialties of pneumology (n = 10; 36 %), internal medicine, psychiatric and psychosomatic medicine, and neurology (n = 8; 29 %, respectively). Among the outpatient clinic directors, 64 % (n = 18) stated that the time spent waiting for an appointment was more than one month. Utilization (n = 25; 89 %), appointment demand (n = 26; 93 %), and the need for more Post-COVID outpatient clinics (n = 20; 71 %) were rated as high by the outpatient clinic directors. Nearly all directors reported networking with in-clinic facilities (n = 27; 96 %), with primary care physicians and with specialists in private practice (n = 21; 75 %, respectively).The main focus of care is pneumology. Internal medicine, psychiatry/psychosomatics and neurology are also equally represented. Our data further suggest a high demand for Post-COVID outpatient clinics and the need to expand this care offer.

Representation of published core outcome sets in practice guidelines.

OBJECTIVES: A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers. Previous work has looked at the uptake of COS in trials, systematic reviews, health technology assessments and regulatory guidance but to date there has been no evaluation of the use of COS in practice guideline development. The objective of this study was to investigate the representation of core outcomes in a set of international practice guidelines. STUDY DESIGN AND SETTING: We searched for clinical guidelines relevant to ten high-quality COS (with focus on the United Kingdom, Germany, China, India, Canada, Denmark, United States and World Health Organisation). We matched scope between COS and guideline in terms of condition, population and outcome. We calculated the proportion of guidelines mentioning or referencing COS and the proportion of COS domains specifically, or generally, matching to outcomes specified in each guideline populations, interventions, comparators and outcome (PICO) statement. RESULTS: We found 38 guidelines that contained 170 PICO statements matching the scope of the ten COS and of sufficient quality to allow data extraction. None of the guidelines reviewed explicitly mentioned or referenced the relevant COS. The median (range) of the proportion of core outcomes covered either specifically or generally by the guideline PICO was 30% (0%-100%). CONCLUSION: There is no evidence that COS are being used routinely to inform the guideline development process, and concordance between outcomes in published guidelines and those in COS is limited. Further work is warranted to explore barriers and facilitators in the use of COS when developing clinical guidelines.

Allergic diseases as risk factors for Long-COVID symptoms: Systematic review of prospective cohort studies.

OBJECTIVE: The role of allergy as a risk factor for Long-COVID (LC) is unclear and has not been thoroughly examined yet. We aimed to systematically review and appraise the epidemiological evidence on allergic diseases as risk factors for LC. DESIGN: This is an initial systematic review. Two reviewers independently performed the study selection and data extraction using Covidence. Risk of bias (RoB) and certainty of evidence (GRADE) were assessed. Random effects meta-analyses were used to pool unadjusted ORs within homogeneous data subsets. DATA SOURCES: We retrieved articles published between January 1st, 2020 and January 19th, 2023 from MEDLINE via PubMed, Scopus, the WHO-COVID-19 database and the LOVE platform (Epistemonikos Foundation). In addition, citations and reference lists were searched. ELIGIBILITY CRITERIA: We included prospective cohort studies recruiting individuals of all ages with confirmed SARS-CoV-2 infection that were followed up for at least 12 months for LC symptoms where information on pre-existing allergic diseases was available. We excluded all study designs that were not prospective cohort studies and all publication types that were not original articles. RESULTS: We identified 13 studies (9967 participants, range 39-1950 per study), all assessed as high RoB, due to population selection and methods used to ascertain the exposures and the outcome. Four studies did not provide sufficient data to calculate Odds Ratios. The evidence supported a possible relationship between LC and allergy, but was very uncertain. For example, pre-existing asthma measured in hospital-based populations (6 studies, 4019 participants) may be associated with increased risk of LC (Odds Ratio 1.94, 95% CI 1.08, 3.50) and findings were similar for pre-existing rhinitis (3 studies, 1141 participants; Odds Ratio 1.96, 95% CI 1.61, 2.39), both very low certainty evidence. CONCLUSIONS: Pre-existing asthma or rhinitis may increase the risk of LC.

[Concepts to support dynamic updating processes of guidelines and their practical implementation-Systematic literature review]. / Konzepte zur Unterstützung dynamischer Aktualisierungsprozesse von Leitlinien und ihre Implementierung in der Praxis ­ systematische Literaturrecherche.

BACKGROUND: Clinical practice guidelines (CPG), which are crucial for evidence-based healthcare, should be kept up to date, especially on topics where emerging evidence could modify one of the recommendations with implications for the healthcare service; however, an updating process, which is practicable for guideline developers as well as users represents a challenge. OBJECTIVE: This article provides an overview of the currently discussed methodological approaches for the dynamic updating of guidelines and systematic reviews. MATERIAL AND METHODS: As part of a scoping review, a literature search was conducted in the databases MEDLINE, EMBASE (via Ovid), Scopus, Epistemonikos, medRxiv, as well as in study and guideline registers. Concepts on the dynamic updating of guidelines and systematic reviews or dynamically updated guidelines and systematic reviews or their protocols published in English or German were included. RESULTS: The publications included most frequently described the following main processes that must be adapted in dynamic updating processes 1) the establishment of continuously working guideline groups, 2) networking between guidelines, 3) the formulation and application of prioritization criteria, 4) the adaptation of the systematic literature search and 5) the use of software tools for increased efficiency and digitalization of the guidelines. CONCLUSION: The transformation to living guidelines requires a change in the needs for temporal, personnel and structural resources. The digitalization of guidelines and the use of software to increase efficiency are necessary instruments, but alone do not guarantee the realization of living guidelines. A process in which dissemination and implementation must also be integrated is necessary. Standardized best practice recommendations on the updating process are still lacking.

Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review.

BACKGROUND: Games and game components have become a major trend in the realm of digital health research and practice as they are assumed to foster behavior change and thereby improve patient-reported and clinical outcomes for patients with type 2 diabetes. OBJECTIVE: The aim of this systematic review was to summarize and evaluate the current evidence on the effectiveness of digital health interventions containing game components on behavioral, patient-reported, and clinical outcomes for patients with type 2 diabetes. METHODS: An electronic search was conducted in MEDLINE and PsycINFO in April 2020; updated in April 2022; and supplemented by additional searches via Google Scholar, Web of Science (which was used for forward citation tracking), and within the references of the included records. Articles were identified using predefined inclusion and exclusion criteria. In total, 2 reviewers independently conducted title, abstract, and full-text screening and then individually performed a critical appraisal of all the included studies using the Cochrane risk-of-bias tool version 2. A consensus was reached through discussion. RESULTS: Of 2325 potentially relevant titles (duplicates excluded), 10 (0.43%) randomized controlled trials were included in this review. Quality assessment revealed a high risk of bias for all randomized controlled trials except for 10% (1/10), with performance bias due to the lack of blinding being the major source of bias. There is evidence suggesting that digital health interventions containing game components can substantially improve motivation for physical activity (1/1, 100% of the studies dealing with PA motivation), exercise intensity (3/5, 60%), dietary behavior (4/4, 100%), health literacy (1/3, 33%), mental quality of life (2/2, 100%), glycated hemoglobin level (2/6, 33%), BMI (1/3, 33%), fasting plasma glucose level (1/2, 50%), waist circumference (1/1, 100%), and aerobic capacity (1/1, 100%). CONCLUSIONS: Published studies indicated that digital health interventions containing game components might improve health behavior patterns, quality of life, and clinical outcomes in patients with type 2 diabetes. However, the intervention types and outcomes studied were heterogeneous, and study quality was mostly low, which translates to ambiguous results. Future research should focus on sound methodology and reporting as well as on identifying game components that contribute to significant positive effects. TRIAL REGISTRATION: PROSPERO CRD42020209706; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=209706.

[Necessity and Ways to Develop Care Goals for the Health System in Germany - a Position Paper of the DNVF]. / Notwendigkeit und Wege zur Entwicklung von Versorgungszielen für das Gesundheitssystem in Deutschland ­ ein Positionspapier des DNVF.

Goals for health and health care are an indispensable basic requirement for a functioning health care system. The dilemma of the German health care system is that it has not been designed in a planned way, but that it has grown historically. In recent years, it has developed through the free play of forces into what it is today. The OECD characterizes the current state as follows: The costs of the German health system do not correspond to the often only average health outcomes for the population. To meet the legal requirements (especially SGB V §§ 12, 27 and 70), health care/the health system in Germany needs concrete goals. An orientation towards health care goals entails measures on all levels of health care: on the macro level (overall system/total population), on the meso level (subdivided according to regions, specific population groups, etc.) as well as on the micro level (patients and health care providers). Based on national and international experiences, this position paper of the DNVF e.V. (German Network for health services research) shows the potential of how operationalised health care targets can ensure effective, affordable and high-quality health care. The coalition agreement of the current government propagates a reorientation with patient-related health care goals. Now it is important to derive concrete and realisable goals from this declaration of intent and to involve all important groups in the process. In addition, values and ethical standards for implementation shall be agreed upon in this process. The Health Ministry (BMG) should facilitate and promote the process of societal will-building for the definition of national health care goals. This requires a clear political will. As a result, the National Health Care Goals are available at the end of the process, which are published and maintained together with evidence-based facts as well as valid and resilient data in a Manual "National Health Care Goals". The operational responsibility for implementation could lie with the newly to be founded Federal Institute of Public Health, as already announced in the agreement of the governing coalition. The DNVF is willing to actively participate in the development of health care targets.

[The Delphi technique: Methodology, variants and usage examples]. / Das Delphi-Verfahren: Methodik, Varianten und Anwendungsbeispiele.

In the field of medicine and health sciences, Delphi methods are applied mainly in the exploratory or evaluative phases of a research process. Explicit and implicit knowledge of respected experts from research and practice is systematically synthesized. Originally developed as a method for structuring a group communication process, Delphi techniques have been established in the health sector as a consensus method. The findings are used to improve the evidence and acceptance of planned interventions or necessary standards or guidelines and to increase the probability of successful implementation in practice. However, different variants of Delphi methods have been developed in recent years, which are systematically contrasted and reflected in this paper with regard to key epistemological and methodological research activities. Based on this overview, researchers should be enabled to select the most suitable Delphi technique for their own research questions and research endeavors.

Indication Criteria for Total Hip Arthroplasty in Patients with Hip Osteoarthritis-Recommendations from a German Consensus Initiative.

Background: Osteoarthritis of the hip (hip OA) is a leading cause of pain and disability in elderly people. If non-surgical therapies become ineffective, patients may consider total hip arthroplasty (THA). The biggest challenge in recommending a THA is identifying patients for whom the benefits of this procedure outweigh the potential risks. The aim of this initiative was to develop a clinical practice guideline with accompanying algorithm to guide consultations on THA, supported by a pocket-sized checklist. Methods: The initiative "Evidence- and consensus-based indication criteria for total hip replacement (EKIT-Hip)" used a stepwise approach, starting with an inauguration workshop, where a multidisciplinary German stakeholder panel from various scientific societies agreed on the working process. A Project Coordinating Group (PCG) was formed, and it performed a comprehensive systematic literature search of guidelines and systematic reviews related to the indication criteria for THA, as well as factors influencing outcomes. Based on best-available evidence, preliminary recommendations were formulated by the PCG and discussed with the stakeholder panel during a consensus meeting. In addition, the panel was asked to assess the feasibility of an extracted algorithm and to approve a final checklist. Results: In total, 31 recommendations were approved by 29 representatives of 23 societies. These were used to underpin an algorithm (EKIT-Algorithm), which indicates the minimum requirements for a THA (confirmed diagnosis of hip OA, present and documented individual burden of illness, ineffectiveness of non-surgical therapies, and absence of any contraindications). Once these criteria are fulfilled, further considerations should encompass the medical implications of modifiable risk factors and patients' individual treatment goals, as discussed during shared decision making. The subsequently developed checklist (EKIT-Checklist) lists relevant criteria for decision making. Conclusions: Adherence to the EKIT-Algorithm, conveniently accessed via the EKIT-Checklist, should improve the standardization of decision making leading to a recommendation for THA. By applying minimum requirements and patient-related risk factors, as well as considering patients' individual goals, it is possible to identify patients for whom the benefits of THA may exceed the potential risks.

Total Hip Replacement for Osteoarthritis-Evidence-Based and Patient-Oriented Indications.

BACKGROUND: Total Hip Replacement (THR) belongs to the most common inpatient operations in Germany, with over 240 000 procedures performed per year. 90% of the artificial joints are still functional at 15 years, and up to 60% at 20 years after surgery. It is essential that the indications for such procedures should be uniform, appropriate, and patient-oriented. METHODS: This review is based on publications retrieved by a systematic literature search for national and international guidelines and systematic reviews on the topic of hip osteoarthritis and THR. RESULTS: THR should be performed solely with radiologically demonstrated advanced osteoarthritis of the hip (Kellgren and Lawrence grade 3 or 4), after at least three months of conservative treatment, and in the presence of high subjective distress due to symptoms arising from the affected hip joint. Contraindications include refractory infection, acute or chronic accompanying illnesses, and BMI ≥= 40 kg/m2. Patients should stop smoking at least one month before surgery. In patients with diabetes mellitus, preoperative glycemic control to an HbA1c value below 8% is advisable. It is recommended that patients should lower their weight below a BMI of 30 kg/m2. CONCLUSION: The decision to perform THR should be taken together by both the physician and the patient when the expected treatment benefit outweighs the risks. Evidence suggests that a worse preoperative condition is associated with a poorer surgical outcome.

An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial.

BACKGROUND: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. METHODS: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. DISCUSSION: There is a high potential for transferring the intervention into routine practice if the evaluation is positive. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.

Prenatal Methamphetamine Exposure: Effects on Child Development­A Systematic Review.

BACKGROUND: In Germany, the 12-month prevalence of methamphetamine use among persons aged 15 to 34 is 1.9%. An increasing number of newborns are being born after a prenatal methamphetamine exposure (PME). In 2014, in the German state of Saxony, approximately four out of 1000 newborns were affected. METHODS: This systematic review (Prospero registration number CRD42017060536) includes publications that were published between January 1990 and November 2019. The purpose was to determine the effects of PME on the peri- and neonatal condition of the affected children and on their further long-term development. Observational studies with a control group were included in the review and examined for their methodological quality. RESULTS: 31 publications, which dealt with two prospective and six retrospective cohort studies, were included in the review. The studies involved a total of 4446 mother-child pairs with PME, compared with 43 778 pairs without PME. A metaanalysis revealed that PME was associated with, among other findings, lower birth weight (SMD = -0.348; 95% confidence interval [-0.777; 0.081]), shorter body length (SMD= -0.198 [-0.348; -0.047]), and smaller head circumference (SMD= -0.479 [-1.047; 0.089]). Some differences between the groups with and without PME persist into the toddler years. Moreover, children with PME much more commonly display psychological and neurocognitive abnormalities, which are more severe in children growing up in problematic surroundings (discord, violence, poverty, low educational level of the parent or caregiver). A limitation of this review is that not all studies employed an objective or quantitative measure of methamphet - amine use. CONCLUSION: The documented effects of PME on child development necessitate early treatment of the affected expectant mothers, children, and families. Emphasis should be placed on structured and interdisciplinary preventive measures for methamphetamine use.

[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

International experiences in the development and implementation of guideline-based quality indicators: a qualitative study.

OBJECTIVES: Evidence-based clinical guidelines play an important role in healthcare and can be a valuable source for quality indicators (QIs). However, the link between guidelines and QI is often neglected and methodological standards for the development of guideline-based QI are still lacking. The aim of this qualitative study was to get insights into experiences of international authors with developing and implementing guideline-based QI. SETTING: We conducted semistructured interviews via phone or skype (September 2017-February 2018) with guideline authors developing guideline-based QI. PARTICIPANTS: 15 interview participants from eight organisations in six European and North American countries. METHODS: Organisations were selected using purposive sampling with a maximum variation of healthcare settings. From each organisation a clinician and a methodologist were asked to participate. An interview guide was developed based on the QI development steps according to the 'Reporting standards for guideline-based performance measures' by the Guidelines International Network. Interviews were analysed using qualitative content analysis with deductive and inductive categories. RESULTS: Interviewees deemed a programmatic approach, involvement of representative stakeholders with clinical and methodological knowledge and the connection to existing quality improvement strategies important factors for developing QI parallel to or after guideline development. Methodological training of the developing team and a shared understanding of the QI purpose were further seen conducive. Patient participation and direct patient relevance were inconsistently considered important, whereas a strong evidence base was seen essential. To assess measurement characteristics interviewees favoured piloting, but often missed implementation. Lack of measurability is still experienced a serious limitation, especially for qualitative aspects and individualised care. CONCLUSION: Our results suggest that developing guideline-based QI can succeed either parallel to or following the guideline process with careful planning and instruction. Strategic partnerships seem key for implementation. Patient participation and relevance, measurement of qualitative aspects and piloting are areas for further development. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00013006).

Impact of regionalisation and case-volume on neonatal and perinatal mortality: an umbrella review.

OBJECTIVE: This umbrella review summarises and critically appraises the evidence on the effects of regulated or high-volume perinatal care on outcome among very low birth weight/very preterm infants born in countries with neonatal mortality <5/1000 births. INTERVENTION/EXPOSITION: Perinatal regionalisation, centralisation, case-volume. PRIMARY OUTCOMES: Death. SECONDARY OUTCOMES: Disability, discomfort, disease, dissatisfaction. METHODS: On 29 November 2019 a systematic search in MEDLINE and Embase was performed and supplemented by hand search. Relevant systematic reviews (SRs) were critically appraised with A MeaSurement Tool to Assess systematic Reviews 2. RESULTS: The literature search revealed 508 hits and three SRs were included. Effects of perinatal regionalisation were assessed in three (34 studies) and case-volume in one SR (6 studies). Centralisation has not been evaluated. The included SRs reported effects on 'death' (eg, neonatal), 'disability' (eg, mental status), 'discomfort' (eg, maternal sensitivity) and 'disease' (eg, intraventricular haemorrhages). 'Dissatisfactions' were not reported. The critical appraisal showed a heterogeneous quality ranging from moderate to critically low. A pooled effect estimate was reported once and showed a significant favour of perinatal regionalisation in terms of neonatal mortality (OR 1.60, 95% CI 1.33-1.92). The qualitative evidence synthesis of the two SRs without pooled estimate suggests superiority of perinatal regionalisation in terms of different mortality and non-mortality outcomes. In one SR, contradictory results of lower neonatal mortality rates were reported in hospitals with higher birth volumes. CONCLUSIONS: Regionalised perinatal care seems to be a crucial care strategy to improve the survival of very low birth weight and preterm births. To overcome the low and critically low methodological quality and to consider additional clinical and patient-reported results that were not addressed by the SRs included, we recommend an updated SR. In the long term, an international, uniformly conceived and defined perinatal database could help to provide evidence-based recommendations on optimal strategies to regionalise perinatal care. PROSPERO REGISTRATION NUMBER: CRD42018094835.

Correction to: Guideline-based quality indicators-a systematic comparison of German and international clinical practice guidelines.

An amendment to this paper has been published and can be accessed via the original article.

Do drug-related safety warnings have the expected impact on drug therapy? A systematic review.

PURPOSE: The need for drug-related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. METHODS: Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case-control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. RESULTS: Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the "psychotropic drugs" group (23%) than in the "others" group (53%). CONCLUSION: Drug-related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.

[(How) Are quality indicators for measuring and appraising the quality of healthcare derived from evidence-based clinical practice guidelines? A review]. / (Wie) Erfolgt die Ableitung von Qualitätsindikatoren zur Messung und Bewertung der Versorgungsqualität im Rahmen von S3-Leitlinien? Eine Übersichtsarbeit.

BACKGROUND: Evidence-based and formally consensus-based clinical practice guidelines (CPGs) offer potential for the development of quality indicators (QIs). Although QIs are recommended as part of some CPGs, there is no accepted gold standard for the specific development process of guideline-based QIs. The purpose of this review, which is embedded in a mixed-methods research project, was to analyze the current state of methodological approaches for QI development in German CPGs to derive insights for the development of a national evidence-guided and consensus-based standard for guideline-based development of QIs. METHODS: In order to identify valid CPGs containing recommendations for QIs, a search was carried out (July 31, 2016) via the guideline database of the German Association of the Scientific Medical Societies (AWMF). Based on a stratified random sample per guideline program (guidelines published by medical societies, National Program for Disease Management Guidelines (DMG), and the German Guideline Program in Oncology [GGPO]), 11 CPGs were selected. With regard to QIs, the specific development methodology, indications on their psychometric properties and how the quality of care should be examined by recommended QIs were extracted and compared by using the guideline documents. RESULTS: In 35 of the 109 (16/85 medical societies, 4/8 DMG, 15/16 GGPO) (32 %) valid CPGs, a total of 372 QIs were recommended. Based on 11 randomly selected guidelines (5 published by medical societies, 1 DMG, 5 GGPO; a total of 109 QIs), the QI development methodology was inconsistent in all five medical societies guidelines (including QI presentation, usage and selection of guideline recommendations for QI derivation) compared to DMG and GGPO. Based on all 109 QIs, 2 (2 %) were presented as a quantitative measure with a reference range, and quality objectives were formulated for 17 (16 %). There was no guideline explicitly reporting about the results of a pilot study or data-based analysis of the psychometric properties of the recommended QIs. The GGPO guideline documents were the only ones providing information on the assessment of the quality of care based on recommended QIs. DISCUSSION: The usage of the QI manuals of the DMG and GGPO leads to a largely standardized development of guideline-based QIs. In the CPGs of the medical societies - if at all - QIs are developed inconsistently and mostly unsystematically. Due to largely missing reference ranges and quality objectives, the identified QIs cannot yet be used to transparently identify potential quality deficits in health care. This requires results of pilot studies and further development of guideline-based QI. CONCLUSIONS: A standard for QI development is needed for German guideline authors to seize the opportunity and develop clinically relevant, widely accepted and evidence-based QIs in the guideline development process. In addition, it must be ensured that appropriate structures are used or set up in order to be able to apply the recommended QIs in the German healthcare system.