Patient safety indicators are core measures for improving healthcare. We aimed to conceptualize the prioritization of such indicators and the requirements for developing a core set of nationwide, valid, low-bureaucracy patient safety indicators. We also aimed to develop a decision aid for adapting the core set to strengthen the resilience of healthcare provision with respect to crisis situations and to identify factors related to successful implementation. A hybrid focus group design of 4 guided online focus group interviews was used by combining a semi-structured discussion and supporting materials, including questionnaires. The data were analyzed using content and descriptive analysis. A framework for prioritizing patient safety indicators for core set development and adaptation was developed. Indicator prioritization is guided by the aim of the core set, considering stakeholders' needs, potential for improvement, context of use, scientific quality, and implementability criteria. Together with the requirement criteria, such as patient safety dimensions, the breadth and depth of the indicator set can be defined. The developed decision aid for crisis events was deemed suitable for maintaining patient safety. A modular system is recommended for the adaptation of the core set to address several different indicator measurement scenarios. The developed framework and decision aid allow context-(in)dependent prioritization on the basis of the criteria for prioritizing patient safety indicators for a core indicator set and for indicator decision-making in adapting the core set for crisis events. Further real-world validation of the framework and decision aid and the associated criteria is recommended.

BACKGROUND:Neurocardiac autonomic impairment with reduced heart rate variability (HRV) has been linked to SARS-CoV-2 infection and may persist in patients with post-COVID-19 syndrome. We synthesised meta-analytic data on HRV in post-COVID-19 syndrome. METHODS:Our systematic review and meta-analysis were guided by PRISMA standards. We used MEDLINE, Embase and Web of Science to identify non-randomised studies of HRV in patients with post-COVID-19 syndrome, conducted more than 3 months after infection and compared with healthy controls. The search covered the period from 01/2020 to 09/2023. We pooled data on the following HRV parameters: standard deviation of normal-to-normal intervals (SDNN), root mean square of successive differences (rMSSD) and low-frequency to high-frequency ratio (LF/HF ratio). We applied a random effects model to account for heterogeneity. Risk of bias was assessed. RESULTS:From 856 initially identified records, we included 11 studies with a total of 1162 participants (593 post-COVID-19 patients and 565 healthy controls). We observed a trend toward lower HRV in post-COVID patients compared to controls, with small to medium effects for SDNN (SMD: 0.26, 95% CI: -0.03 to 0.56, p = 0.09), rMSSD (SMD: 0.11, 95% CI: -0.15 to 0.36, p = 0.41) and LF/HF ratio (SMD: -0.271, 95% CI: -0.61 to 0.07, p = 0.12). Moderate to high statistical heterogeneity of the effects was observed (I2 = 83% for SDNN and 78% for rMSSD) and nine of 11 studies had a high risk of bias. CONCLUSION:This meta-analysis suggests a possible association between post-COVID condition and alterations in neurocardiac autonomic function.

Abstract Background Trochanteric femoral fractures (TFFs) are frequent injuries in older adults, with unstable patterns (AO/OTA 31-A2 and A3) carrying a higher risk of complications. Intramedullary nailing (IMN) and sliding hip screw (SHS) are the two main surgical options. However, guideline recommendations differ, and prior meta-analyses are limited. This study aimed to systematically compare the efficacy and safety of IMN versus SHS in treating adult patients with unstable TFFs based on randomized controlled trials (RCTs). Methods MEDLINE, Embase, and CENTRAL (January 2008–March 2025) were searched for eligible RCTs, which included adults with 31-A2 or A3 fractures randomized to IMN or SHS. Primary outcomes were mortality and reoperation. Secondary outcomes included implant failures, nonunion, surgical parameters, and postoperative mobility, pain, and function. Risk of bias (RoB) was assessed using RoB 2, and the certainty of evidence (CoE) with GRADE. Results Eighteen RCTs (n = 3237 patients) were included. No significant differences were found between IMN and SHS in three-month (low CoE) and 12-month mortality (moderate CoE). Reoperation rates trended higher with SHS, but not significantly (pooled OR = 1.70; 95% CI, 0.97–2.97; low CoE). SHS was associated with higher rates of arthroplasty conversion (pooled OR 1.92; 95% CI 1.00–3.68; low CoE), nonunion (pooled OR 1.93; 95% CI 1.12–3.34; low CoE), and infection (pooled OR 2.20; 95% CI 1.29–3.74; low CoE), while implant failure did not differ significantly (pooled OR 1.35; 95% CI 0.91 to 2.01; low CoE). IMN was associated with higher functional scores, less pain (within three months), and a greater likelihood of regaining pre-fracture mobility (CoE low- moderate). Conclusions IMN demonstrated comparable mortality to SHS. Although overall reoperation rates did not differ significantly, IMN was associated with lower odds of arthroplasty conversion, nonunion, and infection, as well as reduced early postoperative pain and improved early postoperative function. However, given the overall low to moderate CoE, these findings should be interpreted with caution. Implant selection should remain individualized, taking into account patient characteristics, fracture morphology, and surgeon experience.

Pertrochanteric femoral fractures account for approximately half of all hip-related fractures and are associated with a significant loss of mobility and quality of life as well as a high mortality risk within the first year. The increasing incidence of these fractures is primarily attributed to demographic changes in our aging society. The majority of these injuries, also referred to as fragility fractures, result from low-energy trauma and are often facilitated by reduced bone quality due to osteoporosis. Globally, the incidence of proximal femoral fractures is projected to quadruple from 1.7 million cases per year in 1990 to 6.3 million cases per year by 2050. For pertrochanteric femoral fractures the gender distribution is 69% female and 31% male and the age distribution is 13% under 70 years and 87% over 70 years. This article provides a short overview on the most important surgical and interdisciplinary treatment aspects for the care of older patients with pertrochanteric femoral fractures.

A substantial proportion of patients remain dissatisfied following total knee replacement (TKR), possibly due to a lack of standardised indication criteria and inadequate incorporation of patients’ preoperative expectations. Therefore, a practice guideline for TKR indication was developed to ensure the careful selection of patients suitable for this procedure. Based on this guideline, we developed a personalised digital decision aid (EKIT tool) to support implementing its recommendations and to improve shared decision-making (SDM) in routine care. This study explored patients’ and orthopaedic surgeons’ perceptions of the EKIT tool’s facilitators and barriers. This descriptive qualitative study was nested in a randomised controlled trial that assessed the effectiveness of the EKIT tool. We conducted semi-structured telephone interviews with patients considering TKR and orthopaedic surgeons, focusing on themes such as usability, comprehensibility, and perceived usefulness, which we used to identify facilitators and barriers of the EKIT tool. The interviews were transcribed verbatim and analysed using qualitative content analysis. Seventeen participants were interviewed: nine patients and eight orthopaedic surgeons. Both groups highlighted the EKIT tool’s positive impact on SDM as a major facilitator. The orthopaedic surgeons emphasised that the EKIT tool enhanced the implementation of a structured, patient-centred and guideline-based consultation, facilitated clearer communication regarding patients’ expectations and included a thorough consideration of their possible achievement by TKR. The patients also emphasised the importance of addressing individual expectations during consultations. Those patients who had already made their decision before the consultation reported lower perceived usefulness of the EKIT tool but felt validated and more confident in their decisions. Main barriers reported by the orthopaedic surgeons were the time required and patient-related factors such as heterogeneous information needs and moderate health literacy. Some patients felt overwhelmed by the amount of health information provided. The EKIT tool has great potential for patients and orthopaedic surgeons to improve SDM in TKR consultations, appears to increase an informed decision for patients who are undecided, and increases confidence for patients who have already decided. All barriers can be addressed, leading to an optimised EKIT tool.

In Germany, statutory health insurance reimburses digital health applications (DiGAs) approved by the Federal Institute for Drugs and Medical Devices (BfArM). Permanent approval requires evidence of positive healthcare effects, either medical benefits or patient-relevant improvements in structures and processes (pSVV). This systematic review analyzed all 23 DiGA approval studies available as of March 15, 2024. The studies, conducted between 2012 and 2022, included 56 to 1245 participants and intervention durations from 1.5 to 12 months. Drop-out rates varied (mean 21.7% in intervention, 11.8% in control group). Most studies (13/23) focused on primary outcomes related to mental health conditions; one addressed pSVV. All reported significant medium to large effects, but risk of bias was high, particularly in outcome measurement (21/23) and due to missing data (15/23). These findings raise concerns about the robustness of the evidence supporting DiGA efficacy. The review recommends revising the DiGA approval process to enhance study quality. The systematic review was registered prospectively with PROSPERO https://www.crd.york.ac.uk/prospero/ (CRD42023460497).

Background:The sharing of health data (HD) remains intensely debated, such as in the context of the European Health Data Space. While HD sharing has great potential, the factors influencing patients' willingness to share their HD remain unclear. Understanding patients' perspectives is crucial to enhancing their motivation to share their HD, both with healthcare providers (primary use [PU]) and for purposes unrelated to patient care (secondary use [SU]). Objective:This overview of systematic reviews (SRs) synthesizes and qualitatively appraises available research on factors affecting patients' willingness to share their digital HD for PU and SU. Methods:The MEDLINE, Embase, and Scopus literature databases were searched in June 2023, complemented by additional searches, to identify SRs focusing on the determinants of patients' willingness to share HD published from 2013 to 2023. SRs underwent a multistage screening process using the inclusion and exclusion criteria based on the Population, Concept/Construct, and Context (PCC) framework, followed by data extraction and quality assessment using revised measurement tool to assess systematic reviews (R-AMSTAR2). Factors were categorized through a combined deductive-inductive thematic coding process, considering theories on HD sharing and technology acceptance. Results:Eleven SRs published between 2014 and 2021 were included, encompassing 321 articles with diverse study designs. Forty-one influencing factors (labeled as facilitators, barriers and inconsistent for unclassifiable factors) were identified and grouped into 15 main categories: 22 facilitators, nine barriers, and four inconsistent factors for PU and 13 facilitators, six barriers, and six inconsistent factors for SU. The key facilitators for PU and SU included higher education, trust, confidentiality, and transparency. The major barriers for PU and SU were privacy and security concerns. The R-AMSTAR2 overall confidence rating of all SRs was critically low. Conclusion:Our findings highlight modifiable and nonmodifiable factors affecting patients' willingness to share their HD. Policymakers and healthcare providers should focus on modifiable factors such as individual usefulness, public benefit, and privacy and security concerns. High-quality SRs are urgently needed to provide reliable recommendations and to develop a holistic, practical framework. Protocol registration number:CRD42023429302.

Long COVID, Post COVID Syndrome or PASC (post-acute sequelae of COVID-19), according to the World Health Organization (WHO), is defined as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation. The term Long COVID will be used throughout this review. Little is known about individuals with pre-existing mental health conditions experiencing Long COVID. This scoping review aims to provide an overview of these individuals, focusing on: 1) the course of mental disorders, 2) care needs, 3) utilization of healthcare services, and 4) psychosocial aspects, as outlined by the International Classification of Functioning (ICF). This review followed the JBI (Joanna Briggs Institute) methodology for scoping reviews and the PRISMA extension for scoping reviews. We included reports focusing on individuals with at least one pre-existing mental health diagnosis and Long COVID. Full-text reports in English or German were included, with no geographical limitations. Literature searches were conducted in PubMed, Embase, and PsycINFO on November 1, 2023, for records published between January 2020 and October 2023. Six reviewers participated in the screening process in pairs, independently conducting study selection and data extraction. Conflicts were resolved by consensus. Citation tracking was performed, and data were summarized narratively in tables. From 4256 initial hits and citation tracking, 8 reports were included. The studies were heterogeneous, including chart reviews, case reports, cross-sectional, and longitudinal studies. Evidence on the impact of Long COVID on pre-existing mental health conditions was inconsistent. Most findings focused on the course of mental health disorders, ranging from symptom worsening to new symptoms of anxiety, depression, or insomnia. Evidence on mental health care needs, service utilization, and psychosocial aspects was limited. Limited evidence suggests that individuals with pre-existing mental health disorders who experience Long COVID may be at an increased risk of worsening mental health. However, critical aspects such as care needs, service utilization, and psychosocial factors remain under-researched, highlighting the need for further studies on mental health care for Long COVID. Open Science Framework https://osf.io/tqexa . Not applicable.

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.

ImportanceOutcome 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.ObjectiveTo recommend instruments to measure clinical signs of AD in clinical practice.Evidence ReviewFollowing 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.FindingsThe 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 RelevanceThis 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.

ZusammenfassungNach akuter Infektion mit dem SARS-CoV-2-Virus leiden bis zu 10 % der Erkrankten an längerfristigen gesundheitlichen Beeinträchtigungen, dem sogenannten „Long-COVID-Syndrom“. Zur Versorgung dieser Patient*innen wurden in Deutschland spezialisierte Ambulanzen eingerichtet. Eine strukturierte Erfassung der Versorgungssituation ist für eine bedarfsgerechte Versorgung essenziell. Ziel der vorliegenden Studie ist strukturelle und prozessbezogene Versorgungsaspekte von Long-COVID-Ambulanzen in Deutschland darzustellen.Mittels Online-Befragung wurden Aspekte wie Struktur und Organisation der Ambulanzen, Leistungsangebote und Vernetzung der Versorgung erhoben. Insgesamt konnten 95 Ambulanzen identifiziert werden. Die Einladung der Ambulanzleiter*innen zur Teilnahme an der Befragung erfolgte per E-Mail. Die Datenerhebung fand zwischen Februar und Mai 2022 statt. Die Auswertung der Daten erfolgte deskriptiv.Insgesamt haben 28 Ambulanzleiter*innen (29 %) an der Umfrage teilgenommen. Die Befragten waren zwischen 32 und 66 Jahre alt; 61 % davon (n = 17) waren männlich. Die Ambulanzen waren am häufigsten an die Fachbereiche Pneumologie (n = 10; 36 %), Innere Medizin, Psychiatrie und Psychosomatische Medizin sowie Neurologie (jeweils n = 8; 29 %) angegliedert. Nach Aussage der Ambulanzleiter*innen betrug die Wartezeit auf einen Termin in 64 % der Fälle (n = 18) mehr als einen Monat. Die Auslastung (n = 25; 89 %), die Terminnachfrage (n = 26; 93 %) sowie der Bedarf an weiteren Post-COVID-Ambulanzen (n = 20; 71 %) wurden von den Befragten als hoch bewertet. Nahezu alle Ambulanzleiter*innen gaben an, mit klinikinternen Einrichtungen (n = 27; 96 %) sowie Haus- und niedergelassenen Fachärzt*innen (jeweils n = 21; 75 %) vernetzt zu sein.Die Ergebnisse zeigen einen Schwerpunkt der Versorgung im Bereich der Pneumologie sowie zu gleichen Teilen in der Inneren Medizin, Psychiatrie/Psychosomatik und Neurologie. Weiterhin weisen die Ergebnisse auf einen hohen Bedarf an Post-COVID-Ambulanzen und die Notwendigkeit des Ausbaus dieses Versorgungsangebotes hin.

BACKGROUND:While different proposals exist for a guideline on reporting Delphi studies, none of them has yet established itself in the health and social sciences and across the range of Delphi variants. This seems critical because empirical studies demonstrate a diversity of modifications in the conduction of Delphi studies and sometimes even errors in the reporting. The aim of the present study is to close this gap and formulate a general reporting guideline. METHOD:In an international Delphi procedure, Delphi experts were surveyed online in three rounds to find consensus on a reporting guideline for Delphi studies in the health and social sciences. The respondents were selected via publications of Delphi studies. The preliminary reporting guideline, containing 65 items on five topics and presented for evaluation, had been developed based on a systematic review of the practice of Delphi studies and a systematic review of existing reporting guidelines for Delphi studies. Starting in the second Delphi round, the experts received feedback in the form of mean values, measures of dispersion, a summary of the open-ended responses and their own response in the previous round. The final draft of the reporting guideline contains the items on which at least 75% of the respondents agreed by assigning scale points 6 and 7 on a 7-point Likert scale. RESULTS:1,072 experts were invited to participate. A total of 91 experts completed the first Delphi round, 69 experts the second round, and 56 experts the third round. Of the 65 items in the first draft of the reporting guideline, consensus was ultimately reached for 38 items addressing the five topics: Title and Abstract (n = 3), Context (n = 7), Method (n = 20), Results (n = 4) and Discussion (n = 4). Items focusing on theoretical research and on dissemination were either rejected or remained subjects of dissent. DISCUSSION:We assume a high level of acceptance and interdisciplinary suitability regarding the reporting guideline presented here and referred to as the "Delphi studies in social and health sciences-recommendations for an interdisciplinary standardized reporting" (DELPHISTAR). Use of this reporting guideline can substantially improve the ability to compare and evaluate Delphi studies.

Sharing of health data (HD) is currently under intense debate, for example in the context of the European Health Data Space (EHDS). Although HD sharing holds great potential, the corresponding determinants of patients are still uncertain. Hearing the patients’ voice is therefore crucial to better understand their needs and increase motivation for HD sharing, which is essential for the beneficial utilization of HD with their healthcare providers (known as Primary Use (PU)) and for purposes other than patient care like research (known as Secondary Use (SU)). We conducted an overview of reviews to provide a meta-level synthesis on the research question “Which factors influence patients’ willingness to share their digital health data for primary and secondary use?”. This overview has been registered before starting the review (PROSPERO reference CRD42023429302). An electronic literature search was performed in June 2023 using MEDLINE, Embase and Scopus, complemented by additional searches. We included systematic reviews (SRs), published between 2013 and 2023, that focused on determinants influencing patients’ willingness for HD sharing. All initial records were screened in a multi-stage process. After pretesting, the data extraction and quality assessment with R-AMSTAR2 were carried out by one reviewer and verified for accuracy and completeness by a second reviewer. Factors were clustered and categorized following a combined deductive-inductive thematic coding process. As a theoretical basis for category development, available theories on HD sharing and technology acceptance were considered. A total of 11 SRs was included, published between 2014 and 2021, incorporating 321 papers with heterogeneous study designs, mostly quantitative (158/321, 49.2%) and qualitative (108/321, 33.6%). A total of 41 influencing factors compiled into 15 main categories were identified. For PU, 22 factors were found as facilitators, nine as barriers and four could not be clearly assigned. For SU, 13 factors turned out as facilitators, six as barriers and six were inconsistent. The most important facilitators investigated were higher education status as well as trust, confidentiality and transparency on data sharing approaches, both for PU and SU, and higher income for PU only. The most important barriers determined were existing privacy and security concerns and concerns on data processing, both for PU and SU. The R-AMSTAR2 overall confidence rating indicated critically low quality for all included SRs. The review identified modifiable and non-modifiable facilitators and barriers as relevant. If policymakers, healthcare providers or researchers aim to increase the willingness of patients towards HD sharing they should focus on modifiable factors such as expected individual usefulness, public benefit or privacy and security concerns. Due to the critically low quality of all included SRs more high-quality SRs are needed to enable the derivation of reliable, evidence-based recommendations and to develop a holistic framework for practice. PROSPERO: CRD42023429302, registered on 04/06/2023; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=429302

Introduction Pressure injuries are a common and significant concern in clinical practice, often serving as a vital quality indicator. While (clinical) practice guidelines have been established to offer recommendations for mitigating hospital-acquired pressure injuries, adherence among stakeholders remains inconsistent. The subjective perceptions of stakeholders, such as patients and nurses, may impede adherence to pressure ulcer prevention guidelines, potentially reducing the effectiveness of these interventions. However, there is currently insufficient evidence to comprehensively understand this influence. Therefore, this review aims to offer a broader understanding of how the perspectives of patients and nurses engaged in pressure injury prevention affect the effectiveness of specific interventions for pressure ulcer management.Methods and analysis We will conduct a convergent, segregated mixed-methods systematic review and perform a narrative synthesis with a focus on evidence of the effectiveness of pressure injury prevention strategies and patient and nurse perceptions. Our search will encompass several databases, including the 'Centre for Reviews and Dissemination' (CRD) Database, Medline (via Ovid), CINAHL (via Ebsco) and Scopus (via Elsevier). Additionally, we will cross-check reference lists from all included systematic reviews. Two independent reviewers will screen titles, abstracts, and full texts and extract data from the included studies. The quality of methodology of systematic reviews will be assessed using 'A Measurement Tool to Assess Systematic Reviews-2' (AMSTAR 2) and the risk of bias using 'Risk of Bias in Systematic Reviews' (ROBIS). Qualitative studies will undergo critical appraisal using appropriate Joanna Briggs checklists. If it is feasible to pool data from included studies, we will synthesise them accordingly, using meta-analysis for quantitative reviews and meta-aggregation for qualitative studies. The results from both qualitative and quantitative analyses will be compared with derive new recommendations for healthcare practice aimed at enhancing the quality of care.Ethics and dissemination Ethical approval is not required due to the nature of this intended review. The results of this review will be disseminated through publications, reports and conference presentations.PROSPERO registration number CRD42023438792

Background: We studied whether an individualized digital decision aid can improve decision-making quality for or against knee arthroplasty. Methods: An app-based decision aid (EKIT tool) was developed and studied in a stepped-wedge, cluster-randomized trial. Consecutive patients with knee osteoarthritis who were candidates for knee replacement were included in 10 centers in Germany. All subjects were asked via app on a tablet about their symptoms, prior treatments, and preferences and goals for treatment. For the subjects in the intervention group, the EKIT tool was used in the doctor-patient discussion to visualize the individual disease burden and degree of fulfillment of the indication criteria, and structured information on knee arthroplasty was provided. In the control group, the discussion was conducted without the EKIT tool in accordance with the local standard in each participating center. The primary endpoint was the quality of the patient's decision on the basis of the discussion of indications, as measured with the Hip and Knee Quality Decision Instrument (HK-DQI). (Registration number: ClinicalTrials.gov:NCT04837053). Results: 1092 patients were included, and data from 1055 patients were analyzed (616 in the intervention group and 439 in the control group). Good decision quality, as rated by the HKDQI, was achieved by 86.0% of patients in the intervention group and 67.4% of patients in the control group (relative risk, 1.24; 95 % confidence interval, [1.15; 1.33]). Conclusion: A digital decision aid significantly improved the quality of decision-making for or against knee replacement surgery. The widespread use of this instrument may have an even larger effect, as this trial was conducted mainly in hospitals with high case numbers.

Background 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. Methods 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. Results 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/m(2)). 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. Conclusions 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.

Zusammenfassung Die Implantation einer Knieendoprothese zählt mit ca. 170000 Eingriffen pro Jahr zu den am häufigsten stationär durchgeführten Operationen in Deutschland. Eine einheitliche, angemessene und patientenorientierte ärztliche Indikationsstellung ist bei einem solchen Eingriff unerlässlich. Das Update der S2k-Leitlinie „Indikation Knieendoprothese“ beinhaltet auf aktueller Evidenz basierende und im breiten Konsens abgestimmte Empfehlungen und eine Checkliste im praxistauglichen Format. Für dieses Leitlinien-Update wurde eine systematische Literaturrecherche nach (inter-)nationalen Leitlinien und systematischen Übersichtsarbeiten zur Gonarthrose und Knieendoprothetik durchgeführt, um klinisch relevante Fragestellungen zu Diagnostik, Prädiktoren für das Outcome, Risikofaktoren und Kontraindikatoren zu beantworten. Eine Knieendoprothese soll nur bei radiologisch nachgewiesener fortgeschrittener Gonarthrose (Kellgren-Lawrence-Grad 3 oder 4), nach vorangegangener konservativer Therapie über mindestens 3 Monate sowie bei hohem subjektivem Leidensdruck hinsichtlich der kniebezogenen Beschwerden und nach Ausschluss möglicher Kontraindikationen (Infektionen, Begleiterkrankungen, BMI ≥ 40 kg/m2) erfolgen. Modifizierbare Risikofaktoren (wie Rauchen, Diabetes mellitus, Anämie) sollen zuvor adressiert und ggf. optimiert werden. Die Ziele der Patient*innen sollen erfragt und deren Eintrittswahrscheinlichkeit gemeinsam besprochen werden. Schließlich ist die Entscheidung zur Knieendoprothese von Patient*in und Operateur*in gemeinsam zu treffen, wenn der zu erwartende Nutzen die möglichen Risiken überwiegt. Das Update der S2k-Leitlinie wurde um die unikondyläre Knieendoprothese erweitert, die präoperative Optimierung modifizierbarer Risikofaktoren ergänzt sowie Konkretisierungen der Hauptindikationskriterien vorgenommen.