Käthe Goossen

Background: Patient involvement (PI) in the development of clinical practice guidelines (CPGs) is recognized as a key aspect of trustworthy and high‐quality CPGs. However, difficulties exist and PI is not yet consistently implemented in the development of CPGs. Our study aimed at exploring the experiences and perspectives of patients and their representatives regarding their involvement in CPG development processes and to unravel existing challenges. Methods: Qualitative semi‐structured interviews were conducted with patient representatives who already participated in the development of a German evidence‐ and consensus‐based CPG. The interviews were conducted using a semi‐structured interview guide developed a priori. They took place via the online meeting tool WebEx and were digitally recorded. The interview data was analyzed using qualitative content analysis as described by Mayring using MAXQDA. Results: In total, we conducted 23 interviews from November 2024 to February 2025. Participation in CPG development processes as active and contributing member of the guideline development group was emphasized as the dominating involvement strategy. For a positive PI experience, participants emphasized several influencing factors such as preparatory training, participation of other patient representatives, and appreciation from other guideline group members. Moreover, several challenges were anticipated for the future, for instance the recruitment of patients as well as the need for a more inclusive and diverse involvement. Discussion: Our study found that overall participants were satisfied with the predominant involvement method of acting as participatory members in the guideline development group. Nevertheless, the findings also revealed certain unmet needs. Preparatory activities, such as targeted training sessions or meetings, were identified as essential and should become standard practice. To ensure equitable implementation, CPG developers should consider taking responsibility for preparing patient representatives to participate effectively, rather than relying on patient organizations for this.

Purpose: Our objective was to update the evidence-based and consensus-based recommendations for the initial surgical management of upper extremity injuries in patients with suspected multiple and/or severe injuries based on current evidence. This guideline topic is part of the 2025 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries. Methods: MEDLINE and Embase were systematically searched to September 2024. Further literature reports were obtained from clinical experts. Randomised controlled trials (RCTs) or observational studies reporting risk-adjusted outcomes were included if they compared early versus delayed surgical treatment for fractures, vascular injuries, or nerve injuries affecting the upper extremities in patients with multiple and/or severe injuries. Studies comparing limb salvage versus amputation or comparing amputation criteria for the upper extremities were also included. We considered patient-relevant outcomes such as mortality and limb salvage, as well as the sensitivity and specificity of scores for predicting upper extremity amputation. Risk of bias was assessed at the outcome level using ROBINS-I for observational studies and AMSTAR-2 for systematic reviews. We used available meta-analyses if possible; alternatively, we synthesised the evidence narratively. We used GRADE to rate the certainty of evidence. Expert consensus was used to develop recommendations and determine their strength. Results: Among 2498 records screened for eligibility, four studies were included. Observational studies addressed the timing of humeral fixation, the timing of revascularisation, or compared limb salvage with amputation. A systematic review evaluated scoring systems for mangled upper limb salvage. Four recommendations were modified, and one consensus-based recommendation was added. All five recommendations achieved strong consensus. Conclusion: The timing of surgical intervention for upper extremity injuries in polytrauma patients should be individualized, based on the patient’s physiological status, injury pattern, and the risks and benefits of early versus delayed surgery. Although early surgery may improve functional outcomes and reduce complications, adequate patient stabilization is essential before proceeding. Limb salvage should be attempted for patients with a MESS score of less than seven, provided the patient is sufficiently stable and depending on the condition of the amputated limb.Although the guideline addresses patients with multiple and/or severe injuries, the scarce evidence, heterogeneity of the included studies and the limited representation of true polytrauma cohorts may restrict the applicability of the findings to the broader critically injured trauma population.

Purpose Our aim was to update the evidence-based and consensus-based recommendations on criteria for transport and destination hospital for patients with suspected multiple and/or severe injuries based on available evidence. This guideline topic is part of the 2025 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries. Methods MEDLINE and Embase were systematically searched to January/February 2024. Further literature reports were obtained from clinical experts. Randomised controlled trials (RCTs) or observational studies reporting risk-adjusted outcomes were included if they compared different transport strategies or destination hospitals for patients with (suspected) multiple and/or severe injuries. We considered patient-relevant outcomes such as mortality and neurological outcomes. Risk of bias was assessed at outcome level using ROBINS-I for observational studies and RoB 2 for RCTs. We conducted meta-analyses if possible; alternatively, we synthesised the evidence narratively. We used GRADE to rate the certainty of evidence. Expert consensus was used to develop recommendations and determine their strength. Results A total of 127 studies were identified. They addressed helicopter vs. ground emergency medical services (EMS) transport, ground EMS with vs. without a physician, on-scene time, and handover on arrival at the hospital. Studies on destination hospitals have compared trauma centres at different levels, the nearest hospital vs. higher-level trauma centres, or hospitals with specialised services for trauma patients in general or specific subgroups, among others. Four recommendations were modified and five additional recommendations were developed. The guideline panel rejected one proposed recommendation. All accepted recommendations (n=8) achieved strong consensus. Conclusion The key recommendations are summarised as follows: 1. For the prehospital management of severe trauma, helicopter emergency medical services should be deployed, taking into account operational and tactical considerations. 2. Prolong the on-scene time only to perform indicated, stabilising therapeutic interventions. 3. For patients with penetrating or perforating torso trauma, keep the prehospital rescue time as short as possible. 4. Transport patients with severe blunt trauma primarily to a regional or supraregional trauma centre. 5. Transport patients with penetrating or perforating trauma to the nearest appropriate hospital capable of providing definitive haemorrhage control. 6. Patients with severe traumatic brain injury should primarily be transported to the nearest trauma centre with 24-hour availability of neurotraumatological expertise. 7. The following patients should be transported to a supraregional trauma centre: • Patients with unstable pelvic fractures and hemodynamic instability; • Patients with neurological deficits following spinal injury. 8. Use a standardized handover concept in the trauma bay.

Purpose: Our aim was to update the evidence-based and consensus-based recommendations for prehospital coagulation management and fluid replacement therapy in patients with multiple and/or severe injuries on the basis of current evidence. This guideline topic is part of the 2022 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries. Methods: MEDLINE and Embase were systematically searched to May 2021. Further literature reports were obtained from clinical experts. Randomised controlled trials, prospective cohort studies, and comparative registry studies were included if they compared interventions for fluid replacement therapy, the transfusion of blood products, the management of coagulation, or intravenous/intraosseous access in patients with multiple and/or severe injuries in the prehospital setting. We considered patient-relevant clinical outcomes such as mortality and bleeding control, or coagulation parameters as surrogate outcomes. Risk of bias was assessed using NICE 2012 checklists. The evidence was synthesised narratively, and expert consensus was used to develop recommendations and determine their strength. Results: Thirty-five new studies were identified. Interventions covered were prehospital fluid replacement therapy ( n = 5 studies), infusions ( n = 3), transfusions ( n = 11), coagulation management ( n = 13), and intraosseous access ( n = 2). Four recommendations were modified, and six additional recommendations were developed. All achieved strong consensus. Conclusion: The following key recommendations are made. Fluid replacement therapy should be initiated in severely injured patients. In patients with uncontrolled bleeding, fluid replacement therapy should be limited (MAP of 65 mmHg, SBP of 80 mmHg) in order to maintain minimum haemodynamic stability while not increasing blood loss. In hypotensive patients with suspected isolated or concomitant significant traumatic brain injury, the objective of fluid replacement should be to maintain normal blood pressure (MAP of 85 mmHg, SBP of 110 mmHg). Intravenous access is used in trauma patients. If intravenous access cannot be achieved in trauma patients, intraosseous access is used for the delivery of fluids and medications. If there are no signs and symptoms of volume depletion, fluid replacement therapy should not be provided. If the administration of a sufficient volume of fluids fails to achieve adequate blood pressure in a polytrauma patient, the titrated use of vasopressors for circulatory support may be considered. The lethal triad of hypothermia, acidosis, and coagulopathy should be addressed at the prehospital stage. One gram of tranexamic acid should be administered in cases of existing or imminent haemorrhagic shock. The administration of fibrinogen may also be considered in cases of uncontrollable bleeding, as may the administration of erythrocyte and plasma concentrates.

Introduction: Sports pre‐participation evaluations (PPEs) aim to identify people at increased risk of acute adverse events during physical activity. Little is known about their acceptability and feasibility among physicians and participants (‘interest holders’). During the development of a consensus‐based PPE guideline in Germany targeted at healthy adults who plan to take up or resume intense physical activity, we used surveys to assess interest holder perceptions of the acceptability and feasibility of the PPE, and to obtain their feedback on draft guideline recommendations. Methods: Cross‐sectional online surveys were conducted separately in two interest holder groups. Acceptability was evaluated among adults (≥ 18 years) in Germany (‘consumers’), the target population of the PPE guideline. Feasibility was investigated among potential guideline users, which included sports medicine specialists and general practitioners practising in Germany (‘sports physicians’). Agreement with nine acceptability and feasibility statements was analysed descriptively. Comments on draft recommendations were collected and grouped thematically. Results: A total of 144 consumers and 204 physicians (186 with certification in sports medicine) completed the survey. Among the consumers, 82% would consider making use of a PPE, 8% were neutral, and 10% would not. Only 1% had ‘concerns or reservations’. The main barrier was a potential non‐reimbursement of the PPE by their health insurance (61%). Of the 186 certified sports physicians, 83% would offer or already offer a PPE, 12% were neutral, and 5% would not offer a PPE. Potential barriers were non‐reimbursement by health insurers (20%), the required time and effort (13%), and qualification issues (14%). About half of the draft recommendations (11/23, 48%) were modified based on interest holder feedback. Discussion: Conducting consumer and end‐user surveys as part of the guideline development process increased awareness of the main acceptability and feasibility issues, provided relevant suggestions to the draft recommendations, and identified considerations for guideline implementation.

Purpose: Our aim was to update the evidence-based and consensus-based recommendations for inhospital coagulation management and fluid replacement therapy in patients with multiple and/or severe injuries on the basis of current evidence. This guideline topic is part of the 2022 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries. Methods: MEDLINE and Embase were systematically searched to May 2021. Further literature reports were obtained from clinical experts. Randomised controlled trials, prospective cohort studies, and comparative registry studies were included if they compared interventions for the prevention of acidaemia, hypocalcaemia and hypothermia, for coagulation management, fluid replacement therapy, blood product transfusions, viscoelastic assays, or central venous access in patients with multiple and/or severe injuries in the hospital setting. We considered patient-relevant clinical outcomes, such as mortality and bleeding control, or coagulation parameters as surrogate outcomes. Risk of bias was assessed using NICE 2012 checklists. The evidence was synthesised narratively, and expert consensus was used to develop recommendations and determine their strength. Results: Fifty-nine new studies were identified. Interventions covered were blood products ( n = 19 studies), coagulation management ( n = 14), viscoelastic assays ( n = 12), temperature management ( n = 5), fluid replacement therapy ( n = 4), base excess/lactate ( n = 3), calcium ( n = 1), and intravenous access ( n = 1). Twelve recommendations were modified, and seven additional recommendations were developed. All achieved strong consensus. Conclusion: The key recommendations are summarised as follows. Trauma-induced coagulopathy (TIC) is a distinct clinical entity requiring early diagnostic and therapeutic interventions. Perform viscoelastic assays in order to aid in the diagnosis and treatment of TIC in severely bleeding trauma patients. Since only approximately 20% of trauma patients are hyperfibrinolytic and tranexamic acid is not beneficial in the absence of hyperfibrinolysis, TXA should not be indiscriminately used in all patients in the emergency department. Coagulation factor concentrates as well as TXA are indicated in patients with life-threatening haemorrhage and/or haemorrhagic shock.

Background: Pre-participation evaluation (PPE) aims to support safe participation in sports. The goal of this systematic review was to aggregate evidence- and consensus-based recommendations for the PPE of recreational or competitive athletes as preparation for developing a German guideline on this subject. Methods: Five databases, including MEDLINE, were searched in August 2022, complemented by searches on the websites of relevant guideline organisations and specialty medical associations and citation screening. We included guidelines/consensus statements with recommendations for PPE of adult recreational athletes or competitive athletes of any age, excluding those with certain chronic illnesses. We extracted and synthesised data in a structured manner and appraised quality using selected domains of the AGREE-II tool. Results: From the 6611 records found, we included 35 documents. Overall, the quality of the included documents was low. Seven documents (20%) made recommendations on the entire PPE process, while the remainder focussed on cardiovascular screening (16/35, 45.7%) or other topics. We extracted 305 recommendations. Of these, 11.8% (36/305) applied to recreational athletes and 88.2% (269/305) applied to athletes in organised or competitive sports. A total of 12.8% (39/305) of recommendations were directly linked to evidence from primary studies. Conclusion: Many recommendations exist for PPE, but only a few are evidence based. The lack of primary studies evaluating the effects of screening on health outcomes may have led to this lack of evidence-based guidelines and contributed to poor rigour in guideline development. Future guidelines/consensus statements require a more robust evidence base, and reporting should improve. Registration: PROSPERO CRD42022355112.

Introduction: Patient involvement (PI) is a key element of clinical practice guidelines (CPGs). However, PI in CPGs often falls short of quality standards. For evidence‐ and consensus‐based CPGs in Germany, a study in 2018 showed that a mere 58% had included a patient (participation), 56% with voting right. We aimed to provide an update on whether and how patients were involved in CPGs (participation and consultation), on the availability of patient versions (PVGs) (communication) and to investigate whether CPGs in Germany adhere to the RIGHT checklist.Methods: An electronic search on the Register of the Association of Scientific Medical Societies was performed. Eligibility criteria were defined a priori. We included evidence‐ and consensus‐based CPGs valid on 31 March 2023. A data extraction form including 35 items was designed and piloted. Five researchers independently extracted data from CPGs, methodology reports and PVGs. Data were analysed descriptively.Results: The search identified 135 CPGs meeting the eligibility criteria. Participation has increased to 79% (107/135 CPGs), in 73% of CPGs (98/135) with voting right. Participation was more common in CPGs for chronic than acute conditions (76/86 CPGs, 88% chronic vs. 23/38 CPGs, 61% acute). Consultation was scarcely employed (3/135 CPGs, 2%). Communication, operationalised as PVGs being available on the internet, increased from 33% (35/105) in 2018 to 43% (58/135) in 2023. 26% of CPGs (28/107) with participation reported on patients' selection as required by the RIGHT checklist.Discussion: PI has improved, although around 20% of CPGs were still developed without participation. This applies in particular to CPGs on acute conditions where PI should be strengthened. At the same time, innovative and efficient methods for consultation and for evaluating patients' impact are required. Moreover, communication should be expanded. To further improve transparency in CPGs, guideline development groups should specifically report on patients' recruitment and selection.