Implementation of quality indicators for vulvar cancer in gynaecological cancer centres certified by the German Cancer Society (DKG).

PURPOSE: In 2018, the first guideline-based quality indicators (QI) for vulvar cancer were implemented in the data-sheets of certified gynaecological cancer centres. The certification process includes guideline-based QIs as a fundamental component. These indicators are specifically designed to evaluate the level of care provided within the centres. This article aims to give an overview of the developing process of guideline based-QIs for women with vulvar cancer and presents the QIs results from the certified gynaecological cancer centres. METHODS: The QIs were derived in a standardized multiple step process during the update of the 2015 S2k guideline "Diagnosis, Therapy, and Follow-Up Care of Vulvar Cancer and its Precursors" (registry-number: no. 015/059) and are based on strong recommendations. RESULTS: In total, there are eight guideline-based QIs for vulvar cancer. Four QIs are part of the certification process. In the treatment year 2021, 2.466 cases of vulvar cancer were treated in 177 centres. The target values in the centres for pathology reports on tumour resection and lymphadenectomy as well as sentinel lymph nodes have increased since the beginning of the certification process and have been above 90% over the past three treatment years (2019-2021). DISCUSSION: QIs based on strong guideline recommendations, play a crucial role in measuring and allowing to quantify essential aspects of patient care. By utilizing QIs, centres are able to identify areas for process optimization and draw informed conclusions. Over the years the quality of treatment of vulvar cancer patients measured by the QIs was improved. The certification system is continuously reviewed to enhance patient care even further by using the outcomes from QIs revaluation.

Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers.

BACKGROUND: People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers' perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers' perspective in Germany. METHODS: Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring's qualitative content analysis with MAXQDA software was utilised to analyse the data. RESULTS: A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants' trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients' knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician-patient talks. Healthcare provider's unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. CONCLUSION: Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician-patient communication.

Application of the PANELVIEW instrument to evaluate the guideline development process of the German polytrauma guideline.

BACKGROUND: PANELVIEW is an instrument for evaluating the appropriateness of the process, methods, and outcome of guideline development and the satisfaction of the guideline group with these steps. OBJECTIVE: To evaluate the guideline development process of the German guideline on the treatment of patients with severe/multiple injuries ('German polytrauma guideline') from the perspective of the guideline group, and to identify areas where this process may be improved in the future. METHODS: We administered PANELVIEW to the participants of the 2022 update of the German polytrauma guideline. All guideline group members, including delegates of participating medical societies, steering group members, authors of guideline chapters, the chair, and methodological lead, were invited to participate. Responses were analysed using descriptive statistics. Comments received were categorised by domains/items of the tool. RESULTS: After the first, second, and last consensus conference, the guideline group was invited via email to participate in a web-based survey. Response rates were 36% (n/N = 13/36), 40% (12/30), and 37% (20/54), respectively. The mean scores for items ranged between 5.1 and 6.9 on a scale from 1 (fully disagree) to 7 (fully agree). Items with mean scores below 6.0 were related to (1) administration, (2) consideration of patients' views, perspectives, values, and preferences, and (3) the discussion of research gaps and needs for future research. CONCLUSION: The PANELVIEW tool showed that the guideline group was satisfied with most aspects of the guideline development process. Areas for improvement of the process were identified. Strategies to improve response rates should be explored.

Barriers and facilitators in developing patient versions of clinical practice guidelines - qualitative interviews on experiences of international guideline producers.

BACKGROUND: Several guideline organizations produce patient versions of clinical practice guidelines (PVGs) which translate recommendations into simple language. A former study of our working group revealed that few guideline organizations publish their methods used to develop PVGs. Clear definitions of PVGs do not prevail and their purposes often remain unclear. We aimed to explore experts' perspectives on developing, disseminating and implementing PVGs to discuss and incorporate these experiences when consenting on methodological guidance and further improving PVGs. METHODS: We conducted 17 semi-structured telephone interviews with international experts working with PVGs from September 2021 through January 2022. We conducted the interviews in English or German, they were recorded and transcribed verbatim. We utilized Mayring's qualitative content analysis with MAXQDA software to analyze the data. RESULTS: In two interviews two participants were interviewed at the same time. This resulted in a total of 19 participants from 16 different organizations and eight different countries participated. Most were female (16/19) and their experience in working with PVGs ranged from 1 to 20 years. All follow methodological standards when developing PVGs, but the extent of these standards and their public accessibility differs. Aims and target groups of PVGs vary between organizations. Facilitators for developing PVGs are working with a multidisciplinary team, financial resources, consultation processes and a high-quality underlying CPG. Facilitators for disseminating and implementing PVGs are using various strategies. Barriers, on the other hand, are the lack of these factors. All participants mentioned patient involvement as a key aspect in PVG development. CONCLUSION: The steps in the PVG development process are largely similar across the countries. Focus is placed on the involvement of patients in the development process, although the extent of participation varies. The experts collectively attribute great importance to PVGs overall, but in order to constantly adapt to medical progress and changing conditions, the focus in the future may be more on formats like living guidelines. Although there are different views on the mandatory development of PVGs, there is a consistent call for more transparency regarding the methodology used for PVGs.

[Development of criteria for the prospective assessment of the need for updating guideline recommendations: The AGIL criteria]. / Entwicklung von Kriterien für die prospektive Einschätzung des Aktualisierungsbedarfs von Leitlinienempfehlungen: AGIL-Kriterien.

BACKGROUND: Evidence-based guideline and vaccination recommendations should continuously be updated to appropriately support health care decisions. However, resources for updating guidelines are often limited. The aim of this project was to develop a list of criteria for the prospective assessment of the need for updating individual guideline or vaccination recommendations, which can be applied from the time a guideline or guideline update is finalised. METHODS: In this article we describe the development of the AGIL criteria (Assessment of Guidelines for Updating Recommendations). The AGIL criteria were developed by experienced scientists and experts in the field of guideline development in a multi-step process. The five steps included: 1) development of an initial list of criteria by the project team; 2) online survey of guideline experts on the initial version of the criteria list; 3) revision of the criteria list based on the results of the online survey; 4) workshop on the criteria list at the EbM Congress 2023; 5) creation of version 1.0 of the AGIL criteria based on the workshop results. RESULTS: The initial list included the following three criteria: 1) relevance of the question 2) availability of new relevant evidence, and 3) impact of potentially new evidence. The response rate of the online survey for fully completed questionnaires was 31.0% (N=195; 630 guideline experts were contacted by email). For 90.3% (n=176) of the respondents, the criteria list included all essential aspects for assessing the need for updating guideline recommendations. More than three quarters of respondents rated the importance of the three criteria as "very important" or "important" (criteria 1-3: 75.3%, 86.1%, 85.2%) and - with the exception of criterion 1 - comprehensibility as "very comprehensible" or "comprehensible" (criteria 1-3: 58.4%, 75.9%, 78.5%). The results of the online survey and the workshop generally confirmed the three criteria with their two sub-questions. The incorporation of all feedback resulted in the AGIL criteria (version 1.0), recapping: 1) relevance of the question regarding a) PICO components and b) other factors, e.g. epidemiological aspects; 2) availability of new evidence a) on health-related benefits and harms and b) on other decision factors, e.g. feasibility, acceptability; 3) impact of new evidence a) on the certainty of evidence on which the recommendation is based and b) on the present recommendation, e.g. DISCUSSION: The moderate response rate of the online survey may have limited its representativeness. Nevertheless, we consider the response rate to be satisfactory in this research context. The inclusion of many experts in the online survey and the EbM Congress workshop is a strength of the project and supports the quality of the results. CONCLUSIONS: The AGIL criteria provide a structured guidance for the prospective assessment of the need for updating individual guideline recommendations and other evidence-based recommendations. The implementation and evaluation of the AGIL criteria 1.0 in a field test is planned.

Motivational interviewing for substance use reduction.

BACKGROUND: Substance use is a global issue, with around 30 to 35 million individuals estimated to have a substance-use disorder. Motivational interviewing (MI) is a client-centred method that aims to strengthen a person's motivation and commitment to a specific goal by exploring their reasons for change and resolving ambivalence, in an atmosphere of acceptance and compassion. This review updates the 2011 version by Smedslund and colleagues. OBJECTIVES: To assess the effectiveness of motivational interviewing for substance use on the extent of substance use, readiness to change, and retention in treatment. SEARCH METHODS: We searched 18 electronic databases, six websites, four mailing lists, and the reference lists of included studies and reviews. The last search dates were in February 2021 and November 2022. SELECTION CRITERIA: We included randomised controlled trials with individuals using drugs, alcohol, or both. Interventions were MI or motivational enhancement therapy (MET), delivered individually and face to face. Eligible control interventions were no intervention, treatment as usual, assessment and feedback, or other active intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane, and assessed the certainty of evidence with GRADE. We conducted meta-analyses for the three outcomes (extent of substance use, readiness to change, retention in treatment) at four time points (post-intervention, short-, medium-, and long-term follow-up). MAIN RESULTS: We included 93 studies with 22,776 participants. MI was delivered in one to nine sessions. Session durations varied, from as little as 10 minutes to as long as 148 minutes per session, across included studies. Study settings included inpatient and outpatient clinics, universities, army recruitment centres, veterans' health centres, and prisons. We judged 69 studies to be at high risk of bias in at least one domain and 24 studies to be at low or unclear risk. Comparing MI to no intervention revealed a small to moderate effect of MI in substance use post-intervention (standardised mean difference (SMD) 0.48, 95% confidence interval (CI) 0.07 to 0.89; I2 = 75%; 6 studies, 471 participants; low-certainty evidence). The effect was weaker at short-term follow-up (SMD 0.20, 95% CI 0.12 to 0.28; 19 studies, 3351 participants; very low-certainty evidence). This comparison revealed a difference in favour of MI at medium-term follow-up (SMD 0.12, 95% CI 0.05 to 0.20; 16 studies, 3137 participants; low-certainty evidence) and no difference at long-term follow-up (SMD 0.12, 95% CI -0.00 to 0.25; 9 studies, 1525 participants; very low-certainty evidence). There was no difference in readiness to change (SMD 0.05, 95% CI -0.11 to 0.22; 5 studies, 1495 participants; very low-certainty evidence). Retention in treatment was slightly higher with MI (SMD 0.26, 95% CI -0.00 to 0.52; 2 studies, 427 participants; very low-certainty evidence). Comparing MI to treatment as usual revealed a very small negative effect in substance use post-intervention (SMD -0.14, 95% CI -0.27 to -0.02; 5 studies, 976 participants; very low-certainty evidence). There was no difference at short-term follow-up (SMD 0.07, 95% CI -0.03 to 0.17; 14 studies, 3066 participants), a very small benefit of MI at medium-term follow-up (SMD 0.12, 95% CI 0.02 to 0.22; 9 studies, 1624 participants), and no difference at long-term follow-up (SMD 0.06, 95% CI -0.05 to 0.17; 8 studies, 1449 participants), all with low-certainty evidence. There was no difference in readiness to change (SMD 0.06, 95% CI -0.27 to 0.39; 2 studies, 150 participants) and retention in treatment (SMD -0.09, 95% CI -0.34 to 0.16; 5 studies, 1295 participants), both with very low-certainty evidence. Comparing MI to assessment and feedback revealed no difference in substance use at short-term follow-up (SMD 0.09, 95% CI -0.05 to 0.23; 7 studies, 854 participants; low-certainty evidence). A small benefit for MI was shown at medium-term (SMD 0.24, 95% CI 0.08 to 0.40; 6 studies, 688 participants) and long-term follow-up (SMD 0.24, 95% CI 0.07 to 0.41; 3 studies, 448 participants), both with moderate-certainty evidence. None of the studies in this comparison measured substance use at the post-intervention time point, readiness to change, and retention in treatment. Comparing MI to another active intervention revealed no difference in substance use at any follow-up time point, all with low-certainty evidence: post-intervention (SMD 0.07, 95% CI -0.15 to 0.29; 3 studies, 338 participants); short-term (SMD 0.05, 95% CI -0.03 to 0.13; 18 studies, 2795 participants); medium-term (SMD 0.08, 95% CI -0.01 to 0.17; 15 studies, 2352 participants); and long-term follow-up (SMD 0.03, 95% CI -0.07 to 0.13; 10 studies, 1908 participants). There was no difference in readiness to change (SMD 0.15, 95% CI -0.00 to 0.30; 5 studies, 988 participants; low-certainty evidence) and retention in treatment (SMD -0.04, 95% CI -0.23 to 0.14; 12 studies, 1945 participants; moderate-certainty evidence). We downgraded the certainty of evidence due to inconsistency, study limitations, publication bias, and imprecision. AUTHORS' CONCLUSIONS: Motivational interviewing may reduce substance use compared with no intervention up to a short follow-up period. MI probably reduces substance use slightly compared with assessment and feedback over medium- and long-term periods. MI may make little to no difference to substance use compared to treatment as usual and another active intervention. It is unclear if MI has an effect on readiness to change and retention in treatment. The studies included in this review were heterogeneous in many respects, including the characteristics of participants, substance(s) used, and interventions. Given the widespread use of MI and the many studies examining MI, it is very important that counsellors adhere to and report quality conditions so that only studies in which the intervention implemented was actually MI are included in evidence syntheses and systematic reviews. Overall, we have moderate to no confidence in the evidence, which forces us to be careful about our conclusions. Consequently, future studies are likely to change the findings and conclusions of this review.

S3 guideline "actinic keratosis and cutaneous squamous cell carcinoma" - update 2023, part 2: epidemiology and etiology, diagnostics, surgical and systemic treatment of cutaneous squamous cell carcinoma (cSCC), surveillance and prevention.

Actinic keratosis (AK) are common lesions in light-skinned individuals that can potentially progress to cutaneous squamous cell carcinoma (cSCC). Both conditions may be associated with significant morbidity and constitute a major disease burden, especially among the elderly. To establish an evidence-based framework for clinical decision making, the guideline "actinic keratosis and cutaneous squamous cell carcinoma" was updated and expanded by the topics cutaneous squamous cell carcinoma in situ (Bowen's disease) and actinic cheilitis. The guideline is aimed at dermatologists, general practitioners, ear nose and throat specialists, surgeons, oncologists, radiologists and radiation oncologists in hospitals and office-based settings, as well as other medical specialties, policy makers and insurance funds involved in the diagnosis and treatment of patients with AK and cSCC. A separate guideline exists for patients and their relatives. In this part, we will address aspects relating to epidemiology and etiology, diagnostics, surgical and systemic treatment of cutaneous squamous cell carcinoma (cSCC), surveillance and prevention.

Correction: Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry Number 015/025, September 2022) - Part 1 with Recommendations on the Epidemiology, Etiology, Prediction, Primary and Secondary Prevention of Preterm Birth.

[This corrects the article DOI: 10.1055/a-2044-0203.].

Correction: Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/025, September 2022) - Part 2 with Recommendations on the Tertiary Prevention of Preterm Birth and on the Management of Preterm Premature Rupture of Membranes.

[This corrects the article DOI: 10.1055/a-2044-0345.].

[Diagnosis and treatment of asthma: a guideline for respiratory specialists 2023 - published by the German Respiratory Society (DGP) e. V.] / S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023.

The management of asthma has fundamentally changed during the past decades. The present guideline for the diagnosis and treatment of asthma was developed for respiratory specialists who need detailed and evidence-based information on the new diagnostic and therapeutic options in asthma. The guideline shows the new role of biomarkers, especially blood eosinophils and fractional exhaled NO (FeNO), in diagnostic algorithms of asthma. Of note, this guideline is the first worldwide to announce symptom prevention and asthma remission as the ultimate goals of asthma treatment, which can be achieved by using individually tailored, disease-modifying anti-asthmatic drugs such as inhaled steroids, allergen immunotherapy or biologics. In addition, the central role of the treatment of comorbidities is emphasized. Finally, the document addresses several challenges in asthma management, including asthma treatment during pregnancy, treatment of severe asthma or the diagnosis and treatment of work-related asthma.

Heterogeneous methodology in the development of patient versions of clinical practice guidelines: a scoping review.

OBJECTIVES: We aimed to gain an overview of the methods and approaches used to develop, disseminate, and implement patient versions of clinical practice guidelines (PVGs). METHODS: We searched PubMed and MEDLINE through Ovid for articles reporting on the development, dissemination, or implementation of PVGs until March 2022. We searched the homepages of guideline organizations, screened the reference lists of the included documents, and asked experts to complement the publications. We narratively synthesized the findings. RESULTS: Of 3,941 publications screened, 27 were included in the study. The identified method reports focused on patient involvement and peer-review processes. The other included publications highlighted the relevance of broad dissemination strategies and emphasized the importance of patient involvement and improving the readability of PVGs by using lay terms and shorter sentences. CONCLUSION: The terminology used for PVGs varies widely. The extent to which the methods were described was heterogeneous. Organizations developing PVGs should make their methods publicly available and use uniform labeling for PVGs in English to improve their use and recognition, not only for other PVG producers but also for patients and the public. A consensus regarding a minimum reporting standard for developing PVGs internationally and developing guiding principles is desirable.