Awareness, use and perception of patient versions of clinical practice guidelines - a national cross-sectional survey among patients with a cancer diagnosis and healthcare providers.

BACKGROUND: To investigate awareness, use, and perceptions of the patient guidelines (PGs) of the German Guideline Program in Oncology (GGPO) and to explore general preferences regarding cancer information among patients and healthcare providers (HCPs). METHODS: Two cross-sectional surveys among patients with cancer (November 2020-May 2021) and among HCPs (April -June 2021) were set up as anonymised, self-administered, semi-structured online surveys, including open-ended questions. Data were analysed with descriptive statistics and qualitative thematic analysis. Patients were recruited from national self-help organisations and certified cancer centres located all over Germany. HCPs were recruited from cancer centres, scientific medical societies and guideline groups. RESULTS: Of 816 participating patients, 45% were aware of the GGPO-PGs, while 55% of the 455 participating HCPs were aware of them. Of those aware of the GGPO-PGs, 65% of patients and 86% of HCPs perceived them as helpful, while 95% in both groups saw them as comprehensive. Seventy-five percent of patients and 85% of HCPs were satisfied with the GGPO-PGs, 22%/13% were partially satisfied, and 3%/2% were rather/not at all satisfied. In addition to self-help organisations, physicians and hospitals were perceived as central in distributing the GGPO-PGs. More patients (78%) than HCPs (56%) stated a preference for detailed information, although the wish for concise information - e.g. decision aids - was concurrently expressed by the majority of all participants. Thematic analysis showed that up-to-dateness, trustworthiness, and supportive messaging are important properties for PGs. CONCLUSIONS: HCPs found the GGPO-PGs helpful, but awareness was low, which suggests that dissemination should be improved. This is also true for patients; however, further research needs to be done to increase the helpfulness of PGs for patients. Oncological PGs seem to be needed in different formats according to patients' situational needs. Theory-driven research should investigate how to best frame patient information in a supportive way.

A methodological protocol for the development of a national guideline on perioperative management of gastrointestinal tumors in Germany.

BACKGROUND: The success of abdominal cancer surgery depends not only on the surgery itself but is influenced by the overall perioperative management. Given the multitude of perioperative measures and the ever-increasing number of studies on perioperative management, it is difficult to keep track and provide evidence-based perioperative management. The planned guideline on perioperative management will review the existing evidence and derive treatment recommendations. METHODS: The processing of the evidence is carried out by 6 working groups according to an 8-step scheme: after drafting the guideline questions in PICO format (1), a systematic literature search is carried out (2), and the records found are screened by two independent reviewers from the coordination team. Subsequently, the full texts of the potentially relevant articles are made available to the working groups for full text screening (3). All articles to be included are reviewed for methodological quality (4) before summary of findings tables are generated (5). In line with the GRADE approach, confidence in the evidence is assessed (6) before a recommendation is derived from the evidence, using a modified GRADE Evidence to Decision Framework (7). Finally, all recommendations are compiled and agreed within the guideline group (8). DISCUSSION: Guidelines serve as foundation for therapy decisions in everyday clinical practice and should therefore be based on up-to-date research results. However, while primary studies and systematic reviews are critically reviewed for their methodological quality, the process of guideline development is often not comprehensible. A protocol with predefined methodology should therefore create transparency and strengthen confidence in the recommendations. TRIAL REGISTRATION: The guideline is registered in the AWMF (Association of the Scientific Medical Societies) Guideline Register (088-010OL).

[Update of the 2Sk guidelines on the diagnostics, treatment and metaphylaxis of urolithiasis (AWMF register number 043-025) : What is new?] / Aktualisierung der S2k-Leitlinie zur Diagnostik, Therapie und Metaphylaxe der Urolithiasis (AWMF Registernummer 043-025) : Was ist neu?

The increase of medical knowledge and technical innovations together with the demographic change represent a challenge for the new conception of guidelines and clinical studies. The present S2k guidelines, which are exclusively concerned with kidney and ureteral stones, should support the treatment of urolithiasis in hospitals and private practices and provide information on urolithiasis for patients. Increasing interdisciplinary collaboration in stone treatment is also demonstrated in the number of professional and working groups participating in the update of the new guidelines. The present S2k guidelines emerged from a consensus process and demonstrate the current recommendations in step with actual practice. They provide decision-making guidance for diagnostics, treatment and metaphylactic measures based on expert opinions and available published fundamental evidence from the literature.

[S3 guidelines on the diagnosis and treatment of carcinoma of the endometrium : Requirements for pathology]. / S3-Leitlinie Diagnostik und Therapie des Endometriumkarzinoms : Anforderungen an die Pathologie.

The present article summarises the relevant aspects of the S3 guidelines on endometrioid carcinomas. The recommendations include the processing rules of fractional currettings as well as for hysterectomy specimens and lymph node resections (including sentinel lymph nodes). Besides practical aspects, the guidelines consider the needs of the clinicians for appropriate surgical and radiotherapeutic treatment of the patients. Carcinosarcomas are assigned to the endometrial carcinoma as a special variant. For the first time, an algorithmic approach for evaluation of the tumour tissue for Lynch syndrome is given. Prognostic factors based on morphologic findings are summarised.

[Methodology report of the 2017 guidelines on fibromyalgia syndrome]. / Methodenreport der Leitlinie 2017 zum Fibromyalgiesyndrom.

BACKGROUND: The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was planned for April 2017. METHODS: The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n = 8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest. RESULTS: A systematic search of the literature from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was achieved by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of therapies available were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines. CONCLUSION: The guidelines are published in several forms, i.e. complete and short scientific versions and clinical practice and patient versions.

[Impact of conflicts of interest on guideline recommendations : Empirical study within the second update of the German interdisciplinary S3 guidelines on fibromyalgia syndrome]. / Der Einfluss von Interessenkonflikten auf Leitlinienempfehlungen : Eine empirische Studie zur zweiten Aktualisierung der interdisziplinären S3­Leitlinie zum Fibromyalgiesyndrom.

BACKGROUND: The impact of conflicts of interest (COI) in general and of academic COI in particular on guideline recommendations in pain medicine has not yet been studied. Whether the inclusion of patients and of representatives of all relevant healthcare professions into a guidelines group is protective against a systematic bias of decisions of a guidelines group is currently unknown. METHODS: All members of the guidelines group declared their COI before the consensus conferences by a standard form according to the rules and standards of the Association of the German Medical and Scientific Societies. The acceptance or rejection and the strength of consensus of recommendations of the second update of the interdisciplinary guidelines on fibromyalgia syndrome was analyzed twice by first including and then excluding the votes of the guideline group members with COI related to a recommendation from the results of anonymous voting via an internet platform. RESULTS: A total of 42 persons from different healthcare professions and patients participated in the online voting on recommendations. Of the participants 29% had no COI according to the predefined criteria, 53% met the criteria of academic and 33% the criteria of financial COI. In the case of exclusion of participants with a COI related to a specific recommendation, 2 out of 23 recommendations (homeopathy, tramadol) were not accepted. In all votes, there were more participants without COI than with COI. CONCLUSION: Academic COI were more frequent than financial COI in the second update of the German interdisciplinary guidelines group on fibromyalgia syndrome. The impact of COI on guideline recommendations was low. The inclusion of patients and of all relevant healthcare professionals into a guidelines group is a protective factor against the influence of COI on guideline recommendations.

[Guideline adherence - is more always better?]. / Leitlinienadhärenz - je mehr desto besser?

Guidelines play an increasing role in the health system. Guidelines are intended to provide guidance in the sense of ?corridors for action and decision", whereby in certain justified cases actions can - or even must - deviate from them. "Cookbook medicine" is not the aim of guidelines.Guideline adherence can not necessarily be equated with guideline conformity. Adherence presumes an agreed treatment goal between patient and physician and focuses the behavior of the patient. Based on current studies on guideline adherence, the use of the term in studies on urological tumors is analyzed.

[Erratum to: Methodology of the development of the updated LONTS guidelines for long-term administration of opioids in noncancer pain]. / Erratum zu: Methodenreport der aktualisierten Leitlinie "Langzeitanwendung von Opioiden bei nicht-tumorbedingten Schmerzen - LONTS".

In the sentence "For dichotomous variables, the threshold for 'appreciable benefit' or 'appreciable harm' was set at a relative risk reduction (RRR) or relative risk increase (RRI) ≥ 10 % [5]" the relative risk increase (RRI) is not ≥10 %, but ≥ 25 %.

[Methodology of the development of the updated LONTS guidelines for long-term administration of opioids in noncancer pain]. / Methodenreport der aktualisierten Leitlinie "Langzeitanwendung von Opioiden bei nicht-tumorbedingten Schmerzen - LONTS".

BACKGROUND: The update of the German S3 guidelines on long-term opioid therapy of chronic noncancer pain (CNCP), the"LONTS" (AWMF registration number 145/003) was scheduled for May 2014. METHODS: The guidelines were developed by 25 scientific societies and two patient self-help organizations under the coordination of the German Pain Society and the Association of the Scientific Medical Societies in Germany (AWMF). RESULTS: A systematic literature search was performed in the CENTRAL, MEDLINE and Scopus databases from October 2008 to October 2013. Meta-analyses of randomized controlled trials (RCT) of opioids in CNPC of study duration ≥ 4 weeks were conducted. Levels of evidence were assigned according to the Oxford Centre for Evidence-Based Medicine version 2009 classification system. The formulation and strength of recommendations was established in a multistep formalized consensus procedure, in accordance with AWFM rules and standards. The guidelines were reviewed by three scientific societies not involved in their development and were approved by the executive boards of the societies that were engaged in development of the guidelines. CONCLUSION: The guidelines will be published in several forms: complete and short scientific versions, as well as clinical practice and patient versions.

[Methodology and process of developing the S3 guideline for prostate cancer]. / Methodik und Entwicklungsprozess der S3-Leitlinie zum Prostatakarzinom.

Despite the high incidence of prostate cancer and a variability of care due to different options for primary therapy, a comprehensive German clinical guideline has been missing up to now. Therefore, in 2005 the German Society for Urology initiated the development of a multidisciplinary and evidence-based S3 guideline for the early detection, diagnosis, and treatment of the different clinical manifestations of prostate cancer. There were 76 experts from 10 different medical societies and organizations including a patient organization involved in the development process. A total of 42 key questions were addressed. As a result of systematic literature searches and formal consensus processes, 170 recommendations and 42 statements were made. This article describes the objectives and the process of development of the guideline focusing on the cooperation between clinical and methodological experts as well as on the evidence and consensus basis of the recommendations.