Colombo N.

Concin N.

Creutzberg C. L.

Curigliano G.

Douillard J. -Y.

Marinoni K.

Pentheroudakis G.

Rauh S.

Sessa C.

Torri V.

Wimberger P.

English

AIR Universita degli studi di Milano

  1Sessa C, et al. ESMO Open 2020;5:e001130. doi:10.1136/esmoopen-2020-001130Open access Implementing clinical practice guidelines: time to assess itCristiana Sessa   ,1 Nicoletta Colombo,2 Carien L Creutzberg,3 Nicole Concin,4 Pauline Wimberger,5 Giuseppe Curigliano   ,6 Klizia Marinoni,7 Jean- Yves Douillard,7 George Pentheroudakis,7 Valter Torri,8 Stefan Rauh   9 EditorialTo cite: Sessa C, Colombo N, Creutzberg CL, et al. Implementing clinical practice guidelines: time to assess it. ESMO Open 2020;5:e001130. doi:10.1136/esmoopen-2020-001130Received 19 October 2020Accepted 20 October 2020For numbered affiliations see end of article.Correspondence toProfessor Cristiana Sessa;   cristiana. sessa@ eoc. ch© Author (s) (or their employer(s)) 2020. Re- use permitted under CC BY- NC. No commercial re- use. Published by BMJ on behalf of the European Society for Medical Oncology.WHY AND WHAT WAS DONEESMO clinical practice guidelines (CPGs) have been developed to provide recommen-dations for the standard of care according to the highest quality evidence- based data (EBD). European Society for Medical Oncology (ESMO) is also conducting consensus conference (CC) activities to provide answers to crucial questions of clin-ical relevance, which are then formulated as recommendations.To be successful, a CPG has to be imple-mented in daily practice, a multistep process which can be affected by CPG features (complexity, poor access), external factors (social norms, health carers workload, local and national guidelines) and physician personal factors (knowledge and attitudes), but mostly relies on dissemination and physi-cian awareness.1 2Compliance of physicians with national and/or international guidelines has emerged as an important criterium to assess quality of care. Studies to evaluate the compliance with international guide-lines, like National Comprehensive Cancer Network (NCCN), have been performed in patients with breast cancer and in elderly patients with stage III colon cancer3 4 by auditing patients medical records.In 2014, the three main European soci-eties active in gynaecological oncology (ESMO, European Society of Gynaecolog-ical Oncology (ESGO), European SocieTy for Radiotherapy and Oncology (ESTRO)) performed a CC in endometrial cancer (EC), the most common gynaecological cancer in developed countries, for the treat-ment of which a multidisciplinary approach is needed.5 To evaluate the clinical imple-mentation of the recommendations 5 years after the endometrial CC, the three societies conducted a survey, the results of which were reported at ESMO 2020.6HOW WAS IT DONEThe survey was based on three clinical cases, one by each society. Each case consisted of five questions, each with five possible answers, but only one correct according to CC recom-mendations and adequate for the specific clinical situation.The selected topics were the management of early stage endometrioid EC, of high- grade serous histotype and of poorly differentiated stage IIIC EC.The survey was sent by each society to the members specialised in gynaecological cancers for about a total of 5000 contacts. The answers were collected via Survey Monkey platform in the ESMO website survey dedi-cated page.The heterogeneity (H) of answers among the three societies was quantified with I2 statistics (ref: http:// handbook. cochrane. org/ chapter_ 9/ 9_ 5_ 2_ identifying_ and_ measuring_ heterogeneity. htm).Values of I2 >50% represented substantial H.As indicator of clinical implementation, the percentage (%) of correct answer was adopted with a 70% cut- off value, as it is done with Delphi method for consensus statement in case of a single response.7 8WHICH WERE THE RESULTSThe survey was kept open from July 2019 to October 2019 and 586 members (of whom 54% from ESGO, 30% from ESMO and 16% from ESTRO) replied.Overall, >50% of the responders were working in University Hospital or Academic Institutions and 20% in General Hospi-tals, around 30% were <40 year old, 49% were women and 51% men, 69% of ESGO members were gynaecological oncologists, 74% of ESMO medical oncologists and 86% of ESTRO radiation oncologists specialised in the treatment of gynaecological cancers.Published online 25 November 2020 Open access2 Sessa C, et al. ESMO Open 2020;5:e001130. doi:10.1136/esmoopen-2020-001130The first case discussed the management of a premenopausal woman with an early stage grade 2 endometrioid cancer, treated with complete surgery followed by adjuvant therapy.For this clinical situation, the CC recommendations indicated two acceptable options (brachytherapy or no further treatment) according to patient’s age and daily practice because of the lack of EBD. Overall, for each society, the mean % of correct answers was low, from 23% to 60% for ESMO, from 23% to 82% for ESGO and from 35% to 85% for ESTRO (table 1).The second case was that of a patient with a ‘high- risk’ rare serous histotype, treated with surgery and adjuvant treatment, who presented an isolated pelvic recurrence.Again, the mean % of ‘correct’ answers was very low, ranging from 17% to 35% for ESMO, from 16% to 49% for ESGO, from 12% to 50% for ESTRO.The third case discussed the management of a poorly differentiated EC case with lymph node metastases at diagnosis. The main question was on the modalities of the adjuvant therapy, with the possible options of chemo-therapy or of chemotherapy in combination with radio-therapy. The highest H was in the preferred sequence of the combined approach and on the modalities of the initial surgery. Overall, the mean % of correct answers ranged from 17% to 44% for ESMO, from 8% to 56% for ESGO, from 19% to 46% for ESTRO (table 1).The per cent of non- responders increased from the second case up to a maximum of 48% in the third one, thus affecting the value of the results.WHAT WE LEARNEDEven though EC is the most common gynaecological malignancy in developed countries, EBD on some aspects of clinical management are limited and often daily prac-tice is still based on personal experience and traditional approaches. In addition, EC has for a long time been considered a slowly growing disease, mainly of older women with many comorbidities, usually diagnosed at an early stage, hormone- dependent and well controlled by surgery and pelvic radiotherapy in selected cases, treated by gynaecologists or gynaecological oncologists and radi-ation oncologists. Trials on adjuvant chemotherapy in high- risk disease and the increased knowledge of the different genomic profiles, resulting into four subgroups with different molecular signatures of prognostic value, have significantly changed the clinical management, introducing targeted treatments and reinforcing the need of a multidisciplinary approach with an essential role for medical oncology.The previous studies to assess compliance with NCCN guidelines were done by auditing medical records,3 4 the results of which were affected by the availability and completeness of the source documents; our approach, based on Q&A on clinical cases, is possibly more corre-spondent to physician knowledge and local practice.A limitation of our study is the relatively small, selected sample size studied (586 responders over about 5000 contacted, with >50% responders working in University Hospital or Academic Institutions). Still, the results of this survey are of value because they showed a limited imple-mentation of the recommendations of the CC, regardless of specialty and main topic of the question. In addition, the great H of responses among the three societies might indicate the lack of a multidisciplinary perspective on the clinical management and different interpretations of the published data. Other potential factors for H among the three societies performance could have been the different degrees and type of clinical experience, which is related to previous and ongoing activities, work setting (eg, large specialised centre vs general hospital) and local availability of therapeutic resources.Possible reasons for the low % of correct responses were the lack of EBD to support a strong recommenda-tion or the lack of a specific recommendation in the CC, the lack of EBD because of the rarity of the disease, the introduction of a new surgical technique like sentinel node biopsy or the availability of new significant clinical results, shortly after the publication of the CC recommen-dations, as it was the case for the management of stage III C9–11 with changes in clinical practice.The high per cent of non- responders decreases the value of the results and might indicate a lack of knowl-edge due to limited experience, lack of time or lack of interest, the last two points suggesting that the survey was felt to be too long, with too many cases and too many questions.HOW TO MOVE FORWARDESMO is greatly committed to make available updated, evidence- based (EB), complete high- quality multidisci-plinary CPG and CC recommendations as free accessible tool to improve patients care.This first ESMO attempt to evaluate the implementa-tion in clinical practice of the CC recommendations on EC was somewhat disappointing because it showed an Table 1 Heterogeneity and mean % of correct answer in each clinical caseClinical scenario Case 1 early stage Case 2 high- grade serous Case 3 stage III C1>50% Heterogeneity 3/5 questions 3/5 questions 4/5 questionsOverall mean % correct answers (range) 26%–75% 16%–44% 14%–51%ESMO mean % correct answers (range) 23%–60% 17%–38% 17%–44%Open access3Sessa C, et al. ESMO Open 2020;5:e001130. doi:10.1136/esmoopen-2020-001130 Sessa C, et al. ESMO Open 2020;5:e001130. doi:10.1136/esmoopen-2020-001130overall limited implementation; however, it has been useful to identify pitfalls in the CC recommendations (lack of regular updates, lack of clarity in wording, avail-ability of different options, ambiguous indications, lack of recommendations on some crucial topics). Besides improving the quality of CC recommendations and CPG features, ESMO is also very much committed to expand the guidelines- related activities, in which dissemination and training are a priority, to be further promoted by a direct involvement of the authors, by providing a set of slides for citation at meetings, public presentations and local training; compliance can be then regularly assessed by surveys with case histories with a maximum of four straightforward questions, formulated with a clear wording, specifically referring to CC recommendations or CPG.Once more, this survey confirmed the value and the need of a multidisciplinary approach in the preparation of the CC recommendations and CPG and in the clinical management of patients with cancer.Author affiliations1Department of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland2Department of Gynaecologic Oncology, IEO, Milano, Lombardia, Italy3Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands4Department of Gynaecology and Obstetrics, Medical University of Innsbruck, Innsbruck, Austria5Department of Gynaecology and Obstetrics, Technische Universität Dresden, Dresden, Germany6Department of Medical Oncology, IEO, Milano, Lombardia, Italy7European Society for Medical Oncology, Lugano, Switzerland8Department of Oncology Research, IRCCS Istituto di Ricerche Farmacologiche Mario Negri Centro Anna Maria Astori, Milan, Italy9Department of Medical Oncology, Hospital Centre Emile Mayrisch, Esch- sur- Alzette, LuxembourgContributors No conflict of interest to declare.Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not- for- profit sectors.Competing interests None declared.Patient consent for publication Not required.Provenance and peer review Commissioned; internally peer reviewed.Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non- commercially, and license their derivative works on different terms, provided the original work is properly cited, any changes made are indicated, and the use is non- commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.ORCID iDsCristiana Sessa http:// orcid. org/ 0000- 0001- 8132- 2527Giuseppe Curigliano http:// orcid. org/ 0000- 0003- 1781- 2518Stefan Rauh http:// orcid. org/ 0000- 0002- 3039- 0711REFERENCES 1 Grol R. Successes and failures in the implementation of evidence- based guidelines for clinical practice. Med Care 2001;39:II–46. 2 Fischer F, Lange K, Klose K, et al. Barriers and strategies in guideline Implementation—A scoping review. Health Care 2016;4:36. 3 Dvorak T. Assessment of compliance with NCCN guidelines for breast cancer patients treated at comprehensive cancer canter. Abstracts S541 2012;84. 4 O'Grady MA, Slater E, Sigurdson ER, et al. Assessing compliance with national comprehensive cancer network guidelines for elderly patients with stage III colon cancer: the Fox Chase cancer center partners' initiative. Clin Colorectal Cancer 2011;10:113–6. 5 Colombo N, Creutzberg C, Amant F, et al. ESMO- ESGO- ESTRO consensus conference on endometrial cancer: diagnosis, treatment and follow- up. Ann Oncol 2016;27:16–41. 6 Sessa C. Limited implementation of the ESMO- ESGO (European Society of Gynaecological Oncology)- ESTRO (European SocieTy for Radiotherapy and Oncology) Consensus Conference Recommendations (CCR) on Endometrial Cancer (EC). ESMO Congress 2020:861. 7 Mokkink LB, Terwee CB, Knol DL, et al. Protocol of the COSMIN study: consensus- based standards for the selection of health measurement instruments. BMC Med Res Methodol 2006;6. 8 Zafar SY, Currow DC, Cherny N, et al. Consensus- Based standards for best supportive care in clinical trials in advanced cancer. Lancet Oncol 2012;13:e77–82. 9 de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high- risk endometrial cancer (PORTEC-3): final results of an international, open- label, multicentre, randomised, phase 3 trial. Lancet Oncol 2018;19:295–309. 10 Randall ME, Filiaci V, McMeekin DS, et al. Phase III trial: adjuvant pelvic radiation therapy versus vaginal brachytherapy plus paclitaxel/carboplatin in High- Intermediate and high- risk early- stage endometrial cancer. JCO 2019;37:1810–8. 11 Matei D, Filiaci V, Randall ME, et al. Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. N Engl J Med 2019;380:2317–26.

Implementing clinical practice guidelines : Time to assess it

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Implementing clinical practice guidelines : Time to assess it

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