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Development of process-of-care measures and evaluation of their performance in adults with eosinophilic esophagitis (EoE-Q-CARE)

English title Development of process-of-care measures and evaluation of their performance in adults with eosinophilic esophagitis (EoE-Q-CARE)
Applicant Safroneeva Ekaterina
Number 185008
Funding scheme Project funding (special)
Research institution Institut für Sozial- und Präventivmedizin Universität Bern
Institution of higher education University of Berne - BE
Main discipline Internal Medicine
Start/End 01.03.2020 - 29.02.2024
Approved amount 480'480.00
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Keywords (8)

Quality of care; Outcome assessment; Patient-reported outcomes; Randomized controlled clinical trial; Eosinophilic esophagitis; Treat to target; Swiss IBD cohort; Large nested project

Lay Summary (German)

Die eosinophile Oesophagitis ist eine allergen-vermittelte chronische Entzündung der Speiseröhre. Betroffene Patienten leiden unter Schluckstörungen mit dem Gefühl der verzögerten Passage von Nahrungsmitteln. Die Behandlungsqualität der betroffenen Patienten wurde bisher nie systematisch untersucht. Dieses Projekt leistet einen Beitrag um die Behandlungsqualität der betroffenen Patienten systematisch zu erfassen, dann zu standardisieren, und letztlich die Behandlungsqualität zu verbessern.
Lay summary

Inhalt und Ziele des Forschungsprojekts:

In einem ersten Schritt  untersucht dieses Projekt systematisch die Behandlungsqualität bezüglich Diagnose und Therapie. Die Erhebung des aktuellen Ist-Zustandes der Behandlungsqualität erfolgt unter Miteinbezug der betroffenen Patienten in Form von Interviews. Nach Erfassung der Behandlungsqualität werden wir einen Katalog erstellen mit Minimal-Anforderungen welche eine Behandlung von betroffenen Patienten zu erfüllen hat.

In einem zweiten Schritt werden wir im Rahmen einer kontrollierten klinischen Studie untersuchen ob die Lebensqualität der betroffenen Patienten besser ist bei alleinigem Fokussieren auf Symptomenfreiheit verglichen mit Symptomenfreiheit plus strikter biologischer Entzündungskontrolle.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojekts:

Dieses Projekt dient der Entwicklung von Qualitätsstandards für die Betreuung von erwachsenen Patienten mit eosinophiler Oesophagitis.

Direct link to Lay Summary Last update: 09.02.2020

Responsible applicant and co-applicants

Project partner

Associated projects

Number Title Start Funding scheme
160115 Defining clinically meaningful therapeutic endpoints in Eosinophilic Esophagitis 01.05.2015 Project funding (special)
135665 Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study 01.04.2011 Project funding (Div. I-III)


Background: Eosinophilic esophagitis (EoE) is a chronic, immune-mediated condition with a current prevalence of about 1/2,000 inhabitants in industrialized countries. Untreated inflammation leads to esophageal remodeling with stricture formation and food bolus impactions. The optimal long-term therapeutic strategy still needs to be defined. Preliminary data in adults with EoE show that there is room for improvement in quality of care as it relates to screening, diagnosis, treatment, and follow-up of these patients. For example, mean diagnostic delay (time from onset of first symptoms to EoE diagnosis) in Switzerland is 5 years, a period much too long given that dysphagia, a leading symptom of this condition, may be indicative of esophageal cancer. The quality of care received by adults with EoE has never been assessed, and means by which EoE quality of care can be measured have never been developed. The quality of care measures fall into four categories: 1) structure (e.g. setting of care characteristics, including personnel and facilities); 2) process (e.g. patients receiving recommended care); 3) outcome (e.g. patients’ health as a result of received care); and 4) patient experience of their care. Of all quality of care measures, the measures of processes are of most interest, as these are directly controlled by physicians and are consistent with structure of clinical practice guidelines. Over the last 7 years, the international EoE Activity Index (EEsAI) study group, began the efforts of developing questionnaires to assess disease activity and establishing the core outcome set to be assessed in EoE clinical trials. EoE community is now in a position to develop both process-of-care quality indicators and outcome measures, which can help us to determine the effect appropriate care (provided according to developed process-of-care quality indicators) might have on EoE patients’ health status, and function, and whether the goals of care can be accomplished.Objectives: I intend to take advantage of my expertise in EoE activity and outcome assessment as well as that of Swiss and international collaborators to address the following aims in two inter-related projects carried out in adults with EoE:Project I: Project team will develop a set of process-of-care quality indicators, as they relate to screening, diagnosis, treatment, and follow-up of EoE and assess the quality of current patient care using these measures;Project II: Project team will conduct a 2-year randomized controlled clinical trial evaluating the outcome of EoE patient care carried out according to the defined process-of-care quality indicators (inflammation and symptom control) vs. standard of care (symptom control only).Methods:For project I, project team will use the Research ANd Development (RAND)-UCLA modified Delphi methodology to first create candidate process-of-care quality indicators, collect evidence to support these indicators, hold Delphi rounds to rank the validity of proposed indicators (ranking the validity on a scale from 1 [low] to 9 [high] - once before and once after a face-to-face/phone conference discussion). After omitting indicators with low validity, the remaining ones will be used to assess quality of care currently provided to patients enrolled into the Swiss EoE Cohort Study. Psychologist-guided focus groups and surveys will be used to gain insight into patients’ experience with their care.For project II, EoE patients will be randomized to the following two groups: A) patients treated according to developed process-of-care quality indicators (histologic [<15 eosinophils per high-power field] and clinical remission [EEsAI patient-reported symptom-based score = 20] are treatment targets); or B) patients treated according to the standard of care (clinical remission only is treatment target). The primary endpoint will be the EoE-specific quality of life (EoE-QoL-A) score. Secondary endpoints will be endoscopic reference score and stricture formation. To detect the difference of 0.4 points (with a standard deviation of 0.5) between EoE-QoL-A scores in group A and B, we will need to recruit 60 patients into each group (two-sided alpha of 0.05, 90% power, and Student's t-test).Expected results and importance: Assessing the quality of care currently provided to adults with EoE and developing the process-of-care quality indicators will lay the ground work for improving care in this patient population. If our hypothesis is correct, the care provided in accordance with newly-developed process-of-care quality indicators, such as targeting histologic inflammation and symptoms, will result in better care outcomes, including better EoE-related quality of life, fewer strictures and episodes of food impactions, and more positive patient experience of care, when compared to current standard of care (aiming to achieve symptom control only).