Development of a Multinational Clinical Practice Guideline: A Practical Structured Procedure.

INTRODUCTION: The development of a clinical guideline is a challenging process. National and international organizations have established a variety of approaches, grading systems, evaluation scales, and voting modes; however, a practical description which illustrates all steps from starting the initiative to publication and dissemination of the guideline is usually not provided. We describe a structured guideline procedure that can be adjusted to the requirements of other multinational guidelines. METHODS: A group of European specialist gastroenterological societies and national societies initiated a guideline for the use of breath tests in gastroenterology. A balance between scientific evidence and clinical experience was achieved by involving European specialist societies and physicians from 18 European countries. For persons contributing to the guideline process, different levels of involvement were defined. The tasks were assigned to different groups of persons, which formed scientific institutions. RESULTS: We describe organizational structures and institutions, the stepwise approach, and illustrate the multistep guideline development procedure in a flowchart diagram that shows workflow and assigned responsibilities and provides details for the execution of each step, including timelines. The process is split into 4 phases: foundation, preparation, voting, and publication. DISCUSSION: This structured procedure of a gastroenterological clinical practice guideline can serve as a blueprint for future multinational guideline initiatives and may aid future attempts to standardize and harmonize guideline development processes in gastroenterology and in other medical fields. Although the described procedure is for a diagnostic guideline, it may also be appropriate for therapeutic guidelines by adjusting the acceptance criteria for recommendations.

European guideline on indications, performance, and clinical impact of hydrogen and methane breath tests in adult and pediatric patients: European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Neurogastroenterology and Motility, and European Society for Paediatric Gastroenterology Hepatology and Nutrition consensus.

INTRODUCTION: Measurement of breath hydrogen (H2 ) and methane (CH4 ) excretion after ingestion of test-carbohydrates is used for different diagnostic purposes. There is a lack of standardization among centers performing these tests and this, together with recent technical developments and evidence from clinical studies, highlight the need for a European guideline. METHODS: This consensus-based clinical practice guideline defines the clinical indications, performance, and interpretation of H2 -CH4 -breath tests in adult and pediatric patients. A balance between scientific evidence and clinical experience was achieved by a Delphi consensus that involved 44 experts from 18 European countries. Eighty eight statements and recommendations were drafted based on a review of the literature. Consensus (≥80% agreement) was reached for 82. Quality of evidence was evaluated using validated criteria. RESULTS: The guideline incorporates new insights into the role of symptom assessment to diagnose carbohydrate (e.g., lactose) intolerances and recommends that breath tests for carbohydrate malabsorption require additional validated concurrent symptom evaluation to establish carbohydrate intolerance. Regarding the use of breath tests for the evaluation of oro-cecal transit time and suspected small bowel bacterial overgrowth, this guideline highlights confounding factors associated with the interpretation of H2 -CH4 -breath tests in these indications and recommends approaches to mitigate these issues. CONCLUSION: This clinical practice guideline should facilitate pan-European harmonization of diagnostic approaches to symptoms and disorders, which are very common in specialist and primary care gastroenterology practice, both in adult and pediatric patients. In addition, it identifies areas of future research needs to clarify diagnostic and therapeutic approaches.

Coordinated Multi-Language Translation of A Validated Symptom Questionnaire for Carbohydrate Intolerances: A Practical Structured Procedure.

BACKGROUND AND AIMS: Validated questionnaires help to minimize diagnostic bias, to standardize symptom assessment and to achieve comparability between studies and centers. In a recent European guideline the adult and the pediatric carbohydrate perception questionnaires (aCPQ and pCPQ), were recommended to be used for the diagnosis of carbohydrate intolerances in adult and pediatric patients. The implementation of this guideline into clinical practice makes availability of validated translations a necessity. METHODS: Clinical experts who recognized the need for these questionnaires to be available in their own language participated in the translation process. The tasks were assigned and a workflow following a predefined procedure based on recommendations of the Rome foundation was developed. The procedure had 5 phases: foundation, nomination, translation, revision, cognitive debriefing. RESULTS: Within eight months the aCPQ was translated into Bulgarian, French, Hungarian, Italian, Polish, Romanian, Russian and Slovenian language and the pCPQ into Dutch, French and Romanian. This expands the population which can be served with the aCPQ from 160 million to over 500 million Europeans. The reach of pCPQ expanded from 92 million to 193 million Europeans. CONCLUSIONS: We report the development and implementation of a centrally organized process of translation of validated questionnaires, following a predefined procedure based on recommendations of the Rome foundation. This structured procedure may aid future efforts to standardize and harmonize the translation of validated questionnaires.

Carbohydrate-induced gastrointestinal symptoms: development and validation of a test-specific symptom questionnaire for an adult population, the adult Carbohydrate Perception Questionnaire.

OBJECTIVES: Carbohydrate intolerances may affect a majority of the worlds-population but there is no validated, test-specific assessment of carbohydrate-induced symptoms during breath tests. We aimed to develop and validate a questionnaire for evaluation and quantification of carbohydrate intolerance. METHODS: A visual analog scale-questionnaire with five complaints (pain, nausea, bloating, flatulence, and diarrhea) was designed. The time frame of symptoms was 'current' (for baseline symptoms) and 'since filling out the last questionnaire'. Validity was determined in focus-group style interviews and during breath tests in an original (n = 342) and follow-up patient groups (n = 338). RESULTS: The questionnaire had good face validity, content validity ratio according to Lawshe was 1. Intraclass correlation coefficients (n = 195; 30-min' interval) demonstrated excellent reliability (P < 0.001), Cohen's d (measure of effect size) was small (≤0.19 for each symptom). Convergent and discriminant validity were supported against patient interviews. Questionnaire-derived results highly correlated with a medical interview (P < 0.001; n = 338). Responsiveness to change was verified during breath tests despite small effect sizes (≤0.32). Additional cross-validation and external validation studies (follow-up in-house: n = 182; external: n = 156) demonstrated generalizability and identified relevant numbers of patients in whom there was no co-occurrence of carbohydrate malabsorption and intolerance. CONCLUSIONS: The adult Carbohydrate Perception Questionnaire is a valid instrument for the assessment of gastrointestinal symptoms after carbohydrate ingestion with excellent psychometric properties. It allows standardized, test-specific diagnosis of carbohydrate intolerance and evaluation of the relation between malabsorption and intolerance. It shall be useful for future studies on treatment of carbohydrate intolerance.

European guideline on indications, performance and clinical impact of 13 C-breath tests in adult and pediatric patients: An EAGEN, ESNM, and ESPGHAN consensus, supported by EPC.

INTRODUCTION: 13 C-breath tests are valuable, noninvasive diagnostic tests that can be widely applied for the assessment of gastroenterological symptoms and diseases. Currently, the potential of these tests is compromised by a lack of standardization regarding performance and interpretation among expert centers. METHODS: This consensus-based clinical practice guideline defines the clinical indications, performance, and interpretation of 13 C-breath tests in adult and pediatric patients. A balance between scientific evidence and clinical experience was achieved by a Delphi consensus that involved 43 experts from 18 European countries. Consensus on individual statements and recommendations was established if ≥ 80% of reviewers agreed and <10% disagreed. RESULTS: The guideline gives an overview over general methodology of 13 C-breath testing and provides recommendations for the use of 13 C-breath tests to diagnose Helicobacter pylori infection, measure gastric emptying time, and monitor pancreatic exocrine and liver function in adult and pediatric patients. Other potential applications of 13 C-breath testing are summarized briefly. The recommendations specifically detail when and how individual 13 C-breath tests should be performed including examples for well-established test protocols, patient preparation, and reporting of test results. CONCLUSION: This clinical practice guideline should improve pan-European harmonization of diagnostic approaches to symptoms and disorders, which are very common in specialist and primary care gastroenterology practice, both in adult and pediatric patients. In addition, this guideline identifies areas of future clinical research involving the use of 13 C-breath tests.