reporting des études évaluant un délai diagnostique
5. Conclusions et perspectives
Avec cette reporting guideline, nous espérons pouvoir sensibiliser les auteurs d’étude investiguant un délai diagnostique aux points importants à rapporter dans les articles et ainsi en améliorer la qualité. Cette reporting guideline devra être optimisée après une phase d’utilisation « pilote » comme cela a été fait pour d’autres reporting guidelines comme CONSORT.(118) Le processus de construction de cette guideline nous a permis de mettre en exergue des points méthodologiques potentiellement à risque de biais et d’obstacles à la transportabilité pouvant compromettre la fiabilité et l’applicabilité* des résultats des études sur les délais diagnostiques. Nous avons donc appliqué cette réflexion méthodologique à l’étude des soins suboptimaux dans la prise en charge initiale des IBS de l’enfant qui a fait l’objet de la partie II de cette thèse.
Partie I – Chapitre 3
6. Figures et tableaux
Checklist mise au point dans le chapitre 1 (35 items) Checklist préliminaire (25 items) Checklist révisée Checklist finale + 2 items issus de l’Aarhus statement Validation et affinement : • 16 experts sollicités (comité scientifique) • 1er tour de questions et commentaires anonymes • Puis discussion ouverte par forum Validation large : • 185 auteurs sollicités : 36 répondants Enquête en ligne • Commentaires soumis au comité scientifique 23 items spécifiques 12 items génériques (déjà validés dans d’autres reporting guidelines)Figure 8. Déroulement de la validation de la checklist pour le reporting des études
Partie I – Chapitre 3
Tableau 6. Version finale de la checklist.
Items
Introduction
1. Identify the article as a study on time to diagnosis
2a. †Explain the scientific background and rationale for the study 2b. †State specific objective(s)
Methods
3. †Describe the setting, location(s), and relevant dates, including periods of recruitment
4. State eligibility criteria of participants (i.e., inclusion and exclusion criteria, especially diagnostic criteria)
5. Describe the source population [i.e., the population with signs and symptoms that usually trigger healthcare professionals to initiate the diagnostic procedure(s)] and how the participants were identified within it
6. *State how known sub-groups of participants with an inherent individual risk of short or long time to diagnosis were handled (e.g., by sub-group analysis, exclusion)
7. Define time points (e.g., time of first signs and symptoms, time of diagnosis) and *time intervals (e.g., patient or physician intervals)
8. State the methods used to collect study data
9. Describe how time points were assessed (e.g., number of assessors, their qualifications)
10a. *If the study aims to evaluate associations between participant characteristics and time to diagnosis, state whether assessors of time to diagnosis were blinded to these characteristics
10b. *If the study aims to evaluate associations between time to diagnosis and participant health outcomes (e.g., survival), state whether assessors of time to diagnosis were blinded to these outcomes
11. Describe the statistical methods used, including whether time to diagnosis was analysed as a continuous or categorized variable (e.g., delayed versus not delayed)
12. *If the study aims to evaluate associations between time to diagnosis and other factors (e.g., participant characteristics or health outcomes), describe which confounders were considered and how they were chosen, measured and analysed
13. †Give a rationale for the sample size Results
14. Report the number of individuals at each step of the selection process between the source population and participants and provide a flowchart (see example). Give reasons for non-participation at each stage 15. †Report demographic and clinical characteristics of participants
16. Report the distribution of time to diagnosis
17. *If associations between time to diagnosis and other factors (e.g., participant characteristics or health outcomes) are described, report measures of association and their precision (e.g., confidence intervals) Discussion
18. †Summarize key results with reference to study objectives and discuss their potential clinical implications
19a. Discuss sources of potential bias, including bias due to the selection of participants from the source population (e.g., undiagnosed cases) and to the assessment of time points
19b. *If association between time to diagnosis and survival was studied, discuss possible lead-time bias
Les items marqués par une croix « †» sont communs à d’autres reporting guidelines (CONSORT, STARD, STROBE), les items marqués par un astérisque « * » sont optionnels selon les objectifs de l’étude
Partie I – Chapitre 3
Figure 9. Diagramme de flux proposé pour détailler le processus de sélection des participants
Partie I – Chapitre 3
Figure 10. Explication des items spécifiques fournis avec la checklist pour guider les auteurs
dans le reporting des études sur les délais diagnostiques.
ITEM 4 (Methods section). State eligibility criteria of participants (i.e., inclusion and exclusion criteria, especially diagnostic criteria).
Example: “All patients under the age of 18 years who presented with imported malaria to the emergency
departments of the seven participating hospitals were included. Imported malaria was defined as the presence of Plasmodium trophozoites in blood after a stay in a malaria-endemic area, regardless of the clinical
symptoms present. (…) If so, the search for Plasmodium trophozoites in thick and/or thin blood smears was ordered.” (Chalumeau, Eur J Clin Microbiol Infect Dis 2006)
Explanation: Studies of time to diagnosis by definition focus on patients with a positive diagnosis. Authors
must detail the diagnosis criteria used in order to help readers to evaluate whether they are accurate.
ITEM 5 (Methods section). Describe the source population [i.e., the population with signs and symptoms that usually trigger healthcare professionals to initiate the diagnostic procedure(s)] and how the participants were identified within it.
Example: “In the participating emergency departments, the routine protocol for children with fever was to ask
if they had recently visited a malaria-endemic area. If so, the search for Plasmodium trophozoites in thick and/or thin blood smears was ordered.” (Chalumeau, Eur J Clin Microbiol Infect Dis 2006)
Explanation: In this item, authors should describe the population presenting signs and symptoms that are
usually used by healthcare professionals to trigger the diagnostic procedure (in the present example: children with fever and having recently visited a malaria-endemic area). They should also state whether the surveillance of these signs and symptoms was performed routinely or ad hoc (in this example, authors stated that all the children with fever and having visited an endemic area were tested for malaria during the study period). They should also state the mechanism for identifying participants among the source population and how participants were sampled (consecutive or random sampling, other).
ITEM 6 (Methods section). *State how known sub-groups of participants with an inherently short or long time to diagnosis were handled (e.g., by sub-group analysis, exclusion).
Example 1: “Clinical, diagnostic, and family history information is then reviewed by a clinical review
committee to classify the patients into one of the following case definitions: definite, probable, possible, asymptomatic, female, or not Duchenne or Becker Muscular Dystrophy. For this study we included definite or probable cases of Duchenne Muscular Dystrophy without known family history of Duchenne Muscular Dystrophy prior to birth.” (Ciafaloni, J Pediatr 2009)
Example 2: The clinical charts of 64 consecutive patients who presented to the Memorial Sloan-Kettering
Cancer Center with newly diagnosed retinoblastoma between November 11, 1993, and January 14, 1998, were reviewed. Seven patients with a family history of retinoblastoma were excluded from the results. (Butros,
Pediatrics 2002)
Explanation: In the first example, the studied condition is an X-linked disease; females (at risk of longer time to
diagnosis) were identified as a separate group. In the first and the second example, people with known family history (at risk of shorter time to diagnosis) were excluded.
Partie I – Chapitre 3
ITEM 7 (Methods section). Define time points (e.g., time of first signs and symptoms, time of diagnosis) and *time intervals (e.g., patient or physician intervals).
Example: “Patient delay was defined as the time between fever onset and the first medical consultation.
Doctor delay was the time between the first consultation and the parasitological diagnosis. The total delay was
the sum of the two. We defined a late medical diagnosis as a doctor delay of longer than 12 h.” (Chalumeau,
Eur J Clin Microbiol Infect Dis 2006)
Explanation: Authors should detail how they defined time points (in this example, using a single symptom –
fever) in order to help readers evaluate whether they are accurate. With several possible signs and symptoms, authors should list all of them. Sub-divisions composing the delay can also be defined, depending on the objective of the authors. Subdividing the diagnostic delay may help target corrective actions (health education and/or medical education) by measuring the role of each participant in the delay (patients/parents, physicians/healthcare system). The use of a framework may be useful to report these subdivisions.
Example of a framework (Olesen, Br J Cancer 2009)