Table 2 Delphi consensus approach – results of the overall approach round 1 and 2
Questions | Round 1 (N = 38)* | Round 2 (N = 28)* | ||||||
|---|---|---|---|---|---|---|---|---|
Yes | No | Yes | No | |||||
Need for standardized clinical endpoints and operationalization | No. | (%) | No. | (%) | No. | (%) | No. | (%) |
1.1.1 Should specific clinical endpoints be defined for dengue interventional trials? | 32 | (84) | 0 | (0) | ||||
1.1.2 If not, briefly explain why not. | ||||||||
1.1.3 Do you think we also need clinical endpoint definitions for pathogenesis research? | 31 | (82) | 1 | (3) | ||||
1.2.1 Do you think operationalization of severe dengue endpoints is necessary for interventional trials? | 31 | (82) | 0 | (0) | ||||
2.1.1 Please let us know what information you consider essential to further characterize these endpoints. | ||||||||
Ideal time to collect clinical samples and clinical information | 26 | (93) | 2 | (7) | ||||
Details on how to measure endpoints (specific assays, instrumentation, etc) | 25 | (89) | 3 | (11) | ||||
Chart with endpoints and checkboxes | 18 | (64) | 10 | (36) | ||||
Different instructions for children and adults | 17 | (61) | 11 | (39) | ||||
2.1.2 Could you please provide additional suggestions/ideas? | ||||||||
Moderate severity endpoints | ||||||||
1.3.1 Do you think there should be a moderate disease severity category? | 29 | (76) | 3 | (11) | ||||
1.3.2 Briefly explain why or why not. | ||||||||
2.2.1 The goal of this project is to develop endpoints for dengue intervention clinical research. These endpoints are meant for interventional clinical research only and we were never meant to modify or substitute the 2009 WHO classification. Do you think moderate endpoints should be proposed based on the best scientific evidence available so far and validated afterward utilizing ongoing or new studies? | 27 | (96) | 1 | (4) | ||||
2.2.2 Please explain your answer. | ||||||||
Hospitalization as moderate endpoint | ||||||||
1.4.1 Should prevention of hospitalization be the endpoints for dengue interventional trials? | 14 | (37) | 18 | (47) | ||||
1.4.2 Briefly explain why or why not. | ||||||||
2.4.1 Do you think that information on hospitalization should be collected during interventional clinical trials and used in conjunction with other endpoints of disease severity? | 25 | (89) | 1 | (4) | ||||
2.4.2 What is the main reason why information on hospitalization should be collected during an interventional trial? | ||||||||
2.4.3 Please explain your answers. | ||||||||
Potential ramifications for public health practice | ||||||||
1.5.1 Do you think the severe/moderate dengue severity endpoints for research purposes should be based on/aligned with the dengue classification for severity as set forth WHO 2009? | 22 | (58) | 10 | (26) | ||||
1.5.2 Do you think moderate disease severity endpoint definitions will impact public health practices? | 19 | (50) | 12 | (32) | ||||
1.5.3 Briefly explain why or why not. | ||||||||
2.3.1 Can you please elaborate on why do you think the severe/moderate endpoints should or should not be based on the 2009 WHO dengue classification? | ||||||||
2.3.2 Can you suggest ways to minimize the potential impact of these endpoints for research on public health practices? | ||||||||
Granularity of endpoints | ||||||||
1.6.1 To measure disease severity in interventional research, do you think that a categorical system (e.g. moderate vs. severe) or a numerical point system (e.g. 1–10) would be better? | 18 | (47) | 13 | (34) | ||||
1.6.2 Briefly explain your selection. | ||||||||
2.5.1 Should a categorical system be developed first? | 20 | (71) | 6 | (21) | ||||
2.5.2 Do you think it’s a good idea to develop a numerical system in parallel and that relative weight / importance / comparability be assessed prospectively? | 20 | (71) | 7 | (25) | ||||
Validation of endpoints | ||||||||
1.7.1 Should suggested endpoints be validated with large prospective data sets? | 28 | (74) | 3 | (8) | ||||
1.7.2 If not, briefly explain why not. | ||||||||