Background
Evidence-based medicine and evidence-based public health
The PRECEPT approach
Methods
Objectives
Scope and definitions
Identification of relevant questions and study designs
Identification of QATs
Eligibility criteria for QATs
Data extraction for QATs
Analysis
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A matrix was constructed that mapped study designs to relevant questions, and QATs to study designs.
-
The data extracted from the original descriptions of the QATs was summarized in one abstract per QAT.
-
The number of questions/items of each QAT, information on the structure (checklist, scale, summary score) and validation of each QAT was summarized across all QATs.
Results
Relevant questions
Study designs
Quality appraisal tools (QATs)
Domain1
| No. | Question | Study design | Quality appraisal tools (Reference)2
|
---|---|---|---|---|
A | 1 | Characteristics of the pathogen? | Laboratory study | Van der Worp [37]3
|
A | 2 | Subtypes, serotypes and local epidemiology of the pathogen? | Laboratory study | Van der Worp [37] |
Cross-sectional study | ||||
A | 3 | Modes of transmission? | Animal study | Van der Worp [37] |
Cohort study | ||||
Case series | Cho [30] | |||
Case-control study | ||||
B | 4 | Incidence of the disease? | Cohort study | |
B | 5 | Prevalence/seroprevalence of the disease? | Cross-sectional study | |
B | 6 | Consequences or sequelae of the disease (hospitalization/mortality/complications/disabilities)? | Cohort study | |
Case series | Cho [30] | |||
Case report | Cho [30] | |||
B | 7 | Perception of the disease in the target population? | Cross-sectional study | |
Cohort study | ||||
Focus groups | ||||
Interview study | ||||
C | 8 | Sensitivity of tests? | Diagnostic test accuracy study | SIGN [42] |
C | 9 | Specificity of tests? | Diagnostic test accuracy study | SIGN [42] |
D | 10 | Risk factors (for transmission/colonization/infection/disease/exacerbation/complication)? | Cohort study | |
Case-control study | ||||
Ecological study | NICE [47] | |||
Cross-sectional study | ||||
Animal study | Van der Worp [37] | |||
E | 11 | Effects of intervention (in terms of efficacy/effectiveness/surrogate markers/adverse events/harms)? | Controlled before-and-after study | |
RCT | ||||
NRCT | ||||
Cluster-randomized trial | ||||
Cohort study | ||||
Case-control study | ||||
Uncontrolled before-and-after study | ||||
Ecological study | NICE [47] | |||
Interrupted time series | ||||
Self-controlled case series | ||||
F | 12 | Feasible to implement? | Cross-sectional study | |
Cohort study | ||||
Focus groups | ||||
Interview study | ||||
F | 13 | Cost-effectiveness of the intervention? | Cost-effectiveness (-benefit, -consequence) analysis | |
Cost-utility analysis | QHES [34] | |||
F | 14 | Acceptable to stakeholders? | Focus groups | |
Interview study | ||||
Cross-sectional study | ||||
F | 15 | Equitable? | Cross-sectional study | |
Cohort study | ||||
F | 16 | Enablers/barriers to success? | Cross-sectional study | |
Interview study (observation) | ||||
Document analysis | ||||
Focus groups | ||||
Process evaluation | ||||
F | 17 | Coverage rates for positive population level effects? | Cohort study | |
Non-economic modeling study | ||||
F | 18 | Communication of advice? | RCT | |
NRCT | ||||
Cohort study | ||||
Cross-sectional study | ||||
Focus groups | ||||
Interview study | ||||
F | 19 | Weighing and valuing of population preferences? | Cross-sectional study | |
Focus groups | ||||
Interview study | ||||
F | 20 | Effectiveness of alternative measures? | Controlled before-after study | |
RCT | ||||
NRCT | ||||
Cluster-randomized trial | ||||
Cohort study | ||||
Case-control study | ||||
Uncontrolled before-after study | ||||
Ecological study | NICE [47] | |||
Interrupted time series | ||||
Self-controlled case series |
-
For the research question “Is neonatal sepsis a risk factor for neurodevelopmental delay?”, the user would choose domain D, question no. 10 (risk factors). Five different study designs are suggested to be applicable: cohort study, case-control study, ecological study, cross-sectional study and animal study. If the user has identified a cohort study, he/she is guided by the matrix to use one out of five different QATs to assess the methodological quality of the study (Downs, SIGN, Cho, EHPP or NOS).
-
For the research question “What is the prevalence of neonatal sepsis?”, the user would choose domain B, question 5 (prevalence). He/she is guided to cross-sectional studies as the appropriate study design. For methodological quality appraisal of this type of studies, five QATs are suggested (Al-Jader, Loney, Hoy, Cho and NICE).
QAT (Reference)1
| Animal study | Before-and-after study (controlled) | Before-and-after-study (uncontrolled) | Case-control study | Case report | Case series | (Cluster) rRCT | Cohort study | Cost-effectiveness (-benefit, -consequence) analysis | Cost-utility analysis | Cross-sectional study | Diagnostic test accuracy study | Document analysis | Ecological study | Focus groups | (Individually) RCT | Interrupted time series | Interview study (Observation study) | Laboratory study | Non-economic modeling study | nRCT | Process evaluation | Self-controlled case series |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Van der Worp [37] |
X
|
X
| |||||||||||||||||||||
NICE (qualitative) [48] |
X
|
X
|
X
|
X
| |||||||||||||||||||
CASP [36] |
X
|
X
|
X
|
X
| |||||||||||||||||||
SIGN (diagnostic) [42] |
X
| ||||||||||||||||||||||
Cho [30] |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| ||||||||||||
Hoy [45] |
X
| ||||||||||||||||||||||
Al-Jader [33] |
X
| ||||||||||||||||||||||
SIGN (cohort) [40] |
X
| ||||||||||||||||||||||
NOS [44] |
X
|
X
|
X
| ||||||||||||||||||||
EPOC [50] |
X
| ||||||||||||||||||||||
SIGN (case-control) [41] |
X
|
X
| |||||||||||||||||||||
NICE (intervention) [46] |
X
|
X
|
X
| ||||||||||||||||||||
Cochrane [35] |
X
| ||||||||||||||||||||||
SIGN (RCT) [39] |
X
| ||||||||||||||||||||||
NICE (correlation) [47] |
X
| ||||||||||||||||||||||
Downs et al. [31] |
X
|
X
|
X
|
X
|
X
|
X
|
X
| ||||||||||||||||
Loney et al. [32] |
X
| ||||||||||||||||||||||
QHES [34] |
X
|
X
|
X
| ||||||||||||||||||||
EPHPP [38] |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| |||||||||||||||
SIGN (economic) [43] |
X
|
X
| |||||||||||||||||||||
NICE (economic) [49] |
X
|
X
|
QAT (Reference) | No. of questions or items | Checklist (C) or scale (S)? | Summary score? (yes/no) | Validation? (yes/no) |
---|---|---|---|---|
Van der Worp [37] | 9 | C | No | No |
NICE [47] | 20 | C | No | No |
SIGN [39] | 10 | C | No | yes |
Cho [30] | 24 | C | yes | Yes |
Hoy [45] | 10 | C | No | Yes |
Al-Jader [33] | 9 | S | Yes | Yes |
SIGN [40] | 16 | C | No | Yes |
NOS [44] | 8 | S | No | Yes |
EPOC [50] | 7 | C | No | No |
SIGN [41] | 13 | C | No | Yes |
NICE [46] | 27 | C | No | No |
Cochrane [35] | 6 | C | No | Yes |
SIGN [42] | 28 | C | No | Yes |
Loney [32] | 8 | S | Yes | Yes |
Downs [31] | 27 | S | Yes | Yes |
EPHPP [38] | 20 | C | Yes | Yes |
CASP [36] | 10 | C | No | No |
NICE [48] | 15 | C | No | No |
SIGN [43] | 20 | C | No | Yes |
NICE [49] | 19 | C | No | No |
QHES [34] | 16 | S | Yes | Yes |
Discussion
Conclusions
Ethical approval
Appendix A
Glossary of study designs
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Animal study/other laboratory study
-
Before-and-after study (controlled: experimental; uncontrolled: observational)
-
Case-control study
-
Case report
-
Case series
-
Cohort study
-
Cost-benefit analysis
-
Cost-consequence analysis
-
Cost-effectiveness analysis
-
Cost-utility analysis
-
Cross-sectional study
-
Diagnostic test accuracy study
-
Document analysis
-
Ecological study
-
Focus groups
-
Interrupted time series
-
Interview study (qualitative)
-
Non-economic modeling study (mathematical model)
-
Non-randomized controlled trial (NRCT)
-
Observation/participant observation
-
Process evaluation
-
Randomized controlled trial (RCT)/cluster-randomized controlled trial
-
Self-controlled case series