Table 1.

Data charting form for the scoping review on methods of benefit–risk assessment

	Questions and information	Description/options (examples)
General information	First author and publication year	Silva, 2012
	Institutions involved in the document development	Industry, academic institution, health institution, regulatory agency, HTA body, consulting firm, others (specify)
	Main institution(s)/ organisation(s)/body(ies)/agency(ies) who produced the document	Description
	Main institution (s)/organisation (s)/body (ies)/agency (ies) who sponsored/supported/funded/ the development of the document	Description
	A geographical area that the institutions who developed the methodological document	Description. Examples: international (global) or continent (Europe) or country (Germany) or not reported
	A geographical area of the context of where the methodological document is destinated	Description. Examples: international (Global) or continent (Europe) or country (Germany) or not reported
	Composition body	Description of individuals involved in the development process (methodology) such as methodologists, health professionals and patients. If not explicitly described, it will be informed as not reported
	Target audience	Description of the target audience (individual to whom the document is intended). Examples: researchers, methodologists, payers, the public and others
	The conflict of interest was reported?	Yes, no
	Is there a conflict of interest from individuals involved in research support or employment, including salaries, equipment, supplies, reimbursement for attending symposia and other expenses; any stocks or shares and any consultation fees or other forms of remuneration from the manufacturer?	Yes, no, not possible to identify/evaluate
General methodological information	Publication type	Methodological guidelines, report of HTA body, report of a regulatory agency, methodological report of health and/or academic and/or research institution, methodological systematic review, narrative review with methodological recommendations and others (specify)
	Types of technology addressed	Pharmaceutical drugs, vaccines, medical devices, procedures, diagnostic tests, equipment, general (it can be addressed or be applied to any health technology) and others (specify)
	Context of benefit–risk assessment was made for	Regulatory decision, POS marketing guidance, coverage, or reimbursement in HTA decisions, evidence synthesis, clinical trials, clinical decision and others (specify)
	General methodology	Report with systematic and transparent methods, systematic review, systematic literature review as rapid literature review, literature review, interviews, review of reports, methodological guidelines/manuals, multiple methods that were not available as an option, relevant papers in the field, real-world case studies and others (specify)
	Was the definition of benefits given?	Yes, no Description from the authors
	Was the definition of risks or harms given?	Yes, no Description from the authors
	Was the definition of benefit–risk assessment given?	Yes, no Description from the authors
	Information regarding evidence to be used in the benefit–risk assessment	Real-world evidence, systematic reviews and meta-analysis, phase III clinical trials: non-randomised clinical trial, phase III clinical trials: randomised clinical trial, phase II clinical trials: non-randomised clinical trial, phase II clinical trials: randomised clinical trial, phase I clinical trials, observational studies, others (specify) or not reported
	Types of frameworks	Type of framework (quantitative and/or descriptive framework, not reported) Type of framework (designation name of the framework) Framework(s) recommended by the authors
Specific methodological information (methods for balancing benefit–risk)	Types of metrics (systems of measurement, eg, health indices and trade-off indices)	Type of metrics (designation name of the metric) Metric(s) recommended by the authors
	Types of estimation techniques (generic statistical techniques)	Type of estimation techniques (designation name of the estimation techniques) Estimation techniques recommended by the authors
	Types of utility survey techniques (methods to elicit and collect utilities and value preferences of various outcomes)—only for quantitative framework	Type of utility survey techniques (designation name of utility survey techniques) Utility survey techniques recommended by the authors
	Does the methodological document recommend a checklist for benefit–risk assessment?	Yes, no
	Is there any description of visual tools for communicating evidence and translating knowledge of the benefit–risk assessment?	Yes, no
	Is there any description of general recommendations for communicating evidence and translating knowledge of the benefit–risk assessment?	Yes, no. If yes, provide the general recommendations
	Types of identified visual tools (visual representation of results)	Type of visual tools (designation name of the visual tools)

HTA, health technology assessment.