COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study

Table 3 Consensus on components of outcome measurement instruments that involve biological sampling

Component	Consensus^a on the term (%)	Elaboration	Consensus on the elaboration (%)
Equipment	See above	All equipment used in the preparation, the administration, and the determination of the values of the outcome measurement instrument	See above
Preparatory actions preceding sample collection by professionals, patients, and others (if applicable)	See above	1. General preparatory actions, such as required expertise or training for professionals to prepare, administer, store and determine the value 2. Specific preparatory actions for each measurement, such as • preparations of equipment, environment, and storage by professionals^b • preparation of the patient^c by the professional • Preparatory actions undertaken by the patients	See above
Collection of biological sample	32/38 (84%) (R2^d)	All actions undertaken to collect the biological sample, before any sample processing	33/38 (87%)^e (R2)
Biological sampling processing and storage	Combining^f 33/35 (94%) (R3^g) Term: 29/35 (83%) (R3)	All actions undertaken to be able to preserve, transport, and store the biological sample for determination; and, if applicable, further actions undertaken on the stored sample to be able to conduct the determination of the biological sample	35/36 (97%) (R3)
Determination of the value of the sample⁵	20/35 (57%) (R3) 31/35 (89%)ⁱ (R3)	Methods used for counting or quantifying the amount of the substance or entity of interest^h	27/36 (75%) (R3)

^a Consensus was set at 67% of the panelists (strongly) agreed to a proposal, the denominator can be decreased because panelists considered themselves to have ‘no expertise’ on a specific proposal or dropped-out; ^b Professionals are those who are involved in the preparation or the performance of the measurement, in the data processing, or in the assignment of the score; this may be done by one and the same person, or by different persons; ^c In the COSMIN methodology we use the word ‘patient.’ However, sometimes the target population is not patients, but e.g. healthy individuals, caregivers, clinicians, or body structures (e.g. joints, or lesions). In these cases, the word patient should be read as e.g. healthy volunteer, or clinician; ^d R2: consensus reached R2: consensus reached in Round 2; ^e After round 2 we changed the formulation, but we did not rated agreement among panelists; ^f In round 2 we proposed two components ‘initial processing and storage’ and ‘second processing’, which we proposed to combine in Round 3; ^g R3: consensus reached in Round 3; ^h Decision by the steering committee; ⁱ Consensus reached in R3 on the term ‘value’

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