Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol

Figures & data

Figure 1 Representation of the four-step approach used to develop the core outcome set.

Abbreviation: COS, core outcome set.

Table 1 Repartition of all stakeholder groups and subgroups with number planned to be recruited in each center

Participant groups	Characteristics	Place of recruitment
		Locally in each center*	International
Group 1: patients and carers		16
Patients	65–80 years old and living at home	6
	>80 years old and living at home	6
Carers	Living at home	2
Patient/carer	Nursing home	2
Group 2: health care professionals		13
Primary care	GP	6
	Pharmacists	1
	Nurses (1 at home; 1 in nursing home)	2
Secondary care	Physicians	2
	Clinical pharmacists	1
	Nurses	1
Group 3: scientifics and experts		5	20
Researchers specialized in medication review			20
Researchers in related fields (nonmedical)		2
Policy makers		2
Experts from professional associations		1
Total number to be recruited		136	20

Notes:

* Four centers in total: University of Bern, Switzerland; University College Cork, Ireland; Université catholique de Louvain, Belgium; University Medical Centre Utrecht, Netherlands.

Abbreviation: GP, general practitioner.

Table S1 Methodological aspects to be defined before starting the Delphi survey to improve both the quality of the survey and its reporting, as recommended by Sinha et al² along with the paragraph of the study protocol that addressed each given issue

Size and composition of the panel
The total number of participants invited, and the number who completed the first round	Table 1
Whether the following types of participants were involved in the study: clinicians (and whether they were eligible on the basis of treating patients with the condition of interest, or whether clinical trial involvement was an additional requirement), patients or their families, researchers, biostatisticians, representatives from the pharmaceutical industry, representatives from drug regulatory authorities, or other types of participants	Table 1 and Key stakeholders to recruit section
The proportion of each type of participant described above	Table 1
How participants were identified/sampled	Key stakeholders to recruit section
Methodology of the Delphi process
Administration of questionnaires: postal, email, internet, in person (eg, at a clinic), or at a meeting	Maximizing response rate section
Information about outcomes, known to the facilitators before the study, which was provided to participants before the first round: for example, if the Delphi process followed a review of outcomes measured in clinical trials, were the results of the review shared with participants? Alternatively, if some work had been conducted prior to the Delphi survey (eg, workshop meeting, or focus groups among patients), were the results presented to the participants?	List of eligible outcomes to propose section
How outcomes were considered in the first questionnaire: were participants asked an open question, that is, no outcomes were initially listed, or were they asked to comment on a prespecified list? If the latter, was the source of the list identified? Where possible, the questions asked to participants should be described in the methods, or made available to the reader, as supplementary information	List of eligible outcomes to propose section Online questionnaire and anonymity section Rounds 1–3 section
What was asked in subsequent rounds: where possible, the questions asked to participants should be described in the methods, or made available to the reader, as supplementary information	Rounds 1–3 section
Feedback to participants after each round: if the results were not fed back, but only certain outcomes were carried forward to the next round (eg, only those suggested by at least 10% were carried forward), this should be clearly described	Rounds 1–3 section
Level of anonymity should be described: In order to be “fully anonymised”, participants should not know the identities of the other individuals in the group, nor should they know the specific answers that any other individual gave. In studies that are “quasi-anonymised”, the participants should know the identities of some or all of the other individuals, but should not know how they individually responded to any of the questions in any round. In studies that are not anonymized, participants must know the identity of some or all of the other individuals, and also know how some or all of them responded to any of the questions in any round	Online questionnaires and anonymity section
If a predetermined definition of consensus was used, this should be clearly described in the methods section of the study report	Consensus section
Were nonresponders invited to subsequent rounds, or were they excluded from the rest of the study? Were additional people invited as the Delphi survey progressed?	Rounds 1–3 section

SinhaIPSmythRLWilliamsonPRUsing the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studiesPLoS Med201181e100039321283604

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