Polypharmacy Project Brief

Content validation for questionnaire to gather patient reported outcome measures (PROMs) for polypharmacy

1. Purpose

The Digital Health & Care Innovation Centre (DHI) is issuing this invitation to quote on behalf of the Scottish Government Effective Prescribing and Therapeutics Division (SG EPT.) This project is part of Scottish Government’s work to improve safe, appropriate medicines management, focused on personal outcomes, for people taking multiple medicines (polypharmacy). The project aims to validate the wording of the questionnaires DHI and SG EPT have created to gather Patient Reported Outcome Measures (PROMs) before and after polypharmacy medicines review.

2. Background

The care of patients with multi-morbidities (multiple medical conditions) is one of the greatest challenge now faced by the health service, as it can create overly complex health care for some of the most vulnerable in society. The vast majority of medical research, guidelines and contractual agreements have focussed on single targets for single disease states, whereas in reality most patients have multi-morbidities, requiring multiple treatments[1].  The resulting polypharmacy (use of multiple medicines) can be appropriate or inappropriate and the key healthcare aim for the individual patient is to ensure the safe and effective use of their multiple medicines.

Polypharmacy becomes inappropriate when the medication risks begin to outweigh benefits for an individual patient.  The national Polypharmacy Guidance developed by SG EPT aims to address this by helping to identify those patients at greatest risk of harm and to agree a medication regimen that is tailored to their changing needs and expectations

This project forms part of a wider body of work to facilitate implementation of this national Polypharmacy Guidance.  Specifically, it supports the guidance aim of a person-centred approach to management of polypharmacy, based on the Realistic Medicine principles of empowering patients to self-manage, and engaging patients in shared decision-making with professionals.

2.1 Existing questionnaires

As a key enabler of implementing the polypharmacy guidance, DHI has developed for SG EPT a patient and carer toolkit within the national polypharmacy web and mobile app [2].  The “Questions for my Review” section within this app comprises two sets of questions, designed to gather Patient Reported Outcome Measures before and after medicines review.

These questions have been developed through:

• A research study funded by SG EPT which synthesised existing published evidence on PROMs relevant to polypharmacy, followed by consultation with patients, carers and professionals on key requirements for polypharmacy PROMs.
• A series of patient and professional workshops facilitated by DHI to draft and review questions that would reflect the themes and priorities identified in the research study.
• Incorporation of the EQ-5D-3L instrument to describe and value health status. This will support economic analysis of impact of medicines review on Quality Associated Life Years (QALYs).

The questionnaires can be completed in four ways:

1. By a patient, who then submits their answers by email to their healthcare professional to provide a person-centred focus to the medicines review.
2. In collaboration by a patient and carer.
3. By a healthcare professional (e.g., practice pharmacist, GP, hospital clinician) asking the patient the questions and filling in the answers on their behalf.
4. By non-clinically trained staff (e.g. community connectors, link workers, care home  and care at home workers), supporting the patient to complete the questionnaires.

The completed questionnaires are emailed to the healthcare professional as a record and to provide a person-centred focus for shared decision-making within the medicines review.

2.2 iSIMPATHY study

These pre- and post-medicines review questionnaires are being used across NHS Scotland boards.  They are also being used to gather PROMs in the iSIMPATHY research study led by SG EPT. iSIMPATHY isa 3-year EU funded project (2019-2022) operating in Scotland, Northern Ireland and the border areas of the Republic of Ireland. It aims to develop an optimal, sustainable and scalable approach to use of medications for people with multiple morbidity.  A key aspect of the study is enabling patients to live healthy and active lives by supporting them and their healthcare professionals to define goals for medicines treatment that reflect the outcomes that matter to them. The project will train healthcare professionals across the three health jurisdictions to deliver 15,000 medicines reviews by September 2022. The capture of PROMs before and after medicines review through the questionnaires in the web and mobile app is essential to analysing the impact of medicines reviews on patient reported outcomes and QALYs.

SG EPT has now provided funding for DHI to manage delivery of this project, to validate the content of the questionnaires.

3.Project objectives

To validate the content of the pre- and post-medicine review questionnaires by:

3.1 Identifying sources of response error in the current question wording. This will include assessing for:

• User comprehension
• Clarity and potential for ambiguity
• Consistency between users’ understanding and questioners’ intentions.

3.2 Making recommendations on how to optimise the wording to ensure full and consistent understanding across the range of potential users.

4. Scope and methodology

Researchers are encouraged to build on the following recommended methodological approaches:

4.1 Use of  cognitive interviewing as the primary investigative methodology – for example, using think aloud and verbal probing techniques. If you are proposing an alternative methodology, please provide a clear justification for this.

4.2 The cross-section of users for interview should include:

• Patients and carers from each of the health jurisdictions involved in the SIMPATHY study – Scotland, Northern Ireland, Republic of Ireland.
• Healthcare professionals – including practice pharmacists, GPs, hospital doctors and pharmacists, care home nurses, as the main healthcare professional groups who will complete the questionnaires with or on behalf of patients.
• Non-clinical staff who may support patients to complete the questionnaires – e.g. link workers, community connectors, care at home workers.
• People with at risk of exclusion due to relevant protected characteristics – e.g. older people; people whose first language is not  English not their first language, people with learning disabilities or other cognitive impairment; people with mental health issues.

DHI and SG EPT will support identification of users where necessary, but we encourage suggestions from bidders as to networks and user groups to which they already have access.

4.3 Analysis of the data derived from cognitive interviews should take the form of written summaries that describe the problems observed on a question-by-question basis, with recommended modifications to address these problems. Recommendations may include wording, ordering and grouping of questions.

4.4 On the basis of these results and suggestions, researchers should revise the questions in consultation with DHI and SG EPT. They should then conduct one or more further rounds of cognitive testing to determine if the proposed solutions have solved identified problems without introducing additional difficulties.

4.5 The DHI Programme Lead and SG EPT team expect to be actively involved and consulted in defining the research methodology, analysis of results and definition of recommendations.

4.6 Research governance

• All data collection and analysis should be carried out in compliance with GDPR.

• Researchers should outline how they will conduct the research in compliance with ethical principles and standards.

4.7 Out of scope

• Suppliers should note that the EQ-5D-3L is an existing validated research instrument. The wording of statements from the EQ-5D-3L is therefore fixed and cannot be modified.

• Analysis of digital accessibility and usability are out of scope for this study and will be reviewed separately.

5. Deliverables

• Report outlining results of the research and the recommended modifications to the questionnaires.
• Proposed modified versions of the questionnaires.

6. Milestones and timescales

7. Fees and Costs

£10,000 is available for this project, exclusive of VAT. This includes all additional expenses – e.g. travel, subsistence - howsoever incurred.

Note that this research will be VAT exempt,  as it relates to medical treatment.

8. Project reporting and involvement of project lead and sponsors

Delivery of this project will be coordinated and monitored by the Programme Lead for Knowledge and Decision Support within the Digital Health & Care Innovation Centre, working in close partnership with the Scottish Government Effective Prescribing and Therapeutics Division. Suppliers will report to the Programme Lead through fortnightly phonecalls and checkpoint reports, with additional email or phone communication as required.

The Head of Effective Prescribing and Therapeutics in Scottish Government and the Programme Lead will jointly sign off deliverables at each milestone.

9. Additional information

All intellectual property generated by this project is the right of Scottish Government.

The Head of SG EPT and wider EPT team, and the DHI Programme Lead, should be actively involved in any writing up of this study for publication and should be cited as co-authors.

10. Award Criteria

Bids will be assessed on the following criteria

11. Instructions to suppliers

Responses and quotations should be returned to ann.wales@dhi-scotland.com by 6 pm on 15 November 2021. Suppliers should structure their responses under the following headings, which reflect the award criteria outlined in section 10 above.

a) Understanding of project context, aims, why this project is valuable to the health service, and specific project requirements.

b) Previous relevant experience

c) Methodology and approach proposed

d) Specific expertise

e) Specific expertise

f) Price

[1] Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012;380(9836):37-43.

[2] Links to download mobile apps are in footer of website. Google Play  Apple

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