D3.2 Report on Results of Delphi Validation Study

Transcription

1 D3.2 Report on Results of Delphi Validation Study Nature: Report This document is part of SIMPATHY project (663082),which has received funding from the European Union s Health Programme ( ) Disclaimer: The material contained in this document is provided for information purposes only. No warranty is given in relation to use that may be made of it and neither Page the 1 copyright of 56 owners or the European Commission accept Version: any 1.0 liability for loss or damage to a third party arising from Status: such use. FINAL

2 Description of the deliverable D3.2 Lead Beneficiary Authors Work Package Robert Gordon University Derek Stewart, Katie Gibson-Smith, Katie MacLure SIMPATHY Project Consortium: Scottish Government, Fundació Clínic per a la Recerca Biomèdica, Uppsala Lans Landsting, Northern Health And Social Services Trust, Medisinische Hochschule Hannover, Universidade de Coimbra, Asienda Ospedaliera Universitaria Federico II, Uniwersytet Medyczny W Lodzi, University Of Peloponnese, WP3 Version 1.0 Status FINAL Last modified 25 February 2017 Approved by Date 27/02/2017 Disclaimer: The material contained in this document is provided for information purposes only. No warranty is given in relation to use that may be made of it and neither the copyright owners or the European Commission accept any liability for loss or damage to a third party arising from such use. Copyright Notice: Copyright SIMPATHY Consortium All rights reserved. Page 2 of 56 Version: 1.0 Status: FINAL

3 Table of Contents 1. Executive summary Introduction The Delphi technique Team Delphi statements Determining consensus Expert panel members Recruitment of panel members Delphi rounds Results Recruitment Round Round Round Strengths and weaknesses Conclusions References Appendices 47 Appendix 1, Participant information leaflet. 47 Appendix 2, Consent form 50 Appendix 3, Summary of findings provided to panel members. 51 Page 3 of 56 Version: 1.0 Status: FINAL

4 1. Executive summary SIMPATHY (Stimulating Innovation Management of Polypharmacy and Adherence in The Elderly) aims to stimulate, promote and support innovation across the European Union (EU) in the management of appropriate polypharmacy and adherence in the elderly, in order to contribute to efficient and sustainable healthcare systems. As part of Work Package 3, a Delphi study consensusbased approach was employed to provide information on the degree to which the findings of previous SIMPATHY Work Packages could be both contextualised and operationalised across the EU. The aim of the consensus study was to determine the levels of consensus amongst key stakeholders in the EU in relation to aspects of the management of polypharmacy and adherence in older people. Forty-six statements for the first round of the Delphi were developed from the findings generated from SIMPATHY Work Packages 4, 5 and 6, focusing on structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in older people. Consensus was deemed to have been met at 80% (summative of and strongly ) for each individual statement. Panel members were to be one policy maker, two healthcare commissioners, one healthcare provider director level and one clinician from each of the 28 European Union member states, giving a target of 140 Delphi panel members. Ninety-three panel members were recruited, with four member states over-recruiting, giving an adjusted recruitment rate of 90/140 (64.3%). The target of five (or more) per EU member states was achieved in 13/28 member states (46.4%), with no recruitment in six member states (21.4%). Participation levels were high throughout the three Delphi rounds (91.1%, 83.3%, 72.2%). During Round 1, consensus was obtained for 27/46 statements (58.7%), with consensus obtained for an additional two statements in Round 2 and none in Round 3. The total number of statements for which consensus was achieved was therefore 29/46 (63.0%). Page 4 of 56 Version: 1.0 Status: FINAL

5 Consensus was obtained as follows: 1. statements relating to potential gain arising polypharmacy management, 3/4 statements; 2. statements relating to strategic development, 7/7 statements; 3. statements relating to strategic change management, 5/7 statements; 4. statements relating to indicator measures, 4/6 statements; 5. statements relating to legislation, 0/3 statements; 6. statements relating to awareness raising, 5/5 statements; 7. statements relating to patient centred polypharmacy reviews 5/7 statements; 8. statements relating to the vision for the EU by /7 statements. The main areas of non-consensus were in relation to legislation and the SIMPATHY vision for the EU by Panel members felt generally that there was no need for changes in legislation to support aspects of polypharmacy management. For the SIMPATHY vision for the EU by 2025, analysis of the comments provided by panel members indicated that these statements were considered too ambitious and not achievable within the timeframe of In conclusion, consensus was obtained amongst key stakeholders in the EU in relation to many aspects of the management of polypharmacy and adherence in older people. Key areas of consensus were around potential gain arising from polypharmacy management, strategic development, change management, indicator measures, awareness raising and patient centred polypharmacy reviews. While the SIMPATHY vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU. Page 5 of 56 Version: 1.0 Status: FINAL

6 2. Introduction SIMPATHY (Stimulating Innovation Management of Polypharmacy and Adherence in The Elderly) aims to stimulate, promote and support innovation across the European Union (EU) in the management of appropriate polypharmacy and adherence in the elderly, in order to contribute to efficient and sustainable healthcare systems. 1 As part of Work Package 3, a consensus-based approach was employed to provide information on the degree to which the findings of previous SIMPATHY Work Packages could be both contextualised and operationalised across the EU. In doing so, data would be provided on the internal and external validity of SIMPATHY Work Package findings. The aim of the consensus approach was to determine the levels of consensus amongst key stakeholders in the EU in relation to aspects of the management of polypharmacy and adherence in older people. Particular consideration was given to aspects of structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence. Structures are the characteristics of the care setting, including: attributes of material resources (e.g. facilities); human resources (e.g. number and types of qualified personnel involved) and of organisational structure (e.g. methods of reimbursement). Processes detail what is carried out as part of giving care (e.g. practitioner s activities in consulting patients and prescribing and reviewing medicines). Outcomes attempt to describe the resultant impact on the patient (status of health, quality of life) and economic outcomes. 2 Consensus, also termed collective ment, designs are employed in many situations: where unanimity of opinion does not exist; to enhance decision-making; to develop guidelines and policies; and to assess or develop quality indicators. 3 Consensus designs are described as group facilitation approaches which aim to determine the level of consensus among a group of experts (stakeholders) by aggregation of opinions into refined d opinion. Page 6 of 56 Version: 1.0 Status: FINAL

7 The three main consensus designs are the Delphi technique, the consensus development technique and the nominal group technique. 4-6 The Delphi technique was considered most appropriate for this Work Package. 2.1 The Delphi technique The Delphi technique is a structured, isolated, indirect, multistage interaction based on repeated administration of anonymous questionnaires, usually across two or three rounds of data collection. 7 The classic Delphi technique employs a first round generating qualitative data to gather a wide array of opinions, which are then written as questionnaire items. A modified Delphi technique, which omits the qualitative round, can be employed in those situations where the statements are derived from the literature or previous research, as in this Work Package. The Delphi technique (classic and modified) is characterised by anonymity of participants, with the advantage over other consensus approaches being that it eliminates the influence of dominant participants. Other characteristics of the Delphi technique are: iteration, through a number of rounds; controlled feedback where participants can reconsider their responses; and the statistical aggregation of group response which is fed back to all participants. 8,9 Page 7 of 56 Version: 1.0 Status: FINAL

8 3. Methods 3.1 Team A Task Team was established representing SIMPATHY members across the different Work Packages and Partners. 3.2 Delphi statements The statements for the first round of the Delphi were developed from the findings generated from SIMPATHY Work Packages 4, 5 and 6, focusing on structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in older people. Draft statements were developed and reviewed by the Task Team for appropriateness and clarity, refined and finalised. These were formatted into the Round 1 questionnaire in eight distinct sections as follows: 1. statements relating to potential gain arising polypharmacy management (4 statements); 2. statements relating to strategic development (7 statements); 3. statements relating to strategic change management (7 statements); 4. statements relating to indicator measures (6 statements); 5. statements relating to legislation (3 statements); 6. statements relating to awareness raising (5 statements); 7. statements relating to patient centred polypharmacy reviews (7 statements); 8. statements relating to the vision for the EU by 2025 (7 statements). The Round 1 questionnaire was developed in Survey Monkey and functionality pilot tested with Task Team members. Page 8 of 56 Version: 1.0 Status: FINAL

9 3.3 Determining consensus A six-point Likert scale was used for participants to rate their level of ment or ment with each statement: strongly ; ; somewhat ; somewhat ; ; and strongly. There are many different approaches described in the literature for determining the point of consensus: a stipulated number of rounds; subjective analysis; certain level of ment; average percent of majority opinions cut-off rate; mode, mean, median ratings and rankings; interquartile range; coefficient of variation; and post-group consensus. 10 While there is no ment on the best approach, the certain level of ment is the most commonly used and hence was adopted. In addition, there is no accepted, set standard for the target percentage of ment, and while 70% (summative of and strongly ) is commonly reported in the literature, given the importance of promoting appropriate polypharmacy and adherence, the consensus was deemed to have been met at 80% (summative of and strongly ) for each individual statement. 3.4 Expert panel members The careful selection and recruitment of participants as expert panel members is an essential step to provide robust and valid data. Panellists should represent the key stakeholders, generally those considered to be experts in the field, and policy and decision makers, who can effect change. For this Delphi, the panel were to be five members from each EU member state (n=28), giving a total of 140 members. Furthermore, these five would represent one policy maker, two healthcare commissioners, one healthcare provider director level and one clinician (physician or pharmacist). Page 9 of 56 Version: 1.0 Status: FINAL

10 3.5 Recruitment of panel members The recruitment and engagement of the panel members is crucial to the success of any Delphi. Response rates are typically 85% and any reduction may compromise the internal and external validity of the findings. 10 For SIMPATHY partner countries, the associated member of the Task Team was responsible for the initial contact and securing ment to participate. This was continued until the required number and types of panel members were recruited. For non-partner countries, several sources including the SIMPATHY stakeholder database and professional networks were used to identify potential panel members. These were allocated to members of the Task Team and a similar approach to recruiting within partner countries adopted. Each potential panel member was provided with full study information, outlining the aim of the Delphi, the extent and timing of their expected involvement and the potential societal benefits. In addition, they were each requested to complete and return a consent form. Copies of the information leaflets and consent forms are provided in Appendices 1 and Delphi rounds Round 1 At the point of commencing the Delphi, each panel member was sent a personalised with a link to the online questionnaire designed, formatted and hosted using Survey Monkey. In addition to the Delphi statements, the online questionnaire captured demographic information on each panel member. A two week deadline was set for rating levels of ment or ment with each statement. A comments box was included for each statement, allowing justification of responses and the opportunity to propose new statements. All panel members were sent a reminder at weekly intervals. Data generated from completing the online questionnaire were extracted to Microsoft Excel for descriptive analysis (frequencies and percentages) to identify whether or not consensus had been obtained for each statement. A content analysis approach was performed on any textual responses. 11 Page 10 of 56 Version: 1.0 Status: FINAL

11 Round 2 In Round 2, collective feedback of all panel members Round 1 responses were provided, highlighting levels of consensus achieved for each statement and also all comments for each statement where consensus was not achieved. The Round 2 questionnaire required participants to rerate only those statements that did not meet consensus in round one. As in Round 1, a two-week deadline was given for completion and return, with the approach to reminders and analysis the same as round one. Round 3 Round 3 proceeded as per Round 2. Those statements not achieving consensus in Round 3 were deemed non-ment. Page 11 of 56 Version: 1.0 Status: FINAL

12 4. Results 4.1 Recruitment The table below provides the levels of recruitment of experts across the 28 EU member states. A total of 95 panel members were recruited, with four member states over-recruiting, giving an adjusted recruitment rate of 90/140, 64.3%. The target of five (or more) per member stated was achieved in 13/28 member states, 46.4%, and no recruitment in six member states, 21.4%. Delphi recruitment per EU member states Member state Number recruited Member state Number recruited Austria 5 Italy 4 Belgium 3 Latvia 0 Bulgaria 1 Lithuania 0 Croatia 0 Luxembourg 0 Cyprus 5 Malta 2 Czech Republic 3 Netherlands 5 Denmark 5 Poland 5 Estonia 0 Portugal 5 Finland 4 Romania 3 France 0 Slovakia 1 Germany 5 Slovenia 7* Greece 6* Spain 5 Hungary 6* Sweden 5 Ireland 4 United Kingdom 6* *denotes over-recruitment Page 12 of 56 Version: 1.0 Status: FINAL

13 4.2 Round 1 Eighty-two panel members participated in Round 1 (response rate of 91.1%). Recruitment per EU member state is given in the following table. Responses from five panel members (the target) were received in eight EU member states. Round 1 Delphi participation per EU member states Member state Number participating Member state Number participating Austria 4 Italy 2 Belgium 3 Latvia 0 Bulgaria 1 Lithuania 0 Croatia 0 Luxembourg 0 Cyprus 3 Malta 2 Czech Republic 3 Netherlands 5 Denmark 5 Poland 5 Estonia 0 Portugal 4 Finland 3 Romania 3 France 0 Slovakia 2 Germany 5 Slovenia 5 Greece 5 Spain 4 Hungary 5 Sweden 4 Ireland 4 United Kingdom 5 The roles of panel members within their organisations are given below, with 36 members (43.9%) having multiple roles. Roles of Round 1 Delphi panel members Role Number of panel members Lead/ Director/ Head/ Chief/ Chair 30 Physician 29 Pharmacist 28 Academic 22 Commissioner 5 Politician 1 Nurse 1 Patient organisation 1 Consensus was obtained for 27/46 (58.7%) of statements. Page 13 of 56 Version: 1.0 Status: FINAL

14 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 1, Statements relating to potential gain arising polypharmacy management (4 statements) Consensus was obtained for three statements as follows: There is a need for an EU level coordinated approach to identify, share, disseminate, promote and support best practice around polypharmacy management (n=82) Comments were received from 25 panel members in themes of: 1. need across the EU, there is certainly this need in the UK; working across the EU would be ideal. 2. being cognisant of member state differences, Large differences in health care systems may lead to different approaches. A one-size-fits-all approach in Europe may not be the optimal approach. Polypharmacy management should lead to considerable health gain (n=82) Comments were received from 17 panel members in the theme of: 1. health gain, there is no doubt, based on evidence, that Polypharmacy management should lead to considerable health gain. Adverse reactions and hospital admissions and will be reduced. In addition resources could be saved and used appropriately. All the above would improve quality in terms of health gain. Polypharmacy management should lead to better healthcare workforce utilisation and efficiency (n=82) Comments were received from 13 panel members in the theme of: 1. integrated care, if organized as an collaborative practice or integrated care approach, where teams of health care providers work together with patients and their care givers, case managers etc. Page 14 of 56 Version: 1.0 Status: FINAL

15 Strongly Dis Agree Strongly % Consensus SIMPATHY Consensus was NOT obtained for one statement, which was carried forward into Round 2. Polypharmacy management should lead to considerable economic societal gain (n=82) Comments were received from 22 panel members in themes of: 1. potential for economic gain, with better polypharmacy management less health care services needed (due to interactions, side effects). 2. lack of evidence, It might even be more expensive, e.g. interventions are expensive and up to now it has not been shown that polypharmacy management is effective. 3. potential to increase economics, main motivator should be the individual health - polypharmacy management may even increase cost due to a higher need in personal resources. Page 15 of 56 Version: 1.0 Status: FINAL

16 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 2, statements relating to strategic development Consensus was obtained for all seven statements as follows: Leaders of polypharmacy management should articulate a clear vision encompassing aims, objectives, motivating factors and outcomes (n=82) Comments were received from 12 panel members in themes of: 1. engagement, Yes, a clear vision articulated to all key stakeholders would assist with 'buy-in' to the concept of polypharmacy management and provide clarity for all. 2. change management, this is for sure. Articulate a clear vision encompassing aims, objectives, motivating factors and intended outcomes are absolutely needed in order to plan for the appropriate changes. Leaders of polypharmacy management should ensure that the strategic vision is shared and understood by all involved in implementation (n=82) Comments were received from 14 panel members in the theme of: 1. shared vision, if not, everybody will give its own 'turn' to the project and you'll end up with all kinds of projects not directly related to the specific strategic goals. Polypharmacy management should be overseen by a diverse range of stakeholders including policy makers, physicians, pharmacists, nurses, and patients or patient advocates (n=82) Comments were received from 18 panel members in the theme of: 1. many perspectives, there are so many factors relating to polypharmacy management, you can't oversee or influence it as a single party in the total chain and the environment around it. Polypharmacy management should be incorporated into health policy strategies at local, regional and national levels that guide the course of care delivery (n=82) Comments were received from 14 panel members in the theme of: 1. implementation, yes, as often it is only through incorporation in health policy strategies that key initiatives such as this are put into practice. Page 16 of 56 Version: 1.0 Status: FINAL

17 Polypharmacy management should be evaluated fully prior to large scale implementation, encompassing both quantitative outcome measures and the perspectives of key stakeholder groups (n=81) * Comments were received from 20 panel members in themes of: 1. pragmatic evaluation, it should be evaluated in the way mentioned; but these kinds of evaluations take a long period and need money. Therefore, I think that the implementation of polypharmacy management should start based on evaluations made thus far and new evaluations should be done continuously. 2. outcome measures, There is a question of tools to evaluate. Individual health benefits are easier to see, social economic gains are difficult to prove. Usually economic gains are considered most important but QoL to individual is most important. How do one measure QoL if side effect or clinically important interaction has been prevented? Information and communications technology tools should be developed and implemented across all healthcare settings to support polypharmacy management (n=81) Comments were received from 20 panel members in themes of: 1. resource implications, I do, provided that information and technology communications is selected appropriately to respond to the needs and be cost effective. 2. other solutions, technology is a tool but the first point is to change the mentality of the prescribers because technology is not the solution, it is only the tool. Polypharmacy management should be developed as essential components of larger initiatives in the healthcare system such as patient safety, management of long term conditions, and care for older people (n=82) Comments were received from 11 panel members in the theme of: 1. need for integration, Polypharmacy management is integral to these larger initiatives. * statements with 79% ment were so close to the 80% cut-off that they were also deemed as achieving consensus Page 17 of 56 Version: 1.0 Status: FINAL

18 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 3, statements relating to strategic change management Consensus was obtained for four statements as follows: When developing polypharmacy management, leaders should develop an explicit change management strategy and plan (n=82) * Comments were received from 19 panel members in themes of: 1. need for change management plan, Yes, only with a good initial strategy a guide for polypharmacy management could be done. 2. likely complexity, an explicit change management strategy and plan - sounds like it is feasible to plan in advance. Suggest this might require more consideration of the complexity and heterogeneity of change management and implementation across organisations and settings. Prior to implementation of polypharmacy management, the culture of the organisation should be assessed for both strengths and potential barriers to implementation (n=82) Comments were received from 13 panel members in themes of: 1. need to assess culture, yes, I think this would be very helpful as barriers in particular could be identified and strategies put in place to try to overcome these. 2. likely complexity, that is a huge work load and it takes a lot of time. I would prefer training instead to assessment of culture. Policy makers should regulate that assessment of medication need to be done and there can be economical gains for those who assessment of medication. A detailed assessment of the need for additional resources required to support the implementation and evaluation of polypharmacy management should be undertaken (n=82) * Comments were received from 16 panel members in themes of: 1. need to assess resources, the assessment gives answers about additional human and economic resources to the politicians and leaders. 2. pragmatic assessment, don't wait until everything is perfect. Start with small steps and 'trial and error' to find out what really works and don't hesitate to directly implement quick wins. Leaders of polypharmacy management should work across care settings and boundaries to ensure implementation is in a standard manner throughout the health system (n=82) * Comments were received from 14 panel members in the theme of: 1. need to work across all boundaries, consensus among all stakeholders in a national perspective about the definitions and structured provision of integrated care is needed before implementation will work. Page 18 of 56 Version: 1.0 Status: FINAL

19 Strongly Dis Agree Strongly % Consensus SIMPATHY Consensus was NOT obtained for three statements, which were carried forward into Round 2. Health systems should design payment mechanisms and incentives that align with the work required to implement polypharmacy management (n=82) Comments were received from 17 panel members in themes of: 1. care being the priority, I think, that implementing polypharmacy management should be somehow the concern of health professionals, doctors, nurses, pharmacist and it shouldn't be connected with additional gratification. 2. current economic situation, I do not argue the necessity of this statement, however I strongly argue whether health systems in countries with severe financial problems, will go no with such a project (usually favouring short-term projects). To facilitate implementation, polypharmacy management should be captured within contractual arrangements for health professionals (n=81) Comments were received from 21 panel members in themes of: 1. potential risk, I that new mechanism are sometimes needed to enable the implementation. However contractual arrangement regarding financial incentives (like pay for performance) also have great risks that have to be taken into account. 2. responsibilities, care should be taken not to conflate contractual and professional responsibilities. Contractual arrangements are by design inflexible and unambiguous whereas professional responsibilities should be more responsive to the changing nature of practice. The development of the clinical pharmacy workforce, particularly in primary care, will be a key enabler of service provision around polypharmacy management (n=82) Comments were received from 16 panel members in themes of: 1. support for clinical pharmacy, clinical pharmacy workforce is essential. Physicians and nurses need cooperators who really know the details in polypharmacy managements. 2. other professions, focus should also be set on physician resources, ie clinical pharmacologist, geriatrics. ; The general Practitioner is a key factor because as the first entry point in Health Care Services he can introduce and apply new strategies. (The GP works very close with patients and can disseminate new practices). Page 19 of 56 Version: 1.0 Status: FINAL

20 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 4, statements relating to indicator measures Consensus was obtained for three statements as follows: There is a need to develop valid, reliable and sensitive indicators to quantify the extent of inappropriate and appropriate polypharmacy (n=82) Comments were received from 16 panel members in themes of: 1. need for indicators, with these kinds of indicators we could make comparative studies in EU countries. 2. existing indicators, using validated screening tools to quantify PIMs? -> STOPP/START, BEERS, RASP, likely complexity, that is not possible. The indicators are individual. Persons with same disease might need different medication and solutions. There is a need to develop valid, reliable and sensitive indicators to quantify the impact on patient clinical outcomes relating to the extent of inappropriate and appropriate polypharmacy (n=82) Comments were received from 17 panel members in the theme of: 1. need for such indicators, of cardinal importance. Valid, reliable and sensitive process indicators relating to polypharmacy management should be developed (n=82) Comments were received from 17 panel members in the theme of: 1. need for process indicators, although developing these kinds on indicators is difficult, I strongly. They would help the practical work of management processes. Page 20 of 56 Version: 1.0 Status: FINAL

21 Strongly Dis Agree Strongly % Consensus SIMPATHY Consensus was NOT obtained for three statements, which were carried forward into Round 2. There is a need to develop valid, reliable and sensitive indicators to quantify the economic impact relating to the extent of inappropriate and appropriate polypharmacy (n=82) Comments were received from 20 panel members in themes of: 1. need for economic indicators, quantification of economic impact could generate resources for the deployment of more health care professionals. 2. priorities, for me, on a personal level, this is less important than the clinical outcomes. Yet, without any sound financial backing or background, national stakeholders will probably not want to provide financial support. But even then, I think (and I cannot base this on any evidence whatsoever) that the increased incidence of clinical outcomes is the main driver for increased costs. Data relating to valid, reliable and sensitive indicators of inappropriate and appropriate polypharmacy should be reported routinely to key stakeholder groups at local, regional and national levels (n=82) Comments were received from 19 panel members in themes of: 1. potential benefits, there is strong evidence that audit/feedback programs improve appropriateness of drug use in real clinical practice. 2. additional workload, huge amount of additional work, if it would not be a part of electronic documentation system. Valid, reliable and sensitive indicators of inappropriate and appropriate polypharmacy should be developed at the EU level (n=82) Comments were received from 22 panel members in themes of: 1. potential benefits, comparison is one of the drivers to change; also it would be interesting to see the outcome of such consensus. 2. readiness, rest of EU isn't ready for that, maybe the north-european countries. Page 21 of 56 Version: 1.0 Status: FINAL

22 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 5, statements relating to legislation Consensus was NOT obtained for any of the three statements, which were carried forward into Round 2. Legislation governing healthcare delivery that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=79) Comments were received from 17 panel members in the theme of: 1. legislation not the issue, I don't think legislation is the biggest bottle neck. Legislation governing remuneration for healthcare services that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=79) Comments were received from 12 panel members in the theme of: 1. no need, why would we need incentives? Legislation governing the scope of practice of relevant health professionals (e.g. nurses, pharmacists) that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=79) Comments were received from 13 panel members in the theme of: 1. legislation not the issue, I think it is more a problem of limitations in the clinical practice ( time, resources, training...) that a legislation limitation. Page 22 of 56 Version: 1.0 Status: FINAL

23 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 6, statements relating to awareness raising Consensus was obtained for all five statements as follows: There is a need to increase awareness of the issues relating to polypharmacy amongst health policy leaders (n=82) Comments were received from 5 panel members in the theme of: 1. need for awareness raising, there is no doubt, that health policy leaders should be aware in order to plan appropriate tailored for the local needs changes. There is a need to increase awareness of the issues relating to polypharmacy amongst health professional leaders (n=82) Comments were received from 9 panel members in the theme of: 1. health professionals aware, I would hope that many health professional leaders already have a good awareness. There is a need to increase awareness of the issues relating to polypharmacy amongst patient representative leaders (n=82) Comments were received from 7 panel members in the theme of: 1. empowerment, to promote patient empowerment and understanding the importance of performing medication reviews at regular basis. Education on polypharmacy management needs to be integrated into undergraduate curricula for all health professionals, particularly doctors, pharmacists and nurses (n=82) Comments were received from 9 panel members in the theme of: 1. importance of education, education is the basis of any desirable change Polypharmacy management needs to be integrated into continuing professional development programmes for all health professionals, particularly doctors, pharmacists and nurses (n=82) Comments were received from 8 panel members in the theme of: 1. need for CPD, they all don't have to become specialists in managing polypharmacy, but integration to a certain extent would be advisable. Page 23 of 56 Version: 1.0 Status: FINAL

24 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 7, statements relating to patient centred polypharmacy reviews Consensus was obtained for five statements as follows: There is a need for evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=82) Comments were received from 10 panel members in themes of: 1. multimorbidity, particularly (crucially) if these contain a multi-morbidity aspect. 2. specific tools, although a number of tools exist, there is a lack of consensus as to which tool is best. 3. patient centred, the polypharmacy revision should be centred on the person. In general the function of guidelines are progressively becoming less necessary among this group of patients (high complex patients). The roles and responsibilities of the members of the multidisciplinary team delivering patient centred polypharmacy reviews must be clearly defined and articulated (n=82) Comments were received from 7 panel members in themes of: 1. role clarification, yes, I think role clarification is important but where there may be areas of overlap, I feel this may ultimately provide an additional layer of security, which will ultimately benefit the patient. 2. need for flexibility, this can be very different according to the setting, the region, the country. Clinical decision support systems should be developed and implemented to facilitate patient centred polypharmacy reviews (n=82) Comments were received from 8 panel members in themes of: 1. existing systems, there are already some systems already put in place. I think you should start taking a closer look to systems that already seem more or less successful. 2. need for professional input, as long as they facilitate/support/identify, I. But not to replace HCP as such... this is an inherent risk of using CDSS. In teaching houses there might also be the particular downfall of physicians not receiving any live training, because of the presence of CDSS. Page 24 of 56 Version: 1.0 Status: FINAL

25 Strongly Dis Agree Strongly % Consensus SIMPATHY Those involved in delivery of patient centred polypharmacy reviews should have electronic access to all relevant patient information Comments were received from 15 panel members in themes of: 1. need for access, one might argue that without full access, there is no such thing as polypharmacy management. 2. availability, that will represent a problem in some countries in EU - because of lack of development of IT technology (and of course financial impact). 3. confidentiality, provided that personal data protection is safeguarded. All affected patients, regardless of setting or environment, should have access to a polypharmacy review (n=82) Comments were received from 12 panel members in the theme of: 1. prioritisation, at the beginning of the implementation of the polypharmacy reviews priority groups of patients could be defined due to economic capacity. Long-term goal should be availability for all affected patients. Consensus was NOT obtained for two statements, which were carried forward into Round 2. There is a need for common EU evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=82) Comments were received from 9 panel members in themes of: 1. potential benefits, yes, this will give the opportunity for all EU member countries to work together and provide better guidelines. 2. national focus, national focus will be more recognizable for health care professionals and other stakeholders. Each EU member state should develop their own national or regional evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=82) Comments were received from 24 panel members in themes of: 1. generalisable evidence, evidence based guidelines shouldn t be different but it could be accompanied by certain recommendations, which vary from State to State. 2. collaboration, Not all EU countries have the potential, experience and resources to develop their own national or regional evidence based guidelines. Share information, experience, and effective collaboration could be cost effective. Page 25 of 56 Version: 1.0 Status: FINAL

26 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 8, statements relating to the vision for the EU by 2025 Consensus was NOT obtained for any of the seven statements, which were carried forward into Round 2. By 2025, European healthcare will be recognised widely for effective policies on the management of polypharmacy through multidisciplinary teams (n=82) Comments were received from 15 panel members in themes of: 1. not achievable, I am not sure about the exact year, if this is possible in 8 years...!!! In my opinion policy change needs also a change in legislation and practicing and 8 years period is really short for both changes (in the whole EU). 2. aspiration, a fine ambition, but I don t think this will happen... By 2025, innovative, coordinated and comprehensive interventions will be in place across Europe, in all settings, supporting patient empowerment, safety and addressing polypharmacy Management (n=82) Comments were received from 12 panel members in themes of: 1. not achievable, we have been working for almost 5 years on this specific subject; there are still too many unknowns. 2. aspiration, that would be great, but I'm not sure if possible in this period of time. By 2025, integrated, user friendly dedicated information and communications technology tools will be supporting the management of polypharmacy (n=82) Comments were received from 13 panel members in themes of: 1. not achievable, since there are no data for all EU countries it is risky to predict that this could be feasible. 2. not complete solution,...technology support will be probably developed...technology development is always easier than development of highly skilled clinical pharmacists or a legislation change or a healthcare system change. But, technology itself cannot solve polypharmacy problem. Page 26 of 56 Version: 1.0 Status: FINAL

27 By 2025, information and communications technology systems in all healthcare organisations will be facilitating improved communication between all healthcare providers (n=82) Comments were received from 6 panel members in the theme of: 1. not achievable, Belgium started Vitalink a long time ago. It would link the drug information between primary and hospital-based care, with also access for city pharmacists. I think that the project started almost 10 years ago?... It still doesn't work. By 2025, each citizen will have a personalised healthcare record incorporating full medicines information (n=82) Comments were received from 13 panel members in themes of: 1. importance, we really should work on this. It's key for making further improvements. 2. confidentiality, until now, patient privacy is blocking this development. I don't see this changing in the next few years. By 2025, patient involvement and empowerment will be a key priority in all healthcare related developments (n=82) Comments were received from 7 panel members in themes of: 1. evidence of action, there is increasing evidence of greater patient involvement and empowerment, and it would be hoped that this will continue to improve. 2. priorities, patient empowerment is (for me) secondary to the HCP knowing what to do with drug therapies in the elderly. By 2025, there will be a 50% reduction (compared to the current level) in patients receiving inappropriate polypharmacy (n=82) Comments were received from 20 panel members in themes of: 1. complexity of change, there are many persons involved e.g. clinical pharmacists, physician or several of them, patient and his/hers relatives. Communication has many obstacles, also changing human behaviour. 2. changing landscape, the problem is growing at the same time that we are developing solutions. 3. training issues, too optimistic given the poor pharmacology knowledge of most doctors. We must first improve medical training which will slowly lead to better prescribing. 4. outcome measures, and even then, how would you measure this? 5. not achievable, the objective is too high. We should be aware that each reduction in percentage is a success (in both healthcare and economic aspect). Page 27 of 56 Version: 1.0 Status: FINAL

28 4.3 Round 2 Seventy-five panel members participated in Round 2 (response rate of 83.3%). Recruitment per EU member state is given below. Responses from five panel members (the target) were received in six EU member states. Round 2 Delphi participation per EU member states Member state Number participating Member state Number participating Austria 4 Italy 1 Belgium 3 Latvia 0 Bulgaria 0 Lithuania 0 Croatia 0 Luxembourg 0 Cyprus 3 Malta 2 Czech Republic 3 Netherlands 3 Denmark 4 Poland 4 Estonia 0 Portugal 5 Finland 4 Romania 1 France 0 Slovakia 1 Germany 5 Slovenia 5 Greece 5 Spain 4 Hungary 5 Sweden 4 Ireland 4 United Kingdom 5 The roles of panel members within their organisations are given below, with 33 (44.0%) having multiple roles. Roles of Round 2 Delphi panel members Role Number of panel members Lead/ Director/ Head/ Chief/ Chair 27 Physician 29 Pharmacist 28 Academic 19 Commissioner 2 Politician 1 Nurse 0 Patient organisation 1 Consensus was obtained for an additional two statements. Combined with Round 1, the total number of statements for which consensus was achieved was 29/46 (63.0%). Page 28 of 56 Version: 1.0 Status: FINAL

29 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 1, statements relating to potential gain arising polypharmacy management Consensus was NOT obtained for one statement, which was carried forward into Round 3. Polypharmacy management should lead to considerable economic societal gain (n=75) Comments were received from 17 panel members in themes of: 1. not main focus, I that caution is required when discussing outcomes and economics. The priority must always be the outcomes from the patient perspective and d by clinicians not budget holders. 2. need for evidence, I think more evidence-based studies on this topic are needed, also focusing on the different figures in different EU countries. Page 29 of 56 Version: 1.0 Status: FINAL

30 Strongly Dis Agree Strongly % Consensus Strongly Dis Agree Strongly % Consensus SIMPATHY Section 3, statements relating to strategic change management Consensus was obtained for one statement as follows: The development of the clinical pharmacy workforce, particularly in primary care, will be a key enabler of service provision around polypharmacy management (n=75) Comments were received from 13 panel members in themes of: 1. support for clinical pharmacy, the importance of the clinical pharmacist must be recognized in all countries. 2. other professions, clinical pharmacists should be used more for training and coaching physicians and nurses in polypharmacy management. Obviously, polypharmacy management should be taught already in Medical schools, but continuous education will always be necessary. For more complicated clinical cases, the input of an "drug expert", such as a clinical pharmacist or pharmacologist, is valuable. Consensus was NOT obtained for two statements, which were carried forward into Round 3. Health systems should design payment mechanisms and incentives that align with the work required to implement polypharmacy management (n=75) Comments were received from 19 panel members in the theme of: 1. care being the priority, even more convinced that we should not need incentives to do the right thing - would maybe have been better to split incentives into financial and non-financial e.g. time/training. To facilitate implementation, polypharmacy management should be captured within contractual arrangements for health professionals (n=75) Comments were received from 17 panel members in themes of: 1. potential benefit, whether we like it or not, and despite there being professional obligations, contracts do facilitate change and can improve practice. This has been the UK experience. 2. potential risk, it could be misused. 3. responsibilities, it should be our professional responsibility to decrease polypharmacy. Page 30 of 56 Version: 1.0 Status: FINAL

31 Strongly Dis Agree Strongly % Consensus Strongly Dis Agree Strongly % Consensus SIMPATHY Section 4, statements relating to indicator measures Consensus was obtained for one statement as follows: Data relating to valid, reliable and sensitive indicators of inappropriate and appropriate polypharmacy should be reported routinely to key stakeholder groups at local, regional and national levels (n=75) Comments were received from 14 panel members in themes of: 1. potential benefits, this is a powerful instrument - and should be seen as an element of strong governance. 2. absence of measures, it's very difficult to measure this indicator. Depending on the patient status and clinical situation. Beers, stop/start, MAI, criteria can use, but not always are easy to apply. Remember, we are trying to work on the patient centred care model. And sometimes, the criteria, mentioned before, can't be applied. Consensus was NOT obtained for two statements, which were carried forward into Round 3. There is a need to develop valid, reliable and sensitive indicators to quantify the economic impact relating to the extent of inappropriate and appropriate polypharmacy (n=75) Comments were received from 18 panel members in the theme of: 1. need for economic indicators, polypharmacy management may not save costs for the society, but it should be cost-effective, i.e. good value for money (the cost for the improvement of care must be reasonable and affordable). It is necessary to have reliable indicators in order to estimate the costeffectiveness. Valid, reliable and sensitive indicators of inappropriate and appropriate polypharmacy should be developed at the EU level (n=75) Comments were received from 12 panel members in the theme of: 1. country specific focus, I think this would be helpful but not sure that all countries systems are similar enough to make this a reality. Page 31 of 56 Version: 1.0 Status: FINAL

32 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 5, statements relating to legislation Consensus was NOT obtained for three statements, which were carried forward into Round 3. Legislation governing healthcare delivery that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=66) Comments were received from 15 panel members in the theme of: 1. legislation not the issue, Not sure how legislation gets in the way. Legislation governing remuneration for healthcare services that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=67) Comments were received from 14 panel members in the theme of: 1. no need, doctors and pharmacists don't need legislation governing remuneration for their healthcare services. Legislation governing the scope of practice of relevant health professionals (e.g. nurses, pharmacists) that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=69) Comments were received from 14 panel members in the theme of: 1. legislation not the issue, not an issue in my country. Page 32 of 56 Version: 1.0 Status: FINAL

33 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 7, statements relating to patient centred polypharmacy reviews Consensus was NOT obtained for two statements, which were carried forward into Round 3. There is a need for common EU evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=75) Comments were received from 12 panel members in themes of: 1. potential benefits, yes, this will give the opportunity for all EU member countries to work together and provide better guidelines. 2. national focus, focus on the national context with international examples of evidence based practice development. Each EU member state should develop their own national or regional evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=75) Comments were received from 16 panel members in themes of: 1. national approach I think this has to be done at country level (but I see it from the UK perspective). 2. collaboration, There is no need for doing the same work in each country, it would be better with an EU guideline, that can be adopted according to the local setting. Page 33 of 56 Version: 1.0 Status: FINAL

34 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 8, statements relating to the vision for the EU by 2025 Consensus was NOT obtained for any of the seven statements, which were carried forward into Round 3. By 2025, European healthcare will be recognised widely for effective policies on the management of polypharmacy through multidisciplinary teams (n=75) Comments were received from 10 panel members in the theme of: 1. not achievable, It is a short time between 2017 and 2025, so it does not appear very realistic, but we can always hope! By 2025, innovative, coordinated and comprehensive interventions will be in place across Europe, in all settings, supporting patient empowerment, safety and addressing polypharmacy Management (n=75) Comments were received from 12 panel members in the theme of: 1. not achievable, maybe. Hope so. But I think more like By 2025, integrated, user friendly dedicated information and communications technology tools will be supporting the management of polypharmacy (n=75) Comments were received from 11 panel members in the theme of: 1. aspiration, great vision, but I'm not sure if possible in this period of time. By 2025, information and communications technology systems in all healthcare organisations will be facilitating improved communication between all healthcare providers (n=75) Comments were received from 10 panel members in themes of: 1. not achievable, this seems not really realistic - implementation of new Information Technology - in particular cross-organisational - takes longer than 8 years. 2. country dependant, depending on the country. In my country yes. In the EU I don't think so. Page 34 of 56 Version: 1.0 Status: FINAL

35 By 2025, each citizen will have a personalised healthcare record incorporating full medicines information (n=75) Comments were received from 13 panel members in themes of: 1. importance, there is a start for personalized healthcare record incorporating full medicines information of patients in my country. 2. confidentiality, hopefully - it will take another Information campaign to persuade each citizen that it will be good for him/her and not harmful (protection of data privacy). By 2025, patient involvement and empowerment will be a key priority in all healthcare related developments (n=75) Comments were received from 9 panel members in the theme of: 1. need for empowerment, patient involvement is very important and patients organisations are very powerful. By 2025, there will be a 50% reduction (compared to the current level) in patients receiving inappropriate polypharmacy (n=75) Comments were received from 14 panel members in themes of: 1. outcome measures, it would be great, but how will you show this? 2. not achievable, there will be some improvement, but the target is probably too high. Page 35 of 56 Version: 1.0 Status: FINAL

36 4.4 Round 3 Sixty-five panel members participated in Round 3 (response rate of 72.2%). Recruitment per EU member state is given below. Responses from five panel members (the target) were received in three EU member states. Round 3 Delphi participation per EU member states Member state Number participating Member state Number participating Austria 4 Italy 1 Belgium 3 Latvia 0 Bulgaria 0 Lithuania 0 Croatia 0 Luxembourg 0 Cyprus 3 Malta 2 Czech Republic 3 Netherlands 2 Denmark 3 Poland 4 Estonia 0 Portugal 2 Finland 4 Romania 2 France 0 Slovakia 1 Germany 5 Slovenia 5 Greece 4 Spain 3 Hungary 3 Sweden 3 Ireland 3 United Kingdom 5 The roles of panel members within their organisations are given below, with 23 (35.4%) having multiple roles. Roles of Round 3 Delphi panel members Role Number of panel members Lead/ Director/ Head/ Chief/ Chair 19 Physician 21 Pharmacist 23 Academic 18 Commissioner 4 Politician 0 Nurse 0 Patient organisation 0 Consensus was not obtained for any additional statements, hence the overall number of statements for which consensus was achieved was 29/46 (63.0%). Page 36 of 56 Version: 1.0 Status: FINAL

37 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 1, statements relating to potential gain arising polypharmacy management Consensus was NOT obtained for one statement. Polypharmacy management should lead to considerable economic societal gain (n=65) Comments were received from 17 panel members in the theme of: 1. priorities, economic outcomes are not the main goal. Our priority and main goals are the patient safety and efficacy, and efficiency. Page 37 of 56 Version: 1.0 Status: FINAL

38 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 3, statements relating to strategic change management Consensus was NOT obtained for two statements. Health systems should design payment mechanisms and incentives that align with the work required to implement polypharmacy management (n=65) Comments were received from 15 panel members in the theme of: 1. care being the priority, polypharmacy management should be part of the 'normal' services so in that sense it should be part of the payment mechanisms, too, however, these services should be part of the clinical obligation to patients. To facilitate implementation, polypharmacy management should be captured within contractual arrangements for health professionals (n=65) Comments were received from 9 panel members in themes of: 1. potential benefit, contractual arrangements for health professionals would facilitate implantation by providing well defined job obligations. 2. responsibilities, it is a professional obligation in the first place, the contract with society which is the basis for the existing pharmacy practice development. Page 38 of 56 Version: 1.0 Status: FINAL

39 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 4, statements relating to indicator measures Consensus was NOT obtained for two statements. There is a need to develop valid, reliable and sensitive indicators to quantify the economic impact relating to the extent of inappropriate and appropriate polypharmacy (n=65) Comments were received from 10 panel members in the theme of: 1. need for economic indicators, health Services and polypharmacy have a cost, thus, economic evaluation is mandatory with well-defined indicators. Valid, reliable and sensitive indicators of inappropriate and appropriate polypharmacy should be developed at the EU level (n=65) Comments were received from 11 panel members in the theme of: 1. country specific focus, very difficult to get consensus in this topic. Each country is different. Health care models are different too. Page 39 of 56 Version: 1.0 Status: FINAL

40 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 5, statements relating to legislation Consensus was NOT obtained for three statements, Legislation governing healthcare delivery that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=58) Comments were received from 12 panel members in the theme of: 1. legislation not the issue, not a matter of legislation. Legislation governing remuneration for healthcare services that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=58) Comments were received from 11 panel members in the theme of: 1. legislation not the issue, not a matter of legislation. Legislation governing the scope of practice of relevant health professionals (e.g. nurses, pharmacists) that limits the implementation of polypharmacy management should be addressed as part of a long-term implementation plan (n=60) Comments were received from 9 panel members in the theme of: 1. legislation not the issue, better prepare the practice (physicians, nurses, pharmacists and patients) how to perform integrated polypharmacy management and go for it. Page 40 of 56 Version: 1.0 Status: FINAL

41 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 7, statements relating to patient centred polypharmacy reviews Consensus was NOT obtained for two statements, There is a need for common EU evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=65) Comments were received from 13 panel members in themes of: 1. potential benefits, yes, I cannot find a valid counterargument. It's not like each and every EU country will try to adjust/adapt the ESC guidelines on AFIB management. I also suppose, that guidelines will need to incorporate practice algorithms and not only build upon lists and lists and lists. It would make more sense if guidelines would contain practical (!) guidance on how to assess frailty, sarcopenie, residual function, life expectancy, therapy response in severe cognitive dysfunction, lag time to benefit, etc. 2. national focus, more focus on national context based patient centred polypharmacy reviews (e.g. integrated care, with collaboration of GPs) is better than to put energy in EU based guideline development. Exchange of expertise and knowledge to support practice development all over Europe is fine. But we have organizations to support that, such as PCNE. Each EU member state should develop their own national or regional evidence based guidelines promoting a systematic approach to patient centred polypharmacy reviews (n=65) Comments were received from 11 panel members in themes of: 1. national approach, as above I think EU wide guidelines should be developed first and then national guidelines should be developed where necessary as a sub-set. Page 41 of 56 Version: 1.0 Status: FINAL

42 Strongly Dis Agree Strongly % Consensus SIMPATHY Section 8, statements relating to the vision for the EU by 2025 Consensus was NOT obtained for any of the seven statements. By 2025, European healthcare will be recognised widely for effective policies on the management of polypharmacy through multidisciplinary teams (n=65) Comments were received from 10 panel members in the theme of: 1. not achievable, I still do not with the timeline seems to come too early for this plan to be feasible. 1.Research => because 'effective' policy. 2.Teaching, implementation => multidisciplinary teams 3.Legislation, remuneration in order to have it implemented. 4. Obtaining data + analysis of implementation 5. Dissemination of results 6. Wide recognition. By 2025, innovative, coordinated and comprehensive interventions will be in place across Europe, in all settings, supporting patient empowerment, safety and addressing polypharmacy Management (n=65) Comments were received from 10 panel members in the theme of: 1. not achievable, EU, has different: health care systems, models, economic situation, we need more time. By 2025, integrated, user friendly dedicated information and communications technology tools will be supporting the management of polypharmacy (n=65) Comments were received from 9 panel members in the theme of: 1. aspiration, changes in pharmacy practice will be much more influenced by rapidly introduced ICT innovations than we think. So be prepared for it. By 2025, information and communications technology systems in all healthcare organisations will be facilitating improved communication between all healthcare providers (n=65) Comments were received from 8 panel members in the theme of: 1. not achievable, improvements will be made, that's for sure. But also here, the timeline is strict. In my country, several initiatives are coming to fruition as we speak. The problem is that we have been saying this for the last 10 years. Governments work slowly. Page 42 of 56 Version: 1.0 Status: FINAL

43 By 2025, each citizen will have a personalised healthcare record incorporating full medicines information (n=65) Comments were received from 6 panel members in themes of: 1. importance, timescale too optimistic. 2. implementation started, personalised healthcare records are already incorporating almost full medicines information. By 2025, patient involvement and empowerment will be a key priority in all healthcare related developments (n=65) Comments were received from 6 panel members in the theme of: 1. need for empowerment, patients will become more than ever in control, supported by case managers, families and user friendly technologies. By 2025, there will be a 50% reduction (compared to the current level) in patients receiving inappropriate polypharmacy (n=65) Comments were received from 11 panel members in the theme of: 1. not achievable, too ambitious. I would rather want to see an improvement of quality of life, function, control of symptoms and a reduction in unplanned admissions. Appendix 3 gives a summary of all three rounds provided to panel members on completion of the study. Page 43 of 56 Version: 1.0 Status: FINAL

44 4.5 Strengths and weaknesses Best practice in conducting consensus studies was followed throughout this Delphi study. A very high level of engagement was achieved, and while this decreased as the Rounds progressed, the lowest response rate was 72.2%. Many, and often detailed, comments were received from panel members to justify their responses. The panel members represented a spectrum of director level physicians, pharmacists and academics. There are, however, some weaknesses to the Delphi study hence the findings should be interpreted with caution. Despite all efforts, the target number of recruiting five panel members per EU member state was only achieved in 11 member states, with no recruitment in six. Furthermore, in Round one, the target of five responses per member state was only achieved in eight member states, with this falling to six in Round 2 and three In Round 3. Very few commissioners or politicians were recruited, with most panel members being Director level health professionals. Recruitment and response biases may have been present, with those recruited and participating being those most positive. These weaknesses may limit the generalisability of the results to the entire EU and beyond. Page 44 of 56 Version: 1.0 Status: FINAL

45 5. Conclusions During Round 1, consensus was obtained for 27/46 statements (58.7%), with consensus obtained for an additional two statements in Round 2 and none in Round 3. The total number of statements for which consensus was achieved was therefore 29/46 (63.0%). Consensus was obtained as follows: 1. statements relating to potential gain arising polypharmacy management, 3/4 statements; 2. statements relating to strategic development, 7/7 statements; 3. statements relating to strategic change management, 5/7 statements; 4. statements relating to indicator measures, 4/6 statements; 5. statements relating to legislation, 0/3 statements; 6. statements relating to awareness raising, 5/5 statements; 7. statements relating to patient centred polypharmacy reviews 5/7 statements; 8. statements relating to the vision for the EU by /7 statements. The main areas of non-consensus were in relation to legislation and the SIMPATHY vision for the EU by Panel members felt generally that there was no need for changes in legislation to support aspects of polypharmacy management. For the SIMPATHY vision for the EU by 2025, analysis of the comments provided by panel members indicated that these statements were considered too ambitious and not achievable within the timeframe of In conclusion, consensus was obtained amongst key stakeholders in the EU in relation to many aspects of the management of polypharmacy and adherence in older people. Key areas of consensus were around potential gain arising from polypharmacy management, strategic development, change management, indicator measures, awareness raising and patient centred polypharmacy reviews. While the SIMPATHY vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU. Page 45 of 56 Version: 1.0 Status: FINAL

46 6. References 1. Stewart D, Mair A, Wilson M, Kardas P, Lewek P, Alonso A, McIntosh J, MacLure K & SIMPATHY consortium. Guidance to manage inappropriate polypharmacy in older people: systematic review and future developments. Expert Opinion on Drug Safety 2017;16(2); Donabedian A. Explorations in quality assessment and monitoring: the definition of quality and approaches to its assessment. MI: Health Administration Press, Fink A, Kosecoff J, Chassin M, Brook R H. Consensus methods: characteristics and guidelines for use. American Journal of Public Health 1984;74(9): Jones J, Hunter D. Qualitative research: consensus methods for medical and health services research. British Medical Journal 1995;311: Hutchings A, Raine R, Sanderson C, Black N. A comparison of formal consensus methods used for developing clinical guidelines. Journal of Health Services Research and Policy 2006;11(4): Campbell SM, Cantrill JA. Consensus methods in prescribing research. Journal of Clinical Pharmacy and Therapeutics 2001;26: Clayton MJ. Delphi: a technique to harness expert opinion for critical decision-making tasks in education. Educational Psychology 1997;17(4): Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. Journal of Advanced Nursing 2000;32(4): Keeney S, Hasson F, McKenna H. Consulting the oracle: ten lessons from using the Delphi technique in nursing research. Journal of Advanced Nursing 2006;53(2): von der Gracht HA. Consensus measurement in Delphi studies Review and implications for future quality assurance. Technological Forecasting & Social Change 2012;79: Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Education Today 2004;24(2): Page 46 of 56 Version: 1.0 Status: FINAL

47 7. Appendices Appendix 1, Participant information leaflet A Delphi study: structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly Participant Information Leaflet Research Group SIMPATHY Consortium Project Leads Professor Derek Stewart, Dr Katie MacLure and Mrs Katie Gibson Smith, Robert Gordon University You have been invited to participate in a research study. Before you decide if you would like to take part, it is important that you understand the purpose of the research and what it will involve. Please take the time to read through the following information and feel free to talk to others about the study. If you have any questions or if you would like any further information about the study, please feel free to contact [name] by phone (+44 [insert] ) or ([insert]@rgu.ac.uk). What is the purpose of this study? The aim of this study is to determine the level of consensus amongst key stakeholders in the European Union relating to aspects of structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly. Page 47 of 56 Version: 1.0 Status: FINAL

48 Why have I been selected? Key stakeholders, generally considered to be experts in the field, and policy and decision makers, who can affect change, have been selected to participate in the research. Up to five panel members will be selected from each European Union country. Do I have to take part? No, it is up to you if you take part or not. Participation in this study is voluntary. If you change your mind later, you may withdraw at any point during the study or up to 14 days after completing the final questionnaire. To withdraw from the study, please contact [name] by phone ( [insert]) or ([insert]@rgu.ac.uk). All data and consent forms will be destroyed if you decide you no longer wish to be a part of the study. Your relationship with the researchers will not be affected by your decision to withdraw. What will happen to me if I take part? If you do decide to take part, please complete and submit the electronic consent form included in the invitation . Once your consent form is received, you will be sent a link to an online questionnaire. The questionnaire will require you to indicate the level to which you or with a series of statements developed with regard to structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly. It is required that you complete the questionnaire within two weeks. You will be sent a reminder at the end of week one and then two. The consensus approach being used comprises multiple rounds and thus, you will receive a minimum of two and maximum of three questionnaires depending on the results received from stakeholders and extent of ment. The remaining questionnaires will require that you rate your ment or ment with statements which have been revised in accordance with the results from the previous rounds. Questionnaires will be sent at two weekly intervals and once responses for each round have been received. Hence you would need to be available to complete each questionnaire within the next 6-8 weeks. As prior, you will be sent a reminder at the end of week one and then two. Each questionnaire will take around 20 minutes to complete. What are the possible benefits of taking part? There is no direct benefit to you participating in the study. The research may help us understand aspects of structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly. Will my taking part in this study be kept confidential? All questionnaire responses will be kept completely anonymous. You will not be named in any reports or publications that result from this study. Page 48 of 56 Version: 1.0 Status: FINAL

49 What will happen to the results of this study? The findings of this study will be used to help us understand aspects of structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly. We may publish the findings of the study in a study report, a healthcare journal and present at a conference. You will not be named in any report or publication. Who is organising and funding the research? The study is being managed by Robert Gordon University and the SIMPATHY Consortium. What next? If you decide you would like to participate in the study, please complete the consent form included in the invitation . Thank you for your time and consideration. If you have any questions about the study please contact [name] by phone ( [insert] ) or ([insert]@rgu.ac.uk). Page 49 of 56 Version: 1.0 Status: FINAL

50 Appendix 2, Consent form A Delphi study: structures, processes and outcomes around the promotion of appropriate polypharmacy and adherence in the elderly Consent Form Please place your initials alongside each statement if you to the following (you may either type your response, save and return or if you prefer print, complete in ink, scan and return): I confirm that I have read and understood the participant information sheet (September 29 th 2016 Version 1) and been provided with adequate opportunity to ask any questions. I understand that my participation is voluntary and that I am free to withdraw at any point during the study and up to 14 days after submission of the final questionnaire. I understand that the data collected during this study will be used for research purposes including publication of anonymised findings. I grant permission to do so on the basis that my confidentiality will be protected. I to take part in round 1 of this study. I to take part in round 2 of this study. I to take part in round 3 of this study. Name Date Country of residence Please return your completed consent form to k.l.gibson-smith@rgu.ac.uk Page 50 of 56 Version: 1.0 Status: FINAL