<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">NIHR Open Res</journal-id>
            <journal-title-group>
                <journal-title>NIHR Open Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2633-4402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.3310/nihropenres.13746.2</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>In what context and by which mechanisms can creative arts interventions improve wellbeing in older people? A realist review protocol</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 2; peer review: 2 approved]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Caulfield</surname>
                        <given-names>Alexandra</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-2483-4427</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ferrey</surname>
                        <given-names>Anne</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-5644-2735</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Roberts</surname>
                        <given-names>Nia</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-1142-6440</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Leslie-Spinks</surname>
                        <given-names>Jeremy</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-4169-0522</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>M&#x00f6;lsted Alvesson</surname>
                        <given-names>Helle</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Wong</surname>
                        <given-names>Geoff</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-5384-4157</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Greenhalgh</surname>
                        <given-names>Trish</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-2369-8088</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>University of Oxford Nuffield Department of Primary Care Health Sciences, Oxford, England, UK</aff>
                <aff id="a2">
                    <label>2</label>University of Oxford Bodleian Libraries, Oxford, England, UK</aff>
                <aff id="a3">
                    <label>3</label>Karolinska Institute Department of Global Public Health, Stockholm, Stockholm County, Sweden</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:alexandra.caulfield@conted.ox.ac.uk">alexandra.caulfield@conted.ox.ac.uk</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>16</day>
                <month>6</month>
                <year>2025</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2025</year>
            </pub-date>
            <volume>5</volume>
            <elocation-id>19</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>13</day>
                    <month>6</month>
                    <year>2025</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Caulfield A et al.</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://openresearch.nihr.ac.uk/articles/5-19/pdf"/>
            <abstract>
                <sec>
                    <title>Background</title>
                    <p>In recent years, there has been growing interest at national and international policy level in the potential of creative arts to support individual and community wellbeing. Creative arts encompass a wide range of activities, including performing arts, visual arts, design and craft, literature, culture and digital and electronic arts. Participation in creative arts has been linked to lower mental distress, increased social connection, improved quality of life, personal growth and empowerment. Despite this, it remains unclear exactly how participation in creative arts interventions can improve wellbeing in older individuals. This realist review aims to synthesize evidence on how elements of creative arts interventions improve wellbeing amongst older people, in particular when, how, for whom and to what extent they work.</p>
                </sec>
                <sec>
                    <title>Methods and analysis</title>
                    <p> This review will follow the RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) quality standards and Pawson&#x2019;s five iterative stages to locate existing theories, search for evidence, select literature, extract data, and draw conclusions. It will be guided by stakeholder engagement with policymakers, practitioners, commissioners, and people with lived experience. A realist approach will be used to analyse data and develop causal explanations, in the form of context-mechanism-outcome-configurations (CMOCs), which explain how creative arts interventions impact wellbeing in older people. The CMOCs will be organised into one or more programme theories. Our refined programme theory will then be used to develop guidance for service providers of creative arts who want to use their services to improve wellbeing of older people.</p>
                </sec>
                <sec>
                    <title>Ethics and dissemination</title>
                    <p>This research will comply with the UK Policy Framework for Health and Social Care Research. Dissemination will be guided by our stakeholder group, building on links with policymakers, commissioners, providers, and the public. A final stakeholder event focused on knowledge mobilisation will aid development of recommendations.</p>
                    <p>PROSPERO registration CRD42024580770.</p>
                </sec>
            </abstract>
            <abstract abstract-type="plain-language-summary">
                <title>Plain Language Summary</title>
                <p>Creative activities (such as singing, painting, crafts, writing etc.) can help people feel better and improve their wellbeing. Taking part in these activities may make it easier to meet others, create a sense of belonging, a feeling of achievement and improve quality of life. In recent years, the World Health Organisation and the UK government have encouraged research to explore these benefits. They want to understand how creative activities can improve health for people and their communities. At the moment, we don&#x2019;t know much about exactly how these creative activities might affect wellbeing. This review aims to identify how creative activities work to improve wellbeing in older adults, and in what kind of circumstances they work best. We hope to use our results to develop practical guidance for people who teach or provide creative arts activities. This will help improve the wellbeing of older people living in the community.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Creative arts</kwd>
                <kwd>older people</kwd>
                <kwd>wellbeing</kwd>
                <kwd>mental health</kwd>
                <kwd>creative health</kwd>
                <kwd>creative ageing</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1" xlink:href="http://dx.doi.org/10.13039/501100000272">
                    <funding-source>National Institute for Health and Care Research - Academic Clinical Fellowship</funding-source>
                    <award-id>ACF-2022-13-016</award-id>
                </award-group>
                <funding-statement>This project is funded by the National Institute for Health and Care Research (NIHR) under its NIHR Academic Clinical Fellowship (ACF-2022-13-016) 

The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. </funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
        <notes>
            <sec sec-type="version-changes">
                <label>Revised</label>
                <title>Amendments from Version 1</title>
                <p>Please find a summary of changes made in our published response to reviewers. Briefly, these include an expanded definition of wellbeing and clarification of details concerning our stakeholder group.</p>
            </sec>
        </notes>
    </front>
    <body>
        <sec sec-type="intro">
            <title>Introduction</title>
            <sec>
                <title>Creative arts and health</title>
                <p>In recent years, there has been growing interest in the potential of creative arts to support individual and community wellbeing. Creative arts encompass a wide range of activities, including performing arts, visual arts, design and craft, literature, culture and digital and electronic arts
                    <sup>
                        <xref ref-type="bibr" rid="ref-1">1</xref>
                    </sup>. Involvement may be receptive (e.g. watching a film, visiting a museum) or participatory (e.g. painting, writing), depending on the degree to which the participant is involved in the creative process, though in reality engagement likely falls across a spectrum between the two. Across the UK, 9.4 million people are thought to participate regularly in &#x2018;everyday creativity&#x2019; or non-formalised art activities
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>
                    </sup>. In addition, more formal arts programmes take place in a variety of settings, some with a specific health focus (often in conjunction with social prescribing schemes), and others without, although they may still impact health and wellbeing.</p>
                <p>Access to and engagement in art is a fundamental human right, under Article 27 of the Universal Declaration of Human Rights (UNHR), and creativity can be seen as an intrinsic part of what it means to be human
                    <sup>
                        <xref ref-type="bibr" rid="ref-3">3</xref>
                    </sup>. Creative arts interventions have the potential to build social capital in communities, and to harness the positive power of community agency, improving public health
                    <sup>
                        <xref ref-type="bibr" rid="ref-4">4</xref>&#x2013;
                        <xref ref-type="bibr" rid="ref-6">6</xref>
                    </sup> Creative arts interventions may offer economic benefits for society and can reduce pressure on an overburdened health system
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>,
                        <xref ref-type="bibr" rid="ref-7">7</xref>
                    </sup>. At an individual level, the benefits of participating in creative arts are well-recognised and include lower mental distress, increased social connection, improved quality of life
                    <italic toggle="yes">,</italic> personal growth and empowerment
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>,
                        <xref ref-type="bibr" rid="ref-7">7</xref>&#x2013;
                        <xref ref-type="bibr" rid="ref-12">12</xref>
                    </sup>.</p>
                <p>Against this background, there is an international policy drive calling for stronger pathways between arts, health and social care. This recognises the importance of realising the full potential for arts in public health policy and their role in helping achieve the UN Sustainable Development Goals
                    <sup>
                        <xref ref-type="bibr" rid="ref-13">13</xref>,
                        <xref ref-type="bibr" rid="ref-14">14</xref>
                    </sup>. Countries are shifting towards economic policies which incorporate wellbeing, recognising the impact of this on root causes of mental ill health, and creativity has been cited as a skill of the future by the World Economic Forum
                    <sup>
                        <xref ref-type="bibr" rid="ref-15">15</xref>
                    </sup>. (
                    <ext-link ext-link-type="uri" xlink:href="https://www.weforum.org/agenda/2022/08/free-thinking-boosts-creativity/">https://www.weforum.org/agenda/2022/08/free-thinking-boosts-creativity/</ext-link>) In the UK, a recent All Party Parliamentary Group on Arts and Health has emphasized the value of arts to health, and called for a cross party departmental Creative Health Strategy
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>
                    </sup>.</p>
            </sec>
            <sec>
                <title>Wellbeing in older people</title>
                <p>Like many populations worldwide, the UK population is ageing; currently 11 million people (19% of the population) are over 65 and this number is increasing
                    <sup>
                        <xref ref-type="bibr" rid="ref-16">16</xref>
                    </sup>. However, the number of years spent living in good health is falling
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>
                    </sup>. There are multiple reasons for this, but particular challenges facing older people may include declining social networks, loneliness, physical health challenges, loss of partners, caring roles, economic challenges and ageism
                    <sup>
                        <xref ref-type="bibr" rid="ref-17">17</xref>&#x2013;
                        <xref ref-type="bibr" rid="ref-20">20</xref>
                    </sup>. Compared with previous generations, families are often more geographically distant than before, with implications for community networks and support
                    <sup>
                        <xref ref-type="bibr" rid="ref-21">21</xref>
                    </sup>. With regard to mental health, there is an unmet need for support: depression affects around 22% of men and 28% of women over 65, yet it is estimated that 85% of older people with depression receive no help at all from the NHS 
                    <italic toggle="yes">(
                        <ext-link ext-link-type="uri" xlink:href="https://www.mentalhealth.org.uk/explore-mental-health/statistics/older-people-statistics">https://www.mentalhealth.org.uk/explore-mental-health/statistics/older-people-statistics</ext-link>)</italic>.</p>
                <p>Whilst mental health and wellbeing are interrelated concepts, they may also be discrete; one can be mentally ill whilst still achieving a state of subjective wellbeing; conversely one could lack a state of wellbeing without being mentally ill. Previous studies in this field have tended to focus on how creative arts interventions impact patient groups with specific diagnoses e.g. mental illness, dementia, cancer etc
                    <sup>
                        <xref ref-type="bibr" rid="ref-22">22</xref>
                    </sup>. This review will look at individuals living in the community who have not been included in arts interventions by virtue of a particular diagnosis (e.g. mental ill-health, dementia etc.), and examine impact of creative arts interventions on individual wellbeing.</p>
                <p>We recognise that wellbeing is a difficult concept to define and will mean different things to different individuals. Following the literature in this field, we define wellbeing as a state of an individual &#x2018;living well&#x2019;, which may include elements of experienced, evaluative, eudaimonic and social wellbeing
                    <sup>
                        <xref ref-type="bibr" rid="ref-23">23</xref>
                    </sup>. Experienced wellbeing relates to an individual&#x2019;s emotional state, evaluative wellbeing refers to judgements about how satisfying one&#x2019;s life is, eudaimonic wellbeing to living in line with a sense of purpose and personal growth allowing an individual to &#x2018;flourish&#x2019;, and social wellbeing to subjective perceptions of one&#x2019;s social relationships
                    <sup>
                        <xref ref-type="bibr" rid="ref-23">23</xref>
                    </sup>.</p>
                <p>Wellbeing is an important aspect of health; the WHO defines health as &#x2018;a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity&#x2019;
                    <sup>
                        <xref ref-type="bibr" rid="ref-24">24</xref>
                    </sup>; This is a bold definition, and such a comprehensive state of wellbeing may be difficult to achieve, yet it remains an important goal; interventions which may facilitate movement towards an improved state of wellbeing are key to individual and community health.</p>
            </sec>
            <sec>
                <title>Towards a theory of creative arts and wellbeing</title>
                <p>Despite the recognised health benefits of participating in creative arts, it remains unclear exactly how creative arts interventions impact participants&#x2019; wellbeing. There is a recognised need for better theoretical understanding of how elements of creative arts programmes impact wellbeing amongst older people, and in particular when, how, for whom and to what extent they work
                    <sup>
                        <xref ref-type="bibr" rid="ref-2">2</xref>,
                        <xref ref-type="bibr" rid="ref-18">18</xref>,
                        <xref ref-type="bibr" rid="ref-23">23</xref>,
                        <xref ref-type="bibr" rid="ref-25">25</xref>&#x2013;
                        <xref ref-type="bibr" rid="ref-27">27</xref>
                    </sup>. With this in mind, our review seeks to answer the question 
                    <italic toggle="yes">&#x2018;in what contexts and by which mechanisms can creative arts interventions impact wellbeing in older people?&#x2019;.</italic> We will use a realist approach, which is well-suited to complex interventions with multiple components, such as creative arts programmes. We will look at participatory arts interventions, defining these as an intervention where an individual has an opportunity to actively take part in the creative process e.g. by painting or writing or singing. We will also seek to uncover possible negative impacts of interventions, as well as highlighting evidence gaps within the existing literature. The knowledge gained should be helpful to those planning and taking part in interventions, and will add to a growing theoretical understanding of this field.</p>
            </sec>
        </sec>
        <sec>
            <title>Aim</title>
            <p>This project aims to synthesize the evidence on how elements of creative arts programmes improve wellbeing amongst older people, and in particular when, how, for whom and to what extent they work. Using this knowledge, we hope to develop guidance for providers who want to use creative arts interventions to improve the wellbeing of older people living in the community.</p>
        </sec>
        <sec>
            <title>Objectives</title>
            <list list-type="bullet">
                <list-item>
                    <label>1.</label>
                    <p>Conduct a realist review of the existing literature to develop an in-depth understanding (captured in a realist programme theory) of the use of the creative arts to improve the wellbeing of older people living in the community: (Work Package (WP)1, months 1-9)</p>
                </list-item>
                <list-item>
                    <label>2.</label>
                    <p>Use the knowledge within the realist programme theory to develop guidance for service providers of creative arts who want to use their services to improve the wellbeing of older people living in the community (WP2, months 10-12)</p>
                </list-item>
            </list>
            <p>This project will run from September 2024 - August 2025.</p>
        </sec>
        <sec sec-type="methods">
            <title>Methods</title>
            <sec>
                <title>Patient and public involvement</title>
                <p>Our stakeholder group (comprising older people with lived experience of creative arts interventions, practitioners, policymakers, and commissioners) will be formally involved at each stage of this review. We will discuss our emerging findings and sense-check our developing theory with this group. Dissemination and practical outputs to share knowledge will be guided by our stakeholder group and will target a range of audiences, building on links with policymakers, commissioners, providers, and the public, and designed reach key actors within the field of creative health e.g. the National Centre for Creative Health and the Creative Ageing Development Agency. A final stakeholder event focused on knowledge mobilisation will aid development of recommendations.</p>
                <p>This review (PROSPERO registration no: CRD42024580770) will follow Pawson&#x2019;s five iterative steps for realist reviews. Realist review is well-suited to research on creative arts interventions because such interventions are complex and multi-faceted
                    <sup>
                        <xref ref-type="bibr" rid="ref-28">28</xref>
                    </sup>. Context is key to determining the relative success or failure of any given intervention, and the mechanisms underlying how context relates to outcome are not always clear. A realist approach allows us to identify and understand some of these mechanisms, building on work done by others in the field
                    <sup>
                        <xref ref-type="bibr" rid="ref-25">25</xref>,
                        <xref ref-type="bibr" rid="ref-29">29</xref>
                    </sup>. The review will be guided by the RAMESES quality standards for realist synthesis
                    <sup>
                        <xref ref-type="bibr" rid="ref-30">30</xref>
                    </sup>.</p>
                <p>For the purposes of this review, the outcome is wellbeing, as defined by the authors of the primary literature; this may be measured by subjective or evaluative means.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Step 1: locating existing theories</italic>
                    </bold>
                </p>
                <p>The first step of the review process will be to source existing theories within the field of creative health and from other disciplines which may shed light on the contexts and mechanisms at play in creative arts interventions for older people. Early discussions and literature scoping have informed an initial programme theory (
                    <xref ref-type="fig" rid="f1">Figure 1</xref>), showing the possible contexts and mechanisms of interest.</p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>Figure 1. </label>
                    <caption>
                        <title>Sketch of initial programme theory.</title>
                        <p>Overarching concept of ageing as a transition process at the top. Blue boxes identify concepts (possible contexts or mechanisms) which may be important in contributing to potential impact of creative arts interventions on wellbeing.</p>
                    </caption>
                    <graphic orientation="portrait" position="float" xlink:href="https://nihropenresearch-files.f1000.com/manuscripts/15242/e1d0b8f3-84c7-422f-b5fe-b2673543734b_figure1.gif"/>
                </fig>
                <p>
                    <bold>
                        <italic toggle="yes">Step 2: searching for evidence</italic>
                    </bold>
                </p>
                <p>The second step will involve searching the literature for relevant papers to include in the review. The search strategy will combine textword and subject heading terms for our key concepts of creative arts, wellbeing, older people and UK. Searches will identify literature published in the English language across ten databases (ASSIA (Proquest), CINAHL(EBSCOHost), Embase(OvisSP), Medline(OvisSP), PsycINFO(OvidSP, Science Citation Index, Social Science Citation Index, Arts &amp; Humanities Citation Index, Conference Proceedings Citation Index - Science and Conference Proceedings Citation index - Social Science &amp; Humanities (Web of Science Core Collection), without restriction based on study type or publication date.</p>
                <p>The search strategy will be designed, piloted and conducted by an experienced librarian in collaboration with the rest of the project team. In addition to database searches, this will include citation tracking and searching grey literature, as it is likely that there are many creative arts programmes for older people which may not be formally evaluated within the scientific literature, but which would include valuable material for developing the programme theory. In line with the iterative nature of realist reviews, further searching will take place to provide more data for specific subsections of the programme theory as required.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Screening</italic>
                    </bold>
                </p>
                <p>References will be exported to Covidence where duplicates will be removed and screening will be undertaken first by title and abstract and full text by AC (
                    <italic toggle="yes">Covidence. [Internet]. 2024 [20th August 2024]. Available from: 
                        <ext-link ext-link-type="uri" xlink:href="https://www.covidence.org/">https://www.covidence.org/</ext-link>
                    </italic>.). At both stages, a 10% random sample will be independently reviewed by another member of the research team, AF. Disagreements not resolved through discussion between the researchers will be resolved through majority vote within the research team. We will seek additional information from study authors where necessary to resolve questions about eligibility.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Inclusion and exclusion criteria</italic>
                    </bold>
                </p>
                <list list-type="bullet">
                    <list-item>
                        <label>- </label>
                        <p>Inclusion criteria</p>
                        <list list-type="bullet">
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Intervention</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>participatory creative arts programme run in a community setting in the UK</p>
                                    </list-item>
                                </list>
                            </list-item>
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Population</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>UK adults aged 65 and over</p>
                                    </list-item>
                                </list>
                            </list-item>
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Outcome:</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>wellbeing</p>
                                    </list-item>
                                </list>
                            </list-item>
                        </list>
                    </list-item>
                    <list-item>
                        <label>- </label>
                        <p>Exclusion criteria:</p>
                        <list list-type="bullet">
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Intervention</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>creative arts programmes with receptive involvement (where the individual has a more receptive role in the activity e.g. going to a museum, watching a film)</p>
                                    </list-item>
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>programmes run in non-community settings (e.g. nursing or care settings)</p>
                                    </list-item>
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>programmes run in countries other than England, Wales, Scotland, Northern Ireland</p>
                                    </list-item>
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>programmes involving activities such as gardening, cooking and volunteering (following a consensus in the literature that these are not generally considered as creative arts activities, though we recognise that this may be debatable) or with an intergenerational focus</p>
                                    </list-item>
                                </list>
                            </list-item>
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Population</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>older people selected for inclusion in programmes by virtue of a specific diagnosis (e.g. dementia, cancer, mental ill health) or carer role</p>
                                    </list-item>
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>or previous profession (e.g. veterans, music therapists)</p>
                                    </list-item>
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>older people living in a non-community setting (care home, nursing home, or inpatient in hospital etc.)</p>
                                    </list-item>
                                </list>
                            </list-item>
                            <list-item>
                                <label>&#x2022;</label>
                                <p>Outcome</p>
                                <list list-type="bullet">
                                    <list-item>
                                        <label>&#x25e6;</label>
                                        <p>programmes looking at outcomes other than wellbeing </p>
                                    </list-item>
                                </list>
                            </list-item>
                        </list>
                    </list-item>
                </list>
                <p>
                    <bold>
                        <italic toggle="yes">Step 3: article selection</italic>
                    </bold>
                </p>
                <p>Full text articles will be selected for inclusion in the review based on relevance and rigour. Relevance will be determined by what the article is able to offer towards the development of the programme theory. Rigour will be assessed in two ways - at the level of the quality of the methods used in included articles to generate relevant data and at the level of the explanatory value of the programme theory. We will undertake quality assessment of the methodological quality of included articles only when we find that a particular article has contributed a substantial amount of data to our CMOCs or programme theory, or when a CMOC draws heavily on one article. We will judge the explanatory quality of the programme theory using criteria of consilience, simplicity and analogy. Briefly, consilience refers to the ability of any explanation to account for as much of the data as possible. Simplicity is based on Occam&#x2019;s Razor and thus expects the theoretical explanations to be as simple as possible with minimal to no ad hoc exceptions. Finally analogy refers to the whether what we have found fits in with existing knowledge
                    <sup>
                        <xref ref-type="bibr" rid="ref-31">31</xref>
                    </sup>. A random sample of 10% of the included articles will again be independently reviewed by a second member of the research team, AF. As previously, any disagreement not resolved by discussion will be decided upon by majority vote within the research team.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Step 4: extracting and organising data</italic>
                    </bold>
                </p>
                <p>Data will be extracted by AC. Descriptive data from the included studies will be inputted into an Excel spreadsheet. These descriptive data will include details of the study (authors, publication date, country), participants (number, age), intervention (type of activity, setting, duration, referral pathway, funding) and outcome (measurement, findings). Data extracted for analytic purposes to develop and test (confirm, refute or refine) the CMOCs and emerging programme theory will be inputted into NVivo (
                    <italic toggle="yes">Lumivero (2023) NVivo (Version 14) 
                        <ext-link ext-link-type="uri" xlink:href="https://lumivero.com/">www.lumivero.com</ext-link>
                    </italic>), after rereading the full texts of the papers. The papers will initially be thematically coded in NVivo, both inductively (to enable the development of new ideas for the programme theory), deductively (based on the concepts contained within the initial programme theory) and retroductively (to infer what may be functioning as mechanisms). Codes will be refined through discussion as above, and interpretations and judgements agreed upon with the rest of the team, and at key points with the stakeholder group. As refinements are made, included papers will be reassessed for further contribution to the developing theory.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Step 5: synthesising the evidence and drawing conclusions</italic>
                    </bold>
                </p>
                <p>The analysis will then proceed to develop realist causal explanations for outcomes that are relevant to the programme theory, within each theme. The analysis will use a realist logic of analysis, moving between the data and the theory to explore how creative arts impact wellbeing in older people. The analysis will use interpretations of the coded data to build causal explanations that take the form of Context (C), Mechanism (M) and Outcome (O) configurations (CMOCs). The final programme theory will contain CMOCs that explain in which contexts certain mechanisms are triggered to produce outcomes relating to wellbeing, and consider the relative importance of these contexts. Our stakeholder group will provide feedback on the final programme theory.</p>
            </sec>
        </sec>
        <sec>
            <title>Ethics and consent</title>
            <p>As this realist review is a secondary evidence synthesis of existing literature, ethical approval was not sought; however, this research will be conducted in full compliance with the Declaration of Helsinki on medical research and the UK Policy Framework for Health and Social Care Research
                <sup>
                    <xref ref-type="bibr" rid="ref-32">32</xref>
                </sup>.</p>
        </sec>
    </body>
    <back>
        <sec sec-type="data-availability">
            <title>Data availability</title>
            <p>
                <bold>Figshare:</bold> PRISMA-P checklist for &#x2018;In what context and by which mechanisms can creative arts interventions improve wellbeing in older people? A realist review protocol&#x2019;. 
                <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.27302667.v1">https://doi.org/10.6084/m9.figshare.27302667.v1</ext-link>
                <sup>
                    <xref ref-type="bibr" rid="ref-33">33</xref>
                </sup>.</p>
            <p> Data are available under the terms of the (CC0 1.0 Public domain dedication).</p>
        </sec>
        <ack>
            <title>Acknowledgements</title>
            <p>The authors would like to acknowledge and thank the members of our stakeholder group for their ongoing involvement in the project.</p>
            <p>For the purpose of Open Access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript (AAM) version arising from this submission.</p>
        </ack>
        <ref-list>
            <ref id="ref-1">
                <label>1</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Fancourt</surname>
                            <given-names>D</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Finn</surname>
                            <given-names>S</given-names>
                        </name>
</person-group>:
                    <article-title>What is the evidence on the role of the arts in improving health and well-being? A scoping review.</article-title>Copenhagen: WHO Regional Office for Europe; (Health Evidence Network (HEN) synthesis report 67),<year>2019</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://iris.who.int/handle/10665/329834">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-2">
                <label>2</label>
                <mixed-citation publication-type="book">
                    <collab>The All-Party Parliamentary Group on Arts Health and Wellbeing and The National Centre for Creative Health</collab>:
                    <article-title>Creative Health Review - how policy can embrace creative health.</article-title>London: National Centre for Creative Health,<year>2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.artsandhealth.ie/research-evaluation/creative-health-review-how-policy-can-embrace-creative-health/">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-3">
                <label>3</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>MacGregor</surname>
                            <given-names>N</given-names>
                        </name>
</person-group>:
                    <article-title>A history of the world in 100 objects.</article-title>New York: Penguin Books,<year>2013</year>.</mixed-citation>
            </ref>
            <ref id="ref-4">
                <label>4</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Morgan</surname>
                            <given-names>A</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Swann</surname>
                            <given-names>C</given-names>
                        </name>
</person-group>
                    <person-group>, 

                        <collab>NHS Health Development Agency</collab>
</person-group>:
                    <article-title>Social capital for health: issues of definition, measurement and links to health.</article-title>London: Health Development Agency,<year>2004</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://now-test.koha-ptfs.co.uk/cgi-bin/koha/opac-detail.pl?biblionumber=36852&amp;shelfbrowse_itemnumber=66209">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-5">
                <label>5</label>
                <mixed-citation publication-type="book">
                    <collab>New Local</collab>:
                    <article-title>Rapid review of community agency and control, as final outcomes, or enablers of place-based interventions to improve community wellbeing.</article-title>London: New Local,<year>2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.tnlcommunityfund.org.uk/media/insights/documents/Rapid-Review-Community-Agency-and-Control.pdf?mtime=20230630142438&amp;focal=none">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-6">
                <label>6</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Daykin</surname>
                            <given-names>N</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Mansfield</surname>
                            <given-names>L</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Meads</surname>
                            <given-names>C</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>The role of social capital in participatory arts for wellbeing: findings from a qualitative systematic review.</article-title>
                    <source>

                        <italic toggle="yes">Arts Health.</italic>
</source>
                    <year>2021</year>;<volume>13</volume>(<issue>2</issue>):<fpage>134</fpage>&#x2013;<lpage>157</lpage>.
                    <pub-id pub-id-type="pmid">32809907</pub-id>
                    <pub-id pub-id-type="doi">10.1080/17533015.2020.1802605</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-7">
                <label>7</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Sumner</surname>
                            <given-names>RC</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Crone</surname>
                            <given-names>DM</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Hughes</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Arts on prescription: observed changes in anxiety, depression, and well-being across referral cycles.</article-title>
                    <source>

                        <italic toggle="yes">Public Health.</italic>
</source>
                    <year>2021</year>;<volume>192</volume>:<fpage>49</fpage>&#x2013;<lpage>55</lpage>.
                    <pub-id pub-id-type="pmid">33631514</pub-id>
                    <pub-id pub-id-type="doi">10.1016/j.puhe.2020.12.008</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-8">
                <label>8</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Fancourt</surname>
                            <given-names>D</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Bone</surname>
                            <given-names>JK</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Bu</surname>
                            <given-names>F</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>The impact of arts and cultural engagement on population health: findings from major cohort studies in the UK and USA 2017&#x2013;2022.</article-title>London: UCL,<year>2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://sbbresearch.org/wp-content/uploads/2023/03/Arts-and-population-health-FINAL-March-2023.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-9">
                <label>9</label>
                <mixed-citation publication-type="book">
                    <collab>Mental Health Foundation</collab>:
                    <article-title>An evidence review of the impact of participatory arts on older people.</article-title>Edinburgh: MHF,<year>2011</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://baringfoundation.org.uk/wp-content/uploads/2011/04/EvidenceReview.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-10">
                <label>10</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Milligan</surname>
                            <given-names>C</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Neary</surname>
                            <given-names>D</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Payne</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Older men and social activity: a scoping review of Men's Sheds and other gendered interventions.</article-title>
                    <source>

                        <italic toggle="yes">Ageing Soc.</italic>
</source>
                    <year>2016</year>;<volume>36</volume>(<issue>5</issue>):<fpage>895</fpage>&#x2013;<lpage>923</lpage>.
                    <pub-id pub-id-type="doi">10.1017/S0144686X14001524</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-11">
                <label>11</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Coulton</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Clift</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Skingley</surname>
                            <given-names>A</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Effectiveness and cost-effectiveness of community singing on mental health-related quality of life of older people: randomised controlled trial.</article-title>
                    <source>

                        <italic toggle="yes">Br J Psychiatry.</italic>
</source>
                    <year>2015</year>;<volume>207</volume>(<issue>3</issue>):<fpage>250</fpage>&#x2013;<lpage>5</lpage>.
                    <pub-id pub-id-type="pmid">26089304</pub-id>
                    <pub-id pub-id-type="doi">10.1192/bjp.bp.113.129908</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-12">
                <label>12</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Poulos</surname>
                            <given-names>RG</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Marwood</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Harkin</surname>
                            <given-names>D</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Arts on prescription for community-dwelling older people with a range of health and wellness needs.</article-title>
                    <source>

                        <italic toggle="yes">Health Soc Care Community.</italic>
</source>
                    <year>2019</year>;<volume>27</volume>(<issue>2</issue>):<fpage>483</fpage>&#x2013;<lpage>492</lpage>.
                    <pub-id pub-id-type="pmid">30345578</pub-id>
                    <pub-id pub-id-type="doi">10.1111/hsc.12669</pub-id>
                    <pub-id pub-id-type="pmcid">7379368</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-13">
                <label>13</label>
                <mixed-citation publication-type="book">
                    <collab>World Health Organization</collab>:
                    <article-title>Intersectoral action: the arts, health and well-being: sector brief on arts.</article-title>Copenhagen: WHO Regional Office for Europe,<year>2019</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://iris.who.int/handle/10665/346537">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-14">
                <label>14</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Dow</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Warran</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Letrondo</surname>
                            <given-names>P</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>The arts in public health policy: progress and opportunities.</article-title>
                    <source>

                        <italic toggle="yes">Lancet Public Health.</italic>
</source>
                    <year>2023</year>;<volume>8</volume>(<issue>2</issue>):<fpage>e155</fpage>&#x2013;<lpage>e160</lpage>.
                    <pub-id pub-id-type="pmid">36709054</pub-id>
                    <pub-id pub-id-type="doi">10.1016/S2468-2667(22)00313-9</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-15">
                <label>15</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Occhipinti</surname>
                            <given-names>JA</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Skinner</surname>
                            <given-names>A</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Doraiswamy</surname>
                            <given-names>PM</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>The influence of economic policies on social environments and mental health.</article-title>
                    <source>

                        <italic toggle="yes">Bull World Health Organ.</italic>
</source>
                    <year>2024</year>;<volume>102</volume>(<issue>5</issue>):<fpage>323</fpage>&#x2013;<lpage>329</lpage>.
                    <pub-id pub-id-type="pmid">38680470</pub-id>
                    <pub-id pub-id-type="doi">10.2471/BLT.23.290286</pub-id>
                    <pub-id pub-id-type="pmcid">11046160</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-16">
                <label>16</label>
                <mixed-citation publication-type="report">
                    <collab>Centre for Ageing Better</collab>:
                    <article-title>Summary report: the state of ageing in 2022.</article-title>London: Centre for Ageing Better,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://ageing-better.org.uk/sites/default/files/2022-04/The-State-of-Ageing-2022-online.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-17">
                <label>17</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Kharicha</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Manthorpe</surname>
                            <given-names>J</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Iliffe</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Managing loneliness: a qualitative study of older people's views.</article-title>
                    <source>

                        <italic toggle="yes">Aging Ment Health.</italic>
</source>
                    <year>2021</year>;<volume>25</volume>(<issue>7</issue>):<fpage>1206</fpage>&#x2013;<lpage>13</lpage>.
                    <pub-id pub-id-type="pmid">32091237</pub-id>
                    <pub-id pub-id-type="doi">10.1080/13607863.2020.1729337</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-18">
                <label>18</label>
                <mixed-citation publication-type="report">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Mughal</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Polley</surname>
                            <given-names>M</given-names>
                        </name>

                        <name name-style="western">
                            <surname> Sabey</surname>
                            <given-names>A</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>How arts, heritage and culture can support health and wellbeing through social prescribing.</article-title>London: National Academy for Social Prescribing,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://socialprescribingacademy.org.uk/media/5xhnkfwh/how-arts-heritage-and-culture-can-support-health-and-wellbeing-through-social-prescribing.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-19">
                <label>19</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Dowlen</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Gray</surname>
                            <given-names>K</given-names>
                        </name>
</person-group>:
                    <article-title>Research digest: older people - culture, community, connection.</article-title>Leeds: Centre for Cultural Value,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.culturehive.co.uk/CVIresources/older-people-culture-community-connection/">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-20">
                <label>20</label>
                <mixed-citation publication-type="web">
                    <collab>National Institute for Health and Care Excellence</collab>:
                    <article-title>Mental wellbeing and independence for older people.</article-title>Quality standard [QS137],<year>2016</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.nice.org.uk/guidance/qs137">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-21">
                <label>21</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Hume</surname>
                            <given-names>V</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Parikh</surname>
                            <given-names>M</given-names>
                        </name>
</person-group>:
                    <article-title>From surviving to thriving: building a model for sustainable practice in creativity and mental health.</article-title>Leeds: Culture Health &amp; Wellbeing Alliance,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.culturehealthandwellbeing.org.uk/sites/default/files/BF_From%20surviving%20to%20thriving_WEB%202.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-22">
                <label>22</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Ganga</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Davies</surname>
                            <given-names>L</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Wilson</surname>
                            <given-names>K</given-names>
                        </name>
</person-group>:
                    <article-title>Arts &amp; wellbeing - a review of the social value of place-based arts interventions.</article-title>Liverpool: Liverpool John Moores University,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://whatworkswellbeing.org/wp-content/uploads/2022/12/Arts-Wellbeing.-A-review-of-the-social-value-of-place-based-arts-interventions-updated-30.01.2023.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-23">
                <label>23</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Bone</surname>
                            <given-names>JK</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Fancourt</surname>
                            <given-names>D</given-names>
                        </name>
</person-group>:
                    <article-title>Arts, culture &amp; the brain: a literature review and new epidemiological analyses.</article-title>London: Arts Council England,<year>2022</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://discovery.ucl.ac.uk/id/eprint/10154961/">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-24">
                <label>24</label>
                <mixed-citation publication-type="book">
                    <collab>World Health Organization</collab>:
                    <article-title>Constitution of the World Health Organization.</article-title>Geneva: World Health Organisation,<year>1946</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.globalhealthrights.org/instrument/constitution-of-the-world-health-organization-who/">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-25">
                <label>25</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Fancourt</surname>
                            <given-names>D</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Aughterson</surname>
                            <given-names>H</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Finn</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>How leisure activities affect health: a narrative review and multi-level theoretical framework of mechanisms of action.</article-title>
                    <source>

                        <italic toggle="yes">Lancet Psychiatry.</italic>
</source>
                    <year>2021</year>;<volume>8</volume>(<issue>4</issue>):<fpage>329</fpage>&#x2013;<lpage>339</lpage>.
                    <pub-id pub-id-type="pmid">33581775</pub-id>
                    <pub-id pub-id-type="doi">10.1016/S2215-0366(20)30384-9</pub-id>
                    <pub-id pub-id-type="pmcid">7613155</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-26">
                <label>26</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>O'Donnell</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Lohan</surname>
                            <given-names>M</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Oliffe</surname>
                            <given-names>JL</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>The acceptability, effectiveness and gender responsiveness of participatory arts interventions in promoting mental health and Wellbeing: a systematic review.</article-title>
                    <source>

                        <italic toggle="yes">Arts Health.</italic>
</source>
                    <year>2022</year>;<volume>14</volume>(<issue>2</issue>):<fpage>186</fpage>&#x2013;<lpage>203</lpage>.
                    <pub-id pub-id-type="pmid">33661710</pub-id>
                    <pub-id pub-id-type="doi">10.1080/17533015.2021.1894463</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-27">
                <label>27</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Sheppard</surname>
                            <given-names>A</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Broughton</surname>
                            <given-names>MC</given-names>
                        </name>
</person-group>:
                    <article-title>Promoting wellbeing and health through active participation in music and dance: a systematic review.</article-title>
                    <source>

                        <italic toggle="yes">Int J Qual Stud Health Well-being.</italic>
</source>
                    <year>2020</year>;<volume>15</volume>(<issue>1</issue>):
                    <elocation-id>1732526</elocation-id>.
                    <pub-id pub-id-type="pmid">32267216</pub-id>
                    <pub-id pub-id-type="doi">10.1080/17482631.2020.1732526</pub-id>
                    <pub-id pub-id-type="pmcid">7178871</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-28">
                <label>28</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Pawson</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Greenhalgh</surname>
                            <given-names>T</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Harvey</surname>
                            <given-names>G</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Realist review--a new method of systematic review designed for complex policy interventions.</article-title>
                    <source>

                        <italic toggle="yes">J Health Serv Res Policy.</italic>
</source>
                    <year>2005</year>;<volume>10 Suppl 1</volume>:<fpage>21</fpage>&#x2013;<lpage>34</lpage>.
                    <pub-id pub-id-type="pmid">16053581</pub-id>
                    <pub-id pub-id-type="doi">10.1258/1355819054308530</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-29">
                <label>29</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Tierney</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Libert</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Gorenberg</surname>
                            <given-names>J</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Tailoring cultural offers to meet the needs of older people during uncertain times: a rapid realist review.</article-title>
                    <source>

                        <italic toggle="yes">BMC Med.</italic>
</source>
                    <year>2022</year>;<volume>20</volume>(<issue>1</issue>): 260.
                    <pub-id pub-id-type="pmid">35999539</pub-id>
                    <pub-id pub-id-type="doi">10.1186/s12916-022-02464-4</pub-id>
                    <pub-id pub-id-type="pmcid">9398500</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-30">
                <label>30</label>
                <mixed-citation publication-type="web">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Wong</surname>
                            <given-names>G</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Greenhalgh</surname>
                            <given-names>T</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Westhorp</surname>
                            <given-names>G</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>RAMESES Project. Quality standards for realist synthesis (for researchers and peer-reviewers).</article-title>London,<year>2024</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.ramesesproject.org/media/RS_qual_standards_researchers.pdf">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-31">
                <label>31</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Wong</surname>
                            <given-names>G</given-names>
                        </name>
</person-group>:
                    <article-title>Data gathering for realist reviews: looking for needles in haystacks.</article-title>Emmel N, Greenhalgh J, Manzano A, Monaghan M, Dalkin S, editors
                    <italic toggle="yes">Doing Realist Research</italic>. London: SAGE,<year>2018</year>.
                    <pub-id pub-id-type="doi">10.4135/9781526451729.n9</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-32">
                <label>32</label>
                <mixed-citation publication-type="journal">
                    <collab>World Medical Association</collab>:
                    <article-title>World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.</article-title>
                    <source>

                        <italic toggle="yes">JAMA.</italic>
</source>
                    <year>2013</year>;<volume>310</volume>(<issue>20</issue>):<fpage>2191</fpage>&#x2013;<lpage>4</lpage>.
                    <pub-id pub-id-type="pmid">24141714</pub-id>
                    <pub-id pub-id-type="doi">10.1001/jama.2013.281053</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-33">
                <label>33</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Caulfield</surname>
                            <given-names>A</given-names>
                        </name>
</person-group>:
                    <article-title>PRISMA-P-checklist.docx.</article-title>
                    <source>

                        <italic toggle="yes">figshare.</italic>
</source>Journal contribution,<year>2024</year>.
                    <ext-link ext-link-type="uri" xlink:href="http://www.doi.org/10.6084/m9.figshare.27302667">http://www.doi.org/10.6084/m9.figshare.27302667</ext-link>
                </mixed-citation>
            </ref>
        </ref-list>
    </back>
    <sub-article article-type="reviewer-report" id="report36026">
        <front-stub>
            <article-id pub-id-type="doi">10.3310/nihropenres.15242.r36026</article-id>
            <title-group>
                <article-title>Reviewer response for version 2</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>West</surname>
                        <given-names>Julian</given-names>
                    </name>
                    <xref ref-type="aff" rid="r36026a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-0549-3436</uri>
                </contrib>
                <contrib contrib-type="author">
                    <name>
                        <surname>Zeilig</surname>
                        <given-names>Hannah</given-names>
                    </name>
                    <xref ref-type="aff" rid="r36026a2">2</xref>
                    <role>Co-referee</role>
                </contrib>
                <aff id="r36026a1">
                    <label>1</label>Royal Academy of Music, London, UK</aff>
                <aff id="r36026a2">
                    <label>2</label>London College of Fashion, University of the Arts London, London, England, UK</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>20</day>
                <month>8</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 West J and Zeilig H</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport36026" related-article-type="peer-reviewed-article" xlink:href="10.3310/nihropenres.13746.2"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>As mentioned in our first review, this is a strong study protocol. We do feel that points 1 and 2 which were raised in our initial review have not been addressed and that the reasons for omitting the research on wellbeing, creative&#x00a0; arts and people with dementia could be clarified.&#x00a0;</p>
            <p> The more nuanced discussion of wellbeing is welcome.</p>
            <p> Points 4 and 5 have not been addressed.</p>
            <p> Point 6 has been addressed with the inclusion of practitioners in the stakeholder group.</p>
            <p> We understand that point 7 is difficult to address, but do feel the study would be strengthened by sense checking&#x00a0; the search strategy with the the wider stakeholder group.</p>
            <p> Finally point 8 is addressed in the introduction and in the description of the exclusion criteria.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Yes</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>Not applicable</p>
            <p>Reviewer Expertise:</p>
            <p>NA</p>
            <p>We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.</p>
        </body>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report34945">
        <front-stub>
            <article-id pub-id-type="doi">10.3310/nihropenres.14930.r34945</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Karkou</surname>
                        <given-names>Vicky</given-names>
                    </name>
                    <xref ref-type="aff" rid="r34945a1">1</xref>
                    <role>Referee</role>
                </contrib>
                <aff id="r34945a1">
                    <label>1</label>Edge Hill University, Ormskirk, UK</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>10</day>
                <month>5</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Karkou V</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport34945" related-article-type="peer-reviewed-article" xlink:href="10.3310/nihropenres.13746.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This is a very well written piece that provides a strong rationale and study design consistent with the approach adopted.&#x00a0; Some minor comments for improvement are:</p>
            <p> </p>
            <p> There is a good overview of arts-based interventions.&#x00a0; The text sets out the whole field but it is only later on (towards the end of the introduction) that it becomes clear that the review is concerned with participatory arts interventions only.</p>
            <p> </p>
            <p> It is now clear how the RAMESES quality standards will be used (and not used consistently within the text: are you referring to quality standards or publication standards?).</p>
            <p> </p>
            <p> It will be good practice to move the websites from the text and reference website as a normal reference following relevant conventions.&#x00a0;&#x00a0;</p>
            <p> </p>
            <p> p.4. I would not refer to men as a subgroup, but maybe simply a group.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Yes</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>Not applicable</p>
            <p>Reviewer Expertise:</p>
            <p>Arts-based interventions, systematic literature reviews, realist evaluations, mixed methods researcher.</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.</p>
        </body>
        <sub-article article-type="response" id="comment3447-34945">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Caulfield</surname>
                            <given-names>Alexandra</given-names>
                        </name>
                        <aff>University of Oxford, Oxford, England, UK</aff>
                    </contrib>
                </contrib-group>
                <author-notes>
                    <fn fn-type="conflict">
                        <p>
                            <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                    </fn>
                </author-notes>
                <pub-date pub-type="epub">
                    <day>12</day>
                    <month>6</month>
                    <year>2025</year>
                </pub-date>
            </front-stub>
            <body>
                <p>
                    <bold>Response to Reviewers</bold>
                </p>
                <p> </p>
                <p> The authors would like to thank all the reviewers for taking the time to review and provide insightful feedback on our protocol. Please find your comments addressed below:</p>
                <p> </p>
                <p> 
                    <bold>Reviewer 1</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>Our study population is community-dwelling UK adults aged 65 years or over recruited to interventions not by virtue of a particular diagnosis. We have chosen this population as less is known about the impact of creative arts interventions than for individuals recruited on the basis of a specific diagnosis, and it is possible that different mechanisms may be at play. It is unfortunately outside the scope of this review to include these populations in addition to our study population, and within these limitations it was felt useful to focus on a population about which less is known.</p>
                        </list-item>
                        <list-item>
                            <p>However, we acknowledge the point made by Reviewer 1 that previous theoretical work done with other populations provides important background to our current review and can enhance our understanding of the identified CMOCs. The realist framework developed by Windle et al. (2018) and the work of Cousins et al. (2020) provide valuable perspectives for situating our findings within the broader research landscape, and we aim to reflect on how our findings relate to this wider body of theoretical work in an upcoming results paper.</p>
                        </list-item>
                        <list-item>
                            <p>The concept of &#x2018;wellbeing&#x2019; is complex and challenging to define, as rightly noted by Reviewer 1. In light of this observation, we have expanded our definition to include further discussion of the experienced, evaluative, eudaimonic and social aspects of wellbeing. The concept of &#x2018;flourishing&#x2019;, an idea very relevant to creative arts participation, seems to fall within the concept of eudaimonic wellbeing, or living one&#x2019;s life in line with a sense of purpose and personal growth (Fancourt et al. 2022).</p>
                        </list-item>
                        <list-item>
                            <p>We acknowledge the valid criticism of the WHO definition of health and wellbeing. This definition has been criticised for its failure to acknowledge that an individual may simultaneously experience &#x2018;ill-being&#x2019; as a part of subjective wellbeing (Zeilig et al. 2019); we hope we have clarified that wellbeing can co-exist alongside illness states. Social isolation and loneliness feed into experiences of wellbeing. To ensure inclusivity, we have adhered to the definitions of wellbeing used by the original study authors, rather than imposing a singular framework. Quality of life and wellbeing are interrelated concepts, and it falls beyond the scope of this paper to compare and contrast the two; the term wellbeing was chosen for this review as it seems to be most frequently used in more recent papers examining these concepts, and it may be more subjective than QoL measures (Ruggeri et al. 2020, Meiselman 2016).</p>
                        </list-item>
                        <list-item>
                            <p>We would like to clarify that artists are included within our stakeholder group under the term 
                                <italic>practitioner</italic>, and are represented within our research team (JLS). This terminology, drawn from a recent arts and public health policy paper (Dow et al. 2023), was selected to provide an inclusive descriptor which may encompass various types of artists and facilitators leading interventions.</p>
                        </list-item>
                        <list-item>
                            <p>Our stakeholder group will be consulted on how best to produce practical guidance for a range of providers (facilitators, artists, and other relevant parties e.g. linkworkers who may refer or speak to older people about the benefits of attending such programmes), and what form this should take. We have updated our PPI paragraph to make this clear.</p>
                        </list-item>
                        <list-item>
                            <p>The most commonly represented demographic at participatory creative arts interventions for over 65s in the UK is women of white British background (Dowlen 2023). We have removed the reference to men as a subgroup and clarified that our review will highlight evidence gaps within the existing literature. We will comment in our findings on any identified gaps in the literature, including where this may relate to people from global majority communities.</p>
                        </list-item>
                        <list-item>
                            <p>With regard to search strategy, this was piloted to ensure it picked up relevant papers. We sought to include a comprehensive list of databases from a range of disciplines, as well as unpublished literature, and will contact authors to source papers or clarify details as required. Due to capacity, we were unable to run the search strategy past our stakeholder group prior to running the search, but stakeholders will be offered the opportunity to comment on the search strategy during ongoing engagement work.</p>
                        </list-item>
                        <list-item>
                            <p>We acknowledge Reviewer 1&#x2019;s important point regarding the complexity of distinguishing between participatory and receptive arts activities. This distinction is indeed highly debatable, with considerable practical and philosophical overlap that our study cannot fully resolve. For the purposes of this review, we have chosen to focus on arts activities that emphasize participatory elements, as we believe the mechanisms involved may differ from those in more &#x2018;receptive&#x2019; experiences (such as attending a museum or concert), where active individual engagement may be less central. However, we recognize that the distinction is far from clear-cut. Individuals may attend participatory programmes but opt not to engage directly in the artistic activity, choosing instead to simply be present or to participate socially. We will acknowledge this limitation within the discussion of our findings.</p>
                        </list-item>
                    </list> </p>
                <p> 
                    <bold>Reviewer 2</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>The RAMESES quality standards were used to inform the development of the review protocol published here. The RAMESES publication standards will be used to guide the write-up of review findings in a forthcoming paper. Thank you for pointing out the error referencing publication standards in the main text. This has been amended.</p>
                        </list-item>
                        <list-item>
                            <p>Whilst we agree with Reviewer 2 that website references may be more readable if included in the reference list, these links are included in the main text in line with NIHR Open referencing standards: &#x2018;Web links, URLs, and links to the authors&#x2019; own websites should be included as hyperlinks within the main body of the article, and not as references.&#x2019;</p>
                        </list-item>
                    </list> </p>
                <p> 
                    <bold>References</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>Windle G, Gregory S, Howson-Griffiths T, Newman A, O&#x2019;Brien D, Goulding A. Exploring the theoretical foundations of visual art programmes for people living&#x00a0; with dementia. Dementia. 2017;17(6):702-727.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Cousins E, Tischler V, Garabedian C, Dening T. A Taxonomy of Arts Interventions for People With Dementia. Gerontologist. 2020 Jan 24;60(1):124-134. doi: 10.1093/geront/gnz024</p>
                        </list-item>
                        <list-item>
                            <p>Bone JK, Fancourt D: Arts, culture &amp; the brain: a literature review and new epidemiological analyses. London: Arts Council England,2022.</p>
                        </list-item>
                        <list-item>
                            <p>Zeilig H, Tischler V, van der Byl Williams M, West J, Strohmaier S. Co-creativity, well-being and agency: A case study analysis of a co-creative arts group for people with dementia. J Aging Stud. 2019 Jun;49:16-24.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Ruggeri, K., Garcia-Garzon, E., Maguire, &#x00c1;. et al. Well-being is more than happiness and life satisfaction: a multidimensional analysis of 21 countries. Health Qual Life Outcomes 18, 192 (2020).</p>
                        </list-item>
                        <list-item>
                            <p>Meiselman, H. L. (2016). Quality of life, well-being and wellness: Measuring subjective health for foods and other products. Food Quality and Preference, 54, 101&#x2013;109.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Dow R, Warran K, Letrondo P, Fancourt D. The arts in public health policy: progress and opportunities. Lancet Public Health. 2023 Feb;8(2):e155-e160. doi: 10.1016/S2468-2667(22)00313-9</p>
                        </list-item>
                        <list-item>
                            <p>Dowlen, R. (2023) Vision paper: culture, health and wellbeing. January 2023. Leeds: Centre for Cultural Value.&#x00a0;</p>
                        </list-item>
                    </list>
                </p>
            </body>
        </sub-article>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report35074">
        <front-stub>
            <article-id pub-id-type="doi">10.3310/nihropenres.14930.r35074</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>West</surname>
                        <given-names>Julian</given-names>
                    </name>
                    <xref ref-type="aff" rid="r35074a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-0549-3436</uri>
                </contrib>
                <contrib contrib-type="author">
                    <name>
                        <surname>Zeilig</surname>
                        <given-names>Hannah</given-names>
                    </name>
                    <xref ref-type="aff" rid="r35074a2">2</xref>
                    <role>Co-referee</role>
                </contrib>
                <aff id="r35074a1">
                    <label>1</label>Royal Academy of Music, London, UK</aff>
                <aff id="r35074a2">
                    <label>2</label>London College of Fashion, University of the Arts London, London, England, UK</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>23</day>
                <month>4</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 West J and Zeilig H</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport35074" related-article-type="peer-reviewed-article" xlink:href="10.3310/nihropenres.13746.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>In this article, the authors present the argument that despite the growing interest in the potential for the creative arts to support wellbeing, understanding concerning the mechanisms whereby these interventions impact wellbeing for older adults is poorly understood.&#x00a0; They also describe additional reasons for why older people should have access to art. The use of a realist review is proposed, involving context-mechanism-outcome configurations (CMOCs) to create programme theories which can be used to support those who provide services aimed at improving the wellbeing of older people. The methods of the proposed study are described in detail and seem both appropriate for addressing the research question and rigorously designed. We agree that there are recognised health benefits to participating in the creative arts, but as outlined by Clift et al (2021, 2025) there is a need for more robust, systematic work in this area.</p>
            <p> </p>
            <p> We would like to offer a few observations which may further strengthen this study.</p>
            <p> &#x00a0; 
                <list list-type="order">
                    <list-item>
                        <p>Whilst we agree that there is not a great deal known about how creative activities affect wellbeing, we are aware that this has been of increasing interest in the last decade. For instance, Windle, G., et al., 2018 (Ref 3)&#x00a0;explore the theoretical foundations of visual art programmes for people with dementia using realist synthesis; Cousins, E, et al., 2020 (Ref 4) created a taxonomy of arts interventions again drawing on realist methodology; there is also multi-disciplinary research into the benefits of music for people with dementia - see for example the work of S&#x00e4;rk&#x00e4;m&#x00f6;. The assumption that research pertaining to people living with dementia might not be helpful in informing work for all older adults seems problematic.</p>
                    </list-item>
                    <list-item>
                        <p>Following on from the previous point, we would question and appreciate further clarity on why this review excludes arts interventions that focus on older people with specific diagnoses (e.g. mental health, dementia or cancer.)&#x00a0; Although we agree that previous work has tended to focus on older people with conditions such as those outlined, we think that the excellent work in this area could still be usefully informative for understanding arts interventions and their impact on wellbeing for all older adults. We think it might be important to build on and extrapolate from work that has already identified some of the CMOCs that explain in which contexts certain mechanisms operate to effect wellbeing in arts interventions.</p>
                    </list-item>
                    <list-item>
                        <p>As wellbeing is a central focus for this paper a more nuanced and rigorous definition might be helpful. The concept of flourishing has also been identified as key for wellbeing - especially in relation to the arts. For instance, how does wellbeing differ from quality of life and to what extent should loneliness and social isolation (the absence of these) also be considered? In addition, we are unclear what evaluative and social wellbeing refers to. Finally, the WHO definition is widely accepted but fails to acknowledge the &#x2018;ill-being&#x2019; that can be encompassed as part of wellbeing (Zeilig H, et al., 2019 (Ref 6)).</p>
                    </list-item>
                    <list-item>
                        <p>A stated aim is to develop guidance for providers; it would perhaps be useful to have a little more detail on the form that this might take and how this might be differentiated for a range of providers.</p>
                    </list-item>
                    <list-item>
                        <p>There is no mention of the different needs and contexts of people who are from global majority communities and how this will be considered, and we are unclear why men are mentioned as a &#x2018;subgroup&#x2019; (is this due to demographic exigencies?)</p>
                    </list-item>
                    <list-item>
                        <p>In identifying the stakeholder group, we wonder why artists are not explicitly mentioned. The invaluable perspective of artists who lead groups for older people in a wide variety of contexts (often over long periods of time) should be fully integrated and yet is routinely overlooked (West, J., et al., 2024 (Ref 5)). This review could be strengthened by their inclusion.</p>
                    </list-item>
                    <list-item>
                        <p>The search strategy which will be conducted by an experienced librarian and the project team could also be sense-checked by the wider stakeholder group, especially older people with lived experience of arts groups.</p>
                    </list-item>
                    <list-item>
                        <p>With regard to the exclusion criteria, we query whether going to a museum can be considered a receptive activity in the same way as watching a film might be. This (as the authors do acknowledge) is highly debatable especially since many museums include activities that encourage creative engagement. Overall, we wonder whether a creative arts activity can be clearly distinguished as being EITHER receptive OR participatory. These distinctions are complex and could be clarified.</p>
                    </list-item>
                </list> </p>
            <p> References: 
                <list list-type="bullet">
                    <list-item>
                        <p>Clift, S., et al, 2021 (Ref 1)</p>
                    </list-item>
                    <list-item>
                        <p>Grebosz-Haring, K. et al., 2025 (Ref 2)</p>
                    </list-item>
                    <list-item>
                        <p>Windle, G., et al., 2018 (Ref 3)&#x00a0;</p>
                    </list-item>
                    <list-item>
                        <p>Cousins, E, et al., 2020 (Ref 4)</p>
                    </list-item>
                    <list-item>
                        <p>West, J., et al., 2024 (Ref 5)</p>
                    </list-item>
                    <list-item>
                        <p>Zeilig H, et al., 2019 (Ref 6)</p>
                    </list-item>
                </list>
            </p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Yes</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>Not applicable</p>
            <p>Reviewer Expertise:</p>
            <p>NA</p>
            <p>We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above.</p>
        </body>
        <back>
            <ref-list>
                <title>References</title>
                <ref id="rep-ref-35074-1">
                    <label>1</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>The need for robust critique of research on social and health impacts of the arts</article-title>.
                        <source>
                            <italic>Cultural Trends</italic>
                        </source>.<year>2021</year>;<volume>30</volume>(<issue>5</issue>) :
                        <elocation-id>10.1080/09548963.2021.1910492</elocation-id>
                        <fpage>442</fpage>-<lpage>459</lpage>
                        <pub-id pub-id-type="doi">10.1080/09548963.2021.1910492</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35074-2">
                    <label>2</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>The need for a critical perspective on arts and health research and evidence reviews</article-title>.<year>2025</year>;
                        <elocation-id>10.31235/osf.io/y7axd_v2</elocation-id>
                        <pub-id pub-id-type="doi">10.31235/osf.io/y7axd_v2</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35074-3">
                    <label>3</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>Exploring the theoretical foundations of visual art programmes for people living with dementia.</article-title>
                        <source>
                            <italic>Dementia (London)</italic>
                        </source>.<year>2018</year>;<volume>17</volume>(<issue>6</issue>) :
                        <elocation-id>10.1177/1471301217726613</elocation-id>
                        <fpage>702</fpage>-<lpage>727</lpage>
                        <pub-id pub-id-type="pmid">28914090</pub-id>
                        <pub-id pub-id-type="doi">10.1177/1471301217726613</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35074-4">
                    <label>4</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>A Taxonomy of Arts Interventions for People With Dementia.</article-title>
                        <source>
                            <italic>Gerontologist</italic>
                        </source>.<year>2020</year>;<volume>60</volume>(<issue>1</issue>) :
                        <elocation-id>10.1093/geront/gnz024</elocation-id>
                        <fpage>124</fpage>-<lpage>134</lpage>
                        <pub-id pub-id-type="pmid">30840060</pub-id>
                        <pub-id pub-id-type="doi">10.1093/geront/gnz024</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35074-5">
                    <label>5</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>Making a living moment more resonant: an exploration of the role of the artist in co-creative work with people living with dementia</article-title>.
                        <source>
                            <italic>Wellcome Open Research</italic>
                        </source>.<year>2024</year>;<volume>8</volume>:
                        <elocation-id>10.12688/wellcomeopenres.19357.3</elocation-id>
                        <pub-id pub-id-type="doi">10.12688/wellcomeopenres.19357.3</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35074-6">
                    <label>6</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>Co-creativity, well-being and agency: A case study analysis of a co-creative arts group for people with dementia.</article-title>
                        <source>
                            <italic>J Aging Stud</italic>
                        </source>.<year>2019</year>;<volume>49</volume>:
                        <elocation-id>10.1016/j.jaging.2019.03.002</elocation-id>
                        <fpage>16</fpage>-<lpage>24</lpage>
                        <pub-id pub-id-type="pmid">31229214</pub-id>
                        <pub-id pub-id-type="doi">10.1016/j.jaging.2019.03.002</pub-id>
                    </mixed-citation>
                </ref>
            </ref-list>
        </back>
        <sub-article article-type="response" id="comment3446-35074">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Caulfield</surname>
                            <given-names>Alexandra</given-names>
                        </name>
                        <aff>University of Oxford, Oxford, England, UK</aff>
                    </contrib>
                </contrib-group>
                <author-notes>
                    <fn fn-type="conflict">
                        <p>
                            <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                    </fn>
                </author-notes>
                <pub-date pub-type="epub">
                    <day>12</day>
                    <month>6</month>
                    <year>2025</year>
                </pub-date>
            </front-stub>
            <body>
                <p>
                    <bold>Response to Reviewers</bold>
                </p>
                <p> </p>
                <p> The authors would like to thank all the reviewers for taking the time to review and provide insightful feedback on our protocol. Please find your comments addressed below:</p>
                <p> </p>
                <p> 
                    <bold>Reviewer 1</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>Our study population is community-dwelling UK adults aged 65 years or over recruited to interventions not by virtue of a particular diagnosis. We have chosen this population as less is known about the impact of creative arts interventions than for individuals recruited on the basis of a specific diagnosis, and it is possible that different mechanisms may be at play. It is unfortunately outside the scope of this review to include these populations in addition to our study population, and within these limitations it was felt useful to focus on a population about which less is known.</p>
                        </list-item>
                        <list-item>
                            <p>However, we acknowledge the point made by Reviewer 1 that previous theoretical work done with other populations provides important background to our current review and can enhance our understanding of the identified CMOCs. The realist framework developed by Windle et al. (2018) and the work of Cousins et al. (2020) provide valuable perspectives for situating our findings within the broader research landscape, and we aim to reflect on how our findings relate to this wider body of theoretical work in an upcoming results paper.</p>
                        </list-item>
                        <list-item>
                            <p>The concept of &#x2018;wellbeing&#x2019; is complex and challenging to define, as rightly noted by Reviewer 1. In light of this observation, we have expanded our definition to include further discussion of the experienced, evaluative, eudaimonic and social aspects of wellbeing. The concept of &#x2018;flourishing&#x2019;, an idea very relevant to creative arts participation, seems to fall within the concept of eudaimonic wellbeing, or living one&#x2019;s life in line with a sense of purpose and personal growth (Fancourt et al. 2022).</p>
                        </list-item>
                        <list-item>
                            <p>We acknowledge the valid criticism of the WHO definition of health and wellbeing. This definition has been criticised for its failure to acknowledge that an individual may simultaneously experience &#x2018;ill-being&#x2019; as a part of subjective wellbeing (Zeilig et al. 2019); we hope we have clarified that wellbeing can co-exist alongside illness states. Social isolation and loneliness feed into experiences of wellbeing. To ensure inclusivity, we have adhered to the definitions of wellbeing used by the original study authors, rather than imposing a singular framework. Quality of life and wellbeing are interrelated concepts, and it falls beyond the scope of this paper to compare and contrast the two; the term wellbeing was chosen for this review as it seems to be most frequently used in more recent papers examining these concepts, and it may be more subjective than QoL measures (Ruggeri et al. 2020, Meiselman 2016).</p>
                        </list-item>
                        <list-item>
                            <p>We would like to clarify that artists are included within our stakeholder group under the term 
                                <italic>practitioner</italic>, and are represented within our research team (JLS). This terminology, drawn from a recent arts and public health policy paper (Dow et al. 2023), was selected to provide an inclusive descriptor which may encompass various types of artists and facilitators leading interventions.</p>
                        </list-item>
                        <list-item>
                            <p>Our stakeholder group will be consulted on how best to produce practical guidance for a range of providers (facilitators, artists, and other relevant parties e.g. linkworkers who may refer or speak to older people about the benefits of attending such programmes), and what form this should take. We have updated our PPI paragraph to make this clear.</p>
                        </list-item>
                        <list-item>
                            <p>The most commonly represented demographic at participatory creative arts interventions for over 65s in the UK is women of white British background (Dowlen 2023). We have removed the reference to men as a subgroup and clarified that our review will highlight evidence gaps within the existing literature. We will comment in our findings on any identified gaps in the literature, including where this may relate to people from global majority communities.</p>
                        </list-item>
                        <list-item>
                            <p>With regard to search strategy, this was piloted to ensure it picked up relevant papers. We sought to include a comprehensive list of databases from a range of disciplines, as well as unpublished literature, and will contact authors to source papers or clarify details as required. Due to capacity, we were unable to run the search strategy past our stakeholder group prior to running the search, but stakeholders will be offered the opportunity to comment on the search strategy during ongoing engagement work.</p>
                        </list-item>
                        <list-item>
                            <p>We acknowledge Reviewer 1&#x2019;s important point regarding the complexity of distinguishing between participatory and receptive arts activities. This distinction is indeed highly debatable, with considerable practical and philosophical overlap that our study cannot fully resolve. For the purposes of this review, we have chosen to focus on arts activities that emphasize participatory elements, as we believe the mechanisms involved may differ from those in more &#x2018;receptive&#x2019; experiences (such as attending a museum or concert), where active individual engagement may be less central. However, we recognize that the distinction is far from clear-cut. Individuals may attend participatory programmes but opt not to engage directly in the artistic activity, choosing instead to simply be present or to participate socially. We will acknowledge this limitation within the discussion of our findings.</p>
                        </list-item>
                    </list> </p>
                <p> 
                    <bold>Reviewer 2</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>The RAMESES quality standards were used to inform the development of the review protocol published here. The RAMESES publication standards will be used to guide the write-up of review findings in a forthcoming paper. Thank you for pointing out the error referencing publication standards in the main text. This has been amended.</p>
                        </list-item>
                        <list-item>
                            <p>Whilst we agree with Reviewer 2 that website references may be more readable if included in the reference list, these links are included in the main text in line with NIHR Open referencing standards: &#x2018;Web links, URLs, and links to the authors&#x2019; own websites should be included as hyperlinks within the main body of the article, and not as references.&#x2019;</p>
                        </list-item>
                    </list> </p>
                <p> 
                    <bold>References</bold> 
                    <list list-type="bullet">
                        <list-item>
                            <p>Windle G, Gregory S, Howson-Griffiths T, Newman A, O&#x2019;Brien D, Goulding A. Exploring the theoretical foundations of visual art programmes for people living&#x00a0; with dementia. Dementia. 2017;17(6):702-727.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Cousins E, Tischler V, Garabedian C, Dening T. A Taxonomy of Arts Interventions for People With Dementia. Gerontologist. 2020 Jan 24;60(1):124-134. doi: 10.1093/geront/gnz024</p>
                        </list-item>
                        <list-item>
                            <p>Bone JK, Fancourt D: Arts, culture &amp; the brain: a literature review and new epidemiological analyses. London: Arts Council England,2022.</p>
                        </list-item>
                        <list-item>
                            <p>Zeilig H, Tischler V, van der Byl Williams M, West J, Strohmaier S. Co-creativity, well-being and agency: A case study analysis of a co-creative arts group for people with dementia. J Aging Stud. 2019 Jun;49:16-24.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Ruggeri, K., Garcia-Garzon, E., Maguire, &#x00c1;. et al. Well-being is more than happiness and life satisfaction: a multidimensional analysis of 21 countries. Health Qual Life Outcomes 18, 192 (2020).</p>
                        </list-item>
                        <list-item>
                            <p>Meiselman, H. L. (2016). Quality of life, well-being and wellness: Measuring subjective health for foods and other products. Food Quality and Preference, 54, 101&#x2013;109.&#x00a0;</p>
                        </list-item>
                        <list-item>
                            <p>Dow R, Warran K, Letrondo P, Fancourt D. The arts in public health policy: progress and opportunities. Lancet Public Health. 2023 Feb;8(2):e155-e160. doi: 10.1016/S2468-2667(22)00313-9</p>
                        </list-item>
                        <list-item>
                            <p>Dowlen, R. (2023) Vision paper: culture, health and wellbeing. January 2023. Leeds: Centre for Cultural Value.&#x00a0;</p>
                        </list-item>
                    </list>
                </p>
            </body>
        </sub-article>
    </sub-article>
</article>
