Abstract
Abstract
Introduction
Prisons present both unique opportunities and challenges for delivering healthcare to individuals who often experience significant vulnerabilities and often have poor health outcomes. Actions and solutions informed by the health literacy strengths and challenges (ie, health literacy-informed interventions) of people in prison offer an opportunity to build fit-for-purpose and effective interventions in this unique context. This study aims to adapt and apply the three-phase Optimising Health Literacy and Access (Ophelia) process in a state-wide prison context to generate codesigned improvements in information, resources and services for people in prison.
Methods and analysis
Health Literacy Questionnaire data from 471 people in prison will be analysed using descriptive and cluster analyses (Ophelia Phase 1). Clusters, with qualitative interview data, will then inform vignette development for use in ideas generation workshops and yarning circles with stakeholders to develop health literacy-informed interventions. Selection, prioritisation and testing of identified interventions will be undertaken (Phase 2), followed by implementation and evaluation (Phase 3). This project will advance intervention development in the prison context, enabling the voice of people in prison and service providers to be heard through codesign. The protocol will inform the development and implementation of interventions to systematically improve the delivery of information, services and resources for people in prison, which may be relevant to prison healthcare authorities globally.
Ethics and dissemination
Ethical approval to undertake Phase 1 of the Ophelia process has been granted from the following Human Research Ethics Committees: Swinburne University of Technology (Ref: 20236977–15461), Justice Health NSW (Ref: 2022/ETH01433), Aboriginal Health and Medical Research Council (Ref: 2007/22) and the Corrective Services Ethics Committee (Ref: D2022/1452326). Dissemination of the study findings will be the Justice Health NSW codesign process and ownership of the project through authentic engagement with people with lived experience and health and corrective staff. It will also be disseminated through publication in a PhD thesis, peer-reviewed research papers and conference presentations.
Keywords: Prisons, Health Literacy, Organisational development, Health Services, Health Equity, PUBLIC HEALTH
STRENGTHS AND LIMITATIONS OF THIS STUDY.
The Health Literacy in Prison Project will use the Optimising Health Literacy and Access (Ophelia) process, a well-documented and proven approach to equitable health services improvement.
The use of bottom-up and top-down stakeholder engagement processes will enhance the development of fit-for-purpose and effective health literacy-informed solutions in a context where people experience substantial vulnerabilities.
A strength of this study is the authentic codesign process that will engage people in prison, health and corrective staff in harnessing local wisdom to collaboratively develop actions and solutions to improve access to health information and services.
A weakness of this protocol is limited engagement with non-English speakers, those who may not access healthcare and those in rural or remote prisons, which may result in the needs assessment not fully capturing the experiences of all people in New South Wales prisons.
A potential limitation is the absence of people who feel unsafe in group settings or cannot provide informed consent to participate in ideas generation workshops and later study phases.
Background
Prisons are not conducive environments for health.1,3 Prisons are institutions of the criminal justice system designed to restrict an individual’s liberty for a period as determined by a judicial authority (ie, the courts).4 The role of these institutions is to protect society and rehabilitate an individual for their return to the community.5 6 Over the past 50 years, political agendas, such as the ‘war on drugs’7 and reforms such as mandatory sentence lengths, have put considerable strain on criminal justice systems globally.8 Additionally, safety and security take precedence in prisons, creating structural barriers to engaging with or providing healthcare services.9 10
People in prison
People in prison experience a wide range of vulnerabilities and poorer health outcomes compared with the general populations.11 12 Globally, it is estimated that 11 million people are incarcerated.13 At any given time, over 42 000 people are in Australian prisons.14 Among Australia’s seven states and territories, New South Wales (NSW) has the largest prison population of 12 917 people in prison as of June 2024,15 accounting for over one-quarter of the Australian prison population.15 16 Consistent with other countries with Indigenous populations, Australia and, more specifically, NSW have a 10-fold over-representation of Indigenous Australians in custody.15 17 Moreover, the prison population is mainly male,8 15 relatively young compared with the general population8 and over one-third are on remand (ie, people who are yet to be tried and/or sentenced, therefore, are not serving a custodial sentence).15
Compared with the general population, people in NSW prisons experience a disproportionate burden of communicable and non-communicable diseases.18 The burden of health conditions observed in the NSW prison system includes hepatitis B, C and HIV,1118,21 as well as drug and alcohol misuse,11 18 21 mental and other physical health conditions.11 18 19 21 22 The health disparities observed in the NSW prison population compared with the general population are like others globally.1221 23,25
The New South Wales prison system
There are 34 prisons across NSW, with three run by private operators.26 Corrective Services NSW (CSNSW) is the government authority that runs the 31 public prisons. CSNSW’s remit is to maintain order and security of these facilities. Alongside CSNSW, the Justice Health and Forensic Mental Health Network (Justice Health NSW) provides healthcare to people in prison. Justice Health NSW is a statutory health organisation established under the Health Services Act (NSW) 1997.27 Justice Health NSW provides healthcare to approximately 30 000 people annually.28 Services provided to people in prison include primary care, Aboriginal health, mental health, population health, oral health, women’s health and drug and alcohol programmes. However, access to these services has been observed to vary from site to site.29 For example, a small rural correctional centre typically does not have the same health service provision as a large metropolitan one. Moreover, primary and limited secondary healthcare services are provided akin to a community out-patients clinic, with people requiring acute care transferred to a community healthcare provider.10 In principle, healthcare services provided to people in prison are done so underpinned by a model of equivalence of care as stated in the United Nations Nelson Mandela Rules.30 Using a human rights-based perspective, where healthcare authorities should achieve equivalent health outcomes among people in prisons, not just the provision of equivalent care, when compared with the general population.31 A new and previously unexplored way of achieving equivalent health outcomes in the prison context is through the recently developed World Health Organization (WHO) health literacy development approach.32
Health literacy of those in prison
Health literacy is recognised as a multidimensional concept,33,35 a social determinant of health36 and a mechanism to improve healthcare systems and health outcomes of individuals and communities.34 Individual health literacy represents how people access, understand, appraise, remember and use health information and services to maintain and improve their health.34 In contrast, community health literacy extends the concept to include the people around an individual as well as the way organisations provide healthcare along with the influence of both cultural and contextual norms.32 34 Thus, health literacy is not just a personal characteristic; it is also a characteristic of interactions between an individual’s social and healthcare environment. In this milieu, a person’s lack of skills or confidence can be alleviated by the resources available within their immediate context and community.
Despite the well-documented health disparities between people in prison and general populations, the health literacy of people in prison has been rarely investigated. To the authors’ knowledge, only two studies have examined health literacy using a multidimensional measure.29 37 38 Both studies reported that people in prison had lower health literacy, with descriptions varying depending on the measurement tool used. In their 2021 study, Mehay et al38 explored the health literacy of a group of young males (n=104; age range 18–21 years) in a single English prison using a modified version of a European health literacy survey. They reported that the majority of participants had some health literacy limitations. However, as noted by the authors,38 these findings cannot be generalised due to the limitations associated with the study setting and the context-specific nature of health literacy.
The second study of 471 people, undertaken within Justice Health NSW, using the nine-dimension Health Literacy Questionnaire (HLQ), reported that this population had substantially lower scores than the general Australian population.29 37 Comparisons between subpopulations (eg, sex and legal status) exhibited different health literacy strengths and challenges,29 demonstrating that the prison population is not homogenous. These HLQ data are integral to the new WHO Health Literacy Development approach that embraces variance in subpopulations and builds interventions based on the observed strengths and challenges.32 34 Such an approach is timely, as recent literature has highlighted that health interventions in prison environments lack critical evidence to generate and sustain improved health outcomes for people in prison.39 Moreover, health interventions in prison usually address areas such as mental health,40 41 substance use42 43 and infectious disease,44,46 with a small number of studies conducted in Australia and none yet to consider health literacy.
A health literacy development approach: the Optimising Health Literacy and Access (Ophelia) process
According to the WHO, health literacy development refers to how the over-arching health system inclusive of ‘health workers, services, organisations and policy-makers (across government sectors and through cross-sectoral public policies) build the knowledge, confidence and comfort of individuals, families, groups and communities through enabling environments.’ (32, p. XIII). The Optimising Health Literacy and Access (Ophelia) process is a widely used health literacy development approach,47 48 which is systematic and grounded in the needs of the healthcare system end user.
Ophelia captures a population’s health literacy strengths and challenges by undertaking a needs assessment using the HLQ.49 The needs assessment explores how individuals’ access, understand and use health information and services available to them in a particular context. Equity is at the heart of the Ophelia process, enabling those with lived experience to specify and codesign needed and wanted solutions when accessing and using healthcare services. Further, the approach draws on intervention mapping, quality improvement collaboratives and realist synthesis to build and refine fit-for-purpose and effective interventions.47
The Ophelia process consists of three phases (figure 1), underpinned by eight guiding principles (table 1).47 48 Throughout each phase, close collaboration with stakeholders, including those with lived experience, frontline personnel and managers, is undertaken to guide the project and build organisational capacity.47 48
Figure 1. The three phases and eight steps of the Ophelia process. Source: Reproduced (with permission) from Osborne.67.
Table 1. The eight principles of the Ophelia (Optimising Health Literacy and Access) process.
| Principle | Description |
| 1. Focus on outcomes | Focus on improving health and well-being outcomes |
| 2. Driven by equity | Focus on increasing equity in health outcomes and access to services for people with varying health literacy needs |
| 3. Driven by local wisdom | Prioritise local wisdom, culture and systems |
| 4. Diagnosis of local needs | Respond to locally identified health literacy needs |
| 5. Codesign approach | Engage all relevant stakeholders in the codesign and implementation of actions |
| 6. Responsiveness | Respond to the varying and changing health literacy needs of individuals and communities |
| 7. Applied across systems | Focus on improvement at and across all levels of health systems |
| 8. Sustainable | Focus on achieving sustained improvements through changes to environments, practices, cultures and policies |
Source: Reproduced (with permission) from Osborne.67
The utility of the process has been recently demonstrated through a series of WHO National Health Literacy Demonstration Projects.32 It has been applied in a range of countries and settings to build effective interventions, such as in disease-specific groups,50 cancer screening,51 older people,52 community,53,55 hospitals56 57 and is the primary health literacy development method being applied in an EU4Health Joint Action on Heart Disease and Diabetes programme across 24 projects in 14 countries.58 Previous applications of the Ophelia process have led to the development and implementation of interventions across various settings.48 These have included increased engagement with breast screening51 and reduction in hospitalisation among older people with chronic obstructive pulmonary disease.59 However, it has yet to be applied in a prison context where people may experience diverse challenges and vulnerabilities.
Applying codesign methods in prisons
Central to the application of the Ophelia process is stakeholder engagement and codesign. Codesign is a form of participatory research engagement that sits on a spectrum from informing to empowering individuals and communities throughout a research project.60 For this protocol, we use codesign as a form of meaningful collaboration between stakeholders to solve an identified problem.61 The codesign process seeks to ensure end-user participation in designing a solution,62 with engagement ranging from relatively passive participation to highly active involvement.63
The prison context presents an array of structural (eg, institutional approvals, physical barriers and access) and ethical issues for careful consideration to ensure successful codesign is undertaken with people in prison.64 For example, in NSW, researchers must first receive ethical approval to engage people in prison in research activities,65 66 limiting their involvement in the conception phase of research. Further, when undertaking codesign activities in prisons, researchers must navigate complex informed consent processes, address power imbalances and build trust through culturally safe and respectful engagement.64 Despite these potential barriers to codesign in the prison context, the eight Ophelia process principles (table 1), combined with extensive stakeholder engagement and strong project governance, provide guidance to overcome and enable codesign activities within this challenging context.
Research aims
The Health Literacy in Prisons Project aims to apply a health literacy development approach (the Ophelia process) to the NSW prison system to codesign actions and solutions to improve health service quality and health outcomes for people in prison. This paper aims to detail Ophelia Phase 1 methods and provide an overview of the subsequent study phases in the NSW prison context.
Methods and analysis
Patient and public involvement
The involvement of people in prison (eg, patients) and members of the public in protocol development and ongoing project governance is integral to this study and follows the Ophelia principles of codesign and user engagement.47 48 67 The involvement of stakeholders is outlined below.
Protocol development
People in prison were not involved in the protocol development for Ophelia Phase 1. The current protocol was developed through consultations with representatives from key stakeholder organisations, including Aboriginal Community Controlled Health Organisations, Justice Health NSW and CSNSW personnel and health services decision-makers (eg, Executives). People in prison, Justice Health NSW and CSNSW personnel will be involved in generating ideas for interventions. People in prison, Justice Health NSW and CSNSW personnel, health services decision-makers and governance group members (described below) will be involved in selecting, developing and implementing interventions in Ophelia Phases 2 and 3.
Project governance
Given the ethical considerations (eg, access, payments, informed consent, recruitment and trust) and requirements (ie, community oversight of research involving Aboriginal people) associated with conducting research with people in prison,64 two project advisory groups have been established to provide ongoing governance:
Aboriginal Community Reference Group. This group of external independent community members with experience in representing their community will provide input into the proposed research, aims, purpose and recruitment. The group will provide feedback and guidance on study activities and research findings.
Health Literacy Project Advisory Group. This group was established to advise and assist the investigators in achieving the project aims. The group includes representatives from across both the health and corrective services structures of NSW prisons. They will provide strategic and operational advice to maximise the practical and policy impact, advise on the interpretation of research findings, contribute to prioritisation of identified solutions and contribute to the refinement and implementation of interventions informed by health literacy (ie, health literacy-informed interventions).
Both groups will play a pivotal role in assessing research findings for implementation and scalability due to their oversight and decision-making authority within the organisations and project team. By critically evaluating the research findings, these two groups will ensure that proposed actions and solutions (ie, interventions) align with strategic objectives and are feasible for implementation within the NSW prison context. Additionally, their involvement will facilitate the identification of potential barriers to methods and the development of strategies to address them, thereby enhancing the likelihood of successful adoption and dissemination of health literacy-informed interventions. Overall, their assessment helps to bridge the gap between research and practice, ensuring that evidence-informed solutions can be effectively implemented to maximise their impact. Moreover, the research team will partner with both governance groups to ensure the eight guiding principles of the Ophelia process (table 1) are applied throughout the project’s phases.
Study design
This is a mixed-methods action research study, with the outcomes of each phase informing the next.
Phase 1: identification of local strengths, challenges and issues
Phase 1 of the Ophelia process67 uses a mixed-methods sequential explanatory design. The first step is to set up a project team to define the scope and aim of the project. A health literacy needs assessment of intended beneficiaries (ie, people in prison) will be undertaken to obtain detailed information about their health literacy strengths and challenges using the HLQ.67 The HLQ is a 44-item questionnaire that assesses nine independent yet complementary scales (with four to six items per scale).49 The nine HLQ scales broadly cover concepts related to how people engage with and use health services and information and their social support (see table 2 and online supplemental file 1 for a description of each scale). A total score is not generated for the HLQ, with each scale score calculated by the sum of responses divided by the number of items in the scale and reported separately.
Table 2. Health Literacy Questionnaire scales49.
| Scales | Number of items |
| Scales 1–5 are rated on a 4-point agreement scale (1: strongly disagree to 4: strongly agree) | |
| 1. Feeling understood and supported by healthcare providers | 4 |
| 2. Having sufficient information to manage my health | 4 |
| 3. Actively managing my health | 5 |
| 4. Social support for health | 5 |
| 5. Appraisal of health information | 5 |
| Scales 6–9 are rated on a 5-point ease scale (1: cannot do or always difficult to 5: always easy) | |
| 6. Ability to actively engage with healthcare providers | 5 |
| 7. Navigating the healthcare system | 6 |
| 8. Ability to find good health information | 5 |
| 9. Understanding health information well enough to know what to do | 5 |
Ophelia Phase 1 for the current study will use existing HLQ and participant characteristic data (n=471) collected as part of the Justice Health NSW 2021 Health Literacy Study (described above), which has been reported elsewhere.29 37 The previously collected HLQ data68 will be analysed using cluster analysis. Cluster analysis, a multivariate technique, will be used to uncover health literacy profiles among groups of individuals with similar patterns of health literacy scores across the 9 HLQ scales.68 This method will provide a more nuanced understanding of the health literacy strengths and challenges experienced by people in prison and inform the development of vignettes (see below). Semi-structured interviews will be undertaken with people in prison to gain further insights into how people engage with health information and services. A series of vignettes, one per cluster, will then be generated from the cluster analysis and typically reveal patterns of health literacy strengths and challenges. The vignette development is also informed by the demographic profile of a cluster and from (deidentified) narratives from the semi-structured interviews.
Vignettes will be codesigned with each of the stakeholder groups. The vignettes are typically incrementally improved through rounds of review with stakeholders, including people in prison, corrective and health staff and members of the two governance groups. Once finalised, vignettes will be presented at a series of ideas generation workshops with 6 to 12 participants. In separate workshops, people in prison and personnel (health and corrections) will discuss several vignettes and suggest ideas and solutions to help the issues raised for the persona depicted in each vignette.
Primary data collection
Semi-structured interviews
To inform vignette development, semi-structured interviews will be conducted with people in prison to gather contextual data about their experiences of healthcare while in prison, such as privacy, demographic characteristics, and explore why they scored low or high on particular HLQ scales (online supplemental file 2). Using purposive recruitment,69 people in prison with varying health literacy scores will be invited to participate in the interviews. It is anticipated that up to 10 interviews will provide sufficient contextual data to support vignette development. Interviews will be conducted face-to-face and audio recorded with participants’ consent. The interviews are expected to take 30 min to complete. Semi-structured interview data will be transcribed. These data will then be analysed to extract valuable contextual insights to inform the development of the vignettes.
Ideas generation workshops and Yarning circles
Vignettes developed from the Phase 1 needs assessment and interviews will be presented to different stakeholder groups (ie, people in prison, Justice Health NSW and CSNSW personnel) in ideas generation workshops and yarning circles (ie, a conversational form of Aboriginal data collection where researchers listen ‘to participants’ stories about their lived experiences, feelings, thoughts and ideas on the research topic’70 (p38)) to generate health literacy-informed interventions to improve health service quality and health outcomes for people in prison.
Workshops and yarning circles will be about 1 hour to 2.5 hours, depending on the stakeholder group. Six to ten ideas generation workshops and yarning circles will be undertaken with participants across NSW prisons and Justice Health NSW sites, with between 6 and 12 participants per group. A group size of 6 to 12 participants has been chosen based on evidence to enhance participants’ comfort and active participation.71 Each group will contain participants from that stakeholder group. Depending on the stakeholder group, participants will be recruited via various direct and indirect approaches. For example, people in prison will be recruited by promoting the study via Inmate Development Committee meetings (ie, a prison community meeting), study posters and direct recruitment in the prisons. Justice Health NSW and CSNSW personnel will be recruited by sharing study information via email, intranet pages, internal communications and study posters in work locations. The goal is to recruit 30 people in prison, 30 Justice Health NSW and 20 CSNSW personnel to participate in ideas generation workshops and yarning circles. This goal has been set as it will provide a cross-sectional representation of the different stakeholder groups in NSW prisons. Ideas generation workshops and yarning circles will continue until data saturation. The stakeholder inclusion and exclusion criteria for ideas generation workshops and yarning circles are outlined in table 3.
Table 3. Stakeholder group inclusion and exclusion criteria for ideas generation workshops and yarning circles.
| Stakeholder group | Inclusion criteria | Exclusion criteria |
| Justice Health NSW personnel |
|
|
| CSNSW personnel |
|
|
| People in prison |
|
|
Following informed consent procedures, the facilitators will provide an overview of the project and the aims and process of the ideas generation workshop or yarning circle. A facilitator will then read a vignette to the group and start the discussion by asking the first guiding question. Four questions will guide the ideas generation workshops for Justice Health NSW and CSNSW personnel, while separate workshops and yarning circles, guided by a different set of four questions, will be conducted with people in prison (table 4). These questions have been designed to encourage participants to relate to the lived experience expressed in each vignette and emote genuine engagement.54 67 Throughout the ideas generation workshop or yarning circle, the facilitators will encourage participants to expand and build on the actions and solution ideas generated. Following the discussion of each vignette, facilitators will summarise the discussion with participants to confirm that the action and solution ideas are understood. This process will be repeated for subsequent vignettes. Three to five vignettes are expected to be discussed in each idea generation workshop or yarning circle.
Table 4. Stakeholder group question routes for ideas generation workshops and yarning circles.
| Stakeholder group | Question route |
| Justice Health NSW and CSNSW personnel |
|
| People in prison |
|
Data analysis
Cluster analysis
Descriptive analysis will be conducted on the 471 survey responses, including participant characteristics and HLQ scale scores using SPSS V. 29.0.72 To generate health literacy profiles, hierarchical cluster analysis following Ward’s method73 74 will be undertaken as recommended by the Ophelia Manual67 and previous Ophelia studies.50,5355 Currently, no consensus exists for an adequate sample size to undertake cluster analysis.75 However, based on previous Ophelia studies, Hawkins et al50 suggest that sample sizes over 100 can generate a robust cluster solution and provide rich information about potential subgroups in a population. Therefore, the 471 survey responses previously collected are assumed sufficient for this study.
A cluster solution of up to 20 clusters will be generated, and the patterns of health literacy profiles will be explored alongside the corresponding participant demographic characteristics. A separate cluster solution will be examined for individuals who identified as Aboriginal, Torres Strait Islander or both. The separate cluster solution for Aboriginal identity will be undertaken due to the over-representation of Aboriginal people in the prison system and in recognition of their cultural perspectives of health (eg, holistic view76) that may differ from that of the dominant Western health system in prisons. The cluster selection process will be undertaken by one researcher followed by discussions with the research team.
Ideas generation workshops and Yarning circles
Health literacy action and solution ideas identified through the workshops and yarning circles will undergo thematic analysis via an inductive theoretical approach as recommended in the Ophelia Manual.67 Actions identified to improve health literacy are expected to broadly fall within three contexts,47 that is, with individuals, health service providers and organisational and policy structures. The analysis will be undertaken by one researcher and reviewed by other research team members.
Following completion of the thematic analysis of the identified local health literacy actions and solutions, a prioritisation workshop will be held with key stakeholders including members of both project advisory groups, Justice Health NSW and CSNSW personnel and health decision-makers. The actions and solutions selected to be implemented and evaluated in Phase 3 will be determined by the outcome of Phase 2 activities.
Phase 2: select, plan and test health literacy actions
In Phase 2 of the Ophelia process,67 local stakeholders—including advisory groups, researchers and other relevant stakeholders—will review and become familiar with the ideas generated during Phase 1. This familiarisation will take place through workshops focused on discussing the depth and breadth of the ideas, as well as identifying patterns, linkages and synergies. Stakeholders will then evaluate these ideas based on local priorities and the project’s objectives. Additionally, a rapid literature review will be conducted to determine whether evidence exists to support the identified and prioritised actions.
A programme logic model (ie, a model outlining how a programme is intended to function by describing the causal links and mechanisms required to achieve the desired outcome77) is then developed to align interventions with project objectives and guide implementation. Once developed, intervention and evaluation planning will ensue. This will involve identifying the implementation team, defining roles and responsibilities and confirming timelines and budgets. The final step in Phase 2 will be to develop, test and refine the health literacy-informed interventions48 using plan-do-study-act cycles—structured, iterative testing of a potential intervention where each cycle incrementally improves the product.78
Phase 3: implement, evaluate and improve health literacy actions
The final phase, Phase 3 of the Ophelia process,67 is to implement and evaluate the selected health literacy interventions. This phase uses the finalised products derived from the preceding phases, that is, ready to be implemented interventions. Feedback will be collected from implementation sites through process and outcome evaluations. The project team will also develop an ongoing quality improvement strategy to ensure the sustained effectiveness of the interventions.
Discussion
The needs of people in prison have been widely detailed in literature over the past three decades; however, only recently have the health literacy strengths and challenges been investigated and described.29 37 To date, limited studies have systematically used health literacy to develop localised actions and solutions to reduce health disparities observed in prison populations.
Healthcare authorities and organisations providing care to people in prison need to explore new ways of working to reduce the health disparities observed in this population. There needs to be a shift from the principle of equivalence of care30 (ie, equality in care) to a principle of equivalent health outcomes (ie, equity in health)31 to help reduce these disparities. This protocol should generate local actions and solutions that the system end user (ie, people in prison) needs and wants while meeting environmental constraints.
The Ophelia process systematically generates such evidence with a focus on developing localised practice-based solutions. While the Ophelia process draws on insights from other intervention development approaches, including Intervention Mapping,79 Quality Improvement Collaboratives,80 81 realist synthesis,82 and the Medical Research Council (MRC) framework for developing and evaluating complex interventions,83,85 it seeks to ensure the inputs are based on deep understanding of individual health literacy needs in context (ie, through the HLQ). Ophelia also employs ideas generation workshops facilitated by empirically derived vignettes, including vignettes of people who may be experiencing substantial marginalisation and vulnerability, with the embedded health literacy challenges. The ideas generation workshops ensure both people in prison and professionals have equal voice on what solutions may improve health and service access in highly localised contexts. Consequently, the process focuses on both bottom-up and top-down codesign approaches, embedding the lived experience of people in prison and organisational personnel who hold solutions to provide care within a heavily scrutinised and rigid system. This protocol details an adaptation to the Ophelia process for the NSW prison context, which is highly relevant to other prison and healthcare authorities in Australia and globally looking to meet the needs of those in their care.
Potential implications relevant to other prison and healthcare authorities from the Health Literacy in Prisons Project are that stakeholders with lived experience, importantly, will have their voices heard and that this can influence policy and practice to improve how this voice of tough-to-reach individuals is included in service delivery and planning. This process will also inform how Justice Health NSW and CSNSW (and other Australian and international prison and healthcare authorities providing care to incarcerated populations) provide the types of services and information people in prison need and want to manage their health. Furthermore, the Ophelia process could be used by other services providing care to people in prison to understand the strengths and challenges of the people they care for. Understanding and improving the health literacy of people in prison has the potential to reduce observed health disparities and inequities in a population that experiences substantial marginalisation, moving prison healthcare authorities to aim for equivalent health outcomes, not just equivalence of care.
Potential limitations of this study
Potential limitations of the current protocol include those who did not speak English, did not access the health clinic or were in rural or remote prisons were excluded from the initial health literacy needs assessment.29 37 Therefore, the needs assessment may not fully represent the voice and lived experience of people in NSW prisons. The study will aim to mitigate this limitation by seeking advice from the two project advisory groups. Moreover, the voices of people with similar experiences may again be excluded in the ideas generation workshops. Where opportunities present to include this voice and in line with codesign principles, modifications will be made to ensure the lived experience of these groups is heard and included in data collection activities. The study setting poses several potential limitations, such as conducting codesign, engaging actively with stakeholders and developing feasible interventions within a restrictive environment. To address these challenges, a strong governance structure has been established to minimise impacts, mitigate perceived barriers and enhance engagement with study activities. This structure aims to foster local ownership and ensure that all stakeholder voices are heard and treated equally.
Ethics and dissemination
Ethical approval to undertake Phase 1 of the Ophelia process has been granted from the following Human Research Ethics Committees: Swinburne University of Technology (Ref: 20236977–15461), Justice Health NSW (Ref: 2022/ETH01433), Aboriginal Health and Medical Research Council (Ref: 2007/22) and the Corrective Services Ethics Committee (Ref: D2022/1452326). Dissemination of the study findings will be the Justice Health NSW codesign process and ownership of the project through authentic engagement with people with lived experience and health and corrective staff. It will also be disseminated through publication in a PhD thesis, peer-reviewed research papers and conference presentations. Written informed consent will be obtained from all participants. In accordance with Chapter 2.3 of the National Statement on Ethical Conduct in Human Research,65 a waiver of consent has been granted to access and undertake secondary analysis of the previously collected HLQ data.
supplementary material
Acknowledgements
The authors would like to acknowledge the Aboriginal Community Reference Group members Chad White, Debbie Lee, Kyle Burgess, Rebecca Shephard and Eli Toombs for their gracious time, guidance and support in the development of the proposed research. The authors would like to acknowledge the members of the Health Literacy Project Advisory Group for their ongoing strategic advice and guidance in the development and implementation of the proposed research.
Footnotes
Funding: This study has been in part funded by Justice Health NSW. Professor Richard Osborne is in part funded by a National Health and Medical Research Council Grant (GNT1155125) and Investigator Grant (2025522). Scott Gill is the recipient of an Australian Government Research Training Program Scholarship.
Prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-092128).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
References
- 1.De Viggiani N. Unhealthy prisons: exploring structural determinants of prison health. Sociol Health Illness. 2007;29:115–35. doi: 10.1111/j.1467-9566.2007.00474.x. [DOI] [PubMed] [Google Scholar]
- 2.Cloud DH, Garcia-Grossman IR, Armstrong A, et al. Public Health and Prisons: Priorities in the Age of Mass Incarceration. Annu Rev Public Health. 2023;44:407–28. doi: 10.1146/annurev-publhealth-071521-034016. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Massoglia M, Remster B. Linkages Between Incarceration and Health. Public Health Rep . 2019;134:8S–14S. doi: 10.1177/0033354919826563. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Lin B, Delahunty B, Clancey G. In: Australian politics and policy. Barry N, Fenna A, Ghazarian Z, et al., editors. Sydney, New South Wales: Sydney University Press; 2024. Law and order’ policy. [Google Scholar]
- 5.MacCormick A. The Prison’s Role in Crime Prevention. Journal of Criminal Law and Criminology (1931-1951) 1950;41:36. doi: 10.2307/1138385. [DOI] [Google Scholar]
- 6.Flynn N, Hurd D. Introduction to Prisons and Imprisonment. Winchester: Waterside Press; 2002. [Google Scholar]
- 7.Phelps MS. Rehabilitation in the Punitive Era: The Gap between Rhetoric and Reality in U.S. Prison Programs. Law Soc Rev . 2011;45:33–68. doi: 10.1111/j.1540-5893.2011.00427.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Productivity Commission . Productivity Commission, Canberra, Australia; 2021. [28-Nov-2023]. Australia’s prison dilemma, research paper.https://www.pc.gov.au/research/completed/prison-dilemma/prison-dilemma.pdf Available. Accessed. [Google Scholar]
- 9.Herbert K, Plugge E, Foster C, et al. Prevalence of risk factors for non-communicable diseases in prison populations worldwide: a systematic review. The Lancet. 2012;379:1975–82. doi: 10.1016/S0140-6736(12)60319-5. [DOI] [PubMed] [Google Scholar]
- 10.Inspector of Custodial Service Health services in NSW correctional facilities. Sydney, Australia. 2021. [8-Nov-2024]. https://inspectorcustodial.nsw.gov.au/content/dam/dcj/icsnsw/documents/inspection-reports/Health_Services_in_NSW_Correctional_Facilities.pdf Available. Accessed.
- 11.Australian Institute of Health and Welfare The health of people in Australia’s prisons 2022. Canberra, Australia. 2023. [28-Nov-2023]. https://www.aihw.gov.au/reports/prisoners/the-health-of-people-in-australias-prisons-2022 Available. Accessed.
- 12.Fazel S, Baillargeon J. The health of prisoners. The Lancet. 2011;377:956–65. doi: 10.1016/S0140-6736(10)61053-7. [DOI] [PubMed] [Google Scholar]
- 13.Fair H, Walmsley R. World prison population list 14th edition. United Kingdom: World Prison Brief, Institute for Crime & Justice Policy Research; 2024. [8-Nov-2024]. https://www.prisonstudies.org/sites/default/files/resources/downloads/world_prison_population_list_14th_edition.pdf Available. accessed. [Google Scholar]
- 14.Australian Bureau of Statistics . Canberra: Australian Bureau of Statistics; 2023. [27-Sep-2023]. Corrective services, Australia.https://www.abs.gov.au/statistics/people/crime-and-justice/corrective-services-australia/latest-release Available. Accessed. [Google Scholar]
- 15.NSW Bureau of Crime Statistics and Research New South Wales custody statistics. Sydney, New South Wales, Australia. 2024. [8-Nov-2024]. https://bocsar.nsw.gov.au/content/dam/dcj/bocsar/documents/publications/custody/2024_06_NSW_Custody_Statistics_Jun_2024.pdf Available. Accessed.
- 16.Australian Bureau of Statistics . Canberra: Australian Bureau of Statistics; 2024. [8-Nov-2024]. Prisoners in Australia, 2023.https://www.abs.gov.au/statistics/people/crime-and-justice/prisoners-australia/latest-release#cite-window1 Available. Accessed. [Google Scholar]
- 17.Australian Bureau of Statistics New South Wales: aboriginal and Torres Strait Islander population summary. 2022. [24-Jan-2023]. https://www.abs.gov.au/articles/new-south-wales-aboriginal-and-torres-strait-islander-population-summary Available. Accessed.
- 18.Justice Health and Forensic Mental Health Network . Sydney, Australia; 2022. [7-Feb-2023]. People in NSW public prisons: 2020 health status and service utilisation report.https://www.nsw.gov.au/sites/default/files/2023-06/people-in-nsw-public-prisons-2020-health-status-and-service-utilisation-report.pdf Available. accessed. [Google Scholar]
- 19.Justice Health and Forensic Mental Health Network 2015 network patient health survey report Sydney, New South Wales, Australia: Justice Health and Forensic Mental Health Network. 2017. [18-Mar-2022]. https://www.justicehealth.nsw.gov.au/publications/2015_NHPS_FINALREPORT.pdf Available. Accessed.
- 20.Butler T, Simpson M. Sydney, Australia: Kirby Institute; 2017. [7-Feb-2023]. National prison entrants’ blood-borne virus survey report 2004, 2007, 2010, 2013 and 2016.https://unsworks.unsw.edu.au/fapi/datastream/unsworks:47996/bin671f0aae-9c8f-4bea-a2d5-bcdd6f7c8ec5?view=true Available. accessed. [Google Scholar]
- 21.Kinner SA, Young JT. Understanding and Improving the Health of People Who Experience Incarceration: An Overview and Synthesis. Epidemiol Rev. 2018;40:4–11. doi: 10.1093/epirev/mxx018. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Australian Institute of Health and Welfare The health of Australia’s prisoners 2018. Canberra, Australia. 2019. [28-Nov-2023]. https://www.aihw.gov.au/getmedia/2e92f007-453d-48a1-9c6b-4c9531cf0371/aihw-phe-246.pdf.aspx?inline=true Available. Accessed.
- 23.Dumont DM, Brockmann B, Dickman S, et al. Public health and the epidemic of incarceration. Annu Rev Public Health. 2012;33:325–39. doi: 10.1146/annurev-publhealth-031811-124614. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Binswanger IA, Krueger PM, Steiner JF. Prevalence of chronic medical conditions among jail and prison inmates in the USA compared with the general population. J Epidemiol Community Health. 2009;63:912–9. doi: 10.1136/jech.2009.090662. [DOI] [PubMed] [Google Scholar]
- 25.Binswanger IA, Merrill JO, Krueger PM, et al. Gender differences in chronic medical, psychiatric, and substance-dependence disorders among jail inmates. Am J Public Health. 2010;100:476–82. doi: 10.2105/AJPH.2008.149591. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Corrective Services New South Wales Fact sheet 1. 2022. [12-Feb-2023]. https://correctiveservices.dcj.nsw.gov.au/content/dam/dcj/corrective-services-nsw/prisons-fact-sheet.pdf Available. Accessed.
- 27.Health Services Act (NSW) no 154, New South Wales, Australia legislation. 1997 https://legislation.nsw.gov.au/view/html/inforce/current/act-1997-154 Available.
- 28.Justice Health and Forensic Mental Health Network Justice health NSW year in review 2022. Sydney, Australia. 2022. [7-Feb-2023]. https://www.nsw.gov.au/sites/default/files/2023-08/justice-health-nsw-year-in-review-2022.pdf Available. Accessed.
- 29.Gill S, Zeki R, Kaye S, et al. Health literacy strengths and challenges of people in New South Wales prisons: a cross-sectional survey using the Health Literacy Questionnaire (HLQ) BMC Public Health. 2023;23:1520. doi: 10.1186/s12889-023-16464-3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.UN General Assembly United nations standard minimum rules for the treatment of prisoners (the Nelson Mandela rules): resolution / adopted by the general assembly. Report No: A/RES/70/175. 2016
- 31.Lines R. From equivalence of standards to equivalence of objectives: The entitlement of prisoners to health care standards higher than those outside prisons. Int J Prison Health. 2006;2:269–80. doi: 10.1080/17449200601069676. [DOI] [Google Scholar]
- 32.World Health Organization . Geneva, Switzerland: World Health Organization; 2022. Health literacy development for the prevention and control of noncommunicable diseases: volume 2. A globally relevant perspective. [Google Scholar]
- 33.Osborne RH, Cheng CC, Nolte S, et al. Health literacy measurement: embracing diversity in a strengths-based approach to promote health and equity, and avoid epistemic injustice. BMJ Glob Health. 2022;7:e009623. doi: 10.1136/bmjgh-2022-009623. [DOI] [Google Scholar]
- 34.Osborne RH, Elmer S, Hawkins M, et al. Health literacy development is central to the prevention and control of non-communicable diseases. BMJ Glob Health. 2022;7:e010362. doi: 10.1136/bmjgh-2022-010362. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 35.Sørensen K, Van den Broucke S, Fullam J, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12:80. doi: 10.1186/1471-2458-12-80. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 36.Nutbeam D, Lloyd JE. Understanding and Responding to Health Literacy as a Social Determinant of Health. Annu Rev Public Health. 2021;42:159–73. doi: 10.1146/annurev-publhealth-090419-102529. [DOI] [PubMed] [Google Scholar]
- 37.Justice Health and Forensic Mental Health Network 2021 health literacy study: people in NSW prisons and a high secure forensic mental health setting Sydney, Australia. 2022. [30-Jun-2022]. https://www.nsw.gov.au/sites/default/files/2023-06/2021-health-literacy-study-report.pdf Available. Accessed.
- 38.Mehay A, Meek R, Ogden J. Understanding and supporting the health literacy of young men in prison: a mixed-methods study. Health Educ. 2021;121:93–110. doi: 10.1108/HE-08-2020-0076. [DOI] [Google Scholar]
- 39.Blackaby J, Byrne J, Bellass S, et al. Interventions to improve the implementation of evidence-based healthcare in prisons: a scoping review. Health Justice. 2023;11:1. doi: 10.1186/s40352-022-00200-x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 40.Carter A, Butler A, Willoughby M, et al. Interventions to reduce suicidal thoughts and behaviours among people in contact with the criminal justice system: A global systematic review. EClinicalMedicine. 2022;44:101266. doi: 10.1016/j.eclinm.2021.101266. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 41.Perdacher E, Kavanagh D, Sheffield J. Well-being and mental health interventions for Indigenous people in prison: systematic review. BJPsych Open. 2019;5:e95. doi: 10.1192/bjo.2019.80. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 42.de Andrade D, Ritchie J, Rowlands M, et al. Substance Use and Recidivism Outcomes for Prison-Based Drug and Alcohol Interventions. Epidemiol Rev. 2018;40:121–33. doi: 10.1093/epirev/mxy004. [DOI] [PubMed] [Google Scholar]
- 43.Fuge TG, Tsourtos G, Miller ER. A systematic review and meta-analyses on initiation, adherence and outcomes of antiretroviral therapy in incarcerated people. PLoS One. 2020;15:e0233355. doi: 10.1371/journal.pone.0233355. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 44.Beaudry G, Zhong S, Whiting D, et al. Managing outbreaks of highly contagious diseases in prisons: a systematic review. BMJ Glob Health. 2020;5:e003201. doi: 10.1136/bmjgh-2020-003201. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 45.Rumble C, Pevalin DJ, O’Moore É. Routine testing for blood-borne viruses in prisons: a systematic review. Eur J Public Health. 2015;25:1078–88. doi: 10.1093/eurpub/ckv133. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 46.Tavoschi L, Vroling H, Madeddu G, et al. Active Case Finding for Communicable Diseases in Prison Settings: Increasing Testing Coverage and Uptake Among the Prison Population in the European Union/European Economic Area. Epidemiol Rev. 2018;40:105–20. doi: 10.1093/epirev/mxy001. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 47.Batterham RW, Buchbinder R, Beauchamp A, et al. The OPtimising HEalth LIterAcy (Ophelia) process: study protocol for using health literacy profiling and community engagement to create and implement health reform. BMC Public Health. 2014;14:694. doi: 10.1186/1471-2458-14-694. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 48.Beauchamp A, Batterham RW, Dodson S, et al. Systematic development and implementation of interventions to OPtimise Health Literacy and Access (Ophelia) BMC Public Health. 2017;17:230. doi: 10.1186/s12889-017-4147-5. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 49.Osborne RH, Batterham RW, Elsworth GR, et al. The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ) BMC Public Health. 2013;13:658. doi: 10.1186/1471-2458-13-658. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 50.Hawkins M, Massuger W, Cheng C, et al. Codesign and implementation of an equity-promoting national health literacy programme for people living with inflammatory bowel disease (IBD): a protocol for the application of the Optimising Health Literacy and Access (Ophelia) process. BMJ Open. 2021;11:e045059. doi: 10.1136/bmjopen-2020-045059. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 51.Beauchamp A, Mohebbi M, Cooper A, et al. The impact of translated reminder letters and phone calls on mammography screening booking rates: Two randomised controlled trials. PLoS One. 2020;15:e0226610. doi: 10.1371/journal.pone.0226610. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 52.Goeman D, Conway S, Norman R, et al. Optimising Health Literacy and Access of Service Provision to Community Dwelling Older People with Diabetes Receiving Home Nursing Support. J Diabetes Res. 2016;2016:2483263.:2483263. doi: 10.1155/2016/2483263. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 53.Anwar WA, Mostafa NS, Hakim SA, et al. Health literacy strengths and limitations among rural fishing communities in Egypt using the Health Literacy Questionnaire (HLQ) PLoS One. 2020;15:e0235550. doi: 10.1371/journal.pone.0235550. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 54.Jawahar Z, Elmer S, Hawkins M, et al. Application of the optimizing health literacy and access (Ophelia) process in partnership with a refugee community in Australia: Study protocol. Front Public Health. 2023;11:1112538. doi: 10.3389/fpubh.2023.1112538. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 55.Boateng MA, Agyei-Baffour E, Angel S, et al. Co-creation and prototyping of an intervention focusing on health literacy in management of malaria at community-level in Ghana. Res Involv Engagem . 2021;7:55. doi: 10.1186/s40900-021-00302-0. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 56.Jessup RL, Osborne RH, Buchbinder R, et al. Using co-design to develop interventions to address health literacy needs in a hospitalised population. BMC Health Serv Res. 2018;18:989. doi: 10.1186/s12913-018-3801-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 57.Aaby A, Simonsen CB, Ryom K, et al. Improving Organizational Health Literacy Responsiveness in Cardiac Rehabilitation Using a Co-Design Methodology: Results from The Heart Skills Study. Int J Environ Res Public Health. 2020;17:1015. doi: 10.3390/ijerph17031015. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 58.The European Commission New joint action to reduce the burden of cardiovascular disease and diabetes. [29-Nov-2023]. https://ec.europa.eu/newsroom/sante/items/809524/en Available. Accessed.
- 59.Borge CR, Larsen MH, Osborne RH, et al. Impacts of a health literacy-informed intervention in people with chronic obstructive pulmonary disease (COPD) on hospitalization, health literacy, self-management, quality of life, and health costs - A randomized controlled trial. Patient Educ Couns. 2024;123:108220. doi: 10.1016/j.pec.2024.108220. [DOI] [PubMed] [Google Scholar]
- 60.Vaughn LM, Jacquez F. Participatory Research Methods – Choice Points in the Research Process. J Particip Res Methods. 2020;1 doi: 10.35844/001c.13244. [DOI] [Google Scholar]
- 61.Vargas C, Whelan J, Brimblecombe J, et al. Co-creation, co-design, co-production for public health – a perspective on definition and distinctions. Public Health Res Pract . 2022;32 doi: 10.17061/phrp3222211. [DOI] [PubMed] [Google Scholar]
- 62.Sánchez de la Guía L, Puyuelo Cazorla M, de-Miguel-Molina B. Terms and meanings of “participation” in product design: From “user involvement” to “co-design”. Des J. 2017;20:S4539–51. doi: 10.1080/14606925.2017.1352951. [DOI] [Google Scholar]
- 63.Slattery P, Saeri AK, Bragge P. Research co-design in health: a rapid overview of reviews. Health Res Policy Syst. 2020;18:17. doi: 10.1186/s12961-020-0528-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 64.Roberts L, Indermaur D. The Ethics of Research with Prisoners. Curr Iss Crim Justic. 2008;19:309–26. doi: 10.1080/10345329.2008.12036436. [DOI] [Google Scholar]
- 65.National Health and Medical Research Council . Canberra: National Health and Medical Research Council, Australian Research Council and Universities Australia; 2024. National statement on ethical conduct in human research 2023. [Google Scholar]
- 66.Corrective Services New South Wales Corrective services ethics committee. 2023. [8-Nov-2024]. https://correctiveservices.dcj.nsw.gov.au/resources/research-and-reports/corrections-research-evaluation-and-statistics/corrective-services-ethics-committee.html Available. Accessed.
- 67.Osborne RH, Elmer S, Hawkins M, et al. The optimising health literacy and access (Ophelia) process to plan and implement national health literacy demonstration projects. Melbourne, Australia: Centre for Global Health and Equity, School of Health Sciences, Swinburne University of Technology; 2021. [Google Scholar]
- 68.Cheng C, Elmer S, Batterham R, et al. Measuring health literacy to inform actions to address health inequities: a cluster analysis approach based on the Australian national health literacy survey. J Public Health (Oxf) 2024;46:e663–74. doi: 10.1093/pubmed/fdae165. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 69.Palinkas LA, Horwitz SM, Green CA, et al. Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research. Adm Policy Ment Health . 2015;42:533–44. doi: 10.1007/s10488-013-0528-y. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 70.Bessarab D, Ng’andu B. Yarning About Yarning as a Legitimate Method in Indigenous Research. IJCIS . 2010;3:37–50. doi: 10.5204/ijcis.v3i1.57. [DOI] [Google Scholar]
- 71.Krueger R, Casey M. Focus groups: a practical guide for applied research. 5th. Sage publications; 2014. edn. [Google Scholar]
- 72.IBM Corp . IBM SPSS statistics for windows, version 29.0. Armonk, NY: IBM Corp; 2022. [Google Scholar]
- 73.Everitt BS, Landau S, Leese M, et al. Cluster analysis. United Kingdom: Wiley; 2011. Hierarchical clustering; pp. 71–110. [Google Scholar]
- 74.Hair JF, Black WC, Babin BJ, et al. Multivariate data analysis. 8th. Hampshire: Cengage Learning; 2019. edn. [Google Scholar]
- 75.Windgassen S, Moss-Morris R, Goldsmith K, et al. The importance of cluster analysis for enhancing clinical practice: an example from irritable bowel syndrome. J Ment Health . 2018;27:94–6. doi: 10.1080/09638237.2018.1437615. [DOI] [PubMed] [Google Scholar]
- 76.Gee G, Dudgeon P, Schultz C, et al. Working together: aboriginal and Torres Strait Islander mental health and wellbeing principles and practice. 2nd. Canberra: Australian Government Department of the Prime Minister and Cabinet; 2014. Aboriginal and Torres Strait Islander social and emotional wellbeing. edn. [Google Scholar]
- 77.Funnell SC, Rogers PJ. Purposeful program theory: effective use of theories of change and logic models. United States: John Wiley & Sons, Incorporated; 2011. [Google Scholar]
- 78.Knudsen SV, Laursen HVB, Johnsen SP, et al. Can quality improvement improve the quality of care? A systematic review of reported effects and methodological rigor in plan-do-study-act projects. BMC Health Serv Res. 2019;19:683. doi: 10.1186/s12913-019-4482-6. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 79.Bartholomew LK, Parcel GS, Kok G. Intervention Mapping: A Process for Developing Theory and Evidence-Based Health Education Programs. Health Educ Behav . 1998;25:545–63. doi: 10.1177/109019819802500502. [DOI] [PubMed] [Google Scholar]
- 80.Nadeem E, Olin SS, Hill LC, et al. Understanding the components of quality improvement collaboratives: a systematic literature review. Milbank Q. 2013;91:354–94. doi: 10.1111/milq.12016. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 81.Hulscher M, Schouten LMT, Grol R, et al. Determinants of success of quality improvement collaboratives: what does the literature show? BMJ Qual Saf . 2013;22:19–31. doi: 10.1136/bmjqs-2011-000651. [DOI] [PubMed] [Google Scholar]
- 82.Pawson R, Greenhalgh T, Harvey G, et al. Realist review - a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy . 2005;10:21–34. doi: 10.1258/1355819054308530. [DOI] [PubMed] [Google Scholar]
- 83.Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 84.Skivington K, Matthews L, Simpson SA, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061. doi: 10.1136/bmj.n2061. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 85.Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–6. doi: 10.1136/bmj.321.7262.694. [DOI] [PMC free article] [PubMed] [Google Scholar]

