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Evaluation of the PATH-SAFE programme

Evaluation of the PATH-SAFE programme - Evaluation framework

This chapter sets out the framework through which the evaluation of PATH-SAFE will be operationalised.

Diweddarwyd ddiwethaf: 19 July 2024
Gweld yr holl ddiweddariadau
Diweddarwyd ddiwethaf: 19 July 2024
Gweld yr holl ddiweddariadau

The chapter comprises two distinct but interrelated frameworks: a process evaluation framework and an outcome evaluation framework. Presented in tabular form, each framework outlines evaluation questions (EQs), looking to assess progress made towards the PATH-SAFE ToC components. For each EQ, the frameworks contain indicators and proposed data sources that will be used to collect evidence to enable us to answer the EQ. Alongside process and outcome evaluation frameworks, the chapter also provides further detail on the data collection methods and analytical approaches that will be used for each type of evaluation. Impact feasibility is not included in this chapter as Section 3.3 describes the approach that will be undertaken to conduct the feasibility assessment. We have not ascribed indicators and data sources for the ToC impacts at this point as a result. 

4.1.    Process evaluation framework 

As highlighted in Chapter 3, the process evaluation will seek to understand the extent to which PATH-SAFE’s programme governance and resourcing has been fit for purpose and assess the mechanisms of actions across the four WSs. This assessment will be done through the lens of the principles of relevance and coherence based on the OECD criteria. Table 1 below sets out the process evaluation framework. Each WS’s activities (A) and outputs (O) are assigned key EQs which will be assessed through the relevant indicators and data sources listed. The last column lists the methodology that will be undertaken for answering each EQ.  Sections 4.1.1 and 4.1.2 describe in more detail the data collection tools and analytical approaches that will be used to undertake the process evaluation. 

Table 1. Process evaluation framework

WS Category  ToC Key evaluation questions Indicators  Data sources Methods
Programme-level Programme-level Programme-level

How appropriately resourced has PATH-SAFE been throughout the stages of inception, design and implementation?

How effective and appropriate is the governance in place to support delivery of PATH-SAFE

Feedback from inter/cross-govt stakeholders on strength of relationships established and any perceptions of barriers  

Interviews with FSA PATH-SAFE programme team and governance documentation

Interviews with relevant PATH-SAFE partners and FSA PATH-SAFE programme team

Interviews with inter/cross-govt PATH-SAFE stakeholders/partners

 

Interviews and documentary review
Programme-level Programme-level Programme-level How is cross-government interaction being enabled/conducted?

Number and nature of opportunities and communication platforms set up to facilitate cross-govt interaction

Feedback from inter/cross-govt stakeholders on strength of relationships established and any perceptions of barriers  

Interviews with relevant PATH-SAFE partners and FSA PATH-SAFE programme team

Interviews with inter/cross-govt PATH-SAFE stakeholders/partners

Interviews

Programme-level Programme-level Programme-level How is PATH-SAFE linked to existing/developing surveillance programmes?   Level of alignment and linkages between PATH-SAFE and other relevant surveillance programmes mapped and outlined using conceptualisation documents Management information (project business case and bids and approval outputs); interviews with FSA programme management team; desk research on key surveillance mechanisms across Europe and US (for example, GenomeTrackr) and devolved nations Interviews, documentary review and desk research
WS1  Activity and Outputs 

A: Establish a curated and national FBP (and their AMR) genomic data platform with Salmonella as exemplar pathogen

O: Functional and scalable data platform that houses sequences and facilitates analysis of exemplar pathogens (for example, Salmonella and their AMR genes

 O: Data platform is interoperable and can interact with other systems like Enterobase and provide an interrogatable user interface

To what extent have relevant end users been engaged and how have their needs been incorporated into the design of the database?

How has data interconnectivity and interoperability been considered in designing the platform? 

Breadth of end users engaged 

Satisfaction of end users

Types of databases and datasets consulted for interoperability (for example, NCBI, Enterobase, etc.)

Interoperability assessments undertaken and recommendations

Data access and sharing arrangements in place

Interviews with intended end users and delivery partners; review of updates/notes from delivery board meetings, discovery project outputs and end user reports

Interviews with intended end users

Review of highlight reports and DAG and SAG reports

Interviews with delivery partners

Interviews with delivery partners and FSA management, review of DES/highlight/DAG/SAG reports

Interviews and documentary review

Interviews

Documentary review

Interviews

Interviews and documentary review

WS2 and WS1b Activity and Output

A: Pilot new FBP and AMR surveillance approaches based on regular, multi-location sampling in a range of settings, combined with novel technologies (for example, WGS)

O: AMR and FBP and AMR curated sample data captured from multiple sources, and tested using novel analysis techniques                

O: Evidence on the utility and suitability of the piloted FBP and AMR surveillance and modelling approaches

What existing and novel analysis technologies are being utilised?

What is the extent of data collection and curation?

How (if at all) are new capabilities being generated to improve surveillance

How is data being accessed/ shared across relevant stakeholders and departments?

Number and type of analysis technologies being utilised; assessment of existing capability utilisation

Number of samples taken; number of sampling sites accessed; number of genome sequences generated

Consolidation of sampling and data curation outputs; number of new tools and models developed; 

Data access and sharing arrangements in place

Interviews with sponsors and delivery partners; review of highlight/activity reports

Delivery partners reports/Delivery board updates

Interview with sponsors and delivery partners; review of highlight and activity reports

Interviews with delivery partners and FSA management; review of highlight/DAG/SAG reports

Interviews and documentary review

Documentary review

Interview and documentary review

Interviews and documentary review

WS3 Activity and Output

A: Map and test new and repurposed technologies for rapid onsite FBP testing in collaboration with end users                  

O: TRL assessment of rapid onsite FBP testing tools with end users    

O: Evidence on utilising COVID-19 testing technology (LAMP) for FBP detection in wastewater

To what extent is the TRL assessment approach valuable for identification of relevant technology?

To what extent has the work divulged utility of LAMP as a feasible method?
How is LAMP assessment feeding into TRL mechanisms for FBP diagnostics?

Type of technologies being assessed; review of process of assessment; end users views on TRL assessments and other outputs being fit for purpose

Assessment of utilisation of WS3b outputs into 3a 

Interviews with delivery partners and end users; review of activity reports and TRL assessment outputs

Interview with delivery partners; review of activity reports and TRL assessment outputs

Interviews and documentary review

Interviews and documentary review

WS4 Activity and Output

A: Develop a pilot AMR surveillance system based on mechanisms of AMR spread in the environment

O: AMR surveillance framework and suite of diagnostics enabling monitoring of AMR across the environment within a catchment area

What is being learnt and incorporated from existing AMR surveillance systems and tools?

How is connectivity between the WS4 AMR environment platform and WS1a being considered?

How is evidence being aggregated across the multiple departments involved in WS4 delivery

Breadth of mapping and engagement with existing AMR surveillance systems and tools

Engagement between WS4 and WS1a; understanding of interoperability between platforms

Assessment of WS4 delivery partner engagement mechanisms and frequency

Interviews with delivery partners and review of activity reports

Interviews with delivery partners; review of shared terms/project outputs/highlight reports

Review of WS4 governance and reporting mechanisms

Interviews and documentary review

Interviews and documentary review

Documentary review

4.1.1.    Process evaluation data collection methods

As shown in Table 1, the process evaluation will rely on three main methods of data collection: document review, desk research, and key informant interviews. These data collection methods are described in more detail below.  

Document review

We will conduct a review of PATH-SAFE management information such as business case bids, initial design documentation, and governance and monitoring requirements/criteria to further develop our understanding of PATH-SAFE programme processes. Documents to be reviewed will also include programme WS specific documentation such as WS project briefs (noting any changes in scope and delivery), latest highlight reports, and latest documentation for a given month/quarter from the Data Advisory Group (DAG), Shared Outcomes Fund, Scientific Advisory Group (SAG) and the Strategic Board. We will also review WS activity/technical reports where appropriate and available. This will be undertaken at both the interim process evaluation and the final process evaluation stages to assess the extent to which the intended outputs have been delivered. 

Desk research

We will review the AMR national action plan and the NBN documents to assess alignment with PATH-SAFE in more detail as helpful context of the process evaluation. We will also undertake a high-level grey literature search to map out key pathogen surveillance initiatives across Europe and the devolved nations in the UK to create a robust assessment of surveillance mechanisms and infrastructure already in place in the agriculture/environment sectors. 

Key informant interviews

Alongside document review, data on how the programme has been received by key delivery partners, government stakeholders and any other end users, as well as experience of engagement and incorporation of views into WSs, will be collected primarily through key informant interviews. To inform the process evaluation at the interim stage, we will conduct interviews with: 

  • Up to four central operational staff at FSA 
  • Up to 10 delivery partners including academics across WSs 1-4
  • Up to 15 end users/key government stakeholders across DEFRA, UKHSA, FSS, EA, DHSC and Public Health Wales and NI, etc.

To inform the final process evaluation (and the outcome evaluation) we will conduct interviews with:

  • Up to three central operational staff at FSA
  • Up to six delivery partners across WSs 1-4
  • Up to 10 key government stakeholders/end users

Interviewees will be selected based on the PATH-SAFE stakeholder database, using a purposive sampling approach to ensure representation across WSs, government departments and types of end users. This will be done in consultation with the PATH-SAFE central team at FSA. Interview topic guides and analysis coding will be guided by the evaluation questions as specified in Table 1. We will also complement interviews through engagement with PATH-SAFE central and delivery teams at bi-weekly meetings and attendance at monthly Delivery Board meetings. 

4.1.2.    Process evaluation analysis

Data collected through the methods above will be brought together and triangulated against our process evaluation framework to create an understanding of how processes supported and/or created barriers in delivery of PATH-SAFE. In addition, to create an exemplified picture of effectiveness of PATH-SAFE processes, we propose to develop two case studies based on existing data collection methods highlighted with a potential for deeper dives into the proposed topics via interviews and documentary reviews. 

Case studies

Case studies will be selected purposively and will be used to tease out instances in which processes have worked exceptionally well, or to highlight examples where things haven’t gone as expected, highlighting opportunities for improvement. This will be determined through consultation with the programme team and considering the data emerging during the interim process evaluation. We propose to develop two process case studies. 

Given the central importance of cross-government engagement, we suggest focusing one case study on exemplifying good practice of an instance where cross-government collaboration has worked particularly well (this could be at central programme or at WS level). The case study will not only centre on what worked well but also look to identify enabling factors and levers for change that could be applied across the rest of the programme. 

We propose to focus the second case study on data sharing enablement, given its importance across multiple WSs and the programme as a whole. We will again look to exemplify good practice of where data sharing has been enabled or an agreement put in place and go further to identify what catalysed the process and what barriers remain to be addressed. 

4.2.    Outcome evaluation framework

As described in Chapter 3 Evaluation approach, the outcome evaluation will provide an assessment of the extent to which the outcomes outlined in the ToC have been realised. This will be a theory-led approach and will utilise CA to validate central claims made about the programme’s success, utilising the evidence collected against key outcomes and the key EQs (see section 3.4.1 and 4.2.2 for more info). Within the outcome evaluation framework, most outcomes listed are broadly mapped to the key WSs that are likely to contribute towards them, but some are at a programme-level, to which all WSs are anticipated to contribute. All outcomes have been assigned key EQs which will be assessed through the relevant indicators and data sources listed. The last column lists the methodology that will be undertaken for answering each EQ. Section 4.2 describes in more detail the data collection tools and analytical approaches that will be used to undertake the outcome evaluation.
 
Table 2. Outcome evaluation framework

Workstream Category TOC Key evaluation question (s) Indicator Data source Method
WS1 Outcomes Key stakeholders can more easily share and access data across organisations for rapid identification and tracking of foodborne pathogens and AMR, bringing together multiple data sources  Has data access, sharing, and use for FBP and AMR been enabled and improved across government departments?      
WS1 Outcomes Predictive assessment of risk and threat is enabled when assessing a new isolate through access to a comparative repository of pathogen sequences and metadata To what extent has the platform supported use of relevant metadata and historic isolates for comparative assessments and risk profiles of FBP?      
WS2 and 4 Outcomes

Improved understanding of source attribution and infection threat of FBP and AMR through various environments and international entry points.

Additional knowledge of how to expand existing surveillance mechanisms to support a robust national surveillance infrastructure and improved monitoring

Informed consideration, based on evidence surfaced, on how proactive, rapid and efficient management can be used to reduce the risk of FBP and AMR introduction into the wider environment and food systems.

How has the collective source detection efforts and use of novel technology translated to (if at all) improved surveillance of FBP and AMR?

To what extent have the pilot efforts been able to exemplify practice and enhance national surveillance capability?

What kind of strategies and operations have been enhanced, enabled and influenced (if at all) through the surveillance activities?

Speed of FBP/AMR detection in number of days looking at end to end process

Comprehensiveness of coverage for example, density of testing, number of sampling sites covered, and sequences curated and comparative strain assessment

Feedback from end users and relevant PATH-SAFE partners/govt stakeholders on improvements made in surveillance

Feedback from end users and relevant PATH-SAFE partners on national surveillance capability improvements

Types of strategies and operations that have been enabled; other national strategies and action plans enhanced or influenced (for example, NBN, AMR NAP, etc.); knowledge generated

Review of project activity reports/highlight reports

Review of project activity reports/highlight reports

Workshop with PATH-SAFE delivery partners and key government stakeholders 

Workshop with relevant PATH-SAFE stakeholders (include representatives of UK and devolved governments and their agencies (for example, FSA, DEFRA, Welsh Government), health agencies and health boards (for example,  Public Health Wales, UKHSA)

Review of final reports, board reports, publications/grey lit citations; and interviews with FSA programme management

Documentary review

Documentary review

Workshop

Workshop

Interviews and documentary review

WS3 Outcomes Guide the use of novel and existing/repurposed rapid onsite FBP testing technology with improved knowledge of where further development is needed Have the tools identified been useful for end users? Can they be utilised?
To what extent have gaps been identified to further development of onsite rapid FBP detection?
Types (and number) of technologies and tools identified; feedback from end users on relevance and utility; evidence of gaps identified to proceed further on tech development Review of project activity reports/highlight reports; end user interviews Interviews and documentary review
Programme Level Outcomes

Key stakeholders and decision makers are brought together to engage with evidence and take forward policy recommendations.

Contributing to the ‘One Health’ ambitions of reducing threats to public health and the ecosystem.

How has PATH-SAFE (if at all) enabled a community of practice and decision makers to come together to inform and act on surveillance of FBPs and AMR?

How and to what extent has PATH-SAFE evidence (if at all) contributed to national policies and frameworks for improved public health

Feedback from end users and policymakers on awareness of and engagement with PATH-SAFE 

Knowledge generated (publications/grey lit citations);

Feedback from end users and policymakers on use of PATH-SAFE evidence into policy and strategies for public health, agriculture and environment interventions 

Workshop with relevant PATH-SAFE stakeholders (including representatives of UK and devolved governments and their agencies (for example, FSA, DEFRA, Welsh Government), health agencies and health boards (for example,  Public Health Wales, UKHSA)

Desk research and use of bibliographic databases

Interviews with key government decision makers

Workshop

Desk research

Interviews

4.2.1.    Outcome evaluation data collection methods

As indicated in Table 2, the outcome evaluation will draw on a wide range of sources underpinned by four main methodologies: documentary review, desk research, key informant interviews, and a workshop.  

Documentary review

Analysis of key activity reports and papers from meetings of the SAG, DAG, shared outcomes fund, and the strategic board will be analysed to assess the extent to which outcomes have been realised. More focus will be placed on direct WS reports to provide a sense of progress towards intended outcomes at the WS level.

Desk research

Desk research will be conducted on Google Scholar to assess grey literature outputs that can be attributed to PATH-SAFE. We will do this for the first 100 hits through a targeted search. In addition, an assessment of publications of academic papers, strategy and policy documents will be conducted through a search on bibliographic data platforms to assess what publications PATH-SAFE has enabled, if any, which will provide an understanding of PATH-SAFE knowledge generation and wider influence. 

Key informant interviews

To further strengthen our understanding of the extent and mechanism of outcome realisation, we will conduct key informant interviews. Please note that these will be the same set of interviews that are proposed for the final process evaluation stage to reduce burden on interview respondents. We foresee speaking to the same set of stakeholders and given the parallel timelines of the final process and the outcome evaluation, these set of interviews will look to assess both process and outcome EQs. As mentioned in section 4.1.1, we will conduct the following interviews for the final process and outcome evaluations:

  • Up to three central operational staff at FSA
  • Up to six delivery partners across WSs 1-4
  • Up to 10 key government stakeholders/end users

As with the process evaluation interviews, topic guides will be developed based on the key EQs in Table 1 and Table 2, and all interviews will follow a semi-structured format. 

Workshop

Assessment of step changes or any improvements made on high level outcomes of ‘improvements in surveillance capabilities and mechanisms’ and ‘awareness and engagement across government departments and key decision/policy makers’ will be more appropriately gleaned through a large workshop/group exercise (with up to 15 participants) undertaken with the relevant stakeholders. The central programme team will be key in determining the most appropriate mix of stakeholders to engage in this exercise.  

4.2.2.    Outcome evaluation analysis

The evidence from the methodologies outlined above will be triangulated to develop a holistic understanding of the difference PATH-SAFE has made. This will be crucially underpinned by undertaking a contribution analysis exercise (detailed below) and development of two case studies exemplifying a select component of a given outcome. 

Case studies

Case studies will be selected purposively and will be used to tease out instances where tangible examples of progress can be seen towards outcome realisation and/or to highlight examples where things haven’t gone as expected, or where outcomes have been significantly delayed, highlighting key barriers. This will be determined through consultation with FSA and considering the data emerging during the early phase of the outcome evaluation. We propose to develop two outcome case studies. 
We propose to focus one case study on showcasing an example (if available) of PATH-SAFE influencing a nationally linked operation/strategy (for example, the NBN), and focus on the enablers of influence and the nature of the influence to understand its importance. We propose to focus the second case study on an example of a novel tool or framework for testing/surveillance that has been developed and assess its value to improvement of surveillance. 

Contribution analysis

As mentioned before, CA is a method for assessing causal claims that provides a framework for capturing progress towards aims through testing working hypotheses and establishing a case to explain the contribution made by PATH-SAFE and its projects over alternative hypotheses. The six steps involved in CA are as follows:

  1. Set out the cause-effect issue to be addressed.
  2. Develop the postulated ToC and risks to it, including other influencing factors.
  3. Gather the existing evidence on the ToC.
  4. Assemble and assess the contribution claim, and challenges to it. 
  5. Gather new evidence from the implementation of the intervention.
  6. Revise and strengthen the contribution story. 

At this stage of the evaluation, Steps 1, 2 and 3 have been completed. Based on our understanding of what PATH-SAFE is aiming to achieve and the ToC underpinning the evaluation, we propose three main contribution claims for the programme as an output of Step 4. These are hypotheses that are central to the programme and can be interpreted as high-level and holistic outcomes of the programme. 

  • The processes established in PATH-SAFE programme lead to cross-government collaboration on FBP and AMR surveillance because of increased transparency and engagement across departments through the work on interrelated WSs.
  • The development of the data platform in PATH-SAFE leads to easier data sharing across government departments because of data sharing agreements put in place and extent of user engagement carried out.
  • The collective outputs of the WSs in PATH-SAFE leads to establishment of a nationally connected and improved FBP and AMR surveillance approach because of multilocation sampling, novel testing tools and an interconnected data platform.

We plan to utilise the process and outcome evaluation evidence holistically (i.e., evidence from interviews, workshops and case studies) to address Step 4 in assessing the body of evidence to validate the contribution claim. We will then create an overarching narrative (i.e., the contribution story) relative to the strength of the evidence that makes a qualitative judgement on whether the contribution claims stand or whether an alternative hypothesis exists for what caused the change to occur. The alternative hypothesis in particular will be tested through interviews and a workshop, and will be derived from the external initiatives listed in Section 2.2.2. The contribution story will identify any gaps in the evidence or weak links, where we will look to alternative sources of data and revise the contribution narrative accordingly. The contribution narrative will ultimately rest on the collective evidence surfaced through the process and outcome evaluations.