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Randomized trials and similarly robust research methods generate evidence in carefully controlled settings, often with strict inclusion criteria. But patients in the ‘real world’ often have multiple comorbidities, and treatments are delivered within diverse environments. Trials are also difficult to fund, and rarely collect longitudinal data. Because of these, and other limitations, researchers are increasingly recognizing the inherent value of real world evidence (RWE). This is not only true for pharmaceutical products, and may have even more relevance in the evaluation of complex interventional procedures and non-medicines healthcare technologies. The Idea, Development, Exploration, Assessment, Learning (IDEAL) Framework guides the developmental ‘pipeline’ of surgical (and other) procedures, as well as medical device research (IDEAL-D). IDEAL informs the production of high-quality evidence of safety and effectiveness, but there is potential to further expand its applications.
Our aim is to investigate the feasibility of using of RWE alongside the IDEAL Framework in the assessment of procedures and devices. Methodological experts from the IDEAL Collaboration, HTA agencies and other healthcare research organisations are contributing their unique perspectives and experiences to explore these methods. As part of this work, Cedar Healthcare Technology Research Centre (Cedar) has attempted to retrospectively apply the IDEAL criteria to a series of RWE projects conducted on behalf of the National Institute for Health and Care Excellence (NICE) Interventional Procedures and Medical Technologies Evaluation Programmes.
Cedar's experience indicates that there may be options for using retrospective routinely-collected linked data and other existing sources to address some of the requirements of IDEAL. Likewise, the IDEAL Framework is expected to be a helpful reference when designing new databases and clinical registries for prospective collection of relevant and informative evidence. Examples from several projects will be shared at the Health Technology Assessment International (HTAi) conference.
Initial signs are that there are likely to be a number of ways in which IDEAL and RWE could complement one another.
Co-production relates to patients and health professionals working in equal partnership with shared decision-making. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are increasingly being used to involve patients and measure healthcare quality. We set out to develop a set of universal experience questions for use across Wales. These will be used in various settings, including the national electronic PROMs and PREMs platform, which is already collecting outcome data across Wales and has received over 7,000 responses to date.
Patient experience leads and clinical leads were invited to a workshop to discuss standardized PREMs collection in Wales, with all health boards and trusts represented. It was agreed that quantitative patient experience data collection, while limited, would be a pragmatic way to collect responses from a large cohort. It was agreed that a previously developed set of PREMs questions could be adapted for use in all healthcare settings. Patient focus groups reduced the number of questions to a shortlist of those considered most important by patients. Wording was improved and an additional question was added.
In partnership with stakeholders we developed and agreed on a set of universal PREMs questions. These have been added to the national electronic platform, with collection commencing imminently. This will allow patients accessing secondary care in Wales to provide PREMs and PROMs responses.
Development of a standardized set of PREMs has allowed us to initiate collection on a national basis. Addition of PREMs to the national electronic platform provides a unique means of collecting large volumes of data consistently, allowing us to benchmark across and within organizations. It will also allow experience teams to target improvement initiatives and identify good practice. Together with outcomes responses, the data will be used to measure experience of care in Wales.
Prudent health care aims to do the minimum needed to achieve the greatest patient benefit. This aim relies on the availability of evidence on the safety and efficacy of interventions to support decision making. The principles of prudent healthcare support co-production, whereby service users contribute to service provision. Collection of patient reported data is becoming more widespread, however use of this data to inform decision making is limited.
A national patient reported outcome measures (PROMs) program has been formed supported by the Welsh Government, Welsh Health Boards and the NHS Wales Informatics Service. An electronic platform has been developed to facilitate collection of PROMs and patient reported experience measures (PREMs) from patients treated in secondary care. We collected baseline PROMs where possible and invited patients to submit PROMs and PREMs post-treatment. Data collected included EuroQuol five dimensions questionnaire (EQ5D), co-morbidities, body mass index (BMI), smoking history and alcohol intake. Disease specific tools were used where available and responses linked to clinical data. Individual level data will be available during clinic consultations, and collated data analyzed on national and health board levels to assess clinical effectiveness. The platform is currently being piloted in several sites across Wales.
Initial baseline pilot data from hip replacement patients found that over 55 percent of responders were classed as overweight or obese, with over 80 percent carrying out less than the national guidelines for exercise.
The baseline scores for hip patients were; EQ-5D Index (Mean .29, median .29, range (-.59 -1)), EuroQol-visual analogue scales (EQ-VAS) (Mean 57.8, median 60, range (0:100)), and Oxford Hip Score (Mean 14.9, median 14, range (0:48)).
When compared to baseline scores collected by NHS England in 2015/16 (1), the average EQ5D Index and Oxford Hip Score collected in Wales was lower than that in England (p< .05).
The program will provide a large dataset from patients across all of Wales with data on numerous chronic and acute conditions. The data collected will facilitate service improvements and will inform decision making as part of the prudent healthcare agenda.
Generation of high-quality evidence on medical devices through clinical trials can be challenging. The United Kingdom's National Institute for Health and Care Excellence (NICE) has developed a research commissioning framework for producing clinical evidence where gaps in the literature prevent definitive recommendations in their medical technology guidance and diagnostics guidance. The research commissioning framework involves NICE's external assessment centers collaborating with clinical researchers to secure funding and to design, conduct, and publish a study to address research recommendations within 3 years of guidance publications. We aimed to describe the early results of the framework.
Publically available information and results from an informal survey of NICE's external assessment centers were reviewed.
As of December 2016, NICE has published a total of thirty medical technology guidance topics and twenty-four diagnostics guidance topics, five and twenty of which have research recommendations, respectively. A total of fourteen research commissioning framework-facilitated projects have been initiated. Two research projects have successfully secured external funding for a clinical trial: (i) non-contact low frequency ultrasound therapy for wound healing; and (ii) Parafricta bootees for pressure ulcer prevention. Further projects have produced published outputs without external funding. Four projects have been completed and undergone guidance review; one guidance topic was withdrawn and three have been transferred to the “static list”. Early experiences of NICE's research commissioning framework suggest that securing financial support from manufacturers or funding bodies for interventional clinical trials to answer single technology research questions within a short time frame is challenging but possible. The value of early feasibility studies to assess the likelihood of obtaining funding and of addressing NICE's research recommendations was recognised.
NICE can facilitate independent research through its research commissioning framework initiative. Securing funding has proved challenging but recent successes have shown that approach is possible. Outputs which fill the evidence gap to an extent where a definitive guidance update is possible have been rare.
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