Health Outcome

Outcomes research evaluates the effect of health care interventions on patient-related, clinical, humanistic and economic outcomes. Outcomes research focuses on end-results, such as the ability to function, health-related quality of life and survival, rather than surrogate endpoints. This research supports informed decision-making by providing evidence about benefits, risks, and results of treatments.

The Utility of High-Tech Drug Analysis to the Decision Maker

Collaborators: National Centre for Pharmacoeconomics, Materials and Surface Science Institute (MSSI), University of Limerick, National Cancer Registry of Ireland, Royal College of Surgeons Ireland

Status: Ongoing

Summary:

Awarding Body: Health Research Board – Applied Partnership Award 2016

Award Value: €239,998

Principle Investigator: Cathal Walsh, Materials and Surface Science Institute (MSSI), University of Limerick

Co-Applicants: Cara Usher (NCPE), National Centre for Pharmacoeconomics, Michael Barry, National Centre for Pharmacoeconomics, Laura McCullagh, Trinity College Dublin, Kathleen Bennett, Royal College of Surgeons Ireland, Kerri Clough-Gorr, National Cancer Registry of Ireland.

The Health Act 2013 requires reimbursement decisions to be made about new drugs by the health payer, and revised every 3 to 5 years. At present these decisions are based on estimates of market share projections and on (often limited) clinical trial data. A large number of cancer drugs, and treatments for rare diseases are funded through the High-Tech Drug scheme (which has increased in spend from €52 million in 2000 to €500 million in 2014.) Post reimbursement, the usage of drugs is tracked by the High-Tech prescription database. Outcome data for patients has been linked with this database and thus provides observational real-world evidence on the effectiveness of the interventions.

This research, in consultation with stakeholders and patient groups will:

Develop an approach to the synthesis of the evidence contained in the existing large databases together with randomized controlled trial data.
Inform the pharmacoeconomic evaluation process within the NCPE in terms of appropriate comparators, likely budget impact and real-world compared to clinical trial effectiveness for a given class of drugs.
Facilitate the re-evaluation of drugs in the High-Tech scheme.

This research brings together statistical and data analytical expertise in order to better inform the choices the Irish state makes in treating its population. The proposal will further develop statistical methodology to allow us to combine data from observational cohorts with randomized controlled trial evidence which will better estimate the efficacy of interventions.

GP practice-based Pharmacist Medicines Optimisation Programme

Collaborators: National Centre for Pharmacoeconomics, HRB Centre for Primary Care Research and Department of General Practice, RCSI

Status: Ongoing

Summary: Awarding Body: Health Research Board – Research Collaborative for Quality and Patient Safety (RCQPS) Award 2016

Principle Investigator: Susan Smith, HRB Centre for Primary Care Research and Department of General Practice, RCSI

Co-Applicants: Michael Barry, NCPE, Tom Fahey, Department of General Practice, RCSI

Laura McCullagh, Trinity College Dublin, Barbara Clyne, Department of General Practice, RCSI, Emma Wallace, HRB Centre for Primary Care Research, RCSI

Cardwell K, Clyne B, Moriarty F, Wallace E, Fahey T, Boland F, McCullagh L, Clarke S, Finnigan K, Daly M, Barry M,  Smith SM (on behalf of the General Practice Pharmacist (GPP) Study Group). Supporting prescribing in Irish primary care: protocol for a non-randomised pilot study of a general practice pharmacist (GPP) intervention to optimise prescribing in primary care. <em>Pilot and Feasibility Studies https://doi.org/10.1186/s40814-018-0311-7 https://doi.org/10.1186/s40814-018-0311-7

Quality of life in non-melanoma skin cancer

Collaborators: Dr Rupert Barry, Department of Dermatology, St James Hospital Dublin, National Centre for Pharmacoeconomics

Status: Ongoing

Summary: Over 6,300 cases of non-melanoma skin cancer (NMSC) are diagnosed in Ireland annually. Almost all of these are either basal cell carcinomas (BCC) accounting for 68%, or squamous cell carcinoma (SCC) (30%). There has been a significant increase in the incidence of NMSC in Ireland; rates in 2011 are between 33% and 39% higher than in 2002. Research published by the National Cancer Registry of Ireland (NCRI) has examined the correlation between incidence rates, the deprivation index and urban or rural area of residence, and has shown that there are statistically significant higher rates of incidence of NMSC in the most affluent areas.

The impact of NMSC on quality of life (QOL) may arise from the tumour itself or treatment associated with the tumour, or through symptoms, cosmetic burden, functional limitations and fear and anxiety regarding appearance or disease spread. Research has shown that a significant proportion of patients with NMSC will have unmet social care needs and experience heightened distress levels. A number of condition specific measures have been created and validated in NMSC populations to measure patient quality of life with the condition.

This study aims to derive a mapping algorithm from the condition specific non-preference based QoL instruments the Skin Cancer Index and Skindex-16, to EQ-5D, a generic preference based instrument. This mapping algorithm will allow the substantial body of quality of life data published in the literature to be utilised in a cost-effectiveness analysis comparing Mohs microscopy to alternative interventions. This study will evaluate QOL in an Irish patient cohort with NMSC, and examine if there is a correlation between socio-demographics, deprivation status and QOL.

Relating Health-related Quality of Life to Disability Progression in Multiple Sclerosis

Collaborators: National Centre for Pharmacoeconomics, St. Vincent’s University Hospital Department of Neurology, Trinity College Dublin Department of Statistics.

Status: Complete

Summary: Multiple sclerosis (MS) is a chronic debilitating disease associated with significant economic and health-related quality of life (HRQoL) burden. From the health policy perspective, HRQoL is widely used to inform resource allo¬cation decision-making through the application of the Quality Adjusted Life Year (QALY). In order to inform resource allocation decision-making through the applica¬tion of the QALY, clinical outcomes must be related to HRQoL. The relationship between the Expanded Disability Status Scale (EDSS) and HRQoL, as a reflection of patients’ overall well-being, is therefore of significant importance. The objective of this study was to explore the relationship between the MS patients’ EDSS score and HRQoL utility, using the 5-level EQ-5D assessment instrument (EQ-5D-5L)

Publications:

Relating Health-related Quality of Life to Disability Progression in Multiple Sclerosis using the Five-level EQ-5D. Fogarty E, Walsh C, Adams R, McGuigan C, Barry M, Tubridy N. Multiple Sclerosis 2013;19(9):1190-1196

The Health Related Quality of Life of Patients with Ischaemic Cardiovascular Disease – Mapping from TILDA to the EQ5D

Collaborators: National Centre for Pharmacoeconomics, TILDA – The Irish Longitudinal Study on Aging Trinity College Dublin

Status: Ongoing

Summary: The Irish Longitudinal Study on Aging is (TILDA) is a nationally representative longitudinal study which collects information from over 8,000 participants aged 50 and over in Ireland. The depth and breadth of data collected is substantial with information collected on participant’s health, economic and social circumstances every two years. The EQ5D is a preference based health related quality of life (HRQoL) outcome measure commonly used in the economic evaluation of health care interventions. While the EQ5D was not administered in TILDA, detailed data was collected on the 5 domains that comprise the EQ5D: Mobility, Self-Care, Pain/Discomfort, Anxiety/Depression and Usual Activities. The aim of this study is to measure the health related quality of life of patients with ischaemic cardiovascular disease and to map this information to data collected by TILDA in cardiovascular patients. This will allow further research to harness the longitudinal power of TILDA to examine how HRQoL changes over time after an ischemic event and the relationship between HRQoL and the wealth of other data collected in TILDA. This study also acts as a pilot study for the generation of a mapping algorithm in a sample representative of the total population covered by TILDA or other survey designs.