Overview

Patients’ views are essential to achieving high-quality care. Their perspective complements that of clinicians, providing unique insights into perceptions of their health status (symptoms, functional status) and health-related quality of life (HRQL). It is therefore important to find ways of involving patients to report on their own health outcomes.

PROMs, which measure a patient’s health status (symptoms, function, HRQL), are gathered through short, self-completed questionnaires. PROMs may be collected before and after a procedure or at regular intervals for those with long-term conditions. This information gives an indication of the outcomes or quality of care delivered to patients.

We have been at the forefront of PROMs research for over 25 years. Our work has been instrumental in the implementation of policies which allow patients to report on their own health outcomes. We have also made major contributions to developing and psychometrically testing PROMs for a wide range of conditions and interventions.

History of PROMs research

Work on PROMs at the School started in the 1980s with studies of prostate surgery in men and hysterectomy in women. In the 1990s, experts from medicine, sociology, psychology, epidemiology and statistics developed and tested new PROMs using rigorous qualitative and quantitative methods. PROMs were developed for stress incontinence, menorrhagia, plastic surgery, multiple sclerosis, day surgery, and coronary revascularisation.

This work was complemented by studies covering a range of methodological aspects on the routine use of PROMs in health care, including the influence of patients’ preoperative health, their expectations of outcomes, the impact of non-recruitment and non-response, and comparisons of patients’ and clinicians’ views of outcomes.

Psychometric expertise

The school has been contributing work in psychometric methods for over 30 years and has become one of the best known UK groups able to undertake robust psychometric evaluation and development.  Our early work was based in Classical Test Theory but has now broadened to include modern psychometric methods based on Rasch Measurement Theory.

We have used these methods to develop and evaluate questionnaire based measurement instruments across a wide range of clinical areas (including stroke, visual impairment, intensive care, dementia, heavy menstrual bleeding, diabetic neuropathy, childhood disability, carer well-being, diabetic neuropathy, and unplanned pregnancy, prostate cancer).

We host the “Outcomes Group” – a UK wide methodological forum which meets three times a year to share, discuss and debate issues arising in health related measurement.

PROMs in elective surgery

In 2005, a systematic review of ways to assess outcomes following hip and knee replacement, varicose vein surgery, hernia repair and cataract surgery was conducted. Pre and post-operative questionnaires for the four procedures were identified, and the feasibility of their routine use in the NHS tested. The findings highlighted that it was possible to recruit patients, follow them up and make risk-adjusted comparisons of providers, all at reasonable cost.

‘A major development in the history of surgery’

These findings were reported to the Department of Health in England in 2007 which announced that PROMs would be mandatory for all NHS patients undergoing groin hernia operations, hip replacements, knee replacements and varicose vein operations from April 2009. This continues and since 2011, these PROMs have been included in the NHS Outcomes Framework.

More than half a million patients participated in the programme in its first three years, representing 70% of eligible patients. Since April 2010, the outcomes for every hospital in the NHS in England have been published online.

In 2011 Professor Sir Bruce Keogh, Medical Director of the NHS, told the Financial Times newspaper that the advent of PROMs ‘would shift the focus among doctors [away] from technocratic results, where an operation was deemed a success regardless of whether the patient remained in pain.’ In 2012, Professor Sir Norman Williams, then president of the Royal College of Surgeons, described PROMs as a ‘major development in the history of surgery’.

From 2010 to 2015 we have studied many methodological aspects of using PROMs to compare providers, including:

• The relationship with patients’ views of the humanity (experience) of their care
• Impact of differences in surgery rates between districts
• Impact of different ways of defining outlier providers, equity of use and of outcome
• Impact of variations in outcomes of individual surgeons.

PROMs in dementia

Since 2013, we have been working on a programme of research to measure the health-related quality of life of people with dementia and their lay carers. Building on pioneering work a decade earlier that developed PROMs both for completion by people with dementia (DEMQOL) and by their lay care-givers (DEMQOL-Proxy), we have transformed those instruments using modern psychometric methods so that proxies’ views can reliably provide an indication of patients’ views. This means, that for the first time, the health-related quality of people with severe dementia (who cannot self-report) can be estimated from the reports of their lay care-givers.

These new PROMs have been used to assess the impact of memory clinics and have shown the improvements in quality of life that result. This has shown that these services can be cost-effective (ie meet the NICE criterion of £30 000 per QALY) if services are organised and delivered in the right way.

PROMs in emergency admissions to hospital

The inevitable lack of any knowledge of a person’s health status before an emergency admission to hospital has prevented the meaningful use of PROMs in assessing the quality of the care they receive. We have shown that the use of PROMs based on patients’ recall of their pre-admission health in elective surgery can provide a valid and reliable estimation of the benefits of the intervention. Assuming the same would be true for unexpected emergency admissions for a medical condition (heart attack) and for a surgical condition (emergency laparotomy for gastro-intestinal conditions), we have demonstrated that it is feasible to ask patients to recall their state of health up to four weeks before their admission.

We now want to institute a large national programme involving up to 30 hospitals carrying out emergency laparotomy in collaboration with the National Emergency Laparotomy Audit.

Role and impact of PROMs

While there is widespread support for the introduction of PROMs as a means of supporting more patient-centred health care, there has been little attention aid to how the use of PROMs might bring about improvements. Many PROMs have been adopted without any explicit consideration of the theory and mechanisms by which either the clinical management of individual patients or the quality of services might be expected to improve.

We have been involved with colleagues at the Universities of Leeds and Oxford to carry out a realist review. This has successfully identified the three theories that underlie people’s expectations as to why PROMs will be beneficial and the nine mechanisms that people believe will result in improvements. The review considered the use of PROMs at both the level of individual patients and collectively for providers of services. It revealed the lack of empirical evidence to back up most of the widely held beliefs about the benefits. It demonstrated the need for much more research on the impact of PROMs so those of us who are enthusiastic supporters can justify the policy and persuade others.

Influence of comorbidity on outcomes of hip and knee replacement

We have used PROMs to look at the influence of comorbidities on outcomes. Secondary conditions (comorbidity) often delay access to elective joint replacement. In a study of patients who had undergone a hip or knee replacement we found that most patients with comorbidities reported similar levels of benefit from joint replacement as patients without comorbidities. We also demonstrated that while comorbidities increase the risks of the surgery, this effect is so small that for most patients with comorbidities hip and knee replacement is a very effective and safe procedure.

PROMs in prostate cancer

We are conducting studies examining how patients’ reports of their health-related quality of life differ between different treatments for prostate cancer and between different providers. A key barrier for this research is that although established disease-specific PROMs for patients with prostate cancer claim to measure health-related quality of life they are restricted to adverse effects on urinary, sexual and bowel function. Accepting this limitation, we have used PROMs collected 18 months after patients were newly diagnosed with prostate cancer to assess the adverse effects of different surgical approaches and radiotherapy regimens.