Commentary
DOI: 10.1111/1471-0528.12901 www.bjog.org
Developing core patient-reported outcomes in maternity: PRO-Maternity A Mahmud,a,b E Morris,c S Johnson,d KM Ismaila,b a
Centre for Women’s & Children Health and the School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK b Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham, UK c Department of Obstetrics & Gynaecology, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK d RCOG Quality and Knowledge Directorate, Royal College of Obstetricians and Gynaecologists, London, UK Correspondence: Prof KM Ismail, Professor of Obstetrics and Gynaecology, Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham B15 2TG, UK. Email [email protected] Accepted 16 April 2014.
Please cite this paper as: Mahmud A, Morris E, Johnson S, Ismail KM. Developing core patient-reported outcomes in maternity: PRO-Maternity. BJOG 2014; 121 (Suppl. 4): 15–19.
Introduction If quality is to be at the heart of everything we do, it is important to be able to measure the clinical effectiveness of our healthcare interventions and their impact on patients from their own perspective. The latter can be measured through patient-reported outcome (PRO) measures.1 Undoubtedly, patients who regularly access and use healthcare services are uniquely placed to judge the quality and effectiveness of the health care they receive. In England, the use of PRO measures to assess healthcare effectiveness has been recommended in several National Health Service (NHS) reports.1,2 More recently, the Francis Report stressed the lack of patient and public involvement in health care and highlighted the need to increase this to ensure that the service provided is compassionate and patient-centric.3 Patient-reported outcome measures provide a means of gauging patients’ views on their health and assessing the impact that treatments or interventions have on their clinical condition, wellbeing and quality of life. It is important to differentiate PRO measures from Patient-Reported Experience Measures (PREMs). PREMs are assessments of the patients’ satisfaction with the care they received. Although both are measures based on the patient’s perspective, PREMs are measures of ‘healthcare processes’ while PRO measures are measures of ‘clinical-care effectiveness’. Several procedure-related measures are regularly collected as part of healthcare service delivery; however, these outcomes do not take into account the views of most patients whose healthcare experiences do not end up in a specific
ª 2014 Royal College of Obstetricians and Gynaecologists
procedure or, indeed, patients who suffer a poor outcome. Moreover, current measures of patient-reported satisfaction, used as surrogate measures for quality, sometimes lack validity, detail and specificity. When PRO measures were introduced in the NHS in 2009; the main goal was to provide measures that could be used not only to assess a patient’s perspective of treatment but also, to use this information to direct funding and management of healthcare services.1 The Department of Health introduced the PRO measures programme in a limited number of surgical procedures initially. However, the use of PRO measures is currently being explored in a range of chronic health conditions including mental health, cancer, asthma, chronic obstructive pulmonary disease, diabetes and stroke. PRO measures are currently not in use within maternity or neonatal health services. The evidence collected from this work will impact on the future use of PRO measures across other specialties.4 PRO measures are an important quality improvement measure and form an essential component in domain four of the NHS Outcome Framework—patient experience.5
Types of PRO measures An ideal PRO measure should have validity, reliability and be able to measure change over time. At present, PRO measures are being collected before and after treatment, which is in line with these principles.6 The majority of PRO measure tools that are currently in use are derived from already existing patient reported instruments and questionnaires that have undergone a varied process of
15
Mahmud et al.
validation, modification and testing before their implementation. Two different types of PRO measures have been described.
Generic PRO measures Generic PRO measures; such as the EQ-5D (EuroQOL) and SF-36 (Short Form 36 Health Survey) measure the effect of health status in relation to an individual’s ability to function and enjoy life as a healthy individual. The principles behind generic PRO measure questionnaires are similar but differ in certain aspects because they vary in the type of health domains being gauged. For example, sexual health is an important domain in gynaecology, whereas mobility and usual activity are domains more relevant to orthopaedics. Therefore, the use of the same set of PRO measures across all specialties is not advisable. This is why specialty-specific and condition-specific PRO measures are needed. This is particularly the case for maternity care where pregnancy is not a disease but a normal physiological state that can have different outcomes.
Condition-specific or disease-specific PRO measures Condition-specific PRO measures assess the impact of a condition or intervention on a specific aspect of health that is linked to the natural history of the disease or its treatment. A few examples of currently used questionnaires are shown in Table 1. Generic and condition-specific PRO measures can be used collectively or individually to evaluate healthcare services and interventions. Some PRO measures are designed to measure both generic and condition-specific aspects. As an example, patients undergoing continence surgery com-
plete an electronic personal assessment questionnaire (ePAQ) before and, usually, 6 months after treatment. The ePAQ has been primarily designed as a clinical tool to help assessment of pelvic floor problems. This in turn shortens the gap in communication between patients and clinicians. As a validated and reliable tool its origins lie in instruments designed for use as PRO measures. As such it contains a mixture of both generic quality of life and pelvic floor dysfunction-specific measures. Another example of a PRO measure is the modified and validated version of the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL) developed by the Royal College of Obstetricians and Gynaecologists for use in heavy menstrual bleeding as part of benign gynaecology. This PRO measure has produced good evidence when used in women with fibroids.6
Developing PRO measures: benefits and limitations The processes involved in developing PRO measures can be summarised in four steps, as shown in Figure 1.4 These processes are refined and strengthened by the incorporation of feedback at each step, making the outcome of the process more reliable and relevant. It is known that well-developed PRO measures have the ability to capture a patient’s assessment of their own health both at a certain point in time or at different times during the course of treatment.7 The information generated can be used in various ways. Patient-reported outcome measures can be used as assessors of clinical quality for treatment providers (clinicians)
IdenƟficaƟon or generaƟon of a PRO measures instrument Table 1. Examples of PRO measures used in National Health Service (England) Generic PRO measures
Hip surgery Knee surgery Varicose vein surgery
EQ-5D EQ-5D EQ-5D
Hernia repair Tension-free vaginal tape (TVT)* Heavy menstrual bleeding in women with fibroids
SF-36 and EQ-5D ePAQ (generic and condition specific) EQ-5D and SF-36
*TVT for genuine stress incontinence.
16
Condition-specific PRO measures
PiloƟng process: evaluaƟon and review of potenƟal PRO measures tools
Oxford hip score Oxford knee score Aberdeen varicose vein questionnaire No condition-specific
ImplementaƟon of PRO measures: data collecƟon and processing
UFS-QOL
EvaluaƟon of impact on healthcare services and stakeholders
Feedback to refine
Surgical procedure/ condition
Figure 1. Processes involved in developing patient-reported outcome measures.
ª 2014 Royal College of Obstetricians and Gynaecologists
Developing core patient-reported outcomes in maternity
and as a performance tool for managers and commissioners. Moreover, use of PRO measures should provide room to research what works best in health care and to reduce health inequalities by promoting good-quality patient-centred care. Certain PRO measures also have a role in economic evaluations such as estimation of quality-adjusted life-years (QALYs). Patient-centred care is an essential, but poorly integrated, concept as shown by the recent Francis report and the Everyone Counts proposal by NHS England.8 Following the Francis Report, National Voices stressed the importance of the availability of public information on the experience and outcomes of care from the point of view of the patient and the need for PRO measures to be rolled out more widely and reported at the individual clinical team level.9 Indeed, a move to measures that are not only reported on but also defined by patients, ensuring that outcomes really matter to patients, is needed. This would promote patient and public involvement, individualised patient care plans, healthy competition and better performance of service providers; all aimed at improving patient outcome. Therefore, the relevance of PRO measures is underpinned by the methodology used in their development to ensure that they are truly patient centred. Although there are several advantages to using PRO measures, there is much to be considered before PRO measures can be used effectively. Measuring the wrong PRO measures or focusing on smaller groups, ethnic barriers or financial limitations can all lead to inadequate output or data that may be faulty. Therefore, to ascertain that correct PRO measures are used requires a combination of literature review, in-depth patient interviews and statistical thematic analysis of qualitative data. It is also equally important that the selected PRO measures provides evidence of reliability, precision, validity and responsiveness. Limitations related to what PRO measures can measure and what they cannot measure must also be considered. Patient acceptability, simplicity of questionnaires and response rates are other factors that can impact on data generated from PRO measures.10,11
Women-centred PRO measures in maternity The NHS spent £2.6 billion on maternity care in 2012/13 and more than 700 000 women use different aspects of the maternity services in the UK per annum, yet there are no routine PRO measures in place to assess the actual impact of the health care being delivered to women using these services.12 Guidance for PRO measure-based assessment in maternity care does not exist. More recently, a systematic review of Health Related Quality Of Life measures
ª 2014 Royal College of Obstetricians and Gynaecologists
(HR-QOL) in pregnancy and postpartum care highlighted the lack of PRO instruments in maternity; especially the lack of patient-generated PRO instruments.13 Ensuring the delivery of a high-quality service is an important determinant of unit performance and the level of the Clinical Negligence Scheme for Trusts (CNST) contribution. Collecting and monitoring outcomes that are relevant to users is an important measure and driver for quality. It is important to recognise that CNST standards are changing and this approach may certainly be very different in the future. However, PRO measures could become an important tool to assist trusts with the new NHS Litigation Authority approach to ‘learning from claims’ and Care Quality Commission assessments. Care Quality Commission Maternity Surveys have shown that benchmarking services against each other is a driver for improvement. Maternity PRO measures would add another dimension to benchmarking services by acting as an adjunct; one that is derived entirely from the woman’s perspective. This will help to identify variations in practice and outliers in the system. This would allow health services to be restructured and potentially avoid hefty medico-legal claims. The outlier issue here is key, particularly if maternity PRO measures are used to interlink unit performance with the Royal College of Obstetricians and Gynaecologists clinical indicators project.14 Patient-reported outcome measures in maternity should provide a quality assessment tool that can link women’s health status to outcomes. They can be used to devise a plan of care that matches the woman’s personalised health needs and can then track the impact of such a care plan on her outcomes. This will allow funds and services to be tailored according to user needs and act as a reliable tool to inform healthcare commissioners. Interventions or treatments that do not improve health can then be identified and either modified or eliminated to increase the efficiency of health service delivery. Hence, PRO measures have the potential to act as a driver to improve both the quality and cost-effectiveness of maternity services. Indeed, the rising costs of service delivery, growing number of births and patients’ expectations of quality of care mean that PRO measures have a significant role in determining policy and allocation of healthcare resources.9 Currently, there is an international move towards developing sets of core clinical outcomes (Core Outcomes in Women’s Health [CROWN] initiative) that will be used as condition-specific minimal data sets to be reported in research studies.15 This notion will ensure that relevant outcomes are reported and hence reduce heterogeneity between studies if data are to be further analysed. However, these core clinical outcomes could be complemented by the parallel development of core patient-centred PRO measures.
17
Mahmud et al.
Once refined, a logical extension of the development of maternity PRO measures would be the production of parent-reported neonatal outcomes. When developed, these would overlap between the postnatal and early neonatal periods, and would allow detailed analysis of the complex interface between midwifery, obstetrics and paediatric care. Strong patient-centric healthcare leadership and delivery cannot occur without accurate, useful and relevant information. Maternity PRO measures have an essential role in providing such data, especially as they contribute to the culture of openness. Above all, this will generate new insights into women’s perspectives of healthcare delivery, allowing changes in attitude, practice and organisational services. On a much larger scale this will shift the pendulum of service delivery in favour of society and individuals while ensuring the most effective use of NHS resources.
Global perspective on PRO measures Patient-reported outcome measures have been developed, used and implemented across the globe in various developed countries, including the Netherlands, England and the USA. Currently the trends in PRO measure reporting and application are changing to accommodate an international audience. Certainly, the CROWN initiative (in collaboration with Core Outcome Measures in Effectiveness Trials [COMET] initiative) and the US National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) initiative are moving towards development and standardisation of PRO measures across studies and settings.15,16 This application of PRO measures will help to provide a framework for standardised reporting of outcomes in clinical trials and studies, at both national and international levels. There are several potential challenges in development and application of PRO measures globally. Although countries with well-developed healthcare systems may quickly find the transition, application and benefits useful, some low-income countries may struggle to adopt PRO measures. The potential barriers would be variations in healthcare delivery systems, cultural diversity and literacy rates. Furthermore, costs associated with translation, collection and measurement of PRO measures alongside the need for training in PRO measure analysis and assessment are all factors that should be taken into account. Hence, these challenges could greatly influence global acceptability and application of PRO measures across all specialties including maternity care.16 We propose that these challenges may not apply when using PRO measures ‘selectively’ for reporting outcomes in clinical trials or studies. A robust and validated PRO
18
measure questionnaire could be translated and used to report clinical trials and studies without being influenced by barriers relevant to local healthcare systems. Indeed, these limitations may reduce with ongoing work in PRO measure development and application.
Summary Women-centred maternity PRO measures can generate outcome measures that will allow benchmarking of service delivery using meaningful outcomes that will drive service improvement to ensure commitment to a culture of openness, patient satisfaction, patient safety and the delivery of clinically effective care. Moreover, they can generate new insights into women’s perspectives of healthcare delivery, allowing changes in attitude, practice and organisational services. Once developed, the adoption of PRO measures within units is likely to come at additional cost. However, the expected benefits in improved woman and family satisfaction, reduced legal claims and the presence of an early indicator of compromised quality of care will have the potential to save a significant amount of money for individual units and the wider health economy.
Acknowledgements The authors would like to acknowledge the support of PRO-Maternity team members from Royal College of Obstetricians and Gynaecologists, NHS England, Birth Trauma Association, National Childbirth Trust, Royal College of Nursing and Royal College of Midwives.
Disclosure of interests AM, EM, SJ and KI are collaborators together with a wider team involved in developing patient-centred PRO measures for maternity.
Contribution to authorship The idea of developing women-centred PRO measures in maternity was conceived by KI. The first draft of the manuscript was prepared by AM. SJ, EM and KI have provided additional literature resources and actively contributed to the final version of the manuscript.
Details of ethics approval Not applicable.
Funding AM is funded by a Birmingham Women’s NHS Foundation Trust R&D Springboard fellowship and in addition holds a Wellbeing of Women Scholarship—‘An Entry Level Scholarship awarded to mark the birth of HRH Prince George of Cambridge’. &
ª 2014 Royal College of Obstetricians and Gynaecologists
Developing core patient-reported outcomes in maternity
References 1 Darzi A. High Quality Care for All: NHS Next Stage Review Final Report. London, Department of Health, 2008. [www.gov.uk/ government/uploads/system/uploads/attachment_data/file/228836/74 32.pdf]. Accessed 7 March 2014. 2 Smith S, Cano S, Lamping D, Staniszewska S, Browne J, Lewsey J, et al. Patient-Reported Outcome Measures (PROMs) for Routine use in Treatment Centres: Recommendations Based on A Review of the Scientific Evidence. London, Health Services Research Unit, London School of Hygiene and Tropical Medicine, 2005. [www.lshtm.ac.uk/ php/hsrp/research/promsnickblack2005.pdf]. Accessed 8 March 2014. 3 Department of Health. Independent inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2005–March 2009. Chaired by Robert Francis. HC 375-1. Stationery Office, 2010. [www.midstaffspublicinquiry.com/report]. Accessed 8 March 2014. 4 Devlin N, Appleby J. Getting the Most out of PROMs. Putting Health Outcomes at the Heart of NHS Decision-Making. London, The King’s Fund, 2010. [http://www.kingsfund.org.uk/publications/getting-mostout-proms]. Accessed 8 March 2014. 5 Department of Health, London. 2012. The NHS outcomes framework 2013/14. [www.gov.uk/government/uploads/system/uplo ads/attachment_data/file/213055/121109-NHS-Outcomes-Framework2013-14.pdf]. Accessed 10 March 2012. 6 Royal College of Obstetricians and Gynaecologists, London; April 2012. Patient-reported outcome measures in gynaecology: scientific impact paper 31. [www.rcog.org.uk/womens-health/clinical-guid ance/patient-reported-outcome-measures-gynaecology-sac-opinionpaper-31]. Accessed 11 March 2014. 7 Patrick D, Burke L, Powers J, Scott J, Rock E, Dawisha S, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. [Internet]. Value Health. 2007;S125–37. [www.ncbi.nlm.nih.gov/pubmed/17995471]. Accessed 8 March 2014.
ª 2014 Royal College of Obstetricians and Gynaecologists
8 National Health Service Commissioning Board. Everyone counts: planning for patients 2013/14. [www.england.nhs.uk/everyone counts/]. Accessed 2 February 2014. 9 After Francis: doing justice—a national voices paper on ensuring safe and high quality patient care—March 2013. [www.national voices.org.uk/publications]. Accessed 10 February 2014. 10 Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010;340:c186. 11 Patient reported outcome measures (PROMs) in clinical trials and health care—an introduction. Keith Meadows Director DHP Research & Consultancy 2010. [http://thepatientoutcomesblog.com/category/ patient-reported-outcomes-2/]. Accessed 2 February 2014. 12 Department of Health, London. National audit office-maternity services in England. 2013. [www.nao.org.uk/wp-content/uploads/ 2013/11/10259-001-Maternity-Services-Book-1.pdf]. Accessed 4 February 2014. 13 Mogos M, August E, Salinas-Miranda A, Sultan D, Salihu H. A systematic review of quality of life measures in pregnant and postpartum mothers. [Internet]. Appl Res Qual Life 2013;219–50. [www.ncbi.nlm.nih.gov/pubmed/23734167]. Accessed 3 March 2014. 14 Royal College of Obstetricians and Gynaecologists, London: Research and audit-clinical indicators project. [www.rcog.org.uk/ our-profession/research-and-audit/clinical-indicators-project]. Accessed 11 February 2014. 15 BJOG: Core Outcomes in Women’s Health (CROWN). [www.bjog.org/view/0/crown-initiative.html]. Accessed 11 March 2014. 16 Alonso J, Bartlett SJ, Rose M, Aaronson NK, Chaplin JE, Efficace F, et al. The case for an international patient reported outcomes measurement information system (PROMIS) initiative. Health and Quality of Life Outcomes 2013;11:210. [www.hqlo.com/content/pdf/ 1477-7525-11-210.pdf]. Accessed 11 March 2014.
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DOI: 10.1111/1471-0528.12901 www.bjog.org
Developing core patient-reported outcomes in maternity: PRO-Maternity A Mahmud,a,b E Morris,c S Johnson,d KM Ismaila,b a
Centre for Women’s & Children Health and the School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK b Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham, UK c Department of Obstetrics & Gynaecology, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK d RCOG Quality and Knowledge Directorate, Royal College of Obstetricians and Gynaecologists, London, UK Correspondence: Prof KM Ismail, Professor of Obstetrics and Gynaecology, Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham B15 2TG, UK. Email [email protected] Accepted 16 April 2014.
Please cite this paper as: Mahmud A, Morris E, Johnson S, Ismail KM. Developing core patient-reported outcomes in maternity: PRO-Maternity. BJOG 2014; 121 (Suppl. 4): 15–19.
Introduction If quality is to be at the heart of everything we do, it is important to be able to measure the clinical effectiveness of our healthcare interventions and their impact on patients from their own perspective. The latter can be measured through patient-reported outcome (PRO) measures.1 Undoubtedly, patients who regularly access and use healthcare services are uniquely placed to judge the quality and effectiveness of the health care they receive. In England, the use of PRO measures to assess healthcare effectiveness has been recommended in several National Health Service (NHS) reports.1,2 More recently, the Francis Report stressed the lack of patient and public involvement in health care and highlighted the need to increase this to ensure that the service provided is compassionate and patient-centric.3 Patient-reported outcome measures provide a means of gauging patients’ views on their health and assessing the impact that treatments or interventions have on their clinical condition, wellbeing and quality of life. It is important to differentiate PRO measures from Patient-Reported Experience Measures (PREMs). PREMs are assessments of the patients’ satisfaction with the care they received. Although both are measures based on the patient’s perspective, PREMs are measures of ‘healthcare processes’ while PRO measures are measures of ‘clinical-care effectiveness’. Several procedure-related measures are regularly collected as part of healthcare service delivery; however, these outcomes do not take into account the views of most patients whose healthcare experiences do not end up in a specific
ª 2014 Royal College of Obstetricians and Gynaecologists
procedure or, indeed, patients who suffer a poor outcome. Moreover, current measures of patient-reported satisfaction, used as surrogate measures for quality, sometimes lack validity, detail and specificity. When PRO measures were introduced in the NHS in 2009; the main goal was to provide measures that could be used not only to assess a patient’s perspective of treatment but also, to use this information to direct funding and management of healthcare services.1 The Department of Health introduced the PRO measures programme in a limited number of surgical procedures initially. However, the use of PRO measures is currently being explored in a range of chronic health conditions including mental health, cancer, asthma, chronic obstructive pulmonary disease, diabetes and stroke. PRO measures are currently not in use within maternity or neonatal health services. The evidence collected from this work will impact on the future use of PRO measures across other specialties.4 PRO measures are an important quality improvement measure and form an essential component in domain four of the NHS Outcome Framework—patient experience.5
Types of PRO measures An ideal PRO measure should have validity, reliability and be able to measure change over time. At present, PRO measures are being collected before and after treatment, which is in line with these principles.6 The majority of PRO measure tools that are currently in use are derived from already existing patient reported instruments and questionnaires that have undergone a varied process of
15
Mahmud et al.
validation, modification and testing before their implementation. Two different types of PRO measures have been described.
Generic PRO measures Generic PRO measures; such as the EQ-5D (EuroQOL) and SF-36 (Short Form 36 Health Survey) measure the effect of health status in relation to an individual’s ability to function and enjoy life as a healthy individual. The principles behind generic PRO measure questionnaires are similar but differ in certain aspects because they vary in the type of health domains being gauged. For example, sexual health is an important domain in gynaecology, whereas mobility and usual activity are domains more relevant to orthopaedics. Therefore, the use of the same set of PRO measures across all specialties is not advisable. This is why specialty-specific and condition-specific PRO measures are needed. This is particularly the case for maternity care where pregnancy is not a disease but a normal physiological state that can have different outcomes.
Condition-specific or disease-specific PRO measures Condition-specific PRO measures assess the impact of a condition or intervention on a specific aspect of health that is linked to the natural history of the disease or its treatment. A few examples of currently used questionnaires are shown in Table 1. Generic and condition-specific PRO measures can be used collectively or individually to evaluate healthcare services and interventions. Some PRO measures are designed to measure both generic and condition-specific aspects. As an example, patients undergoing continence surgery com-
plete an electronic personal assessment questionnaire (ePAQ) before and, usually, 6 months after treatment. The ePAQ has been primarily designed as a clinical tool to help assessment of pelvic floor problems. This in turn shortens the gap in communication between patients and clinicians. As a validated and reliable tool its origins lie in instruments designed for use as PRO measures. As such it contains a mixture of both generic quality of life and pelvic floor dysfunction-specific measures. Another example of a PRO measure is the modified and validated version of the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL) developed by the Royal College of Obstetricians and Gynaecologists for use in heavy menstrual bleeding as part of benign gynaecology. This PRO measure has produced good evidence when used in women with fibroids.6
Developing PRO measures: benefits and limitations The processes involved in developing PRO measures can be summarised in four steps, as shown in Figure 1.4 These processes are refined and strengthened by the incorporation of feedback at each step, making the outcome of the process more reliable and relevant. It is known that well-developed PRO measures have the ability to capture a patient’s assessment of their own health both at a certain point in time or at different times during the course of treatment.7 The information generated can be used in various ways. Patient-reported outcome measures can be used as assessors of clinical quality for treatment providers (clinicians)
IdenƟficaƟon or generaƟon of a PRO measures instrument Table 1. Examples of PRO measures used in National Health Service (England) Generic PRO measures
Hip surgery Knee surgery Varicose vein surgery
EQ-5D EQ-5D EQ-5D
Hernia repair Tension-free vaginal tape (TVT)* Heavy menstrual bleeding in women with fibroids
SF-36 and EQ-5D ePAQ (generic and condition specific) EQ-5D and SF-36
*TVT for genuine stress incontinence.
16
Condition-specific PRO measures
PiloƟng process: evaluaƟon and review of potenƟal PRO measures tools
Oxford hip score Oxford knee score Aberdeen varicose vein questionnaire No condition-specific
ImplementaƟon of PRO measures: data collecƟon and processing
UFS-QOL
EvaluaƟon of impact on healthcare services and stakeholders
Feedback to refine
Surgical procedure/ condition
Figure 1. Processes involved in developing patient-reported outcome measures.
ª 2014 Royal College of Obstetricians and Gynaecologists
Developing core patient-reported outcomes in maternity
and as a performance tool for managers and commissioners. Moreover, use of PRO measures should provide room to research what works best in health care and to reduce health inequalities by promoting good-quality patient-centred care. Certain PRO measures also have a role in economic evaluations such as estimation of quality-adjusted life-years (QALYs). Patient-centred care is an essential, but poorly integrated, concept as shown by the recent Francis report and the Everyone Counts proposal by NHS England.8 Following the Francis Report, National Voices stressed the importance of the availability of public information on the experience and outcomes of care from the point of view of the patient and the need for PRO measures to be rolled out more widely and reported at the individual clinical team level.9 Indeed, a move to measures that are not only reported on but also defined by patients, ensuring that outcomes really matter to patients, is needed. This would promote patient and public involvement, individualised patient care plans, healthy competition and better performance of service providers; all aimed at improving patient outcome. Therefore, the relevance of PRO measures is underpinned by the methodology used in their development to ensure that they are truly patient centred. Although there are several advantages to using PRO measures, there is much to be considered before PRO measures can be used effectively. Measuring the wrong PRO measures or focusing on smaller groups, ethnic barriers or financial limitations can all lead to inadequate output or data that may be faulty. Therefore, to ascertain that correct PRO measures are used requires a combination of literature review, in-depth patient interviews and statistical thematic analysis of qualitative data. It is also equally important that the selected PRO measures provides evidence of reliability, precision, validity and responsiveness. Limitations related to what PRO measures can measure and what they cannot measure must also be considered. Patient acceptability, simplicity of questionnaires and response rates are other factors that can impact on data generated from PRO measures.10,11
Women-centred PRO measures in maternity The NHS spent £2.6 billion on maternity care in 2012/13 and more than 700 000 women use different aspects of the maternity services in the UK per annum, yet there are no routine PRO measures in place to assess the actual impact of the health care being delivered to women using these services.12 Guidance for PRO measure-based assessment in maternity care does not exist. More recently, a systematic review of Health Related Quality Of Life measures
ª 2014 Royal College of Obstetricians and Gynaecologists
(HR-QOL) in pregnancy and postpartum care highlighted the lack of PRO instruments in maternity; especially the lack of patient-generated PRO instruments.13 Ensuring the delivery of a high-quality service is an important determinant of unit performance and the level of the Clinical Negligence Scheme for Trusts (CNST) contribution. Collecting and monitoring outcomes that are relevant to users is an important measure and driver for quality. It is important to recognise that CNST standards are changing and this approach may certainly be very different in the future. However, PRO measures could become an important tool to assist trusts with the new NHS Litigation Authority approach to ‘learning from claims’ and Care Quality Commission assessments. Care Quality Commission Maternity Surveys have shown that benchmarking services against each other is a driver for improvement. Maternity PRO measures would add another dimension to benchmarking services by acting as an adjunct; one that is derived entirely from the woman’s perspective. This will help to identify variations in practice and outliers in the system. This would allow health services to be restructured and potentially avoid hefty medico-legal claims. The outlier issue here is key, particularly if maternity PRO measures are used to interlink unit performance with the Royal College of Obstetricians and Gynaecologists clinical indicators project.14 Patient-reported outcome measures in maternity should provide a quality assessment tool that can link women’s health status to outcomes. They can be used to devise a plan of care that matches the woman’s personalised health needs and can then track the impact of such a care plan on her outcomes. This will allow funds and services to be tailored according to user needs and act as a reliable tool to inform healthcare commissioners. Interventions or treatments that do not improve health can then be identified and either modified or eliminated to increase the efficiency of health service delivery. Hence, PRO measures have the potential to act as a driver to improve both the quality and cost-effectiveness of maternity services. Indeed, the rising costs of service delivery, growing number of births and patients’ expectations of quality of care mean that PRO measures have a significant role in determining policy and allocation of healthcare resources.9 Currently, there is an international move towards developing sets of core clinical outcomes (Core Outcomes in Women’s Health [CROWN] initiative) that will be used as condition-specific minimal data sets to be reported in research studies.15 This notion will ensure that relevant outcomes are reported and hence reduce heterogeneity between studies if data are to be further analysed. However, these core clinical outcomes could be complemented by the parallel development of core patient-centred PRO measures.
17
Mahmud et al.
Once refined, a logical extension of the development of maternity PRO measures would be the production of parent-reported neonatal outcomes. When developed, these would overlap between the postnatal and early neonatal periods, and would allow detailed analysis of the complex interface between midwifery, obstetrics and paediatric care. Strong patient-centric healthcare leadership and delivery cannot occur without accurate, useful and relevant information. Maternity PRO measures have an essential role in providing such data, especially as they contribute to the culture of openness. Above all, this will generate new insights into women’s perspectives of healthcare delivery, allowing changes in attitude, practice and organisational services. On a much larger scale this will shift the pendulum of service delivery in favour of society and individuals while ensuring the most effective use of NHS resources.
Global perspective on PRO measures Patient-reported outcome measures have been developed, used and implemented across the globe in various developed countries, including the Netherlands, England and the USA. Currently the trends in PRO measure reporting and application are changing to accommodate an international audience. Certainly, the CROWN initiative (in collaboration with Core Outcome Measures in Effectiveness Trials [COMET] initiative) and the US National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) initiative are moving towards development and standardisation of PRO measures across studies and settings.15,16 This application of PRO measures will help to provide a framework for standardised reporting of outcomes in clinical trials and studies, at both national and international levels. There are several potential challenges in development and application of PRO measures globally. Although countries with well-developed healthcare systems may quickly find the transition, application and benefits useful, some low-income countries may struggle to adopt PRO measures. The potential barriers would be variations in healthcare delivery systems, cultural diversity and literacy rates. Furthermore, costs associated with translation, collection and measurement of PRO measures alongside the need for training in PRO measure analysis and assessment are all factors that should be taken into account. Hence, these challenges could greatly influence global acceptability and application of PRO measures across all specialties including maternity care.16 We propose that these challenges may not apply when using PRO measures ‘selectively’ for reporting outcomes in clinical trials or studies. A robust and validated PRO
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measure questionnaire could be translated and used to report clinical trials and studies without being influenced by barriers relevant to local healthcare systems. Indeed, these limitations may reduce with ongoing work in PRO measure development and application.
Summary Women-centred maternity PRO measures can generate outcome measures that will allow benchmarking of service delivery using meaningful outcomes that will drive service improvement to ensure commitment to a culture of openness, patient satisfaction, patient safety and the delivery of clinically effective care. Moreover, they can generate new insights into women’s perspectives of healthcare delivery, allowing changes in attitude, practice and organisational services. Once developed, the adoption of PRO measures within units is likely to come at additional cost. However, the expected benefits in improved woman and family satisfaction, reduced legal claims and the presence of an early indicator of compromised quality of care will have the potential to save a significant amount of money for individual units and the wider health economy.
Acknowledgements The authors would like to acknowledge the support of PRO-Maternity team members from Royal College of Obstetricians and Gynaecologists, NHS England, Birth Trauma Association, National Childbirth Trust, Royal College of Nursing and Royal College of Midwives.
Disclosure of interests AM, EM, SJ and KI are collaborators together with a wider team involved in developing patient-centred PRO measures for maternity.
Contribution to authorship The idea of developing women-centred PRO measures in maternity was conceived by KI. The first draft of the manuscript was prepared by AM. SJ, EM and KI have provided additional literature resources and actively contributed to the final version of the manuscript.
Details of ethics approval Not applicable.
Funding AM is funded by a Birmingham Women’s NHS Foundation Trust R&D Springboard fellowship and in addition holds a Wellbeing of Women Scholarship—‘An Entry Level Scholarship awarded to mark the birth of HRH Prince George of Cambridge’. &
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Developing core patient-reported outcomes in maternity
References 1 Darzi A. High Quality Care for All: NHS Next Stage Review Final Report. London, Department of Health, 2008. [www.gov.uk/ government/uploads/system/uploads/attachment_data/file/228836/74 32.pdf]. Accessed 7 March 2014. 2 Smith S, Cano S, Lamping D, Staniszewska S, Browne J, Lewsey J, et al. Patient-Reported Outcome Measures (PROMs) for Routine use in Treatment Centres: Recommendations Based on A Review of the Scientific Evidence. London, Health Services Research Unit, London School of Hygiene and Tropical Medicine, 2005. [www.lshtm.ac.uk/ php/hsrp/research/promsnickblack2005.pdf]. Accessed 8 March 2014. 3 Department of Health. Independent inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2005–March 2009. Chaired by Robert Francis. HC 375-1. Stationery Office, 2010. [www.midstaffspublicinquiry.com/report]. Accessed 8 March 2014. 4 Devlin N, Appleby J. Getting the Most out of PROMs. Putting Health Outcomes at the Heart of NHS Decision-Making. London, The King’s Fund, 2010. [http://www.kingsfund.org.uk/publications/getting-mostout-proms]. Accessed 8 March 2014. 5 Department of Health, London. 2012. The NHS outcomes framework 2013/14. [www.gov.uk/government/uploads/system/uplo ads/attachment_data/file/213055/121109-NHS-Outcomes-Framework2013-14.pdf]. Accessed 10 March 2012. 6 Royal College of Obstetricians and Gynaecologists, London; April 2012. Patient-reported outcome measures in gynaecology: scientific impact paper 31. [www.rcog.org.uk/womens-health/clinical-guid ance/patient-reported-outcome-measures-gynaecology-sac-opinionpaper-31]. Accessed 11 March 2014. 7 Patrick D, Burke L, Powers J, Scott J, Rock E, Dawisha S, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. [Internet]. Value Health. 2007;S125–37. [www.ncbi.nlm.nih.gov/pubmed/17995471]. Accessed 8 March 2014.
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8 National Health Service Commissioning Board. Everyone counts: planning for patients 2013/14. [www.england.nhs.uk/everyone counts/]. Accessed 2 February 2014. 9 After Francis: doing justice—a national voices paper on ensuring safe and high quality patient care—March 2013. [www.national voices.org.uk/publications]. Accessed 10 February 2014. 10 Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010;340:c186. 11 Patient reported outcome measures (PROMs) in clinical trials and health care—an introduction. Keith Meadows Director DHP Research & Consultancy 2010. [http://thepatientoutcomesblog.com/category/ patient-reported-outcomes-2/]. Accessed 2 February 2014. 12 Department of Health, London. National audit office-maternity services in England. 2013. [www.nao.org.uk/wp-content/uploads/ 2013/11/10259-001-Maternity-Services-Book-1.pdf]. Accessed 4 February 2014. 13 Mogos M, August E, Salinas-Miranda A, Sultan D, Salihu H. A systematic review of quality of life measures in pregnant and postpartum mothers. [Internet]. Appl Res Qual Life 2013;219–50. [www.ncbi.nlm.nih.gov/pubmed/23734167]. Accessed 3 March 2014. 14 Royal College of Obstetricians and Gynaecologists, London: Research and audit-clinical indicators project. [www.rcog.org.uk/ our-profession/research-and-audit/clinical-indicators-project]. Accessed 11 February 2014. 15 BJOG: Core Outcomes in Women’s Health (CROWN). [www.bjog.org/view/0/crown-initiative.html]. Accessed 11 March 2014. 16 Alonso J, Bartlett SJ, Rose M, Aaronson NK, Chaplin JE, Efficace F, et al. The case for an international patient reported outcomes measurement information system (PROMIS) initiative. Health and Quality of Life Outcomes 2013;11:210. [www.hqlo.com/content/pdf/ 1477-7525-11-210.pdf]. Accessed 11 March 2014.
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