The use of Patient Reported Outcomes and quality in primary care

1. Introduction

The development of instruments is at the forefront of implementation research to transform health care services and reform welfare contracts especially in Western European socialized systems. Health systems, dominantly driven by ideologies, do not easily incorporate tools or instruments that are commonly developed in management. Experiences such as the New Public Management (NPM) often lead to complex and wicked problems of governance (see Appendix), some under the forms of networks, some of which include providers of care.

Moreover, facing budget restrictions in many areas or organizations, governmental agencies could benefit from information systems that include more reported outcomes for critical decision points, where better optimization of resources could lead to more affordable access to care. Observational instruments on physician-patient communication still need more research, especially from behavioral sciences and the increased use of computer/mobile applications and social media may require additional indicators to identify sources of confusions between providers and other sources. The roundtable co-organized with the PAN Academy of Sciences helped to discuss new quality metrics for regions or organizations at risk (www.medyk.com.pl).

2. Role of patient reported outcomes for quality in medicine

This contribution highlights the major steps needed to transform patient surveys on quality into a Patient Reported Outcomes (PROs) instrument that is useful to decision makers. It was based on a case study of a quality improvement tool on drug care indicators, co-developed with an academic institution and a consumer association, and currently of interest as an input for the Organization for Economic Cooperation and Development (OECD) in a new international survey on chronic care (PaRIS initiative) since May 2018 [1]. Decisions in health care are often based on outcomes; payment systems also tend to incentivize providers such as physicians to increase performance management, also using major outcome indicators. This led to a strong academic community, identified as outcome research (www.ispor.org) commonly funded by the industry to show and quantify the comparative value of different services or technologies. The use of PROs is more recent. It originated mainly in Phase III of clinical trials and in observational studies for post marketing surveillance. Regulators often ignored such information, which, in terms of levels of evidence, was lower than randomized control trials studies. The definition of a PRO used in this paper is provided by the PRO task force from Ispor Society: “A measurement of any aspect of a patient’s health status that comes directly from the patient, without interpretation of the patient’s response by a physician or anyone else, it captures how a patient feels and functions”. It may often be used in combination with other categories of Reported Outcomes: Observed Reported Outcomes (ObsPROs), Clinical Reported Outcomes (CROs), and/or Clinical Based Performance Outcomes (PerfOs) (www.ispor.org/TaskForces/ClinicalOutcomesAssessment).

Currently, several stakeholders in health systems express a growing interest in the use of PROs to incorporate more individual or group levels of various patient groups in decision making processes [2]: Payers, accreditors, professional organizations and even regulators (e.g. role of PROs in FDA hematology and oncology product labels [3] Ispor; NIH cancer research1

In order to encourage the use of PROs in other disease areas or delivery systems, the research community should currently address the needs for better study design, encourage the use of validation methods for the studies, include the digitalization of PROs (ePROs) and control the sources of bias between various models of administration (paper based questionnaires, web based data entry, interactive voice response systems or other uses of ePRO devices). Instrument developers are usually responsible to ensure a faithful migration between modes of administration, for instance with different types of parallel or cross over study designs, especially if mixed modes of administration are used, they also need to integrate various formats to capture data. Evolving delivery systems face the increasing adoption of various devices; medical and social apps also force developers to implement quality monitoring systems (e.g. with data quality managers).

The methodology to develop PROs usually includes the following steps: Identification of relevant domains and their lists of items, saturation issues and use and reliability tests between modes of administration. The survey instrument developed for pharmaceutical indicators [4, 5] was used, for instance, as an outpatient pharmaceutical care quality improvement tool for a primary care organization under a clinical governance leadership. As an implementation research tool, it was reformatted for the Agency for Healthcare Research and Quality (AHRQ) in the USA for five domains: Information, communication, trust, clinical quality and access. Therefore, additional validations in other health care organizations would be required. It was also considered for the US federal initiative for the development of item banks called PROMIS on chronic diseases (www.promis.org) or for data elements for the OECD PaRIS on chronic care mentioned earlier.

There is a large consensus that good quality exists in large welfare and socialized systems, however, such beliefs probably would need to be updated and not solely based on individual cases, they should incorporate research on additional evidence. One major problem however is that poor evidence of course may jeopardize specific political agenda. However, feedback on medical errors and problems on the market from different groups of the population or professionals can enhance conventional top down approaches from surveillance systems. In case of market disruptions (e.g. shortage of drug supplies) or unpredictable events, new PROs instruments can help address inadequate quality improvements tools. In addition, such PROs developed at an international level may benefit from the new strand of research in behavioral economics, for instance with a way to overcome cultural barriers and social influence on mental models [6].