Patient‐reported Outcome Measures in Emergency Care Research: A Primer for Researchers,Peer Reviewers,and Readers

Patient‐reported outcomes (PROs) are of increasing importance in clinical research because they capture patients’ experience with well‐being, illness, and their interactions with health care. Because PROs tend to focus on specific symptoms (e.g., pain, anxiety) or general assessments of patient functioning and quality of life that offer unique advantages compared to traditional clinical outcomes (e.g., mortality, emergency department revisits), emergency care researchers may benefit from incorporation of PRO measures into their research design as a primary or secondary outcome. Patients may also benefit from the ability of PROs to inform clinical practice and facilitate patient decision making, as PROs are obtained directly from the lived experience of other patients with similar conditions or health status. This review article introduces and defines key terminology relating to PROs, discusses reasons for utilizing PROs in clinical research, outlines basic psychometric and practical assessments that can be used to select a specific PRO measure, and highlights examples of commonly utilized PRO measures in emergency care research.     

Clinician's Checklist for Reading and Using an Article About Patient-Reported Outcomes

Clinicians need evidence-based medicine to help them make clinical decisions with their patients. For many health problems, the goal of treatment is to help the patient to function and feel better. To measure patient functioning, well-being, and symptoms, questionnaires referred to as patient-reported outcome (PRO) measures are often used. Clinicians are generally not trained in survey design, scale development, and questionnaire administration, making it difficult for them to interpret and effectively use PROs as clinical evidence. It is increasingly important that clinicians be able to understand and use outcomes measured from both the clinical and patient perspectives to inform their practice. We aim to provide a “Clinician's Checklist” to help practicing clinicians understand clinical research articles that include PROs so that the information can be used for decision making. This checklist provides an itemization of important areas for the reader to consider in evaluating research articles. We propose that clinicians consider 5 elements when reading a study using PROs: study design and PRO assessment strategy, PRO measure performance, validity of results, context of the findings, and generalizability to their own patient population. Patient-reported outcomes play an increasingly prominent role in clinical research and practice, and this trend has the potential to improve the patient-centeredness of care. Clinicians will need to understand how to use PROs to partner with patients and help them function and feel better. The proposed Clinician's Checklist can help clinicians systematically evaluate PRO studies by determining whether the study design was appropriate and whether the measurement approach was adequate and properly executed as well as by assisting in the interpretation and application of the results to a specific patient population.     

Use of Patient-Reported Outcomes: Rationale and Clinical Implementation

Routine collection and use of patient-reported outcomes (PROs) benefits patients, providers, and health care organizations. PROs are useful in clinical decision making, in measuring and improving patient experience, in research, and in quality improvement. They are of increasing fiscal importance as payers transition to value-based reimbursement. Through a quality improvement project using a Plan-Do-Study-Act framework, team members developed a process to increase the PRO collection rate from 4% to more than 85% of eligible clinic visits. Incorporation of PRO collection into the clinic workflow is facilitated by multidisciplinary collaboration and recognition of the value generated by the process.     

Systematic collection of patient reported outcome research data: A checklist for clinical research professionals

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries.Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings.     

PS1-49: Methods for Integrating Patient-Reported Outcomes Into the Electronic Health Record

Background/Aims Patient-reported outcomes (PROs) provide valuable information to the clinician about the patient's symptoms and how the patient is responding to treatment. In some cases, electronic or phone-based PROs can reduce the need for office visits. In order to be maximally useful, PROs need to be integrated with electronic health record (EHR) data so providers can evaluate the PRO in the context of a patient's complete clinical record. In this work we identified methods for integrating PROs into the EHR. We focused primarily on PROs collected through electronic interfaces such as personal health records, email, external websites and standalone apps for smartphones and tablets. Methods We compared the benefits and drawbacks of different methods for integrating PROs into Epic Systems Corporations' suite of EHR products. Available methods for automatic integration of PROs into the EHR includes the flowsheet and questionnaire extensions to Epic's MyChart product and HL7 messaging from external applications such as websites or smartphone/tablet apps. Results The questionnaire and flowsheet methodologies within Epic's MyChart product provide a technically simple way to collect PROs. However, these methods are relatively inflexible in terms of how you can present information to the patient. For example, neither method allows you to present images or drawings that can help patients better express concepts such as where symptoms occur in their body. In contrast, website and smartphone/tablet applications can provide much more flexible patient interface options, but the data can be harder to integrate into the EHR system. Regardless of how PROs are collected, integrating the information into the provider's workflow remains a challenge. Discussion Multiple methodologies exist for collecting and integrating PROs into the Epic EHR. Major trade-offs include the flexibility of the patient interface and the ease of integrating the data back into the EHR.     

Medicare and the nurse. The peer review organization (PRO)

The PRO process is just one of the many reviews that HHAs are subjected to at any given time. On a practical level, HHA should incorporate PRO criteria and GQSs into its QA program. At present, there is no mechanism in place for denial of payment for substandard care, although proposed regulations were published in the January 18, 1989 Federal Register. Medicare certification, and therefore payment, could be lost if the facility or HHA were sanctioned. The Medicare law requires PROs to coordinate their activities with other review organizations. HCFA, however, has not established procedures for providing reports from fiscal intermediaries and PROs to the state survey agencies or coordinating state surveys with PRO reviews. HHAs should have structure and process criteria in place (either manual or computerized) to identify selected records for review. This enables the agency to monitor its internal quality assurance activities so that it has confidence that the GQSs will be met when reviewed by external agencies, including the PRO. This internal monitoring will also enable the agency to document patient outcomes. This is an important aspect of the evaluation process, since the emphasis of certification and accreditation programs and site visits will be focused on patient outcomes in the 1990s.     

Patient Reported Outcomes and Unscheduled Health Services use During Oral Anti-Cancer Treatment

ContextPeople on oral anti-cancer agents must self-manage their symptoms with less interaction with oncology providers compared to infusion treatments. Symptoms and physical function are key patient-reported outcomes (PROs) and may lead to unscheduled health services uses (urgent care and emergency department [ED] visits, hospitalizations), which in turn lead to increased health care costs.ObjectivesTo evaluate the prediction of unscheduled health services uses using age, sex, and comorbidity, then determine the extent to which PRO data (symptoms and functioning) improve that prediction.MethodsThis post-hoc exploratory analysis was based on data from the control group of a trial of medication adherence reminder and symptom self-management intervention for people starting a new oral anti-cancer agent (n = 117 analyzed). Severity and interference with daily life for 18 symptoms, physical function, and depressive symptoms were assessed at intake (oral agent start), and four, eight, and 12 weeks later. Unscheduled health services use during three four-week periods after the start of oral agents was analyzed using generalized mixed effects models in relation to age, sex, comorbidity, and PROs at the beginning of each time period.ResultsThe summed severity index of 18 symptoms and physical function were significant predictors of hospitalizations in the four weeks following PRO assessment. The addition of PROs improved areas under the receiver operating characteristic curves to be over .70 in most time periods.ConclusionMonitoring of PROs has the potential of reducing unscheduled health services use if supportive care interventions are deployed based on their levels.     

A Delphi Study of Core Patient-Reported Outcomes for Advanced Renal Cell Carcinoma and Advanced Hepatocellular Carcinoma

ObjectivesThere is little research to help health care professionals understand what patient outcomes are considered a priority in advanced liver or kidney cancer. Knowing what is important to patients can help promote person-centered approaches to treatment and disease management. The aim of this study was to identify those patient-reported outcomes (PROs) that patients, carers, and health care professionals consider as “core” when providing care to those with advanced liver or kidney cancer.Data sourcesA three-round Delphi study was undertaken to ask experts by profession or experience to rank PROs identified from a previous literature review. Fifty-four experts, including people living with advanced liver or kidney cancer (44.4%), family members and caregivers (9.3%), and health care professionals (46.8%), reached consensus on 49 PROs including 12 new items (eg, palpitations, hopefulness, or social isolation). Items with the highest rate of consensus included quality of life, pain, mental health, and capacity to do daily activities.ConclusionPeople living with advanced liver or kidney cancer experience complex health care needs. Some important outcomes were not actually captured in practice in this population and were suggested as part of this study. There are discrepancies between the views of health care professionals, patients, and family in what is important, highlighting the need of using measures to facilitate communication.Implications for Nursing PracticeIdentification of priority PROs reported here will be key to facilitate more focused patient assessments. The actual use of measures in cancer nursing practice to allow monitoring of PROs must be tested for feasibility and usability.     

Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life

As the patient is the primary recipient of treatment, there is a need to recognize and value the patient's perception of change in response to treatment in clinical trials. A new outcomes classification, patient-reported outcomes (PROs), has been proposed by regulators. The PROs are used as an umbrella term and include, for example measures of subjective symptoms, health-related quality of life (HRQL) and treatment satisfaction. In this sense, the PROs are unique and complementary indicators of disease activity as well as of treatment efficacy. Frequently, pharmaceutical companies desire to include PRO benefits in the product label in order to reach a broad range of customers, including prescribers as well as patients. Therefore such information must be based on results that are scientifically valid. The measurement strategy, i.e. the thinking about and decision-making related to PRO and HRQL evaluations, needs to be explicit for clinical trials. First of all it is necessary to specify and provide the rationale for measuring the PROs. Similarly, the reason for selecting particular instruments should be stated and, for the selected instruments, the psychometric evidence should be summarized. The key PRO domains must be prespecified and evidence of their importance to patients should be provided. The research question under study and potential claims need to be clearly delineated. Hence, instrument selection is a key initial step for planning successful and scientifically adequate clinical trials intended to support labelling and promotional claims of PRO benefits to patients. The scientific criteria and design issues of clinical trials are the same for clinical and PRO endpoints. However, important issues of particular relevance to PRO assessments, such as missing values, multiple outcomes, and the statistical analysis, require careful attention. The thinking and planning involved in developing the PRO component of the clinical trial need to be articulated. Successful evaluation of PROs in clinical trials relies on careful planning provided the treatment shows sufficient effectiveness.     

Use, misuse and non-use of health care assistants: understanding the work of health care assistants in a hospital setting

AIM(S): This study is concerned with understanding the work of non-registered nurses (health care assistants) in a UK hospital setting. BACKGROUND: There are increasing numbers of health care assistants employed by the National Health Service in the UK to support registered nurses providing nursing care. However, little is known about the make-up of the health care assistant workforce and the changing nature of their role. This study addresses some of these gaps in the research-based literature. METHODS: A single case study design using mixed methods (survey, interviews, participant observations, focus groups and documents) was used to generate an in-depth account of health care assistants' work in one organization. The study is built upon what health care assistants say they do, compared with what they actually do in practice. It explores how and whether the work of health care assistants is adequately supervised, tensions between the work of health care assistants and registered nurses and the subsequent effects on teamwork and patient care. FINDINGS: There are policy expectations associated with the work of health care assistants. However, this study reveals significant deviations from these goals. The workplace arena and the negotiations between health care assistants and registered nurses that take place within it, actively shape the health care assistants' work. Findings suggest dynamic patterns of use, misuse and non-use of the health care assistants as a resource to patient care. DISCUSSION AND IMPLICATIONS FOR PRACTICE: The changing roles of registered nurses have direct implications for the roles of health care assistants: as registered nurses take on extra duties and responsibilities they are conceding some of their role to health care assistants. This has implications for nurse managers. The competence of health care assistants to carry out nursing work needs to be reassessed and there also needs to be ongoing monitoring and supervision of their work to maximize, and further develop, their contribution to patient care and to ensure quality standards. Managers also need to be aware of the importance of workplace negotiations in the interpretation of formal policies and the subsequent shaping of health care assistants' work at the level of service delivery.     

The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval

Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient's response by a clinician or anyone else.     

Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology

Ensuring that the patient’s voice is routinely incorporated in all aspects of health care in oncology is essential to provide quality care. Patient reported outcomes (PROs) are standardized measures that are used to obtain the patient’s perspective and are increasingly used in all aspects of health care to ensure optimal delivery of patient-centered care. The US Food and Drug Administration encourages that PROs be used in studies for label indications. There are no uniform standardized methods to use PROs nor is there consensus on which PROs are best for regulatory approval, comparative effectiveness research, toxicity assessment, health-related quality of life, or symptom monitoring. For this review, we conducted a literature search using PubMed and Google Scholar, and herein summarize the evidence related to the use of PROs in clinic care and research. Using valid, reliable, and easily interpretable PROs developed in comparable populations will provide the most useful results. Various ways that PROs can be used successfully in oncology have been exemplified in this overview to provide clinicians and researchers practical guidance.     

Primary health care practitioners' tools for mental health care

The purpose of this study was to describe and analyse the content of mental health care from the practitioner's point of view. The specific aim of this paper was to outline the types of mental health care tools and the ways in which they are used by primary health care practitioners. The data were derived from interviews with doctors and nurses (n = 29) working in primary health care in six different health care centres of the Pirkanmaa region in Finland. The data were analysed by using qualitative content analysis. The tools of mental health care used in primary health care were categorized as communicative, ideological, technical and collaborative tools. The interactive tools are either informative, supportive or contextual. The ideological tools consist of patient initiative, acceptance and permissiveness, honesty and genuineness, sense of security and client orientation. The technical tools are actions related to the monitoring of the patient's physical health and medical treatment. The collaborative tools are consultation and family orientation. The primary health care practitioner him/herself is an important tool in mental health care. On the one hand, the practitioner can be categorized as a meta-tool who has control over the other tools. On the other hand, the practitioner him/herself is a tool in the sense that s/he uses his/her personality in the professional context. The professional skills and attitudes of the practitioner have a significant influence on the type of caring the client receives. Compared with previous studies, the present informants from primary health care seemed to use notably versatile tools in mental health work. This observation is important for the implementation and development of mental health practices and education.     

Patient satisfaction in home health care

Aims and objectives. To assess the current use of patient satisfaction measures in home health care and to examine the reliability and validity of current measures of patient satisfaction in home health care. Background. Patient satisfaction has been one of the widely used measures in home health care as an indicator of quality of care. A few efforts have been made to develop psychometrically sound patient satisfaction scales for use in home health care. Design. A critical review of the literature. Methods. Electronic databases were systematically searched to identify the studies or publications that measured and addressed patient satisfaction and its measurement in home health care. Results. The review of the literature showed that patient satisfaction measures have been used in the evaluation of care programmes including rehabilitation programmes, discharge and home follow‐up programmes, care process and management practices. Also, patient satisfaction measures were used to evaluate new care protocols and treatments. Conclusions. Home healthcare agencies need valid and reliable patient satisfaction scales. Frameworks of patient satisfaction are still in their early developmental stage. Only some of the variables related to patient satisfaction are explained by many frameworks. Relevance to clinical practice. Home healthcare mangers and researchers need to take in consideration the reliability and validity of measures and tools of patient satisfaction.     

Trends in the perceived complexity of primary health care: a secondary analysis

Rationale If the complexity of the patient's medical problems increases or the complexity of the interactions between the doctor and the patient, the staff or the health care system increase, then complexity of patient care will increase. This study examined trends in patient complexity, and identified doctor, practice and improvement strategy characteristics associated with perceived complexity. Methods This secondary analysis used data from three Community Tracking Surveys with 22 134 primary care doctors completing surveys about themselves, their practice setting, practice improvement strategies and complexity of care in three consecutive 2‐year time periods (1996–1997, 1998–1999, 2000–2001). Data were analysed using hierarchical logistic regression. Results The proportion of primary care doctors who perceived that complexity of care had increased over the past 2 years rose from 31.5% to 35.9%. Perceived complexity of patient care was consistently related to being in solo practice and the belief that they could not frequently obtain high‐quality services and referrals for patients. As availability of services increased, complexity decreased whereas as use of practice improvement strategies increased, complexity also increased. Conclusions Understanding that we cannot determine whether respondents understood care as ‘complicated’ or ‘complex’, potential consequences of this increase in complexity include an increase in medical errors and referral rates along with decreased quality of patient care and career satisfaction.     

Anthroposophic health care--different and home-like

Anthroposophic health care is rooted in the work of Steiner and Wegman in Switzerland during the 1920s. The Swedish hospital in this study offers integrated conventional and anthroposophic health care therapies which are conceptualized as an extended and integrative variant of health care and not as CAM. In anthroposophic care, health is viewed as a matter of body, soul and spirit in balance. Therapeutic resources include nursing care, therapeutic conduct (art and body therapies) and medicines based on natural remedies. This study aims to deepen the understanding of what constitutes good care from a patient's perspective to alleviate patients' suffering and to identify clinical markers for good care. As anthroposophic care is associated with theory and holistic ideas, this study aims at exploring whether or not anthroposophic care has a beneficial effect. A qualitative method was used, and the analysis was conducted with a phenomenological hermeneutic approach. Sixteen former patients, of whom nine were diagnosed with various kinds of cancer and seven with burnout syndrome, were interviewed regarding their experience of anthroposophic care. Patients especially noted the benefits of the holistic caring environment; the empathetic approach and true caring offered, as well as the peaceful atmosphere and rest. A turning point or shift in perspectives, implying a home coming in relation to inner aspects was discussed as an outcome. Although patients in general were overwhelmingly impressed and positive they were also ambivalent. One interpretation is that there is a gap between the anthroposophic and conventional paradigm that affects patients negatively. As mutual scepticism still prevents any real integration between integrative and conventional care, the onus appears to be on the patient to take the risk and act as bridge-builder. From a caring science perspective, the study shows that appropriation of specific values and theory makes it possible to create a true caring culture.     

Meanings of giving touch in the care of older patients: becoming a valuable person and professional

Touch is central to nursing and health care workers frequently touch their patients, consciously or unconsciously in their interactions with them. Most literature has studied touch from a patient perspective, thus inquiry about professionals' experiences are rare. The aim of this study was to illuminate meanings of giving touch in nursing care of older patients. To understand the meaning of lived experiences of giving touch in care of older patients, interviews with 12 health care professionals in northern Sweden were analysed using a phenomenological-hermeneutic approach influenced by the philosophy of Ricoeur. The findings show that giving touch in the care of older patients is a transforming experience, where one suddenly perceives oneself as both a valuable person and professional who no longer powerlessly confronts patients' haunted and disrupted bodies, but who, by means of touch, has gained power to ease this suffering. The experience also transforms the way one regards older patients. Instead of seeing a severely demanding patient suffering from dementia and/or pain, one is able to see the person behind the disease as a human being, like oneself. A relationship described as calm, friendly and humane is created between caregiver and patient when giving touch, a relationship that transcends the moment of touch and influences one's way of caring. This understanding is presented using the theoretical framework of the philosophy of Marcel. Giving touch has the power to shed new light on health care professionals' experiences of caring for older patients suffering from dementia and/or pain, giving them the power to be a valuable person and professional.