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Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol.

ABSTRACT: BACKGROUND:The successful implementation of patient-reported outcomes (PROs) in clinical routine faces many challenges, first and foremost the lack of consideration thereof in the patient care process. The aim of this study will be to first identify relevant barriers and facilitators and then design suitable implementation strategies which will be evaluated to improve the effectiveness of a PRO measure assessment in inpatient and outpatient cancer routine care. METHODS:During the preparation phase, interviews with oncological patients (N?=?28) and medical staff (N?=?4) as well as focus groups with medical staff (N?=?18) across five different departments caring for cancer patients were conducted. On the basis of these, qualitative content analysis revealed relevant barriers and facilitators for implementation of PROs in cancer care. Subsequently, implementation strategies and a model of implementation were developed. In the study phase, implementation strategies will be evaluated based on nine different implementation outcomes in five different oncological clinics. Evaluation of the implementation process will take place during three months in each clinic and data will be conducted pre, while and post implementation of the PRO measure. Therefore a sample size of 60 participants of whom 30 staff members and 30 participants will be questioned using existing and newly developed implementation outcome evaluation instruments. DISCUSSION:Key to improving the effectiveness of PRO assessment in the time-critical clinical environment is the utilization of easy-to-use, electronic PRO questionnaires directly linked to patients' records thereby improving consideration of PROs in patient care. In order to validate the effectiveness of this implementation process further, an evaluation parallel to implementation following an observational study design with a mixed-methods approach will be conducted. This study could contribute to the development of adequate evaluation processes of implementation of PROs to foster sustainable integration of PRO measures into routine cancer care. TRIAL REGISTRATION:This study was registered at Open Science Framework (https://osf.io/y7xce/).

SUBMITTER: Gorlach MG

PROVIDER: S-EPMC6941251 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol.

Görlach Mirja Gianna MG Schrage Theresa T Bokemeyer Carsten C Kröger Nicolaus N Müller Volkmar V Petersen Cordula C Betz Christian Stephan CS Krüll Andreas A Schulz Holger H Bleich Christiane C

Health and quality of life outcomes 20200102 1

<h4>Background</h4>The successful implementation of patient-reported outcomes (PROs) in clinical routine faces many challenges, first and foremost the lack of consideration thereof in the patient care process. The aim of this study will be to first identify relevant barriers and facilitators and then design suitable implementation strategies which will be evaluated to improve the effectiveness of a PRO measure assessment in inpatient and outpatient cancer routine care.<h4>Methods</h4>During the ...[more]

PMID: 31898544

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Project description:BackgroundThere is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings.ObjectiveThis study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies.MethodsWe designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care.ResultsA multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021.ConclusionsA large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies.International registered report identifier (irrid)DERR1-10.2196/28391.

Project description:BACKGROUND:Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. OBJECTIVE:The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. METHODS:Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. RESULTS:This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. CONCLUSIONS:Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/14579.

Project description:PurposeOur purpose was to report outcomes of a novel palliative radiation therapy protocol that omits computed tomography simulation and prospectively collects electronic patient-reported outcomes (ePROs).Methods and materialsPatients receiving extracranial, nonstereotactic, linear accelerator-based palliative radiation therapy who met inclusion criteria (no mask-based immobilization and a diagnostic computed tomography within 4 weeks) were eligible. Global pain was scored with the 11-point numerical pain rating scale (NPRS). Patients were coded as having osseous or soft tissue metastases and no/mild versus severe baseline pain (NPRS ≥ 5). Pain response at 4 weeks was measured according to the international consensus (no analgesia adjustment). Transition to ePRO questionnaires was completed in 3 phases. Initially, pain assessments were collected on paper for 11 months, then pilot ePROs for 1 month and then, after adjustments, revised ePROs from 1 year onwards. ePRO feasibility criteria were established with reference to the paper-based process and published evidence.ResultsBetween May 2018 and November 2019, 542 consecutive patients were screened, of whom 163 were eligible (30%), and 160 patients were successfully treated. The proportion of patients eligible for the study improved from approximately 20% to 50% by study end. Routine care pain monitoring via ePROs was feasible. One hundred twenty-seven patients had a baseline NPRS recording. Ninety-five patients had osseous (61% severe pain) and 32 had soft tissue (25% severe pain) metastases. Eighty-four patients (66%) were assessable for pain response at 4 weeks. In the 41 patients with severe osseous pain, overall and complete pain response was 78% and 22%, respectively.ConclusionsBy study completion, 50% of patients receiving palliative extracranial radiation therapy avoided simulation, streamlining the treatment process and maximizing patient convenience. Pain response for patients with severe pain from osseous lesions was equivalent to published evidence.

Project description:BackgroundDigital patient reported outcomes are used increasingly in daily care and treatment of inflammatory bowel disease. Their purpose includes increased focus on patient wellbeing, reduction in avoidable follow-up consultations and increased patient self-management. However, implementation issues occur and studies indicate patients may have concerns, particularly regarding having fewer face-to-face consultations. This study aims to explore patients' perspectives of use and non-use of digital patient reported outcomes and to understand the mechanisms underpinning patient reluctance to engage with this health technology.ResultsSixteen patients with inflammatory bowel disease at a regional hospital in Denmark were interviewed about their experiences of, and perspectives on, digital patient reported outcomes. A certain level of eHealth literacy was found to be a fundamental condition for use, while other factors were barriers or facilitators for use of digital PROs. Patients' main concerns were about potential consequences for their care and relationship with the clinic. Most patients in stable remission were satisfied with the hospital being a "life-line" if their symptoms worsened, and perceived digital patient reported outcomes to be an efficient tool to establish that "life-line". Patients with severe symptoms and a high degree of emotional distress related to their disease valued the potential for digital patient reported outcomes to increase their clinicians' focus on mental health and extra-intestinal symptoms.ConclusionThis study found that if patients had sufficient digital literacy, they perceived digital patient reported outcomes to be a useful replacement for face-to-face consultations. However, they were concerned about digital patient reported outcomes' effect on the patient-clinician relationship and its ability to detect worsening of symptoms. These concerns may be mitigated by good patient-clinician relationships, and the option for patients to maintain direct telephone contact with their gastroenterology specialist.

Project description:IntroductionDiabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality.MethodsWe will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials-Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs.Ethics and disseminationEthical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences.Systematic review registrationThis systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.

Project description:BackgroundDiscrepancies in symptom assessment between providers and patients are reported in cancer care, and the use of patient-reported outcome measures (PROMs) has been recommended for patients receiving palliative care. However, the status of the routine use of PROMs in palliative care in Japan is presently unclear. Therefore, this study aimed to clarify this complex question. To this end, we administered a questionnaire survey either online or via telephone interviews (questionnaire: sent to 427 designated cancer hospitals, 423 palliative care units [PCUs], and 197 home hospices; interviews: conducted at 13 designated cancer hospitals, nine PCUs, and two home hospices).ResultsQuestionnaires were returned from 458 institutions (44% response rate). We found that 35 palliative care teams (PCTs, 15%), 66 outpatient palliative care services (29%), 24 PCUs (11%) and one (5%) home hospice routinely used PROMs. The most frequently implemented instrument was the Comprehensive Care Needs Survey questionnaire. Moreover, 99 institutions (92%) that routinely used PROMs responded these instruments as useful in relieving patients' symptoms; and moreover, the response rate in regard to usefulness in symptom management was higher than that of institutions that did not routinely use PROMs (p = 0.002); > 50% of the institutions that routinely used PROMs stated that use of these instruments was influenced by disease progression and patients' cognitive function. Moreover, 24 institutions agreed to be interviewed, and interviews demonstrated the benefits of and the barriers to the implementation of PROMs. Effective methods used in the implementation of PROMs were introduced as efforts to reduce the burden placed on patients and to promote healthcare providers' education in the use of PROMs.ConclusionsThis survey quantified the status of the routine use of PROMs within specialized palliative care in Japan, revealed barriers to wider PROM use, and identified needed innovations. Only 108 institutions (24%) routinely used PROMs within specialized palliative care. Based on the results of the study, it is necessary to carefully consider the usefulness of PROs in clinical palliative care, perform careful selection of PROMs according to the patient's condition, and evaluate how specifically to introduce and operate PROMs.

Dataset Information

Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol.

Publications

Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol.

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