Facilitators and barriers to implementing patient-reported outcomes in clinical oncology practice: a systematic review based on the consolidated framework for implementation research.

This study integrates and identifies specific facilitators and barriers to PRO implementation in oncology clinical practice settings based on the Consolidated Framework for Implementation Research. This systemic review identified 52 facilitators and 50 barriers for PROs to be implemented in an oncology setting, covering all areas of the CFIR, and the main constructs involved included: "Innovation Evidence-Base," "Innovation Complexity", "Innovation Design", "Structural Characteristics", "Compatibility", "Incentive Systems", "Access to Knowledge & Information", "Innovation Deliverers", "Innovation Recipients", and "Planning". The facilitators and barriers identified through the CFIR will inform stakeholders as they formulate intervention strategies to enhance the routine application of PRO tools in clinical oncology practice.

Introduction

Cancer is a common disease that affects public health globally. The symptoms and treatment of cancer often impose various physical and psychological burdens on patients, including anxiety, depression, fatigue, gastrointestinal reactions, pain, and financial constraint. An accurate assessment of these burdens can assist healthcare professionals (HCPs) in managing or resolving the problems experienced by patients [ 1 – 3 ]. Patient-reported outcomes (PROs) are commonly used to assess clinical outcomes. These outcomes are derived directly from patient health information, functional status, and treatment perception [ 4 , 5 ]. PROs are key indicators for improving the quality of treatment and care from the patient's perspective, thereby fully encapsulating the “patient-centered” healthcare concept [ 6 ]. Currently, PROs are widely used in Europe, the United States, Australia, and other regions for clinical effectiveness evaluation, drug review and approval, medical service quality assessment, and health technology assessment [ 7 , 8 ]. Incorporating PROs into oncology clinical practice can enhance the detection of patient clinical issues, doctor-patient communication, patient participation in clinical decision-making, patient experience, and satisfaction with medical services and lay a foundation for implementing new treatment options [ 9 , 10 ]. Additionally, previous studies have reported that effective implementation of PRO symptom monitoring and early warning in oncology survivors could significantly enhance patient physical functioning, health-related quality of life, hospital admission rates, overall survival, patient satisfaction, and cost-effectiveness [ 11 , 12 ].

However, although PRO implementation in clinical practice positively impacts the ability of HCPs to identify and manage patient health outcomes, there are still barriers to their translation into a clinical routine model at different levels [ 13 – 15 ]. At the HCP level, these include time constraints [ 16 ], lack of experience and training [ 17 , 18 ], and skepticism about PROs [ 19 ]. At the patient level, these include disease burden [ 20 , 21 ], unfamiliarity with the questionnaire [ 18 ], difficulty in accessing the questionnaire [ 22 ], and language barriers [ 16 , 23 ]. For the implementation environment, the barriers include a lack of appropriate workflow [ 24 ], embedded electronic health records (EHR) [ 25 ], and material resources and information technology support [ 16 , 26 ]. Previous studies have identified facilitators and barriers to PRO implementation. However, some of these studies lacked an appropriate framework, resulting in a limited understanding of the influencing factors. Therefore, the impact of various factors on PRO implementation in clinical settings may have been underestimated. Relying on a comprehensive and credible framework to systematically identify, analyze, and interpret the influencing factors in PRO implementation is essential to further improving the use of PROs in oncology clinical practice.

Consequently, this systematic review employed implementation science (IS) to integrate facilitators and barriers to PRO implementation. According to the National Institution of Health, IS is a discipline of research methods designed to facilitate the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings to improve the impact on population health [ 27 ]. IS identifies facilitators and barriers to implementing an intervention program and develops appropriate coping strategies based on these factors, which can be achieved to maximize assurance that an intervention program will be effectively implemented [ 28 , 29 ]. Different theoretical frameworks are used in implementation research. The consolidated framework for implementation research (CFIR) constructed by Damschroder in 2009 is the most commonly used framework in implementation research [ 30 , 31 ]. CFIR is a publicly available tool encompassing multiple areas and key concepts related to implementation. It can be adapted to different implementation contexts and phases [ 30 ], providing researchers with a structured approach to identify facilitators and barriers to implementation and progress, potential, and actual impact on effectiveness during implementation [ 32 , 33 ].

Accordingly, this systematic review aimed to identify, assess, and analyze facilitators and barriers to PRO implementation in oncology clinical practice by various stakeholders and integrate the available evidence regarding the implementation of PRO tools according to the CFIR to help future studies develop relevant responses to enhance the effectiveness of PRO tools in oncology clinical practice. The main questions to be answered are in the following areas: What are the facilitators and barriers to implementing PROs in clinical oncology practice? How do these facilitators and barriers, guided by the IS, affect PRO implementation in clinical oncology practice? What areas of the CFIR framework can these facilitators and barriers be mapped to?

Methods

This systematic review followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and was registered prospectively in PROSPERO (42024532983).

Search strategy

We searched five databases: PubMed, Web of Science, CINAHL, Embase, and PsycINFO. The search was limited from the database inception to April 2024. A three-step search strategy was strictly followed to retrieve relevant articles systematically. First, search terminologies were identified through an initial search of PubMed and Web of Science and an evaluation of the titles and abstracts of relevant articles. Second, each database was searched comprehensively using a search strategy that combined medical subject heading terms with free words to identify the search terminologies. Finally, the bibliography in the included studies was searched to screen for relevant articles. The search terms were as follows: Implement* AND (barrier* OR facilitat* OR determinant* OR factor* OR affect* OR influenc* OR enhanc* OR improv* OR support* OR gap) AND (‘Patient Reported Outcome Measure’ OR ‘Patient Reported Outcome*’ OR PROM OR PRO) AND (cancer* OR tumor* OR neoplasm* OR carcinoma* OR oncolog* OR malignan*). Supplementary File 1 presents detailed search information for each database.

Inclusion and exclusion criteria

We included original and secondary research published in peer-reviewed journals. These studies were designed to describe facilitators and barriers that affect the implementation of any PRO tools in routine oncology clinical practice settings by various stakeholders, including patients, HCPs, and other health workers. However, this review excluded ineligible researchers with the following themes: 1) reporting the development and feasibility validation of PRO tools; 2) PRO tools completed by an individual other than the patient; 3) unavailable full text or incomplete data; 4) duplicate publications; and 5) non-Chinese OR non-English literature.

Quality assessment

For qualitative and quantitative studies, the Joanna Briggs Institute Critical Appraisal tools were used to evaluate the quality of the literature. In the qualitative research section, the main consideration was whether the methodology used was consistent with the philosophical research questions, data collection, and analysis [ 34 ]. In the quantitative cross-sectional study section, the impact on the overall quality of the study was considered primarily based on the sample source, measurement credibility, and the effective control of confounding factors. For mixed-method research, the quality assessment tool used was the mixed methods appraisal tool (MMAT) [ 35 ]. The tool consists of a two-part evaluation question: 1) two screening questions to confirm whether an article is eligible for the MMAT; 2) scoring based on the type of study by selecting the evaluation criteria that correspond to it, with each category consisting of five evaluation criteria. For the included secondary studies, this study did not qualitatively assess the type of literature because of the lack of relevant quality assessment tools.

Two reviewers, LX and JYH, independently used MMAT to assess the quality of the included literature. Disagreements were resolved after discussion. A third reviewer, YL, performed a double assessment of the quality of the literature to ensure credibility. Studies that met the above inclusion criteria were included regardless of the quality of the study because the focus of the literature quality assessment was to identify the strengths and limitations of the included literature based on the study design and analysis process, which facilitated a rational interpretation of the results in this study.

Data extraction and analysis

The information needed for this systematic review was identified after LX and JYH reviewed the entire test. The research information was independently extracted into a pre-prepared table. Four main categories of information were involved: 1) basic information about the included studies: names of the authors, year of publication, country, purpose of the study, study design, participants, sample size, study setting, collection methods, and methods of analysis; 2) the form, characteristics, and stages of implementation of the PRO tools; 3) stakeholders implementing or receiving PROs; 4) definition and description of factors influencing PRO implementation in the original study.

The facilitators and barriers to PRO implementation reported in the study were imported into the NVivo® and categorized according to the CFIR during the data analysis phase. The CFIR framework is primarily used to predict or explain barriers and facilitators to implementation effectiveness. The revised version of the CFIR framework addresses the five domains of innovation: outer setting, inner setting, individuals, and implementation process, and comprises 48 constructs. ZH and WH independently coded the data based on the updated CFIR framework guidelines. Disagreements were resolved through discussion with a third researcher.

Results

Study selection

We identified 6,549 articles from 5 electronic databases, and 6 additional studies were identified from the reference lists of these articles. After removing duplicates, 4,419 studies unrelated to the research topic were excluded, and 79 studies were reviewed in full text. We excluded 37 studies during the full-text review process because of the following: unoncological clinical practice ( n = 6); protocol ( n = 4); unreported determining factor of PROs ( n = 7); inconsistency of research topics ( n = 18); non-target language ( n = 1); non-PRO instruments ( n = 1). We included 25 primary studies [ 18 – 22 , 24 – 26 , 36 – 52 ] and 5 secondary studies [ 53 – 57 ]. Figure 1 depicts the flowchart of the literature screening process for this review. Fig. 1 PRISMA flowchart of the study selection process

Study characteristics

The 25 original studies comprised a qualitative study ( n = 13), a quantitative cross-sectional study ( n = 7), and a mixed-method study design ( n = 5). The original studies were most frequently conducted in the United States ( n = 8), Australia ( n = 6), the Netherlands ( n = 3), Germany ( n = 3), and one study each in Canada, China, Italy, Norway, and the United Kingdom. Participants in the included studies were primarily cancer survivors and HCPs in routine cancer clinical practice settings. Some studies included hospital management, information technician professionals, and other stakeholders as participants. Based on cancer types, most studies focused on multiple cancer types, while some studies focused on breast cancer [ 20 , 21 , 37 , 42 , 52 ], head and neck cancer [ 26 , 36 ], and gastrointestinal tumors [ 25 , 38 ]. Two studies [ 48 , 49 ] were conducted on pediatric oncology. Based on study settings, most of the studies were conducted in a single-center setting, while some studies [ 22 – 25 , 36 , 37 , 40 , 42 , 43 , 45 ] involved multiple cancer and academic medical centers. Convenience and purposive sampling were often used as research methods in qualitative studies to select interviewees. Semi-structured interviews or focus groups were the primary interview methods used with a sample size of 11–56 interviewees, and thematic and content analyses were often used to analyze qualitative data. In the cross-sectional quantitative studies, perceptions of the stakeholders and determinants of PRO implementation were collected primarily through questionnaires, with sample sizes ranging from 129 to 727. In the mixed studies, mixed methods of qualitative studies combined with cross-sectional quantitative studies were used by most studies. Some studies limited the type of PRO tools used in the oncological clinical practice setting to single or multiple tools, while most studies did not strictly limit their choice. Standard tools included European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30(EORTC QLQ-C30), Common Terminology Criteria for Adverse Events (CACTE), and BREAST-Questionnaire (BREAST-Q). Over half of the studies collected PROs in an electronic format. Table 1 presents basic information on the included studies. Table 1 Basic information included in the primary studies Author, year country Participant Characteristic Cancer Type Study Setting Methods PRO Tools The Form of PRO Breidenbach, 2021 [ 28 ] Germany Target population: HCPs Interviewees ( n = 12): Physician ( n = 7) Nurse ( n = 3) Psychooncologist ( n = 1) Physician Assistant ( n = 1) Colorectal cancer multicenter Study design: qualitative study Participant recruitment: mixture of convenience and snowball sampling Data collection: semistructured interview Data analysis: content analysis approach based on Kuckartz and McWhertor EORTC QLQ-C30 online or on paper Consolo, 2023 [ 21 ] Italy Target population: physicians and nurses directly provided home palliative care Interviewees ( n = 19): Physician ( n = 9) Nurse ( n = 10) Palliative cancer care Istituto Nazionale dei Tumori of Milan Study design: qualitative study Participant recruitment: convenience and purposive sampling Theoretical framework: implementation of change in clinical practice developed by Grol Data collection: semistructured focus groups and field notes Data analysis: reflexive thematic analysis Types of PRO not restricted ePROM Graupner, 2021 [ 23 ] Netherlands Target population: HCPs working in oncological care Interviewees ( n = 19): Physician ( n = 7) Nurse ( n = 10) Other ( n = 2) Breast cancer, gynecological cancer, Colorectal cancer multicenter Study design: qualitative study Participant recruitment: convenience and purposive sampling Theoretical framework: implementation of change in clinical practice developed by Grol Data collection: semistructured interviews Data analysis: thematic analysis Types of PRO not restricted Unclear Iroz, 2023 [ 39 ] America Target population: Gastrointestinal surgery patients and HCPs Interviewees ( n = 15): Physician ( n = 2) Nurse ( n = 2 Physician Assistant ( n = 1) GI surgery patients ( n = 10) Gastrointestinal cancer academic medical center Study design: qualitative study Participant recruitment: purposive sampling Data collection: semistructured interviews Theoretical framework: CFIR Data analysis: phenomenological approach PRO after surgery Unclear Jagsi, 2013 [ 40 ] America Target population: medical oncologists Interviewees ( n = 17): Medical oncologist ( n = 17) All kinds of cancers multicenter Study design: qualitative study Participant recruitment: unclear Data collection: semistructured telephone interview Data analysis: thematic analysis Edmonton Symptom Assessment System Unclear Lai-Kwon, 2024 [ 42 ] Australia Target population: patients and caregivers; HCPs; hospital leaders; information technology specialists Interviewees ( n = 30): Patients ( n = 8) Caregiver ( n = 2) HCPs ( n = 18) IT specialists ( n = 2) All kinds of cancers Peter MacCallum Cancer Center Study design: qualitative study Participant recruitment: Purposive sampling Data collection: Focus groups/interviews Theoretical framework: CFIR Data analysis: deductive approach Types of PRO not restricted Unclear Lopez, 2024 [ 43 ] Canada Target population: cancer survivors, HCPs, clinic leadership Interviewees ( n = 56): Leadership/management ( n = 12) Oncologist ( n = 250 Nurse ( n = 13) Allied health clinicians ( n = 6) Breast cancer, colorectal cancer, head and neck cancer, or lymphoma cancer Four cancer canter in Canada Study design: qualitative study Participant recruitment: Purposive sampling Data collection: semi-structured focus group and interview Theoretical framework: Knowledge-to-Action (KTA) cycle Data analysis: thematic analysis was conducted using a hybrid deductive and inductive approach Prospective Surveillance Model ePROM Minteer, 2023 [ 44 ] America Target population: implementers in the health systems Interviewees ( n = 20): Oncologist ( n = 8) nursing leader ( n = 3) nurse practitioner ( n = 3) Others ( n = 8) All kinds of cancers multicenter Study design: qualitative study Participant recruitment: unclear Data collection: in-person or telephone interview Theoretical framework: CFIR Data analysis: directed content analysis E2C2: Enhanced EHR (electronic health record)-facilitated Cancer Symptom Control ePROM Roberts, 2019 [ 46 ] Target population: staff from multiple disciplines Interviewees ( n = 52): nursing clinicians ( n = 25) medical clinicians ( n = 13) allied health clinicians ( n = 14) All kinds of cancers oncology clinical outpatients’ unit Study design: qualitative study Participant recruitment: unclear Theoretical framework: iPARIHS Data collection: Focus groups and interviews Data analysis: directed content analysis Types of PRO not restricted unclear Sandhu, 2020 [ 48 ] America Target population: Oncologists Interviewees ( n = 16): Medical oncologist ( n = 11) Surgical oncologist ( n = 2) Radiation oncologist ( n = 3) All kinds of cancers Duke University School of Medicine Institution Study design: qualitative study Participant recruitment: convenience sampling Data collection: semistructured interviews Data analysis: thematic content analysis Types of PRO not restricted ePROM Shunmugasundaram, 2023 [ 51 ] Australia Target population: patients and HCPs Interviewees ( n = 31): Pre-testing ( n = 15) exploring barriers and facilitators ( n = 16) All kinds of cancers municipal cancer care Study design: qualitative study Participant recruitment: convenience sampling Data collection: Semi-structured cognitive interviews Data analysis: thematic analysis the Radiation therapy-related Inconvenience Questionnaire (RIQ) Skare, 2023 [ 52 ] Norway Target population: HCPs Interviewees ( n = 16): General practitioner ( n = 2) Nurse ( n = 12) Auxiliary nurses ( n = 2) All kinds of cancers municipal cancer care unit in Mid-Norway Study design: qualitative study Participant recruitment: purposive sampling Data collection: focus groups and individual interviews Data analysis: inductive thematic analysis EIR: a PRO instrument of palliative care ePROM Zhang, 2019 [ 22 ] America Target population: providers who had interacted directly with NMPRO Interviewees ( n = 11): Orthopedics ( n = 2) Cancer canter ( n = 9) All kinds of cancers multicenter Study design: qualitative study Participant recruitment: purposive sampling Data collection: qualitative interview Data analysis: thematic analysis Northwestern Medicine Patient Reported Outcomes ePROM Bruner, 2011 [ 25 ] America Target population: clinical investigators, data managers, NCI staff, FDA staff, cooperative group leadership, or patient advocates Sample size: 727 Researchers ( n = 189) Research staff ( n = 316) Patient advocates ( n = 104) Regulators ( n = 118) All kinds of cancers multicenter Study design: cross-sectional study Participant recruitment: unclear Survey instrument: developed a survey to capture the determinate factors of ePRO Data collection: distribute surveys online or on paper Period: 2008.10–2009.2 Data analysis: descriptive statistics and chi-square analyses CTCAE ePROM Cheung, 2022 [ 27 ] China Target population: HCPs Sample size: 362/402 Nurses ( n = 169) Physicians ( n = 140) Others ( n = 53) All kinds of cancers multinational Study design: cross-sectional study Participant recruitment: combination of convenience and snowball sampling approaches Survey instrument: demographic and work-related information; experiences with PRO collection; 18 items of implementation barriers to the routine collection of PRO Data collection: online survey Period: 2019.12–2020.6 Data analysis: descriptive statistics and chi-square analyses Types of PRO not restricted ePROM Hartkopf, 2017 [ 38 ] Germany Target population: breast cancer survivors Sample size: 202 Nonexposed group ( n = 96) Exposed group ( n = 106) Breast cancer multicenter Study design: cross-sectional study Data collection: paper-based PRO Period: 2015.7–2016.5 Data analysis: descriptive statistics; normality test; chi-square analyses; univariate categorical regression; Mediation analyses EORTC QLQ-C30 ePROM Mott, 2024 [ 24 ] America Target population: breast cancer survivors Sample size: 324/415 Breast cancer University of Colorado Health System Study design: cross-sectional study Survey instrument: convenience sampling Data collection: on-site questionnaire survey and email alert Timeline : after surgery: 2 weeks, 3 months, 6 months, 9 months, 1 year, and 2 years Theoretical framework: RE-AIM Period: 2019.6–2023.3 Data analysis: descriptive statistics BREAST-Q ePROM Nguyen, 2020 [ 29 ] Australia Target population: All HCPs involved in the care of HNC patients Sample size: ( n = 129) Radiation therapists ( n = 72) Oncology specialists ( n = 26) Others ( n = 30) Head and neck cancer Western Sydney Local Health District Study design: cross-sectional study Participant recruitment: convenience sampling Survey instrument: created a survey to recurrent themes of potential barriers and facilitators to routine PROMs use Data collection: disseminated via email Data analysis: descriptive statistics and chi-square testing the use of PROMs and PRO in the routine care of HNC patients Unclear Schepers, 2017 [ 50 ] Netherlands Target population: pediatric cancer survivors and their parents Sample size: 205/281 All kinds of cancers in pediatric Emma Children’s Hospital Study design: cross-sectional study Participant recruitment: convenience sampling Survey instrument: Medical and sociodemographic characteristics; Barriers to and facilitators of implementation; Timeline: after diagnosis:1, 3, 6 months Data collection: disseminated via email Period: 2012.6–2014.3 Data analysis: descriptive statistics, chi-square tests, and independent samples t-test HRQoL-questionnaires; PedsQL 3.0 Acute Cancer Module ePROM Schepers, 2016 [ 49 ] Netherlands Target population: HCPs working in pediatric oncology practice Sample size: ( n = 359) All kinds of cancers in pediatric multicenter Study design: cross-sectional study Participant recruitment: convenience sampling Survey instrument: sociodemographic and clinical background information; current use of PROs in their organization; whether they valued the routine use of PROs in clinical practice and a list of physical and psychosocial PRO content topics; HCPs preferences for receiving PRO information; perceived barriers in the routine assessment of PROs Data collection: disseminated via email Period: 2014.8–2015.1 Data analysis: descriptive statistics, two-tailed Fisher’s exact test Types of PRO not restricted Duman-Lubberding, 2017 [ 37 ] Netherlands Head and neck cancer Department of Otolaryngology-Head and Neck Surgery, VU University Medical Center, Study design: mixed methods design Data collection: structured interview and a study-specific paper-and-pencil questionnaire Period: 2013.4–2013.9 Data analysis: Quantitative data: descriptive statistics, chi-square tests, independent samples t-test, and multiple logistic regression analyses Qualitative data: thematic analyses OncoQuest to monitor HRQOL via the EORTC QLQ-C30 and QLQ-H&N35 questionnaires and the Hospital Anxiety and Depression Scale (HADS) ePROM Kiderlen, 2023 [ 41 ] Germany Target population: patients diagnosed with multiple myeloma under current treatment Samples: ( n = 11/36) Interviewees: ( n = 10) Multiple myeloma an outpatient clinic Study design: mixed methods design Participant recruitment: unclear Data collection: the interview was conducted face-to-face or via telephone Data analysis: descriptive analysis the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) ePROM Naehrig, 2021 [ 45 ] Australia Target population: cancer survivors and HCPs Sample size: 404/1233 Interviewees: 26 All kinds of cancers Chris O’Brien Lifehouse Comprehensive Cancer Center Study design: mixed methods design Data collection: retrospective collection of information on the use of ESAS and semi-structured interviews with clinical staff to collect qualitative data Period: retrospective study stage: 2017.7–2018.6; qualitative study stage: 2019.2–2019.7 Data analysis: Quantitative data: generalized estimating equations and principal component analysis with a varimax rotation were performed Qualitative data: thematic analyses ESAS online or on paper Roberts, 2021 [ 47 ] Australia Target population: cancer survivors and HCPs Samples: ( n = 155) Pre-implementation ( n = 83) Post-implementation ( n = 72) All kinds of cancers Study design: mixed methods design Theoretical framework: iPARIHS Data collection: field notes; survey to collect the HCP’s perceptions of PRO Timeline: pre and post implementation Data analysis: Quantitative data: unclear Qualitative data: content analysis the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Tsangaris, 2023 [ 53 ] America Target population: patients receiving care for breast cancer Sample: ( n = 1070/3031) Breast cancer Multicenter Study design: mixed methods design Theoretical framework: RE-AIM Data collection: semi-structured interview; Data analysis: Quantitative data: descriptive statistics; chi-square test; Fisher exact test; student’s t-test Qualitative data: qualitative description BREAST-Q Breast Cancer Module ePROM Abbreviations : EORTC-QLQ European Organization for Research and Treatment of Cancer, Quality of Life, ePROM electronic Patient Reported Outcome Measures, CFIR the Consolidated Framework for Implementation Research, HCP Health Care Professional, iPARIHS integrated Promoting Action on Research Implementation in Health Services, RE-AIM the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, CTCAE the Common Terminology Criteria for Adverse Events, HRQoL Health Related Quality of Life, ESAS Edmonton Symptom Assessment Scale, NMPRO Northwestern Medicine Patient Reported Outcomes

Table 2 lists the basic information of the five included secondary studies [ 53 – 57 ], which included one review and two scoping and systematic reviews. Table 2 Basic information included in reviews Author, year country Study design Objective Inclusion criteria No. of original studies Finding Abejas, 2023 [ 54 ] Portugal Scoping Review Understand the challenges of implementing ePRO to improve HRQoL Lung cancer and rare diseases; English; Published in 2017–2022; Peer reviewed; Ethics permission obtained Total: 12 Systematic review: 4 Qualitative study: 3 Factors for implementation: 3 Other:2 At least four barriers to PRO implementation exist, including cost, complex programming within health systems, safety, and social and health literacy Easpaig, 2020 [ 55 ] Australia A mixed-method synthesis of the qualitative evidence Identify the attitudes of HCPs toward PRO in oncology, including barriers and facilitators to PRO adoption 1) qualitative data was analyzed and reported separately; 2) published in English and reported primary findings; 3) reported attitudes of HCPs working in oncology towards PRO Total: 34 Qualitative study: 17 Mixed methods: 17 Vital factors influencing practice are the fit of PRO with existing practices, its value, the capacity to respond to PRO, and available supports Howell, 2015 [ 56 ] Canada Scoping Review Identify the PRO used in routine cancer clinical practice, the impact on patient, provider, and system outcomes, and the implementation factors influencing uptake 1) reported on the ‘routine’ use of PRO; 2) the PRO was completed by the patient and resulted in a numeric value; 3) cancer patients or survivors; 4) evaluated outcomes of uptaking or using of PRO Total: 34 Primary studies: 30 Review articles: 4 PRO is increasingly used in routine cancer clinical practice, but the lack of standardized procedures makes using these data for quality monitoring complex in the future Nguyen, 2021 [ 57 ] Australia review Examine the barriers associated with routine PRO and PRO use in oncology Studies focusing on routine PRO use for real-time patient care were included, while articles focusing on the collection of PRO for research purposes were excluded Total: 14 Qualitative study: 6 Quantitative cross-sectional study: 4 Mixed methods: 4 This review examined potential barriers to routine PRO use in the oncology context, including lack of time, incapacity and difficulty using electronic devices, and lack of knowledge and experience van Egdom, 2019 [ 58 ] Netherlands systematic review Provide an overview of the PRO administration methods and their facilitators and barriers in breast cancer clinical practice Studies were excluded if they 1) non-breast cancer patients; 2) had an irrelevant aim; 3) case report, editorial, review, or study protocol; 4) overlapping study population with a related study; 5) unpublished Total: 34 cohort study: 10 RCT: 12 Cross-sectional study: 5 Intervention study: 1 Qualitative study: 4 Observational study: 1 Quality improvement substudy: 1 Systematic PRO collection has a promising impact on patients, providers, and care processes/ systems. Further standardization and reporting on the method and frequency of PRO collection might help increase the effectiveness of PRO interventions Abbreviations : ePRO electronic Patient Reported Outcome Measures, HRQoL Health-Related Quality of Life, HCP Health care professional

Quality assessment results

Supplementary File 2 presents the results of the quality assessment.

Qualitative studies

The assessment of the included 13 qualitative studies was good. All studies clarified the purpose of using qualitative research methods, adopted appropriate methods of data collection and analysis, and highlighted the typicality of the subjects and their perspectives in reporting the results. However, most studies did not elaborate on the situation of the researcher and interactions with the study, including their cultural background and values.

Analytical cross-sectional study

The quality of the seven quantitative studies was rated fair. These studies comprehensively described the participant populations, study settings, and analysis methods. However, unlike other quantitative cross-sectional studies, these studies primarily collected facilitators and barriers to implementing PROs, making it challenging to determine confounders, a significant factor that reduces the quality of the literature.

Mixed-method studies

The quality assessment of the five mixed studies was rated fair, primarily because of the lack of detailed descriptions of the research methodology, particularly the quantitative research methodology. Besides, the lack of detailed reporting on the reasons for using mixed studies was an essential factor in this result.

The determinants that affect the implementation of PROs

This systematic review synthesized the facilitators and barriers to implementing PROs from the included studies and categorized them according to the CFIR. Supplementary File 3 presents the detailed results. Overall, 52 facilitators and 50 barriers were identified, which encompassed the domains used in the CFIR framework and covered 39 constructs (39/48; 81.25%), primarily including "Innovation Evidence-Base", "Innovation Complexity", "Innovation Design", "Structural Characteristics", "Compatibility", "Incentive Systems", "Access to Knowledge & Information", "Innovation Deliverers", "Innovation Recipients", and "Planning". We reviewed the essential facilitators and barriers in all included studies according to the construct of the CFIR involved.

Innovation domain

Innovation evidence-base: In this construct, studies stated that a significant contributing factor is the potential for PRO tools to make a practical difference in clinical practice [ 47 ]. For instance, they could assist HCPs in monitoring and managing clinical problems [ 39 ] and improve patient care [ 18 , 42 ]. Conversely, if they are unsure about the utility and effectiveness of PRO tools, this will limit their routine use [ 22 , 26 ].

Innovation relative advantage: This construct indicated that applying PROs in routine oncology clinical practice can benefit various stakeholders, facilitating the implementation and dissemination of PRO tools. For instance, the PRO implementation can reflect and meet patient needs in oncology diagnosis, treatment, rehabilitation, and end-of-life care [ 18 , 42 ]. Furthermore, PROs could assist HCPs in accurately identifying existing or potential clinical problems in patients to improve clinical work efficiency [ 47 ]. However, the routine application of PRO tools is impeded by significant barriers, including the fear of associated legal liabilities and an increased workload, which can result in infringing on the rights of the stakeholders [ 39 , 51 ].

Innovation adaptability: Flexibility in the design of tools facilitates PRO implementation. The design of PRO tools needs to be flexible and changeable according to different clinical settings and patient characteristics [ 41 , 47 ], which can enhance the acceptability of these tools among HCPs and patients. Conversely, the diffusion of a tool would be diminished if it were designed without considering the individual variability of patients [ 42 ].

Innovation complexity and design: The simplicity of the design of the PRO tool and the appropriate difficulty of completion are facilitating factors that promote the routine adoption of the tool. Previous studies reported a high degree of individual variability in the ability of patients to complete the PRO tool [ 22 , 47 , 51 ], and assisting patients in achieving the clinical outcome report is a time-consuming process [ 19 ], which will limit the use of PROs. The complex design and lack of functionality of the PRO system was another significant barrier emphasized by the construct. This is primarily evident in the following: first, the complex design limits the convenience of HCPs and patients in accessing and using the PRO tools [ 42 , 43 ]; second, there is a lack of visualization tools to present the results of the PRO assessment in a quick and precise manner [ 38 , 41 , 49 ].

In the innovation domain, the feasibility of piloting PRO tools on a small scale and controlling PRO implementation costs within acceptable limits are contributing factors [ 46 ] that can effectively facilitate the application of PROs [ 41 ].

Outer setting domain

Partnerships and connections: This construct emphasizes establishing and strengthening partnerships with external organizations. Previous studies reported that collaborative relationships with other organizations, thereby facilitating the dissemination of lessons learned, are one of the facilitating factors for PRO implementation [ 41 , 42 ].

Policies and laws: PRO implementation in compliance with the guidelines and local legal norms is a significant contributing factor emphasized in this area [ 42 , 43 ]. The effective operation of PRO projects will be facilitated by acquiring appropriate resource allocation in this manner [ 42 ]. Conversely, in the absence of policy support, it will be challenging to implement PROs in the current environment [ 41 , 43 ].

Financing: Obtaining external financial support is essential to ensuring the stable operation of PRO programs. For instance, funding for PRO implementation can be increased by lobbying governments and converting PROs into commercialized models. [ 42 ]. However, a previous study reported that there is a lack of specialized funding models for PRO symptom monitoring [ 42 ].

In the outer setting domain, obtaining the support of external organizations [ 41 , 53 ] and the use of PROs as performance evaluation indicators [ 47 ] are factors contributing to the successful implementation of PROs. Barrier factors include the lack of support from local experts [ 24 , 26 ] and limited working hours for HCPs [ 21 ].

Inner setting domain

Structural characteristics: This construct emphasizes that physical, information technology, and work infrastructure are the foundational configuration requirements that impact PRO implementation in routine oncology practice. Configuring portable electronic devices, embedding PROs in the EHR, and planning a rational workflow facilitate PRO implementation in the clinical practice setting. For example, providing several tablets for PRO data collection can increase patient response rates [ 19 , 47 ]. Second, multiple studies have reported that integrating PROs into EHR could facilitate physicians to collect clinical data more conveniently during outpatient or follow-up visits and present these data in an easy-to-understand manner, thus increasing PRO implementation [ 16 , 25 , 41 ]. Furthermore, rational planning of work procedures and clear task assignments can avoid unnecessary work duplication [ 51 ]. However, the lack of equipment support for data collection [ 18 , 22 , 26 ], the absence of an information system for collecting [ 21 , 24 ] and managing PRO data, and the irrational arrangement of work procedures [ 16 , 17 , 49 ] will hinder the routine application of PROs.

Relational connections and communication: This construct focuses on enhancing coordination and information sharing among internal multidisciplinary departments [ 25 ]. Strengthening internal communication is essential in PRO implementation, particularly in the following two areas. First, communication and coordination among HCPs can improve clinical work efficiency and prevent patients from receiving multiple similar or identical surveys in a short duration [ 20 , 41 , 58 ]. Second, it is essential to improve communication between HCPs and patients so that timely feedback and opinions can be obtained from patients to facilitate the continuous improvement of the quality of the application of PRO tools [ 16 , 25 ].

Compatibility: This construct primarily emphasizes that PROs should be aligned with current clinical practice activities and workflows to avoid overlap in different systems [ 25 , 41 ]. The alignment of PRO collection with other clinical practice activities, workflows, and EHR is one of the key factors that facilitate the routine use of PRO [ 22 , 58 ]. However, previous studies reported that different clinical settings have unique work processes and a lack of coordination among departments, limiting the PRO integration into different contexts [ 26 , 43 , 49 ].

Incentive systems: Depending on the use of PRO tools, appropriate incentives, including the following two main approaches, can increase the motivation of HCPs to use PROs: First, material incentives can be provided in return for HCPs integrating PROs into their daily clinical work, including direct financial support and the use of PROs in employee performance evaluations [ 22 , 47 , 58 ]. In addition, intangible incentives are essential in the application of PRO tools. For example, the perceived benefits of the routine implementation of PRO tools by stakeholders [ 41 , 50 , 51 ] and recognition from management for using PROs [ 51 ] will boost the confidence of HCPs in using PROs.

Available resources: This construct emphasizes the integration of all available resources from the three aspects of funding, space, and materials and equipment, including ensuring adequate financial support [ 41 ], providing sufficient time and space [ 22 , 41 ], allocating required materials or equipment [ 19 , 42 ], and rationally distributing human resources, which can provide appropriate resource support for PRO implementation [ 26 ].

Access to knowledge and information: The lack of accessible training for HCPs limits the implementation of PROs. Providing sufficient time and resources to train HCPs can motivate them to use such tools in clinical practice before PRO implementation [ 20 , 50 ]. Besides, patients and their caregivers should be trained, and helping them understand the purpose and role of symptom monitoring will improve their use of PRO tools [ 41 ].

Several significant domain-influencing factors were less mentioned in the literature. These include reflecting people-centered values [ 46 ], considering the timing of PRO introduction into the system [ 41 ], ensuring that PRO projects have specific advantages over other projects [ 41 , 42 ], and setting strategic goals for coordinating PRO implementation [ 24 ]. All should be considered when designing PRO projects.

Individuals domain

This domain primarily emphasizes the crucial role of multi-stakeholders in PRO implementation.

Innovation deliverers: The structure focuses on the capacity and motivation of HCPs in PRO implementation. First, complete awareness, understanding, and familiarity with PRO tools may increase the ability and motivation of HCPs to utilize these tools [ 20 , 42 , 45 ]. However, insufficient implementation experience and limited working hours may hinder the effective use of PROs [ 18 ]. Furthermore, HCPs use PRO tools because of their perceived efficacy in clinical problem management. Therefore, using PRO tools may decrease if their efficacy is uncertain. [ 19 , 49 ].

Innovation recipients: PRO recipients will be limited in their ability to complete the questionnaire due to older age, low literacy, language barriers, severe disease conditions, and poor current physical condition [ 20 , 21 , 26 ]. Several studies have reported that educating patients on the value of PROs can increase their willingness to complete questionnaires [ 30 , 38 ]. However, due to limited clinic time [ 20 , 22 ], questions about the significance of PROs [ 21 ], and fear of replacing communication with HCPs [ 26 ], the willingness of patients to complete the questionnaire can be reduced. Stakeholders, including PRO project management, opinion leaders, and project facilitators who support and participate actively, significantly contribute to PRO implementation [ 41 , 46 ].

Implementation process domain

Teaming: This construct emphasizes the need to form multidisciplinary teams of HCPs, with members from each discipline working together to improve the clinical use of PROs [ 20 , 51 ].

Assess needs: PRO practitioners are looking for a tool to help them manage clinical issues and software support to visualize the PRO details of patients in charts and graphs [ 38 , 43 ]. However, some clinicians preferred using PROs during nurse consultations to increase clinical productivity [ 20 ]. Previous studies have reported that it is essential for PRO recipients to understand and consider the needs of patients and provide them with clear information [ 20 , 43 ]. In addition, patients want to be able to complete self-reporting from home via the Internet or telephone [ 22 ].

Planning: Developing workflows for the corresponding tasks, including the identification of reasonable points in time and frequency of assessment, and integrating the workflows into routine clinical work is necessary to ensure the smooth operation of the PROs [ 26 , 43 , 50 ].

Tailoring strategies: Small-scale system testing before the formal PRO implementation can facilitate long-term stable operations [ 22 , 39 ].

Discussion

PROs in oncology clinical practice settings have received significant attention in recent years. Although previous review studies have investigated facilitators and barriers to implementing PROs, most have not systematically identified and integrated these determinants from the IS perspective [ 53 – 57 ]. Because the CFIR can be used to identify implementation influences, develop strategies, and evaluate implementation effectiveness [ 59 , 60 ], this systematic review will identify and weigh important factors influencing PRO implementation in oncology clinical practice settings. We found 52 facilitators and 50 barriers in the 30 included studies. Consistent with the findings of previous studies [ 53 – 57 ], which mentioned barriers such as time constraints, a lack of relevant training, doubts about the clinical value of PROs, a lack of financial support, and high patient symptom burden, and facilitators including well-functioning electronic tool availability, embedding the EHR, and understanding the clinical value of PROs.

In the innovation domain, the development and design of PRO tools should be based on clinical evidence to ensure that such tools are scientifically feasible to improve clinical effectiveness [ 11 , 61 , 62 ]. Evidence-based PRO practices can assist HCPs in identifying and addressing existing or potential health problems in patients and understanding how PRO tools can enhance clinical practice [ 63 ]. HCPs will reduce PRO use if they believe it is insufficient for current clinical decision-making or realize it will harm them and their patients. Second, the requirements and capabilities of multiple stakeholders need to be considered during the PRO design phase [ 64 , 65 ]. Patients vary in literacy, language communication skills, and medical conditions in clinical practice. Consequently, the ability of patients to complete those tools should be carefully considered when designing the PRO tool. The PRO tool design should be simplified, and strategies including limiting the number of entries, establishing an appropriate questionnaire level of difficulty, having a proper monitoring frequency and duration of follow-up, and being accessible to access and use may increase the acceptability of the PRO tools [ 61 ]. Besides, PRO data should be presented to HCPs in an understandable way, and delivering the collected information through trend graphs or visualizations may help HCPs understand and address the problems of their patients faster.The main factors affecting PRO implementation in the outer setting domain are policy support from government departments, communication between external organizations, and obtaining external financial support [ 66 ]. PRO implementation requires support from various departments. Implementing PROs to collect problems of patients in routine clinical practice should adhere to international and national organizations or government departments' guidelines and local policy norms. Conversely, matching sufficient resources to support the effective PRO implementation will be difficult [ 61 ]. Furthermore, external organizations should strengthen their partnerships and share best practices. Obtaining mutual support across sectors will facilitate better PRO implementation. However, the lack of support from local experts in low-income countries often impedes PRO implementation and promotion. Adequate funding is an essential facilitator in ensuring smooth PRO implementation. Lai-Kwon et al. [ 41 ] conducted a qualitative study to identify barriers and facilitators to implementing ePRO symptom monitoring in routine cancer care using the Consolidated Framework for Implementation Research (CFIR) and the barriers were matched to theory-informed implementation strategies using the CFIR-Expert Recommendations for Implementing Change (ERIC) matching tool. This research reported that appropriate financial support can be obtained by lobbying the government for long-term funding, incorporating oncology funding models, and commercialization. However, the current funding model does not provide dedicated financial support for PROs.

When implementing PROs in an internal clinical practice environment, several factors should be considered. There is a prevailing trend toward using electronic PRO tools to collect questions in clinical practice [ 67 ]. However, Lai-Kwon et al. [ 41 ] reported that it is too early to implement PROs in the early stages of digital transformation in hospitals. The infrastructure configuration of the clinical setting must be met by providing accessible computers, improving system functionality, and planning work processes and staffing [ 63 ]. Moreover, embedding PROs into EHRs should be considered, as it can assist HCPs in collecting and managing patient clinical data efficiently. Based on the internal environment, the ability and motivation of employees to use PRO tools should be considered. Employees can learn and use PRO tools better through systematic training and the promotion of multidisciplinary department exchanges. Furthermore, direct financial incentives and moderate encouragement and recognition from management are needed to motivate the routine use of the PRO tools. Adequate funding is essential in ensuring the successful implementation of PRO.

Multi-stakeholder involvement is essential in the individual domain, as innovation deliverers and recipients play an important role in PRO implementation [ 58 , 68 , 69 ]. The innovation deliverers must be familiar with the content, clinical value, and implementation procedures of PRO tools and boost their confidence in implementing PROs through appropriate training as the prominent members who directly implement PROs. Additionally, the necessary conditions for innovation deliverers to implement PROs, including appropriate space, sufficient time, and available equipment, should be provided. Educational attainment, disease status, cultural differences, and language ability vary among innovative recipients. These factors can limit the application of PRO programs. As mentioned in the innovation domain, differences in patient ability must be considered during the design phase of an innovation program to ensure that the developed PRO tools can meet the needs of different patients. Besides, allowing patients to understand the clinical benefits and scientific value of PRO implementation is essential in increasing their willingness to use them. Other stakeholders, including leaders at all levels of innovation, opinion leaders, and executive leads, can increase the motivation of implementation team members by trusting and affirming the implementation of PRO programs.

Before implementing a PRO program, it is essential to form a multidisciplinary team, design a rational workflow, and test the program on a small scale. A sensible workflow for implementing PRO needs to be planned, including integrating it into the flow of routine clinical practice and determining reasonable nodes and frequency of evaluation practice [ 58 , 63 , 66 ]. As a result, the feasibility of the PRO program can be effectively verified through a small-scale trial, and potential problems in the process can be identified, allowing the workflow of PROs to be rationalized promptly. During implementation, it is necessary to meet the needs of various stakeholders [ 62 ]. Innovation deliverers must meet the hardware requirements of HCPs to implement PROs for information technology support, which can effectively improve implementation efficiency. However, because implementing PROs can be labor-, time-, and money-intensive, it is essential to consider a PRO tool with high sensitivity and specificity for screening patient populations for potential problems. Providing innovation recipients with the information to fill out the PROs, understanding and meeting their needs across the material, psychosocial, and other dimensions of the disease, and, significantly, timely treatment and feedback from HCPs when they experience early warning symptoms can increase the sense of benefit to the patient from filling out the PROM and improve better self-reporting.

The greatest strength of this study is the use of the updated CFIR framework, which provides a comprehensive and systematic categorization of the determinants that influence PRO implementation programs. The updated CFIR framework may provide researchers with a structured approach to analyzing and understanding the various factors influencing the successful implementation of a program, policy, or intervention. However, this study has several limitations. First, the dimensions and constructs of the updated CFIR exhibit instances of synonyms and polysemous terms, resulting in ambiguity during the coding and analysis process. The literature in this systematic review is almost exclusively from developed countries; thus, we have no idea what opportunities and challenges low- and middle-income countries face in implementing PRO programs. Second, cultural and healthcare system differences between countries mean that some of the influences identified in this study are unique to individual countries or regions, and the findings of this study should be applied with caution in clinical practice. Third, the diversity of the study types included the fact that fewer studies used the CFIR framework to identify influencing factors, resulting in variations in definitions and understandings of influencing factors across studies and the differences in how influencing factors were documented across studies, with the strength of the evidence for individual influences being further justified. Fourth, this study only systematically searched Chinese and English databases with no systematic search of literature in other languages. Unfortunately, the initial search of Chinese databases revealed no relevant studies describing the determinants of implementing PRO. This may be because the concept is newly introduced in the Chinese region, and no attention has been paid to implementing specific PROs.

Conclusions

This study systematically reviewed the barriers and facilitators to PRO implementation in oncology clinical practice settings based on the updated CFIR framework. Considering the design characteristics of PROs, available conditions in the outer and inner settings, and meeting the needs of all stakeholders in the implementation process are essential to ensuring the effective implementation of PRO programs. This systematic review provides a reference framework for departments to develop strategies to resolve current PRO implementation issues and ensure successful PRO implementation.

Supplementary Information

Supplementary Material 1. Supplementary Material 2. Supplementary Material 3.

Abbreviations

Patient Reported Outcome

Consolidated Framework for Implementation Research

Clinician-reported outcome

Observer-reported outcome

Performance outcome

Implementation Science

National Institution of Health

Reach, Effectiveness, Adoption, Implementation, Maintenance

Promoting Action on Research Implementation in Health Services Framework

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Hao Zhang and Hua Wang contributed equally to this work and share first authorship.

Acknowledgements

Not applicable.

Authors’ contributions

LJX, ZH: proposed the research question and designed the theoretical construct of the systematic review; ZH, WH, LX, JYH: completed the systematic search of the literature, quality assessment, and data extraction; LJX, ZH, WH: wrote the manuscript; YL, WAP: critically revised the intellectual content of the manuscript. All authors read and approved the final manuscript.

Funding

This work is supported through Graduate Research and Innovation Fund of Chengdu Medical College (YCX2023-01–51), Sichuan Nursing Society ( H22023 ) and Sichuan Medical Association ( S23058 ).

Data Availability

The datasets used and analyzed in this study are available upon request from the corresponding author.

Declarations

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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