Use Of Patient-reported Outcomes Data Research Articles

Making decisions for follow-up chemotherapy based on digital patient reported outcomes data in patients with multiple myeloma and other M protein diseases – A mixed method study

ObjectivesTo test if Patient Reported Outcomes (PRO) data can replace physical on-site consultation in determining if patients with multiple myeloma, AL amyloidosis, or plasma cell leukemia are ready for their next bortezomib treatment without dose reduction. MethodsWe developed an online questionnaire addressing common side effects to bortezomib and an algorithm stratifying patients according to their responses and asked them to complete the questionnaire the day before attending the clinic. Applying a mixed-method study design of PRO data, time registrations, and interviews with patients and healthcare professionals, we tested the usability of electronic PRO data forming the basis of decision-making on whether patients are physically fit for the next treatment with an unchanged dose. ResultsThe questionnaire and the associated algorithm were able to identify patients who were physically fit for treatment without need for further consultation, with a positive predictive value of 98 %. The method proved to be feasible for all groups of patients regardless of age and educational level. Patients and healthcare professionals found the online questionnaire to be advantageous and flexible. ConclusionThe use of PRO data to evaluate patients prior to bortezomib treatment is safe and feasible. Patients prefer to report their side effects themselves as it provides them with more freedom during their treatment.

Barriers and Facilitators to Implementing Patient-Reported Outcome Monitoring in Gastrointestinal Surgery

IntroductionMore than 30% of patients experience complications after major gastrointestinal (GI) surgery, many of which occur after discharge when patients and families must assume responsibility for monitoring. Patient-reported outcomes (PROs) have been proposed as a tool for remote monitoring to identify deviations in recovery, and recognize and manage complications earlier. This study's objective was to characterize barriers and facilitators to the use of PROs as a patient monitoring tool following GI surgery. MethodsWe conducted semistructured interviews with GI surgery patients and clinicians (surgeons, nurses, and advanced practitioners). Patients and clinicians were asked to describe their experience using a PRO monitoring system in three surgical oncology clinics. Using a phenomenological approach, research team dyads independently coded the transcripts using an inductively developed codebook and the constant comparative approach with differences reconciled by consensus. ResultsTen patients and five clinicians participated in the interviews. We identified four overarching themes related to functionality, workflow, meaningfulness, and actionability. Functionality refers to barriers faced by clinicians and patients in using the PRO technology. Workflow represents problematic integration of PROs into the clinical workflow and need for setting expectations with patients. Meaningfulness refers to lack of patient and clinician understanding of the impact of PROs on patient care. Finally, actionability reflects barriers to follow-up and practical use of PRO data. ConclusionsWhile use of PRO systems for postoperative patient monitoring have expanded, significant barriers persist for both patients and clinicians. Implementation enhancements are needed to optimize functionality, workflow, meaningfulness, and actionability.

Hernia Defect Closure With Barbed Suture: An Assessment of Patient-reported Outcomes in Extraperitoneal Robotic Ventral Hernia Repair.

Primary closure of a fascial defect during ventral hernia repair is associated with lower rates of recurrence and better patient satisfaction compared with bridging repairs. Robotic surgery offers enhanced ability to close these defects and this has likely been aided by the use of barbed suture. The goal of this study was to evaluate the perioperative safety and the long-term outcomes for the use of barbed suture for the primary closure of hernia defects during robotic ventral hernia repair (rVHR) with mesh. This is a retrospective study of adult patients who underwent rVHR with the use of a barbed suture for fascial defect closure from August 2018 to August 2020 in an academic center. All the patients included were queried by phone to complete a quality of life assessment to assess patient-reported outcomes (PROs). Subjective sense of a bulge and pain at the previous hernia site has been shown to correlate with hernia recurrence. These questions were used in conjunction with a Hernia-related Quality of Life Survey (HerQles) score to assess a patient's quality of life. A total of 81 patients with 102 hernias were analyzed. Sixty patients (74%) were successfully reached and completed the PRO form at median postoperative day 356 (range: 43 to 818). Eight patients (13% of patients with PRO data) claimed to have both a bulge and pain at their previous hernia site, concerning for possible recurrence. Median overall HerQLes score was 82 [Interquartile Range (IQR): 54 to 99]. Patients with a single hernia defect, when compared with those with multiple defects, had a lower rate of both a bulge (15% vs. 30%) and symptoms (33% vs. 48%), as well as a higher median HerQLes score (85 vs. 62) at the time of PRO follow-up. Patients with previous hernia repair had a lower median HerQLes score of 65 (IQR: 43 to 90) versus 88 (IQR: 62-100). These patients also had a higher rate of sensing a bulge (29% vs. 18%), whereas a sense of symptoms at the site was less (33% vs. 44%). Barbed suture for fascial defect closure in rVHR was found to be safe with an acceptable rate of possible recurrence by the use of PRO data. Patients with multiple hernias and previous repairs had a higher likelihood of recurrence and a lower quality of life after rVHR.

Feedback of aggregate patient-reported outcomes (PROs) data to clinicians and hospital end users: findings from an Australian codesign workshop process

ObjectivesPatient-reported outcomes (PROs) are increasingly used to measure the patient’s perspective of their outcomes following healthcare interventions. The aim of this study was to determine the preferred formats for reporting...

ICF-Based Assessment of Functioning in Daily Clinical Practice. A Promising Direction Toward Patient-Centred Care in Patients With Low Back Pain

Background: Patient-centred care has received increased attention in recent years. Patient-Reported Outcomes (PROs) and shared decision-making are key components of Patient-Centred care. Low back pain (LBP) is a complex symptom affected by multiple, interacting factors. Therefore, evidence strongly recommend a biopsychosocial and patient-centred approach in the assessment and management. The International Classification of Functioning, Disability and Health (ICF) provide a biopsychosocial model for describing functioning and disability. ICF is widely acknowledged, but implementation into clinical practice is lacking. To support the use of a biopsychosocial and patient-centred approach in daily clinical practice among patients with LBP we developed a practice-friendly tool based on ICF; the LBP assessment tool.Objective: To compare an ICF-based assessment facilitated by the LBP assessment tool with standard care in terms of the use of PROs and shared decision-making in order to promote patient-centred care in patients with LBP.Methods: A non-randomized controlled design was used. Eligible patients were allocated to one of two groups: the ICF group, assessed with the LBP assessment tool or the control group, assessed with a conventional LBP assessment. Primary outcome includes use of PROs. Secondary outcomes include use of a graphical overview displaying the patient profile and shared decision-making. A patient evaluation questionnaire was used to collect data.Results: Seven hundred ten patients were assessed for eligibility of whom 531 were allocated to the ICF group (n = 299) or the control group (n = 232). A significantly higher use of PRO data (p < 0.00) and the patient profile (p < 0.00) was reported in favor of the ICF group. Patients in the ICF group also experienced being more involved in decision-making (p = 0.01).Conclusions: This study showed that a functioning assessment, by means of the LBP assessment tool, increased use of PROs and shared decision-making when compared to a conventional LBP assessment. Additionally, this study demonstrated that routine use of ICF-based PRO data and shared decision-making promoted patient-centred care in patients with LBP. The LBP assessment tool may be a strong candidate for a user-friendly ICF-based tool with the potential to support health professionals in a shift toward a biopsychosocial and patient-centred approach to patients with LBP.

Challenges in the implementation of electronic systems for patient report of symptoms in oncology: a scoping review.

Under-recognition and under-treatment of symptoms are prevalent throughout the health care system in the United States. While the reasons for this are complex, it is widely recognized that electronic symptom reports can improve clinicians' ability to manage symptoms. However, electronic symptom reporting has yet to be widely implemented. Electronic systems are most effective when tailored to the specific patient population or clinical setting. For example, numerous oncology-focused electronic symptom reporting systems have been developed for patients with cancer undergoing treatment in the United States. The objective of this scoping review was to identify challenges that arose in the implementation of electronic systems for patient-reported symptoms in oncology clinical practice, and approaches that were taken or recommended to overcome those challenges. This scoping review involved comprehensive searches of Medline, CINAHL, and the Cochrane Central Register of Controlled Trials, which yielded 3,133 articles. Following screening, 20 research studies met the inclusion criteria and were included in this review. Data were systematically extracted from the articles using a qualitative content analysis. Challenges identified were thematically categorized as technical issues, system usability issues, patient lack of comfort/knowledge of technology, incomplete/missing data, lack of patient use of the system, other patient issues, difficulties timing completion with clinical processes, lack of clinic staff involvement/engagement, and lack of clinician comfort/knowledge regarding the use of patient-reported outcome data. The findings of this review highlight challenges that need to be addressed when implementing an electronic symptom reporting system for patients with cancer, and potential strategies for overcoming these challenges. This review may help hospital administrators and clinicians prepare for and improve the implementation of electronic symptom reporting systems into clinical practice, thereby providing evidence to enable their broader use.

International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study

PurposeEvidence suggests that the patient‐reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non‐reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.MethodsSemi‐structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame.ResultsForty‐four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists’ reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified.ConclusionMisconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.

Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient-reported outcomes in randomized controlled trials to support clinical decision-making.

BackgroundGiven the growing importance of patient‐reported outcomes (PROs) as part of “big data” in improving patient care, there is a need to provide a state‐of‐the‐art picture of the added value of using PROs in prostate cancer (PCa) randomized controlled trials (RCTs). We aimed to synthetize the most recent high‐quality PRO evidence‐based knowledge from PCa RCTs and to examine whether quality of PRO reporting in PCa research improved over time.MethodsWe conducted a systematic literature search using PubMed, from April 2012 until February 2019. For benchmarking purposes, we also included RCTs identified in our previously published review of RCTs (2004‐2012). Methodology for study identification and evaluation followed standardized criteria and a predefined data extraction form was used to abstract information. PRO quality of the studies was evaluated using the International Society of Quality of Life Research (ISOQOL) recommended criteria.ResultsA total of 55 new RCTs were published between April 2012 and February 2019. About 24 (43.6%) RCTs were found to be of high‐quality regarding PRO assessments. Of these, 13 (54.2%) have been reported in the most recent European Association of Urology (EAU) PCa Guidelines. Overall QoL and sexual, urinary, and bowel function were the most commonly reported PROs. FACT‐P, EPIC‐26, and EORTC QLQ‐C30 and/or its module PR25 were most frequently used as measurement tools. An overall improvement in the completeness of PRO reporting was noted over time.ConclusionMany PRO trials are currently not included in the EAU guidelines. Our findings suggest that there has to be a better consensus on the use of PRO data for PCa patients, which will then be reflected in the PCa Guidelines and future data collection. Homogeneity in PROs collection and measurement tools will in turn enable “big data” Consortia to increase the patients’ voice in clinical research.

The development of PROmunication: a training-tool for clinicians using patient-reported outcomes to promote patient-centred communication in clinical cancer settings

BackgroundThe value of using real-time patient-reported outcome (PRO) measures in cancer communication has gained attention both in the clinic and in research. Despite this, no internationally accepted guidelines or training programs for clinicians on how to engage in patient-centred communication based on PROs exist. Lack of training may complicate implementation and systematic use of PROs in the clinic. We aimed to develop a short and feasible manual and training session in PRO-based dialogue rooted in patient-centred communication, coined PROmunication.MethodsPROmunication was implemented in two studies using PROs in different clinical cancer settings. We interviewed clinicians twice during the development phase. First, adopting a clinical perspective, they provided ideas for content, length and structure of the training session and the manual. Second, they approved the draft of the manual with minor adjustments on how to document clinician-patient communication. The final version of the PROmunication tool was built on clinicians’ input, theory on patient-centred communication, a literature review, and didactic considerations.ResultsThe one-page manual gave clinicians a brief and clear overview of how to prepare for, undergo and document a PRO-based consultation. Illustrations and verbal phrases were offered to operationalize and facilitate patient-centred communication. The training session included elements like evidence-based knowledge about the rationale, benefits and challenges of using PROs and comprised theory, experimental training and instructions for the use of the manual in clinical practice. Ad hoc training and feedback in the clinic followed the training session.ConclusionsThis paper presents the development of a short, theory-driven manual and training session intended to support and engage clinicians in PRO-based dialogue leading to patient-centred communication. Further testing of the tool is necessary and adjustments may be required if the PROmunication tool should be applied in other clinical settings were patients are seen regularly. An evaluation of the tool is planned to be performed in future studies. Training in PROmunication may further systematic and consistent use of PRO data in the consultation, leading to patient-centred consultations and increased patient involvement.

Integration of patient-reported outcomes (PROs) for personalized symptom management in "real-world" oncology practices: a population-based cohort comparison study of impact on healthcare utilization.

The use of patient-reported outcomes (PROs) for routine cancer distress screening is endorsed globally as a quality-care standard. However, there is little research on the integration of PROs in "real-world" oncology practices using implementation science methods. The Improving Patient Experience and Health Outcome Collaborative (iPEHOC) intervention was established at multisite disease clinics to facilitate the use of PRO data by clinicians for precision symptom care. The aim of this study was to examine if patients exposed to the intervention differed in their healthcare utilization compared with contemporaneous controls in the same time frame. We used a PRE- and DURING-intervention population cohort comparison study design to estimate the effects of the iPEHOC intervention on the difference in difference (DID) for relative rates (RR) for emergency department (ED) visits, hospitalizations, psychosocial oncology (PSO), palliative care visits, and prescription rates for opioids and antidepressants compared with controls. A small significantly lower Difference in Difference (DID) (- 0.223) in the RR for ED visits was noted for the intervention compared with controls over time (0.947, CI 0.900-0.996); and a DID (- 0.0329) for patients meeting ESAS symptom thresholds (0.927, CI 0.869-0.990). A lower DID in palliative care visits (- 0.0097), psychosocial oncology visits (- 0.0248), antidepressant prescriptions (- 0.0260) and an increase in opioid prescriptions (0.0456) in the exposed population compared with controls was also noted. A similar pattern was shown for ESAS as a secondary exposure variable. Facilitating uptake of PROs data may impact healthcare utilization but requires examination in larger scale "real-world" trials.

Fifteen Years' Use of Patient-Reported Outcome Measures at the Group and Patient Levels: Trend Analysis.

BackgroundSince 2004, we have collected patient-reported outcome (PRO) data from several Danish patient populations for use at the group and patient levels.ObjectiveThe aim of this paper is to highlight trends during the last 15 years with respect to patient inclusion, the methods for collection of PRO data, the processing of the data, and the actual applications and use of the PRO measurements.MethodsAll PRO data have been collected using the AmbuFlex/WestChronic PRO system, which was developed by the author in 2004 and has been continuously updated since. The analysis of trends was based on a generic model applicable for any kind of clinical health data, according to which any application of clinical data may be divided into four processes: patient identification, data collection, data aggregation, and the actual data use. Data for analysis were generated by a specific application in the system and transferred for analysis to the R package.ResultsDuring the 15-year period, 78,980 patients within 28 different groups of chronic and malignant illnesses have answered 260,433 questionnaires containing a total of 13,538,760 responses. Several marked changes have taken place: (1) the creation of cohorts for clinical epidemiological research purposes has shifted towards cohorts defined by clinical use of PRO data at the patient level; (2) the development of AmbuFlex, where PRO data are used as the entire basis for outpatient follow-up instead of fixed appointments, has undergone exponential growth and the system is currently in use in 47 International Statistical Classification of Diseases and Related Health Problems groups, covering 16,000 patients and 94 departments throughout Denmark; (3) response rates (up to 92%) and low attrition rates have been reached in group level projects, and there are even higher response rates in AmbuFlex where the patients are individually referred; (4) The answering method has shifted, as while in 2005 a total of 66.5% of questionnaires were paper based, this is the case for only 4.3% in 2019; and (5) the approach methods for questionnaires and reminders have changed dramatically from letter, emails, and short message service text messaging to a national, secure electronic mail system through which 93.2% of the communication to patients took place in 2019. The combination of secure email and web-based answering has resulted in a low turnaround time in which half of responses are now received within 5 days.ConclusionsThe demand for clinical use of PRO measurements has increased, driven by a wish among patients as well as clinicians to use PRO to promote better symptom assessment, more patient-centered care, and more efficient use of resources. Important technological changes have occurred, creating new opportunities, and making PRO collection and use cheaper and more feasible. Several legal changes may constitute a barrier for further development as well as a barrier for better utilization of patients’ questionnaire data. The current legal restrictions on the joint use of health data imposed by the European Union’s General Data Protection Regulation makes no distinction between use and misuse, and steps should be taken to alleviate these restrictions on the joint use of PRO data.

How Oncologists Perceive the Availability and Quality of Information Generated From Patient-Reported Outcomes (PROs).

Background:Despite increased incorporation of patient-reported outcome (PRO) measures into clinical trials, information generated from PROs remains largely absent from drug labeling and electronic health records, giving rise to concerns that such information is not adequately informing clinical practice.Objective:To evaluate oncologists’ perceptions concerning the availability and quality of information generated from PRO measures. Additionally, to identify whether an association exists between perceptions of availability and attitudes concerning quality.Method:An online, 11-item questionnaire was developed to capture clinician perspectives on the availability and use of PRO data to inform practice. The survey also asked respondents to rate information on the basis of 4 quality metrics: “usefulness,” “interpretability,” “accessibility,” and “scientific rigor.”Results:Responses were received from 298 of 1301 invitations sent (22.9% response rate). Perceptions regarding the availability of PRO information differed widely among respondents and did not appear to be linked to practice setting. Ratings of PRO quality were generally consistent, with average ratings for the 4 quality metrics between “satisfactory” and “good.” A relationship was observed between ratings of PRO data quality and perceptions of the availability.Conclusion:Oncologists’ attitudes toward the quality of information generated from PRO measures are favorable but not enthusiastic. These attitudes may improve as the availability of PRO data increases, given the association we observed between oncologists’ ratings of the quality of PRO information and their perceptions of its availability.

Automation and Simplification: Drivers of Innovative Collection and Use of Patient-Reported Outcomes Data.

The aim was to develop an electronic data capture (EDC) system to capture patient-reported outcome (PRO) measures successfully by automating processes identified as barriers to implementation. Clinical success, research impact, and patient acceptance of this system were evaluated during a pilot and a follow-up period 2 years later. During the pilot, there were 44,831 eligible visits. Capture rate was 99.0% (44,374 visits) and completion rate was 99.4% (44,108 visits). Capture rate was 99.4% and completion rate was 95.2% during the follow-up period. Zero help desk tickets were put in for the EDC system during either time period. Patients accepted the EDC system both during the pilot (1.4% refusal rate) and follow-up period (1.2%). An automated Structured Query Language server feed provided data used to produce numerous abstracts and manuscripts. Automation was crucial to overcoming implementation barriers and delivering PRO scores to the electronic health record in real time with minimal impact on clinical workflow. Automation also has supported PRO research.

Patient-reported data and the politics of meaningful data work

Patient-reported outcome data have moved from the realm of research to center stage in efforts to provide patient-centered care. In a Danish context, health authorities are seeking to promote and standardize the use of patient-reported outcome data. This involves normative articulations of what counts as meaningful data work in a healthcare system characterized by intensified data-sourcing. Based on ethnographic material, I suggest that an assemblage of actors, both human and technological, has accomplished the articulation of meaningful data work, with patient-reported outcome as being dependent on the active application of data in clinical trajectories-in contrast to supplying data "passively" for secondary use for research or governance. This normative articulation of "Active patient-reported outcome" legitimizes the Danish patient-reported outcome assemblage by showing alignment of the concerns of patients, clinicians and health authorities. At the same time, "Active patient-reported outcome" foreshadows challenges in making data work meaningful in local practice.

Integrating patient-reported outcomes data into the electronic health record.

186 Background: As a national network of hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer, the network was an early adopter of using patient reported outcome (PRO) data as part of its routine patient assessment and treatment. Since 2012 an externally validated tool has been used to capture patients’ perceived symptom burden for real-time clinical intervention, from the point of first visit throughout the course of treatment, at intervals of 21 days or greater. Research has demonstrated the use of PRO data as a valuable component of a patient’s treatment plan, promoting improved quality and length of life. Methods: The use of this data across the network was expanded such that results once only accessible on paper and via electronically stored images, has now been fully integrated into the electronic health record (EHR). A multidisciplinary project team formulated the specifications for a successful integration of PRO data into the EHR. Results: The project achieved its goal and went beyond data integration to include implementation of a solution to facilitate documentation of intervention against patients’ symptoms. Provider workflow efficiency is greatly enhanced via single system access and visual notification, with critical values flagged, to focus providers’ attention on severe symptoms. Incorporation of a unified EHR flowsheet provides a paperless, one-stop symptom assessment approach and streamlined mechanism for intervention documentation. The documentation module leverages structured data fields and linkage of PRO data with interventions, such as specialist referrals or medication orders, to support enhanced patient care and quality improvement. Conclusions: The ability to easily view an array of patient reported concerns and document interventions against severe or significantly worsening symptoms provides clinicians an enhanced ability to address quality of life related needs. PRO data is now stored electronically in the enterprise warehouse, thus enabling aggregation with data from which to perform population analysis and eventually, pursue opportunities for predictive modeling.

Using Heuristic Evaluation to Enhance the Visual Display of a Provider Dashboard for Patient-Reported Outcomes.

Introduction:With the rising use of patient-reported outcomes (PRO) in clinical practice, there is an increasing need to understand the data visualization needs of clinical teams to support their effective use of PRO data for both individual patient decision making and broader population health applications. A human-centered design (HCD) approach can optimize the visual design of an interactive PRO system.Including Heuristic Evaluation in the HCD Toolbox:Recent literature regarding the use of HCD to design and develop PRO visualizations demonstrates the benefits of iterative methods that engage representative users who are likely to use the system in the future. However, the literature has not explored the additive value of other HCD methods such as heuristic evaluation, which involves expert examination of the interface with respect to recognized usability principles, the heuristics.Insights from Using Heuristic Evaluation:Our experience in using heuristic evaluation to enhance the design of a PRO dashboard led to several recommendations to improve the display, accessibility, and interpretability of the dashboard’s data. Heuristic evaluation can serve as a complement to HCD methods that directly engage users and thereby enhance usability.

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol.

IntroductionEmerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.Methods and analysisCompleted National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.Ethics and disseminationThe study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).Trial registration numberPROSPERO CRD42016036533.

'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review.

PurposeThe CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice.Materials and MethodsThe case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.ResultsFrom 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2).ConclusionIt is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed.

Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System.

Introduction:Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems.Case Description:The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution’s research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system.Strategies:Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization.Conclusion:These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs.

Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care

ABSTRACTStrong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient–provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n = 27) from four geographically diverse HIV and community care clinics in the US that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda setting prior to a visit; and reduction of social desirability bias in patient–provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are (1) tailored to be the most clinically relevant to their population; (2) well integrated into clinic flow; and (3) easy to interpret, highlighting chief patient concerns and changes over time.