There is increasing interest to integrate collection of patient-reported outcomes (PROs) in routine practice to enhance clinical care. Multiple studies show that systematic monitoring of patients ...using PROs improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. The general approach includes a brief electronic survey, administered via the Web or an app or an automated telephone system, with alerts to clinicians for concerning or worsening issues. Patients have generally been asked to self-report on a regular basis (remotely between visits and/or at visits), with reminders prompting patients to self-report that are sent via email, text, or automated phone message. More recently, care management pathways for patients and clinicians have been triggered by PRO system alerts. PRO systems may be free-standing, integrated into electronic health record systems or patient portals, or native functionality of an electronic health record. Despite potential benefits, there are challenges with integrating PROs into practice for monitoring patient status, as there are with any modifications to existing clinical processes. These challenges range from administrative to technical to workflow. A session at the 2018 ASCO Annual Meeting was dedicated to the implementation of PROs in clinical practice. The session focused on practical examples of PRO implementations, with honest reflections on barriers and strategies that may be generalizable to other systems looking to implement PROs. Panelists for that session are the authors of this paper, which describes their respective experiences implementing PROs in practice settings.
Prompted by Frye’s classification of literary works the present paper embarks on an investigation of the ice motif and its manifestations in a mythological and literary context. It is based on a ...restricted corpus, yet the survey made proves the recurrent meaning of ice to be a symbol of death and its various other connotations – inherently associated with the primal meaning revealing it in different aspects in the works to be analyzed.
PURPOSE; To use published literature to estimate large, medium, and small differences in quality of life (QOL) data from the European Organisation for the Research and Treatment of Cancer Quality of ...Life Questionnaire Core 30 (EORTC QLQ-C30).
An innovative method combining systematic review of published studies, expert opinions, and meta-analysis was used to estimate large, medium, and small differences for QLQ-C30 scores. Published mean data were identified from the literature. Differences (contrasts) between groups (eg, between treatment groups, age groups, and performance status groups) were reviewed by 34 experts in QOL measurement and cancer treatment. The experts, blinded to actual QOL results, were asked to predict these differences. A large difference was defined as one representing unequivocal clinical relevance. A medium difference was defined as likely to be clinically relevant but to a lesser extent. A small difference was one believed to be subtle but nevertheless clinically relevant. A trivial difference was used to describe circumstances unlikely to have any clinical relevance. Actual QOL results were combined using meta-analytic techniques to estimate differences corresponding to small, medium, or large effects.
Nine hundred eleven articles were identified, leading to 152 relevant articles (2,217 contrasts) being reviewed by at least two experts. Resulting estimates from the meta-analysis varied depending on the subscale. Thus, the recommended minimum to detect medium differences ranges from 9 (cognitive functioning) to 19 points (role functioning).
Guidelines for the size of effects are provided for the QLQ-C30 subscales. These guidelines can be used for sample size calculations for clinical trials and can also be used to aid interpretation of differences in QLQ-C30 scores.
Background/aims
New classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase ...II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients’ symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting.
Methods
Qualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data.
Results
Interviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review.
Conclusion
Technology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.
Purpose An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to ...evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative’s goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER. Methods We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as “recommended” when >50 % respondents endorsed it as “required as a minimum standard.” Results The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden. Conclusion The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.
Background Ovarian cancer patients require monitoring for relapse. Innovative follow-up methods are increasingly being explored. An electronic patient-reported outcome (ePRO) follow-up pathway was ...developed for women treated for ovarian cancer. This feasibility study explored patient acceptability and compliance. Methods A single-arm non-blinded prospective feasibility study was undertaken at two hospitals. Participants were women who had completed treatment for ovarian cancer whose clinician was happy for them to be monitored remotely. Automated 3-monthly reminders were sent to participants to complete an ePRO questionnaire and obtain blood tests. Participants were reviewed over the phone by their clinical nurse specialist instead of attending clinic-based follow-up. The primary outcome was compliance (expected ePRO completions/blood tests) across the 12-month study period. Secondary outcomes were recruitment, attrition, resource use, symptom severity/alerts and patient acceptability. Results Twenty-four women consented (50% consent rate), and 13 remained on study at 12 months. Seven women relapsed, 3 chose to withdraw, and 1 withdrew for other clinical reasons. ePRO compliance was high and consistent at 75-82%, although the two hospitals differed. Adherence to the clinical protocol was evident for blood tests and contacts with staff (fewer visits, more phonecalls compared to an earlier audit). End-of-study feedback indicated high patient satisfaction. Conclusions Remote ePRO follow-up for ovarian cancer is feasible and acceptable to patients who are able and willing to participate. However, the low recruitment rate (ineligible + declined) indicate it is not suitable/acceptable to all patients immediately post-treatment. Further large-scale research and implementation work is required, especially in a post-COVID era. Trial registration ClinicalTrials.gov ID: NCT02847715 (first registered 19/05/2016). Keywords: Ovarian cancer, Follow-up, Electronic patient-reported outcomes, Feasibility study, Compliance, Acceptability
Previous research on educational data has demonstrated that Rasch fit statistics (mean squares and t-statistics) are highly susceptible to sample size variation for dichotomously scored rating data, ...although little is known about this relationship for polytomous data. These statistics help inform researchers about how well items fit to a unidimensional latent trait, and are an important adjunct to modern psychometrics. Given the increasing use of Rasch models in health research the purpose of this study was therefore to explore the relationship between fit statistics and sample size for polytomous data.
Data were collated from a heterogeneous sample of cancer patients (n = 4072) who had completed both the Patient Health Questionnaire - 9 and the Hospital Anxiety and Depression Scale. Ten samples were drawn with replacement for each of eight sample sizes (n = 25 to n = 3200). The Rating and Partial Credit Models were applied and the mean square and t-fit statistics (infit/outfit) derived for each model.
The results demonstrated that t-statistics were highly sensitive to sample size, whereas mean square statistics remained relatively stable for polytomous data.
It was concluded that mean square statistics were relatively independent of sample size for polytomous data and that misfit to the model could be identified using published recommended ranges.
•We tested the EORTC QLQ-C30 SumScore in a large lung cancer patient’s population.•HRQOL after surgery is worse compared the preoperative values.•The Summary Score is more sensitive than the General ...Health Score.•The SumScore can be used as a parsimonious patient-reported-outcome measure.
We tested the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) summary score (SumSC) to detect changes in the HRQOL after Non-small-cell lung cancer (NSCLC) surgery and compared its performance to the traditional scales.
EORTC QLQ-C30 data was obtained from 326 consecutive pre-operative patients submitted for anatomical lung resections for NSCLC.66 patients completed post-operative assessments 3 months after surgery. The data was analysed to evaluate the ability of the SumSC compared to the traditional scales to 1 preoperatively differentiate between clinical groups 2; detect post-op changes and to 3 compare pre and post-op changes in clinically different groups.The importance of perioperative changes was measured by calculating the effect size (ES).
Of the 326 patients, those older than 70 years, with higher DLCO value and Performance Status (PS) ≤1 had a significantly better preoperative SumScore.
Physical function (PF) showed a large and significant decline (ES 0.91). Role and social function also showed a significant and medium decline (ES 0.62 and 0.41).
Postoperatively some symptoms scales showed significant increases in the values, implying worse symptoms with the largest increase in dyspnoea (ES -0.88). The change in General Health score (GH) was not significant after surgery (ES 0.26, p = 0.062).
The SumSc, decreased significantly postoperatively. In particular, medium or large postoperative declines of SumSc were observed in both males and females, in patients with lower FEV1, lower performance score, and in those older than 70 years. Interestingly the decline of SumSc was observed irrespective of the preoperative DLCO level.
The Summary Score was more sensitive to changes in subjects' HRQOL, than the GH score. The SumSc can be used as a parsimonious and easy to interpreted patient-reported-outcome measure in multi-institutional database and future clinical trials.
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