Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Collecting patient reported outcome (PRO) data in a systematic way enables an objective evaluation of treatment and its related outcomes. By using the disease specific questionnaires developed by the International Consortium of Health Outcome Measurement (ICHOM) this allows for comparison between physicians, hospitals and even different countries. Objective: The aim of this pilot project was to establish a digital system to measure patient reported outcomes for new breast cancer patients who attended the Charité Breast cancer clinic. This approach should serve as a blueprint to further expand the PRO measurement to other disease entities and departments. Methods: In November 2016 we implemented a web-based system to collect PRO data at the breast center at Charité University hospital using the ICHOM data set. All new patients at the breast center were enrolled and were answering a predefined set of questions using a tablet computer. Once they start their treatment at Charité automated emails were sent to the patient at predefined treatment points. Those emails contained a web-based link through which they could access and answer questionnaires. Results: By now 541 patients have been enrolled and 2470 questionnaires initiated. 9.44% of the patients were under the age of 40, 49.7% between 40 and 60, 39.6% between 60-80 and 1.3% over the age of 80. The average return rate of questionnaires was 67%. When asked about preference regarding paper versus online questionnaires 6% of the patients between 50 to 60 , 6% between 60-70 and 13 % over 70 would prefer paper versions. Conclusions: Measuring PRO in breast cancer patients in an automated electronic version is possible across all age ranges while simultaneously achieving a high return rate.

Purpose: The assessment of health-related quality of life (HRQOL) measured via patient-reported outcomes (PROs) is a key component in clinical trials and increasingly used in clinical routine worldwide. Two PRO measures (PROMs) that share the same definition of health and report outcomes on a comparable T-metric anchored to general population samples are the PROMIS-29 and the EORTC QLQ-C30. In this study, we investigate the empirical agreement of these underlying concepts. Methods: We collected PROMIS-29 and EORTC QLQ-C30 data from 1,478 female patients at a breast cancer outpatient centre. We calculated descriptive statistics and correlations between the subscales of both instruments. We performed exploratory (EFA) and confirmatory factor analysis (CFA) in randomly split subsamples in order to assess the underlying psychometric structure of both instruments. Results: The cohort (mean age = 47.4, ± 14.49) reported comparable mean HRQOL scores between the corresponding subscales of both instruments similar to general population reference values. Correlation between the corresponding subscales of both instruments ranged between 0.59 (Social Role) and 0.78 (Physical Functioning). Both an exploratory and a theoretically driven confirmatory factor analysis provided further support for conceptual agreement of the scales. Conclusion: EORTC QLQ-C30 and PROMIS-29 showed similar scores and satisfactory agreement in conceptional and statistical analysis. This suggests that the underlying conceptualization of health is reasonably close. Hence, the development of score transformation algorithms or calibration of both instruments on common scales could prospectively increase the comparability of clinical and research PRO data collected with either instrument.

Patient-reported outcomes in spinal surgery—how can we keep getting better?

Introduction The gathering of health and quality-of-life issues that matter most to patients over so-called patient-reported outcomes (PROs) is a key aspect of patient-centered healthcare. In obstetrics, this approach has the potential to expand the current understanding of what quality entails by including patient perspectives. The International Consortium for Health Outcome Measures (ICHOM), founded in 2012, is a global organization which aims to standardise the collection of PROs and make the results comparable worldwide. A PRO Set for obstetrics, “Pregnancy and Childbirth”, was published in 2018. The aim of our work was to translate the instruments of this set that are not yet available in German into German. Methods The instruments were translated from English into German using the Functional Assessment of Chronic Illness Therapy (FACIT) translation method. The translated instruments consisted of the Breastfeeding Self-Efficacy Scale – Short Form (BSES-SF), the Mother-to-Infant Bonding Scale (MIBS), and the Birth Satisfaction Scale – Revised (BSS-R) as well as a number of individual questions (items). Results The final version of the German translations were found to be easily comprehensible by the target group. During the cognitive debriefing, it became clear that pregnant women and women who had just given birth often used a number of medically incorrect terms to refer to their symptoms or complaints. In the translations great care was taken to ensure that the wording was as close as possible to the general usage of the language while at the same time the terminology was medically correct. To achieve a precise but comprehensible translation, the response structure of the BSES-SF also had to be adapted. Conclusions The instruments of the ICHOM Standard Set “Pregnancy and Childbirth”, which were not previously available in German, were successfully translated into German. This meant dealing with a few challenges such as adapting questions or response structures. The cultural and linguistic comprehensibility of the German translations were confirmed during the subsequent cognitive debriefing. The translations offer the possibility of implementing the complete ICHOM Set for Pregnancy and Childbirth. This would provide an opportunity to expand the existing understanding of quality by including the subjective experience of women during and after childbirth and, in future, to compare outcomes with those of other hospitals across the world. Received: 03 September 2021 Accepted: 09 October 2021 Article published online: 07 July 2022 © 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

Background: Comparing outcomes across different health measurement tools is essential where various patient-reported outcome measures (PROMs) are used. In spinal surgery, where recent studies show that over 30 different PROMs are applied, this need becomes even more pressing. Although several statistical transformations between the Oswestry Disability Index (ODI) and the PROMIS Profile 29 have been proposed, validation studies on conversion equations and cross-walk tables remain limited. In this study, we examined the agreement between observed ODI scores and those predicted from the PROMIS Profile 29 in a large sample of patients with low back pain, collected from routine clinical care. Methods: We compared the performance of regression and linking models at both the individual and group levels. Using Bland–Altman plots, we assessed the mean difference, 95% limits of agreement, root mean squared error (RMSE), and standardized mean differences (Cohen’s d) between predicted and observed ODI scores. Results: While group-level agreement was satisfactory, with negligible effect sizes, individual prediction accuracy was relatively poor. Additionally, regression models showed inconsistent performance across the ODI score range, though incorporating more domains marginally improved predictions. Conclusions: The equipercentile linking approach demonstrated stable agreement across all ODI scores, making it the preferred method. Future regression models should account for nonlinear relationships between PROMs to enhance prediction accuracy.

BACKGROUND Collecting patient-reported outcome (PRO) data systematically enables objective evaluation of treatment and its related outcomes. Using disease-specific questionnaires developed by the International Consortium for Health Outcome Measurement (ICHOM) allows for comparison between physicians, hospitals, and even different countries. OBJECTIVE This pilot project aimed to establish a digital system to measure PROs for new patients with breast cancer who attended the Charité Breast Center This approach should serve as a blueprint to further expand the PRO measurement to other disease entities and departments. METHODS In November 2016, we implemented a Web-based system to collect PRO data at Charité Breast Center using the ICHOM dataset. All new patients at the Breast Center were enrolled and answered a predefined set of questions using a tablet computer. Once they started their treatment at Charité, automated emails were sent to the patients at predefined treatment points. Those emails contained a Web-based link through which they could access and answer questionnaires. RESULTS By now, 541 patients have been enrolled and 2470 questionnaires initiated. Overall, 9.4% (51/541) of the patients were under the age of 40 years, 49.7% (269/541) between 40 and 60 years, 39.6% (214/541) between 60 and 80 years, and 1.3% (7/541) over the age of 80 years. The average return rate of questionnaires was 67.0%. When asked about the preference regarding paper versus Web-based questionnaires, 6.0% (8/134) of the patients between 50 and 60 years, 6.0% (9/150) between 60 and 70 years, and 12.7% (9/71) over the age of 70 years preferred paper versions. CONCLUSIONS Measuring PRO in patients with breast cancer in an automated electronic version is possible across all age ranges while simultaneously achieving a high return rate.