Breast cancer patients enrolled in the Swiss mammography screening program "donna" demonstrate prolonged survival.

STUDY GOAL: We compared the survival rates of women with breast cancer (BC) detected within versus outside the mammography screening program (MSP) "donna". METHODS: We merged data from the MSP with the data from corresponding cancer registries to categorize BC cases as within MSP (screen-detected and interval carcinomas) and outside the MSP. We analyzed the tumor stage distribution, tumor characteristics and the survival of the women. We further estimated hazard ratios using Cox-regressions to account for different characteristics between groups and corrected the survival rates for lead-time bias. RESULTS: We identified 1057 invasive (ICD-10: C50) and in-situ (D05) BC cases within the MSP and 1501 outside the MSP between 2010 and 2019 in the Swiss cantons of St. Gallen and Grisons. BC within the MSP had a higher share of stage I carcinoma (46.5% vs. 33.0%; p < 0.01), a smaller (mean) tumor size (19.1 mm vs. 24.9 mm, p < 0.01), and fewer recurrences and metastases in the follow-up period (6.7% vs. 15.6%, p < 0.01). The 10-year survival rates were 91.4% for women within and 72.1% for women outside the MSP (p < 0.05). Survival difference persisted but decreased when women within the same tumor stage were compared. Lead-time corrected hazard ratios for the MSP accounted for age, tumor size and Ki-67 proliferation index were 0.550 (95% CI 0.389, 0.778; p < 0.01) for overall survival and 0.469 (95% CI 0.294, 0.749; p < 0.01) for BC related survival. CONCLUSION: Women participating in the "donna" MSP had a significantly higher overall and BC related survival rate than women outside the program. Detection of BC at an earlier tumor stage only partially explains the observed differences.

Cost-effectiveness of a patient-reported outcome-based remote monitoring and alert intervention for early detection of critical recovery after joint replacement: A randomised controlled trial.

BACKGROUND: While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement. METHODS AND FINDINGS: The cost-effectiveness analysis (CEA) is based on a multicentre randomised controlled trial encompassing 3,697 patients with hip replacement and 3,110 patients with knee replacement enrolled from 2019 to 2020 in 9 German hospitals. The analysis was conducted with a subset of 546 hip and 492 knee replacement cases with longitudinal cost data from 24 statutory health insurances. Patients were randomised 1:1 to a PROM-based remote monitoring and alert intervention or to a standard care group. All patients were assessed at 12-months post-surgery via digitally collected PROMs. Patients within the intervention group were additionally assessed at 1-, 3-, and 6-months post-surgery to be contacted in case of critical recovery paths. For the effect evaluation, a PROM-based composite measure (PRO-CM) was developed, combining changes across various PROMs in a single index ranging from 0 to 100. The PRO-CM included 6 PROMs focused on quality of life and various aspects of physical and mental health. The primary outcome was the incremental cost-effectiveness ratio (ICER). The intervention group showed incremental outcomes of 2.54 units PRO-CM (95% confidence interval (CI) [0.93, 4.14]; p = 0.002) for patients with hip and 0.87 (95% CI [-0.94, 2.67]; p = 0.347) for patients with knee replacement. Within the 12-months post-surgery period the intervention group had less costs of 376.43€ (95% CI [-639.74, -113.12]; p = 0.005) in patients with hip, and 375.50€ (95% CI [-767.40, 16.39]; p = 0.060) in patients with knee replacement, revealing a dominant ICER for both procedures. However, it remains unclear which step of the multistage intervention contributes most to the positive effect. CONCLUSIONS: The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings. TRIAL REGISTRATION: Registration: German Register for Clinical Studies (DRKS) under DRKS00019916.

Patient-Reported Outcome Measures as an Intervention: A Comprehensive Overview of Systematic Reviews on the Effects of Feedback.

OBJECTIVES: Patient-reported outcome measures (PROMs) have emerged as a promising approach to involve patients in their treatment process. Beyond serving as outcome measures, PROMs can be applied to provide feedback to healthcare providers and patients, thereby offering valuable insights that can improve health outcomes and care processes. This overview offers a comprehensive synthesis of the effects of PROM feedback, contributing to the evidence-based discussion on PROMs' potential to enhance patient care. METHODS: Following Cochrane Collaboration recommendations, this overview included literature reviews across diverse treatment areas, investigating the impact of PROM feedback on patient health outcomes (including quality of life, symptoms, or survival) and care process outcomes (including communication, symptom identification, or clinical practice). The methodological quality of the evidence was assessed with a modified version of A Measurement Tool to Assess Systematic Reviews 2, and the potential overlap of primary studies was quantified. Results were narratively synthesized. RESULTS: Forty reviews grouped into 4 categories of treatment areas were included. Overall, their methodological quality was low. The overall overlap of primary studies was 2.2%, reaching up to 15.7% within specific treatment areas. The results indicate that PROM feedback may enhance the quality-of-care processes, whereas its effects on patient health outcomes remained less conclusive. CONCLUSIONS: PROM feedback positively influences the interaction between physicians and patients across the included treatment areas. Further research is needed to comprehend the trickle-down effects of PROM feedback and how to enhance its potential in yielding health benefits for patients.

Gender health gap pre- and post-joint arthroplasty: identifying affected patient-reported health domains.

BACKGROUND: As patient-reported outcomes (PROs) gain prominence in hip and knee arthroplasty (HA and KA), studies indicate PRO variations between genders. Research on the specific health domains particularly impacted is lacking. Hence, we aim to quantify the gender health gap in PROs for HA/KA patients, differentiating between general health, health-related quality of life (HrQoL), physical functioning, pain, fatigue, and depression. METHODS: The study included 3,693 HA patients (1,627 men, 2,066 women) and 3,110 KA patients (1,430 men, 1,680 women) receiving surgery between 2020 to 2021 in nine German hospitals, followed up until March 2022. Questionnaires used were: EQ-VAS, EQ-5D-5L, HOOS-PS, KOOS-PS, PROMIS-F-SF, PROMIS-D-SF, and a joint-specific numeric pain scale. PROs at admission, discharge, 12-months post-surgery, and the change from admission to 12-months (PRO-improvement) were compared by gender, tested for differences, and assessed using multivariate linear regressions. To enable comparability, PROs were transformed into z-scores (standard deviations from the mean). RESULTS: Observed differences between genders were small in all health domains and differences reduced over time. Men reported significantly better health versus women pre-HA (KA), with a difference of 0.252 (0.224) standard deviations from the mean for pain, 0.353 (0.243) for fatigue (PROMIS-F-SF), 0.327 (0.310) for depression (PROMIS-D-SF), 0.336 (0.273) for functionality (H/KOOS-PS), 0.177 (0.186) for general health (EQ-VAS) and 0.266 (0.196) for HrQoL (EQ-5D-5L). At discharge, the gender health gap reduced and even disappeared for some health dimensions since women improved in health to a greater extent than men. No gender health gap was observed in most PRO-improvements and at month 12. CONCLUSIONS: Men experiencing slightly better health than women in all health dimensions before surgery while experiencing similar health benefits 12-months post-surgery, might be an indicator of men receiving surgery inappropriately early, women unnecessarily late or both. As studies often investigate the PRO-improvement, they miss pre-surgery gender differences, which could be an important target for improvement initiatives in patient-centric care. Moreover, future research on cutoffs for meaningful between-group PRO differences per measurement time would aid the interpretation of gender health disparities. TRIAL REGISTRATION: German Register for Clinical Trials, DRKS00019916, 26 November 2019.

A Collection of Components to Design Clinical Dashboards Incorporating Patient-Reported Outcome Measures: Qualitative Study.

BACKGROUND: A clinical dashboard is a data-driven clinical decision support tool visualizing multiple key performance indicators in a single report while minimizing time and effort for data gathering. Studies have shown that including patient-reported outcome measures (PROMs) in clinical dashboards supports the clinician's understanding of how treatments impact patients' health status, helps identify changes in health-related quality of life at an early stage, and strengthens patient-physician communication. OBJECTIVE: This study aims to determine design components for clinical dashboards incorporating PROMs to inform software producers and users (ie, physicians). METHODS: We conducted interviews with software producers and users to test preselected design components. Furthermore, the interviews allowed us to derive additional components that are not outlined in existing literature. Finally, we used inductive and deductive coding to derive a guide on which design components need to be considered when building a clinical dashboard incorporating PROMs. RESULTS: A total of 25 design components were identified, of which 16 were already surfaced during the literature search. Furthermore, 9 additional components were derived inductively during our interviews. The design components are clustered in a generic dashboard, PROM-related, adjacent information, and requirements for adoption components. Both software producers and users agreed on the primary purpose of a clinical dashboard incorporating PROMs to enhance patient communication in outpatient settings. Dashboard benefits include enhanced data visualization and improved workflow efficiency, while interoperability and data collection were named as adoption challenges. Consistency in dashboard design components is preferred across different episodes of care, with adaptations only for disease-specific PROMs. CONCLUSIONS: Clinical dashboards have the potential to facilitate informed treatment decisions if certain design components are followed. This study establishes a comprehensive framework of design components to guide the development of effective clinical dashboards incorporating PROMs in health care practice.

Assessing the Relationship between Hospital Process Digitalization and Hospital Quality - Evidence from Germany.

Hospital digitalization aims to increase efficiency, reduce costs, and/ or improve quality of care. To assess a digitalization-quality relationship, we investigate the association between process digitalization and process and outcome quality. We use data from the German DigitalRadar (DR) project from 2021 and combine these data with two process (preoperative waiting time for osteosynthesis and hip replacement surgery after femur fracture, n = 516 and 574) and two outcome quality indicators (mortality ratio of patients hospitalized for outpatient-acquired pneumonia, n = 1,074; ratio of new decubitus cases, n = 1,519). For each indicator, we run a univariate and a multivariate regression. We measure process digitalization holistically by specifying three models with different explanatory variables: (1) the total DR-score (0 (not digitalized) to 100 (fully digitalized)), (2) the sum of DR-score sub-dimensions' scores logically associated with an indicator, and (3) sub-dimensions' separate scores. For the process quality indicators, all but one of the associations are insignificant. A greater DR-score is weakly associated with a lower mortality ratio of pneumonia patients (p < 0.10 in the multivariate regression). In contrast, higher process digitalization is significantly associated with a higher ratio of decubitus cases (p < 0.01 for models (1) and (2), p < 0.05 for two sub-dimensions in model (3)). Regarding decubitus, our finding might be due to better diagnosis, documentation, and reporting of decubitus cases due to digitalization rather than worse quality. Insignificant and inconclusive results might be due to the indicators' inability to reflect quality variation and digitalization effects between hospitals. For future research, we recommend investigating within hospital effects with longitudinal data.

A composite measure for patient-reported outcomes in orthopedic care: design principles and validity checks.

BACKGROUND: The complex, multidimensional nature of healthcare quality makes provider and treatment decisions based on quality difficult. Patient-reported outcome (PRO) measures can enhance patient centricity and involvement. The proliferation of PRO measures, however, requires a simplification to improve comprehensibility. Composite measures can simplify complex data without sacrificing the underlying information. OBJECTIVE AND METHODS: We propose a five-step development approach to combine different PRO into one composite measure (PRO-CM): (i) theoretical framework and metric selection, (ii) initial data analysis, (iii) rescaling, (iv) weighting and aggregation, and (v) sensitivity and uncertainty analysis. We evaluate different rescaling, weighting, and aggregation methods by utilizing data of 3145 hip and 2605 knee replacement patients, to identify the most advantageous development approach for a PRO-CM that reflects quality variations from a patient perspective. RESULTS: The comparison of different methods within steps (iii) and (iv) reveals the following methods as most advantageous: (iii) rescaling via z-score standardization and (iv) applying differential weights and additive aggregation. The resulting PRO-CM is most sensitive to variations in physical health. Changing weighting schemes impacts the PRO-CM most directly, while it proves more robust towards different rescaling and aggregation approaches. CONCLUSION: Combining multiple PRO provides a holistic picture of patients' health improvement. The PRO-CM can enhance patient understanding and simplify reporting and monitoring of PRO. However, the development methodology of a PRO-CM needs to be justified and transparent to ensure that it is comprehensible and replicable. This is essential to address the well-known problems associated with composites, such as misinterpretation and lack of trust.

What is the association between gender and self-perceived health status when controlling for disease-specific conditions? A retrospective data analysis of pre- and post-operative EQ-5D-5L differences in total hip and knee arthroplasty.

BACKGROUND: The self-perceived health status of patients undergoing total hip and knee arthroplasty (THA and TKA) might differ post-operatively due to gender, age, or comorbidities. Patient-reported outcome measures (PROMs) such as the EQ-5D-5L measure the self-perceived health status. This study investigates whether the index score of the EQ-5D-5L is a valid tool for interpreting gender differences in outcomes for patients undergoing THA and TKA. METHODS: Routine and PROM-data of elective primary THA or TKA patients in two German hospitals between 2016 and 2018 were analyzed. Univariate analysis with Pearson's chi-square was conducted to identify control variables for gender. To quantify the association between gender and the EQ-5D-5L dimensions, a cumulative odds ordinal logistic regression with proportional odds was conducted. RESULTS: Two thousand three hundred sixty-eight​​ THA patients (m = 978; f = 1390) and 1629 TKA patients (m = 715; f = 914) were considered. The regression analysis of the individual EQ-5D-5L dimensions showed that female gender was significantly associated with better self-care (THA and TKA) and better post-operative mobility (THA). In contrast, male gender was significantly associated with less pain/discomfort (TKA) and less anxiety/depression (THA) pre-surgery and 3-months post-surgery. CONCLUSION: Our results confirmed that the self-perceived health status improved after surgery. However, due to the different associations of gender to the individual dimensions of the EQ-5D-5L, the weighted index score clouds the comparability between patients with different gender undergoing THA or TKA. Therefore, we argue to use the individual five dimensions for health status analysis, to reveal relevant additional information.

Patients undergoing total hip and knee arthroplasty (THA and TKA) can fill out standardized questionnaires pre- and post-surgery, such as the EQ-5D-5L, to measure the improvement in the self-perceived health status. The EQ-5D-5L includes mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. We do not know whether male and female patients experience the same improvement in the dimensions or whether significant differences exist. Currently, only index scores of the EQ-5D-5L are used for the comparison of pre- and post-operative health status. However, due to the questionnaire's weighted composition, relevant changes in individual dimensions might be easily missed. Thus, we investigated whether significant differences between gender and the EQ-5D-5L dimensions in patients undergoing TKA and TKA are observable. We found that female patients reported significantly better scores in self-care (THA and TKA) and post-operative mobility (THA). In contrast, male gender was significantly associated with less pain/discomfort (TKA) and less anxiety/depression (THA) pre-surgery and 3-months post-surgery. The EQ-5D-5L's weighted index score, however, does not directly represent these differences. Therefore, we argue to use the individual five dimensions for health status analysis, as relevant additional information on improvement over time would otherwise be missed.

[Specialised treatment of colorectal cancer in certified cancer centres: Do patients really have to travel further?] / Spezialisierte Behandlung von Darmkrebs in zertifizierten Krebszentren: Müssen Patient*innen wirklich weitere Wege auf sich nehmen?

INTRODUCTION: In Germany, many cancer patients are treated outside of cancer centres certified by the German Cancer Society (DKG) resulting in underuse of these facilities and inferior oncological treatment. One way to address this issue would be to restructure the healthcare landscape by following the Danish approach that limits cancer treatment to specialized hospitals. Such an approach would have an impact on the travelling times to treatment centers. The present study determines the impact on patient travel times using the example of colorectal cancer. METHODS: For the present analysis, data from structured quality reports (sQB) and from patients insured with the AOK who underwent resection of the colon or rectum during 2018 were used. In addition, data from the DKG regarding an existing certification of a colorectal cance centre were used. Travel time was defined as the time patients spent in an average car with average traffic from the midpoint of the ZIP code of their residence to the coordinates of the hospital. The coordinates of the hospitals and the midpoints of the ZIP codes were obtained by querying the Google API. Travel times were calculated with a local Open Routing Machine server. The statistical programs R and Stata were used for analyses and cartographic representations. RESULTS: In 2018, nearly half of all patients with colon cancer were treated at the hospital nearest to their place of residence, of whom approximately 40% were treated at a certified colorectal cancer centre. Overall, only about 47% of all treatments took place at a certified colorectal cancer centre. Travel time to the chosen treatment site averaged 20 minutes. It was minimally shorter (18 minutes) if no certified centre was chosen and minimally longer (21 minutes) for those whose treatment took place in a certified colorectal cancer centre. Modeling of redistributions of all patients to certified centres resulted on an average travel time of 29 minutes. CONCLUSION: Even if treatment were limited to specialized hospitals, treatment close to home would still be guaranteed. Regardless of certification, parallel structures can be identified, especially in metropolitan areas, which indicate a potential for restructuring.

The impact of quality on hospital choice. Which information affects patients' behavior for colorectal resection or knee replacement?

Quality competition among hospitals, induced by patients freely choosing their hospital in a price regulated market, can only be realized if quality differences between hospitals are transparent, understandable, and thus influence patients' hospital choice. We use data from ~145,000 German patients and ~ 900 hospitals for colorectal resections and knee replacements to investigate whether patients value quality and specialization when choosing their hospital. Using a random utility choice model, we estimate patients' marginal utilities, willingness to travel and change in hospital demand for quality improvements. Patients respond to service quality and specialization and thus, quality competition seems to be present. Colorectal resection patients are willing to travel longer for more specialized hospitals (+9% for procedure volume, +9% for certification). Knee replacement patients travel longer for hospitals with better service quality (+6%) and higher procedure volume (+12%). However, clinical quality indicators, often difficult to access and interpret, barely play a role in patients' hospital choice. Furthermore, we find that competition on quality for colorectal resection is rather local, whereas for knee replacement we observe regional competition patterns.

Exploring treatment effect heterogeneity of a PROMs alert intervention in knee and hip arthroplasty patients: A causal forest application.

Patient reported outcome measures (PROMs) experience an uptake in use for hip (HA) and knee arthroplasty (KA) patients. As they may be used for patient monitoring interventions, it remains unclear whether their use in HA/KA patients is effective, and which patient groups benefit the most. Nonetheless, knowledge about treatment effect heterogeneity is crucial for decision makers to target interventions towards specific subgroups that benefit to a greater extend. Therefore, we evaluate the treatment effect heterogeneity of a remote PROM monitoring intervention that includes ∼8000 HA/KA patients from a randomized controlled trial conducted in nine German hospitals. The study setting gave us the unique opportunity to apply a causal forest, a recently developed machine learning method, to explore treatment effect heterogeneity of the intervention. We found that among both HA and KA patients, the intervention was especially effective for patients that were female, >65 years of age, had a blood pressure disease, were not working, reported no backpain and were adherent. When transferring the study design into standard care, policy makers should make use of the knowledge obtained in this study and allocate the treatment towards subgroups for which the treatment is especially effective.

Robotic-assisted surgery for prostatectomy - does the diffusion of robotic systems contribute to treatment centralization and influence patients' hospital choice?

BACKGROUND: Between 2008 and 2018, the share of robotic-assisted surgeries (RAS) for radical prostatectomies (RPEs) has increased from 3 to 46% in Germany. Firstly, we investigate if this diffusion of RAS has contributed to RPE treatment centralization. Secondly, we analyze if a hospital's use of an RAS system influenced patients' hospital choice. METHODS: To analyze RPE treatment centralization, we use (bi-) annual hospital data from 2006 to 2018 for all German hospitals in a panel-data fixed effect model. For investigating RAS systems' influence on patients' hospital choice, we use patient level data of 4614 RPE patients treated in 2015. Employing a random utility choice model, we estimate the influence of RAS as well as specialization and quality on patients' marginal utilities and their according willingness to travel. RESULTS: Despite a slight decrease in RPEs between 2006 and 2018, hospitals that invested in an RAS system could increase their case volumes significantly (+ 82% compared to hospitals that did not invest) contributing to treatment centralization. Moreover, patients are willing to travel longer for hospitals offering RAS (+ 22% than average travel time) and for specialization (+ 13% for certified prostate cancer treatment centers, + 9% for higher procedure volume). The influence of outcome quality and service quality on patients' hospital choice is insignificant or negligible. CONCLUSIONS: In conclusion, centralization is partly driven by (very) high-volume hospitals' investment in RAS systems and patient preferences. While outcome quality might improve due to centralization and according specialization, evidence for a direct positive influence of RAS on RPE outcomes still is ambiguous. Patients have been voting with their feet, but research yet has to catch up.

Electronic Patient-Reported Outcome Monitoring to Improve Quality of Life After Joint Replacement: Secondary Analysis of a Randomized Clinical Trial.

Importance: Although remote patient-reported outcome measure (PROM) monitoring has shown promising results in cancer care, there is a lack of research on PROM monitoring in orthopedics. Objective: To determine whether PROM monitoring can improve health outcomes for patients with joint replacement compared with the standard of care. Design, Setting, and Participants: A 2-group, patient-level randomized clinical trial (PROMoting Quality) across 9 German hospitals recruited patients aged 18 years or older with primary hip or knee replacement from October 1, 2019, to December 31, 2020, with follow-up until March 31, 2022. Interventions: Intervention and control groups received the standard of care and PROMs at hospital admission, discharge, and 12 months after surgery. In addition, the intervention group received PROMs at 1, 3, and 6 months after surgery. Based on prespecified PROM score thresholds, at these times, an automated alert signaled critical recovery paths to hospital study nurses. On notification, study nurses contacted patients and referred them to their physicians if necessary. Main Outcomes and Measures: The prespecified outcomes were the mean change in PROM scores (European Quality of Life 5-Dimension 5-Level version [EQ-5D-5L; range, -0.661 to 1.0, with higher values indicating higher levels of health-related quality of life (HRQOL)], European Quality of Life Visual Analogue Scale [EQ-VAS; range, 0-100, with higher values indicating higher levels of HRQOL], Hip Disability and Osteoarthritis Outcome Score-Physical Function Shortform [HOOS-PS; range, 0-100, with lower values indicating lower physical impairment] or Knee Injury and Osteoarthritis Outcome Score-Physical Function Shortform [KOOS-PS; range, 0-100, with lower values indicating lower physical impairment], Patient-Reported Outcomes Measurement Information System [PROMIS]-fatigue [range, 33.7-75.8, with lower values indicating lower levels of fatigue], and PROMIS-depression [range, 41-79.4, with lower values indicating lower levels of depression]) from baseline to 12 months after surgery. Analysis was on an intention-to-treat basis. Results: The study included 3697 patients with hip replacement (mean [SD] age, 65.8 [10.6] years; 2065 women [55.9%]) and 3110 patients with knee replacement (mean [SD] age, 66.0 [9.2] years; 1669 women [53.7%]). Exploratory analyses showed significantly better health outcomes in the intervention group on all PROMs except the EQ-5D-5L among patients with hip replacement, with a 2.10-point increase on the EQ-VAS in the intervention group compared with the control group (HOOS-PS, -1.86 points; PROMIS-fatigue, -0.69 points; PROMIS-depression, -0.57 points). Patients in the intervention group with knee replacement had a 1.24-point increase on the EQ-VAS, as well as significantly better scores on the KOOS-PS (-0.99 points) and PROMIS-fatigue (-0.84 points) compared with the control group. Mixed-effect models showed a significant difference in improvement on the EQ-VAS (hip replacement: effect estimate [EE], 1.66 [95% CI, 0.58-2.74]; knee replacement: EE, 1.71 [95% CI, 0.53-2.90]) and PROMIS-fatigue (hip replacement: EE, -0.65 [95% CI, -1.12 to -0.18]; knee replacement: EE, -0.71 [95% CI, -1.23 to -0.20]). The PROMIS-depression score was significantly reduced in the hip replacement group (EE, -0.60 [95% CI, -1.01 to -0.18]). Conclusions and Relevance: In this randomized clinical trial, the PROM-based monitoring intervention led to a small improvement in HRQOL and fatigue among patients with hip or knee replacement, as well as in depression among patients with hip replacement. Trial registration: Deutsches Register Klinischer Studien ID: DRKS00019916.

Thresholds for meaningful improvement in WOMAC scores need to be adjusted to patient characteristics after hip and knee replacement.

PURPOSE: To calculate unstratified and patient-specific meaningful improvement (MI) and patient acceptable symptom states (PASS) for the WOMAC total score in patients after total hip (THR) or total knee replacement (TKR). METHODS: A retrospective observational cohort study. Anchor-based receiver operator characteristics curves were used to estimate MI and PASS thresholds. RESULTS: Recovery paths were specific to individual characteristics of patients. An unstratified 12-months MI threshold of 28.1 (PASS: 13.3) and 17.8 (PASS: 15.8) for patients after THR and TKR, respectively, would unfairly detect critical recovery paths. CONCLUSIONS: Thresholds for treatment success need to be as patient-specific as possible.

The use of digitally collected patient-reported outcome measures for newly operated patients with total knee and hip replacements to improve post-treatment recovery: study protocol for a randomized controlled trial.

BACKGROUND: The number of total knee replacements (TKRs) and total hip replacements (THRs) has been increasing noticeably in high-income countries, such as Germany. In particular, the number of revisions is expected to rise because of higher life expectancy and procedures performed on younger patients, impacting the budgets of health-care systems. Quality transparency is the basis of holistic patient pathway optimization. Nevertheless, a nation-wide cross-sectoral assessment of quality from a patient perspective does not yet exist. Several studies have shown that the use of patient-reported outcome measures (PROMs) is effective for measuring quality and monitoring post-treatment recovery. For the first time in Germany, we test whether early detection of critical recovery paths using PROMs after TKR/THR improves the quality of care in a cost-effective way and can be recommended for implementation into standard care. METHODS/DESIGN: The study is a two-arm multi-center patient-level randomized controlled trial. Patients from nine hospitals are included in the study. Patient-centered questionnaires are employed to regularly measure digitized PROMs of TKR/THR patients from the time of hospital admission until 12 months post-discharge. An expert consortium has defined PROM alert thresholds at 1, 3, and 6 months to signal critical recovery paths after TKR/THR. An algorithm alerts study assistants if patients are not recovering in line with expected recovery paths. The study assistants contact patients and their physicians to investigate and, if needed, adjust the post-treatment protocol. When sickness funds' claims data are added, the cost-effectiveness of the intervention can be analyzed. DISCUSSION: The study is expected to deliver an important contribution to test PROMs as an intervention tool and examine the determinants of high-quality endoprosthetic care. Depending on a positive and cost-effective impact, the goal is to transfer the study design into standard care. During the trial design phase, several insights have been discovered, and there were opportunities for efficient digital monitoring limited by existing legacy care models. Digitalization in hospital processes and the implementation of digital tools still represent challenges for hospital personnel and patients. Furthermore, data privacy regulations and the separation between the in- and outpatient sector are roadblocks to effectively monitor and assess quality along the full patient pathway. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00019916. Registered November 26, 2019 - retrospectively registered.