title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Treatment protocol | Patients received three courses of SOX | PMC10468941 | ||
Neoadjuvant SOX chemotherapy | Patients were scheduled to receive three courses of NAC with oxaliplatin (130 mg/m | PMC10468941 | ||
Surgery | Since the current clinical trial was for older patients, the protocol surgery was only stipulated as “surgery for curative purposes.” Surgery was performed after confirming that the following two conditions were met. (1) A CT scan performed within 7–56 days from the date of the last S-1 administration to determine that... | PMC10468941 | ||
Post-operative evaluation | ADVERSE EVENT, SURGICAL COMPLICATIONS, POSTOPERATIVE HEMORRHAGE, COMPLICATIONS | From the end of surgery to 30 days after surgery, the items that were evaluated included: (1) Initial discharge date after surgery; (2) Presence or absence of postoperative hemorrhage; (3) Presence or absence of re-operation; (4) Pathological findings; and (5) Postoperative early complications. The principal investigat... | PMC10468941 | |
Statistical analysis | The primary endpoint of the trial was the dose intensity (DI) of the preoperative SOX | PMC10468941 | ||
Results | PMC10468941 | |||
Discussion | death, neutropenia, diarrhea, hyponatremia, dehydration, gastric cancer | NEUTROPENIA, ADVERSE EVENTS, DISEASE, HYPONATREMIA, DEHYDRATION, GASTRIC CANCER | This phase II study tested the safety and efficacy of SOXThe main research hypothesis of this study was that “NAC + radical gastrectomy for LAGC in older patients is as safe and effective as in the young.” The participants in this study were older than 70 years of age, were more likely to have comorbidities, and the in... | PMC10468941 |
Conclusion | In this trial, the safety and efficacy of NAC-SOX | PMC10468941 | ||
Acknowledgements | We sincerely thank the participating patients and their families. We are indebted to the physicians and all other medical staff. We also thank Ms. Sakamoto and the staff at Clinical Research Support Center (CReS), Kyushu for their excellent data collection and management, secretarial assistance, and support. Editorial ... | PMC10468941 | ||
Funding | This research was funded by Yakult Honsha Co., Ltd. Head Office and was carried out by the CReS Kyushu. Due consideration was given so that the interests of the participants and the interests of the researchers do not conflict with each other (conflict of interest) by receiving funding from the company. The CReS Kyushu... | PMC10468941 | ||
Declarations | PMC10468941 | |||
Conflict of interest | Hiroshi Saeki (Department of General Surgical Science, Graduate School of Medicine, Gunma University), who is the Research Director of this study, is not in a state of conflict of interest with the Yakult Honsha Co., Ltd. Head Office. Y. Kakeji has received an honorarium from Taiho Pharmaceutical Co., Ltd. N. Izawa rec... | PMC10468941 | ||
Human rights statement and informed consent | All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. This study was approved by the Clinical Research Network Fukuoka Certified Review Board (Certification No... | PMC10468941 | ||
References | PMC10468941 | |||
Subject terms | trauma, traumatic | EVENTS, EVENT, RECRUITMENT | Intensive care unit (ICU) staff continue to face recurrent work-related traumatic events throughout the COVID-19 pandemic. Intrusive memories (IMs) of such traumatic events comprise sensory image-based memories. Harnessing research on preventing IMs with a novel behavioural intervention on the day of trauma, here we ta... | PMC10131522 |
Introduction | traumatic, post-traumatic stress disorder, PTSD, deaths, primarily visual memories, trauma | EVENTS, EVENT, RECRUITMENT, VEHICLE ACCIDENT | Throughout the COVID-19 pandemic, frontline healthcare workers have been repeatedly exposed to potentially psychologically traumatic events, such as untimely and excess deaths of patients. After trauma, it is common to experience intrusive memories (IMs) of the event. These are emotional, sensory, and primarily visual ... | PMC10131522 |
Material and methods | PMC10131522 | |||
Study design and participants | death, PTSD, DSM-5, traumatic | EVENT | We conducted a two-arm, parallel-group, randomised, adaptive Bayesian optimisation trial of a remotely delivered digital intervention. Ethical approval for the trial was granted by the Wales Research Ethics Committee (Wales REC 6, 21/WA/0173). The trial was registered prospectively at Clinical.Trials.gov (CTR: NCT04992... | PMC10131522 |
Trial profile. | CONSORT diagram showing enrolment, allocation, and the analysis populations. | PMC10131522 | ||
Randomisation and masking | ® | Participants were randomly assigned (1:1) using a remote, secure web-based clinical research system (P1vital® ePRO) to either immediate intervention arm (immediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks) or delayed intervention arm (usual care for 4 weeks fol... | PMC10131522 | |
The intervention | ® | Straight after randomisation, participants in the immediate intervention arm gained access to the digital imagery-competing task intervention with symptom monitoring of IMs for 4 weeks. The intervention was delivered on a secure web platform (i-spero®) via smartphone, tablet, or computer. Participants had an initial re... | PMC10131522 | |
Assessments | PMC10131522 | |||
Baseline | After informed consent, participants completed a daily IM diary online for 7 days (baseline week, day 0–6 i.e. run-in week on Fig. | PMC10131522 | ||
Primary outcome | trauma, PTSD, Clinician-Administered PTSD, traumatic | During week 4, participants in both arms were asked to again complete the daily IM diary for 7 days (i.e. from day 22 to 28, where day 1 is the guided session in immediate arm/equivalent timeframe in delayed arm) to record the number of IMs of traumatic event(s); The primary outcome measure was the total number of IMs ... | PMC10131522 | |
Safety | ADVERSE EVENT | Adverse events were monitored through a standardised question (“have you experienced any untoward medical occurrences or other problems?”) at week 4 and week 8, as well as through any spontaneous reports from participants at any time point during the study. | PMC10131522 | |
Other outcomes | SECONDARY | The present article focuses solely on the sequential Bayesian analyses on the primary outcome measure. A standard analysis (using frequentist statistics) of the final study population including secondary outcome measures will be reported elsewhere [ | PMC10131522 | |
Statistical analysis | Informed by power estimates based on an effect size of The fundamental idea to a Bayesian approach is simple [All analyses were completed in R (version 4.1.2) on an intention-to-treat basis. We fitted a Bayesian model, where the primary outcome (intrusive memory count) was modelled using a Poisson linear mixed model. T... | PMC10131522 | ||
Boxplots for intrusive memory (IM) measures. | The midline of the boxplot is the median value, with the upper and lower limits of the box being the third and first quartile (75th and 25th percentile), and the whiskers covering 1.5 times the IQR. The dots depict outliers (each dot represents one participant that departed more than 1.5 times the IQR above the third q... | PMC10131522 | ||
Results | Between Aug 16, 2021 and Apr 19, 2022, 125 participants were screened by the study team following pre-screening questionnaires (Fig. | PMC10131522 | ||
Baseline characteristics | SD | Trial participants had a mean age of 38.7 years (SD 9.9), were predominantly women ( | PMC10131522 | |
Treatment effects | Bayesian analyses of the primary outcome involved seven sequential analyses (after 20, 23, 29, 37, 41, 45, and 75 participants completed the primary outcome). From the first analysis (at | PMC10131522 | ||
Evidence progression. | SENSITIVITY | Sequential Bayesian analyses showed that the evidence (BFFor the final sample (For the round of “usability enhancement” optimisations (see “Method”) conducted on Feb 7, 2022, there was evidence for a positive treatment effect of the optimised intervention (BF = 7.31) based on analyses of 28 participants who entered the... | PMC10131522 | |
Safety | By using sequential analyses, we could early (at | PMC10131522 | ||
Discussion | traumas, trauma, affective or cognitive elements, traumatic | EVENTS, EVENT | Results showed strong evidence that ICU staff experiencing IMs after work-related traumatic events in the COVID-19 pandemic, had fewer IMs (median = 1 per week, IQR = 0–3) when they were given access to the brief digital imagery-competing task intervention, as opposed to usual care for 4 weeks (median = 10 per week, IQ... | PMC10131522 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41380-023-02062-7. | PMC10131522 | ||
Acknowledgements | ® | The study was funded by the Wellcome Trust (223016/Z/21/Z). TJ is supported by a grant from UK Medical Research Council (MC_UU_00002/14). For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. Tetris® has been licen... | PMC10131522 | |
Author contributions | EAH | EAH and JK conceived the trial, gained funding, and contributed to the study design. CS and MBB provided expert input into the conception of the trial, and MBB and TJ into the study design. LI delivered the intervention, acquired the data, and with JK, JH and CS contributed to interpretation of the work. VR and MBB acc... | PMC10131522 | |
Funding | The study was funded by the Wellcome Trust (223016/Z/21/Z). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. P1vital Products Ltd was the trial sponsor. Open access funding was provided by Uppsala University. | PMC10131522 | ||
Data availability | OSF | Anonymised databases with the individual participant data and the metadata for Bayesian analyses, along with a data dictionary are available on the Open Science Framework (OSF) (osf.io/m5cvj) for anyone who wishes to access the data for any purpose. The Study Protocol and Bayesian Statistical Analysis Plan are availabl... | PMC10131522 | |
Code availability | OSF | Analytical code files (R scripts) are available on the Open Science Framework (OSF) (osf.io/m5cvj) for anyone who wishes to access the code for any purpose. This will be shared indefinitely with no end date on the OSF platform. | PMC10131522 | |
Competing interests | EAH | The study was funded by the Wellcome Trust (223016/Z/21/Z). JK is shareholder and director of P1vital Products Ltd which is the study sponsor and manufacturer of i-spero®. VR and LI are employed by P1vital Products Ltd. MBB is an adjunct member of the DMC. CS salary is partly funded by National Institute for Health Res... | PMC10131522 | |
References | PMC10131522 | |||
Purpose | hip arthroplasty, MP, THA | This study aimed to evaluate the efficacy and safety of combined methylprednisolone (MP) and tranexamic acid (TXA) in promoting accelerated rehabilitation following total hip arthroplasty (THA). We further investigated effective strategies for rapid rehabilitation post-THA. | PMC10548678 | |
Methods | nausea, MP, pain | INFLAMMATION | Conducted as a randomized controlled trial involving 80 patients, the study allocated subjects into two groups. The control group received saline and TXA, whereas the experimental group was administered with an additional dose of MP. Several clinical parameters, including markers of inflammation, pain, nausea, and coag... | PMC10548678 |
Results | postoperative nausea and fatigue, blood glucose fluctuations, MP, pain | COMPLICATIONS | It was observed that the group receiving the MP + TXA treatment showcased significant reductions in postoperative levels of CRP and IL-6, as well as an alleviation in pain scores. Furthermore, this group demonstrated lower incidences of postoperative nausea and fatigue, facilitating enhanced hip joint mobility. Interes... | PMC10548678 |
Conclusion | nausea, MP, fatigue, pain | PERIOPERATIVE COMPLICATION | The findings suggest that the combined administration of MP and TXA can appreciably enhance postoperative recovery, by reducing inflammatory markers, alleviating pain, reducing nausea and fatigue, and improving hip mobility, without leading to an increased risk of severe perioperative complications. This highlights the... | PMC10548678 |
Keywords | PMC10548678 | |||
Background | THA, terminal hip pathologies | Total Hip Arthroplasty (THA) constitutes a highly cost-effective therapeutic approach for terminal hip pathologies, as evidenced by a wide body of literature [ | PMC10548678 | |
Materials and methods | PMC10548678 | |||
Study design | thrombo-embolism, infections, hepatic and renal dysfunctions, cardio-pulmonary disorders, coagulation abnormalities, MP, THA | RHEUMATOID ARTHRITIS, TRANEXAMIC ACID ALLERGY, INFECTIONS, HEMATOLOGICAL DISORDERS, MALIGNANCIES | Our study adhered strictly to the protocols established by the Institutional Ethics Review Board of our institution and complied meticulously with the Guidelines on Standards for Reporting of Trials (CONSORT). We enrolled all patients undergoing initial Total Hip Arthroplasty (THA) in this study. However, we establishe... | PMC10548678 |
Intervention | In the control group (TXA group, | PMC10548678 | ||
Perioperative management | thrombosis, nausea, pneumonia, hyperalgesia, Postoperative pain, PostOperative Nausea and Vomiting, pain, PONV | THROMBOSIS, PNEUMONIA, PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS | All surgeries were conducted by senior orthopedic surgeons in a class-100 laminar flow operating theatre, employing either general or epidural anesthesia with a posterolateral surgical approach. The hip prostheses implanted were all uncemented and we did not place any drainage catheters.Postoperatively, the patients we... | PMC10548678 |
Outcome measurements | blood loss, postoperative nausea and vomiting, fatigue, pain | BLOOD LOSS, COMPLICATIONS | Our primary outcome parameters included inflammatory marker (CRP and IL-6) levels at 24, 48, and 72 h post-surgery in both groups. We evaluated patients' pain levels using the VAS score, and we recorded both the quantity of pain and the amount of analgesics (tramadol and meperidine hydrochloride) used to assess the ana... | PMC10548678 |
Statistical analysis | For statistical analysis, we employed SPSS version 22.0. We reported continuous variables and mean standard deviations with a 95% confidence interval. We applied the Wilcoxon Mann–Whitney U test for numerical variables not normally distributed or anisotropic. We compared categorical variables using the Pearson χ2 test ... | PMC10548678 | ||
Results | PMC10548678 | |||
Patient selection and baseline information | dysplasia, ONFH, MP, fatigue | OSTEONECROSIS OF THE FEMORAL HEAD, SECONDARY, DYSPLASIA, OSTEOARTHRITIS | Out of 89 consecutively screened patients, a final cohort of 80 was selected for participation in this study, following a six-month follow-up period and the application of exclusion criteria that removed 8 individuals. A further individual declined to participate. Of the remaining patients, 40 were allocated to the TXA... | PMC10548678 |
Inflammatory markers: CRP and IL-6 levels | MP | Postoperative levels of CRP and IL-6 showed an increase in comparison with preoperative levels in both treatment cohorts. Peak CRP levels were observed at 48 h postoperative; however, the MP + TXA group demonstrated lower levels at 24 h (Level of CRP in the two groups. MP:Methylprednisolone; TXA: Tranexamic acid Pre-, ... | PMC10548678 | |
Pain evaluation and analgesic use | MP, pain | Postoperative VAS pain scores demonstrated a reduction in both treatment groups when compared to preoperative levels. At 24 h postoperatively, the MP + TXA group reported lower pain scores during both rest (Level of VAS scores at rest in the two groups. MP:Methylprednisolone; TXA: Tranexamic acid Pre-,preoperative; pos... | PMC10548678 | |
Postoperative nausea, vomiting, and antiemetic use | PONV, postoperative nausea and vomiting, MP, Postoperative nausea and vomiting | DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, DVT | The incidence of postoperative nausea and vomiting (PONV) was significantly lower in the MP + TXA group compared to the TXA group (Secondary outcome indicators and complicationsPONV: Postoperative nausea and vomiting; ICFS: Identity-con-sequence-fatigue-scale; ROM: Range of motion; LOS: Length of hospital stay; Hb: Hem... | PMC10548678 |
Blood glucose variability | MP | BLOOD | There was no statistically significant difference in preoperative blood glucose profiles between the two groups (Level of Blood sugar fluctuations in the two groups. MP:Methylprednisolone; TXA: Tranexamic acid; Pre-, preoperative; post, postoperative.**** | PMC10548678 |
ICFS and ROM evaluation | Preoperatively, a comparison of the ICFS and ROM metrics between the two groups demonstrated no significant variation ( | PMC10548678 | ||
Blood loss, transfusion rates, and postoperative hemoglobin and hematocrit levels | blood loss | BLOOD LOSS | There were no significant differences observed between the two groups with regards to total blood loss ( | PMC10548678 |
Discussion | paresthesia, infections or gastrointestinal bleeds, postoperative nausea and vomiting, hyperglycemia, postoperative fatigue, PONV, MP, THA, trauma | HYPERGLYCEMIA, INFLAMMATION, PARESTHESIA, INTESTINAL OBSTRUCTION | In our research, we delved into the possibility of MP and TXA amalgamation to additionally lessen postoperative inflammatory reactions and stimulate swift recuperation. As far as we are aware, there is a lack of extensive research examining the effectiveness and safety of MP and TXA combined usage in patients undergoin... | PMC10548678 |
Author contributions | ZH was responsible for the design and writing of the article. Data retrieval, collection, and statistical analysis were undertaken by HD, CY, CZ, and WW. | PMC10548678 | ||
Funding | This project was sponsored by Hezhou Self-financed Project. | PMC10548678 | ||
Availability of data and materials | Data for this article were sourced from patients hospitalized at our institution for total hip arthroplasty. The data are both credible and reliable. | PMC10548678 | ||
Declarations | PMC10548678 | |||
Ethics approval and consent to participate | The paper was reviewed by the ethics committees of the affiliations of all five authors, who approved its content. All authors affirm their full compliance with ethical standards. The five authors of this article affirm that they fully comply with ethical standards. | PMC10548678 | ||
Informed Consent | Informed consent was required from the patients, and they signed to co-operate with the study. | PMC10548678 | ||
Competing interests | Neither this paper nor any of its authors have any conflicts of interest. | PMC10548678 | ||
References | PMC10548678 | |||
Key Points | PMC10474554 | |||
Question | Does patient-reported outcome measure (PROM)–based remote monitoring after hip and knee replacement surgery improve health outcomes compared with the standard of care? | PMC10474554 | ||
Findings | primary hip replacement, depression, fatigue | This multicenter randomized clinical trial included 3697 patients with primary hip replacement and 3110 with knee replacement across 9 German hospitals. The intervention group had a statistically significantly higher mean increase from baseline to 12 months after surgery in health-related quality of life score, fatigue... | PMC10474554 | |
Meaning | depression, fatigue | This randomized clinical trial found that postoperative PROM monitoring, including alerts for critical recovery, led to small improvements in several health dimensions (health-related quality of life and fatigue after hip and knee replacement and depression after hip replacement). | PMC10474554 | |
Importance | PROM, cancer | CANCER | 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. | PMC10474554 |
Objective | PROM | To determine whether PROM monitoring can improve health outcomes for patients with joint replacement compared with the standard of care. | PMC10474554 | |
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. | PMC10474554 | ||
Interventions | PROM | 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... | PMC10474554 | |
Main Outcomes and Measures | PROM, Knee Injury, Osteoarthritis, fatigue, depression, Disability | OSTEOARTHRITIS | 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 v... | PMC10474554 |
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 E... | PMC10474554 | ||
Conclusions and Relevance | depression, fatigue | 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. | PMC10474554 | |
Trial registration | Deutsches Register Klinischer Studien ID: This randomized clinical trial evaluates whether patient-reported outcome measure monitoring can improve health outcomes for patients with joint replacement compared with the standard of care. | PMC10474554 | ||
Introduction | Patient-reported outcome measures (PROMs) are increasingly used for research and health technology assessment across indications and geographic regionsCritical recovery detection via PROMs has shown promising results in oncology, leading to higher survival rates, improved health-related quality of life (HRQOL), and red... | PMC10474554 | ||
Methods | PMC10474554 | |||
Study Design | Knee Injury, Osteoarthritis | SECONDARY, OSTEOARTHRITIS | A 2-group, parallel patient-level randomized clinical trial, PROMoting Quality, was conducted across 9 German hospitals to assess a PROM-based monitoring intervention for patients with hip replacement or knee replacement. This study presents an a priori–specified analysis of the secondary outcomes. Patients were blinde... | PMC10474554 |
Hospitals | The 9 participating hospitals included 1 university hospital, 1 nonteaching hospital, and 7 teaching hospitals. In Germany, the standard of care includes postsurgery rehabilitation in an inpatient or ambulatory care setting for 3 weeks. Five of the participating hospitals offer inpatient rehabilitation, but where patie... | PMC10474554 | ||
Patients | PROM, tumor | TUMOR | Study nurses and/or physicians aimed to include all eligible patients in the trial. Patients 18 years of age or older with prespecified surgery codes for hip replacement and knee replacement were included. Exclusion criteria were emergency and life-threatening cases, tumor prothesis, American Society of Anesthesiologis... | PMC10474554 |
Outcomes | PROM | SECONDARY | Although the primary outcome of the PROMoting Quality trial was the cost-effectiveness of the intervention using a composite of all PROM scores, the primary outcomes of this secondary analysis are the trial’s secondary outcomes (ie, changes in individual PROM scores from baseline to 12 months after surgery). | PMC10474554 |
Statistical Analysis | PROM | Descriptive analyses were run per group and joint replacement type for the patient characteristics, PROM scores, and clinical characteristics. Analyses were separated per joint replacement type due to their different recovery durations and levels.As sensitivity analyses, the primary outcomes were assessed in a complian... | PMC10474554 | |
Results | PMC10474554 | |||
Patient Characteristics | Overall, 1854 patients with hip replacement (mean [SD] age, 65.9 [10.6] years; 1029 women [55.5%]) and 1564 patients with knee replacement (mean [SD] age, 66.1 [9.1] years; 839 women [53.6%]) were assigned to the intervention group, and 1843 patients with hip replacement (mean [SD] age, 65.7 [10.6] years; 1036 women [5... | PMC10474554 | ||
Characteristics of the Study Population (Intention-to-Treat Population) | Knee Injury, Disability, Osteoarthritis, PROM | OSTEOARTHRITIS | Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); EQ-5D-5L, European Quality of Life 5-Dimension 5-Level version; EQ-VAS, European Quality of Life Visual Analogue Scale; HOOS-PS, Hip Disability and Osteoarthritis Outcome Score–Physical Function Shortform; KOOS-... | PMC10474554 |
Distriubtion of Raw Patient-Reported Outcome Measure (PROM) Scores for the Control and Intervention Groups | Knee Injury, Osteoarthritis | OSTEOARTHRITIS | Higher values on the European Quality of Life Visual Analogue Scale (EQ-VAS) indicate better health levels, whereas lower values in physical functioning (Hip Disability and Osteoarthritis Outcome Score–Physical Function Shortform or Knee Injury and Osteoarthritis Outcome Score–Physical Function Shortform [H/KOOS-PS]), ... | PMC10474554 |
Compliance in Answering the PROM Questionnaires | PROM | In the intervention group, response rates to the PROM questionnaires were at 85.3% (1582 of 1854), 87.8% (1627 of 1854), and 86.1% (1597 of 1854) at intervention time points at 1, 3, and 6 months after surgery, respectively, for patients with hip replacement and 85.1% (1331 of 1564), 85.3% (1334 of 1564), and 84.5% (13... | PMC10474554 | |
Alerts Based on Critical PROM Scores and Reactions to Alerts | PROM | The percentage of alerts based on critical PROM scores as a share of the patients with hip replacement with available information on the critical values was 8.9% (157 of 1772) at 1 month, 25.6% (454 of 1773) at 3 months, and 24.8% (424 of 1709) at 6 months (eTable 6 in The proportion of treatment changes among patients... | PMC10474554 | |
Main Analysis of the Primary Outcome: Mixed-Effect Models | After controlling for patient and treatment attributes in the mixed-effect models, the intervention showed significant effect estimates (EEs) for the changes in EQ-VAS score (EE, 1.66 [95% CI, 0.58-2.74]), PROMIS-fatigue score (EE, −0.65 [95% CI, −1.12 to −0.18]), and PROMIS-depression score (EE, −0.60 [95% CI, −1.01 t... | PMC10474554 | ||
Mixed-Effect Model Effect Estimates for the Intervention per Patient-Reported Outcome Measure (PROM) Score | The mixed-effect models used | PMC10474554 | ||
Discussion | PROM, fatigue | Overall, this randomized clinical trial demonstrated small, statistically significant health benefits in HRQOL and fatigue using the remote PROM monitoring intervention compared with the standard of care for patients with hip replacement and patients with knee replacement; for example, patients with hip replacement had... | PMC10474554 | |
Strengths and Limitations | This study has some strengths. To our knowledge, it is the first randomized clinical trial evaluating the effect of PROM-based remote monitoring among patients receiving joint replacements. The randomized clinical trial design has several advantages, including randomization on the patient level, inclusion of multiple h... | PMC10474554 |
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