The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a pati...The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a patient's health status directly from their perspective,encompassing various domains such as symptom severity,functional status,and overall quality of life.By integrating PROMs into routine clinical practice and research,healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly.The deployment of PROMs supports dynamic patient-provider interactions,fostering better patient engagement and adherence to tre-atment plans.Moreover,PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy,particularly in chronic and mental health conditions.However,challenges in implementing PROMs include data collection and management,integration into existing health systems,and acceptance by patients and providers.Overcoming these barriers necessitates technological advancements,policy development,and continuous education to enhance the acceptability and effectiveness of PROMs.The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings.展开更多
In the practice of healthcare,patient-reported outcomes(PROs)and PRO measures(PROMs)are used as an attempt to observe the changes in complex clinical situations.They guide us in making decisions based on the evidence ...In the practice of healthcare,patient-reported outcomes(PROs)and PRO measures(PROMs)are used as an attempt to observe the changes in complex clinical situations.They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect.For any PROM to be usable in health care,we need it to be reliable,encapsulating the points of interest with the potential to detect any real change.Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview,and this allows the physician and patient to have a meaningful conver-sation as well as a customized plan for each patient.Having mentioned the rationale and the benefits of PROMs,understanding the quantification process is crucial before embarking on management decisions.A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition.There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences.This article details the various quantification metrics used to evaluate the treatment effect using PROMs,their limitations and the scope of usage and implementation in clinical practice.展开更多
AIM To establish minimum clinically important difference(MCID) for measurements in an orthopaedic patient population with joint disorders.METHODS Adult patients aged 18 years and older seeking care for joint condition...AIM To establish minimum clinically important difference(MCID) for measurements in an orthopaedic patient population with joint disorders.METHODS Adult patients aged 18 years and older seeking care for joint conditions at an orthopaedic clinic took the Patient-Reported Outcomes Measurement Information System Physical Function(PROMIS~? PF) computerized adaptive test(CAT), hip disability and osteoarthritis outcome score for joint reconstruction(HOOS JR), and the knee injury and osteoarthritis outcome score for joint reconstruction(KOOS JR) from February 2014 to April 2017. MCIDs were calculated using anchorbased and distribution-based methods. Patient reports of meaningful change in function since their first clinic encounter were used as an anchor.RESULTS There were 2226 patients who participated with a mean age of 61.16(SD = 12.84) years, 41.6% male, and 89.7% Caucasian. Mean change ranged from 7.29 to 8.41 for the PROMIS~? PF CAT, from 14.81 to 19.68 for the HOOS JR, and from 14.51 to 18.85 for the KOOS JR. ROC cut-offs ranged from 1.97-8.18 for the PF CAT, 6.33-43.36 for the HOOS JR, and 2.21-8.16 for the KOOS JR. Distribution-based methods estimated MCID values ranging from 2.45 to 21.55 for the PROMIS~? PF CAT; from 3.90 to 43.61 for the HOOS JR, and from 3.98 to 40.67 for the KOOS JR. The median MCID value in the range was similar to the mean change score for each measure and was 7.9 for the PF CAT, 18.0 for the HOOS JR, and 15.1 for the KOOS JR.CONCLUSION This is the first comprehensive study providing a wide range of MCIDs for the PROMIS? PF, HOOS JR, and KOOS JR in orthopaedic patients with joint ailments.展开更多
BACKGROUND Advances in implant material and design have allowed for improvements in total knee arthroplasty(TKA)outcomes.A cruciate retaining(CR)TKA provides the least constraint of TKA designs by preserving the nativ...BACKGROUND Advances in implant material and design have allowed for improvements in total knee arthroplasty(TKA)outcomes.A cruciate retaining(CR)TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament.Limited research exists that has examined clinical outcomes or patient reported outcome measures(PROMs)of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant.It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores.AIM To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design.METHODS A retrospective,multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System(JOURNEY™II CR;Smith and Nephew,Inc.,Memphis,TN)at an urban,academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon.Patient demographics,surgical information,clinical outcomes,and PROMs data were collected via query of electronic medical records.The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(KOOS JR)and Patient-Reported Outcomes Measurement Information System(PROMIS■)scores.The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests.RESULTS Of the 255 patients,65.5%were female,43.8%were White,and patients had an average age of 60.6 years.Primary osteoarthritis(96.9%)was the most common primary diagnosis.The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home(92.5%).There were 18 emergency department(ED)visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%,including a 2.4%orthopedic-related ED visit rate and a 4.7%non-orthopedic-related ED visit rate.There were three(1.2%)hospital readmissions within 90 d postoperatively.With a mean time to latest follow-up of 3.3 years,four patients(1.6%)required revision,two for arthrofibrosis,one for aseptic femoral loosening,and one for peri-prosthetic joint infection.There were significant improvements in KOOS JR,PROMIS Pain Intensity,PROMIS Pain Interference,PROMIS Mobility,and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores.CONCLUSION The evaluated implant is an effective,novel design offering excellent outcomes and low complication rates.At a mean follow up of 3.3 years,four patients required revisions,three aseptic and one septic,resulting in an overall implant survival rate of 98.4%and an aseptic survival rate of 98.8%.The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.展开更多
Patient-reported outcomes measures form the backbone of outcomes evaluation in orthopaedics,with most of the literature now relying on these scoring tools to measure change in patient health status.This patient-report...Patient-reported outcomes measures form the backbone of outcomes evaluation in orthopaedics,with most of the literature now relying on these scoring tools to measure change in patient health status.This patient-reported information is increasingly collected routinely by orthopaedic providers but use of the data is typically restricted to academic research.Developments in electronic data capture and the outcome tools themselves now allow use of this data as part of the clinical consultation.This review evaluates the role of patient reported outcomes data as a tool to enhance daily orthopaedic clinical practice,and documents how developments in electronic outcome measures,computer-adaptive questionnaire design and instant graphical display of questionnaire can facilitate enhanced patientclinician shared decision making.展开更多
AIM: To evaluate surgical outcomes of modified Z-epicanthoplasty with blepharoplasty that we previously reported from the patient’s perspective using patient-reported outcome measures(PROMs) and patient satisfaction ...AIM: To evaluate surgical outcomes of modified Z-epicanthoplasty with blepharoplasty that we previously reported from the patient’s perspective using patient-reported outcome measures(PROMs) and patient satisfaction scores.METHODS: A total of patients(n=180) who underwent the surgery between January 2013 and June 2016 were randomly selected. Standardized patient satisfaction forms(total score, 40) and validated PROMs questionnaires(total score, 12) were sent to patients for completion. PROMs assesses the severity of scarring, pain and asymmetry, as well as functional and appearance issues.RESULTS: All patients were female, ranging from 18 to 35 years old(mean=24). The response rate was 73.3%(n=132). The majority of patients reported good or excellent outcomes based on PROM analysis. Patients reported minimum or non-visible scarring at both the double eyelid surgical scar(85.6%) and the inner canthus(80.3%). Issues concerning function and appearance were minimal as 80.3% reported satisfaction with both domains. Notably, the majority of patients reported either a high or very high satisfaction rate to yield a mean score of 104 out of 120(P<0.05).CONCLUSION: Integration of our modified Z-epicanthoplasty with blepharoplasty produces good outcomes based on PROM results, which shows a positive linear relationship with patient satisfaction scores.展开更多
We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal (TP) prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This w...We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal (TP) prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 (21.4%) of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy (with 95% scoring 〈5 in a 0-10 scale). Twelve out of 196 men (6.1%) felt pain immediately after the procedure. Despite a high incidence of symptoms (e.g., up to 75% had some hematuria, 47% suffered some pain), it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization (5.5%). There were no inpatient admissions due to complications (hematuria, sepsis). On repeat questioning at a later time point, only 25/199 (12.6%) of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use.展开更多
The mechanisms of fatigue in the group of people with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis are protean. The liver is central in the pathogenesis of fatigue because it uniquely regulates ...The mechanisms of fatigue in the group of people with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis are protean. The liver is central in the pathogenesis of fatigue because it uniquely regulates much of the storage, release and production of substrate for energy generation. It is exquisitely sensitive to the feedback controlling the uptake and release of these energy generation substrates. Metabolic contributors to fatigue, beginning with the uptake of substrate from the gut, the passage through the portal system to hepatic storage and release of energy to target organs (muscle and brain) are central to understanding fatigue in patients with chronic liver disease. Inflammation either causing or resulting from chronic liver disease contributes to fatigue, although inflammation has not been demonstrated to be causal. It is this unique combination of factors, the nexus of metabolic abnormality and the inflammatory burden of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis that creates pathways to different types of fatigue. Many use the terms central and peripheral fatigue. Central fatigue is characterized by a lack of self-motivation and can manifest both in physical and mental activities. Peripheral fatigue is classically manifested by neuromuscular dysfunction and muscle weakness. Therefore, the distinction is often seen as a difference between intention (central fatigue) versus ability (peripheral fatigue). New approaches to measuring fatigue include the use of objective measures as well as patient reported outcomes. These measures have improved the precision with which we are able to describe fatigue. The measures of fatigue severity and its impact on usual daily routines in this population have also been improved, and they are more generally accepted as reliable and sensitive. Several approaches to evaluating fatigue and developing endpoints for treatment have relied of biosignatures associated with fatigue. These have been used singly or in combination and include: physical performance measures, cognitive performance measures, mood/behavioral measures, brain imaging and serological measures. Treatment with non-pharmacological agents have been shown to be effective in symptom reduction, whereas pharmacological agents have not been shown effective.展开更多
Background:The Victorian Institute of Sport Assessment–Patella(VISA-P) scale is the most condition-specific patient-reported outcome measure used to assess symptom severity in athletes with patellar tendinopathy.Prev...Background:The Victorian Institute of Sport Assessment–Patella(VISA-P) scale is the most condition-specific patient-reported outcome measure used to assess symptom severity in athletes with patellar tendinopathy.Previous exploratory factor analyses have been conducted to evaluate the scale's dimensionality,with inconsistent results,and the factor structure of the scale remains unclear.The aims of the present study were to determine the factorial structure of the VISA-P scale using confirmatory factor analysis(CFA) and test measurement invariance across sexes.Methods:The study included a convenience sample of 249 Spanish athletes with patellar tendinopathy.CFA was performed to assess factorial validity.Hypothesized 1-and 2-factor models were tested.Measurement invariance across sexes was evaluated via multi-group CFA with several fit indices using EQS 6.1 software.Results:The internal consistency coefficient was 0.74.Several CFA models were examined and the 1-factor model in which errors for Items 7 and8 were correlated showed acceptable fit in terms of comparative fit index(CFI) and goodness-of-fit index(GFI) statistics(CFI = 0.93;GFI = 0.94;standardized root mean square residual = 0.06;root mean square error of approximation = 0.10;90% confidence interval:0.08–0.13).This model was invariant across sexes.Conclusion:The 1-factor model of the Spanish version of the VISA-P scale(VISA-P-Sp) in which errors for Items 7 and 8 were correlated demonstrated relative fit in CFA.Scores obtained via VISA-P-Sp can be compared between men and women without sexes bias.Further studies should examine the VISA-P scale and other single-score patient-reported outcome measures concurrently.展开更多
大数据时代,患者的管理逐渐转变为理论驱动与数据驱动相结合,实时监测患者动态变化的健康结局数据。患者报告结局电子化实施路径内容无需他人解释,为解决患者随访管理中的信息延续问题提供了新思路,其对实现患者持久、动态、实时的健康...大数据时代,患者的管理逐渐转变为理论驱动与数据驱动相结合,实时监测患者动态变化的健康结局数据。患者报告结局电子化实施路径内容无需他人解释,为解决患者随访管理中的信息延续问题提供了新思路,其对实现患者持久、动态、实时的健康状态监测发挥巨大优势,在造口患者的延续性管理中具有实用性。本文就患者报告结局测量信息系统(patient-reported outcomes measurement information system,PROMIS)和随访管理的概念、造口相关PROMIS评估工具、数据采集方式、应用价值进行综述,以期为我国开展造口患者随访管理提供参考借鉴。展开更多
Objective:Appraisal of treatment outcomes in integrative medicine is a challenge due to a gap between the concepts of Western medicine(WM)disease and traditional Chinese medicine(TCM)syndrome.This study presents an ap...Objective:Appraisal of treatment outcomes in integrative medicine is a challenge due to a gap between the concepts of Western medicine(WM)disease and traditional Chinese medicine(TCM)syndrome.This study presents an approach for the appraisal of integrative medicine that is based on targeted metabolomics.We use non-alcoholic fatty liver disease with spleen deficiency syndrome as a test case.Methods:A patient-reported outcome(PRO)scale was developed based on literature review,Delphi consensus survey,and reliability and validity test,to quantitatively evaluate spleen deficiency syndrome.Then,a metabonomic foundation for the treatment of non-alcoholic fatty liver disease with spleen deficiency syndrome was identified via a longitudinal interventional trial and targeted metabolomics.Finally,an integrated appraisal model was established by identifying metabolites that responded in the treatment of WM disease and TCM syndrome as positive outcomes and using other aspects of the metabonomic foundation as independent variables.Results:Ten symptoms and signs were included in the spleen deficiency PRO scale.The internal reliability,content validity,discriminative validity and structural validity of the scale were all qualified.Based on treatment responses to treatments for WM disease(homeostasis model assessment of insulin resistance)or TCM syndrome(spleen deficiency PRO scale score)from a previous randomized controlled trial,two cohorts comprised of 30 participants each were established for targeted metabolomics detection.Twenty-five metabolites were found to be involved in successful treatment outcomes to both WM and TCM,following quantitative comparison and multivariate analysis.Finally,the model of the integrated appraisal system was exploratively established using binary logistic regression;it included 9 core metabolites and had the prediction probability of 83.3%.Conclusion:This study presented a new and comprehensive research route for integrative appraisal of treatment outcomes for WM disease and TCM syndrome.Critical research techniques used in this research included the development of a TCM syndrome assessment tool,a longitudinal interventional trial with verified TCM treatment,identification of homogeneous metabolites,and statistical modeling.展开更多
Background:Despite the advent of innovative knee prosthesis design,a consistent first-option knee implant design in total knee arthroplasty(TKA)remained unsettled.This study aimed to compare the clinical effects among...Background:Despite the advent of innovative knee prosthesis design,a consistent first-option knee implant design in total knee arthroplasty(TKA)remained unsettled.This study aimed to compare the clinical effects among posterior-stabilized(PS),cruciate-retaining(CR),bi-cruciate substituting(BCS),and bi-cruciate retaining designs for primary TKA.Methods:Electronic databases were systematically searched to identify eligible randomized controlled trials(RCTs)and cohort studies from inception up to July 30,2021.The primary outcomes were the range of knee motion(ROM),and the secondary outcomes were the patient-reported outcome measures(PROMs)and complication and revision rates.Confidence in evidence was assessed using Confidence in Network Meta-Analysis.The Bayesian network meta-analysis was performed for synthesis.Results:A total of 15 RCTs and 18 cohort studies involving 3520 knees were included.The heterogeneity and inconsistency were acceptable.There was a significant difference in ROM at the early follow-up when PS was compared with CR(mean difference[MD]=3.17,95%confidence interval[CI]0.07,7.18)and BCS was compared with CR(MD=9.69,95%CI 2.18,17.51).But at the long-term follow-up,there was no significant difference in ROM in any one knee implant compared with the others.No significant increase was found in the PROMs and complication and revision rates at the final follow-up time.Conclusions:At early follow-up after TKA,PS and BCS knee implants significantly outperform the CR knee implant in ROM.But in the long run,the available evidence suggests different knee prostheses could make no difference in clinical outcomes after TKA with extended follow-up.展开更多
Background: Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients' experiences after AMI hospitalization, especially on long-tern1 adv...Background: Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients' experiences after AMI hospitalization, especially on long-tern1 adverse events and patient-reported outcomes (PROs). Methods: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Prospective AMI Study will enroll 4000 consecutive AM I patients from 53 diverse hospitals across China and follow them longitudinally for 12 months to docunlent their treatment, recovery, and outcomes. Details of patients' medical history, treatment, and in-hospital outcomes are abstracted from medical charts. Comprehensive baseline interviews are being conducted to characterize patient demographics, risk factors, presentation, and healthcare utilization. As part of these interviews, validated instruments are administered to measure PROs, including quality of life, symptoms, mood, cognition, and sexual activity. Follow-up interviews, measuring PROs, medication adherence, risk factor control, and collecting hospitalization events are conducted at 1, 6, and 12 months after discharge. Supporting documents for potential outcomes are collected for adjudication by clinicians at the National Coordinating Center. Blood and urine samples are also obtained at baseline, 1 - and 12-month follow-up. In addition, we are conducting a survey of participating hospitals to characterize their organizational characteristics. Conclusion: The China PEACE-Prospective AMI study will be uniquely positioned to generate new information regarding patient's experiences and outcomes alter AMI in China and seiwe as a foundation for quality improveinent activities.展开更多
Background:Subjective residual symptoms persist after clinical remission of rheumatoid arthritis(RA)in Japanese patients.Few studies have examined the relationship between these symptoms and subclinical inflammation u...Background:Subjective residual symptoms persist after clinical remission of rheumatoid arthritis(RA)in Japanese patients.Few studies have examined the relationship between these symptoms and subclinical inflammation using high-sensitivity imaging(musculoskeletal ultrasound[MSUS]and magnetic resonance imaging[MRI]).We examined the relationship between subjective residual symptoms and imaging findings in patients with RA who achieved clinical remission.Methods:We enrolled 30 patients with RA.The primary endpoint was the patients'subjective residual symptoms.The secondary endpoint was the relationship between the aforementioned symptoms and imaging findings.Results:Despite a mean Simplified Disease Activity Index of 1.3,imaging evaluation revealed inflammatory findings.In the multivariate analysis,the Health Assessment Questionnaire Disability Index(HAQ-DI)and pain visual analog scale(VAS)scores were extracted as independent related factors of subjective residual symptoms.The stratified analysis according to HAQ-DI showed a significant difference in synovitis on MRI between patients with and without residual disability(12.0±8.7 vs.5.3±5.3,respectively;p=0.0192).However,MSUS scores showed no significant difference in these two groups.In addition,no significant differences were found in MSUS and MRI scores between patients with and without residual pain VAS.Conclusions:Our findings demonstrated residual synovitis related to patientreported outcomes in patients with RA who achieved clinical remission.In particular,patients with an HAQ-DI score of>0.25 even after achieving clinical remission should be further examined by MRI and/or MSUS for the evaluation of residual synovitis.展开更多
文摘The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a patient's health status directly from their perspective,encompassing various domains such as symptom severity,functional status,and overall quality of life.By integrating PROMs into routine clinical practice and research,healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly.The deployment of PROMs supports dynamic patient-provider interactions,fostering better patient engagement and adherence to tre-atment plans.Moreover,PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy,particularly in chronic and mental health conditions.However,challenges in implementing PROMs include data collection and management,integration into existing health systems,and acceptance by patients and providers.Overcoming these barriers necessitates technological advancements,policy development,and continuous education to enhance the acceptability and effectiveness of PROMs.The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings.
文摘In the practice of healthcare,patient-reported outcomes(PROs)and PRO measures(PROMs)are used as an attempt to observe the changes in complex clinical situations.They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect.For any PROM to be usable in health care,we need it to be reliable,encapsulating the points of interest with the potential to detect any real change.Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview,and this allows the physician and patient to have a meaningful conver-sation as well as a customized plan for each patient.Having mentioned the rationale and the benefits of PROMs,understanding the quantification process is crucial before embarking on management decisions.A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition.There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences.This article details the various quantification metrics used to evaluate the treatment effect using PROMs,their limitations and the scope of usage and implementation in clinical practice.
基金National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health,No.U01AR067138.
文摘AIM To establish minimum clinically important difference(MCID) for measurements in an orthopaedic patient population with joint disorders.METHODS Adult patients aged 18 years and older seeking care for joint conditions at an orthopaedic clinic took the Patient-Reported Outcomes Measurement Information System Physical Function(PROMIS~? PF) computerized adaptive test(CAT), hip disability and osteoarthritis outcome score for joint reconstruction(HOOS JR), and the knee injury and osteoarthritis outcome score for joint reconstruction(KOOS JR) from February 2014 to April 2017. MCIDs were calculated using anchorbased and distribution-based methods. Patient reports of meaningful change in function since their first clinic encounter were used as an anchor.RESULTS There were 2226 patients who participated with a mean age of 61.16(SD = 12.84) years, 41.6% male, and 89.7% Caucasian. Mean change ranged from 7.29 to 8.41 for the PROMIS~? PF CAT, from 14.81 to 19.68 for the HOOS JR, and from 14.51 to 18.85 for the KOOS JR. ROC cut-offs ranged from 1.97-8.18 for the PF CAT, 6.33-43.36 for the HOOS JR, and 2.21-8.16 for the KOOS JR. Distribution-based methods estimated MCID values ranging from 2.45 to 21.55 for the PROMIS~? PF CAT; from 3.90 to 43.61 for the HOOS JR, and from 3.98 to 40.67 for the KOOS JR. The median MCID value in the range was similar to the mean change score for each measure and was 7.9 for the PF CAT, 18.0 for the HOOS JR, and 15.1 for the KOOS JR.CONCLUSION This is the first comprehensive study providing a wide range of MCIDs for the PROMIS? PF, HOOS JR, and KOOS JR in orthopaedic patients with joint ailments.
文摘BACKGROUND Advances in implant material and design have allowed for improvements in total knee arthroplasty(TKA)outcomes.A cruciate retaining(CR)TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament.Limited research exists that has examined clinical outcomes or patient reported outcome measures(PROMs)of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant.It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores.AIM To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design.METHODS A retrospective,multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System(JOURNEY™II CR;Smith and Nephew,Inc.,Memphis,TN)at an urban,academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon.Patient demographics,surgical information,clinical outcomes,and PROMs data were collected via query of electronic medical records.The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(KOOS JR)and Patient-Reported Outcomes Measurement Information System(PROMIS■)scores.The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests.RESULTS Of the 255 patients,65.5%were female,43.8%were White,and patients had an average age of 60.6 years.Primary osteoarthritis(96.9%)was the most common primary diagnosis.The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home(92.5%).There were 18 emergency department(ED)visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%,including a 2.4%orthopedic-related ED visit rate and a 4.7%non-orthopedic-related ED visit rate.There were three(1.2%)hospital readmissions within 90 d postoperatively.With a mean time to latest follow-up of 3.3 years,four patients(1.6%)required revision,two for arthrofibrosis,one for aseptic femoral loosening,and one for peri-prosthetic joint infection.There were significant improvements in KOOS JR,PROMIS Pain Intensity,PROMIS Pain Interference,PROMIS Mobility,and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores.CONCLUSION The evaluated implant is an effective,novel design offering excellent outcomes and low complication rates.At a mean follow up of 3.3 years,four patients required revisions,three aseptic and one septic,resulting in an overall implant survival rate of 98.4%and an aseptic survival rate of 98.8%.The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.
文摘Patient-reported outcomes measures form the backbone of outcomes evaluation in orthopaedics,with most of the literature now relying on these scoring tools to measure change in patient health status.This patient-reported information is increasingly collected routinely by orthopaedic providers but use of the data is typically restricted to academic research.Developments in electronic data capture and the outcome tools themselves now allow use of this data as part of the clinical consultation.This review evaluates the role of patient reported outcomes data as a tool to enhance daily orthopaedic clinical practice,and documents how developments in electronic outcome measures,computer-adaptive questionnaire design and instant graphical display of questionnaire can facilitate enhanced patientclinician shared decision making.
文摘AIM: To evaluate surgical outcomes of modified Z-epicanthoplasty with blepharoplasty that we previously reported from the patient’s perspective using patient-reported outcome measures(PROMs) and patient satisfaction scores.METHODS: A total of patients(n=180) who underwent the surgery between January 2013 and June 2016 were randomly selected. Standardized patient satisfaction forms(total score, 40) and validated PROMs questionnaires(total score, 12) were sent to patients for completion. PROMs assesses the severity of scarring, pain and asymmetry, as well as functional and appearance issues.RESULTS: All patients were female, ranging from 18 to 35 years old(mean=24). The response rate was 73.3%(n=132). The majority of patients reported good or excellent outcomes based on PROM analysis. Patients reported minimum or non-visible scarring at both the double eyelid surgical scar(85.6%) and the inner canthus(80.3%). Issues concerning function and appearance were minimal as 80.3% reported satisfaction with both domains. Notably, the majority of patients reported either a high or very high satisfaction rate to yield a mean score of 104 out of 120(P<0.05).CONCLUSION: Integration of our modified Z-epicanthoplasty with blepharoplasty produces good outcomes based on PROM results, which shows a positive linear relationship with patient satisfaction scores.
文摘We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal (TP) prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 (21.4%) of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy (with 95% scoring 〈5 in a 0-10 scale). Twelve out of 196 men (6.1%) felt pain immediately after the procedure. Despite a high incidence of symptoms (e.g., up to 75% had some hematuria, 47% suffered some pain), it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization (5.5%). There were no inpatient admissions due to complications (hematuria, sepsis). On repeat questioning at a later time point, only 25/199 (12.6%) of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use.
文摘The mechanisms of fatigue in the group of people with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis are protean. The liver is central in the pathogenesis of fatigue because it uniquely regulates much of the storage, release and production of substrate for energy generation. It is exquisitely sensitive to the feedback controlling the uptake and release of these energy generation substrates. Metabolic contributors to fatigue, beginning with the uptake of substrate from the gut, the passage through the portal system to hepatic storage and release of energy to target organs (muscle and brain) are central to understanding fatigue in patients with chronic liver disease. Inflammation either causing or resulting from chronic liver disease contributes to fatigue, although inflammation has not been demonstrated to be causal. It is this unique combination of factors, the nexus of metabolic abnormality and the inflammatory burden of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis that creates pathways to different types of fatigue. Many use the terms central and peripheral fatigue. Central fatigue is characterized by a lack of self-motivation and can manifest both in physical and mental activities. Peripheral fatigue is classically manifested by neuromuscular dysfunction and muscle weakness. Therefore, the distinction is often seen as a difference between intention (central fatigue) versus ability (peripheral fatigue). New approaches to measuring fatigue include the use of objective measures as well as patient reported outcomes. These measures have improved the precision with which we are able to describe fatigue. The measures of fatigue severity and its impact on usual daily routines in this population have also been improved, and they are more generally accepted as reliable and sensitive. Several approaches to evaluating fatigue and developing endpoints for treatment have relied of biosignatures associated with fatigue. These have been used singly or in combination and include: physical performance measures, cognitive performance measures, mood/behavioral measures, brain imaging and serological measures. Treatment with non-pharmacological agents have been shown to be effective in symptom reduction, whereas pharmacological agents have not been shown effective.
文摘Background:The Victorian Institute of Sport Assessment–Patella(VISA-P) scale is the most condition-specific patient-reported outcome measure used to assess symptom severity in athletes with patellar tendinopathy.Previous exploratory factor analyses have been conducted to evaluate the scale's dimensionality,with inconsistent results,and the factor structure of the scale remains unclear.The aims of the present study were to determine the factorial structure of the VISA-P scale using confirmatory factor analysis(CFA) and test measurement invariance across sexes.Methods:The study included a convenience sample of 249 Spanish athletes with patellar tendinopathy.CFA was performed to assess factorial validity.Hypothesized 1-and 2-factor models were tested.Measurement invariance across sexes was evaluated via multi-group CFA with several fit indices using EQS 6.1 software.Results:The internal consistency coefficient was 0.74.Several CFA models were examined and the 1-factor model in which errors for Items 7 and8 were correlated showed acceptable fit in terms of comparative fit index(CFI) and goodness-of-fit index(GFI) statistics(CFI = 0.93;GFI = 0.94;standardized root mean square residual = 0.06;root mean square error of approximation = 0.10;90% confidence interval:0.08–0.13).This model was invariant across sexes.Conclusion:The 1-factor model of the Spanish version of the VISA-P scale(VISA-P-Sp) in which errors for Items 7 and 8 were correlated demonstrated relative fit in CFA.Scores obtained via VISA-P-Sp can be compared between men and women without sexes bias.Further studies should examine the VISA-P scale and other single-score patient-reported outcome measures concurrently.
文摘大数据时代,患者的管理逐渐转变为理论驱动与数据驱动相结合,实时监测患者动态变化的健康结局数据。患者报告结局电子化实施路径内容无需他人解释,为解决患者随访管理中的信息延续问题提供了新思路,其对实现患者持久、动态、实时的健康状态监测发挥巨大优势,在造口患者的延续性管理中具有实用性。本文就患者报告结局测量信息系统(patient-reported outcomes measurement information system,PROMIS)和随访管理的概念、造口相关PROMIS评估工具、数据采集方式、应用价值进行综述,以期为我国开展造口患者随访管理提供参考借鉴。
基金supported by the Evidence-Based Capacity Building Project for Basic Traditional Chinese MedicineSpecialized Diseases(No.2019XZZX-XH012)Shanghai Municipal Health Commission+1 种基金Three Year Action Plan for InheritanceInnovation and Development of Traditional Chinese Medicine(ZY[2021-2023]-0211)。
文摘Objective:Appraisal of treatment outcomes in integrative medicine is a challenge due to a gap between the concepts of Western medicine(WM)disease and traditional Chinese medicine(TCM)syndrome.This study presents an approach for the appraisal of integrative medicine that is based on targeted metabolomics.We use non-alcoholic fatty liver disease with spleen deficiency syndrome as a test case.Methods:A patient-reported outcome(PRO)scale was developed based on literature review,Delphi consensus survey,and reliability and validity test,to quantitatively evaluate spleen deficiency syndrome.Then,a metabonomic foundation for the treatment of non-alcoholic fatty liver disease with spleen deficiency syndrome was identified via a longitudinal interventional trial and targeted metabolomics.Finally,an integrated appraisal model was established by identifying metabolites that responded in the treatment of WM disease and TCM syndrome as positive outcomes and using other aspects of the metabonomic foundation as independent variables.Results:Ten symptoms and signs were included in the spleen deficiency PRO scale.The internal reliability,content validity,discriminative validity and structural validity of the scale were all qualified.Based on treatment responses to treatments for WM disease(homeostasis model assessment of insulin resistance)or TCM syndrome(spleen deficiency PRO scale score)from a previous randomized controlled trial,two cohorts comprised of 30 participants each were established for targeted metabolomics detection.Twenty-five metabolites were found to be involved in successful treatment outcomes to both WM and TCM,following quantitative comparison and multivariate analysis.Finally,the model of the integrated appraisal system was exploratively established using binary logistic regression;it included 9 core metabolites and had the prediction probability of 83.3%.Conclusion:This study presented a new and comprehensive research route for integrative appraisal of treatment outcomes for WM disease and TCM syndrome.Critical research techniques used in this research included the development of a TCM syndrome assessment tool,a longitudinal interventional trial with verified TCM treatment,identification of homogeneous metabolites,and statistical modeling.
基金National Natural Science Foundation of China(No.81974347)Postdoctoral Science Foundation of China(No.2021M702351)Medical Science and Technology Program of Health Commission of Sichuan Province of China(No.21PJ040)
文摘Background:Despite the advent of innovative knee prosthesis design,a consistent first-option knee implant design in total knee arthroplasty(TKA)remained unsettled.This study aimed to compare the clinical effects among posterior-stabilized(PS),cruciate-retaining(CR),bi-cruciate substituting(BCS),and bi-cruciate retaining designs for primary TKA.Methods:Electronic databases were systematically searched to identify eligible randomized controlled trials(RCTs)and cohort studies from inception up to July 30,2021.The primary outcomes were the range of knee motion(ROM),and the secondary outcomes were the patient-reported outcome measures(PROMs)and complication and revision rates.Confidence in evidence was assessed using Confidence in Network Meta-Analysis.The Bayesian network meta-analysis was performed for synthesis.Results:A total of 15 RCTs and 18 cohort studies involving 3520 knees were included.The heterogeneity and inconsistency were acceptable.There was a significant difference in ROM at the early follow-up when PS was compared with CR(mean difference[MD]=3.17,95%confidence interval[CI]0.07,7.18)and BCS was compared with CR(MD=9.69,95%CI 2.18,17.51).But at the long-term follow-up,there was no significant difference in ROM in any one knee implant compared with the others.No significant increase was found in the PROMs and complication and revision rates at the final follow-up time.Conclusions:At early follow-up after TKA,PS and BCS knee implants significantly outperform the CR knee implant in ROM.But in the long run,the available evidence suggests different knee prostheses could make no difference in clinical outcomes after TKA with extended follow-up.
文摘Background: Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients' experiences after AMI hospitalization, especially on long-tern1 adverse events and patient-reported outcomes (PROs). Methods: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Prospective AMI Study will enroll 4000 consecutive AM I patients from 53 diverse hospitals across China and follow them longitudinally for 12 months to docunlent their treatment, recovery, and outcomes. Details of patients' medical history, treatment, and in-hospital outcomes are abstracted from medical charts. Comprehensive baseline interviews are being conducted to characterize patient demographics, risk factors, presentation, and healthcare utilization. As part of these interviews, validated instruments are administered to measure PROs, including quality of life, symptoms, mood, cognition, and sexual activity. Follow-up interviews, measuring PROs, medication adherence, risk factor control, and collecting hospitalization events are conducted at 1, 6, and 12 months after discharge. Supporting documents for potential outcomes are collected for adjudication by clinicians at the National Coordinating Center. Blood and urine samples are also obtained at baseline, 1 - and 12-month follow-up. In addition, we are conducting a survey of participating hospitals to characterize their organizational characteristics. Conclusion: The China PEACE-Prospective AMI study will be uniquely positioned to generate new information regarding patient's experiences and outcomes alter AMI in China and seiwe as a foundation for quality improveinent activities.
文摘Background:Subjective residual symptoms persist after clinical remission of rheumatoid arthritis(RA)in Japanese patients.Few studies have examined the relationship between these symptoms and subclinical inflammation using high-sensitivity imaging(musculoskeletal ultrasound[MSUS]and magnetic resonance imaging[MRI]).We examined the relationship between subjective residual symptoms and imaging findings in patients with RA who achieved clinical remission.Methods:We enrolled 30 patients with RA.The primary endpoint was the patients'subjective residual symptoms.The secondary endpoint was the relationship between the aforementioned symptoms and imaging findings.Results:Despite a mean Simplified Disease Activity Index of 1.3,imaging evaluation revealed inflammatory findings.In the multivariate analysis,the Health Assessment Questionnaire Disability Index(HAQ-DI)and pain visual analog scale(VAS)scores were extracted as independent related factors of subjective residual symptoms.The stratified analysis according to HAQ-DI showed a significant difference in synovitis on MRI between patients with and without residual disability(12.0±8.7 vs.5.3±5.3,respectively;p=0.0192).However,MSUS scores showed no significant difference in these two groups.In addition,no significant differences were found in MSUS and MRI scores between patients with and without residual pain VAS.Conclusions:Our findings demonstrated residual synovitis related to patientreported outcomes in patients with RA who achieved clinical remission.In particular,patients with an HAQ-DI score of>0.25 even after achieving clinical remission should be further examined by MRI and/or MSUS for the evaluation of residual synovitis.