Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges

Insulin therapy plays a crucial role in the management of type 2 diabetes as the disease progresses.Over the past century,insulin formulations have undergone significant modifications and bioengineering,resulting in a diverse range of available insulin products.These products show distinct pharmacokinetic and pharmacodynamic profiles.Consequently,various insulin regimens have em-erged for the management of type 2 diabetes,including premixed formulations and combinations of basal and bolus insulins.The utilization of different insulin regimens yields disparate clinical outcomes,adverse events,and,notably,patient-reported outcomes(PROs).PROs provide valuable insights from the patient’s perspective,serving as a valuable mine of information for enhancing healthcare and informing clinical decisions.Adherence to insulin therapy,a critical patient-reported outcome,significantly affects clinical outcomes and is influenced by multiple factors.This review provides insights into the clinical effectiveness of various insulin preparations,PROs,and factors impacting insulin therapy adherence,with the aim of enhancing healthcare practices and informing clinical decisions for individuals with type 2 diabetes.

A Systematic Review of Patient-Reported Outcome Measurement for Psoriasis in Chinese Population

Objective To review the development of patient-reported outcome measurement(PROM)for patients with psoriasis in China,and to analyze the main results and methodology.Methods The systematic review method of COSMIN(consensus-based standards for the selection of health measurement instruments)was adopted,and the domestic and foreign databases were searched to find the patient-reported outcome scales based on Chinese psoriasis patients.Then,the included studies were evaluated by using COSMIN risk of bias checklist.Results and Conclusion A total of 3 studies were included,involving 3 scales.We found that the quality evaluation of the development process of the 3 scales was not high,and there were large methodological loopholes in the whole cycle of scale development and verification.The included studies have many problems such as low extrapolation,poor quality,and lack of validation,which can provide more insights for the quality control requirements of the whole cycle of scale development in the future.

Patient-reported Outcomes (PROs): An Approach to Evaluate Treatment Efficacy of Chinese Medicine or Integrative Medicine

Chinese medicine (CM) has been an experience based practice over the past three thousand years. The safety and efficacy of CM has been practised through experience, rather than nowadays’ modern scientific measurements. In this way, the development of CM has not been keeping pace with the advance in science and technology and the progress in orthodox medicine. In order to meet the requirements of modern science and technology, an evidence based approach must be adopted. Reassurance is needed to convince people for safety and efficacy of CM and give confidence to the evidence based demands ——“Tradition is confirmed by Modern Science” (1) .

Clinical study inpatient-reported outcomes after binocular implantation of aspheric intraocular lens of different negative spherical aberrations

Objective: To compare patient-reported outcomes after implantation of the ZA9003 intraocular lens(IOLs), or the MCX11 ASP IOLs or the spherical IOLs(HQ-201HEP). Methods: Prospective nonrandomized controlled trial was used. A total of 105 patients(210 eyes) were divided into three groups according to the type of IOLs: ZA9003(35 patients, 70 eyes), MCX11 ASP(35 patients, 70 eyes) or HQ-201HEP(35 patients, 70 eyes). The main outcome was scores of Catquest nine-item short-form questionnaire. Additional outcome was best corrected visual acuities, spherical aberration(SA) and total higher-order aberrations(HOAs). Results: The global score was significantly lower in the spherical IOL group than the aspherical IOL group of-020 μm SA(P < 0.05) and the aspherical IOL group of-027 μm SA(P < 0.05), and no significant difference was found in the global score between the aspherical IOL group of-020 μm SA than the aspherical IOL group of-027 μm SA(P > 0.05). Significant differences were also found in question 2, question 5, question 6 and question 8 between the spherical IOLs and the aspherical IOLs. Conclusion: Implantation of an aspherical IOL could improve vision-related quality of life compared with a spherical IOL. However, there were no statistically significant differences in vision-related quality of life between aspheric IOLs with different negative spherical aberrations.

Establishing minimum clinically important difference values for the Patient-Reported Outcomes Measurement Information System Physical Function, hip disability and osteoarthritis outcome score for joint reconstruction, and knee injury and osteoarthritis out

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.

Patient-reported dissatisfaction following second side in staged bilateral total knee arthroplasty: A systematic review

BACKGROUND Around one third of patients who undergo total knee arthroplasty(TKA)will eventually have the contralateral knee replaced.Overall patient satisfaction after staged bilateral total knee arthroplasty procedures performed on different days is reportedly similar to unilateral TKA.Nevertheless,in our anecdotal experience patients often report less satisfying outcomes following the second side.A cursory review of available literature tended to confirm that observation.We sought therefore to consolidate all of the available data on this issue to further investigate this phenomenon.AIM To consolidate available published data revealing satisfaction scores among patients following staged bilateral TKA,and to evaluate the phenomenon of less satisfying results following TKA2.METHODS A systematic review of available literature reporting on satisfaction with TKA1 and TKA2 after staged bilateral knee arthroplasty was undertaken using PubMed,Google Scholar,and Embase.From 427 records,five full-length articles met criteria for inclusion in the meta-analysis.The data were then extracted and assessed on the basis of the Reference Citation Analysis(https://www.referencecitationanalysis.com/).RESULTS A total of 1889 patients with an average age of 68(range:38–92)underwent staged bilateral TKA with outcomes reported at 1 year following each TKA with a mean 21.9 mo between surgeries(range:2 d to 14.5 years).Overall satisfaction with both knees was 83.70%(1581)and dissatisfaction with both knees was 2.75%(52).In the remaining 13.56%(256)who were dissatisfied with one side,61.0%were dissatisfied with TKA2,and 39.0%were dissatisfied with TKA1.Patient-reported outcome scores for TKA2 were frequently lower than TKA1 even in patients reporting overall satisfaction with both knees.CONCLUSION At 1-year follow-up,there was a 50%greater risk of dissatisfaction with TKA2 among the 13.56%of patients reporting dissatisfaction in one knee after staged bilateral TKA.Whether the interval between procedures or long-term follow-up changes these results requires further investigation.

Patient-Reported Outcomes of Surgery of Non-Small Cell Lung Cancer: Evaluation Based on the Questionnaires of Anti-Aging Quality of Life and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

Background: Patient-reported outcomes of the quality of life (QOL) after an open thoracotomy have not been studied. To determine the physical and mental changes in surgical patients is very important for medical staffs. The surgical patient’s satisfaction and overall healthy changes were evaluated by the patient-self assessment questionnaires. Materials and Methods: From July 2007 to April 2008, 26 patients with non-small cell lung cancer (NSCLC) underwent surgical resection. The outcome of the QOL was evaluated by using two kinds of questionnaire surveys from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the anti-aging QOL assessment (AA-QOL). The EORTC QLQ-C30 consisted of five domains (physical, role, cognitive, emotional, and social functionings) and global QOL. The AA-QOL contained 51 items;30 physical and 21 mental symptoms regarding the elderly and the aging population. The patients replied to the two questionnaires at two different times, i.e., at pre-surgery (baseline) and at post-surgery (2 weeks after the operation). The obtained data of these scores were averaged and compared between the two points of the pre-surgery and post-surgery. Results: Regarding the outcomes of the EORTC QLQ-C30, the physical and social functioning became significantly worse after the surgery. In contrast, the global QOL significantly became better after the surgery. For the symptom at post-surgery, three of which were “nausea and vomiting”, “pain”, and “appetite loss”, became significantly worse compared to those at pre-surgery. Regarding the outcomes of the AA-QOL, the physical symptoms (muscular pain/stiffness, palpitations, dyspnea, no feeling of good health, anorexia, and coughing and sputum) became significantly worse after the surgery. Regarding the mental symptoms, there were no significant differences. Conclusions: Regarding the outcomes based on the changes in the QOL after surgery, the physical symptoms became worse compared to the mental symptoms. To clarify the perioperative healthy changes of the QOL reported by patients with lung cancers is very important for multidisciplinary teamwork, which should play a role in providing the appropriate care and treatment and useful information for a preoperative patient’s decision making of receiving surgical treatment.

Patient-Reported Fatigue Is Associated with Poor Energy Intake and Readmission to Hospital

Objective: To investigate patient-reported factors those promote or inhibit food intake in older people after discharge from hospital. Background: Disease-related malnutrition leads to poor appetite, decreased food intake and affects convalescence negatively. Design: Secondary analysis of two intervention groups from an RCT. Methods: 111 older adults received nutritional follow-up one, two and four weeks after discharge. Self-reported food intake was classified as adequate (AQ) or inadequate (IAQ) energy intake two weeks after discharge. Data on inhibitory and promoting factors, body weight, ADL-function, readmission and mortality were analysed and comparison made between AQ and IAQ groups. Results: More IAQ participants reported fatigue and eating all meals alone. All participants lost body weight, but more IAQ participants lost body weight. More IAQ participants were readmitted to hospital 30 days after discharge. Conclusion: “Fatigue” and “eating all meals alone” affect food intake negatively, leading to loss of body weight and readmission to hospital.

Patient-Reported Outcomes in Prostate Cancer: Prospective Changes Analysis for Prognosis Prediction

Prostate cancer is affecting a higher proportion of male population. Health Related Quality of Life assessment can guide the development of an interdisciplinary and patient-centered care intervention. This study is aimed to assess Health Related Quality of Life in prostate cancer patients. Relationships between socio-demographic, clinical characteristics and patient-reported outcomes have been considered. Consecutive outpatients with prostate cancer, admitted at the Urology Clinic of the Instituto Português de Oncologia do Porto, were studied (n = 300). Health Related Quality of Life was assessed as part of the routine practice. The European Organisation for Research and Treatment of Cancer general questionnaire, QLQ-C30, and its specific module for prostate cancer patients, QLQ-PR25, were used. Evolution along time (elapsed since diagnosis, and up to 5 years) was considered in order to search for a prognosis prediction in prostate cancer patients. This study confirms the feasibility of a systematic Health Related Quality of Life assessment. Global Health Related Quality of Life was found to be higher 6 months after diagnosis, decreasing then until the second year after diagnosis and improving thereafter. A peak with better scores was identified at the fifth year after diagnosis. Social and physical dimensions revealed a similar pattern. Clinical significance was found 6 months and 5 years after diagnosis. The prospective analysis of Health Related Quality of Life changes is able to explore the patients’ outcomes in order to find patterns and relationships for prognosis prediction along the disease course. Such approach might promote patient confidence and thus a better cancer experience.

Patient-Reported Outcomes of Chemotherapy Involving Non-Small Cell Lung Cancer: Evaluation by Questionnaires of Quality of Life Regarding Anti-Aging and Anti-Cancer Drugs

Background: Patient-reported outcomes (PROs) of quality of life (QOL) during chemotherapy involving lung cancer are very important for the medical staffs. Patients’ satisfaction and healthy changes were evaluated by the patient-self assessment. Materials and Methods: From July 2007 to April 2008, a total of 19 patients received chemotherapy. The QOL data were collected by using the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD) and the anti-aging QOL assessment (AA-QOL). The AA-QOL contained 51 items: 30 of physical and 21 of mental symptoms of the elderly and the aging population. The patients replied to the questions at two different times, i.e., at pre-chemotherapy (baseline) and at post-chemotherapy (2 weeks after the chemotherapy). Results: Regarding the hematological toxicities, for the grade 3/4 toxicities, there were 12 neutropenia (12/19, 63.2%) and 3 thrombocytopenia (3/19, 15.8%). For the grade 3 febrile neutropenia, there were 5 cases (5/19, 26.3%). Regarding the non-hematological toxicities, there was no grade 3 and grade 4 toxicities. Based on the outcomes of the QOL-ACD, the three items (“physical condition”, “social attitude”, and “overall QOL”) at post-chemotherapy became significantly worse compared to the baseline. Regarding the outcomes of the AA-QOL, 4 items of physical symptoms (“thirst”, “anorexia”, “early satiety”, and “diarrhea”) became significantly worse compared to the baseline. Regarding the mental symptoms, 2 items (“nothing to look forward in life” and “a sense of uselessness”) became significantly worse compared to the baseline. Conclusion: Regarding the PROs of the QOL during the chemotherapy term, both the physical and mental symptoms had become worse. To clarify the changes in the QOL during chemotherapy is very important for multidisciplinary teamwork, which should play the role of providing the appropriate cares and treatment as patient-support.

Research Application of Patient-Reported Outcomes in Assessing the Nutritional Status of Patients with Gastrointestinal Tumors

Objective:To investigate and analyze the changes of nutritional status in patients undergoing postoperative adjuvant chemotherapy for gastrointestinal tumors based on patient-reported outcomes.Methods:From July 2020 to March 2021,60 patients with gastrointestinal tumor who received adjuvant chemotherapy for the first time after surgery under the oncology department of a third-level,first-class hospital in Shaanxi Province were recruited by convenience sampling.The patient-reported nutritional evaluation outcomes within 24 hours after admission and during the fourth chemotherapy cycle incorporated nutritional risk screening 2002(NRS2002),Functional Assessment of Anorexia/Cachexia Therapy(FAACT),psychological pain screening,Generalized Anxiety Disorder Assessment(GAD-7),Patient Health Questionnaire-9(PHQ-9)to screen for depression,dietary self-assessment,health index scale(EQ-5D),and nutrition supervisor overall assessment scale.Results:The self-reported nutritional evaluation outcomes by adjuvant chemotherapy patients showed an upward trend along with their chemotherapy cycle.Their PG-SGA score,FAACT score,psychological pain score,and EQ-5D score during the fourth cycle were better than those during the first chemotherapy cycle(p<0.05)・Conclusion:Based on the patient・reported nutritional evaluation outcomes,the nutritional status and quality of life of patients with gastrointestinal tumors during chemotherapy did not worsen.Medical staff should timely evaluate the nutritional status of patients with gastrointestinal tumors during chemotherapy and implement reasonable nutritional intervention to improve the quality of life of patients.In the future,patient-reported outcomes should be considered for integration into clinical practice in order to facilitate patient participation in decision-making and improve their medical experience.

Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial

Objective:To investigate whether the combination of chemotherapy with staged Chinese herbal medicine(CHM) therapy could enhance health-related quality of life(QoL) in non-small-cell lung cancer(NSCLC)patients and prolong the time before deterioration of lung cancer symptoms,in comparison to chemotherapy alone.Methods:A prospective,double-blind,randomized,controlled trial was conducted from December 14,2017 to August 28,2020.A total of 180 patients with stage ⅠB-ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM(chemo+CHM) group(120 cases) or chemotherapy combined with placebo(chemo+placebo) group(60 cases) using stratified blocking randomization.The European Organization for Research and Treatment of Cancer(EORTC) Quality-of-Life-Core 30 Scale(QLQ-C30) was used to evaluate the patient-reported outcomes(PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC.Adverse events(AEs) were assessed in the safety analysis.Results:Out of the total 180 patients,173 patients(116in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses.The initial mean QLQ-C30 Global Health Status(GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups(P>0.05).Compared with baseline,the chemo+CHM group had an improvement in QLQ-C30GHS/QoL score at week 18 [least squares mean(LSM) change 17.83,95% confidence interval(CI) 14.29 to 21.38].Conversely,the chemo+placebo group had a decrease in the score(LSM change-13.67,95% CI-22.70 to-4.63).A significant between-group difference in the LSM GHS/QoL score was observed,amounting to 31.63 points(95% CI25.61 to 37.64,P<0.001).The similar trends were observed in physical functioning,fatigue and appetite loss.At week 18,patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group(P<0.001).The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio(HR)=0.33,95% CI 0.23 to 0.48,P<0.0010],physical functioning(HR=0.43,95% CI 0.25 to 0.75,P=0.0005),fatigue(HR=0.47,95% CI 0.30 to 0.72,P<0.0001) and appetite loss(HR=0.65,95% CI 0.42to 1.00,P=0.0215).The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group(9.83% vs.15.79%,P=0.52).Conclusion:The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy,which is worthy of further clinical research.(Registry No.NCT03372694)

Transperineal prostate biopsies for diagnosis of prostate cancer are well tolerated： a prospective study using patient-reported outcome measures

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.

Evaluation of A Scale of Patient-Reported Outcomes for the Assessment of Myasthenia Gravis Patients in China

Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory （IRT） were used to assess the psychometric characteristics of the MG-PRO scale, Results： The MG-PRO scale included 4 dimensions： physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment （P〈0.05）. All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment （P〈0.05）. IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ＋ 2.5, and no item had uniform or non-uniform differential item functioning （DIF） between gender and age （〈40, 〉140）. Conclusions： The MG-PRO scale is valid for measuring the quality of life （QOL） of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.

Acupuncture-moxibustion for lung cancer patient-reported outcomes:A systematic review and meta-analysis protocol

Background:Lung cancer is one of the most common cancers globally with high incidence and mortality rate.Acupuncture and moxibustion have been used as adjuvant therapies to relieve the symptoms and complications of lung cancer.At present,acupuncture and moxibustion can partially improve the quality of life(QOL)of cancer patients.However,the evidence that acupuncture and moxibustion can improve patient-reported outcomes(PROs)in patients with lung cancer is still insufficient.We aimed to conduct a systematic review and meta-analysis of published randomized controlled trials(RCTs)to determine whether acupuncture and moxibustion can improve PROs among patients with lung cancer,providing a support basis for acupuncture and moxibustion inclusion in relevant guidelines.Methods:We will search the following electronic databases:PubMed,Embase,Cochrane Library,Web of Science,CNKI,CQVIP,Wanfang Data,Sinomed,and gray literature including the ClinicalTrials.gov Database(clinicaltrials.gov)and Chinese Clinical Trial Register(chictr.org.cn).All English and Chinese articles will be searched until July 1,2021.Two researchers independently extracted data.Any disagreement was resolved by discussion until consensus was reached or by consulting a third researcher.The primary outcomes mainly included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30),functional assessment of cancer therapy-lung(FACT-L),and Karnofsky Performance Status(KPS).The secondary outcomes included improvement of individual lung cancerrelated symptoms and the safety of acupuncture intervention.Discussion:Our study is the first to focus on the PROs of acupuncture and moxibustion for lung cancer treatment.The results will contribute to a deeper understanding of the evidence distribution of acupuncture and moxibustion in PROs,which may support the use of acupuncture and moxibustion in lung cancer patients.

PRELIMINARY RESULTS OF VALIDATION OF A NEW PATIENT-REPORTED OUTCOME INSTRUMENT FOR ADVANCED CHRONIC KIDNEY DISEASE

The uremic symptoms of advanced chronic kidney disease(CKD)can severely impair physical function,psychological health and social life.Some patients,especially for the older,chose conservative kidney management(CKM)and Traditional Chinese medicine(TCM)but not dialysis in this stage.To measure the patients-reported outcome(PRO)from these people,Advanced Chronic Kidney

Unveiling hidden outcomes in malignant gastric outlet obstruction research–insights from a"Pancreas 2000"review

Malignant gastric outlet obstruction(mGOO)is a major condition affecting patients with periampullary tumors,including pancreatic cancer.The current treatment options include surgical gastroenterostomy,endoscopic stenting and more recently EUS-guided gastroenterostomy.Most studies comparing the outcomes of the three procedures focus on technical success,clinical success and safety.Several“occult”outcomes relevant to the patient’s viewpoints and perspective may ultimately impact on cancer-related and overall survival,such as body mass composition,nutritional biomarkers,chemotherapy tolerance and patient-reported quality of life.The aim of this review is to provide an overview of potential key outcomes that should be explored in future comparative research around mGOO treatment options.

Soleus arthrogenic muscle inhibition following acute lateral ankle sprain correlates with symptoms and ankle disability but not with postural control

Background:Acute lateral ankle sprains(ALAS)are associated with long-term impairments and instability tied to altered neural excitability.Arthrogenic muscle inhibition(AMI)has been observed in this population;however,relationships with injury-related impairments are unclear,potentially due to the resting,prone position in which AMI is typically measured.Assessing AMI during bipedal stance may provide a better understanding of this relationship.Methods:AMI was assessed in 38 young adults(19 ALAS within 72 h of injury:10 males,21.4±2.7 years;19 healthy controls:10 males,21.9±2.2 years;mean±SD)using the Hoffmann reflex(H-reflex)during bipedal stance.Electrical stimulation was administered to identify the _(max)imal H-reflex(H_(max))and _(max)imal motor response(M_(max))from the soleus,fibularis longus,and tibialis anterior muscles.The primary outcome measure was the H_(max)/M_(max) ratio.Secondary outcomes included acute symptoms(pain and swelling),postural control during bipedal stance,and self-reported function.Results:No significant group-by-limb interactions were observed for any muscle.However,a significant group main effect was observed in the soleus muscle(F(1,35)=6.82,p=0.013),indicating significantly lower H_(max)/M_(max) ratios following ALAS(0.38±0.20)compared to healthy controls(0.53±0.16).Furthermore,lower H_(max)/M_(max) ratios in the soleus significantly correlated with acute symptoms and self-reported function but not with postural control.Conclusion:This study supports previous evidence of AMI in patients with ALAS,providing insight into neurophysiologic impacts of musculoskeletal injury.Our results suggest that assessing AMI in a standing position following acute injury may provide valuable insight into how AMI develops and guide potential therapeutic options to curb and offset the formation of joint instability.

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty

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.

Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas

BACKGROUND Patients with Crohn’s disease(CD)are at risk of developing complications such as perianal fistulas.Patients with Crohn’s perianal fistulas(CPF)are affected by fecal incontinence(FI),bleeding,pain,swelling,and purulent perianal discharge,and METHODS This cross-sectional observational study was conducted in patients with CD aged 21-90 years via a web-enabled questionnaire in seven countries(April-August 2021).Patients were recruited into three cohorts:Cohort 1 included patients without perianal fistulas;cohort 2 included patients with perianal fistulas without fistula-related surgery;and cohort 3 included patients with perianal fistulas and fistula-related surgery.Validated patient-reported outcome measures were used to assess quality of life.Drivers of treatment preferences were measured using a discrete choice experiment(DCE).RESULTS In total,929 patients were recruited(cohort 1,n=620;cohort 2,n=174;cohort 3,n=135).Short Inflammatory Bowel Disease Questionnaire scores were worse for patients with CPF(cohorts 2 and 3)than for those with CD without CPF(cohort 1):Mean score 3.8 and 3.7 vs 4.1,respectively,(P<0.001).Similarly,mean Revised FI and FI Quality of Life scores were worse for patients with CPF than for those with CD without CPF.Quality of Life with Anal Fistula scores were similar in patients with CPF with or without CPF-related surgery(cohorts 2 and 3):Mean score 41 and 42,respectively.In the DCE,postoperative discomfort and fistula healing rate were the most important treatment attributes influencing treatment choice:Mean relative importance 35.7 and 24.7,respectively.CONCLUSION The burden of illness in CD is significantly higher for patients with CPF and patients rate lower postoperative discomfort and higher healing rates as the most desirable treatment attributes.