A continuous PREMs and PROMs Observatory for elective hip and knee arthroplasty: study protocol.
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ABSTRACT: Introduction
Scholars, healthcare practitioners and policymakers have increasingly focused their attention on patient-centredness. Patient-reported metrics support patient-driven improvement actions in healthcare systems. Despite the great interest, patient-reported outcome measures (PROMs) are still not extensively collected in many countries and not integrated with the collection of patient-reported experience measures (PREMs). This protocol describes the methodology behind an innovative observatory implemented in Tuscany, Italy, aiming at continuously and longitudinally collecting PROMs and PREMs for elective hip and knee total replacement.Methods and analysis
The Observatory is digital. Enrolled patients are invited via SMS or email to online questionnaires, which include the Oxford Hip Score or the Oxford Knee Score. Data are real-time reported to healthcare professionals and managers in a raw format, anonymised and aggregated on a web platform. The data will be used to investigate the relationship between the PROMs trend and patients' characteristics, surgical procedure, hospital characteristics, and PREMs. Indicators using patient data will be computed, and they will integrate the healthcare performance evaluation system adopted in Tuscany.Ethics and dissemination
The data protection officers of local healthcare organisations and the regional privacy office framed the initiative referring to the national and regional guidelines that regulate patient surveys. The findings will be reported both in real time and for publication in peer-reviewed journals.
SUBMITTER: De Rosis S
PROVIDER: S-EPMC8458328 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:The number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention. METHODS:The PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30?days before surgery, and then at 6 and 12?months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention. DISCUSSION:The PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy. TRIAL REGISTRATION:Protocol version (1.0) and trial registration data are available on the platform www.clinicaltrial.gov with the identifier NCT03790267 , first posted on December 31, 2018.
| S-EPMC6694507 | biostudies-literature
Project description:IntroductionTo evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty.Methods and analysisThis study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will conduct sensitivity analyses.Ethics and disseminationThe study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.
| S-EPMC7722830 | biostudies-literature
Project description:BackgroundMany orthopaedic units measure hemoglobin (Hb) levels after primary joint arthroplasty to identify patients with postoperative anemia. With the refinement of surgical techniques, blood loss in primary arthroplasty has decreased. The aim of this study was to investigate the postoperative Hb monitoring and transfusion practices in our own institution after elective hip or knee arthroplasty.MethodsWe conducted a retrospective audit of all patients who underwent elective total hip or knee arthroplasty in Galway University Hospital between March 1 and June 1, 2019. We recorded when they underwent postoperative Hb testing, whether or not they had a drop of Hb, which would indicate transfusion (<8 g/dL), and whether or not they were transfused. In patients who underwent transfusion, a chart review was performed to establish the presence of factors that would have triggered repeat Hb testing.ResultsOne hundred thirty-six patients underwent elective primary hip or knee arthroplasty in the period. All had a full blood count sent on the first postoperative day. None (0%) had a clinically significant (to < 8g/dL) postoperative Hb drop on day 1. Eighteen (13.2%) patients underwent repeat testing on day 2 or subsequently. Eight (5.9%) exhibited a drop in Hb to less than 8 g/dL, with a mean Hb drop of 4.26 (standard error of the mean ± 0.862, standard deviation ± 0.98), and 5 (3.7%) proceeded to undergo allogenic blood product transfusion. All 5 underwent documented indications for repeat Hb testing.ConclusionsThere is no evidence for performing routine Hb testing on day 1 after elective hip or knee arthroplasty. We recommend that postoperative Hb testing should only be carried out on patients with additional indications.
| S-EPMC7498732 | biostudies-literature
Project description:ImportanceThe Enhanced Recovery After Surgery (ERAS) care protocol has been shown to improve outcomes compared with traditional care in certain types of surgery.ObjectiveTo assess the association of use of the ERAS protocols with complications in patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA).Design, setting, and participantsThis multicenter, prospective cohort study included patients recruited from 131 centers in Spain from October 22 through December 22, 2018. All consecutive adults scheduled for elective THA or TKA were eligible for inclusion. Patients were stratified between those treated in a self-designated ERAS center (ERAS group) and those treated in a non-ERAS center (non-ERAS group). Data were analyzed from June 15 through September 15, 2019.ExposuresTotal hip or knee arthroplasty and perioperative management. Sixteen individual ERAS items were assessed in all included patients, whether they were treated at a center that was part of an established ERAS protocol or not.Main outcomes and measuresThe primary outcome was postoperative complications within 30 days after surgery. Secondary outcomes included length of stay and mortality.ResultsDuring the 2-month recruitment period, 6146 patients were included (3580 women [58.2%]; median age, 71 [interquartile range (IQR), 63-76] years). Of these, 680 patients (11.1%) presented with postoperative complications. No differences were found in the number of patients with overall postoperative complications between ERAS and non-ERAS groups (163 [10.2%] vs 517 [11.4%]; odds ratio [OR], 0.89; 95% CI, 0.74-1.07; P?=?.22). Fewer patients in the ERAS group had moderate to severe complications (73 [4.6%] vs 279 [6.1%]; OR, 0.74; 95% CI, 0.56-0.96; P?=?.02). The median overall adherence rate with the ERAS protocol was 50.0% (IQR, 43.8%-62.5%), with the rate for ERAS facilities being 68.8% (IQR, 56.2%-81.2%) vs 50.0% (IQR, 37.5%-56.2%) at non-ERAS centers (P?<?.001). Among the patients with the highest and lowest quartiles of adherence to ERAS components, the patients with the highest adherence had fewer overall postoperative complications (144 [10.6%] vs 270 [13.0%]; OR, 0.80; 95% CI, 0.64-0.99; P?<?.001) and moderate to severe postoperative complications (59 [4.4%] vs 143 [6.9%]; OR, 0.62; 95% CI, 0.45-0.84; P?<?.001) and shorter median length of hospital stay (4 [IQR, 3-5] vs 5 [IQR, 4-6] days; OR, 0.97; 95% CI, 0.96-0.99; P?<?.001).Conclusions and relevanceAn increase in adherence to the ERAS program was associated with a decrease in postoperative complications, although only a few ERAS items were individually associated with improved outcomes.
| S-EPMC7042927 | biostudies-literature
Project description:Elective joint arthroplasty improves the quality of life for patients with severe arthritis. In the United States, utilization of services varies with insurance status. We asked the following questions: (1) Is there an increase in the utilization of elective hip and knee arthroplasty after age 65? (2) Does the difference in utilization between the insured and general populations decrease at age 65 (the age at which Medicare provides near universal coverage)? (3) Does Medicare become the primary payer of elective hip and knee arthroplasty after the age of 65? We used the National Inpatient Sample to identify patients and payers of elective hip and knee arthroplasties by age. We analyzed these data using regression models. At age 65, there was an upward shift in the incidence of arthroplasties in the general and the insured populations and the difference between these two populations decreased. Medicare was the primary payer for the majority of arthroplasties after age 65. We conclude at age 65 the following occurs: (1) utilization of elective joint arthroplasty increases; (2) the difference between the insured population and the general population decreases; and (3) Medicare becomes the primary payer of arthroplasties.
| S-EPMC2504650 | biostudies-other
Project description:ObjectiveThe number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overall compliance and predefined ERAS individual items compliance.MethodsThis multicentre, prospective, observational study will include adult patients (aged >18 years) undergoing elective THR and TKR surgery. Consecutive patients undergoing surgery within the 2-month data collection period will be included. Centres that offer the THR and/or TKR surgery will be eligible to participate. The data collection will be done through an online data collection form via a secure, password-protected platform at each centre with predefined data fields.ResultsEthical approval for this study has been obtained from the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (C.P.-C.I. PI18/135; on 23 May 2018). It was prospectively registered on 27 June 2018, at www.clinicaltrials.gov with identification no. NCT03570944.ConclusionThe study will be disseminated through the SPARN-RedGERM, SEDAR, GERM and through social media. Peer-reviewed publications will be published under corporate authorship, including POWER.2 Study Group and SPARN-RedGERM.
| S-EPMC6537954 | biostudies-literature
Project description:BACKGROUND:Postoperative stroke is a rare but potentially devastating complication following total hip arthroplasty (THA) and total knee arthroplasty (TKA). The purpose of the current study was to determine the incidence, independent risk factors, and timing of stroke following THA and TKA utilizing the National Surgical Quality Improvement (NSQIP) database. METHODS:Patients who underwent elective primary THA and TKA were identified in the 2005-2016 NSQIP database. Thirty-day postoperative strokes were identified, timing was characterized, and an incidence curve was created. Multivariate analyses determined the independent predictors of these strokes. RESULTS:Of 333,117 patients identified, 286 (0.09%) experienced a stroke. Given that THA vs TKA was not a univariate predictor of stroke, the two procedures were considered together. The majority (65%) of strokes occurred before discharge. Of the strokes observed, 25% occurred by postoperative day one, 50% by postoperative day two, and 75% by postoperative day nine. Independent risk factors for postoperative stroke were: age (60-69 years old odds ratio [OR] = 4.2; 70-79 years old OR = 8.1; ?80 years old OR = 16.1), higher American Society of Anesthesiologists (ASA) score (ASA?3 OR = 1.7), and smoking [OR = 1.6). CONCLUSION:The incidence of stroke after THA/TKA was low at 0.09%, with the majority occurring prior to discharge and half occurring by postoperative day two. Patients who were older, sicker, or who were smokers were at greater risk of postoperative stroke. These findings can be used to council patients and to optimize patient care. LEVEL OF EVIDENCE:Level III, Retrospective comparative study.
| S-EPMC7498016 | biostudies-literature
Project description:BackgroundHyponatraemia, defined as a serum sodium [Na] concentration below 135 mmol/L, is common following surgery. As inpatient peri-operative stays shorten, there is a need to recognise pre-operative risk factors for post-operative hyponatraemia and complications associated with a peri-operative drop in Na. This audit aimed to investigate the prevalence of, risk factors for, and complications associated with hyponatraemia following elective primary hip and knee arthroplasty.MethodsData were collected within a retrospective audit of inpatient complications and unplanned reattendance or readmission at hospital in consecutive elective primary hip and knee arthroplasty patients in a single high throughput elective primary joint unit. The hospital's electronic database identified 1000 patients who were admitted electively between February 2012 and June 2013 under the care of a single consultant orthopaedic surgeon for either total hip arthroplasty, total knee arthroplasty, or uni-compartmental knee arthroplasty. Groups were compared using appropriate tests, including chi-square analysis (or Fisher's exact test), Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxin signed-rank test. Logistic regression analysis was used to determine factors associated with hyponatraemia.ResultsOf the total 1000 patients, 217 (21.7%) developed post-operative hyponatraemia. Of these, 177 (81.6%) had mild (Na 130-134 mmol/L), 37 (17.1%) had moderate (Na 125-129 mmol/L), and 3 (1.4%) had severe (Na < 125 mmol/L) hyponatraemia. In multivariate analysis, age, pre-operative Na, and fasting glucose on day 1 remained significantly associated with having hyponatraemia post-operatively. There were no significant differences in reattendance at emergency departments and/or readmission within 90 days between those who had post-operative hyponatraemia whilst in hospital (39/217 = 18.0%) and those who did not (103/783 = 13.2%), or between those who were discharged with hyponatraemia (18/108 = 16.7%) and those discharged with normal Na (124/880 = 14.1%).ConclusionApproximately one fifth of elective joint arthroplasty patients had post-operative hyponatraemia. In these patients, older age, lower pre-operative Na and higher fasting glucose predicted post-operative hyponatraemia. We found no evidence that those discharged with hyponatraemia had more reattendance at emergency departments or readmission to hospital. We suggest that otherwise well patients with mild hyponatraemia can safely be discharged and followed up in the community.
| S-EPMC8330106 | biostudies-literature
Project description:ObjectiveThe optimal timing of tumor necrosis factor antagonists before elective surgery is unknown. This study evaluated the association between infliximab timing and serious infection after elective hip or knee arthroplasty.MethodsA retrospective cohort study evaluated US Medicare patients with rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received infliximab within 6 months of elective knee or hip arthroplasty from 2007 to 2013. Propensity-adjusted analyses examined whether infliximab stop timing (time between the most recent infusion and surgery) was associated with hospitalized infection within 30 days or prosthetic joint infection (PJI) within 1 year.ResultsHospitalized infection within 30 days occurred after 270 of 4,288 surgeries (6.3%). Infliximab stop timing <4 weeks versus 8-12 weeks was not associated with an increase in infection within 30 days (propensity-adjusted odds ratio [OR] 0.90 [95% confidence interval (95% CI) 0.60-1.34]). The rate of PJI was 2.9 per 100 person-years and was not increased in patients with stop timing <4 weeks versus 8-12 weeks (hazard ratio [HR] 0.98 [95% CI 0.52-1.87]). Glucocorticoid dosage >10 mg/day was associated with increased risk of 30-day infection (OR 2.11 [95% CI 1.30-3.40]) and PJI (HR 2.70 [95% CI 1.30-5.60]). Other risk factors for infection included elderly age, comorbidities, revision surgery, and previous hospitalized infection.ConclusionAdministering infliximab within 4 weeks of elective knee or hip arthroplasty was not associated with a higher risk of short- or long-term serious infection compared to withholding infliximab for longer time periods. Glucocorticoid use, especially >10 mg/day, was associated with an increased infection risk.
| S-EPMC5529262 | biostudies-literature
Project description:OBJECTIVES:Outcomes in total hip and knee arthroplasty (THA and TKA), such as allogeneic transfusions or extended length of stay (LoS), can be used to compare the performance of hospitals. However, there is much variation in these outcomes. This study aims to rank hospitals and to assess hospital differences of two outcomes in THA and TKA: allogeneic transfusions and extended LoS, and to additionally identify factors associated with these differences. DESIGN:Cross-sectional medical record review study. SETTING:Data were gathered in 23 Dutch hospitals. PARTICIPANTS:1163 THA and 986 TKA patient admissions. OUTCOMES:Hospitals were ranked based on their observed/expected (O/E) ratios regarding allogeneic transfusion and extended LoS percentages (extended LoS was defined by postoperative stay >4 days). To assess the reliability of these rankings, we calculated which percentage of the existing variation was based on differences between hospitals as compared with random variation (after adjustment for variation in patient characteristics). Associations between hospital-specific factors and O/E ratios were used to explore potential sources of differences. RESULTS:The variation in O/E ratios between hospitals ranged from 0 to 4.4 for allogeneic transfusion, and from 0.08 to 2.7 for extended LoS. Variation in transfusion could in 21% be explained by hospital differences in THA and 34% in TKA. For extended LoS this was 71% in THA and 78% in TKA. Better performance (low O/E ratios) in transfusion was associated with more frequent tranexamic acid (TXA) use in TKA (R=-0.43, p=0.04). Better performance in extended LoS was associated with more frequent TXA use in THA (R=-0.45, p=0.03) and TKA (R=-0.65, p<0.001) and local infiltration analgesia (LIA) in TKA (R=-0.60, p=0.002). CONCLUSIONS:Ranking hospitals based on allogeneic transfusion is unreliable due to small percentages of variation explained by hospital differences. Ranking based on extended LoS is more reliable. Hospitals using TXA and LIA have relatively fewer patients with transfusions and extended LoS.
| S-EPMC5541495 | biostudies-literature