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  1. Article ; Online: First knee for pain and function versus second knee for quality of life.

    Lewin, Adriane M / Cashman, Kara / Harries, Dylan / Ackerman, Ilana N / Naylor, Justine M / Harris, Ian A

    Bone & joint open

    2024  Volume 5, Issue 3, Page(s) 202–209

    Abstract: Aims: The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis.: ... ...

    Abstract Aims: The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis.
    Methods: This retrospective cohort study used Australian national arthroplasty registry data from January 2013 to January 2021 to identify participants who underwent elective staged BTKA with six to 24 months between procedures. The primary outcome was Oxford Knee Score (OKS) at six months postoperatively for the first TKA compared to the second TKA, adjusted for age and sex. Secondary outcomes compared six-month EuroQol five-dimension five-level (EQ-5D-5L) domain scores, EQ-5D index scores, and the EQ visual analogue scale (EQ-VAS) between knees at six months postoperatively.
    Results: The cohort included 635 participants (1,270 primary procedures). Preoperative scores were worse in the first knee compared to the second for all instruments; however, comparing the first knee at six months postoperatively with the second knee at six months postoperatively, the mean between-knee difference was minimal for OKS (-0.8 points; 95% confidence interval (CI) -1.4 to -0.2), EQ-VAS (3.3; 95% CI 1.9 to 4.7), and EQ-5D index (0.09 points; 95% CI 0.07 to 0.12). Outcomes for the EQ-5D-5L domains 'mobility', 'usual activities', and 'pain/discomfort' were better following the second TKA.
    Conclusion: At six months postoperatively, there were no clinically meaningful differences between the first and second TKA in either the joint-specific or overall generic health-related quality of life outcomes. However, individual domain scores assessing mobility, pain, and usual activities were notably higher after the second TKA, likely reflecting the cumulative improvement in quality of life after both knees have been replaced.
    Language English
    Publishing date 2024-03-11
    Publishing country England
    Document type Journal Article
    ISSN 2633-1462
    ISSN (online) 2633-1462
    DOI 10.1302/2633-1462.53.BJO-2023-0035.R1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study.

    Ackerman, Ilana N / Cashman, Kara / Lorimer, Michelle / Heath, Emma / Harris, Ian A

    Journal of patient-reported outcomes

    2024  Volume 8, Issue 1, Page(s) 34

    Abstract: Background: The ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly ... ...

    Abstract Background: The ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure.
    Methods: Pre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models.
    Results: Data were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01-17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33-33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54-5.64), compared with those who did (reference).
    Conclusion: Six-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.
    MeSH term(s) Humans ; Arthroplasty, Replacement, Hip/adverse effects ; Quality of Life ; Reoperation ; Treatment Outcome ; Australia/epidemiology ; Back Pain/etiology ; Registries ; Patient Reported Outcome Measures
    Language English
    Publishing date 2024-03-21
    Publishing country Germany
    Document type Journal Article
    ISSN 2509-8020
    ISSN (online) 2509-8020
    DOI 10.1186/s41687-024-00713-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Measurement Properties of the Oxford Shoulder Score and Minimal Clinically Important Changes After Primary Total Shoulder Replacement Surgery.

    Fang, Yi Ying / Ackerman, Ilana N / Page, Richard / Harris, Ian A / Cashman, Kara / Lorimer, Michelle / Heath, Emma / Soh, Sze-Ee

    Arthritis care & research

    2024  

    Abstract: Objective: We evaluated the measurement properties of the Oxford Shoulder Score (OSS) and estimated the minimal clinically important change (MCIC) in patients undergoing primary total shoulder replacement in Australia.: Methods: Deidentified data ... ...

    Abstract Objective: We evaluated the measurement properties of the Oxford Shoulder Score (OSS) and estimated the minimal clinically important change (MCIC) in patients undergoing primary total shoulder replacement in Australia.
    Methods: Deidentified data from the Australian Orthopaedic Association National Joint Replacement Registry were used for this analysis. Pre- and 6-month postoperative OSS scores were used, with the 5-level EuroQoL quality of life instrument and shoulder pain scores used as comparators. Floor and ceiling effects, internal consistency reliability, construct validity, and responsiveness to change were evaluated using standard psychometric methods. Mean change and predictive modeling approaches (with and without adjustment for the proportion of improved patients) were used to calculate MCIC thresholds, with patient-perceived improvement after surgery as the anchor.
    Results: Preoperative OSS data were available for 1,117 patients (59% female; 90% aged ≥60 years) undergoing primary total shoulder replacement. No floor or ceiling effects were observed pre- or postoperatively. The OSS showed high internal consistency reliability (Cronbach alpha >0.89), good construct validity, and high responsiveness to change (effect size 1.88). The MCIC derived from the mean change method was 6.50 points (95% confidence interval [95% CI] 4.41-8.61). The predictive modeling approach produced an MCIC estimate of 8.42 points (95% CI 5.68-12.23) after adjustment.
    Conclusion: The OSS has good measurement properties to capture pain and function outcomes after shoulder replacement procedures and is highly responsive to change. Based on robust methods, an increase in OSS scores of at least eight points can be considered as meaningful improvement after surgery from the patient's perspective.
    Language English
    Publishing date 2024-01-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.25304
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: The association between body mass index and patient-reported outcome measures before and after primary total hip or knee arthroplasty: a registry.

    Mulford, Jonathan S / Ackerman, Ilana / Holder, Carl / Cashman, Kara S / Graves, Stephen E / Harris, Ian A

    ANZ journal of surgery

    2023  Volume 93, Issue 6, Page(s) 1665–1673

    Abstract: Background: The objective is to determine whether body mass index is associated with patient-reported expectations and well-being before primary total hip or total knee arthroplasty, and patient-reported outcomes 6 months after surgery.: Methods: ... ...

    Abstract Background: The objective is to determine whether body mass index is associated with patient-reported expectations and well-being before primary total hip or total knee arthroplasty, and patient-reported outcomes 6 months after surgery.
    Methods: Data were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Outcome measures included pre-operative expectations for post-operative mobility, joint pain and health, pre- and post-operative EQ-5D-5L, EQ-VAS, Oxford Hip/Knee Scores and joint pain scales, and post-operative perceived change and perceived satisfaction. Associations with BMI were assessed using chi-square tests, analysis of variance and Linear Mixed Models equations.
    Results: Data were available for 12 816 primary THA patients and 20 253 primary TKA patients. Pre-operatively, patients in higher BMI categories were significantly more likely to expect ongoing problems with mobility, more joint pain and poorer health following surgery (P<0.01 for all analyses). For arthroplasty patients, higher BMI was associated with poorer pre-operative and post-operative scores for all measures. BMI was positively associated with improvements in EQ-5D, OHS/KS and joint pain. While between-group differences were statistically significant, many were small in magnitude. There was no association between BMI and patient-perceived change or satisfaction after arthroplasty.
    Conclusion: Patients undergoing THA/TKA, higher BMI was associated with lower pre-operative expectations, poorer well-being before surgery, and worse scores after surgery. Patients who were obese demonstrated comparable satisfaction with their operated joint, compared with non-obese patients. BMI was associated with greater pre- to post-operative improvements in outcome scores for EQ-5D, VAS knee, OHS/OKS and joint pain but these differences may not be clinically important.
    MeSH term(s) Humans ; Arthroplasty, Replacement, Knee ; Body Mass Index ; Arthroplasty, Replacement, Hip ; Australia/epidemiology ; Patient Reported Outcome Measures ; Arthralgia ; Registries ; Treatment Outcome ; Quality of Life
    Language English
    Publishing date 2023-04-05
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2050749-5
    ISSN 1445-2197 ; 1445-1433 ; 0004-8682
    ISSN (online) 1445-2197
    ISSN 1445-1433 ; 0004-8682
    DOI 10.1111/ans.18449
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Poor Knee-specific and Generic Patient-reported Outcome Measure Scores at 6 Months Are Associated With Early Revision Knee Arthroplasty: A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

    Ackerman, Ilana N / Harris, Ian A / Cashman, Kara / Rowden, Neville / Lorimer, Michelle / Graves, Stephen E

    Clinical orthopaedics and related research

    2022  Volume 480, Issue 10, Page(s) 1899–1909

    Abstract: Background: The ability to identify which patients are at a greater risk of early revision knee arthroplasty has important practical and resource implications. Many international arthroplasty registries administer patient-reported outcome measures ( ... ...

    Abstract Background: The ability to identify which patients are at a greater risk of early revision knee arthroplasty has important practical and resource implications. Many international arthroplasty registries administer patient-reported outcome measures (PROMs) to provide a holistic assessment of pain, function, and quality of life. However, few PROM scores have been evaluated as potential indicators of early revision knee arthroplasty, and earlier studies have largely focused on knee-specific measures.
    Questions/purposes: This national registry-based study asked: (1) Which 6-month postoperative knee-specific and generic PROM scores are associated with early revision knee arthroplasty (defined as revision surgery performed 6 to 24 months after the primary procedure)? (2) Is a clinically important improvement in PROM scores (based on thresholds for the minimal important change) after primary knee arthroplasty associated with a lower risk of early revision?
    Methods: Preoperative and 6-month postoperative PROM scores for patients undergoing primary knee arthroplasty were sourced from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and Arthroplasty Clinical Outcomes Registry National. Between January 2013 and December 2020, PROM data were available for 19,402 primary total knee arthroplasties; these data were linked to AOANJRR data on revision knee arthroplasty. Of these, 3448 procedures were excluded because they did not have 6-month PROM data, they had not reached the 6-month postoperative point, they had died before 24 months, or they had received revision knee arthroplasty before the 6-month PROMs assessment. After these exclusions, data were analyzed for 15,954 primary knee arthroplasties. Associations between knee-specific (knee pain, Oxford Knee Score, and 12-item Knee injury and Osteoarthritis Outcome Score [KOOS-12]) or generic PROM scores (5-level EuroQol quality of life instrument [EQ-5D], EQ VAS, perceived change, and satisfaction) and revision surgery were explored using t-tests, chi-square tests, and regression models. Ninety-four revision procedures were performed at 6 to 24 months, most commonly for infection (39% [37 procedures]). The early revision group was younger than the unrevised group (mean age 64 years versus 68 years) and a between-group difference in American Society of Anesthesiologists (ASA) grade was noted. Apart from a small difference in preoperative low back pain for the early revision group (mean low back pain VAS 4.2 points for the early revision group versus 3.3 points for the unrevised group), there were no between-group differences in preoperative knee-specific or generic PROM scores on univariate analysis. As the inclusion of ASA grade or low back pain score did not alter the model results, the final multivariable model included only the most clinically plausible confounders (age and gender) as covariates. Multivariable models (adjusting for age and gender) were also used to examine the association between a clinically important improvement in PROM scores (based on published thresholds for minimal important change) and the likelihood of early revision.
    Results: After adjusting for age and gender, poor postoperative knee pain, Oxford, KOOS-12, EQ-5D, and EQ VAS scores were all associated with early revision. A one-unit increase (worsening) in knee pain at 6 months was associated with a 31% increase in the likelihood of revision (RR 1.31 [95% confidence interval (CI) 1.19 to 1.43]; p < 0.001). Reflecting the reversed scoring direction, a one-unit increase (improvement) in Oxford or KOOS-12 score was associated with a 9% and 5% reduction in revision risk, respectively (RR for Oxford: 0.91 [95% CI 0.90 to 0.93]; p < 0.001; RR for KOOS-12 summary: 0.95 [95% CI 0.94 to 0.97]; p < 0.001). Patient dissatisfaction (RR 6.8 [95% CI 3.7 to 12.3]) and patient-perceived worsening (RR 11.7 [95% CI 7.4 to 18.5]) at 6 months were also associated with an increased likelihood of early revision. After adjusting for age and gender, patients who did not achieve a clinically important improvement in PROM scores had a higher risk of early revision (RR 2.9 for the knee pain VAS, RR 4.2 for the Oxford Knee Score, RR 6.3 to 8.6 for KOOS-12, and RR 2.3 for EQ-5D) compared with those who did (reference group).
    Conclusion: Knee-specific and generic PROM scores offer an efficient approach to identifying patients at greater risk of early revision surgery, using either the 6-month score or the magnitude of improvement. These data indicate that surgeons can use single- and multi-item measures to detect a patient-perceived unsuccessful surgical outcome at 6 months after primary knee arthroplasty. Surgeons should be alert to poor PROM scores at 6 months or small improvements in scores (for example, less than 2 points for knee pain VAS or less than 10.5 points for Oxford Knee Score), which signal a need for direct patient follow-up or expedited clinical review.
    Level of evidence: Level III, therapeutic study.
    MeSH term(s) Arthroplasty, Replacement, Knee ; Australia ; Humans ; Low Back Pain/etiology ; Middle Aged ; Orthopedics ; Pain, Postoperative/etiology ; Patient Reported Outcome Measures ; Quality of Life ; Registries ; Treatment Outcome
    Language English
    Publishing date 2022-06-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80301-7
    ISSN 1528-1132 ; 0009-921X
    ISSN (online) 1528-1132
    ISSN 0009-921X
    DOI 10.1097/CORR.0000000000002301
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  6. Article ; Online: Patient-reported outcomes after hip and knee arthroplasty : results from a large national registry.

    Heath, Emma Louise / Ackerman, Ilana N / Cashman, Kara / Lorimer, Michelle / Graves, Stephen E / Harris, Ian A

    Bone & joint open

    2021  Volume 2, Issue 6, Page(s) 422–432

    Abstract: Aims: This study aims to describe the pre- and postoperative self-reported health and quality of life from a national cohort of patients undergoing elective total conventional hip arthroplasty (THA) and total knee arthroplasty (TKA) in Australia. For ... ...

    Abstract Aims: This study aims to describe the pre- and postoperative self-reported health and quality of life from a national cohort of patients undergoing elective total conventional hip arthroplasty (THA) and total knee arthroplasty (TKA) in Australia. For context, these data will be compared with patient-reported outcome measures (PROMs) data from other international nation-wide registries.
    Methods: Between 2018 to 2020, and nested within a nationwide arthroplasty registry, preoperative and six-month postoperative PROMs were electronically collected from patients before and after elective THA and TKA. There were 5,228 THA and 8,299 TKA preoperative procedures as well as 3,215 THA and 4,982 TKA postoperative procedures available for analysis. Validated PROMs included the EuroQol five-dimension five-level questionnaire (EQ-5D-5L; range 0 to 100; scored worst-best health), Oxford Hip/Knee Scores (OHS/OKS; range 0 to 48; scored worst-best hip/knee function) and the 12-item Hip/Knee disability and Osteoarthritis Outcome Score (HOOS-12/KOOS-12; range 0 to 100; scored best-worst hip/knee health). Additional items included preoperative expectations, patient-perceived improvement, and postoperative satisfaction. Descriptive analyses were undertaken.
    Results: For THA and TKA patients respectively, the patient profile was 2,850 (54.5%) and 4,684 (56.4%) female, mean age 66.8 years (SD 10.6) and 67.5 (SD 8.8), and mean BMI 29.9 kg/m
    Conclusion: Large improvements in pain, function, and overall health were evident following primary THA and TKA. Approximately 10% of patients reported dissatisfaction with their surgery. Future analyses will focus on factors contributing to dissatisfaction after arthroplasty. Cite this article:
    Language English
    Publishing date 2021-06-28
    Publishing country England
    Document type Journal Article
    ISSN 2633-1462
    ISSN (online) 2633-1462
    DOI 10.1302/2633-1462.26.BJO-2021-0053.R1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Minimal Clinically Important Changes in HOOS-12 and KOOS-12 Scores Following Joint Replacement.

    Soh, Sze-Ee / Harris, Ian A / Cashman, Kara / Heath, Emma / Lorimer, Michelle / Graves, Stephen E / Ackerman, Ilana N

    The Journal of bone and joint surgery. American volume

    2022  Volume 104, Issue 11, Page(s) 980–987

    Abstract: Background: For patient-reported outcome measures (PROMs) to provide meaningful information to support clinical care, we need to understand the magnitude of change that matters to patients. The aim of this study was to estimate minimal clinically ... ...

    Abstract Background: For patient-reported outcome measures (PROMs) to provide meaningful information to support clinical care, we need to understand the magnitude of change that matters to patients. The aim of this study was to estimate minimal clinically important changes (MCICs) for the 12-item Hip disability and Osteoarthritis Outcome Score (HOOS-12) and Knee injury and Osteoarthritis Outcome Score (KOOS-12) among people undergoing joint replacement for osteoarthritis.
    Methods: Individual-level data from the Australian Orthopaedic Association National Joint Replacement Registry's pilot PROMs program were used for this analysis. Preoperative and 6-month postoperative HOOS-12 and KOOS-12 domain and summary impact scores plus a rating of patient-perceived change after surgery (on a 5-point scale ranging from "much worse" to "much better") were available. Three anchor-based approaches-mean change, receiver operating characteristics (ROC) based on Youden's J statistic, and predictive modeling using a binary logistic regression model-were used to calculate MCICs based on patient-perceived change.
    Results: Data were available for 1,490 patients treated with total hip replacement (THR) (mean age, 66 years; 54% female) and 1,931 patients treated with total knee replacement (TKR) (mean age, 66 years; 55% female). Using the mean change method, the MCIC ranged from 24.0 to 27.5 points for the HOOS-12 and 17.5 to 21.8 points for the KOOS-12. The ROC analyses generated comparable MCIC values (28.1 for HOOS-12 and a range of 15.6 to 21.9 for KOOS-12) with high sensitivity and specificity. Lower estimates were derived from predictive modeling following adjustment for the proportion of improved patients (range, 15.7 to 19.2 for HOOS-12 and 14.2 to 16.5 for KOOS-12).
    Conclusions: We report MCIC values for the HOOS-12 and KOOS-12 instruments that we derived using 3 different methods. As estimates obtained using predictive modeling can be adjusted for the proportion of improved patients, these may be the most clinically applicable. These MCIC values can be used to interpret important changes in pain, function, and quality of life from the patient's perspective.
    Levels of evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
    MeSH term(s) Aged ; Arthroplasty, Replacement, Knee ; Australia ; Female ; Humans ; Male ; Osteoarthritis, Knee/surgery ; Quality of Life ; Reproducibility of Results
    Language English
    Publishing date 2022-02-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 220625-0
    ISSN 1535-1386 ; 0021-9355
    ISSN (online) 1535-1386
    ISSN 0021-9355
    DOI 10.2106/JBJS.21.00741
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  8. Article ; Online: Association between patient factors and hospital completeness of a patient-reported outcome measures program in joint arthroplasty, a cohort study.

    Harris, Ian A / Peng, Yi / Cashman, Kara / Ackerman, Ilana / Heath, Emma / Rowden, Neville / Graves, Stephen E

    Journal of patient-reported outcomes

    2022  Volume 6, Issue 1, Page(s) 32

    Abstract: Background: The collection of patient-reported outcome measures (PROMs) following arthroplasty is common. PROMs data collection programs seek to maximise completeness in order to minimise selection bias and optimise representativeness of the sample ... ...

    Abstract Background: The collection of patient-reported outcome measures (PROMs) following arthroplasty is common. PROMs data collection programs seek to maximise completeness in order to minimise selection bias and optimise representativeness of the sample attained. We aimed to determine if patient factors influence variation in PROMs program completeness between-hospitals.
    Methods: Using data from a national arthroplasty registry PROMs program, we tested for associations between patient characteristics (age, sex, body mass index [BMI] and American Society of Anaesthesiologists [ASA] class) and both potential completeness (registration completeness: the proportion of arthroplasty patients that were registered in the PROMs electronic system) and actual completeness (response completeness: the proportion of arthroplasty patients who provided PROMs data) using linear regression.
    Results: When using all elective primary total hip, knee or shoulder arthroplasty procedures (N = 31,801) from 43 hospitals as the denominator, overall registration completeness was 52%, varying from 5 to 87% between hospitals. Overall pre-operative response completeness was 46%, varying from 5 to 82% between hospitals. There were no significant associations between hospital-level registration completeness or response completeness and age, sex, BMI or ASA score.
    Conclusion: Completeness rates of a PROMs program in arthroplasty varied widely between hospitals but in the absence of a relationship between measured patient factors and completeness rates, the observed variation likely relates to local site factors such as access to patients, local resources and clinician engagement with the program. Efforts to improve the rates of completeness of arthroplasty PROMs programs at individual hospitals may not improve the representativeness of the sample.
    Language English
    Publishing date 2022-04-05
    Publishing country Germany
    Document type Journal Article
    ISSN 2509-8020
    ISSN (online) 2509-8020
    DOI 10.1186/s41687-022-00441-2
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  9. Article ; Online: Are responders to patient health surveys representative of those invited to participate? An analysis of the Patient-Reported Outcome Measures Pilot from the Australian Orthopaedic Association National Joint Replacement Registry.

    Harris, Ian A / Cashman, Kara / Lorimer, Michelle / Peng, Yi / Ackerman, Ilana / Heath, Emma / Graves, Stephen E

    PloS one

    2021  Volume 16, Issue 7, Page(s) e0254196

    Abstract: Background: Patient-reported outcome measures (PROMs) are commonly used to evaluate surgical outcome in patients undergoing joint replacement surgery, however routine collection from the target population is often incomplete. Representative samples are ... ...

    Abstract Background: Patient-reported outcome measures (PROMs) are commonly used to evaluate surgical outcome in patients undergoing joint replacement surgery, however routine collection from the target population is often incomplete. Representative samples are required to allow inference from the sample to the population. Although higher capture rates are desired, the extent to which this improves the representativeness of the sample is not known. We aimed to measure the representativeness of data collected using an electronic PROMs capture system with or without telephone call follow up, and any differences in PROMS reporting between electronic and telephone call follow up.
    Methods: Data from a pilot PROMs program within a large national joint replacement registry were examined. Telephone call follow up was used for people that failed to respond electronically. Data were collected pre-operatively and at 6 months post-operatively. Responding groups (either electronic only or electronic plus telephone call follow up) were compared to non-responders based on patient characteristics (joint replaced, bilaterality, age, sex, American Society of Anesthesiologist (ASA) score and Body Mass Index (BMI)) using chi squared test or ANOVA, and PROMs for the two responder groups were compared using generalised linear models adjusted for age and sex. The analysis was restricted to those undergoing primary elective hip, knee or shoulder replacement for osteoarthritis.
    Results: Pre-operatively, 73.2% of patients responded electronically and telephone follow-up of non-responders increased this to 91.4%. Pre-operatively, patients responding electronically, compared to all others, were on average younger, more likely to be female, and healthier (lower ASA score). Similar differences were found when telephone follow up was included in the responding group. There were little (if any) differences in the post-operative comparisons, where electronic responders were on average one year younger and were more likely to have a lower ASA score compared to those not responding electronically, but there was no significant difference in sex or BMI. PROMs were similar between those reporting electronically and those reporting by telephone.
    Conclusion: Patients undergoing total joint replacement who provide direct electronic PROMs data are younger, healthier and more likely to be female than non-responders, but these differences are small, particularly for post-operative data collection. The addition of telephone call follow up to electronic contact does not provide a more representative sample. Electronic-only follow up of patients undergoing joint replacement provides a satisfactory representation of the population invited to participate.
    MeSH term(s) Aged ; Arthroplasty, Replacement/statistics & numerical data ; Arthroplasty, Replacement, Knee/statistics & numerical data ; Australia ; Female ; Health Surveys/statistics & numerical data ; Humans ; Knee Joint/surgery ; Male ; Orthopedics/statistics & numerical data ; Osteoarthritis/surgery ; Patient Reported Outcome Measures ; Registries/statistics & numerical data ; Treatment Outcome
    Language English
    Publishing date 2021-07-02
    Publishing country United States
    Document type Journal Article
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0254196
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan.

    Sidhu, Verinder Singh / Kelly, Thu-Lan / Pratt, Nicole / Graves, Steven / Buchbinder, Rachelle / Naylor, Justine / de Steiger, Richard / Ackerman, Ilana / Adie, Sam / Lorimer, Michelle / Bastiras, Durga / Cashman, Kara / Harris, Ian

    Trials

    2021  Volume 22, Issue 1, Page(s) 564

    Abstract: Background: This a priori statistical analysis plan describes the analysis for CRISTAL.: Methods: CRISTAL (cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis ...

    Abstract Background: This a priori statistical analysis plan describes the analysis for CRISTAL.
    Methods: CRISTAL (cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study) aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic venous thromboembolism (VTE) following hip arthroplasty (HA) or knee arthroplasty (KA). The study is nested within the Australian Orthopaedic Association National Joint Replacement Registry. The trial was commenced in April 2019 and after an unplanned interim analysis, recruitment was stopped (December 2020), as the stopping rule was met for the primary outcome. The clusters comprised hospitals performing > 250 HA and/or KA procedures per annum, whereby all adults (> 18 years) undergoing HA or KA were recruited. Each hospital was randomised to commence with aspirin, orally, 85-150 mg daily or LMWH (enoxaparin), 40 mg, subcutaneously, daily within 24 h postoperatively, for 35 days after HA and 14 days after KA. Crossover was planned once the registration target was met for the first arm. The primary end point is symptomatic VTE within 90 days. Secondary outcomes include readmission, reoperation, major bleeding and death within 90 days, and reoperation and patient-reported pain, function and health status at 6 months. The main analyses will focus on the primary and secondary outcomes for patients undergoing elective primary total HA and KA for osteoarthritis. The analysis will use an intention-to-treat approach with cluster summary methods to compare treatment arms. As the trial stopped early, analyses will account for incomplete cluster crossover and unequal cluster sizes.
    Conclusions: This paper provides a detailed statistical analysis plan for CRISTAL.
    Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12618001879257 . Registered on 19/11/2018.
    MeSH term(s) Adult ; Arthroplasty, Replacement, Knee/adverse effects ; Aspirin/adverse effects ; Australia ; Heparin, Low-Molecular-Weight/adverse effects ; Humans ; Registries ; Venous Thromboembolism/diagnosis ; Venous Thromboembolism/etiology ; Venous Thromboembolism/prevention & control
    Chemical Substances Heparin, Low-Molecular-Weight ; Aspirin (R16CO5Y76E)
    Language English
    Publishing date 2021-08-24
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1468-6708
    ISSN (online) 1745-6215 ; 1468-6694
    ISSN 1468-6708
    DOI 10.1186/s13063-021-05486-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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