scholarly journals A continuous PREMs and PROMs Observatory for elective hip and knee arthroplasty: study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049826
Author(s):  
Sabina De Rosis ◽  
Francesca Pennucci ◽  
Daniel Adrian Lungu ◽  
Mario Manca ◽  
Sabina Nuti

IntroductionScholars, 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 analysisThe 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 disseminationThe 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.

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Sujin Kang

Abstract Background The degree to which a validated instrument is able to detect clinically significant change over time is an important issue for the better management of hip or knee replacement surgery. This study examines the internal responsiveness of the EQ-5D-3L, the Oxford Hip Score (OHS), and the Oxford Knee Score (OKS) by various methods. Data from NHS patient-reported outcome measures (PROMs) linked to the Hospital Episodes Statistics (HES) dataset (2009–2015) was analysed for patients who underwent primary hip surgery (N = 181,424) and primary knee surgery (N = 191,379). Methods Paired data-specific univariate responsiveness was investigated using the standardized response mean (SRM), the standardized effect size (SES), and the responsiveness index (RI). Multivariate responsiveness was furthermore examined using the defined capacity of benefit score (i.e. paired data-specific MCID), adjusting baseline covariates such as age, gender, and comorbidities in the Box-Cox regression models. The observed and predicted percentages of patient improvement were examined both as a whole and by the patients' self-assessed transition level. Results The results showed that both the OHS and the OKS demonstrated great univariate and multivariate responsiveness. The percentages of the observed (predicted) total improvement were high: 51 (54)% in the OHS and 73 (58)% in OKS. The OHS and the OKS showed distinctive differences in improvement by the 3-level transition, i.e. a little better vs. about the same vs. a little worse. The univariate responsiveness of the EQ-5D-3L showed moderate effects in total by Cohen’s thresholds. The percentages of improvement in the EQ-5D-3L were moderate: 44 (48)% in the hip and 42 (44)% for the knee replacement population. Conclusions Distinctive percentage differences in patients’ perception of improvement were observed when the paired data-specific capacity of benefit score was applied to examine responsiveness. This is useful in clinical practice as rationale for access to surgery at the individual-patient level. This study shows the importance of analytic methods and instruments for investigation of the health status in hip and/or knee replacement surgery. The study finding also supports the idea of using a generic measure along with the disease-specific instruments in terms of cross-validation.


Author(s):  
Gareth S. Turnbull ◽  
Claire Marshall ◽  
Jamie A. Nicholson ◽  
Deborah J. MacDonald ◽  
Nicholas D. Clement ◽  
...  

Abstract Introduction The Olympia femoral stem is a stainless steel, anatomically shaped, polished and three-dimensionally tapered implant designed for use in cemented total hip arthroplasty (THA). The primary aim of this study was to determine the long-term survivorship, radiographic outcome, and patient-reported outcome measures (PROMs) of the Olympia stem. Patients and methods Between May 2003 and December 2005, 239 patients (264 THAs) underwent a THA with an Olympia stem in our institution. Patient-reported outcome measures were assessed using the Oxford Hip Score (OHS), EuroQol-5 dimensions (EQ-5D) score, and patient satisfaction at mean 10 years following THA. Patient records and radiographs were then reviewed at a mean of 16.5 years (SD 0.7, 15.3–17.8) following THA to identify occurrence of complications or revision surgery for any cause following surgery. Radiographs were assessed for lucent lines and lysis according to Gruen’s zones Results Mean patient age at surgery was 68.0 years (SD 10.9, 31–93 years). There were 156 women (65%, 176 THAs). Osteoarthritis was the indication for THA in 204 patients (85%). All cause stem survivorship at 10 years was 99.2% (95% confidence interval [CI], 97.9%–100%) and at 15 years was 97.5% (94.6%–100%). The 15-year stem survival for aseptic loosening was 100%. Analysis of all-cause THA failure demonstrated a survivorship of 98.5% (96.3%–100%) at 10 years and 95.9% (92.4%–99.4%) at 15 years. There were 9 THAs with non-progressive lucent lines in a single Gruen zone and 3 had lines in two zones, and no patient demonstrated signs for lysis. At a mean of 10-year (SD 0.8, 8.7–11.3) follow-up, mean OHS was 39 (SD 10.3, range 7–48) and 94% of patients reported being very satisfied or satisfied with their THA. Conclusions The Olympia stem demonstrated excellent 10-year PROMs and very high rates of stem survivorship at final follow-up beyond 15 years.


2021 ◽  
Vol 103-B (2) ◽  
pp. 338-346
Author(s):  
Yong Zhi Khow ◽  
Ming Han Lincoln Liow ◽  
Merrill Lee ◽  
Jerry Yongqiang Chen ◽  
Ngai Nung Lo ◽  
...  

Aims This study aimed to identify the tibial component and femoral component coronal angles (TCCAs and FCCAs), which concomitantly are associated with the best outcomes and survivorship in a cohort of fixed-bearing, cemented, medial unicompartmental knee arthroplasties (UKAs). We also investigated the potential two-way interactions between the TCCA and FCCA. Methods Prospectively collected registry data involving 264 UKAs from a single institution were analyzed. The TCCAs and FCCAs were measured on postoperative radiographs and absolute angles were analyzed. Clinical assessment at six months, two years, and ten years was undertaken using the Knee Society Knee score (KSKS) and Knee Society Function score (KSFS), the Oxford Knee Score (OKS), the 36-Item Short-Form Health Survey questionnaire (SF-36), and range of motion (ROM). Fulfilment of expectations and satisfaction was also recorded. Implant survivorship was reviewed at a mean follow-up of 14 years (12 to 16). Multivariate regression models included covariates, TCCA, FCCA, and two-way interactions between them. Partial residual graphs were generated to identify angles associated with the best outcomes. Kaplan-Meier analysis was used to compare implant survivorship between groups. Results Significant two-way interaction effects between TCCA and FCCA were identified. Adjusted for each other and their interaction, a TCCA of between 2° and 4° and a FCCA of between 0° and 2° were found to be associated with the greatest improvements in knee scores and the probability of fulfilling expectations and satisfaction at ten years. Patients in the optimal group whose TCCA and FCCA were between 2° and 4°, and 0° and 2°, respectively, had a significant survival benefit at 15 years compared with the non-optimal group (optimal: survival = 100% vs non-optimal: survival = 92%, 95% confidence interval (CI) 88% to 96%). Conclusion Significant two-way interactions between the TCCA and FCCA demonstrate the importance of evaluating the alignment of the components concomitantly in future studies. By doing so, we found that patients who concomitantly had both a TCCA of between 2° and 4° and a FCCA of between 0° and 2° had the best patient-reported outcome measures at ten years and better survivorship at 15 years. Cite this article: Bone Joint J 2021;103-B(2):338–346.


2021 ◽  
Vol 103 (1) ◽  
pp. 64-73
Author(s):  
F Begum ◽  
A Panagiotidou ◽  
C Park ◽  
T Ashdown ◽  
S El-Tawil

Introduction NHS England uses the Oxford Knee Score (OKS) as part of patient-reported outcome measures (PROMs) to evaluate ‘health gains’ following total knee replacement. Policy makers use this to guide healthcare funding and resource allocation. Our study aims to undertake a qualitative and quantitative analysis of OKS among patients who experienced a negative outcome after a total knee replacement at our centre. Materials and methods Between April 2017-March 2018, 19 of 189 (10%) patients had a worsened OKS at our centre. We retrospectively and prospectively reviewed 14 of these patients. Structured telephone interviews with a repeat OKS were carried out in September 2019 (18–29 months post-operation). Results Eight patients were female and the total age range was 57–95, mean average 75.6 (SD 9.9 years). Of 48 (higher scores meaning better outcomes), the average preoperative OKS was 24.2 and the average postoperative OKS at 6 months was 19.4 (decrease of 20%). The average postoperative OKS at 18–29 months was 35.6 (an increase of 83.5% from 6 months). Discussion The OKS was developed and validated over 20 years ago in Oxford. In our study, four patients asked for clarification of questions 4, 6 and 10 owing to ambiguous language. All 14 patients who had negative OKS outcomes had positive outcomes when retested after 18 months, depicting ‘health gains’ not conveyed in PROMs analysis. Conclusion The OKS needs to be revalidated on current patient groups for accurate and reliable data. Further prospective studies should be undertaken on larger cohorts to understand the recovery course and whether PROMs should be carried out later.


2018 ◽  
pp. 1-15 ◽  
Author(s):  
Pasquale Innominato ◽  
Sandra Komarzynski ◽  
Abdoulaye Karaboué ◽  
Ayhan Ulusakarya ◽  
Mohamed Bouchahda ◽  
...  

Purpose To assess the impact of chronomodulated irinotecan fluorouracil-leucovorin and oxaliplatin (chronoIFLO4) delivered at home on the daily life of patients with cancer in real time using a home-based e-Health multifunction and multiuser platform. This involved multidimensional telemonitoring of circadian rest-activity rhythm (CircAct), sleep, patient-reported outcome measures, and body weight changes (BWCs). Patients and Methods Patients received chronoIFLO4 fortnightly at home. Patients completed the 19-item MD Anderson Symptom Inventory on an interactive electronic screen, weighed themselves on a dedicated scale, and continuously wore a wrist accelerometer for CircAct and sleep monitoring. Daily data were securely teletransmitted to a specific server accessible by the hospital team. The clinically relevant CircAct parameter dichotomy index I < O and sleep efficiency (SE) were calculated. The dynamic patterns over time of patient-reported outcome measures, BWC, I < O, and SE informed the oncology team on tolerance in real time. Results The platform was installed in the home of 11 patients (48 to 72 years of age; 45% men; 27% with performance status = 0), who were instructed on its use on site. They received 26 cycles and provided 5,891 data points of 8,736 expected (67.4%). The most severe MD Anderson Symptom Inventory scores were: interference with work (mean: 5.1 of 10) or general activity (4.9), fatigue (4.9), distress (4.2), and appetite loss (3.6). Mean BWC was −0.9%, and mean SE remained > 82%. CircAct disruption (I < O ≤ 97.5%) was observed in four (15%) cycles before chronoIFLO4 start and in five (19%) cycles at day 14. Conclusion The patient-centered multidimensional telemonitoring solution implemented here was well accepted by patients receiving multidrug chemotherapy at home. Moreover, it demonstrated that chronoIFLO4 was a safe therapeutic option. Such integrated technology allows the design of innovative management approaches, ultimately improving patients’ experience with chemotherapy, wellbeing, and outcomes.


2014 ◽  
Vol 1 (3) ◽  
pp. 9-13 ◽  
Author(s):  
Paul McLaughlin ◽  
Melanie Bladen ◽  
Mike Holland ◽  
Kate Khair

Abstract Aim: UK guidelines recommend regular assessment of joint status in children with haemophilia using a standardised tool performed by haemophilia physiotherapists. We surveyed UK physiotherapists working in haemophilia care regarding their current practice with respect to joint scoring. Methods: A survey was posted on SurveyMonkey and all haemophilia physiotherapists practising in the UK were invited to respond. Responses were analysed and discussed at a roundtable meeting attended by invited physiotherapists and specialist haemophilia nurses. Results: In all, responses were received from 29 of the estimated 37 physiotherapists in the UK who see haemophilia patients. Both the survey and subsequent discussion reflected agreement that joint scoring offers a valuable tool to clinicians, but that better ways of assessing joint health were needed. There was enthusiasm for combining joint scoring with systematic and validated patient-reported outcome measures. Conclusion: Greater understanding is needed of the relationship between joint scores and measures of physical function and quality of life.


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