scholarly journals Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement: study protocol for a randomised, controlled, double-blinded clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e040985
Author(s):  
Jonathan Brandt ◽  
Håkan Ledin ◽  
Jonas Ranstam ◽  
Ewa Roos ◽  
Per Aspenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Zoledronic Acid ◽  
Knee Replacement ◽  
Knee Prosthesis ◽  
Patient Reported Outcome ◽  
Ethical Review ◽  
Outcome Score ◽  
Patient Reported ◽  
Double Blinded ◽  
Improve Patient

IntroductionIn Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.Methods and analysisThis is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.Trial registration numberEudraCT: No 2015-001200-55; Pre-results.

scholarly journals Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II Total Knee Arthroplasty in Performance and functional Ability. A Randomised Controlled Trial (CAPAbility). The study protocol.

2019 ◽  
Author(s):  
Celia Clarke ◽  
Valerie Pomeroy ◽  
Allan Clark ◽  
Graham Creelman ◽  
Nicola Hancock ◽  
...  
Keyword(s):  
Knee Replacement ◽  
Functional Ability ◽  
Knee Prosthesis ◽  
Controlled Trial ◽  
Patient Reported Outcome ◽  
Replacement Surgery ◽  
Patient Reported ◽  
Total Knee ◽  
Randomised Controlled ◽  
Genesis Ii

Abstract Background: Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% (Baker et al 2007) of patients report poor functional outcomes following surgery. This study will look at the functional outcome of two TKR; the JOURNEY II Bi Cruciate Stabilised knee, a newer prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee and the GENESIS II, a proven existing design. Aim: The aim of the CAPAbility study is to compare the change in patient reported outcome scores, of the JOURNEY II BCS and the GENESIS II from pre-operation to six months post-operation. Methods: CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral knee replacement surgery across two UK hospitals. Eligible participants (n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery, with patients followed at one week, six to eight weeks and six months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at six months post-operatively. Secondary outcomes include: other patient-reported outcome measures (PROMs), biomechanical, radiological (computer tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre and post-surgery on variables known to affect the outcome of knee replacement surgery. A sub-sample (n=30) will have additional in-depth interviews to explore themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have had surgery. Discussion: This trial will evaluate two generations of TKR by PROMS and kinematic analysis with additional CT measurements and qualitative outcomes from the patient perspective. Trial registration. ISRCTN32315753, 12 December 2017. http://www.isrctn.com/ISRCTN32315753 Keywords: Total Knee Arthroplasty; knee replacement; functional ability; knee prosthesis; kinematics; primary 0steoarthritis.

scholarly journals Assessing responsiveness of the EQ-5D-3L, the Oxford Hip Score, and the Oxford Knee Score in the NHS patient-reported outcome measures

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Sujin Kang
Keyword(s):  
Outcome Measures ◽  
Knee Replacement ◽  
Oxford Knee Score ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Knee Score ◽  
Paired Data ◽  
Replacement Surgery ◽  
Patient Reported ◽  
Oxford Hip Score

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.

scholarly journals ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046450
Author(s):  
Samantha Cruz Rivera ◽  
Richard Stephens ◽  
Rebecca Mercieca-Bebber ◽  
Ameeta Retzer ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Patient Reported Outcome ◽  
Flow Diagram ◽  
Additional Patient ◽  
The Public ◽  
Patient Reported ◽  
Trial Protocols ◽  
User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

scholarly journals Using patient-reported outcome measurement to improve patient care

2017 ◽  
Vol 29 (6) ◽  
pp. 874-879 ◽  
Author(s):  
John Øvretveit ◽  
Lisa Zubkoff ◽  
Eugene C Nelson ◽  
Susan Frampton ◽  
Janne Lehmann Knudsen ◽  
...  
Keyword(s):  
Patient Care ◽  
Outcome Measurement ◽  
Improve Patient Care ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Improve Patient

scholarly journals Exercise-Based Rehabilitation and Manual Therapy Compared With Exercise-Based Rehabilitation Alone in the Treatment of Chronic Ankle Instability: A Critically Appraised Topic

2020 ◽  
Vol 29 (5) ◽  
pp. 684-688 ◽  
Author(s):  
Bridget M. Walsh ◽  
Katherine A. Bain ◽  
Phillip A. Gribble ◽  
Matthew C. Hoch
Keyword(s):  
Manual Therapy ◽  
Ankle Instability ◽  
Patient Reported Outcome ◽  
Chronic Ankle Instability ◽  
Current Evidence ◽  
Bottom Line ◽  
Patient Reported ◽  
Outcome Scores ◽  
The Difference ◽  
Improve Patient

Clinical Scenario: Patients with chronic ankle instability (CAI) commonly display lower levels of self-reported function and health-related quality of life. Several rehabilitation interventions, including manual therapy, have been investigated to help CAI patients overcome these deficits. However, it is unclear if the addition of manual therapy to exercise-based rehabilitation is more effective than exercise-based rehabilitation alone. Clinical Question: Does incorporating manual therapy with exercise-based rehabilitation improve patient-reported outcomes when compared with exercise-based rehabilitation alone? Summary of Key Findings: The literature was searched for articles that examined the difference in outcomes for patients with CAI between manual therapy with exercise-based rehabilitation and exercise-based rehabilitation alone. A total of 3 peer-reviewed randomized controlled trials were identified. Two articles demonstrated improved patient-reported outcome scores following the incorporation of manual therapy with exercise-based rehabilitation, whereas one study found no statistically significant differences between interventions. Clinical Bottom Line: The current evidence suggests that incorporating manual therapy in addition to exercised-based rehabilitation may improve patient-reported outcome scores in patients with CAI. Strength of Recommendation: In accordance with the Strength of Recommendation Taxonomy, the grade of A is recommended due to consistent evidence from high-quality studies.

scholarly journals Capturing Relevant Patient Data in Clinical Encounters Through Integration of an Electronic Patient-Reported Outcome System Into Routine Primary Care in a Boston Community Health Center: Development and Implementation Study (Preprint)

2019 ◽  
Author(s):  
Stephanie Loo ◽  
Chris Grasso ◽  
Jessica Glushkina ◽  
Justin McReynolds ◽  
William Lober ◽  
...  
Keyword(s):  
Primary Care ◽  
Community Health ◽  
Health Center ◽  
Community Health Centers ◽  
Community Health Center ◽  
Improve Patient Care ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Patient Provider Communication ◽  
Improve Patient

BACKGROUND Electronic patient-reported outcome (ePRO) systems can improve health outcomes by detecting health issues or risk behaviors that may be missed when relying on provider elicitation. OBJECTIVE This study aimed to implement an ePRO system that administers key health questionnaires in an urban community health center in Boston, Massachusetts. METHODS An ePRO system that administers key health questionnaires was implemented in an urban community health center in Boston, Massachusetts. The system was integrated with the electronic health record so that medical providers could review and adjudicate patient responses in real-time during the course of the patient visit. This implementation project was accomplished through careful examination of clinical workflows and a graduated rollout process that was mindful of patient and clinical staff time and burden. Patients responded to questionnaires using a tablet at the beginning of their visit. RESULTS Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model in terms of applying technological innovation to streamline clinical processes and improve patient care. CONCLUSIONS Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model for application of technological innovation to streamline clinical processes and improve patient care.

Preoperative patient-reported outcome score thresholds predict the likelihood of reaching MCID with surgical correction of adult spinal deformity

2020 ◽  
Vol 9 (1) ◽  
pp. 207-219
Author(s):  
Andrea Leyton-Mange ◽  
Eeric Truumees ◽  
Kevin J. Bozic ◽  
Devender Singh ◽  
Tiffany C. Liu ◽  
...  
Keyword(s):  
Spinal Deformity ◽  
Adult Spinal Deformity ◽  
Patient Reported Outcome ◽  
Surgical Correction ◽  
Outcome Score ◽  
Patient Reported ◽  
Preoperative Patient

Trust compliance with best practice tariff criteria for total hip and knee replacement

2019 ◽  
Vol 80 (9) ◽  
pp. 537-540
Author(s):  
Ivor Vanhegan ◽  
Andrew Sankey ◽  
Warwick Radford ◽  
Simon Ball ◽  
Charles Gibbons
Keyword(s):  
Knee Replacement ◽  
Best Practice ◽  
Outcome Measure ◽  
Participation Rate ◽  
Patient Reported Outcome ◽  
Measure Data ◽  
National Joint Registry ◽  
Joint Registry ◽  
Patient Reported Outcome Measure ◽  
Patient Reported

Background: Satisfaction of the best practice tariff criteria for primary hip and knee replacement enables on average an additional £560 of reimbursement per case. The Getting it Right First Time report highlighted poor awareness of these criteria among orthopaedic departments. Methods: The authors investigated the reasons for non-compliance with the best practice tariff criteria at their trust and implemented a quality improvement approach to ensure successful adherence to the standards (a minimum National Joint Registry compliance rate of 85%, a National Joint Registry unknown consent rate below 15%, a patient-reported outcome measure participation rate of ≥50%, and an average health gain not significantly below the national average). This was investigated using quarterly online reports from the National Joint Registry and NHS Digital. Results: Initially, the trust had a 31% patient-reported outcome measures participation rate arising from a systematic error in the submission of preoperative patient-reported outcome measure scores. Re-audit following the resubmission of patient-reported outcome measure data under the trust's correct organization data service code confirmed an improvement in patient-reported outcome measure compliance to 90% and satisfaction of all criteria resulting in over £450 000 of additional reimbursement to the trust. Conclusions: The authors would urge others to review their compliance with these four best practice tariff criteria to ensure that they too are not missing out on this significant reimbursement sum.

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