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Validated repeatability of patient-reported outcome measures following primary total hip replacement: a mode of delivery comparison study with randomized sequencing.

ABSTRACT: Background and purpose - Patient-reported outcome measures (PROMs) are used to understand better the outcomes after total hip replacement (THR). These are administered in different settings using a variety of methods. We investigated whether the mode of delivery of commonly used PROMs affects the reported scores, 1 year after THR. Patients and methods - A prospective test-retest mode comparison study with randomized sequence was done in 66 patients who had undergone primary THR. PROMs were administered by 4 modes: self-administration, face-to-face interview, telephone interview, and postal questionnaire. PROMs included: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Hip Score (OHS), EQ5D-3L (EQ5D), and Self-Administered Patient Satisfaction Scale (SAPS). Linear regression was used to estimate relationships between the mean scores for PROMs by mode. Individual paired differences by mode were calculated, relationships between modes were identified, and results adjusted by time delay and participant age. Results - There was no statistically significant difference between the mean PROM scores recorded for each mode of delivery for each score. Statistically significant differences in the individual paired differences were detected between modes for the WOMAC stiffness subscale, OHS, EQ5D, and SAPS. OHS difference in individual paired means between face-to-face and telephone interview exceeded the minimal clinically important difference. Interpretation - PROMs mode of administration can affect the recorded results. Modes should not be mixed and may not be comparable between studies. It should not be assumed that different modes will obtain the same results and where not already established this should be checked by researchers before use.

SUBMITTER: Carpenter CVE

PROVIDER: S-EPMC6300745 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Validated repeatability of patient-reported outcome measures following primary total hip replacement: a mode of delivery comparison study with randomized sequencing.

Carpenter Charlotte V E CVE Blackburn Julia J Jackson John J Blom Ashley W AW Sayers Adrian A Whitehouse Michael R MR

Acta orthopaedica 20181119 6

Background and purpose - Patient-reported outcome measures (PROMs) are used to understand better the outcomes after total hip replacement (THR). These are administered in different settings using a variety of methods. We investigated whether the mode of delivery of commonly used PROMs affects the reported scores, 1 year after THR. Patients and methods - A prospective test-retest mode comparison study with randomized sequence was done in 66 patients who had undergone primary THR. PROMs were admin ...[more]

PMID: 30451047

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Project description:BackgroundCompetition-promoting reforms and economic incentives are increasingly being introduced worldwide to improve the performance of healthcare delivery. This study considers such a reform which was initiated in 2009 for elective hip replacement surgery in Stockholm, Sweden. The reform involved patient choice of provider, free establishment of new providers and a bundled payment model. The study aimed to examine its effects on hip replacement surgery quality as captured by patient reported outcome measures (PROMs) of health gain (as indicated by the EQ-5D index and a visual analogue scale (VAS)), pain reduction (VAS) and patient satisfaction (VAS) one and six years after the surgery.MethodsUsing patient-level data collected from multiple national registers, we applied a quasi-experimental research design. Data were collected for elective primary total hip replacements that were carried out between 2008 and 2012, and contain information on patient demography, the surgery and PROMs at baseline and at one- and six-years follow-up. In total, 36,627 observations were included in the analysis. First, entropy balancing was applied in order to reduce differences in observable characteristics between treatment groups. Second, difference-in-difference analyses were conducted to eliminate unobserved time-invariant differences between treatment groups and to estimate the causal treatment effects.ResultsThe entropy balancing was successful in creating balance in all covariates between treatment groups. No significant effects of the reform were found on any of the included PROMs at one- and six-years follow-up. The sensitivity analyses showed that the results were robust.ConclusionsCompetition and bundled payment had no effects on the quality of hip replacement surgery as captured by post-surgery PROMs of health gain, pain reduction and patient satisfaction. The study provides important insights to the limited knowledge on the effects of competition and economic incentives on PROMs.

Project description:BackgroundUnknown is which response rate on patient-reported outcome measures (PROMs) is needed to both obtain an accurate outcome and ensure generalizability in evaluating total hip arthroplasty (THA) procedures. Without an evidence based minimum response rate (MRR) on THA PROMs, it is possible that hospitals report invalid patient-reported outcomes (PROs) due to a too low response rate. Alternatively, hospitals may invest too much in achieving an unnecessary high response rate. The aim of this study is to gain an insight into the MRR on PROMs needed to adequately evaluate THA procedures from a clinical perspective.MethodsRetrospective study on prospective collected data of primary, elective THA procedures was performed. MRR was investigated for each PROM (NRS pain at rest, NRS pain during activity, EQ-5D-3L, HOOS-PS, anchor function, OHS, anchor pain and NRS satisfaction) separately to calculate the primary outcome: MRR for the THA PROMs set. MRR on a PROM needed to have (condition 1.) similar PRO change score (3 month score minus preoperative score) including confidence interval, (condition 2.) maintaining the influence of each change score predictor and (condition 3.) equal distribution of each predictor, as those of a 100% PROM response rate group. Per PROM, a 100%-group was identified with all patients having the PRO change score. Randomly assessed groups of 90% till 10% response rate (in total 90 groups) were compared with the 100%-group. Linear mixed model analyses and linear regressions were executed.ResultsThe MRR for the THA PROMs set was 100% (range: 70-100% per PROM). The first condition resulted in a MRR of 60%, the second condition in a MRR of 100% and the third condition in a MRR of 10%.ConclusionsA 100% response rate on PROMs is needed in order to adequately evaluate THA procedures from a clinical perspective. All stakeholders using THA PROs should be aware that 100% of the THA patients should respond on both preoperative and 3 month postoperative PROMs. For now, taking the first step in improving evaluation of THA for quality control by achieving at least two of the three conditions of MRR, advised is to require a response rate on PROMs of 60% as the lower limit.

Project description:Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45-70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.Clinicaltrial.gov: NCT01616667.

Project description:BackgroundDislocation, periprosthetic fracture and infection are serious complications of total hip replacement (THR) and which negatively impact on patients' outcomes including satisfaction, quality of life, mental health and function. The accuracy with which patients report adverse events (AEs) after surgery varies. The impact of patient self-reporting of AEs on patient-reported outcome measures (PROMs) after THR is yet to be investigated. Our aim was to determine the effect of confirmed and perceived AEs on PROMs after primary THR.MethodsA prospective single-centre cohort study of patients undergoing primary THR, with one-year follow-up, was performed. Participants completed forms pre-operatively and 3, 6, 9 and 12?months post-operatively, including Work Productivity and Activity Impairment (WPAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol-5D-3?L (EQ5D), Self-Administered Patient Satisfaction (SAPS) and AE reporting questionnaires. Results were reported in three groups: No AE, reported but not confirmed AE and confirmed AE. A generalised linear model was used to compare among groups using robust standard errors (SE).ResultsForty-one AEs were reported in a cohort of 417 patients (234 females), with 30 AEs reported by 3?months. Eleven (27 reported) infections, two (six reported) periprosthetic fractures and two (eight reported) dislocations were confirmed. Those in the no AE group reported significantly better outcomes that the reported AE group as measured by WOMAC Co-Eff 14.27 (p?=?0.01), EQ5D -?0.128 (p?=?0.02) and SAPS -?9.926 (p?=?0.036) and the combined reported and confirmed AE groups as measured by WOMAC Co-Eff 13.72 (p?=?0.002), EQ5D -?0.129 (p?=?0.036) and SAPS -?11.512 (p?=?0.004). No significant differences were seen in WPAI among groups.ConclusionsPatients who report AEs have worse outcomes than those who do not, regardless of whether the AEs can be confirmed by standard medical record review methods. The observed negative trends suggest that patient perception of AEs may influence patient outcome in a similar way to those with confirmed AEs.

Dataset Information

Validated repeatability of patient-reported outcome measures following primary total hip replacement: a mode of delivery comparison study with randomized sequencing.

Publications

Validated repeatability of patient-reported outcome measures following primary total hip replacement: a mode of delivery comparison study with randomized sequencing.

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