A review and evaluation of patient-reported outcome measures for spasticity in persons with spinal cord damage: Recommendations from the Ability Network – an international initiative

Context: Patient-reported outcome measures (PROMs) are valuable for capturing the impact of spasticity on health-related quality of life (HRQoL) in persons with spinal cord damage (SCD) and evaluating the efficacy of interventions.Objective: To provide practical guidance for measuring HRQoL in persons with spasticity following SCD.Methods: Literature reviews identified measures of HRQoL and caregiver burden, utilized in studies addressing spasticity in SCD. Identified measures were evaluated for clinical relevance and practicality for use in clinical practice and research. The PRISM, SCI-SET, EQ-5D and SF-36 instruments were mapped to the International Classification of Functioning, Disability and Health (ICF). The PRISM and SCI-SET were evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist.Results: Two spasticity-specific, five generic, and four preference-based measures were identified. ICF mapping and the COSMIN checklist supported the use of the PRISM and SCI-SET in SCD. The SF-36 is considered the most useful generic measure; disability-adapted versions may be more acceptable but further studies on psychometric properties are required. The SF-36 can be converted to a preference-based measure (SF-6D), or alternatively the EQ-5D can be used. While no measures specific to caregivers of people with SCD were identified, the Caregiver Burden Scale and the Zarit Burden Interview are considered suitable.Conclusion: Recommended measures include the PRISM and SCI-SET (condition-specific), SF-36 (generic), and Caregiver Burden Scale and Zarit Burden Interview (caregiver burden). Consideration should be given to using condition-specific and generic measures in combination; the PRISM or SCI-SET combined with SF-36 is recommended.     

Evaluating quality in clinical care

Defining and maintaining quality is essential to surgical practice. It is only through structured approaches to assessing outcomes that we can ensure that optimal care is delivered. This article will define quality in healthcare and discuss assessment models with reference to pertinent surgical literature. National initiatives are discussed with a critical appraisal of their role and effectiveness. We discuss the aim of quality improvement initiatives and comment on reporting of outcomes. The difficult question of how to maintain quality during a crisis, such as an infectious disease pandemic, is addressed.     

Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients: A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EpClin) use (UCBG 2–14)

PurposeGenomic tests can identify ER-positive HER2-negative localized breast cancer patients who may not benefit from adjuvant chemotherapy. Such tests seem especially interesting in “intermediate” clinico-pathological risk categories. The psychological impact of the decision uncertainty in these women remains largely unexplored. We assessed the clinical and psychological impact of EndoPredict® (EpClin), a clinico-genomic test, in these patients.MethodsThis multicenter, single arm prospective study (NCT02773004) enrolled patients for which adjuvant chemotherapy was uncertain, based on predefined criteria. The primary endpoint was the proportion of change between initial adjuvant decision and final administration of chemotherapy. Secondary endpoints included post-test (Day 17) and 1-year patient reported outcomes.ResultsOne third of 200 evaluable patients had a high EpClin score (≥3.32867; 10 years cumulative risk of distance failure ≥10%). The overall change rate of chemotherapy decision was 72/200 (35.8%, 95% CI 29.2–42.4). Chemotherapy was withdrawn in 57 cases (28.4% [22.2–34.8]) and added in 15 (7.5% [3.8–11.2]. 6 changes (8%) were based on patients’ decisions. Anxiety and distress levels increased at Day 17 when adding chemotherapy after the test result (p < 10⁻⁷ and 0.00022 respectively), while stable in other situations. At 1-year, all patients had returned to the baseline anxiety and distress levels (mean anxiety 51.5, +/− SD = 2.5 [max. 80], mean distress 3±1 [max. 10]).ConclusionsEndoPredict ® (EpClin) is clinically useful in deciding whether or not to administer adjuvant chemotherapy in patients with intermediate risk. A single-step decision is preferable since adding chemotherapy at a later stage increases anxiety and distress.     

The Impact of Body Mass Index on Patient Reported Outcome Measures (PROMs) and Complications Following Primary Hip Arthroplasty

Influence of BMI upon patient outcomes and complications following THA was examined across a national cohort of patients. Outcomes were compared by BMI groups (19.0–29.9 kg/m² [reference], 30.0–34.9 kg/m² [obese class I], 35.0 kg/m²+ [obese class II/III]), adjusted for case-mix differences. Obese class I patients had a significantly smaller improvement in OHS (18.9 versus 20.5, P < 0.001) and a greater risk of wound complications (odds ratio [OR] = 1.57, P = 0.006). For obese class II/III patients, there were significantly smaller improvements in OHS and EQ-5D index (P < 0.001), and greater risk of wound complications (P = 0.006), readmission (P = 0.001) and reoperation (P = 0.003). Large improvements in patient outcomes were seen irrespective of BMI, although improvements were marginally smaller and complication rates higher in obese patients.     

Comparison of patient reported outcomes after Triathlon? and Kinemax Plus prostheses

INTRODUCTION

The Triathlon^® (Stryker, Kalamazoo, MI, US) total knee replacement was designed to improve patient function and survivorship. The aim of this study was to determine whether the Triathlon^® prosthesis produces better patient reported outcomes than a previous design by the same manufacturer, the Kinemax Plus.

METHODS

The outcome of 233 knees of patients with a mean age of 68 years (range: 40–80 years) who received the Kinemax Plus prosthesis were compared with the outcomes of 220 knees of patients with a mean age of 70 years (range: 42–90 years) who received the Triathlon^® prosthesis. Data were collected via postal questionnaire prior to surgery as well as at 8–12 weeks and at 1 year following surgery. Validated questionnaires were used including the WOMAC^® (Western Ontario and McMaster Universities) pain and function scales, the Knee injury and Osteoarthritis Outcome Score quality of life scale and the self-administered patient satisfaction scale.

RESULTS

This study found that patients who had the Triathlon^® prosthesis had significantly better pain relief (p<0.0001), function (p=0.028), knee related quality of life (p<0.0001) and satisfaction (p=0.0003) at three months after surgery than those who received the Kinemax Plus prosthesis. In addition, knee related quality of life (p=0.002) and satisfaction (p=0.021) were significantly higher at one year after surgery in Triathlon^® patients.

CONCLUSIONS

The findings suggest that return to function and reduction in pain may occur more quickly in patients with a Triathlon^® prosthesis than in those with the Kinemax Plus.     

Accurately measuring the quality and effectiveness of lumbar surgery in registry efforts: determining the most valid and responsive instruments

Background contextProspective registries have emerged as a feasible way to capture real-world care across large patient populations. However, the proven validity of more robust and cumbersome patient-reported outcomes instruments (PROis) must be balanced with what is feasible to apply in large-scale registry efforts.PurposeTo determine the relative validity and responsiveness of common PROis in accurately determining effectiveness of lumbar fusion for degenerative lumbar spondylolisthesis in registry efforts.Study designProspective cohort study.Patient sampleFifty-eight patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spondylolisthesisOutcome measuresPatient-reported outcome measures for pain (numeric rating scale for back and leg pain [NRS-BP, NRS-LP]), disability (Oswestry Disability Index [ODI]), general health (Short Form [SF]-12), quality of life (QOL) (EuroQol five dimensions [EQ-5D]), and depression (Zung depression scale [ZDS]) were assessed.MethodsFifty-eight patients undergoing primary TLIF for lumbar spondylolisthesis were entered into an institutional registry and prospectively followed for 2 years. Baseline and 2-year patient-reported outcomes were assessed. To assess the validity of PROis to discriminate between effective and noneffective improvements, receiver operating characteristic curves were generated for each outcomes instrument. An area under the curve (AUC) of ≥0.80 was considered an accurate discriminator. The difference between standardized response means (SRMs) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each instrument.ResultsFor pain and disability, ODI had AUC=0.94, suggesting it as an accurate discriminator of meaningful improvement. Oswestry Disability Index was most responsive to postoperative improvement (SRM difference: 2.18), followed by NRS-BP and NRS-LP. For general health and QOL, SF-12 physical component score (AUC: 0.90), ZDS (AUC: 0.89), and SF-12 mental component score (AUC: 0.85) were all accurate discriminators of meaningful improvement, however, EQ-5D was most accurate (AUC: 0.97). EuroQol five dimensions was also most responsive (SRM difference: 2.83).ConclusionsFor pain and disability, ODI was the most valid and responsive measure of effectiveness of lumbar fusion. Numeric rating scale-BP and NRS-LP should not be used as substitutes for ODI in measuring effectiveness of care in registry efforts. For health-related QOL, EQ-5D was the most valid and responsive measure of improvement, however, SF-12 and ZDS are valid alternatives with less responsiveness.