The use of electronic PROMs provides same outcomes as paper version in a spine surgery registry. Results from a prospective cohort study

Abstract Background and Purpose Patient-Reported Measured Outcomes (PROMs) are essential to gain a full understanding of a patient’s condition, and in spine surgery, these questionnaires are of help when tailoring a surgical strategy. Electronic registries allow for a systematic collection and storage of PROMs, making them readily available for clinical and research purposes. This study aimed to investigate the reliability between the electronic and paper form of ODI (Oswestry Disability Index), SF-36 (Short Form Health Survey 36) and COMI-back (Core Outcome Measures Index for the back) questionnaires. Methods A prospective analysis was performed of ODI, SF-36 and COMI-back questionnaires collected in paper and electronic format in two patients’ groups: Pre-Operatively (PO) or at follow-up (FU). All patients, in both groups, completed the three questionnaires in paper and electronic form. The correlation between both methods was assessed with the Intraclass Correlation Coefficients (ICC). Results The data from 100 non-consecutive, volunteer patients with a mean age of 55.6 ± 15.0 years were analysed. For all of the three PROMs, the reliability between paper and electronic questionnaires results was excellent (ICC: ODI = 0.96; COMI = 0.98; SF36-MCS = 0.98; SF36-PCS = 0.98. For all p < 0.001). Conclusions This study proved an excellent reliability between the electronic and paper versions of ODI, SF-36 and COMI-back questionnaires collected using a spine registry. This validation paves the way for stronger widespread use of electronic PROMs. They offer numerous advantages in terms of accessibility, storage, and data analysis compared to paper questionnaires.

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Cross-cultural translation and validation of the Chinese Oxford Knee Score and the Activity and Participation Questionnaire

Journal of Orthopaedic Surgery ◽

10.1177/2309499020910668 ◽

2020 ◽

Vol 28 (2) ◽

pp. 230949902091066

Author(s):

Cheng Chen ◽

Weijun Wang ◽

Hao Wu ◽

Anqi Gao ◽

Yong Qiu ◽

...

Keyword(s):

Knee Replacement ◽

Short Form ◽

Intraclass Correlation ◽

Oxford Knee Score ◽

Reliability And Validity ◽

Correlation Coefficients ◽

Knee Score ◽

Good Reliability ◽

Sf 36 ◽

Patient Reported

Objective: To cross-culturally translate and validate the Chinese versions of the Oxford Knee Score (OKS) and the Activity and Participation Questionnaire (APQ) in patients with end-stage knee osteoarthritis who are also candidates for knee replacement. Methods: The Chinese version of the OKS and APQ was completed by standard forward–backward translation and adaption. The feasibility was validated by a pretest in 30 patients. The final version together with the Short Form-36 (SF-36), EQ-5D, and EQ visual analog scale were assessed in 150 patients, and the OKS and APQ were repeated in 30 patients after a 2-week interval. The psychometric properties of the OKS and APQ were evaluated for test–retest reliability using intraclass correlation coefficients (ICCs), internal consistency using Cronbach’s α, and construct validity using Spearman’s correlation analysis. Results: All patients were able to understand and complete both the OKS and APQ without difficulty (i.e. no missing data). The ICCs were 0.959 for the OKS, 0.956 for the APQ for total scores, and >0.7 for each item. Cronbach’s α was greater than 0.7, and the corrected item-total correlation was greater than 0.4 for each item of both questionnaires. The OKS and APQ showed better correlations with questions from the pain and function domains than with those from the mental status domains of the SF-36 and EQ-5D. No floor or ceiling effect was identified in either questionnaire. Conclusions: The Chinese versions of the OKS and APQ are easy to understand and complete and showed good reliability and validity. They can be used to assess patient-reported outcomes after undergoing knee replacement in mainland China.

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SF-12 or SF-36 in pituitary disease? Toward concise and comprehensive patient-reported outcomes measurements

Endocrine ◽

10.1007/s12020-020-02384-4 ◽

2020 ◽

Vol 70 (1) ◽

pp. 123-133 ◽

Cited By ~ 2

Author(s):

Merel van der Meulen ◽

Amir H. Zamanipoor Najafabadi ◽

Daniel J. Lobatto ◽

Cornelie D. Andela ◽

Thea P. M. Vliet Vlieland ◽

...

Keyword(s):

Short Form ◽

Outcome Measurement ◽

Intraclass Correlation ◽

Fair Agreement ◽

Substantial Agreement ◽

Cross Sectional ◽

Pituitary Diseases ◽

Sf 36 ◽

Patient Reported ◽

Mean Differences

Abstract Purpose Pituitary diseases severely affect patients’ health-related quality of life (HRQoL). The most frequently used generic HRQoL questionnaire is the Short Form-36 (SF-36). The shorter 12-item version (SF-12) can improve efficiency of patient monitoring. This study aimed to determine whether SF-12 can replace SF-36 in pituitary care. Methods In a longitudinal cohort study (August 2016 to December 2018) among 103 endoscopically operated adult pituitary tumor patients, physical and mental component scores (PCS and MCS) of SF-36 and SF-12 were measured preoperatively, and 6 weeks and 6 months postoperatively. Chronic care was assessed with a cross-sectional study (N = 431). Mean differences and agreement between SF-36 and SF-12 change in scores (preoperative vs. 6 months) were assessed with intraclass correlation coefficients (ICC) and limits of agreement, depicting 95% of individual patients. Results In the longitudinal study, mean differences between change in SF-36 and SF-12 scores were 1.4 (PCS) and 0.4 (MCS) with fair agreement for PCS (ICC = 0.546) and substantial agreement for MCS (ICC = 0.931). For 95% of individual patients, the difference between change in SF-36 and SF-12 scores varied between −14.0 and 16.9 for PCS and between −7.8 and 8.7 for MCS. Cross-sectional results showed fair agreement for PCS (ICC = 0.597) and substantial agreement for MCS (ICC = 0.943). Conclusions On a group level, SF-12 can reliably reproduce MCS in pituitary patients, although PCS is less well correlated. However, individual differences between SF-36 and SF-12 can be large. For pituitary diseases, alternative strategies are needed for concise, but comprehensive patient-reported outcome measurement.

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Cross-Cultural Adaptation, Translation, and Validation of the Toronto Extremity Salvage Score for Extremity Bone and Soft Tissue Tumor Patients in Netherlands

Sarcoma ◽

10.1155/2017/6197525 ◽

2017 ◽

Vol 2017 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Julie J. Willeumier ◽

C. W. P. G. van der Wal ◽

Robert J. P. van der Wal ◽

P. D. S. Dijkstra ◽

Thea P. M. Vliet Vlieland ◽

...

Keyword(s):

Soft Tissue ◽

Physical Function ◽

Short Form ◽

Intraclass Correlation ◽

Retest Reliability ◽

Sf 36 ◽

Toronto Extremity Salvage Score ◽

Patient Reported ◽

Test Retest Reliability ◽

Extremity Salvage

Purpose. The aim of this study was to translate and culturally adapt the Toronto Extremity Salvage Score (TESS) to Dutch and to validate the translated version. Methods. The TESS lower and upper extremity versions (LE and UE) were translated to Dutch according to international guidelines. The translated version was validated in 98 patients with surgically treated bone or soft tissue tumors of the LE or UE. To assess test-retest reliability, participants were asked to fill in a second questionnaire after one week. Construct validity was determined by computing Spearman rank correlations with the Short Form- (SF-) 36. Results. The internal consistency (0.957 and 0.938 for LE and UE, resp.) and test-retest reliability (intraclass correlation coefficients 0.963 and 0.969 for LE and UE, resp.) were good for both questionnaires. The Dutch LE and UE TESS versions correlated most strongly with the SF-36 physical function dimension (r=0.737 for LE, 0.726 for UE) and the physical component summary score (r=0.811 and 0.797 for LE and UE). Interpretation. The Dutch TESS questionnaire for lower and upper extremities is a consistent, reliable, and valid instrument to measure patient-reported physical function in surgically treated patients with a soft tissue or bone tumor.

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The efficacy of coccygectomy in patients with persistent coccydynia

The Bone & Joint Journal ◽

10.1302/0301-620x.103b3.bjj-2020-1045.r2 ◽

2021 ◽

Vol 103-B (3) ◽

pp. 542-546

Author(s):

Stefan Milosevic ◽

Gustav Ø. Andersen ◽

Mads M. Jensen ◽

Mikkel M. Rasmussen ◽

Leah Carreon ◽

...

Keyword(s):

Short Form ◽

Demographic Data ◽

Nonoperative Treatment ◽

Physical Component Score ◽

Component Score ◽

Spine Registry ◽

Sf 36 ◽

Patient Reported ◽

Five Dimension ◽

One Year

Aims The aim of this study was to investigate the efficacy of coccygectomy in patients with persistent coccydynia and coccygeal instability. Methods The Danish National Spine Registry, DaneSpine, was used to identify 134 consecutive patients who underwent surgery, performed by a single surgeon between 2011 and 2019. Routine demographic data, surgical variables, and patient-reported outcomes, including a visual analogue scale (VAS) (0 to 100) for pain, Oswestry Disability Index (ODI), EuroQol five-dimension questionnaire (EQ-5D), and the Physical Component Score (PCS) and Mental Component Score (MCS) of the 36-Item Short-Form Health Survey questionnaire (SF-36) were collected at baseline and one-year postoperatively. Results A total of 112 (84%) patients with a minimum follow-up of one year had data available for analysis. Their mean age was 41.9 years, and 15 (13%) were males. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for the mean VAS for pain (70.99 to 35.34), EQ-5D (0.52 to 0.75), ODI (31.84 to 18.00), and SF-36 PCS (38.17 to 44.74). A total of 78 patients (70%) were satisfied with the outcome of treatment. Conclusion Patients with persistent coccydynia and coccygeal instability resistant to nonoperative treatment may benefit from coccygectomy. Cite this article: Bone Joint J 2021;103-B(3):542–546.

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Translating CESD-20 and PHQ-9 Scores to PROMIS Depression

Assessment ◽

10.1177/1073191115607042 ◽

2016 ◽

Vol 24 (3) ◽

pp. 300-307 ◽

Cited By ~ 19

Author(s):

Jiseon Kim ◽

Hyewon Chung ◽

Robert L. Askew ◽

Ryoungsun Park ◽

Salene M. W. Jones ◽

...

Keyword(s):

Short Form ◽

Outcome Measurement ◽

Intraclass Correlation ◽

Depression Scale ◽

Correlation Coefficients ◽

Patient Reported Outcome ◽

Epidemiologic Studies ◽

Measurement Information ◽

Patient Reported ◽

Patient Health

This study examined the accuracy of depression cross-walk tables in a sample of people with multiple sclerosis (MS). The tables link scores of two commonly used depression measures to the Patient Reported Outcome Measurement Information System Depression (PROMIS-D) scale metric. We administered the 8-item PROMIS-D (Short-Form 8b; PROMIS-D-8), the 20-item Center for Epidemiologic Studies Depression Scale (CESD-20), and the 9-item Patient Health Questionnaire (PHQ-9) to 459 survey participants with MS. We examined correlations between actual PROMIS-D-8 scores and the scores predicted by cross-walks based on PHQ-9 and CESD-20 scores. Intraclass correlation coefficients were used to assess correspondence. Consistency in severity classification was also calculated. Finally, we used Bland–Altman plots to graphically examine the levels of agreement. The correlations between actual and cross-walked PROMIS-D-8 scores were strong (CESD-20 = .82; PHQ-9 = .74). The intraclass correlation was moderate (.77). Participants were consistently classified as having or not having at least moderate depressive symptoms by both actual and cross-walked scores derived from the CESD-20 (90%) and PHQ-9 (85%). Bland–Altman plots suggested the smaller differences between actual and cross-walked scores with greater-than-average depression severity. PROMIS cross-walk tables can be used to translate depression scores of people with MS to the PROMIS-D metric, promoting continuity with previous research.

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Validity, Reliability, and Responsiveness of the Brief Pain Inventory in Inflammatory Bowel Disease

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2016/5624261 ◽

2016 ◽

Vol 2016 ◽

pp. 1-10 ◽

Cited By ~ 10

Author(s):

Lars-Petter Jelsness-Jørgensen ◽

Bjørn Moum ◽

Tore Grimstad ◽

Jørgen Jahnsen ◽

Randi Opheim ◽

...

Keyword(s):

Short Form ◽

Outcome Measurement ◽

Intraclass Correlation ◽

Bodily Pain ◽

Brief Pain Inventory ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Markers Of Inflammation ◽

Sf 36 ◽

Patient Reported

Background and Aims. No patient-reported outcome measures targeting pain have yet been validated for use in IBD patients. Consequently, the aim of this study was to test the psychometrical properties of the brief pain inventory (BPI) in an outpatient population with IBD.Methods. Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the BPI, as well as the Short-Form 36 (SF-36).Results. In total, 410 patients were included. The BPI displayed high correlations with the bodily pain dimension of the SF-36, as well as moderate correlations with disease activity indices. The BPI also displayed excellent internal consistency (Cronbach’s alpha value of 0.91, regardless of diagnosis) and good to excellent test-retest values (intraclass correlation coefficient (ICC) 0.84–0.90 and Kappa values > .70). In UC, calculation of responsiveness revealed that only BPI interference in patients reporting improvement reached the threshold of 0.2. In CD, Cohen’sdranged from 0.26 to 0.68.Conclusions. The BPI may serve as an important supplement in patient-reported outcome measurement in IBD. There is need to confirm responsiveness in future studies. Moreover, responsiveness should ideally be investigated using changes in objective markers of inflammation.

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Patient-Reported Dysphagia in Adults with Eosinophilic Esophagitis: Translation and Validation of the Swedish Eosinophilic Esophagitis Activity Index

Dysphagia ◽

10.1007/s00455-021-10277-5 ◽

2021 ◽

Author(s):

Sofie Albinsson ◽

Lisa Tuomi ◽

Christine Wennerås ◽

Helen Larsson

Keyword(s):

Eosinophilic Esophagitis ◽

Activity Index ◽

Intraclass Correlation ◽

Correlation Coefficients ◽

Control Group ◽

Cronbach’S Alpha ◽

Intraclass Correlation Coefficients ◽

Cronbach's Alpha ◽

Patient Reported ◽

Eortc Qlq

AbstractThe lack of a Swedish patient-reported outcome instrument for eosinophilic esophagitis (EoE) has limited the assessment of the disease. The aims of the study were to translate and validate the Eosinophilic Esophagitis Activity Index (EEsAI) to Swedish and to assess the symptom severity of patients with EoE compared to a nondysphagia control group. The EEsAI was translated and adapted to a Swedish cultural context (S-EEsAI) based on international guidelines. The S-EEsAI was validated using adult Swedish patients with EoE (n = 97) and an age- and sex-matched nondysphagia control group (n = 97). All participants completed the S-EEsAI, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Module 18 (EORTC QLQ-OES18), and supplementary questions regarding feasibility and demographics. Reliability and validity of the S-EEsAI were evaluated by Cronbach’s alpha and Spearman correlation coefficients between the domains of the S-EEsAI and the EORTC QLQ-OES18. A test–retest analysis of 29 patients was evaluated through intraclass correlation coefficients. The S-EEsAI had sufficient reliability with Cronbach’s alpha values of 0.83 and 0.85 for the “visual dysphagia question” and the “avoidance, modification and slow eating score” domains, respectively. The test–retest reliability was sufficient, with good to excellent intraclass correlation coefficients (0.60–0.89). The S-EEsAI domains showed moderate correlation to 6/10 EORTC QLQ-OES18 domains, indicating adequate validity. The patient S-EEsAI results differed significantly from those of the nondysphagia controls (p < 0.001). The S-EEsAI appears to be a valid and reliable instrument for monitoring adult patients with EoE in Sweden.

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OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321001069 ◽

2021 ◽

Vol 37 (S1) ◽

pp. 17-17

Author(s):

Eduardo Pinar ◽

Juan García de Lara ◽

José Hurtado ◽

Miguel Robles ◽

Gunnar Leithold ◽

...

Keyword(s):

High Risk ◽

Aortic Valve ◽

Short Form ◽

Systematic Evaluation ◽

Special Importance ◽

Economic Modelling ◽

Sf 36 ◽

Patient Reported ◽

Clinical Benefits ◽

Sapien 3

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.

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Assessment of computer adaptive testing version of the Neuro-QOL for people with multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458518810159 ◽

2018 ◽

Vol 25 (13) ◽

pp. 1791-1799 ◽

Cited By ~ 1

Author(s):

Brian C Healy ◽

Jonathan Zurawski ◽

Cindy T Gonzalez ◽

Tanuja Chitnis ◽

Howard L Weiner ◽

...

Keyword(s):

Multiple Sclerosis ◽

Outcome Measures ◽

Computerized Adaptive Testing ◽

Short Form ◽

Patient Reported Outcome Measures ◽

Adaptive Testing ◽

Patient Reported Outcome ◽

Longitudinal Change ◽

Sf 36 ◽

Patient Reported

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

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Patient-Reported Outcomes and Patient-Reported Satisfaction After Surgical Treatment for Cervical Radiculopathy

Global Spine Journal ◽

10.1177/2192568218765398 ◽

2018 ◽

Vol 8 (7) ◽

pp. 703-708 ◽

Cited By ~ 12

Author(s):

Andreas Kiilerich Andresen ◽

Rune Tendal Paulsen ◽

Frederik Busch ◽

Alexander Isenberg-Jørgensen ◽

Leah Y. Carreon ◽

...

Keyword(s):

Short Form ◽

Neck Disability Index ◽

Visual Analogue Score ◽

Cervical Radiculopathy ◽

Strongly Correlated ◽

Anterior Cervical Decompression ◽

Sf 36 ◽

Patient Reported ◽

Neck Disability ◽

Cervical Degenerative Disease

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

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