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Correlation between NIH composite skin score, patient-reported skin score, and outcome: results from the Chronic GVHD Consortium.

ABSTRACT: There are no validated criteria to measure skin response in chronic GVHD. In a prospectively assembled, multicenter cohort of patients with chronic GVHD (N = 458), we looked for correlation of change in several different scales recommended by the National Institutes of Health (NIH) Consensus with clinician and patient perception of change and overall survival. Of the clinician scales, the NIH composite 0-3 skin score was the only one that correlated with both clinician and patient perception of improvement or worsening. Of the patient-reported scales, the skin subscale of the Lee Symptom Scale was the only one that correlated with both clinician and patient perception of improvement or worsening. At study entry, NIH skin score 3 and Lee skin symptom score > 15 were both associated with worse overall survival. Worsening of NIH skin score at 6 months was associated with worse overall survival. Improvement in the Lee skin symptom score at 6 months was associated with improved overall survival. Our findings support the use of the NIH composite 0-3 skin score and the Lee skin symptom score as simple and sensitive measures to evaluate skin involvement in clinical trials as well as in the clinical monitoring of patients with cutaneous chronic GVHD.

SUBMITTER: Jacobsohn DA

PROVIDER: S-EPMC3460679 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Correlation between NIH composite skin score, patient-reported skin score, and outcome: results from the Chronic GVHD Consortium.

Jacobsohn David A DA Kurland Brenda F BF Pidala Joseph J Inamoto Yoshihiro Y Chai Xiaoyu X Palmer Jeanne M JM Arai Sally S Arora Mukta M Jagasia Madan M Cutler Corey C Weisdorf Daniel D Martin Paul J PJ Pavletic Steven Z SZ Vogelsang Georgia G Lee Stephanie J SJ Flowers Mary E D ME

Blood 20120706 13

There are no validated criteria to measure skin response in chronic GVHD. In a prospectively assembled, multicenter cohort of patients with chronic GVHD (N = 458), we looked for correlation of change in several different scales recommended by the National Institutes of Health (NIH) Consensus with clinician and patient perception of change and overall survival. Of the clinician scales, the NIH composite 0-3 skin score was the only one that correlated with both clinician and patient perception of ...[more]

PMID: 22773386

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Project description:PurposeThe purpose of this study was to determine if the Single-Assessment Numeric Evaluation (SANE) score correlates with existing validated hip-specific patient-reported outcome measures (PROMs), including the Modified Harris Hip Score (mHHS), the International Hip Outcome Tool (IHOT-33), the Hip Outcome Score, Activities of Daily Living subscale (HOS-ADL), and the Hip Outcome Score, Sport-Specific subscale (HOS-SS), for patients preparing to undergo hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS).MethodsA single surgeon's operative database was retrospectively reviewed to identify patients undergoing primary hip arthroscopy for treatment of FAIS from April 2018 to October 2019. Patient-specific factors including age, sex, body mass index (BMI), and duration of symptoms were collected. Preoperative SANE, mHHS, IHOT-33, HOS-ADL, and HOS-SS scores were analyzed. Statistical analysis using Pearson correlation was performed to identify the relationship between the SANE score and the mHHS, IHOT-33, HOS-ADL, and HOS-SS, preoperatively.Results154 patients were included in the study. The mean mHHS was 54.4 ± 11.7; mean IHOT-33 score was 32.7 ± 15.0; mean HOS-SS 42.9 ± 23.7; and mean HOS-ADL was 63.3 ± 1. The mean SANE score was 36.7 ± 19.9. The Simple Hip Score was directly correlated with the mHHS (P < .01), the IHOT-33 (P < .01); the HOS-ADL (P < .01), and the HOS-SS (P < .01). The mean patient age was 35.9 years; 109 (70.8%) were female and 45 (29.2%) were male. Average patient BMI was 26.9. At the time of patient completion of the questionnaire, the majority of patients (65%) had been having symptoms for >1 year.ConclusionThe SANE score was strongly correlated with mHHS, IHOT-33, HOS-ADL, and HOS-SS in the preoperative setting for patients undergoing hip arthroscopy for treatment of FAIS. Given its simplicity, SANE may be a valuable tool for rapid assessment of joint function and pain in this patient population.Level of evidenceIV, therapeutic case series.

Project description:BackgroundMissing data can introduce bias in the results of randomised controlled trials (RCTs), but are typically unavoidable in pragmatic clinical research, especially when patient reported outcome measures (PROMs) are used. Traditionally applied to the composite PROMs score of multi-item instruments, some recent research suggests that multiple imputation (MI) at the item level may be preferable under certain scenarios. This paper presents practical guidance on the choice of MI models for handling missing PROMs data based on the characteristics of the trial dataset. The comparative performance of complete cases analysis, which is commonly used in the analysis of RCTs, is also considered.MethodsRealistic missing at random data were simulated using follow-up data from an RCT considering three different PROMs (Oxford Knee Score (OKS), EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L), 12-item Short Form Survey (SF-12)). Data were multiply imputed at the item (using ordinal logit and predicted mean matching models), sub-scale and score level; unadjusted mean outcomes, as well as treatment effects from linear regression models were obtained for 1000 simulations. Performance was assessed by root mean square errors (RMSE) and mean absolute errors (MAE).ResultsConvergence problems were observed for MI at the item level. Performance generally improved with increasing sample sizes and lower percentages of missing data. Imputation at the score and subscale level outperformed imputation at the item level in small sample sizes (n ≤ 200). Imputation at the item level is more accurate for high proportions of item-nonresponse. All methods provided similar results for large sample sizes (≥500) in this particular case study.ConclusionsMany factors, including the prevalence of missing data in the study, sample size, the number of items within the PROM and numbers of levels within the individual items, and planned analyses need consideration when choosing an imputation model for missing PROMs data.

Dataset Information

Correlation between NIH composite skin score, patient-reported skin score, and outcome: results from the Chronic GVHD Consortium.

Publications

Correlation between NIH composite skin score, patient-reported skin score, and outcome: results from the Chronic GVHD Consortium.

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