Magnitude Of Change In Scores Research Articles

Do Patient Outcomes Vary by Patient Age Following Primary Total Hip Arthroplasty?

Multiple authors have sought to determine what patient characteristics influence outcome after total hip arthroplasty (THA). Age has shown no effect on outcome in some evaluations, while others have reported higher functional improvement in younger patients. The aim of this study was to determine if outcome after THA varies based on patient age. A prospective, multicenter cohort of 7,934 unilateral primary THA patients from the FORCE-TJR comparative effectiveness consortium was evaluated. Demographic data, comorbid conditions, and Patient-Reported Outcome Measures, including (HOOS), HOOS-12, HOOS JR, and SF-36 (PCS) and (MCS), were collected preop and at 1-year postop. Descriptive statistics were generated, stratified by age (<55 years [younger adult], 55-64 years [older adult], 65-74 years [early elder], and ≥75 years [late elder]), and differences in pain, function, and quality of life among the 4 age groups were evaluated. A multivariate regression model with 95% confidence interval (CI) was used to assess the role of patient age as a predictive factor for HOOS pain and function scores reported 1 year after primary THA. Prior to surgery, younger patients (<55 years) reported worse pain, function, and quality of life than the other 3 patient groups. At 1 year after THA, younger patients (<55 years) reported slightly worse pain and quality of life but better function scores than the 3 older patients' groups. Younger patients (<55 years) achieved higher baseline to 1-year pain, and function score changes when compared to the older patients' groups. The quality of life score changes was not different among the 4 age groups. The differences in 1-year postop scores (ranging from 2.74 to 8.46) and the magnitude of score changes from baseline to 1 year (ranging from 1.9 to 5.85), although statistically significant (P < .001), did not reach the minimal clinically important difference (MCID). The multivariate regression analysis shows that age is a significant predictor for pain at 1 year but not for function. Although HOOS pain score is predicted to be higher by 4.38 points (less pain) 1 year after THA in older patients (≥75), when compared to younger patients (<55 years), again the difference is well below the MCID and is clinically insignificant. Although there are statistically significant differences in pain relief, functional improvement, and quality of life between younger and older patients among different patients' age groups, there is no clinically significant difference. THA provides an improvement in quality of life by decreasing pain and increasing function in all 4 age groups, with large improvements in Patient-Reported Outcome Measures scores (>2 standard deviations) without clinically significant age-related differences in THA outcome at 1 year.

Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery

Introduction and hypothesisPatient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery.MethodsWe used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified.ResultsThe MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9–25.0 (median 24.2) points for PFDI-20 and 9.0–12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7–62.5 (median 60.0) for PFDI-20 and 16.7–17.7 (median 17.2) for POPDI-6.ConclusionA mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.

Across the Spectrum from Borderline Dysplasia to Global Pincer Femoroacetabular Impingement: Arthroscopic Outcomes from a Large Hip Arthroscopy Study Group

Objectives:Outcomes from hip arthroscopy for dysplasia and global pincer FAI have fallen short of those for patients with normal acetabular coverage, but no study has investigated arthroscopic outcomes across the spectrum of acetabular coverage. Our objective is to report comparative hip arthroscopic outcomes of patients with low (borderline dysplasia), normal, and high (global pincer FAI) lateral acetabular coverage.Methods:A retrospective analysis of prospectively-collected data from a large multi-center registry (seven United States centers) was performed. Primary hip arthroscopy patients were assigned to one of three groups based on preoperative lateral center-edge angle (LCEA): borderline dysplasia (≤25°), normal (26-38°), and pincer FAI (≥39°). Repeated measures ANOVA compared pre-operative to 2-year minimum post-operative iHOT-12 scores. Subsequent ANOVA determined the effect of acetabular coverage on magnitude of change in scores.Results:Of 437 patients, the only statistical difference between groups was lower prevalence of acetabuloplasty in the borderline dysplasia group (p=0.001). A significant improvement in the pre-operative to post-operative iHOT-12 scores for patients with normal acetabular coverage, acetabular undercoverage, and acetabular overcoverage was observed; F(1, 339)=311.06; p<0.001, with no statistical differences in pre-operative (p=0.505) and post-operative (p<0.488) iHOT-12 scores when comparing the groups based on acetabular coverage. Mean iHOT-12 scores increased from 37.3 pre-operatively to 68.7 postoperatively, p<0.001, in the borderline dysplasia group, from 34.4 to 72, p<0.001, in the normal coverage group, and from 35.3 to 69.4, p<0.001, in the pincer group. These pre-operative scores increased by 31.4, 37.8, and 34.1, respectively, with no effect for acetabular coverage on the magnitude of change from pre-operative to post-operative iHOT-12 scores, F(2,339) =1.18; p=0.310. 10 subjects (2.3%) underwent conversion arthroplasty and 19 patients (4.4%) underwent revision arthroscopy with no significant effect of acetabular coverage on the incidence of revision or conversion surgery, X2 (6,433)=11.535, P = 0.073.Conclusion:Lateral acetabular coverage did not influence outcomes from primary hip arthroscopy performed in patients with low (borderline dysplasia), normal, and high (global pincer FAI) LCEA. Borderline dysplasia and moderate global pincer FAI with no or minimal osteoarthritis do not compromise successful 2-year minimum outcomes or survivorship following primary hip arthroscopy when performed by experienced surgeons.

Inter-rater reliability in clinical assessments: do examiner pairings influence candidate ratings?

BackgroundThe reliability of clinical assessments is known to vary considerably with inter-rater reliability a key contributor. Many of the mechanisms that contribute to inter-rater reliability however remain largely unexplained and unclear. While research in other fields suggests personality of raters can impact ratings, studies looking at personality factors in clinical assessments are few. Many schools use the approach of pairing examiners in clinical assessments and asking them to come to an agreed score. Little is known however, about what occurs when these paired examiners interact to generate a score. Could personality factors have an impact?MethodsA fully-crossed design was employed with each participant examiner observing and scoring. A quasi-experimental research design used candidate’s observed scores in a mock clinical assessment as the dependent variable. The independent variables were examiner numbers, demographics and personality with data collected by questionnaire. A purposeful sample of doctors who examine in the Final Medical examination at our institution was recruited.ResultsVariability between scores given by examiner pairs (N = 6) was less than the variability with individual examiners (N = 12). 75% of examiners (N = 9) scored below average for neuroticism and 75% also scored high or very high for extroversion. Two-thirds scored high or very high for conscientiousness. The higher an examiner’s personality score for extroversion, the lower the amount of change in his/her score when paired up with a co-examiner; reflecting possibly a more dominant role in the process of reaching a consensus score.ConclusionsThe reliability of clinical assessments using paired examiners is comparable to assessments with single examiners. Personality factors, such as extroversion, may influence the magnitude of change in score an individual examiner agrees to when paired up with another examiner. Further studies on personality factors and examiner behaviour are needed to test associations and determine if personality testing has a role in reducing examiner variability.

Arthroscopic Outcomes as a Function of Acetabular Coverage From a Large Hip Arthroscopy Study Group

To report comparative hip arthroscopic outcomes of patients with low (borderline dysplasia), normal, and high (global pincer femoroacetabular impingement [FAI]) lateral acetabular coverage. A retrospective analysis of prospectively collected data from a multicenter registry was performed. Primary hip arthroscopy patients were assigned to 1 of 3 groups based on preoperative lateral center-edge angle: borderline dysplasia (≤25°), normal (25.1°-38.9°), and pincer (≥39°). Repeated-measures analysis of variance compared preoperative with 2-year minimum postoperative International Hip Outcome Tool (iHOT-12) scores. Subsequent analysis of variance determined the effect of acetabular coverage on magnitude of change in scores. Of 437 patients, the only statistical difference between groups was a lower prevalence of acetabuloplasty in the borderline dysplasia group (P= .001). A significant improvement in the preoperative to postoperative iHOT-12 scores for patients with normal acetabular coverage, acetabular undercoverage, and acetabular overcoverage was observed: F(1, 339)= 311.06; P <.001, with no statistical differences in preoperative (P= .505) and postoperative (P <.488) iHOT-12 scores when comparing the groups based on acetabular coverage. Mean iHOT-12 scores increased from 37.3 preoperatively to 68.7 postoperatively (P <.001) in the borderline dysplasia group, from 34.4 to 72 (P <.001) in the normal coverage group, and from 35.3 to 69.4 (P <.001) in the pincer group. These preoperative scores increased by 31.4, 37.8, and 34.1, respectively, with no effect for acetabular coverage on the magnitude of change from preoperative to postoperative iHOT-12 scores: F(2,339)= 1.18; P= .310. Ten patients (2.3%) underwent conversion arthroplasty, and 19 patients (4.4%) underwent revision arthroscopy with no significant effect ofacetabular coverage on the incidence of revision or conversion surgery: χ2 (6,433)= 11.535; P= .073. Lateral acetabular coverage did not influence outcomes from primary hip arthroscopy when performed in patients with low (borderline dysplasia), normal, and high (global pincer FAI) lateral center-edge angle. Borderline dysplasia and moderate global pincer FAI with no or minimal osteoarthritis do not compromise successful 2-year minimum outcomes or survivorship following primary hip arthroscopy when performed by experienced surgeons. Level III, retrospective therapeutic trial.

Web-based Radiology Subspecialty Training Program: Pilot Feasibility and Effectiveness Analysis on Ethiopian Radiologists

To investigate the feasibility and effectiveness of a novel web-based radiology subspecialty training program. Ten Ethiopian general radiologists were enrolled; each participant selected two out of four available subspecialty training programs including abdominal imaging, neuroradiology, chest imaging, and musculoskeletal imaging. Participants were trained simultaneously in 4-stages over 20-months remotely. The program contains online lectures (previously recorded), online interactive case reviews, learning modules, and one-month observership at Johns Hopkins University. Each subspecialty training program consisted of nearly 50 recorded lectures, 26 case reviews, and 40 modules, all provided by subspecialty-trained radiology faculty. Trainees were evaluated using pre- and postcourse multiple choice questions, and the effectiveness of the program was assessed by comparing pre- and postcourse performances using paired t test or Wilcoxon signed-rank test. Regression analysis was conducted to determine the association between the magnitude of score change and trainees' age and years after graduation. All programs including abdominal imaging (p < 0.001), neuroradiology (p < 0.001), chest imaging (p: 0.001), and musculoskeletal imagining (p = 0.001) led to significant improvements in participants' knowledge (overall mean ± standard deviation of score change: +18.4% ± 11.4%). All stages of training including stage-1 (+29.3% ± 8.4%), stage-2 (+21.0% ± 8.0%), stage-3 (+15.0% ± 13.7%), and stage-4 (+17.0% ± 7.9%) significantly improved trainees' scores; and the percent score change decreased with each stage. Regression analysis revealed that score improvement was not associated with age and years after residency training. Our newly developed web-based radiology subspecialty training program results in improved knowledge of radiologists. Implementation of web-based subspecialty training could be an effective and feasible method for institutions without subspecialty faculty and programs.

A Prospective Study of Outcomes of Septoplasty with Turbinate Reductions in Patients with Allergic Rhinitis.

Examine outcomes of septoplasty with turbinate reductions in patients with allergic rhinitis as compared to patients without allergic rhinitis using validated outcome and quality-of-life (QOL) instruments. Prospective observational cohort study. Single surgeon, university hospital. Consecutive study-eligible patients with a symptomatic nasal septal deviation, with (n = 30) or without (n = 30) documented allergic rhinitis, were enrolled from March 2014 to February 2017. All patients subsequently underwent nasal septoplasty and inferior turbinate reductions. Outcomes were studied using the Nasal Obstruction Symptom Evaluation (NOSE) scale, mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and Ease-of-Breathing (EOB) Likert scores completed preoperatively and, together with a patient satisfaction Likert, at 3 and 6 months postoperatively. NOSE scores, EOB scores, and mini-RQLQ scores improved significantly in both groups at 3 and 6 months postoperatively. Results were sustained from 3 to 6 months. Although mini-RQLQ scores in allergic patients were higher at all intervals, the magnitude of change in scores in both groups was comparable. Although patients with allergic rhinitis report greater allergy-related QOL impairment (mini-RQLQ) on a day-to-day basis than nonallergic patients, this does not appear to attenuate the benefit they might experience from septoplasty and turbinate reductions when indicated for nasal obstruction. Furthermore, the symptomatic relief of their structural nasal obstruction appears to significantly improve their overall allergy-related quality of life. If appropriate expectations are set pre-operatively, allergic rhinitis is neither a contraindication nor a deterrent to septoplasty and turbinate reductions and these patients can reasonably expect a high degree of satisfaction post-operatively.

A comparison of the reliability and validity of SF-6D, EQ-5D and HUI3 utility measures in patients with schizophrenia and patients with depression in Singapore

There is limited evidence of a direct comparison of the psychometric performance of generic preference-based measures in patients with mental illness in an Asian patient population. The current study aimed to compare the test–retest reliability, convergent and known-group validity and magnitude of change in scores of the EuroQol Five-Dimension, Health Utility Index Mark 3 (HUI3) and Short-Form Six-Dimension (SF-6D) measures in patients with depression and patients with schizophrenia spectrum disorder. 500 patients were recruited from a tertiary psychiatric institution in Singapore. The Schizophrenia Quality of Life Scale (SQLS), 8-item Patient Health Questionnaire, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Positive and Negative Syndrome Scale were also included. In the schizophrenia sample, the SF-6D was found to have higher test–retest validity, convergent validity with SQLS domain scores, known-group validity and magnitude of change in scores over 6-month follow up than other measures. In the depression sample, the HUI3 was found to have higher test–retest reliability, convergent validity with Q-LES-Q, known group validity and magnitude of change in scores than other measures. Results suggest that the SF-6D and HUI3 to be more suitable as a utility measure for patients with schizophrenia and depression in an Asian patient population.

Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs.

Placebo effects remain largely unexplored in clinical trials of long-acting injectable (LAI) antipsychotics for schizophrenia. This study aims to characterize patients showing improvements after placebo injections and to search for criteria for the prediction of subsequent response based on the magnitude of score changes after the first week of treatment. Data from 450 patients with schizophrenia (DSM-IV) who received placebo injections in 4 double-blind randomized controlled trials evaluating efficacy of LAI paliperidone palmitate obtained through the Yale University Open Data Access (YODA) project were analyzed. These 4 studies were conducted from October 2003 to March 2008. Multiple logistic regression analyses were conducted to examine associations between placebo response and demographic and clinical characteristics. The predictive power of improvement at week 1 for response at week 9 was investigated; sensitivity and specificity of incremental 5% cutoff points between a 5% and 25% reduction in Positive and Negative Syndrome Scale (PANSS) total score at week 1 were calculated. Percent reduction in the PANSS total score at week 1 and a lower PANSS G12 item score (ie, better in judgment and insight) at baseline were significantly associated with placebo response at week 9 (odds ratio [OR] = 1.063; 95% CI, 1.040-1.087, P < .001; and OR= 0.739; 95% CI, 0.553-0.986, P = .040, respectively, in the per-protocol analysis). Cutoffs of a 10% (accuracy = 0.724 in the per-protocol analysis) and 15% (accuracy = 0.722 in the last-observation-carried-forward analysis) reduction in the PANSS total score at week 1 showed the highest predictive power. The appreciation that longer-term response following placebo injections can be predicted by a 10%-15% PANSS total score reduction at week 1 could guide the design of future clinical trials of LAI antipsychotics in schizophrenia to identify and exclude potential placebo responders early during the course of the study.

Identifying the optimal course delivery platform in an undergraduate animal behavior research course.

There is a critical need to evaluate pedagogical delivery platforms best suited for undergraduates in the information age. Our goal was to identify the optimum course delivery platform for a basic research course based on student performance and critical thinking scores. Students were expected to plan, conduct, and report on an animal behavior research project of their own design. The course was taught in three different formats: traditional, online, and flipped, over 2 yr by the same instructor at both the University of Florida and Santa Fe College. Student assessments included weekly quizzes, assignments, a written report, a poster presentation, and attendance. We conducted pre- and postassessments using the Cornell Critical Thinking Test (CCTT). Students’ grades differed depending on format delivery and were also different between University of Florida and Santa Fe College students. For students at the University of Florida, quiz grades and poster grades did not differ (P < 0.50) between formats. However, assignment grades (P = 0.04) and report grades (P < 0.001) differed by format and were higher in the flipped and online-only version of the course, compared with traditional. For students at the Santa Fe College, quiz grades (P = 0.71) did not differ, but assignment (P < 0.001), report (P = 0.003), and poster (P < 0.001) grades were higher in the flipped and traditional format of the course. Within the flipped format at the University of Florida, student CCTT scores increased (P < 0.001) between pre- and posttest, whereas the scores within the other formats did not differ. When we compared the magnitude of change between pre- and posttest scores across formats, students at the University of Florida in the flipped format tended (P = 0.060) to have a greater gain than students in the online format. For students at Santa Fe College, there was no difference between pre- and posttest CCTT scores for any format, and the magnitude of change in scores did not differ between formats. Overall, our results suggest that teaching format influences student grades and critical thinking scores. Different effects were seen in different student populations; however, positive effects of the flipped format on student grades were seen at both institutions. In conclusion, flipped format courses may improve learning and critical thinking in an early research-based course.

The impact of diabetes mellitus on outcomes of endoscopic sinus surgery: a nested case‐control study

Given the immune impairment associated with diabetes mellitus (DM), its impact on chronic rhinosinusitis (CRS) is a potentially relevant concern; however, it has not been well-studied. A single retrospective study reported worse postoperative quality of life outcomes in DM patients with CRS. Our study evaluated the effect of comorbid DM on outcomes of endoscopic sinus surgery (ESS) using a prospective study design. Using a multicentered, prospective cohort of patients (n = 437) undergoing ESS for recalcitrant CRS, a nested case-control comparison was performed between 20 adult DM patients (cases) and 20 non-DM patients (controls), matched 1:1 for age and Lund-Mackay computed tomography (CT) scores. Outcome measures included 22-item Sinonasal Outcome Test (SNOT-22), Rhinosinusitis Disability Index (RSDI), Patient Health Questionnaire (PHQ-2), and Brief Smell Identification Test (BSIT). Mean follow-up was similar between cases (mean ± standard deviation: 12.6 ± 6.0 months) and controls (12.9 ± 5.9 months; p = 0.862). All preoperative scores were statistically equivalent between DM and non-DM cohorts. Both cohorts showed significant post-ESS improvement in SNOT-22 (p = 0.001) and RSDI scores (p < 0.001), and no significant change in PHQ-2 or BSIT scores. The magnitude of score changes was statistically equivalent between the 2 cohorts for all outcome measures with no differences in postoperative score changes between insulin-dependent DM patients and those managed by oral hypoglycemics or dietary restriction (p ≥ 0.444). DM patients with CRS experience similar degrees of symptomatic benefit from ESS compared to controls. Insulin dependence does not appear to adversely affect surgical outcome but a larger cohort would better assess the effect of DM type and control on surgical outcomes in CRS.

Interinformant agreement of the dementia questionnaire for people with learning disabilities

Accessible summary Many services use carer questionnaires to decide whether people with Down's syndrome are developing dementia. Using one of these questionnaires (the DLD), we looked at how well carers agreed with each other. Only 15% of carers achieved ‘good’ agreement. Carers agreed more with each other when rating people who are less able. This backs up recommendations not to rely only on carer interviews when assessing for dementia. SummaryBecause of difficulties with neuropsychological assessments for dementia in people with learning disabilities, professionals in clinical practice have relied heavily on carer interviews, one of the most widely used being the Dementia Questionnaire for People with Learning Disabilities (DLD – Evenhuis et al. 2006 Dementia questionnaire for people with intellectual disabilities manual (second edition). Amsterdam, Netherlands, Harcourt Test Publishers). Because dementia is indicated by the magnitude of changes in scores between longitudinal assessments, interinformant agreement is paramount. We carried out the DLD interview independently with two carers for each of 26 people with Down's syndrome. Only 15% of pairs of carers achieved ‘good’ agreement. Levels of agreement varied widely across the DLD subscales and individual questions. Interinformant agreement was better for less able people with Down's syndrome than for more able individuals.

Reduced-Toxicity (RTC) Versus Myeloablative Conditioning (MAC) Prior to Allogeneic Stem Cell Transplantation in Pediatric Participants: Significant Improvement in Physical Functioning Following RTC Versus MAC

Abstract 2069Over the past decade there has been a shift in treating pediatric patients with RTC followed by allogeneic stem cell transplantation (alloSCT) for malignant and non-malignant diseases (Satwani/Cairo et al, BBMT 2005). Advantages of RTC over MAC include reduced acute short- and long-term late complications, reduced risk of infections, and improved survival. However, relatively little is known about the impact of RTC on the longitudinal quality of life (QOL) of these patients following alloSCT. The objective of this study was to compare the physical, emotional, and social functioning of children who received RTC versus MAC regimens prior to and after alloSCT.Hierarchical linear modeling (HLM) was used to explore trends in the PedsQL 4.0 physical, emotional, and social functioning and select individual items of 80 children ≥ 5 years of age undergoing alloSCT between Nov. 2002 and Dec. 2008. QOL was assessed once pre-alloSCT and on days 100, 180, 365, and 730, post-alloSCT. In addition, post hoc exploratory analyses were performed to further evaluate the effect of RTC and MAC regimens on QOL outcomes. If significant between- or within-group differences were observed for any of the three sub-scales, HLM procedures were performed for each sub-scale item to identify the item(s) affected by treatment. Since post hoc analyses were exploratory no adjustments were made in the alpha level. This secondary data analysis was not powered to detect statistically significant differences. Effect size (ES) calculations were included to describe the magnitude of change in scores from baseline and were calculated using the within patient standard deviation (SD), whereas the magnitude of the difference in scores between RTC and MAC regimens were calculated using the between group SD and interpreted according to Cohen’s thresholds.Mean age: 12.67 years; malignant/non-malignant 59%/41%; RTC/MAC 54%/46%. There was no significant difference (p = 0.87) between the baseline mean emotional functioning scores of patients treated with RTC (M = 75.90) or MAC (M = 75.30). In addition, there was no appreciable difference (p = 0.08) in the slope function between these two groups. Similarly, the baseline mean social functioning scores did not differ (p = 0.51) between groups with the RTC patients (M = 81.62) having equivalent function to MAC patients (M = 83.73). Furthermore, the rate of change over time between the two groups was not significantly different (p = 0.96). However, a significant change from baseline in overall physical functioning was estimated for RTC (M = 66.84) compared to MAC (M = 68.05) with RTC improving at a rate of 0.48 points per month (ppm)/ 5.82 points per year (ppy) and MAC improving by 0.04ppm/ 0.52ppy (t = 2.34; p = 0.02) (Figure 1). At 2-years post-alloSCT a moderate difference was estimated (ES = 0.71 SD) with RTC scoring 9.35 points higher than MAC. Post hoc analyses of physical functioning items revealed baseline impairments in lifting something heavy for both RTC (M = 55.55) and MAC (M = 56.06). However, the RTC group rapidly improved by 7.12ppm (t = 2.07; p = 0.03) with no lifting problems estimated by 6-months post-alloSCT. MAC improved by 1.27ppm, with some lifting difficulties predicted throughout the follow-up period. A large effect size difference in lifting scores was estimated at 2-years post-alloSCT with MAC scoring 6.74 SD lower than RTC. Greater improvements in fatigue scores were predicted for RTC (M = 60.11; 3.39ppm) compared with MAC (M = 65.19; 2.46ppm) (p > 0.05) with no fatigue estimated by 1-year post-alloSCT for both groups. RTC pain scores improved from baseline by 2.82ppm (M = 66.02) and 5.35ppm for MAC (M = 66.95). No difficulties with pain were estimated by 1-year for RTC and by 6-months for MAC.Emotional and social functioning were not influenced by the intensity of conditioning regimen received. Deficits in physical functioning appeared transient with most perturbations expressed in the acute post-alloSCT period. RTC versus MAC prior to AlloSCT in pediatric recipients was associated with significantly fewer deficits and faster recovery in overall physical functioning, strength, and fatigue. This study highlights the importance of including QOL as part of the treatment investigations to further define outcomes that are related to the intensity of conditioning regimens used in pediatric alloSCT. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Gender-Specific Differences in Pelvic Organ Function After Proctectomy for Inflammatory Bowel Disease

Significant concern exists regarding the effect of proctectomy on sexual function in patients with IBD. Little is known about gender-specific differences. This study aimed to examine sexual function and quality of life in men and women with IBD before and after proctectomy. This is a prospective cohort study. The study was conducted at a colorectal surgery center. The patients included in this study have IBD and underwent proctectomy or proctocolectomy. The treatment provided was proctectomy or proctocolectomy. Validated questionnaires were used to assess sexual function, quality of life, bowel habits, and urinary symptoms, and were completed before and 6 months after surgery. Sixty-six participants (41 men and 25 women) were evaluated at baseline and 6 months after proctocolectomy or completion proctectomy. A total of 48 IPAAs (31 men and 17 women) and 18 end ileostomies (10 men and 8 women) were created. Men reported improved scores on the International Index of Erectile Function (P = .003), a modified Sexual Function Questionnaire (P = .001), Inflammatory Bowel Disease Quality of Life (P < .001), and SF-36 (Mental Component Summary, P = .003; Physical Component Summary, P = .001) after surgery. Women had improvement in the desire subscale of the Female Sexual Function Index (P = .03), Inflammatory Bowel Disease Quality of Life scores (P = .04), and SF-36 (Mental Component Summary, P = .02; Physical Component Summary, P = .02). There was no gender difference in the magnitude of change in scores before and after surgery for any of the measures. Small sample size and sexually inactivity in 50% of cohort may have had an impact on our findings. Both men and women reported improvements in general and IBD-specific quality of life after surgery, but only men demonstrated several areas of improved sexual function. Women reported improved sexual desire but no other sexual function improvement. The postsurgical gender difference in sexual function, despite similar improvements in quality of life, may be accounted for by unexamined aspects of female sexual function.

Commentary on “Investigation of the Dynamic Gait Index in Children

“How should I apply this information?” This article suggests use of a standardized balance assessment, the Dynamic Gait Index (DGI), to describe the balance function of children with mild motor problems. Use of measures, such as the DGI, allows therapists to objectively describe performance and change in functional movement ability of children with motor dysfunction. On the basis of this pilot study, it appears that the DGI is sensitive to differences in the dynamic balance skill of children with and without sensory motor dysfunction. Alsalaheen et al1 used the DGI with a sample of children with concussion and dizziness, following vestibular rehabilitation, and a significant treatment effect was reflected in DGI scores. This further supports the use of the DGI with a pediatric population. The intertester reliability of the total DGI score was good when used with children with typical development (TD) (90%). In children with fetal alcohol spectrum disorder (FASD), intertester reliability of the DGI total score, within 1 point, was slightly less (83%). Test-retest reliability was somewhat lower (ICC = 0.71) for a group of children with and without FASD, but a stronger reliability may have been demonstrated if the test-retest period had been shorter. These data suggest that in populations of children with TD, total scores for the DGI are reliable, but in clinical populations, scores are most reliable within 1 point. “What should I be mindful about in applying this information?” The findings of this pilot study are promising, but the strength of the findings is limited by the small sample size of only 20 children (10 with TD and 10 with FASD), covering a 7-year age range. The age range is an issue when interpreting the findings because children at ages 8 to 9 years present a very different developmental profile than those who are 14 to 15 years old, in cognitive, language, vestibular, and visual system development. Complexity of verbal instructions in the DGI may be problematic for young children. The authors have suggested modifications of the DGI instructions to make them more appropriate, but additional modifications to avoid use of “right” and “left” to indicate a direction may be important. Both the visual and vestibular systems contribute to dynamic balance in children, and the vestibular system may not be fully mature by 8 years of age. Young children and children with sensory motor dysfunction may depend more heavily on the visual system during balance activities. These factors may affect performance on items requiring moving the head while walking. Between 8 and 15 years of age, the onset of puberty may also affect motor performance. It is understood that with the small size of this pilot study, the authors could not compare the performance of the younger and older children, or girls and boys. Future studies should compare the performance of children in the different age groups to examine the effect of age and development on performance of each item on the DGI. Finally, readers should consider if the differences between the groups with FASD and TD were clinically significant. A statistically significant difference in total DGI score was seen between the 2 groups of children, with children with FASD scoring lower on the DGI (mean = 21.4) than those with TD (mean = 23.3). Even though this is approximately a 2-point difference, does it reflect a true difference in performance for these 2 populations? More information is needed related to the error of measurement of the DGI when used with children and the magnitude of change in score that reflects meaningful clinically significant difference. Alsalaheen et al1 reported that a meaningful clinically significant difference for the DGI has not been documented, but a change in score of 3 points seems to reflect meaningful change. Also, readers should consider that the 2 groups of children in this study were matched by age, within 6 months. In this age group, a 6-month age difference may present developmental differences. For this reason, and because of the effect of overall development, it is important to use larger age-matched groups and more closely examine the performance of children in different age groups. Donna J. Cech, PT, DHS, PCS Physical Therapy Program, Midwestern University Downers Grove, Illinois Celine M. Rosati Skertich, PT, MS, PCS Easter Seals DuPage and Fox Valley Region Villa Park, Illinois

Modeling Disease Progression in Acute Stroke Using Clinical Assessment Scales

This article demonstrates techniques for describing and predicting disease progression in acute stroke by modeling scores measured using clinical assessment scales, accommodating dropout as an additional source of information. Scores assessed using the National Institutes of Health Stroke Scale and the Barthel Index in acute stroke patients were used to model the time course of disease progression. Simultaneous continuous and probabilistic models for describing the nature and magnitude of score changes were developed, and used to model the trajectory of disease progression using scale scores. The models described the observed data well, and exhibited good simulation properties. Applications include longitudinal analysis of stroke scale data, clinical trial simulation, and prognostic forecasting. Based upon experience in other areas, it is likely that application of this modeling methodology will enable reductions in the number of patients needed to carry out clinical studies of treatments for acute stroke.

Health-related quality of life measures in routine clinical care: Can FACT-Fatigue help to assess the management of fatigue in cancer patients?

Fatigue is the most common symptom reported by cancer patients. The inclusion of health-related quality of life (HRQL) measures in routine clinical care of cancer patients may improve the management of fatigue. The primary objective of this study is to provide evidence on the magnitude of change in fatigue subscale scores using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) that is clinically important. Consecutive patients with advanced primary lung cancer attending a Canadian tertiary care cancer and, prior to undergoing palliative chemotherapy, were enrolled in the study. Patients completed a battery of questionnaires [FACT-F, Qualitative Patients Self-report of Fatigue Level (QPSRF)] at baseline, follow-up and 2 weeks after their final cycle of chemotherapy. Clinicians assessed the patients using the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at baseline and each follow-up visit. FACT-F change scores were computed as the mean change in score (end of study score minus baseline score). A total of 43 patients with mean age of 59 years were enrolled in the study. Results revealed a mean change in FACT-F subscale score of 5.0 (SE 1.06) for those who rated themselves as more tired, 1.28 (SE 1.00) for those who rated themselves as the same (no change), and -1.52 (SE 0.84) for those patients who rated themselves as less tired. We provide evidence on the magnitude of change in FACT-F score that is associated with the perception by patients of improvement in fatigue and magnitude of change in score that is associated with worsening in fatigue.

Defining Response and Remission in Anxiety Disorders: Toward an Integrated Approach

Response and remission rates are commonly used to evaluate the efficacy of treatments for anxiety disorders and other psychiatric illnesses. Response is generally regarded as a clinically meaningful improvement in symptoms, while remission, the goal of treatment, is generally thought of as the absence or near absence of symptoms following illness, accompanied by a return to premorbid levels of functioning. Response and remission are often defined using psychiatric rating scales, based on score cutoffs or the magnitude of score changes from baseline. While no universally accepted criteria exist, a commonly used threshold for response is a >50% improvement in the total score, while for remission, various cutoff points have been used. Comparison of cutoffs or change scores for disease-specific scales with Clinical Global Impressions ratings is a useful way of evaluating response and remission criteria across disorders. To illustrate the use of disease-specific and global measures, this article summarizes data from randomized, placebo-controlled studies of adult patients with generalized anxiety disorder, social anxiety disorder, or panic disorder treated with the serotonin norepinephrine reuptake inhibitor venlafaxine extended release, for which acute-phase data are available (a total of 13 trials).

An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system

ABSTRACTBackground: The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patient's health-related quality of life (HRQoL) is less well known.Objective: To evaluate HRQoL outcomes in CLBP patients treated with transdermal fentanyl.Research design and methods: An observational study was conducted at 17 clinical centers in the US. Eligible patients had CLBP diagnosis for at least 3 months and were taking short-acting opioids chronically, and then initiated transdermal fentanyl treatment. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF‐36 Health Survey, at baseline and ≥ 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing CLBP patients’ SF‐36 scores to the general US population and low back pain patient norms. HRQoL outcomes were determined by comparing baseline and follow-up TOPS and SF‐36 scores. Additionally, HRQoL outcomes were evaluated across patient groups stratified by changes in pain intensity ratings as measured by an 11-point numerical rating scale.Results: At baseline CLBP patients (N = 131) scored one-to-two standard deviations (SD) below age and gender adjusted SF‐36 general population norms (MANOVA F = 127.1, p < 0.0001) and significantly lower than low back pain norms (MANOVA F = 125.3, p < 0.0001). At follow-up, significant improvement ( p < 0.05) was observed on six of the SF‐36 scales and both SF‐36 summary measures and five of the six TOPS pain-related scales. The magnitude of change in scores in effect size units among these scales ranged from 0.17 to 0.80, which are considered small to large effect size changes. HRQoL score improvement was greatest among patients experiencing the greatest pain relief.Conclusion: CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden. Favorable HRQoL outcomes were observed among patients who reported pain relief.

Opioids in non-cancer pain: Health-related quality of life of chronic low back pain patients: impact of disease and treatment effect of fentanyl transdermal system

Measures of pain frequency and intensity do not capture the extent to which chronic low back pain (CLBP) affects a person’s life and may underestimate the broad benefits of treatment. Understanding the full impact of CLBP and its treatment requires a multidimensional approach that includes health-related quality of life (HRQoL) measures. To assess the impact of CLBP on HRQoL and the effect of transdermal fentanyl treatment on HRQoL. An observational study conducted at 17 clinical centers in the U.S. Eligible patients had CLBP diagnosis for at least 3 months and were transitioned from short-acting opioids to transdermal fentanyl. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and ≥ 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing patient's SF-36 scores to general U.S. population norms. The HRQoL impact of transdermal fentanyl was determined by comparing baseline and follow-up TOPS and SF-36 scores. At baseline CLBP patients (N=122) scored one to two standard deviations (SD) below age and gender adjusted SF-36 general population norms (MANOVA F(8,2102)=119.3, p<0.0001). Significant improvement (p<0.05) was observed on the SF-36 physical functioning, role physical, bodily pain, vitality, social functioning, and physical summary scales and the TOPS total pain summary scale. The magnitude of change in scores in standard deviation units among these scales ranged from 0.21 to 0.73, which are considered small to moderate effect size changes. These changes suggest significant improvements not only in pain relief, but also physical and social functioning. In this preliminary analysis in a usual care setting, CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden that was significantly reduced after transitioning to transdermal fentanyl.