Robert A. Gerber

Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants

Background:The 21-item Three-Factor Eating Questionnaire (TFEQ-R21) is a scale that measures three domains of eating behavior: cognitive restraint (CR), uncontrolled eating (UE) and emotional eating (EE).Objectives:To assess the factor structure and reliability of TFEQ-R21 (and if necessary, refine the structure) in diverse populations of obese and non-obese individuals.Design:Data were obtained from obese adults in a United States/Canadian clinical trial (n=1741), and overweight, obese and normal weight adults in a US web-based survey (n=1275). Confirmatory factor analyses were employed to investigate the structure of TFEQ-R21 using baseline data from the clinical trial. The model was refined to obtain adequate fit and internal consistency. The refined model was then tested using the web-based data. Relationships between TFEQ domains and body mass index (BMI) were examined in both populations.Results:Clinical data indicated that TFEQ-R21 needed refinement. Three items were removed from the CR domain, producing the revised version TFEQ-R18V2 (Comparative Fit Index (CFI)=0.91). Testing TFEQ-R18V2 in the web-based sample supported the revised structure (CFI=0.96; Cronbachs coefficient α of 0.78–0.94). Associations with BMI were small. In the clinical study, the CR domain showed a significant and negative association with BMI. On the basis of the web-based survey, it was shown that the relationship between BMI and CR is population-dependent (obese versus non-obese, healthy versus diabetics).Conclusions:In two independent datasets, the TFEQ-R18V2 showed robust factor structure and good reliability. It may provide a useful tool for characterizing UE, CR and EE.

Independent and combined effects of exercise training and metformin on insulin sensitivity in individuals with prediabetes.

OBJECTIVE Physical activity or metformin enhances insulin sensitivity and opposes the progression from prediabetes to type 2 diabetes. The combination may be more effective because each treatment stimulates AMP-activated protein kinase activity in skeletal muscle. We evaluated the effects of exercise training plus metformin on insulin sensitivity in men and women with prediabetes, compared with each treatment alone. RESEARCH DESIGN AND METHODS For 12 weeks, men and women with prediabetes were assigned to the following groups: placebo (P), 2,000 mg/day metformin (M), exercise training with placebo (EP), or exercise training with metformin (EM) (n = 8 per group). Before and after the intervention, insulin sensitivity was measured by euglycemic hyperinsulinemic (80 mU/m2/min) clamp enriched with [6,6-2H]glucose. Changes due to intervention were compared across groups by repeated-measures ANOVA. RESULTS All three interventions increased insulin sensitivity (P < 0.05) relative to the control group. The mean rise was 25–30% higher after EP than after either EM or M, but this difference was not significant. CONCLUSIONS Insulin sensitivity was considerably higher after 12 weeks of exercise training and/or metformin in men and women with prediabetes. Subtle differences among condition means suggest that adding metformin blunted the full effect of exercise training.

Treatment satisfaction in type 2 diabetes: A comparison between an inhaled insulin regimen and a subcutaneous insulin regimen☆

BACKGROUND In patients with type 2 diabetes, published data suggest that glycemic control can be achieved as effectively with an inhaled insulin regimen (preprandial inhaled intrapulmonary insulin plus a single bedtime Ultralente injection) as with a conventional subcutaneous insulin regimen involving 2 to 3 injections per day. It is unknown whether inhalation delivery of insulin improves patient satisfaction. OBJECTIVE Our objective was to compare patient satisfaction between an inhaled insulin regimen and a subcutaneous insulin regimen. METHODS This was a 12-week randomized, open-label, parallel-group, controlled trial in patients with type 2 diabetes. They were randomized to receive either a subcutaneous insulin regimen (split/mixed insulin with 2 to 3 injections daily) or an inhaled insulin regimen (inhaled insulin before meals and a single Ultralente insulin injection at bedtime). Change in glycosylated hemoglobin (HbA1c) from baseline to week 12 was the studys primary end point. At baseline and week 12, patients completed a questionnaire (Patient Satisfaction with Insulin Therapy Questionnaire) covering attributes of patient satisfaction. Treatment regimens were compared on each item with the Wilcoxon rank sum test and on the overall score with a t test. RESULTS Fifty-one patients (age range, 35-65 years) participated in the study, 26 receiving inhaled insulin and 25 receiving subcutaneous insulin. Forty-seven patients (22 inhaled insulin, 25 subcutaneous insulin) completed the satisfaction questionnaire. The mean percent improvement in overall satisfaction with an inhaled insulin regimen (31%; 95% CI, 14-50) was significantly greater (P < 0.05) than that with a subcutaneous insulin regimen (13%; 95% CI, 7-19). Increases in overall satisfaction correlated with improvements in glycemic control (r = 0.30; P < 0.05). Both treatment regimens experienced a mean HbA1c reduction of approximately 0.7%. Although patient satisfaction was the chief focus of this article, these results should be considered exploratory, as the trial was powered prospectively for HbA1c values (the primary end point) and not for patient satisfaction. CONCLUSIONS Administration of an inhaled insulin regimen may offer the first practical, noninvasive alternative to insulin injections. In the patients with type 2 diabetes studied, an inhaled insulin regimen with the need for only 1 subcutaneous injection at bedtime appeared to offer more ease of use, comfort, and convenience, as well as greater overall satisfaction, than a subcutaneous insulin regimen of 2 to 3 injections daily.

The efficacy and safety of fasciectomy and fasciotomy for Dupuytren’s contracture in European patients: a structured review of published studies

A structured review of published papers was done to assess the efficacy and safety of fasciectomy and fasciotomy in European patients with Dupuytren’s contracture. The outcomes varied across 48 studies. For fasciectomy, outcomes and results were as follows: the proportions of patients with a 100% correction in contracture angle ranged from 61 to 97%, the mean improvement in contracture angle ranged from 58 to 79%, and cases judged excellent/good ranged from 63 to 90%. Fasciotomy had similar outcomes, with a mean improvement in contracture angle ranging from 46 to 88%. Immediate failures upon recovery were reported for both procedures. The average recurrence rates were 39% after a fasciectomy and 62% after a fasciotomy at a median time of about 4 years. Overall, about 20% of fasciectomy and fasciotomy patients experienced an adverse event. In summary, postoperative outcomes were successful, but surgical complications were common and recurrence of a contracture was likely within a few years.

Unité Rhumatologique des Affections de la Main (URAM) scale: Development and validation of a tool to assess Dupuytren's disease–specific disability

To our knowledge, no functional outcome measure has been developed and validated for Dupuytrens disease. We aimed to develop and validate a patient‐reported functional outcome measure for Dupuytrens disease.

Safety and tolerability of collagenase Clostridium histolyticum and fasciectomy for Dupuytren’s contracture

Safety was evaluated for collagenase Clostridium histolyticum (CCH) based on 11 clinical trials (N = 1082) and compared with fasciectomy data in a structured literature review of 48 European studies (N = 7727) for treatment of Dupuytren’s contracture. Incidence of adverse events was numerically lower with CCH vs. equivalent complications from fasciectomy (median [range] incidence), including nerve injury (0% vs. 3.8% [0%−50+%]), neurapraxia (4.4% vs. 9.4% [0%−51.3%]), complex regional pain syndrome (0.1% vs. 4.5% [1.3%−18.5%]) and arterial injury (0% vs. 5.5% [0.8%−16.5%]). Tendon injury (0.3% vs. 0.1% [0%−0.2%]), skin injury (16.2% vs. 2.8% [0%−25.9%]) and haematoma (77.7% vs. 2.0% [0%−25%]) occurred at a numerically higher incidence with CCH than surgery. Adverse events in CCH trials not reported after fasciectomy included peripheral oedema; extremity pain; injection site pain, haemorrhage and swelling; tenderness; pruritus and lymphadenopathy. CCH-related adverse events were reported as predominantly injection-related and transient. These results may support clinical decision-making for treatment of Dupuytren’s contracture.

Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes

In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren’s contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman −0.18, 95% CI −0.32 to −0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

Dupuytren's contracture: a retrospective database analysis to assess clinical management and costs in England.

BackgroundDupuytrens disease is a fibro-proliferative disorder affecting ~3-5% of the UK population. Current surgical treatments for Dupuytrens contracture (DC) include fasciectomy and fasciotomy. We assessed the clinical management of DC in England over a 5-year period; associated NHS costs were assessed for a 1-year period.MethodsHospital Episode Statistics were extracted from April 2003 to March 2008 for patients with Palmar Fascial Fibromatosis (ICD10 = M720) and DC-related procedures. Variables included demographics, OPCS, patient status and physician specialty. To estimate 2010-2011 costs, HRG4 codes and the National Schedule of Tariff 2010-11-NHS Trusts were applied to the 2007-2008 period.ResultsOver 5 years, 75,157 DC admissions were recorded; 64,506 were analyzed. Mean admissions per year were 12,901 and stable. Day cases increased from 42% (2003-2004) to 62% (2007-2008). The percent of patients having two or more admissions per year increased from 5.5% in 2003-2004 to 26.1% in 2007-2008. Between 2003 and 2007, 91% of procedures were Fasciectomy. Revision of Fasciectomy and Fasciotomy each accounted for ~4%; Amputation for 1%. In 2007, classification was extended to identify Digital Fasciectomy, its Revision and Dermofasciectomy. In 2007-2008, admissions were: 70% Palmar Fasciectomy, 16% Digital Fasciectomy, 1.3% Other Fasciectomy, 4.4% Revision of Palmar Fasciectomy, 1.3% Revision of Digital Fasciectomy, 3.8% Division of Palmar Fascia, 2.6% Dermofasciectomy and 1.1% Amputation. 79% of cases were overseen by trauma and orthopaedic surgeons, 19% by plastic surgeons. Mean (±SD) inpatient hospital length of stay was 1.5 (±1.4) days in 2003-2004 and 1.0 (±1.3) days in 2007-2008. Total estimated costs for 1 year (2010-2011) were £41,576,141. Per-patient costs were £2,885 (day case) and £3,534 (inpatient). Costs ranged from £2,736 (day-case Fasciectomy) to £9,210 (day-case Revision Digital).ConclusionsBetween 2003 and 2008, fasciectomy was the most common surgical procedure for DC in England. While procedure rates and physician specialties varied little, there was a reversal in surgical venue: inpatient operations decreased as day-case procedures increased. The change is likely due to economic trends and changes to the healthcare system. Estimated costs for 2010-2011 varied by procedure type and patient status. These findings can be used to understand clinical management of DC and guide healthcare policy.

Efficacy of collagenase in patients who did and did not have previous hand surgery for Dupuytren's contracture

Abstract Collagenase Clostridium histolyticum (CCH) is a non-surgical, efficacious therapy for Dupuytrens contracture (DC). This study evaluated the efficacy and safety of CCH in patients with previous DC surgery. Data from 12 CCH clinical trials were pooled. At screening, patients provided details about the type/date of previous DC surgery. Reviewers coded descriptions to the Operated Hand, finger, and joint. Of 1082 patients, 422 (39%) had previous DC surgery. For these patients with previous surgery, the CCH treatment was coded on the Operated (n = 206) or Non-operated Hand (n = 196). End-points included changes in fixed-flexion contracture (FFC) and range of motion (ROM). Adverse events (AEs) were monitored. After treatment with CCH, FFC at metacarpophalangeal joints was reduced by 75% in previously Operated Hands and by 80% for Non-operated Hands (p = 0.6). Improvements in ROM were 32° and 32°, respectively (p = 0.9). For proximal inter-phalangeal joints, the reductions in FFC for the Operated and Non-operated Hands were 52% and 50%, respectively (p = 0.6); improvements in ROM were 24° and 26°, respectively (p = 0.3). Some AE rates were significantly higher in the Operated vs Non-operated Hand groups, but were not clinically relevant. There were no between-group significant differences in AE duration (p > 0.08). Previous surgery for DC does not affect efficacy or safety of CCH, suggesting CCH is an option in patients with recurring DC. Some AE rates were significantly higher, but not clinically relevant.

Determining Clinically Important Changes in Range of Motion in Patients with Dupuytren’s Contracture

AbstractBackground and Objective: Injectable collagenase Clostridium histolyticum is efficacious in correcting Dupuytren’s contracture as assessed by changes in the angle of contracture and range of motion (ROM). However, clinically important changes in ROM have not been evaluated in depth. The objective of this secondary analysis of the CORD I trial was to identify severity levels using baseline ROM, estimate a clinically important difference (CID) for ROM, and link the results to collagenase treatment and patient satisfaction. Methods: In the CORD I trial, patients with Dupuytren’s disease and joint contractures ≥20° were randomized to receive a maximum of three collagenase 0.58 mg or placebo injections into the cord of the affected hand at 30-day intervals. The primary endpoint was reduction in contracture to ≤5° 30 days after the last injection (day 30). The secondary endpoints, which are reported in this analysis, were ROM, physician- and patient-rated severity (‘normal’, ‘mild’, ‘moderate’, ‘severe’) and improvement, and treatment satisfaction. Linear regression was used to model data for severity classification and CID estimation for ROM based on physician and patient ratings. Results: At baseline, mean ROM was 43.9° in the collagenase-treated joints (n= 197) and 45.3° in the placebo-treated joints (n= 102). On day 30, mean ROM was 80.7° in the collagenase-treated joints and 49.5° in the placebo-treated joints. The mean increase in ROM was 36.7° in the collagenase-treated joints (p < 0.001) and 4.0° in the placebo-treated joints (not significant). The estimated CID for ROM was 13.5° (95% CI 11.9, 15.1), reflecting a one-category change in severity. The mean increase in ROM exceeded the CID in the collagenase-treated joints but not in the placebo-treated joints; the difference between collagenase treatment and placebo in the mean increase in ROM also exceeded the CID, implying that the improvement with collagenase was clinically relevant. The severity classification for ROM was: ≥67.0°