Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

<p>Abstract</p> <p>Background</p> <p>To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia.</p> <p>Methods</p> <p>An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia.</p> <p>Results</p> <p>112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0).</p> <p>Conclusion</p> <p>We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.</p

Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing

Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or refining the use of animals, and (3) recommendations for future work in this area

The Relationship Between Quality of Life and Health-Related Quality of Life in Young Males with Duchenne Muscular Dystrophy

AIM: This study investigated the relationship between quality of life (QoL) and health-related quality of life (HRQoL) and assessed factors other than health that contribute to differences in QoL in young males with Duchenne muscular dystrophy (DMD). METHOD: In this cross-sectional study, QoL and HRQoL measures were completed by 98 parents and 85 children. The Quality of My Life (QoML) questionnaire measured QoL and HRQoL as single-items, and the Pediatric Quality of Life 4.0 Generic Core (PedsQL) questionnaire was used as a multidimensional measure of HRQoL. Simple regression was used to examine the relationship between single-item measures of HRQoL and QoL. Multivariable regression was used to investigate factors that may contribute to difference in QoL and HRQoL. RESULTS: While ratings of QoL and HRQoL were significantly correlated with one another, HRQoL only accounted for 21% and 44% of the variability in QoL by child- and parent-reports respectively. None of the factors measured contributed ratings of the child\u27s QoL to be much higher than HRQoL. INTERPRETATION: QoL and HRQoL are related but distinct constructs as rated by children with DMD and their parents. Further research is needed to elucidate factors outside HRQoL that contribute to QoL. WHAT THIS PAPER ADDS: Quality of life (QoL) and health-related quality of life are distinct concepts rated by young males with Duchenne muscular dystrophy (DMD) and their parents. Factors outside of \u27health\u27 contribute to overall QoL in the paediatric population with DMD. This article\u27s abstract has been translated into Spanish and Portuguese. Follow the links from the abstract to view the translations

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery

PURPOSE: The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. METHODS: This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based “STAR” (Symptoms Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient’s assessment of STAR’s usefulness was measured via an exit survey. RESULTS: Forty-nine patients completed the study. The procedures included the following: hysterectomy +/− staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). CONCLUSION: Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms