Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus

Incretin-based therapies have a glucose-dependent mode of action that results in excellent glucose-lowering efficacy with very low risk of hypoglycaemia, and weight neutrality [dipeptidyl peptidase-4 (DPP-4) inhibitors] or weight loss [glucagon-like peptide-1 (GLP-1) receptor agonists], in people with type 2 diabetes mellitus (T2DM). Patient-reported outcomes (PROs) complement physician evaluations of efficacy and tolerability and offer insights into the subjective experience of using modern diabetes treatments. We conducted a systematic search of clinical trials of the GLP-1 receptor agonists liraglutide, exenatide and long-acting exenatide, one of which included the oral DPP-4 inhibitor sitagliptin as a comparator. No other PRO data for DPP-4 inhibitors were identified. This review summarizes PRO data from eight clinical trials, the majority of which used the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and/or Impact of Weight on Quality of Life-Lite (IWQOL-Lite) to evaluate patient experience. People with T2DM were highly satisfied with modern incretin-based therapies compared with traditional therapies. Treatment satisfaction (including perceptions of convenience and flexibility) was high and generally higher with GLP-1 agonists in association with their greater glucose-lowering efficacy and tendency to facilitate weight loss. Weight-related quality of life (QoL) also improved in people using incretin therapies. The glycaemic improvements achieved with GLP-1 receptor agonists, coupled with the low incidence of hypoglycaemia and ability to cause weight loss, seemed to offset potential concern about injections. It is plausible that superior patient-reported benefits found in clinical trials may translate into improved, clinically meaningful, long-term outcomes through increased treatment acceptability. Long-term, prospective data are needed to ascertain whether this is the case in practice.

Clinical performance of an innovative back surface multifocal contact lens in correcting presbyopia

Purpose: This prospective study was designed to subjectively and objectively evaluate the performance of an aspheric multifocal back surface rigid gas permeable (RGP) contact lens. The multifocal element of this lens design consisted of an aspheric optical zone that varied according to the patient's ametropia, corneal topography, and required reading addition.

Methods: We fit 28 presbyopic subjects with an aspheric multifocal back surface RGP contact lens (age range: 45 to 68 years). Reading additions ranged from +0.75 D to +2.50 D. Subjects were assessed initially and at 2, 6, and 12 weeks for ocular changes, visual performance, and subjective responses.

Results: We required 116 RGP lenses to achieve an acceptable fit and visual acuity in 28 subjects (55 eyes). At the final visit, the distance logMAR acuity with the multifocal contact lens (+0.12 +/-0.10) was not statistically different (t=-0.623, P= 0.5388) from spectacle acuity at the initial visit (+0.10 +/-0.12). The near logMAR acuity with the multifocal contact lens at the final visit (0.36 +/- 0.12) was not statistically different from that for near acuity with spectacles at the initial visit (0.33 +/- 0.13). No slit lamp signs worsened during the study. A reduction in myopia of 0.67 D was noted by the final visit. Spectacle blur was noted if the acuity at the initial refraction was compared to the acuity with the same refraction at the final visit (t= -3.287, P= 0.0028) but not when the refractive changes were incorporated (t= 1.058, P= 0.3127). All subjects rated the performance of the lenses very highly: comfort, 86%; distance acuity, 83%; near acuity, 73%; and stability of vision, 74%. Twenty-four subjects (86%) chose the multifocal contact lens as their preference.

Conclusion: We demonstrated that a multifocal design is able to provide acceptable distance and near correction for presbyopic patients. The aspheric geometry required can be optimized for a given patient by considering his/her degree of ametropia, as well as the corneal topography.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in the United States

Objective: The objectives of this study were to assess current recommendations for replacement frequency (RF) of silicone hydrogel (SH) and daily disposable (DD) lenses, to determine compliance with these recommendations, and to investigate the reasons given for noncompliance.

Methods: A package containing 20 patient surveys was sent to 309 eye care practitioners (ECPs) in the United States who had agreed to participate in the study. One thousand eight hundred fifty-nine completed surveys were received from 158 ECPs and 1,654 surveys were eligible for analysis. Questions related to patient demographics, lens type, lens wearing patterns, the ECP instructions for RF, and the actual patient reported RF. ECPs were asked to provide lens information and their recommendation for RF after the surveys had been completed and sealed in envelopes. All responses were anonymous.

Results: Sixty-six percent of patients were women and their mean age was 34 ± 12 years. Eighty-eight percent of lenses were worn for daily wear, 12.8 ± 3.2 hours a day, 6.2 ± 1.5 days a week. Lens type distribution was 16% DD, 45% 2 week (2W) SH, and 39% 1 month (1M) SH. ECP recommendations for RF varied according to the lens type; 1% of 1M (95% CI 0.2-1.7), 4% of DD (95% CI 2.1-7.2), and 18% of 2W (95% CI 15.1-20.7) patients were given instructions that did not conform to the manufacturers' recommended RF (MRRF). When considering only those patients who were given the correct instructions for RF, 38% were not compliant with the MRRF; noncompliance rates varied according to the lens type and were 12% for DD (95% CI 8.6-17.2), 28% for 1M (95% CI 24.9-32.1), and 52% for 2W (95% CI 47.8-55.8). The most frequent reasons for over wearing lenses were forgetting which day to replace lenses (51%) and to save money (26%). Fifty-three percent believed that a reminder system would aid compliance; the most popular methods being a cell phone reminder or text message (29%) and a nominated day each week or month (26%). Discussions between the ECPs and the patients were more extensive for patients who were compliant with the MRRF.

Conclusions: ECPs recommended RFs more frequently with DD and 1M SH lenses than with 2W SH lenses, consistent with manufacturers' recommendations. Patients were less compliant with RF than ECPs for all lens types investigated. Patients were most compliant with RF when wearing DD lenses and least compliant when wearing 2W SH lenses. Better communication facilitated greater compliance with RF. More than half of those not replacing lenses, when recommended, reported that this was because they forgot which day to replace their lenses.

Comfort and adaptation to silicone hydrogel lenses for daily wear

Objectives. To investigate initial comfort and adaptation of currently successful low oxygen transmissibility soft lens wearers refitted with silicone hydrogel (SH) lenses for daily wear.

Methods. Fifty-five subjects were enrolled in a subject-masked 5-month clinical trial in which they wore 5 SH lenses in a randomized, crossover design. Comfort, burning, and dryness were rated on scales of 0 to 100 immediately on insertion and the time for lens settling was recorded. Symptoms were then rated at various times, using BlackBerry wireless communication devices (Research in Motion, Waterloo, Canada), during the day for 2 cycles of 2 weeks wear for each lens type.

Results. Comfort immediately on insertion varied between lens types (P=0.002). All lens types were reported by the subjects to have settled within 30 to 45 sec of insertion (P=0.14) and settled comfort was greater than comfort immediately on insertion (P<0.001). Comfort within the first hour of wear also varied between lens types (P=0.02). Comfort during the day decreased significantly for all lenses (P=0.001), but there was no difference between lenses (P=0.19) and no effect of lens age (P=0.15). The wearing times were greater with the SH lenses than the habitual lenses worn before study commencement (P=0.001). Overall performance of the lenses after 4 weeks was high, with no difference between lenses (P=0.45).

Conclusions. Initial comfort and adaptation to all SH lenses were good and no differences in the overall ratings were found between the 5 SH lenses investigated. Decreased comfort was noted later in the day with all lens types, but longer wearing times were reported with the SH lenses than previous hydroxyethyl methacrylate-based lenses.

Patient use of smartphones to communicate subjective data in clinical trials

Purpose. Various methods have been used in clinical trials to collect time-sensitive subjective responses, including study diaries, telephone interviews, and use of text messaging. However, all of these methods are limited by the uncertainty of when the participants enrolled in the study actually record their responses. This technical note reports on the utility of the BlackBerry smartphone to collect such data and why such a system provides advantages over other methods to report subjective ratings in clinical studies.

Methods. The Centre for Contact Lens Research developed an on-line web-enabled system that permits participants to record and immediately transmit subjective rating scores in numerical form directly into a web-enabled database. This, combined with the utility of BlackBerrys, enabled time-specific e-mail requests to be sent to the study participants and then for that data to be simultaneously transmitted to the web-enabled database. This system has been used in several clinical trials conducted at the Centre for Contact Lens Research, in which data were collected at various times and in several specific locations or environments.

Results. In the clinical trials conducted using this system, participants provided responses on 97.5% of occasions to the requests for data generated by the automated system. When the request was for data on a set date, this method resulted in responses of 84.1% of the time.

Conclusions. The series of clinical trials reported here show the benefits of the utilization of the BlackBerry to collect time- or environment-sensitive data via a web-enabled system.

Impact of climate change on thermal comfort and energy performance in offices - a parametric study

This paper investigates the impact of climate change on comfort and energy performance in offices in relation to the influence of building design and occupants. It focuses on a typical cellular office room in the context of Athens, Greece, as input for a parametric study using the building simulation software EnergyPlus. Three different building design variations are combined with two different occupant scenarios and 4 different weather data sets for IPCC climate change scenario A2.

For naturally ventilated buildings adaptive thermal comfort is evaluated according to ASHRAE Standard 55 and EN 15251. For mixed mode context evaluation is focused on greenhouse gas emissions and peak heating / cooling loads. Results indicate significant impact of the climate change on thermal comfort, and deviations between both comfort models. Comparing climate change, building design and occupant scenarios indicates that building design is the predominant influence on thermal comfort, whereas occupants are the predominant influence on greenhouse gas emissions.

Patient participation in symptom management in an acute oncology setting

Cancer and cancer treatments are associated with high symptom burden. Effective, safe and quality symptom management requires patient participation in symptom identification and treatment. This mixed methods, in depth investigation of symptom management practices uncovered patient, clinician and symptom factors that play a role in patients’ ability and willingness to participate.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in Canada

Purpose: To assess current recommendations by optometrists for replacement frequency (RF) of silicone hydrogels (SH) and daily disposable (DD) contact lenses in Canada, determine rates of non-compliance with recommendations by both the optometrist and patient, and investigate reasons for non-compliance.

Methods: Survey packages were sent to optometrists in Canada who had agreed to participate. Patients completed survey questions regarding demographics and contact lens wearing patterns, including recommended and actual contact lens RF. Optometrists were asked to provide lens information and their recommendation for RF. Fifty-eight optometrists returned 654 surveys, of which 578 were eligible for analysis.

Results: Seventy percent of patients were female with a median age of 32 years. Lens type distribution was 18% DD, 35% two-week SH, and 47% one-month SH. Six percent were worn for extended wear. Daily wear median wearing time was 12 hours/day, a median of five days/week for DD, seven days/week for SH (two-week and one-month). Optometrists’ recommendations were non-compliant with the manufacturers’ recommended RF for 6% of DD, 35% of two week, and 2% of one-month patients. Patients were non-compliant with recommendations from both the manufacturer and optometrist for 12% of DD, 43% of two-week, and 31% of one-month lens wearers. The most common reason for non-compliance was forgetting which day to replace lenses. Fifty-six percent thought a reminder system would help with compliance. A higher proportion of compliant patients followed the RF because of confidence in their optometrist.

Conclusions: Optometrists generally recommended RFs consistent with manufacturers’ recommendations for DD and one-month SH lenses but often recommended longer intervals for two-week SH lenses. Patients were most compliant when wearing DD lenses and least compliant when wearing two-week SH lenses. Communication between the patient and optometrists concerning the risks of non-compliance, or initiating a reminder system might improve compliance.

Designing for thermal comfort near a glazed exterior wall

In many highly glazed buildings, the thermal comfort of the occupants will tend to be related to the incoming solar energy and the heat transfer behaviour of the glazing. In this study, several glazing systems were designed using the software tools VISION 3 (University of Waterloo 1992) and WINDOW-6 (Lawrence Berkeley National Laboratory 2011), with a view to improving thermal environment of occupants near the glazed wall of a commercial office. The systems were fabricated and experimentally tested to validate the software modelling results. Subsequently, the glazing systems were retro-fitted to the office and tested in situ for a summer month. Results of this testing, in the form of Fangers’ predicted mean vote (PMV) and the predicted percentage dissatisfied (PPD), are presented, and some options for improving the thermal environment in this near-façade zone are discussed.

Patient and business rules extraction and formalisation using SVN and SBVR for automated healthcare

This paper describes advances in automated health service selection and composition in the Ambient Assisted Living (AAL) domain. We apply a Service Value Network (SVN) approach to automatically match medical practice recommendations to health services based on sensor readings in a home care context. Medical practice recommendations are extracted from National Health and Medical Research Council (NHMRC) guidelines. Service networks are derived from Medicare Benefits Schedule (MBS) listings. Service provider rules are further formalised using Semantics of Business Vocabulary and Business Rules (SBVR), which allows business participants to identify and define machine-readable rules. We demonstrate our work by applying an SVN composition process to patient profiles in the context of Type 2 Diabetes Management.