Cost-benefit analysis: The ``gold standard'' re-examined

The dissertation reviews the recommendations of the Panel on Cost Effectiveness in Health and Medicine (Panel) convened by the US Public Health Service in 1993 in four areas: aggregation of costs and benefits, methods of estimating resources used, definition of population impacted and perspective used in cost benefit analysis. Financial data from a clinical trial was used to test whether different approaches in each of the above four areas would change the net benefit resulting from a cost benefit analysis. Differences in aggregation of cost and benefit resulted in the same net benefit, but not the same cost/benefit ratios. Differences in resource use estimation methods, population subgroups definitions and perspectives all produced different net benefits. Difference in perspective resulted in different and often opposing decisions as to whether the proposed intervention from the clinical trial should be implemented. ^

Design and Realization of an Energy Harvester Using Pulsating Arterial Pressure

Most medical implants run on batteries, which require costly and tedious replacement or recharging. It is believed that micro-generators utilizing intracorporeal energy could solve these problems. However, such generators do not, at this time, meet the energy requirements of medical implants.This paper highlights some essential aspects of designing and implementing a power source that scavenges energy from arterial expansion and contraction to operate an implanted medical device. After evaluating various potentially viable transduction mechanisms, the fabricated prototype employs an electromagnetic transduction mechanism. The artery is inserted into a laboratory-fabricated flexible coil which is permitted to freely deform in a magnetic field. This work also investigates the effects of the arterial wall's material properties on energy harvesting potential. For that purpose, two types of arteries (Penrose X-ray tube, which behave elastically, and an artery of a Göttinger minipig, which behaves viscoelastically) were tested. No noticeable difference could be observed between these two cases. For the pig artery, average harvestable power was 42 nW. Moreover, peak power was 2.38 μW. Both values are higher than those of the current state of the art (6 nW/16 nW). A theoretical modelling of the prototype was developed and compared to the experimental results.

Ultra-early intravenous stroke thrombolysis: do all patients benefit similarly?

BACKGROUND AND PURPOSE We previously reported increased benefit and reduced mortality after ultra-early stroke thrombolysis in a single center. We now explored in a large multicenter cohort whether extra benefit of treatment within 90 minutes from symptom onset is uniform across predefined stroke severity subgroups, as compared with later thrombolysis. METHODS Prospectively collected data of consecutive ischemic stroke patients who received i.v. thrombolysis in 10 European stroke centers were merged. Logistic regression tested association between treatment delays, as well as excellent 3-month outcome (modified Rankin scale, 0-1), and mortality. The association was tested separately in tertiles of baseline National Institutes of Health Stroke Scale. RESULTS In the whole cohort (n=6856), shorter onset-to-treatment time as a continuous variable was significantly associated with excellent outcome (P<0.001). Every fifth patient had onset-to-treatment time≤90 minutes, and these patients had lower frequency of intracranial hemorrhage. After adjusting for age, sex, admission glucose level, and year of treatment, onset-to-treatment time≤90 minutes was associated with excellent outcome in patients with National Institutes of Health Stroke Scale 7 to 12 (odds ratio, 1.37; 95% confidence interval, 1.11-1.70; P=0.004), but not in patients with baseline National Institutes of Health Stroke Scale>12 (odds ratio, 1.00; 95% confidence interval, 0.76-1.32; P=0.99) and baseline National Institutes of Health Stroke Scale 0 to 6 (odds ratio, 1.04; 95% confidence interval, 0.78-1.39; P=0.80). In the latter, however, an independent association (odds ratio, 1.51; 95% confidence interval, 1.14-2.01; P<0.01) was found when considering modified Rankin scale 0 as outcome (to overcome the possible ceiling effect from spontaneous better prognosis of patients with mild symptoms). Ultra-early treatment was not associated with mortality. CONCLUSIONS I.v. thrombolysis within 90 minutes is, compared with later thrombolysis, strongly and independently associated with excellent outcome in patients with moderate and mild stroke severity.

Limited clinical benefit of minority K103N and Y181C-variant detection in addition to routine genotypic resistance testing in antiretroviral therapy-naive patients

OBJECTIVE: The presence of minority nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant HIV-1 variants prior to antiretroviral therapy (ART) has been linked to virologic failure in treatment-naive patients. DESIGN: We performed a large retrospective study to determine the number of treatment failures that could have been prevented by implementing minority drug-resistant HIV-1 variant analyses in ART-naïve patients in whom no NNRTI resistance mutations were detected by routine resistance testing. METHODS: Of 1608 patients in the Swiss HIV Cohort Study, who have initiated first-line ART with two nucleoside reverse transcriptase inhibitors (NRTIs) and one NNRTI before July 2008, 519 patients were eligible by means of HIV-1 subtype, viral load and sample availability. Key NNRTI drug resistance mutations K103N and Y181C were measured by allele-specific PCR in 208 of 519 randomly chosen patients. RESULTS: Minority K103N and Y181C drug resistance mutations were detected in five out of 190 (2.6%) and 10 out of 201 (5%) patients, respectively. Focusing on 183 patients for whom virologic success or failure could be examined, virologic failure occurred in seven out of 183 (3.8%) patients; minority K103N and/or Y181C variants were present prior to ART initiation in only two of those patients. The NNRTI-containing, first-line ART was effective in 10 patients with preexisting minority NNRTI-resistant HIV-1 variant. CONCLUSION: As revealed in settings of case-control studies, minority NNRTI-resistant HIV-1 variants can have an impact on ART. However, the sole implementation of minority NNRTI-resistant HIV-1 variant analysis in addition to genotypic resistance testing (GRT) cannot be recommended in routine clinical settings. Additional associated risk factors need to be discovered.

Benefit of a Contralateral Routing of Signal Device for Unilateral Cochlear Implant Users.

Objective: To investigate objective and subjective effects of an adjunctive contralateral routing of signal (CROS) device at the untreated ear in patients with a unilateral cochlear implant (CI). Design: Prospective study of 10 adult experienced unilateral CI users with bilateral severe-to-profound hearing loss. Speech in noise reception (SNR) and sound localization were measured with and without the additional CROS device. SNR was measured by applying speech signals at the untreated/CROS side while noise signals came from the front (S90N0). For S0N90, signal sources were switched. Sound localization was measured in a 12-loudspeaker full circle setup. To evaluate the subjective benefit, patients tried the device for 2 weeks at home, then filled out the abbreviated Speech, Spatial and Qualities of Hearing Scale as well as the Bern benefit in single-sided deafness questionnaires. Results: In the setting S90N0, all patients showed a highly significant SNR improvement when wearing the additional CROS device (mean 6.4 dB, p < 0.001). In the unfavorable setting S0N90, only a minor deterioration of speech understanding was noted (mean -0.66 dB, p = 0.54). Sound localization did not improve substantially with CROS. In the two questionnaires, 12 of 14 items showed an improvement in mean values, but none of them was statistically significant. Conclusion: Patients with unilateral CI benefit from a contralateral CROS device, particularly in a noisy environment, when speech comes from the CROS ear side. © 2014 S. Karger AG, Basel.

Die Rolle des Benefit-Finding für die Qualität der Anpassung an das Leben nach dem Spitzensport

Die Lebensereignisforschung postuliert, dass die Anpassung an eine durch ein kritisches Ereignis veränderte Situation durch Benefit-Finding gefördert wird, indem Menschen Gewinnbringendes für ihr Leben erkennen (Filipp & Aymanns, 2010). Während in der frühen Forschung zum oft als kritisches Lebensereignis beschriebenen Karriereende im Spitzensport Benefit-Finding mitbedacht wurde, wird es in der aktuellen Forschung nur punktuell berücksichtigt (z.B. Curtis & Ennis, 1988, Wippert, 2011). Basierend auf dem Konzept Kritisches Lebensereignis (Filipp, 1995) untersucht die vorliegende Studie die Rolle des Benefit-Finding für die kurz-, mittel- und langfristige Qualität der Anpassung an das Karriereende. Methods: 290 Schweizer Spitzenathleten (Frauenanteil: 32.8%) aus 64 Sportarten wurden etwa 7.46 Jahre nach ihrem Karriereende mittels Fragebogen zum Benefit-Finding, Erleben des Karriereendes, zur Dauer und subjektiven Qualität der Anpassung an das Karriereende sowie zum psychischen Wohlbefinden befragt. Die Datenauswertung erfolgte mittels Strukturgleichungsmodellierung. Results: Das Modell zur Vorhersage der langfristigen Anpassungsqualität (psychische Wohlbefinden) an das Karriereende mit einer Varianzaufklärung von R2 = .26 passt recht gut zu den Daten (χ2 = 114.764, p ≤ .001, df = 56, CFI = .93, SRMR = .06, RMSEA = .06; AGFI = .91). Wie postuliert, hat das Ausmass von Benefit-Finding einen – über die kurz- und mittelfristige Anpassungsqualität (positive Emotionen, Anpassungsdauer und subjektive Anpassungsqualität) – vermittelten Effekt auf das psychische Wohlbefinden im Leben nach dem Spitzensport. Discussion/Conclusion: Das Konzept Kritisches Lebensereignis kristallisierte sich als zielführender Ansatz für die Analyse von zusammenwirkenden Faktoren hinsichtlich Qualität der Anpassung an das Leben nach dem Spitzensport heraus. Die Befunde indizieren, dass sportpsychologische Interventionen mit Fokus auf Benefit-Finding, zusammen mit anderen Elementen der gängigen Career-Assistance-Programme, kurzfristig für eine gelingende Transition und langfristig ein günstiges psychisches Wohlbefinden sinnvoll sind. References: Curtis, J. & Ennis, R. (1988). Negative consequences of leaving competitive sport? Comparative findings for former elite-level hockey players. Sociology of Sport Journal, 5, 87-106. Filipp, S.-H. (Hrsg.) (1995). Kritische Lebensereignisse (3. Aufl.). Weinheim: Beltz. Filipp, S.-H. & Aymanns, P. (2010). Kritische Lebensereignisse und Lebenskrisen. Vom Umgang mit den Schattenseiten des Lebens. Stuttgart: Kohlhammer. Wippert, P.-M. (2011). Kritische Lebensereignisse in Hochleistungsbiografien. Untersuchungen an Spitzensportlern, Tänzern und Musikern. Lengerich: Pabst.

“Therapeutic Advertising”: When Do Female Consumers Really Benefit?

This research examines whether female consumers benefit from brand strategies that attempt to decrease their self-discrepancies by setting more realistic ideals (i.e., therapeutic advertising, such as Body Shop, Aerie, and Always). The results of our preliminary study reveal that therapeutic advertising leads to stronger self-conscious emotions than idealistic advertising. More specifically, it leads to stronger emotions of both pride and shame. However, the latter only holds true for female consumers low in self-liking and high difficulties in abandoning unattainable goals. Female consumers who like themselves and are able to abandon unattainable goals do not feel more ashamed when being exposed to therapeutic advertising compared to idealized advertising. These findings have implications for marketing managers and policy makers.

Clinical benefit response in pancreatic cancer trials revisited.

OBJECTIVES Clinical benefit response (CBR), based on changes in pain, Karnofsky performance status, and weight, is an established palliative endpoint in trials for advanced gastrointestinal cancer. We investigated whether CBR is associated with survival, and whether CBR reflects a wide-enough range of domains to adequately capture patients' perception. METHODS CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer (n = 311) in parallel with patient-reported outcomes (PROs). RESULTS The median time to treatment failure was 3.4 months (range: 0-6). The majority of the CBRs (n = 39) were noted in patients who received chemotherapy for at least 5 months. Patients with CBR (n = 62) had longer survival than non-responders (n = 182) (hazard ratio = 0.69; 95% confidence interval: 0.51-0.94; p = 0.013). CBR was predicted with a sensitivity and specificity of 77-80% by various combinations of 3 mainly physical PROs. A comparison between the duration of CBR (n = 62, median = 8 months, range = 4-31) and clinically meaningful improvements in the PROs (n = 100-116; medians = 9-11 months, range = 4-24) showed similar intervals. CONCLUSION CBR is associated with survival and mainly reflects physical domains. Within phase III chemotherapy trials for advanced gastrointestinal cancer, CBR can be replaced by a PRO evaluation, without losing substantial information but gaining complementary information.