Suchergebnisse

ABSTRACTA pregnant woman was enrolled in a double‐blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention—whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision‐making. We review information about the benefits and harms of unblinding.

ABSTRACTOver recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in‐depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

Sharing data publicly can provide numerous benefits to the data owner, data user, as well as the social work research community as a whole. Given the time and resources required to collect data in randomized controlled trials, gleaning the maximum amount of information from this data is highly desirable. Data sets considered to be exhausted by the primary research team often have valuable information that can be used by researchers with different research interests or analytic skill sets. Sharing these data allows other researchers to use these data to answer their research questions without duplicating the data collection efforts. Sharing data can also increase attention to the work of the primary research team, with papers with open data receiving more citations than those without public data. Engaging in open science practices such as data sharing can lead research to be seen as more trustworthy and reliable.

Abstract
Background The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery.
Methods This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias.
Results From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding.
Conclusion Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.

This article discusses some of the lessons that our multidisciplinary team (spanning Economics, Education, Psychology, and Sociology) learned from implementing randomized controlled trials (RCTs) to assess the impact of metacognitive training on outcomes of Black female college students. Because our data collection is ongoing, the purpose of this article is to describe the collaborative efforts required to make such a project a success and share lessons learned. Future papers will focus on the quantitative findings of the RCTs by looking at the impacts on outcomes such as metacognitive awareness, grade point average, and retention.

[Kurzzusammenfassung] Zahlreiche Studien haben nachgewiesen, dass Energiesparbriefe in den USA eine kosteneffektive nicht-preisbasierte Intervention zur Reduktion von Haushaltsstromverbräuchen darstellen. Basierend auf diesen Erkenntnissen geht dieses Forschungsprojekt der Frage nach, ob die Versendung von Energiesparbriefen auch in Deutschland ein geeignetes nicht-preisbasiertes Politikinstrument sein könnte. Basierend auf Daten von rund 140.000 Haushalten werden anhand eines Randomized Controlled Trials zwei Ausgestaltungen von Energiesparbriefen untersucht: Infobriefe, die den Wissensstand und die Aufmerksamkeit der Haushalte zum Thema Energiesparen erhöhen sollen, und Briefe, die zusätzlich soziale Vergleiche enthalten. Zudem untersucht diese Studie, ob die angesprochene Motivation zum Energiesparen (das "Framing") eine Auswirkung auf die Einspareffekte hat. Um die Eignung als Politikinstrument zu beurteilen, wird auf Basis der durchschnittlichen Stromeinsparungen die Kosteneffektivität der Maßnahmen zur Reduktion von CO2-Emissionen geschätzt. Die Ergebnisse dieser Studie zeigen, dass sowohl die Informationsbriefe als auch die Briefe mit sozialem Vergleich im Durchschnitt relativ geringe Einspareffekte aufweisen. Auch die Variation der angesprochenen Motivation zum Energiesparen führt nicht zu höheren Einspareffekten. Selbst unter vorteilhaften Annahmen liegen die geschätzten CO2-Vermeidungskosten der Briefe im Durchschnitt sehr hoch, sodass die Intervention eine geringe Kosteneffektivität aufweist. Im Resultat ist daher von einer flächendeckenden Einführung von Energiesparbriefen in Deutschland abzuraten. Obwohl die Ergebnisse dieser Studie auch zeigen, dass die Versendung von Energiesparbriefen an ausgewählte Kundengruppen durchaus kosteneffektiv sein kann, ist insgesamt selbst bei einer zielgerichteten Anwendung durch Energiesparbriefe kein erheblicher aggregierter Stromeinspareffekt für Deutschland zu erwarten. Wichtige Gründe für die geringe Kosteneffektivität der Maßnahme liegen in dem deutlich geringeren durchschnittlichen Verbrauch deutscher Haushalte im Vergleich zu US-amerikanischen Haushalten. Darüber hinaus kann davon ausgegangen werden, dass Haushalte in den USA höhere Einsparpotenziale aufweisen. Zudem begünstigen die Rahmenbedingungen in den USA die Effektivität von Energiesparbriefen. Dieses Forschungsprojekt stellt ein weiteres Beispiel dafür dar, wie mit Hilfe moderner Evaluationsmethoden robuste Ergebnisse über tatsächliche Effekte von Maßnahmen ermittelt werden können, auf deren Basis politische Entscheidungsträger informiert Entscheidungen treffen können. Eine systematische Evaluation von Maßnahmen erscheint in vielen Anwendungsfällen, insbesondere im Bereich des Energiesparens, praktikabel und sinnvoll, damit am Ende dort Ressourcen investiert werden, wo sie den größten Nutzen (in diesem Fall für den Klimaschutz) stiften. ; Endbericht - Februar 2017. Forschungsprojekt gefördert durch die Stiftung Mercator.

Purpose. To compare the effects of nut-based snack bars (NBSB) vs. prepackaged 200-kcal portions of typical conventional snack foods, when consumed over a 12-week period by a group of overweight adults. Design. Randomized, single-blind parallel design with two treatment groups. Setting. Clinical trial. Subjects. Thirty-four overweight participants were enrolled. Intervention. Commercially available NBSB or conventional snack foods as part of an ad libitum diet for 12 weeks. Measures. Primary outcome measures: body mass index, body weight, body composition, waist circumference. Secondary outcome measures: blood pressure, lipid profile, nutrients intake, hunger/satiety, quality of life. Analysis. Generalized linear models with time as repeated measure were used to analyze these data. Results. Daily consumption of NBSB for 12 weeks, as compared to daily consumption of conventional snacks, significantly reduced percentage body fat (−1.7% ± 10.8% vs. 6.2% ± 9.3%; p = .04) and visceral fat (−1.3 ± 5.9 vs. 2.7 ± 4.0; p = .03). There were no between-group differences (p > .05) for blood pressure, lipid panel, satiety, or quality of life measures. Conclusion. Our data suggest that daily consumption of NBSB for 12 weeks reduced body fat and had no adverse effects on weight, blood pressure, lipid profile, satiety, or quality of life in this small sample of overweight adults.

Background: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training — concomitant with lifestyle counselling — as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus). Methods/Design: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at followup. We estimate to recruit 35 participants per group. Discussion: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle. Trial registration: Clinical trials.gov. NTC02832453. Registered 6 July 2016 (retrospectively registered). ; The study has been peer-reviewed (blinded) and quoted (6.4/7) by the AGAUR (Agency for Management of University and Research Grants) of the government of Catalonia (Generalitat de Catalonia). GE has been granted for hers' participation to the study as a PhD student. (Ref: 2014-PINEF-00003. PRE/2448/2014, de 30 October, DOGC num 6743–5.11.2014). This funding source had no role in the design of this study and will not have any role during its execution, analyses or interpretation of the data. The study is mainly supported by the National Institute of Physical Education (INEFC)-Centre de Lleida. The funding covers central organisation, design, management, assessments, and analysis and reporting of the study. INEFC has also provided funding's to support the printing of educational resources (Funding's to research-2015) and partially blood analysis reagents (Funding's to research-2016). The Catalonian Health Institute (ICS) provides the setting for the counselling sessions and supports recruitment, phlebotomy and general blood analysis. Ekke's sport centre (local sport centre) provides the setting and the necessary equipment for the physical exercise sessions. The department of Experimental Medicine of the University of Lleida supports blood specimens' storage and metabolomics/lipidomics and miRNA blood analysis. The Primary Care Research Institute (IDIAP) Jordi Gol provides support for the randomization and statistical analysis of data. The Development of Healthy Organizations and Territories (DOTS) group of the University of LLeida and the Diputació de Lleida provided funding's to support partially miRNA blood analysis and the execution of physical activity sessions (Funding to research 25-07-2016).

AbstractThrough a randomized controlled trial, we test whether providing personalized case management alongside emergency financial assistance more effectively prevents homelessness than financial assistance alone. For a sample of young adults and families with children who are at risk of homelessness, our results indicate that participants assigned to case management and financial assistance are more likely to access other homeless programs and no less likely to be evicted. Downstream outcomes are mostly unchanged, though arrests increase. Using non‐experimental variation across staff, we find that case management is associated with better outcomes when it is more intensive and pays financial assistance quickly.