Many non-inferiority trials of a test treatment versus an active control may also, if ethical, incorporate a placebo arm. Inclusion of a placebo arm enables a direct assessment of assay sensitivity. It also allows construction of a non-inferiority test that avoids the problematic specification of an absolute non-inferiority margin, and instead evaluates whether the test treatment preserves a pre-specified proportion of the effect of the active control over placebo. We describe a two-stage procedure for sample size recalculation in such a setting that maintains the desired power more closely than a fixed sample approach when the magnitude of the effect of the active control differs from that anticipated. We derive an allocation rule for randomization under which the procedure preserves the type I error rate, and show that this coincides with that previously presented for optimal allocation of the sample size among the three treatment arms. 相似文献
This is a randomised controlled pilot study using a mixed methods design. The overall aim was to test an educational intervention on existential issues and to describe surgical nurses’ perceived attitudes towards caring for patients dying of cancer. Specific aims were to examine whether the educational intervention consisting of lectures and reflective discussions, affects nurses’ perceived confidence in communication and to explore nurses’ experiences and reflections on existential issues after participating in the intervention. Forty‐two nurses from three surgical wards at one hospital were randomly assigned to an intervention or control group. Nurses in both groups completed a questionnaire at equivalent time intervals: at baseline before the educational intervention, directly after the intervention, and 3 and 6 months later. Eleven face‐to‐face interviews were conducted with nurses directly after the intervention and 6 months later. Significant short‐term and long‐term changes were reported. Main results concerned the significant long‐term effects regarding nurses’ increased confidence and decreased powerlessness in communication, and their increased feelings of value when caring for a dying patient. In addition, nurses described enhanced awareness and increased reflection. Results indicate that an understanding of the patient's situation, derived from enhanced awareness and increased reflection, precedes changes in attitudes towards communication. 相似文献
Summary In an attempt to improve the primary treatment of malignant gliomas we used a concomitant 6-week course of chemoradiotherapy with 5 fluorouracil (5 FU) and hydroyxurea (HU) in 24 adults with anaplastic astrocytoma (AA) (7 cases) or glioblastomas (GLB) (17 cases). This patient population was characterised by a poor prognostic profile; 50% of cases had biopsic or subtotal surgery and 70% had GLB. Patients received 2 Gy/day 18 MV photons with 300m2 of 5 FU in continuous infusion and 500 mg x 4/day per os of HU, five days per week during 6 weeks. Treatment was poorly tolerated in terms of toxicity and implied heavy logistics (hospitalization, central venous access) worsening the quality of life which is already bad in malignant gliomas. Unfortunately we did not improve median survival which does not exceed 26 weeks with 7 long survivors (> 49 weeks). This pilot study does not offer any benefits over current standard approaches. Aggressive locoregional approaches such as this should perhaps be attempted in patients with a better profile. 相似文献
Purpose: To develop and implement mechanisms to collect, report, and assess the World Health Organization (WHO) core eye health indicators in Chile, Honduras, Mexico, Peru, and Uruguay.
Methods: Simple templates for a situational analysis (of data collection and reporting processes), a national data collection strategy, and a national work plan to implement the core eye health indicators were developed. Public and private sector representatives from the ministries of health (MOHs), national vision committees, and national societies of ophthalmology of each country used these tools with 2013 baseline data to improve their data collection processes and collected 2015 data. Final analysis and cross-validation were performed using intraocular lens sales data and last observation carried forward imputation.
Results: Study tools were effectively implemented in all five countries and resulted in improved intersectoral stakeholder collaboration and communications, which improved the data collection and reporting processes. More complete and accurate data were reported by 2015 compared to the 2013 baseline.
Conclusions: Multisectoral stakeholders, including national professional societies and national vision committees, should collaborate with MOHs to improve the quality of data that are reported to WHO. This study involved these stakeholders in the data collection processes to better understand the realities of indicator implementation, better manage their expectations, and improve data quality. WHO Member States across the globe can feasibly adapt the study tools and methodologies to strengthen their data collection processes. Overall, the reliability and validity of the indicators is hampered with limitations that prevent fully accurate data from being collected. 相似文献
Objective: With increasing survival rates, breast cancer is now considered a chronic condition necessitatinginnovative care to meet the long-term needs of survivors. This paper presents the findings of a pilot study onself-management for women diagnosed with breast cancer and their implications for Asian health care providers.Methods: A pre-test/ post-test pilot study was conducted to gain preliminary insights into program feasibilityand barriers to participation, and to provide justification for a larger trial. Results: The study found the 4 weekself management program feasible and acceptable, with a favourable trend in quality of life. The recruitmentbarriers ranged from competing medical appointments, uncollaborative health providers, linguistic barriersand social-household concerns. Supporting facilitators identified were family, health professionals and fellowparticipants (“buddies”). Lessons from the study are discussed with regard to Asian health providers. Conclusion:There is preliminary evidence that self management is a workable and potentially useful model even in an Asiansentrenched-hierarchical medical model of care. The initial challenge was breaking down barriers in acceptanceeof a collaborative stance. A clinical trial is now warranted to gather more evidence. 相似文献
In organized cervical screening programs, typically 25% of the invited women do not attend. The Copenhagen Self‐sampling Initiative (CSi) aimed to gain experiences on participation among screening nonattenders in the Capital Region of Denmark. Here, we report on the effectiveness of different communication platforms used in the pilot with suggestions for strategies prior to a full‐implementation. Moreover, an innovative approach using self‐sampling brushes with unique radio frequency identification chips allowed for unprecedented levels patient identification safety. Nonattenders from the capital region of Denmark were identified via the organized national invitation module. Screening history was obtained via the nationwide pathology registry. Twenty‐four thousand women were invited, and as an alternative to the regular communication platforms (letter and phone), women could request a home test via a mobile‐friendly webpage. Instruction material and video‐animation in several languages were made available online. Chi‐square test was used to test differences. Out of all invited, 31.7% requested a home test, and 20% returned it to the laboratory. In addition, 10% were screened at the physician after receiving the invitation. Stratified by screening history, long‐term unscreened women were less likely to participate than intermittently screened women (28% vs. 16%, p < 0.001). Of all contacts received, 64% (63–65) came via letter, and 31% (95CI: 30–32%) via webpage/mobile‐app. Self‐sampling was well‐accepted among nonattenders. Adopting modern technology‐based platforms into the current organized screening program would serve as a convenient communication method between health authority and citizens, allowing easy access for the citizen and reducing the work load in administrating self‐sampling approaches. 相似文献