Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings

2019 ◽  
Vol 17 (2) ◽  
pp. 129-137
Author(s):  
Susanne May ◽  
Siobhan P Brown ◽  
Robert H Schmicker ◽  
Scott S. Emerson ◽  
Evangelyn Nkwopara ◽  
...  
Keyword(s):  
Confidence Intervals ◽  
Type I Error ◽  
Cost Effective ◽  
Type I ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
New Treatment ◽  
Intent To Treat ◽  
Design Options

Background/aims: After a new treatment is recommended to be first-line treatment for a specific indication, outcome and population, it may be unethical to use placebo as a comparator in trials for that setting. Nevertheless, in specific circumstances, use of a placebo group might be warranted, for example, when it is believed that an active treatment may not be efficacious or cost-effective for a specific subpopulation. An example is antibiotic treatment for pneumonia, which may not be effective for many patients taking it due to the emergence of antibiotic-resistant strains or the high prevalence of viral and low prevalence of bacterial pneumonia. Methods: We explore the applicability of different design options in cases where the benefit of an established treatment is questioned, with particular emphasis on issues that arise in a low-resource setting. Using the example of a clinical trial comparing the effectiveness of placebo versus amoxicillin in treating children 2–59 months of age with fast breathing pneumonia in Lilongwe, Malawi, we discuss the pros and cons of superiority versus non-inferiority designs, an intent-to-treat versus as-treated analysis and the use and interpretation of one- versus two-sided confidence intervals. Results: We find that a non-inferiority design using an intent-to-treat analysis is the most appropriate design and analysis option. In addition, the presentation of one- versus two-sided confidence intervals can depend on the results but can maintain type I error. Conclusion: In the setting where the benefit of a previously established beneficial treatment is questioned, a non-inferiority design that includes placebo as the tested treatment option can be the most appropriate design option.

scholarly journals Predictive and prognostic relevance of immunohistochemical testing of estrogen and progesterone receptors in breast cancer in South East Nigeria: A review of 417 cases

Rare Tumors ◽  
2021 ◽  
Vol 13 ◽  
pp. 203636132110063
Author(s):  
Martin Nzegwu ◽  
Joseph Uzoigwe ◽  
Babatunde Omotowo ◽  
Anthony Ugochukwu ◽  
Benjamin Ozumba ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ductal Carcinoma ◽  
Age Groups ◽  
Progesterone Receptors ◽  
Cost Effective ◽  
Chemotherapeutic Agents ◽  
Southeastern Nigeria ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting

ER/PgR testing are now routinely performed in breast cancer evaluation in Southeastern Nigeria. ER is predictive to show beneficiaries of hormonal therapy and a prognostic marker to establish tumors that will resist paclitaxel induced apoptosis so a cost effective combination of anthracylines can be used as treatment in our low resource setting thus improving survival, reducing recurrence, and cost. Four hundred seventeen cases of breast cancer seen over a period of 3 years were routinely tested for ER/PgR. ER positivity was defined as nuclear positivity of 1% in the presence of internal and external controls. Four hundred seventeen patients with Ductal Carcinoma participated. Majority were females 98.3%. Majority 60.2% were between 31 and 50 years old. Mean age was 33.5 ± 6.4 years. Two hundred fifty-seven (61.6%) were positive both for ER/PgR. 70.3% of age group 41–50 years had positive ER, age groups 20–30, and >70 years had positive ER also. ER positive cancer was 60.2%. Fifty-seven were 1%–9% positive. Most positive estrogen receptors were seen between 41 and 50 years at 70.3%. Least was seen at 31–40 years at 51.4%. Study provides an objective basis for using hormonal manipulation and makes cost affordable with appropriate chemotherapeutic agents in our low resource setting. Presentations were typically late. Seventy-six percent of stage 2 disease survived after 6 years compared with only 56% of stage 2 disease prior to immunotyping and radiotherapy in 2007. Both stage 3 and 4 had remarkable survival too at 55% and 33% respectively when compared with 2007 figures at 33% for stage 3 and 9.2% at stage 4.

scholarly journals Short Stay Thyroid Surgery: Can We Replicate the Same in Low Resource Setting?

2018 ◽  
Vol 2018 ◽  
pp. 1-5
Author(s):  
Naval Bansal ◽  
Sanjay Kumar Yadav ◽  
Saroj Kanta Mishra ◽  
Kamal Kishore ◽  
Anjali Mishra ◽  
...  
Keyword(s):  
Thyroid Surgery ◽  
Subgroup Analysis ◽  
Cost Effective ◽  
Complication Rates ◽  
Short Stay ◽  
Inclusion Criteria ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Significant Difference

Introduction. The concept of short stay thyroidectomy has been tested and in practice in the developed world; the same has not been replicated in countries with limited resources due to lack of organized healthcare system. So, in this study, we tried to analyze if short stay thyroid surgery can be performed in a cost-effective way in developing countries and also if the endocrine surgical trainee can deliver these services safely. Methods. The study was conducted prospectively from January 2013 to July 2014, at Department of Endocrine Surgery, SGPGIMS, Lucknow, India. Study group included patients undergoing short stay hemithyroidectomy whereas matched patients who qualified for inclusion criteria but did not undergo short stay surgery due to various reasons constituted control group. Outcome in both the groups was compared in terms of complication rates, cost benefit, and patient satisfaction. Subgroup analysis was also done for trainee versus consultant performed short stay thyroid surgery. Results. A total of 439 patients with surgical thyroid disorders were evaluated at our institute during the study period and out of these 110 patients (58 cases and 52 controls) fulfilled the inclusion criteria. Younger patients with low socioeconomic status who were paying out of pocket were found to be more inclined to short stay thyroid surgery. There was no significant difference between the two groups in terms of postanesthetic discharge score (PADS), complication rates, and patients satisfaction; however there was significant reduction (p <0.001) in hospital cost in short stay group. In subgroup analysis, procedure time was more in trainee performed surgeries; however there was no significant difference in terms of mean PADS and complication rates. Conclusion. Short stay thyroidectomy can provide a better cost-effective alternative to conventional thyroidectomy in patients undergoing thyroid surgery and can be safely performed by endocrine surgical trainees even in a low resource setting.

Evaluation of a New Protocol of Insulin Dose Adjustment in a Low-Resource Setting

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 93-LB
Author(s):  
EDDY JEAN BAPTISTE ◽  
PHILIPPE LARCO ◽  
MARIE-NANCY CHARLES LARCO ◽  
JULIA E. VON OETTINGEN ◽  
EDDLYS DUBOIS ◽  
...  
Keyword(s):  
Dose Adjustment ◽  
Insulin Dose ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting

scholarly journals Right paraduodenal hernia with extensive bowel gangrene treated with staged surgery: a Bogota bag followed by resection in a low-resource setting

2021 ◽  
Vol 14 (4) ◽  
pp. e239250
Author(s):  
Vijay Anand Ismavel ◽  
Moloti Kichu ◽  
David Paul Hechhula ◽  
Rebecca Yanadi
Keyword(s):  
Plastic Material ◽  
Successful Outcome ◽  
Paraduodenal Hernia ◽  
Transparent Plastic ◽  
Low Resource ◽  
Entire Small Bowel ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Right Paraduodenal Hernia ◽  
Bowel Gangrene

We report a case of right paraduodenal hernia with strangulation of almost the entire small bowel at presentation. Since resection of all bowel of doubtful viability would have resulted in too little residual length to sustain life, a Bogota bag was fashioned using transparent plastic material from an urine drainage bag and the patient monitored intensively for 18 hours. At re-laparotomy, clear demarcation lines had formed with adequate length of viable bowel (100 cm) and resection with anastomosis was done with a good outcome on follow-up, 9 months after surgery. Our description of a rare cause of strangulated intestinal obstruction and a novel method of maximising length of viable bowel is reported for its successful outcome in a low-resource setting.

scholarly journals Humanitarian Surgical Missions in Times of COVID-19: Recommendations to Safely Return to a Sub-Saharan Africa Low-Resource Setting

2021 ◽  
Author(s):  
Víctor Lopez-Lopez ◽  
Ana Morales ◽  
Elisa García-Vazquez ◽  
Miguel González ◽  
Quiteria Hernandez ◽  
...  
Keyword(s):  
Sub Saharan Africa ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Sub Saharan

scholarly journals Vulvar cancer: surgical management and survival trends in a low resource setting

2020 ◽  
Vol 32 (1) ◽  
Author(s):  
Navin Kumar ◽  
Mukur Dipi Ray ◽  
D. N. Sharma ◽  
Rambha Pandey ◽  
Kanak Lata ◽  
...  
Keyword(s):  
Surgical Management ◽  
Vulvar Cancer ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting

Multi-level Chunk-based Constituent-to-Dependency Treebank Transformation for Tibetan Dependency Parsing

2021 ◽  
Vol 20 (2) ◽  
pp. 1-12
Author(s):  
Shumin Shi ◽  
Dan Luo ◽  
Xing Wu ◽  
Congjun Long ◽  
Heyan Huang
Keyword(s):  
Language Processing ◽  
Manual Annotation ◽  
Syntactic Parsing ◽  
Dependency Parsing ◽  
Low Resource ◽  
Resource Setting ◽  
Dependency Tree ◽  
Low Resource Setting ◽  
Novel Method ◽  
Multi Level

Dependency parsing is an important task for Natural Language Processing (NLP). However, a mature parser requires a large treebank for training, which is still extremely costly to create. Tibetan is a kind of extremely low-resource language for NLP, there is no available Tibetan dependency treebank, which is currently obtained by manual annotation. Furthermore, there are few related kinds of research on the construction of treebank. We propose a novel method of multi-level chunk-based syntactic parsing to complete constituent-to-dependency treebank conversion for Tibetan under scarce conditions. Our method mines more dependencies of Tibetan sentences, builds a high-quality Tibetan dependency tree corpus, and makes fuller use of the inherent laws of the language itself. We train the dependency parsing models on the dependency treebank obtained by the preliminary transformation. The model achieves 86.5% accuracy, 96% LAS, and 97.85% UAS, which exceeds the optimal results of existing conversion methods. The experimental results show that our method has the potential to use a low-resource setting, which means we not only solve the problem of scarce Tibetan dependency treebank but also avoid needless manual annotation. The method embodies the regularity of strong knowledge-guided linguistic analysis methods, which is of great significance to promote the research of Tibetan information processing.

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