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Clinical research study write up steps and answers

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The article is: Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial

By: J P Neoptolemos, J A Dunn, D D Stocken, J Almond, K Link, H Beger, C Bassi, M Falconi, P Pederzoli, C Dervenis, L Fernandez-Cruz, F Lacaine, A Pap, D Spooner, D J Kerr, H Friess, M W Büchler for the members of the European Study Group for Pancreatic Cancer

THE LANCET - Vol 358 - November 10, 2001

Using descriptive and ANOVA statistical methods, please provide input / critique of the journal article in the following areas:

Description of the problem under study
The participants and relevant characteristics
A description of the research design
Findings with appropriate significance levels
Conclusion and implications for future research and/or applied work
literature review that establishes the nature of the problem to be addressed in the present study
Purpose of the present study
Specific hypotheses or research questions to be addressed.
The participants and the population they are intended to represent
The number of participants and how the participants were selected
How the research design was executed. Can it be replicated?
Description of the measures used
Description of the results of all statistical tests
If there are tables and figures, are they also described in the text
If there are tables and figures, can they be interpreted "stand alone"
A simple and easy to understand summary of what was found
The limitations of the study
Was the study worthwhile?
Was it well-written and clear to those who may not have as much background in the content area or in statistical design?

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Solution Preview

Description of the problem under study
Study is on investigating the role of adjuvant treatment in pancreatic cancer

The participants and relevant characteristics
541 eligible patients with pancreatic ductal adenocarcinoma were randomized: 285 in the two-by-two factorial design (70 chemo-radiotherapy, 74 chemotherapy, 72 both, 69 observation); a further 68 patients were randomly assigned chemo-radiotherapy or no chemo-radiotherapy and 188 chemotherapy or no chemotherapy.

This paper reports the first planned look at the data at the time the study closed to recruitment (314 events).

A description of the research design
This study had a randomized two-by-two factorial design.

Findings with appropriate significance levels
There was evidence of a survival benefit for adjuvant chemotherapy (median survival 19.7 months in 238 patients with chemotherapy vs 14.0 months in 235 patients without; hazard ratio 0.66 [0.52â?"0.83], p=0.0005)

Conclusion and implications for future research and/or applied work
Overall results showed no benefit for adjuvant chemo-radiotherapy (median survival 15â?¢5 months in 175 patients with chemo-radiotherapy vs 16â?¢1 months in 178 patients without; hazard ratio 1â?¢18 [95% CI 0â?¢90â?"1â?¢55],
p=0â?¢24).

Literature review that establishes the nature of the problem to be addressed in the present study
Pancreatic ductal adenocarcinoma remains one of the most difficult cancers to treat,
The best predictors of survival after surgery are stage of disease, tumor grade, and resection-margin status, but even the most favorable characteristics do not guarantee a cure.

European Organization for Research and Treatment of Cancer ...

Solution Summary

Clinical research
Design evaluation
Paper on research steps
Behavioral statistics
Hypothesis, variable, method, results, findings, discussion.

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a) Are there any statistically significant differences in baseline characteristics between treatment groups? Justify your answer.

b) Write the hypotheses and the test statistic used to compare ages between groups. (No calculations â?" just H0, H1 and form of the test statistic)

c) Write the hypotheses and the test statistic used to compare % females between groups. (No calculations â?" just H0, H1 and form of the test statistic)

d) Write the hypotheses and the test statistic used to compare educational levels between groups. (No calculations â?" just H0, H1 and form of the test statistic)

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