Applied Research and Biostatistics: Critical Review Form Student Name: Student Number: Instructions:...

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Applied Research and Biostatistics: Critical Review Form Student Name: Student Number: Instructions: Use tab or arrow keys to move between fields, mouse or spacebar to check/uncheck boxes. CITATION Provide the full citation for this article in APA 6th format: Masharani, U., Serchan, P., Schloetter, M., Stratford, S., Xiao, A., Sevastian, A., Nolte Kennedy, M., & Frassetto, L. (2015). Metbaolic and physiologic effects from consuming a hunter-gatherer (Paleolithic)-type diet in type 2 diabetes. Journal of Clinical Nutrition, 1-5. http://dx. 10.1038/ejcn.2015.39 STUDY AIMS AND HYPOTHESIS Was the aims stated clearly? Yes No 1.Outline hypothesis of the study. There will be beneficial metabolic effects from consuming a Paleo-style diet compared with an American Diabetic Association (ADA) style diet in type 2 diabetics. 2. Outline aims of the study. To establish if there are beneficial health effects relating to insulin sensitivity and lipid profiles in type 2 diabetics following a Paleolithic style diet compared to an ADA style diet. LITERATURE REVIEW Was relevant background literature reviewed? Yes No Justify the need for this study: The authors explain that external factors such as diet are important in the mechanisms which lead to abnormalities such as those found in type 2 diabetes and that the diet also has an effect on the physiological condition of the patient and their metabolic processes. These factors are also used to justify the concept of a diet more suited to our evolution, such as the Paleolithic diet. Further to this, a short-term study concluded that blood pressure and weight loss improvements were associated with the Paleo diet but without any carbohydrate and lipid metabolism outcomes. Another more long-term study reported that comparisons between the Paleo and Mediterranean diets showed improvements in glucose excursion. Neither of these studies had controlled the diet of the participants nor did they control for weight loss. STUDY DESIGN Randomized (RCT) cohort single case design before and after case-control 1.Describe the study design. Randomized control trial (RCT) intervention study in which which two groups were randomly allocated a diet and provided with pre-prepared meals for a period of two weeks. Caloric intake was controlled, in an attempt to prevent weight loss as a confounding factor. One of the diet groups was put on a ramp-up diet in the week leading up to commencement of the study 2 cross-sectional case study other diet however it is unclear as to what the other group ate during this time. Pre and post measures were taken and included weight, BMI, blood pressures, mean arterial pressure, blood and urine samples. The latter two were used to obtain lipid profiles and glucose control markers as well as urinary electrolyte and metabolite ratios. The sample size was initially 25 but due to several factors, six were lost. After a three month wash-out period, five participants crossed over and increased the sample size to 24. 2.Was the design appropriate for the study question? Intervention study RCTs are appropriate for gaining insight to the differences between two groups relevant to dietary treatment for a condition. However, this study lacked a true control and it would have been beneficial to have included a single-blind design. Furthermore, the sample size was too small and the duration of the study was too short, which makes it difficult to draw significantly conclusive results. The measures used to determine metabolic response to the diets were suited to the study however results from the period between pre and post measures were not referenced making it difficult to determine dietary compliance. 3. Specify any biases that may have been operating ? Recall bias – during the initial 24 hour food recall ? Outcome bias – the high vegetable intake in the Paleo group would have an effect on LDL cholesterol, as plant sterols are well known to lower LDL cholesterol levels ? Study design bias – there was no ramp up diet for the ADA group and salt intake was significantly decreased in the Paleo group; glucose control, lipid lowering and other medicines continued to be taken (which group was taking which medicines was not properly listed) ? Participant bias – participants may have heard about the style of diet they were on which may have influenced their compliance SAMPLE What is total N = 25 Was the sample described in detail? Yes No Was sample size justified? Yes No N/A 1.Sampling (who; characteristics; how many; how was sampling done?), in other words, what was the inclusion criteria and how were they recruited? 25 outpatients with type 2 diabetes from the San Francisco Bay area, aged 50-69 were recruited. Telephone screening followed by an interview excluded anyone with the following conditions: - type 1 diabetes - Pregnant - Hemoglobin levels below 10g/dL - BMI greater than 40 - Those unable to follow the diet - Participating in a program in which may impact upon insulin sensitivity Participants were randomly allocated to a Paleolithic style diet and an American Diabetes Association prescribed diet. Sample was mixed race composed of the following: - 62.5% European American/White - 12.5% African American - 3% Asian - 3% Hispanic 3 2.If more than one group, was there similarity between the groups in the study? If so why or why not? Baseline characteristics of the groups (including age, BMI, blood pressures, mean arterial pressure), bloods and urine indicated no significant difference between the groups. 3.Describe ethics procedures. Was informed consent obtained?: All participants were screened and interviewed prior to signing informed consent. Study was approved UCSF committee on human research with NCT number 00548782. 4 STUDY OUTCOMES Were the outcome measures reliable? Yes No Not addressed Were the outcome measures valid? Yes No Not addressed List the type of outcome(s) measured at pre and post- intervention and what measures were used for each outcome. Insulin resistance - Hemoglobin A1c - Fructosamine - Insulin sensitivity Lipid profiles - Total cholesterol - Triglycerides - HDL cholesterol - LDL cholesterol Urine electrolytes and dietary compliance - Sodium/Potassium - Calcium/Creatinine - Creatinine clearance - pH Weight BMI Systolic & Diastolic blood pressure Mean Arterial Pressure INTERVENTION Intervention was described in detail? Yes No Not addressed Selection biases avoided? Yes No Not addressed N/A Measurement biases was avoided? Yes No Not addressed N/A 1.Provide a short description of the intervention (what was the focus, who delivered it, how often, setting). After participants were recruited and prepared, they were randomly allocated one of two intervention diets; a “Paleolithic” style diet and an ADA style diet, both to be followed for 14 days. Each diet was formulated using ProNutra Nutrition Software and nutrient composition of each was analysed in a laboratory. The meals were pre-packed by research centre staff and consumed at the research centre or taken home by the participants. Pre and post metabolic measures were taken for analysis and results were statistically analysed using appropriate tests. The subjects were then asked to come back for a follow-up one month later. 2.Could the intervention be replicated in practice? It would be difficult to replicate this study based solely on the article as there were details missing which may be significant in relation to the outcomes. Details missing include; what the ADA group ate during the “ramp-up” stage, meal composition for the Paleo group (whereas the ADA group’s diet was based on referenced guidelines). 5 RESULTS Results were reported in terms of statistical significance? Yes No N/A Not addressed Were the analysis method(s) appropriate? Yes No Not addressed 1.What were the results? ? Both groups lost weight ? Mean arterial pressure and systolic pressure decreased in both groups; diastolic pressure decreased in the Paleo group but not in the ADA group ? Both groups had a reduction in urinary potassium and sodium, an increase in potassium to sodium ratio as well as a decrease in the urinary calcium to creatinine ratio ? Both groups showed a decrease in total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides ? Hb1Ac and fructosamine declined in both groups ? Both groups showed a reduction in insulin sensitivity with those most sensitive at baseline in the Paleo group showing the biggest reduction; insulin sensitivity was analysed in a bivariate test to ensure independence from weight loss 2.Were they statistically significant (i.e., p

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Critical Review Form – Quantitative Studies
PUBH3001 Applied Research and Biostatistics: Critical review Template 
Student Name: ___________________________________
Student Number: __________________________________
Instructions: Use tab or arrow keys to move between fields, mouse or spacebar to check/uncheck boxes. Please keep your answers short. Please limit your answers to 100 words or less for each question.
	CITATION
(0.5 marks)
	Provide the full citation for this article in APA format: 
Eames, S., Hoffmann, T., Worrall, L., Read, S., & Wong, A. (2013). Randomised controlled trial of an education and support package for stroke patients and their carers. BMJ Open, 3, 1-10. http://dx.doi.org/10.1136/ bmjopen-2012-002538
	STUDY AIMS AND HYPOTHESIS (2 marks)
Were the aims
stated clearly?
 FORMCHECKBOX 
 Yes
 FORMCHECKBOX 
 No
	1. Outline hypothesis of the study. 
Stroke information based interventions would be effective if active participation of the patient and carer is sought and if information is meticulously tailored (as per the demands of the patients & carer), clarified and reinforced in addition to the standard care through follow-up by an intervention expert/s during pre and post-discharge periods.
2. Outline aims of the study. 
To evaluate the effect of the tailored education on the stroke patient and their respective carers;
To evaluate and understand the effect of the said information package on the knowledge, confidence level, health, behavior (psychosocial)/moods and satisfaction of the participant and also on the patient’s quality of life and carer’s burden. 
	LITERATURE REVIEW
(2 marks)
Was relevant background literature reviewed?
 FORMCHECKBOX 
 Yes
 FORMCHECKBOX 
 No
	Summarise the justification for the study 
The authors have explained that well-tailored stroke information may provide additional support to the patient and carer and may lead to an improved lifestyle of the patient and reduce the burden on the carer. A similar study, where computer generated tailored information was provided to a group under intervention and generic information was given to the control group, showed that the satisfaction levels of the former group were significantly higher than the latter. There are at least 3 separate studies that stress on the need for stroke information by the patient and carer post-discharge.  
	STUDY DESIGN 
(3 marks)
 FORMCHECKBOX 
 Randomized (RCT)
 FORMCHECKBOX 
 cohort
 FORMCHECKBOX 
 single case design
 FORMCHECKBOX 
 before and after
 FORMCHECKBOX 
 case-control
 FORMCHECKBOX 
 cross-sectional
 FORMCHECKBOX 
 case study
 FORMCHECKBOX 
 other
	1. Briefly describe the study design.

Applied Research and Biostatistics: Critical Review Form Student Name: Student Number: Instructions: Use tab or arrow keys to move between fields, mouse or spacebar to check/uncheck boxes. CITATION...

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