From ZERO To RCT

From ZERO To RCT

Abdulelah NuqaliMohammed Badawi

Omar Taibah

The Aim

5 Years Ago.. When I was in 2nd year of medical school

• Newspapers


• Our professors CVs


• Prevalence studies


• Students Achievements

.. 3rd Year Medical Student

Biostatistics

Variables

P- value

SPSS

null hypothesis

4th Year Medical Student

• Community Medicine

Assemble a research team

• 10 members + 1 supervisor• + 1 advisor

Hints:< 5 authors, unless you have a big projectWho are the authors?Role allocation

Choosing a Research Question

• Difficult Vs. Easy

• Smoking among Medical Students at Umm Al-Qura University

After a Literature Review

• The Trend of Smoking Habit through Academic Years among Medical Students at Umm Al-Qura University (UQU) (2010)

Continue a Research Process

Abstract

• Marketing your research

Research Presentation at Conferences

• Poster Vs Oral presentation• 3rd Medical Students Research Day, King

Abdulaziz University• The preparatory scientific meeting of Umm

Al-Qura University Students for the 2nd scientific conference

Publication

• Reasons for rejection of our manuscript:– A lot of authors– The topic was not interesting– Female gender was not included

Research 2

Mohammed I. Badawi

Elements needed

• Research Idea• Supervisor• Research team• Approval• Statistician

Research Idea

• New• Feasible• Achievable• Short time

Psychiatry!

• Suggested research idea: Depression and Anxiety among Chronic rheumatological diseases Patients in Makkah, Saudi Arabia

• Modified research Idea: Depression and Anxiety among Dialysis Patients in Makkah, Saudi Arabia

Issues

• How can we diagnose depression or anxiety?

HADS1. Translation:

Issues

2. Approval.

Data Collection

• Hospital system

• Time (Al hajj vocation for ourselves and patients-personal commitments- far)

What is next?

• Poster• Publication

Depression and Anxiety among Dialysis Patients in Makkah, Saudi Arabia

Authors: Dr.Mohammed Badawi , Dr. Omar Taibah , Dr.Abdulelah Nuqali , Dr. Omar Alserihy , Dr. Muaid Morad , Dr. Emad Kalantan , Dr. Ibrahim Turkistani , Prof. Sirag Al Rady

The WHO estimates that during the early portions of the 21st century depression will be the second most common debilitating illness worldwide .

Depression has been thought to be the most common psychiatric abnormality in End-stage renal disease (ESRD) patients. A study reported that over 70% of patients on maintenance hemodialysis (HD) who had symptoms of depression or anxiety and described barriers to mental health treatment, did not recognize their symptoms or did not perceive that they were in need of therapy for their mental health condition,. Drayer and colleagues found that patients with ESRD and depression have 4.1 times the mortality rate of patients with ESRD who do not have depression .

Another study suggested a higher rate of withdrawal from maintenance dialysis in patients who developed depression while on dialysis than in those patients who were not depressed. These investigators also found a higher risk of mortality and hospitalization associated with depression.

Introduction

Objectives:

Conclusion

Primary: to find out the prevalence of depression and anxiety among Saudi dialysis patient in makkah.

Secondary: to find out the relationship between duration of HD and increase incidence of depression.

MethodsA cross-sectional study of anxiety and depression in (ESRD) Saudi patients in Makkah, conducted during November 2011. The subject’s physical, social and environmental health status were assessed by an interview. The Hospital Anxiety and Depression Scale (HADS) was used to screen for anxiety and depression.

Our study included a sample size of 286 outpatients on maintenance HD from dialysis centers in Makkah, two main centers Al-Noor and Al-Zahir hospitals. The consent was taken orally. All patients were included in the study. Exclusion criteria were non Saudi patients, patients who refuse to fill the questionnaire and patient with communication barriers.

The HADS is one of the most popular self-reporting tool for measuring depressive and anxiety symptoms. Even though the HADS questionnaire is a self-assessment scale, all patients were interviewed by a research member to full fill it.

For data management and statistical analysis, SPSS 12.0.1. was used and P value < 0.05 was considered statistically significant.

Anxiety and depressive symptoms are not uncommon among ESRD patients in Makkah. Early detection and management can improve clinical outcomes.

Results Of 286 ESRD patients on hemodialysis 58.2% were males. The dominant age group is above 40.

Only 32(11.3) were diagnosed with depression or anxiety before the onset of the ESRD, and overall 20(7%) patients were currently on depression or anxiety medication.

57(21.1%) patients diagnosed with anxiety and 63(23.3) subjects were suffering of depression based on HADS.

ReferencesUstun TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJ: Global burden of depressive disorders in the year 2000. Br J Psychiatry 184:386–392, 2004

Kimmel PL: Psychosocial factors in dialysis patients. Kidney Int 59:1599– 1613, 2001Finkelstein FO, Finkelstein SH: Depression in chronic dialysis patients: assessment and treatment. Nephrol Dial Transplant 15:1911–1913, 2000Kimmel PL: Depression in patients with chronic renal disease: what we know and what we need to know. J Psychom Res 53:951–956, 2002Levy NB. What is psychonephrology? J Nephrol. 2008;21 Suppl 13:S51-3.Drayer RA, Piraino B, Reynolds CF, 3rd, et al. Characteristics of depression in hemodialysis patients: symptoms, quality of life and mortality risk. Gen Hosp Psychiatry. 2006;28:306-12.Lopes AA, Bragg J, Young E, et al. Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney Int. 2002;62:199-207.

Normal Border-line Ab-normal

Ab-nor-mal

Family support chronic illnesses

0%20%40%60%80%

100%79.6

64

20.436

Duration of Renal Failureless than 1

year1 - 5 years more than 5

years

Variables Anxiety score

Normal % Border line % Abnormal %

Age Less than 20 years 5.6 2 0

20 - 40 years 33.3 18.4 21.4

Above 40 years 61.1 79.6 78.6

Significance: P=0.026

Major Family Problems Yes 16.1 32 35.1

No 83.9 68 64.9


Anxiety or Depression before ESRD

Yes 8 12 23.2

No 92 88 76.8


Variables Depression score

Normal % Border line % Abnormal %

Age Less than 20 years 4.8 1.8 3.220 - 40 years 34 29.8 12.7

Above 40 years 61.2 68.4 84.1


Major Family Problems Yes 14.9 17.2 38.1

No 85.1 82.8 61.9Significance: P=0.001

Anxiety or Depression before ESRD

Yes 8.7 6.9 21

No 91.3 93.1 79Significance: P=0.019

Table 2. Anxiety Scores with Different VariablesTable 3. Depression Scores with Different Variables

Educational levelUnenlightened Secondary

school or lessParchment

Take home message

1.Do not lose hope.

2.Have a clear goal.

3.Be ready.

4.You can do it.

RESEARCH 3Omar S. Taibah

RANDOMIZED CONTROLLED TRIAL

A Dream ..

• Moving from knowing to changing!• A research in each subject!

• We needed a mentor.

• Choosing a topic.

• We had no experience at all.• First RCT from UQU?

What is next?

• Proposal:- Our goal.- Literature review.- Biostatics.- Protocol.

What is next?

• Ethical approval:- Long process.- It took more than six months.- Enthusiasm only takes you this far.

• WE GOT THE ETHICAL APPROVAL!

Are we there yet?

• We need money!• Getting grant:- An even longer process.- New proposal!- Lots of paper work (consents, Arabic

versions, detailed budget, referees, etc..).- Hope could have been easily lost.

• WE

• WE GOT

• WE GOT 133,000 SR!

• Recruiting:- Verbal agreement with hospitals.- Ongoing.- Presentation skills.

Future tasks..

• Data collection.• Data entry.• Results.• Publication.

Are we there yet?

• NO! we are not even close!

What we got so far..

• Experience.• Knowledge.• HOPE!

What I’m saying is ..

• If we can go this far, YOU can go further!!

• Questions?

From ZERO To RCT

Documents

Transcript of From ZERO To RCT