Background: this study was planned to explore perceptions, attitudes and practices toward research among post graduate students and the factors or problems encountered during protocol writing. This study aimed to audit the submitted protocols for identifying the gaps. Materials And Methods: A checklist for audit of thesis protocol that was designed by subject experts was used for audit of the thesis protocols After taking approval from Institutional ethical committee and proper informed consent from students the pretested questionnaire was then given anonymously to all the students meeting inclusion criteria. Results: Out of 143 participants, 96.5% (138) of the participants had knowledge of approvals which are mandatory for research, each of 83.2% (119) of the participants had knowledge of type of study that uses only the information recorded in the past, 81.1% (116) of the participants have knowledge of double blinding in clinical trial Majority, 87.4 % (125) participants chose a prospective study for their thesis 77.6% (111) had never done any research during graduation. Majority of patients 75 (52.4%) became aware of research project by information from teachers followed by seniors Conclusion: Results of this study bring forward the problems encountered by the students in writing thesis protocols and identifies the mistakes in their protocols.
The medical science continues to evolve and adapt hence biomedical research is essential to explore and continue bringing improvement in the overall health of individuals and the country. Although health research training is recognized as an important component of medical education as the rapid expansion and progress in biomedical research is expected to transform medical care but still it exists as low priority area in developing countries.1 To encourage research orientation in postgraduate students, writing a thesis has been made mandatory for them by National Medical Council of India.2
A thesis is the written product of a systematic study that results from a period of supervised research. Before starting the research for thesis an overview is made in the form of protocol which identifies a research topic and research problem, formulates research question(s) and objective(s), and explains how the research will be designed and implemented. Protocol results in a short comprehensive document that clearly summarizes the project but preparing it is the most difficult stage of conducting a research project.3 there are various factors which create hindrance while preparing research protocol. These factors may be personal i.e. students' knowledge, experience, commitment, socioeconomic condition, communication skill, stress, time management etc.,4 institutional i.e. cooperation, guidance, fund, documentation and physical facilities etc.5, supervision related i.e. student supervisor relationship, supervisor knowledge and interest and regular contact between supervisor and student, timely feedback etc6, environment related i.e. presence of dedicated faculties and Thesis research council/ cell, peer support etc.7A good protocol saves failures at a later stage. If the protocol is poorly prepared and not adhered to, it
is unlikely that the project will yield the information that is intended. Hence a thorough audit of a protocol is essential before approving a thesis project.
Hence, this study was planned to explore perceptions, attitudes and practices toward research among post graduate students and the factors or problems encountered during protocol writing. This study aimed to audit the submitted protocols for identifying the gaps.
Study setting- An observational cross- sectional study was conducted in a Government Medical College of central India which included 143 first year post graduate students of batch 2022 of all the broad specialities, who had submitted thesis protocol in Institutional Ethical Committee of the college for approval. Purposive sampling was used to enroll sample population.
Inclusion criteria- all the first year post graduate students of batch 2022 of all the broad
specialities who were going to present thesis protocol who had given prior consent to
participate in the study.
Exclusion criteria- Those not willing for participating in study
Study tools –
Data collection- After taking approval from Institutional ethical committee and proper informed consent from students the pretested questionnaire was then given anonymously to all the students meeting inclusion criteria, which collected data on background characteristics and responses to questions related to knowledge on research, attitude towards conducting research and perceived barriers to conduct of research. Identity of the student and his department was not mentioned. After the responses were marked, the questionnaire proforma was collected.
Audit of the submitted thesis protocols was done by using structured audit checklist and all the components of the protocol were thoroughly analysed. Collected data was entered into Microsoft excel sheets.
Statistical analysis- statistical analysis was done using SPSS software. Proportions and percentages were used for qualitative data. Means and standard deviation were used to describe the Likert scale data. Mann Whitney score was used for comparison between clinical and paraclinical groups.
Ethical consideration- Ethical approval was taken by Institutional ethics committee of the medical college.
Confidentiality- No identifying information such as name and address was collected in the study
Knowledge of postgraduate students toward medical research-
Out of 143 participants, 96.5% (138) of the participants had knowledge of approvals which are mandatory for research, each of 83.2% (119) of the participants had knowledge of type of study that uses only the information recorded in the past, 81.1% (116) of the participants have knowledge of double blinding in clinical trial (Table 1)
Attitude of postgraduate students regarding medical research-
Majority of students, 98.6% (141) were satisfied with their thesis topic, 96.5% (138) of the participants felt that research is an important aspect in medical field, 90.2% (129) of the study participants were waiting to get chance to attend workshop on research methodology. Total 36.4% (52) of the participant, opined that improving their research skills is the motive behind conducting research, 30% (43) of the participants felt that it fulfils research interest, 21.7% (31) of the participants saw research is useful for their career, but only 11.9% (17) of the study participants felt that it must be mandatory in the curriculum. (Table 1)
Table: I Knowledge, attitude and practices of postgraduate students toward medical research
S.No |
Knowledge |
Correct Response |
Percentage |
1 |
Which of the following approvals is absolutely mandatory before initiating a study? |
138 |
96.5 |
2 |
Any systematic error in the design, conduct or analysis of a study that results in erroneous estimate of an exposure’s effect on the risk of disease is called |
72 |
50.3 |
3 |
What is the type of study that uses only the information recorded in the past? |
119 |
83.2 |
4 |
Exposure is assigned by the investigator in which of the following epidemiological study? |
58 |
40.6 |
5 |
One of the cornerstones of the randomised controlled trials is |
119 |
83.2 |
6 |
Double blinding in a clinical trial involves |
116 |
81.1 |
Attitude |
Yes |
No |
|
1 |
Do you think thesis should be made optional during Post graduate medical education? |
58(40.6%) |
85(59.4%) |
2 |
Do you think Research is important in the medical field? |
138(96.5%) |
5(3.5%) |
3 |
Have you attended any workshop on research methodology during your Undergraduate/ Postgraduate study period? |
76(53.1%) |
67(46.9%) |
4 |
If u get a chance, will you attend workshop on research methodology? |
129(90.2%) |
14(9.8%) |
5 |
Are you satisfied with your topic? |
141(98.6%) |
2(1.4%) |
6 |
What is your motive behind conducting this Research? |
||
Mandatory in the curriculum |
17(11.9%) |
||
Fulfilling research interests |
43(30.1%) |
||
Useful for my future carrier |
31(21.7%) |
||
Improving research skills |
52(36.4%) |
||
Practices |
Frequency |
Percentage |
|
What is the type of thesis study are you undertaking |
|||
A |
Prospective study |
125 |
87.4 |
B |
Retrospective study |
8 |
5.6 |
C |
Randomised control trial |
10 |
7 |
Have you done any research during your Undergraduate study period? |
|||
A |
Yes |
32 |
22.4 |
B |
No |
111 |
77.6 |
How did you come to know about thesis protocol? |
|||
A |
Batchmate |
2 |
1.4 |
B |
Seniors |
54 |
37.8 |
C |
Teachers |
75 |
52.4 |
D |
Office Letter |
11 |
7.7 |
When did you submit synopsis? |
|||
A |
Within allotted time before last day |
11 |
7.7% |
B |
Within allotted time on last day |
80 |
55.9% |
C |
With late fees |
52 |
36.4% |
What was the reason for late submission? (more than one response if applicable) |
|||
A |
Inadequate help by Guide/ Co-Guide/ HOD / Dean / Superintendent |
7 |
4.9 |
B |
Lack of Research Curriculum |
9 |
6.3 |
C |
Personal reasons like, lack of interest/inadequate facility/Lack of time due to work in the department/Family Problems/Marriage/Health issues/ |
33 |
23.1 |
D |
Not applicable |
94 |
65.7 |
Who gave you topic for your thesis? |
|||
A |
Myself with the help of internet |
25 |
17.5 |
B |
Guide |
83 |
58 |
C |
Co-Guide |
9 |
6.3 |
D |
Head of the Department |
5 |
3.5 |
Research practices –
Majority, 87.4 % (125) participants chose a prospective study for their thesis. (Figure 1) 77.6% (111) had never done any research during graduation. Majority of patients 75 (52.4%) became aware of research project by information from teachers followed by seniors (37.8% i.e., 54) (Figure 2) and in 58% (83) cases thesis topic was given by the guide while 17.5 (25%) students informed that they chose their topic themselves by using internet. (Figure 1) Total 63.6% (91) students submitted their thesis protocol within allotted time but it was found that majority out of them 87.9% (80) submitted on the last date of submission. Rest (36.3% i.e. 52) submitted their protocols with late fees. When asked about the reasons of late submission, personal reason was the most commonly chosen option (23.1 % i.e., 33). (Table 1)
Perception towards advantages of conducting thesis-
Perception towards advantage of conducting thesis, showed that only 2.8% (4) of the study participants strongly agreed that conducting thesis develops the critical thinking and essential for the development of new/modified treatment guidelines. 4.2% (6) of the study participant felt that it is essential for the development of new/modified diagnostic test. Total 6.3% (9) of the study participants felt it improves their CV/Resume. 4.2% (6) of the study participant were conducting this thesis to obtain research publication and 6.3% (9) of the participant felt it was useful to train residents on how to conduct research. Majority of student 61.5% students felt that lack of mentor guidance is a challenge in conducting research. Other causes which came out as hindrance in the study are lack of inter departmental coordination (51.1%), lack of interest in participating in thesis (50.4%), no support from technical staff (50.4%), searching topic (42.7%), lack of necessary skills/training/knowledge (35%), inadequate instrument or study tools (34.3%), inadequate lab facilities (31.5%) and lack of time alongside medical studies/clinical work (29.4%). (Table 2)
Table II- Perception of students towards conducting thesis and challenges faced-
Sr. No |
Perception towards Advantages of conducting thesis |
Strongly agree |
Agree |
Neither agree nor disagree |
Disagree |
Strongly disagree |
1 |
Development of critical thinking |
4(2.8%) |
0(0%) |
1(0.7%) |
55(38.5%) |
83(58%) |
2 |
Essential for the development of new/modified treatment guidelines |
4(2.8%) |
0(0%) |
9(6.3%) |
54(37.8%) |
76(53.1%) |
3 |
Essential for the development of new/modified diagnostic test |
5(3.5%) |
1(0.7%) |
18(12.6%) |
51(35.7%) |
68(47.6%) |
4 |
Improving my CV/Resume |
7(4.9%) |
2(1.4%) |
13(9.1%) |
53(37.1%) |
68(47.6%) |
5 |
Obtaining research publication |
5(3.5%) |
1(0.7%) |
9(6.3%) |
52(36.4%) |
76(53.1%) |
6 |
To train residents on how to conduct research |
3(2.1%) |
6(4.2%) |
6(4.2%) |
41(28.7%) |
87(60.8%) |
Sr. No |
Perception towards Advantages of conducting thesis |
Mean |
SD |
Median (50th Percentile) |
25th Percentile |
75th Percentile |
1 |
Development of critical thinking |
4.49 |
0.777 |
5 |
4 |
5 |
2 |
Essential for the development of new/modified treatment guidelines |
4.38 |
0.839 |
5 |
4 |
5 |
3 |
Essential for the development of new/modified diagnostic test |
4.23 |
0.947 |
4 |
4 |
5 |
4 |
Improving my CV/Resume |
4.21 |
1.013 |
4 |
4 |
5 |
5 |
Obtaining research publication |
4.35 |
0.906 |
5 |
4 |
5 |
6 |
To train residents on how to conduct research |
4.42 |
0.915 |
5 |
4 |
5 |
Sr. No |
Perception towards Challenges of conducting thesis |
Strongly agree |
Agree |
Neither agree nor disagree |
Disagree |
Strongly disagree |
1 |
Inadequate lab facilities |
15(10.5%) |
30(21%) |
31(21.7%) |
49(34.3%) |
18(12.6%) |
2 |
Inadequate instrument or study tools |
19(13.3%) |
30(21%) |
40(28%) |
41(28.7%) |
13(9.1%) |
3 |
Incompetent/Unavailable technical staff |
23(16.1%) |
49(34.3%) |
28(19.6%) |
30(21%) |
13(9.1%) |
4 |
Lack of time alongside medical studies/clinical work |
12(8.4%) |
30(21%) |
40(28%) |
32(22.4%) |
29(20.3%) |
5 |
Lack of inter departmental coordination |
14(9.8%) |
59(41.3%) |
32(22.4%) |
27(18.9%) |
11(7.7%) |
6 |
Lack of necessary skills/training/knowledge |
15(10.5%) |
35(24.5%) |
55(38.5%) |
32(22.4%) |
6(4.2%) |
7 |
Lack of interest in participating in thesis |
30(21%) |
42(29.4%) |
49(34.3%) |
18(12.6%) |
4(2.8%) |
8 |
Lack of mentor guidance |
45(31.5%) |
48(33.6%) |
32(22.4%) |
11(7.7%) |
7(4.9%) |
9 |
Searching Topic |
32(22.4%) |
29(20.3%) |
30(21%) |
43(30.1%) |
9(6.3%) |
Sr. No |
Perception towards Challenges of conducting thesis |
Mean |
SD |
Median (50th Percentile) |
25th Percentile |
75th Percentile |
1 |
Inadequate lab facilities |
3.17 |
1.206 |
3 |
2 |
4 |
2 |
Inadequate instrument or study tools |
2.99 |
1.184 |
3 |
2 |
4 |
3 |
Incompetent/Unavailable technical staff |
2.73 |
1.223 |
2 |
2 |
4 |
4 |
Lack of time alongside medical studies/clinical work |
3.25 |
1.236 |
3 |
2 |
4 |
5 |
Lack of inter departmental coordination |
2.73 |
1.113 |
2 |
2 |
4 |
6 |
Lack of necessary skills/training/knowledge |
2.85 |
1.021 |
3 |
2 |
4 |
7 |
Lack of interest in participating in thesis |
2.47 |
1.047 |
2 |
2 |
3 |
8 |
Lack of mentor guidance |
2.21 |
1.119 |
2 |
1 |
3 |
9 |
Searching Topic |
2.78 |
1.269 |
3 |
2 |
4 |
No significant difference was found between the perspectives of post graduates of clinical and non-clinical branches regarding the perception of challenges towards pursuing research activities. (Table 3)
Audit of thesis protocols-
Table III- Median difference among post graduates regarding Advantages and challenges among post graduates.
Mean |
Median |
SD |
Minimum |
Maximum |
IQR |
Mann-Whitney U |
P-value |
||
Perception towards Advantages of conducting thesis |
|||||||||
Clinical |
4.358 |
4.5 |
0.84 |
1 |
5 |
1 |
1310.5 |
0.687 |
|
Para and Non-Clinical |
4.521 |
4.5 |
0.46 |
4 |
5 |
1 |
|||
Perception towards challenges in conducting thesis |
|||||||||
Clinical |
2.733 |
3 |
0.98 |
1 |
5 |
1 |
1365.5 |
0.936 |
|
Para and Non-Clinical |
2.782 |
3 |
1.09 |
1 |
5 |
2 |
|||
Department |
Mean |
SD |
Median |
Maximum |
Minimum |
Man-Whitney |
P-value |
||
Clinical |
4.3667 |
1.22942 |
4 |
6 |
1 |
4.50 |
0.275 |
||
Para and Non-clinical |
4.2609 |
0.81002 |
4 |
3 |
5 |
||||
Department |
Mean |
SD |
Median |
Maximum |
Minimum |
Man-Whitney |
P-value |
||
Clinical |
4.3667 |
1.22942 |
4 |
6 |
1 |
4.50 |
0.275 |
||
Para and Non-clinical |
4.2609 |
0.81002 |
4 |
3 |
5 |
||||
On comparing the thesis protocols of students with the audit sheet it was observed that 47 (32.8%) students had not written title of study in accordance with the checklist. There were mistakes in aim and objectives in 79 (55.2%) protocols. Introduction, methodology and review of literature were having errors in 24 (16.7%), 75 (52.4%), 38 (26.7%) protocols respectively. References were not cited in accordance with the checklist in 78 (54.5%) protocols and informed consent was not appropriate in 93 (65%) protocols. Audit sheet also contain few general observations in the form of language, drafting and sequencing the protocol. On comparing with that, in 78 (54.5%) protocols there were grammatical mistakes and in 42 (29.3%) protocols sign and/or seal were missing. In 4 (2.8%) protocols the study method was not abiding with the ICMR ethical guidelines9. (Table 4)
Table IV: Audit of thesis protocol-
|
YES |
NO |
TITLE Includes problem Includes place of study Includes type of study Too lengthy Too short Use of short forms Use of bracket, inverted commas In accordance with research hypothesis
|
126 (88.1%) 96 (67.1%) 118 (82.5%) 30 (21%) 11 (7.7%) 16 (11.2%) 16 (11.1%) 124 (86.7%) |
17 (11.9%) 47 (32.9) 25 (17.5%) 113 (79%) 132 (92.4%) 127 (88.8%) 127 (88.9%) 19 (13.3%) |
AIMS AND OBJECTIVES Separate aims and objectives Primary and secondary objectives mentioned Clearly defined aims and objectives In accordance with research hypothesis |
64 (44.7%) 87 (60.8%) 95 (66.4%) 123 (86%) |
79 (38.3%) 56 (39.2%) 48 (33.6%) 20 (14%) |
INTRODUCTION Too lenghty Too short Answers why this study is undertaken At least two referrences given |
13 (9%) 10 (7%) 133 (93%) 143 (100%) |
130 (91%) 133 (93%) 10 (6%) 0 |
MATERIAL AND METHODS Includes study type Includes study design Includes place of study Includes duration of study Includes study flow chart Includes sample size calculation Includes outcome measures Explains procedure clearly Includes data management Inclusion and exclusion criteria clearly defined Standard definition of cut offs clearly mentioned |
138 (96.5%) 140 (97.9%) 143 (100%) 143 (100%) 68 (47.5%) 80 (56%) 128 (89.5%) 99 (69.2%) 126 (88.1%) 121 (84.6%) 115 (80.4%) |
5 (3.5%) 3 (2%) 0 0 75 (52.5%) 63 (44%) 15 (10.5%) 44 (30.8%) 17 (11.9%) 22 (15.4%) 28 (19.6%) |
REVIEW OF LITERATURE
Critical and scientific review of published review literature |
118 (82.5%) |
25 (17.5%) |
INFORMED CONSENT Includes nature of procedure Includes risks and benefits of procedure Includes confidentiality Includes right to withdraw In patient’s language
|
72 (50.3%) 50 (35%) 76 (53.1%) 80 (56%) 138 (96.5%) |
71 (49.7%) 93 (65%) 67 (46.9%) 63 (44%) 5 (3.5%) |
REFERRENCE- Relevant Style of citation is appropriate |
111 (77.6%) 92 (64.3%) |
32 (22.4%) 51 (35.7%) |
Legal and ethical issues |
4 (2.8%) |
139 (97.2%) |
Grammatical errors |
78 (54.5%) |
65 (45.5%) |
Sign and/or seal missing |
42 (29.4%) |
101 (70.6%) |
In the present study, it was found that postgraduate students had good knowledge regarding the basic topics of medical research. It was similar to study conducted in north India by R. Gupta et al10, but in contrast to the observation made in studies by M. A. Matin et al11, C. R. Vairamani et al12, Hren13 et al and Ibrahim et al14 who found inadequate research-oriented knowledge in students. Our study observed that despite having knowledge regarding research 77.6% (111) students had never done any research during undergraduate course. This can be due to the existing gap between theoretical knowledge and its practical application in medical curriculum.
On comparing the attitude of students toward medical research the results were found to be similar to many studies in the past. Studies done by Sumi et al15 and P. A. Giri et al16 had also shown that most physicians wanted to attend lectures or seminars on topics related to clinical research. Similar results were obtained in a study done in Madison, USA; in that study, out of 143 postgraduate students 48% were interested in pursuing research during residency, but here also only 8% were active in research.17
However, two studies that were carried out in Canada and Pakistan reflected a contrasting attitude of postgraduate students that a majority of time in residency should be spent learning the clinical aspects of their specialty and they were unwilling to sacrifice personal time for research.18,19
This difference in willingness to do research activities and actual participation might be due to lack of awareness of students regarding research during undergraduate studies and more focus over exam-oriented studies.
It was surprising that many students did not feel that doing thesis improves their research skills and is useful for their future too. Present study reveals that only 36.4% (52) of the participants said that improvement in the research skills is the motive behind conducting research, 30% (43) of the participants felt that it fulfils research interest, 21.7% (31) of the participant saw research is useful for their career, and only 11.9% (17) of the study participants felt that it must be mandatory in the curriculum. Similar to this, in study by C. R. Vairamani et al though nearly two-third (63.2%) agreed that undertaking research increases burden on already over worked resident doctors, but here three-fourth (76.6%) opined that research will be useful for their future career and for improving patient outcome (83.9%), three fourth (75.9%) believed that engaging medical students in conducting research will develop research skills and help boost their careers.12
This study observed that only 11.9% (17) of the study participants felt that research must be mandatory in the curriculum while in study by Khalid M et al,20 67.4% agreed that research should be mandatory for all and 97% of students included in another American study considered research a useful alternative to electives.21 This difference in the perception of the students may be because of difference in the study curriculum and their priorities during and after the postgraduation.
When asked about the challenges perceived during writing thesis protocol majority (61.5%) students felt that lack of mentor guidance was a challenge in conducting research followed by other causes. In contrast to our study R. Gupta et al found that the main barrier to research was lack of time in 88.3% of the students followed by extra time spent on learning the postgraduate subjects in 76.6% of students.10 Similar were the observations made in previously published studies.22,23,24 In study done by C. R. Vairamani et al also, limited time availability for doing research was mainly a matter of concern in clinical specialties.12 Another study done by Sumi et al also reported that too much of paperwork was the most frequently cited obstacle in conducting clinical research, followed by lack of time.15 However, in this study, no significant difference was found between the perspectives of post graduates of clinical and non-clinical branches regarding the perception of challenges towards pursuing research activities.
Not many researches have been done in past to assess the errors in thesis protocol and none of them on postgraduate students in medical institution. Results obtained by us revealed that the section which had majority of errors was aim and objectives. If aim, objectives and methodology is not appropriate and in accordance of research hypothesis the purpose of doing the study is not fulfilled.
Grammatical mistake including writing in past tense in thesis protocol was the commonest mistake done by the students. Taking informed consent from the participants is the essential prerequisite in the human research ethics, but Informed consent was found to be non- specific and same in the thesis protocol of most of the students.
Results of this study bring forward the problems encountered by the students in writing thesis protocols and identifies the mistakes in their protocols. Although biomedical research course has been incorporated in the post graduate curriculum but it should be done at the right time.