Short guide for students, how to develop a Study:

Short guide for students, how to develop a Study

During the clinical rotations, you are expected to finalize your research study and develop a complete dissertation and a one or maximum two page thesis. In this section we try to assist your work by giving you some practical advice on how to do this task.

At the end of the clinical rotation course, students have to submit a dissertation and thesises. We understand that most of our students are experiencing their first step in independent study planning and implementation, and they may have little experience in scientific publication, or in dissertation preparing procedures.

Most medical universities do not provide education on how to prepare a scientific paper. USAIM is in a good position because you have worked before on your other projects, and our Syllabus also provides help to understand the general requirements of study design, management and requirements about medical publications. Still, for the novices it can be a painstaking process with a lot of frustration to learn the methodology to design and perform scientific research and prepare a manuscript for publication readiness. It is hard to find really unselfish peer or senior mentor assistance.

On the other hand, international criteria and agreements exist on how to present your results. We expect our students to follow these formal requirements. For the formal expectation for your dissertation here we are featuring the digested and short version of the expectations of the JAMA and the British Medical Journal. This description might be “high flying” for requirements for medical students, but we expect you to follow the general aspects of a publication, especially the IMRAD structure, with a correctly chosen title, perfect abstract and most importantly, with genuine authorship. Please note that plagiarism is not tolerated and you might risk your right to graduation.

American English is slightly different than British English, for example in punctuation and transcription of Latin terminology. Both languages can be rightly chosen, but once a decision has been made you should consistently use the chosen way for grammar.

You might get further help if you consult with the web page either of the JAMA or the BMJ in any case of doubt or uncertainty. We also strongly recommend consulting with handbooks if needed, and following the methodology of the evidence-based medicine. Please ensure that anything you submit conforms to the uniform requirements for manuscripts submitted to publication in biomedical literature. 

Uniform requirements for manuscripts submitted to biomedical journals are also published in:

International Committee of Medical Journal Editors. Med Educ. 1999; 33(1):66-78
or: http://www.icmje.org/index.html

(Please note that the enclosed material is only referring to the uniform requirement for manuscripts and is edited for simplicity. This document cannot include a comprehensive review of the scientific publication requirements.)

Formulation of Thesis:

The thesis should cover what your paper adds to the literature, and is for readers who would like an overview without reading the whole dissertation paper. It should be divided into two short paragraphs:

Paragraph 1:  What is already known on this subject?

In two or three sentences explain what the state of scientific knowledge was in this area before you did your study and why this study needed to be done. Be clear and specific, not vague. For example you might say: “Numerous observational studies have suggested that tea drinking may be effective in treating depression, but until now evidence from randomised controlled trials has been lacking; the only randomized controlled trial to date was underpowered and was carried out in an unusual population, did not use internationally accepted outcome measures and used too low a dose of tea.”
or: “Evidence from trials of tea therapy in depression have given conflicting results. Although Sjogren and Smith conducted a systematic review in 1995, a further 15 trials have been carried out since then…”

Paragraph 2:  What does this study add?

Give a simple answer to the question “What do we now know as a result of this study that we did not know before?” For example, “This randomized study suggests that tea drinking has no overall benefit in depression”.  Be brief, succinct, specific, and accurate.

You might use the last sentence to summarize any implications for practice, research, policy, or public health. For example, your study might have asked and answered a new question (one whose relevance has only recently become clear), contradicted a belief, dogma, or previous evidence, provided a new perspective on something that is already known in general, or provided evidence of higher methodological quality for a message which is already known.

Please define the clinical question in four aspects: patient, intervention, comparison, and outcome.

The thesises should show that you have searched for, cited, and summarized studies of appropriate relevance, design, and quality, and should state which bibliographic databases you have used. 

Authorship

The uniform requirements for manuscripts submitted state that authorship credit should be based only on substantial contribution to conception and design, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content on final approval of the version to be published.  And this can be only you.

All these conditions must be met. Participation solely in the acquisition of funding or the collection of data does not justify authorship. 

We want authors to assure us that they fulfill the criteria of authorship. In addition we want assurance that there is no one else who fulfils the criteria but has not been included as an author.

The Research and Its Presentation in the Dissertation:  ‘IMRaD’

The dissertation should report original research relevant to clinical medicine. They should follow the IMRAD style (Introduction, Methods, Results and Discussion) and should have a structured abstract.

If you are submitting a randomised controlled trial, please follow the CONSORT guidelines (http://www.consort-statement.org). If you are submitting a systematic review, please follow the QUOROM guidelines (David Moher et al for the QUOROM Group. Lancet 1999;354:1896-1900). And if you are submitting a study of diagnostic accuracy please follow the STARD guidelines (http://www.consort-statement.org/stardstatement.htm ).

We know that people do not read long papers unless they are very interested in the subject. So please try to make your paper concise, and make every word count. Think hard about what really needs to be in the paper to get your message across, and what can be left out.

Please provide all following dissertation items with your paper:

Title page

This should give the title of the paper, including the study design if the paper presents original research.

Structured abstract

No more than 250 words with the following headings and information: 

Objectives - a clear statement of the main aim of the study and the major hypothesis tested or research question posed. 

Design - including factors such as prospective, randomization, blinding, placebo control, case control, crossover, criterion standards for diagnostic tests, etc. 

Setting - include the level of care, e.g. primary, secondary, and the number of participating centers 

Use “Participants” instead of “patients” or “subjects”. Who, how selected, what entry and exclusion criteria used, how many entering and completing the study. Detail the interventions - what, how, for how long, etc. Detail main outcome measures - those planned in protocol, those finally measured (if different, explain why). 

Results - main results with (for quantitative studies) 95% confidence intervals and, where appropriate, the exact level of statistical significance. 

Conclusions - primary conclusions and their implications, and suggest areas for further research if appropriate. 

See: Haines RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med 1990;113:69-76

Qualitative research papers may need fewer headings in the structured abstract. Quality improvement reports have their own style of structured abstract.

The structured abstract for a systematic review or meta-analysis should have these sections: objectives, data sources, review methods, results, and conclusions.

Structured Discussion

We encourage, but do not require authors to write the discussion sections of original research papers in a structured way in order to minimize the risk of careful explanation giving way to polemic. We suggest that the discussion follows this structure:

a.       Statement of principal findings.

b.      Strengths and weaknesses of the study.

c.       Strengths and weaknesses in relation to other studies, discussing important differences in results.

d.      Meaning of the study: possible explanations and implications for clinicians and policymakers.

e.       Unanswered questions and future research..

Please also include: 

a.       Original data if you think they will help our reviewers.

b.      Copies of any non-standard questionnaires and assessment schedules used in the research. 

c.       Copies of patient information sheets used to obtain informed consent. 

d.      Details of sources of funding for the research, if any. (These are now published with all papers.) 

e.       Copies of related papers you have published. This is particularly important where details of the study methods are published elsewhere. 

Stylistic Advice     

 

Please write in a clear, direct, and active style. Many readers do not have English as their first language. 

Preferred dictionaries are:

Chambers 21st Century Dictionary for general usage

“Dorlands” for medical terms. 

Punctuation:

No full stops in initials or abbreviations. 

Minimal commas, but use commas before the "and" and "or" in lists: 

The bishops of Durham, Canterbury, Bath and Wells, and York were invited.

Use commas on both sides of parenthetical clauses or phrases, and with commenting clauses. 

Know the difference between defining clauses (no comma) and commenting clauses (commas needed):

Medical staff who often work overtime are likely to suffer from stress. 

Medical staff, who often work overtime, are likely to suffer from stress. 

Use commas before "and," "or," "but" in two-sentence sentences (when the coordinate conjunction joins two main clauses): 

Instead: Half received drug treatment, but their symptoms did not resolve more quickly. 

Half of the patient received drug treatment, but their symptoms did not resolve more quickly

Note that when a comma is used, both main clauses must have a subject:

Instead: The patients stopped smoking, and they felt better for it. 

The patients stopped smoking and felt better for it. 

Minimal hyphenation - use hyphens only for words with non-, -like, -type, and for adjectival phrases that include a preposition (one-off event, run-in trial). Not using hyphens will help you to avoid noun clusters

Quotation marks - please use double, not single, inverted commas for reported speech. Full stops and commas go inside quotation marks: 

She said, "We will." 

No exclamation marks, except in quotes from other sources. 

Reference numbers go after commas and full stops, before semicolons and colons. 

Minimal capitalization: use capitals only for names and proper nouns. Don't capitalize names of studies. 

Grammar

Published result present tense

Your results: simple past tense

Write in the active and use the first person where necessary. 

Try to avoid long sentences that have several embedded clauses. 

Gender: avoid "he" as a general pronoun. Make the nouns (and pronouns) plural, then use "they"; if that's not possible, use "he or she". 

Nouns and verbs should agree: 

The data are; None is... 

Organizations and groups of people take singular verbs: 

The government is; The team has researched...

Avoid noun clusters: 

"Patient in coronary care unit" rather than "coronary care unit patient." 

Watch out for "danglers" (unattached participles and misrelated clauses): 

Joining the service in 1933, his first post was... (the post didn't join the service) 

Joining the service in 1933, he was first posted to... (this is correct) 

Spelling

Decide American or English:  e.g. if your choice is BMJ recommended English or JAMA spelling, the followings should be considered:

aetiology                      etiology

oestradiol                     estradiol

anaemia                       anemia

haemorrhage                hemorrhage

practice (noun)

practise (verb)

Foetus and fetus are both acceptable in English, but “fetus” in JAMA spelling and the BMJ uses fetus too.  If British (BMJ style): use s-spellings:  minimise, organization, capitalization. Use English spellings for place names: Lyons, not Lyon; (see Whitaker's Almanac or Times Gazeteer) 

Abbreviations:

We allow minimum use of abbreviations because they ae hard to read and often the same abbreviation means different things in different specialities and contexts.

TechnicalTerms

Drugs should be referred to by their approved non-proprietary names, and the source of any new or experimental preparations should be given. 

Scientific measurements should be given in SI units, except for blood pressure, which should be expressed in mm Hg. 

Numbers under 10 are spelt out, except for measurements with a unit (8mmol/l) or age (6 weeks old), or when in a list with other numbers (14 dogs, 12 cats, 9 gerbils). 

Raw numbers should be given alongside percentages, and as supporting data for p values. 

References 

These should be numbered in the order in which they appear in the text. At the end of the article the full list of references should follow the Vancouver style.

Ref: “Uniform requirements for manuscripts submitted to biomedical journals” or: International Committee of Medical Journal Editors. Med Educ. 1999; 33(1):66-78

Please give the names and initials of all authors (unless there are more than six, when only the first three should be given followed by et al). 

Usual way of citations is that the authors' names are followed by the title of the article; the title of the journal abbreviated according to the style of Index Medicus; the year of publication; the volume number; and the first and last page numbers. 

References to books should give the names of any editors, place of publication, editor, and year.

Examples: 

21 Soter A, Wasserman S I, Austen K F. Cold urticaria: release into the circulation of histamine and eosinophil chemotactic factor of anaphylaxis during cold challenge. N Engl J Med 1976;294:687-90 

22 Osler AG. Complement: mechanisms and functions. Englewood Cliffs: Prentice-Hall, 1976.

Information from manuscripts not yet in press, papers reported at meetings, or personal communications should be cited only in the text, not as a formal reference.

Authors should get permission from the source to cite personal communications. 

Authors must verify references against the original documents before submitting the article.

Electronic citations

You may know of other websites that will interest people reading your article. If you know the web addresses (URLs) of those sites, please include them in the relevant places in the text of your article.

Tables, Illustrations and Photographs

Tables should be simple and should not duplicate information in the text of the paper. Illustrations should be used only when data cannot be expressed clearly in any other way. When graphs, scattergrams, or histograms are submitted, the numerical data on which they are based should be supplied; in general, data given in histograms will be converted into tabular form. 

Statistical Methods

Please define the methods and support them with references, describing in detail any that are not in common use. Consult with general guidelines on using statistical methods and interpreting and presenting statistical material, as well as specific recommendations on statistical estimation and significance.  

Also see: Altman DG, Machin D, Bryant TN, Gardner MJ (eds). Statistic with confidence 2nd edition. London: BMJ Books, 2000.

Randomised Controlled Trials

Please report these in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement.  This ensures that you provide enough information for editors, peer reviewers, and readers to see how the trial was performed and to judge whether the findings are likely to be reliable. 

Please provide the following, as described in the CONSORT statement: 

Five extra subheaded sections in the main text of the paper: protocol, assignment, masking, participant flow and follow up, analysis. 

A flow chart showing the progress of participants through the trial 

Systematic reviews and meta-analyses of randomised controlled trials

Please report these in accordance with the QUOROM (Quality of Reporting of Meta-analyses) statement (Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, for the QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Lancet 1999; 354:1896-1900. www.thelancet.com )

The structured abstract should have these sections: objectives, data sources, review methods, results, and conclusions.

Qualitative research

These reports may be difficult to fit into the IMRAD (Introduction, Methods, Results and Discussion) format for original research papers. You may find that presenting the results and discussion together, theme by theme, makes most sense: this is fine, but please ensure that the structured abstract matches the layout of the text.

Economic Evaluations

If you submit a paper reporting an economic evaluation please ensure that it follows the guidelines. These are: study design, data collection, analysis and interpretation of results.

Evaluating Educational Interventions

Many readers may not be familiar with methodologies used to evaluate educational interventions.
Two crucial factors in good studies are: 1./ the educational rationale behind the intervention is made explicit 2./ that the evaluation is planned in advance.