ISSN 1516-3180 printed version
ISSN 1806-9460 online version

INSTRUCTIONS TO AUTHORS

• Aim and editorial policy
• The manuscript and types of articles
• Format
• Documents cited

Indexing and scope

The São Paulo Medical Journal/Evidence for Health Care was founded in 1932. Its articles are indexed in Medline, Lilacs, SciELO, Science Citation Index Expanded, Journal Citation Reports/Science Edition (ISI) and EBSCO Publishing.

Published bimonthly by the Associação Paulista de Medicina, the journal accepts articles in the fields of clinical health science (internal medicine, gynecology and obstetrics, mental health, surgery, pediatrics and public health). Articles will be accepted in the form of original articles (clinical trials, cohort, case-control, prevalence, incidence, accuracy and cost-effectiveness studies and systematic reviews with or without meta-analysis), narrative reviews of the literature, case reports, short communications and letters to the editor. Papers with a commercial objective will not be accepted.

The Journal's policy and procedures

After receipt of the article by the Scientific Publications Sector, the authors will be provided with a protocol number. This number serves to maintain good understanding between the authors and the Scientific Publications Sector. Following this, the article will be read by the Editor, who will verify whether it is consonant with the journal's policy and interests, i.e. whether the research or review is within the fields of health or public health.

Next, the Scientific Publications Sector will verify whether the text complies with the journal's Instructions for Authors. If the text is incomplete or if it is not organized as required, the authors will be asked to resubmit their text after resolving such problems. When its format is acceptable, the Scientific Publications Sector will submit the manuscript to closed review, in which the reviewers will not sign their verdict and will not know the names of the authors. Each paper will be reviewed by at least three reviewers: one expert in the field, one associate editor (who will evaluate the article from the reader's perspective and one ad hoc editorial advisor (who will assess methodological aspects of the study).

The authors will then receive the reviewers' evaluation and will be asked to resolve all the problems that have been pointed out. Once the Scientific Publications Sector receives the manuscript again, the text will be sent to the scientific editor and the proofreader, who will point out problems with sentence construction, spelling, grammar, bibliographical references and other matters. The authors should then provide all further information requiredand corrections requested and should mark in the text all the points at which modifications have been made, using different colors or electronic text marking systems, so that these modifications are easy to see.

When the text is considered acceptable for publication, and only then, it will enter the queue for publication and the author will receive a letter of acceptance of the article. The Scientific Publications Sector will provide a proof, including any tables and figures, for the authors to approve. No article is published without this last procedure.

General guidelines: for all types of articles

Texts must be submitted exclusively through the internet, using the electronic submission system, which is available at http://www.spmj.hemeroteca.com.br. Submissions sent by e-mail or through the post will not be accepted.

The manuscript must be submitted in English. Nonetheless, it must also include a summary and five key words both in Portuguese and in English. The key words must be selected from the DeCS and MeSH lists only, as explained in detail below (no other key words will be accepted).

Papers submitted must be original and therefore all the authors need to declare that the text has not and will not be submitted for publication in any other journal. Papers involving human beings (individually or collectively, directly or indirectly, totally or partially, including the management of information and materials) must be accompanied by a copy of the authorization from the Research Ethics Committee of the institution in which the experiment was performed.

All articles submitted must comply with the editorial standards established in the Vancouver Convention (Uniform Requirements for Manuscripts Submitted to Biomedical Journals)¹ and the specific quality guidelines for papers reporting on clinical trials (CONSORT),² systematic reviews and meta-analyses (PRISMA),^3,4 observational studies (STROBE).^5,6 and accuracy studies on diagnostic tests (STARD).^7,8 The style known as the "Vancouver Style" is to be used not only for the format of the references, but also for the whole text. The Editors recommend that authors should familiarize themselves with this style by accessing http://www.icmje.org.

Abbreviations must not be used, even those in common use. Drugs or medications must be referred to using their generic names, avoid­ing unnecessary mention of commercial or brand names, and should be followed by the dosage and posology. Any prod­uct cited in the Methods section, such as diagnostic or therapeutic equipment, tests, reagents, instruments, utensils, prostheses, orthoses and intraopera­tive devices must be described together with the manufacturer's name and place (city and country) of manufacture in parentheses.

Grants, bursaries and any other financial support for studies must be mentioned separately after the references, in a section named "Acknowledgements", along with any other acknowledgements to individuals or professionals who have helped in producing the study but whose contribution does not constitute authorship (we recommend that the item "Authorship" at http://www.icmje.org should be read to obtain clarifications regarding the criteria for authorship).

For any type of study, all statements in the text that are not results from the study presented for publication in the São Paulo Medical Journal/Evi­dence for Health Care, but are data from other studies already published elsewhere must be accompanied by citations of the pertinent literature. Thus, statements about the incidence or prevalence of diseases, costs, frequency of use of certain therapies and epidemiological data in general should be followed by the references for the surveys that generated this information, even if the data come from government institutions or databases, given that these are data from other studies.

First page (cover page)
The first page must contain:

1) the type of paper (original article, review or updating article, short communication or letter to the editor);
2) the title of the paper in English and Portuguese (or Spanish), which must be short but informative;
3) the full name of each author (do not abbreviate), his/ her academic titles (abbreviated in English), in the order obtained (for example: "MD for medical doctor, MSc for holders of a master's title, PhD for holders of a doctorate" or "BSc for bachelor of science, such as in biology"), and the positions currently held (for example, Doctoral Stu­dent, Attending Physician, Adjunct Professor, Associate Professor, Head of Department, etc.), in the department and institution where he/she works;
4) the place where the work was developed.

Second page: abstract (English and Portuguese) and key words
The second page must include the title and an abstract (English and Portuguese, maximum of 250 words each)⁷ structured in parts in five items:

1) context and objective;
2) design (type of study) and setting (place where the study was developed);
3) methods (described in detail);
4) results; and
5) conclusions.

References

The list of references (in the "Vancouver style", as indicated by the International Committee of Medical Journal Editors, ICMJE) should be laid out in the final part of the article, after the conclusions and before the tables and figures. In the text, the references must be numbered according to the order of citation. The citation numbers must be inserted after periods/full stops or commas in sentences (see examples in the preceding section), and must be in superscripts form (without using parentheses or square brackets). References cited in the legends of tables and figures must maintain sequence with the references cited in the text.

In the list of references, all the authors must be listed if there are up to and including five authors; if there are six or more, the first three should be cited, followed by the expression "et al." For books, the city of publication and the name of the publishing house are mandatory. For books, the city of publication and the name of the publishing house are mandatory. For texts published on the internet, the complete uniform resource locator (URL) or address is necessary (not only the main home page of a website or link), so that by copying the complete address into their computer internet browsers, the journal's readers will be taken to the exact document cited, and not to a general website. The following are some examples of the most common types of references:

Article in journal
- Hurt AC, Hardie K, Wilson NJ, et al. Community transmission of oseltamivir-resistant A(H1N1)pdm09 influenza. N Engl J Med. 2011;365(26):2541-2.

Chapter of book
- Miller WI, Achernabb JC, Fluck CE. The adrenal cortex and its disorder. In: Sperling M. Pediatric endocrinology. 3rd ed. Elservier Health Sciences; 2008. p. 444-511.

Text on the internet
- Centers for Disease Control and Prevention. Children's food environment State Indicator Report, 2011. Availablbre from: http://www.cdc.gov/obesity/downloads/ChildrensFoodEnvironment.pdf. Accessed in 2012 (Mar 7).

Last page

The last page must contain:

1) the date and place of the event at which the paper was presented, if applicable, such as congresses or dissertation or thesis presentations;
2) sources of support in the forms of finance for the project, study bursaries or funding for purchasing equip­ment or drugs. The protocol number for the funding must be presented;
3) description of any conflicts of interest held by the authors. We recommend that the item "Conflicts of interest" at http://www.icmje.org should be read to obtain clarifications regarding what may or may not be considered to be a conflict of interest;
4) the complete postal address, e-mail address and telephone number of the author to be contacted in relation to the publication process in the Journal. The author should also indicate a postal address, e-mail address and telephone number that can be published together with the article.

Figures and tables

Images must have good resolution (minimum of 300 DPI) and be recorded in ".jpg" or ".tif" format. Do not attach images inside Microsoft PowerPoint documents. If photographs are inserted in a Microsoft Word file, the images should also be sent separately. Graphs must be prepared in Microsoft Excel (do not send them in image formats) and must be accompanied by the tables of data from which they have been generated. The number of illustrations must not exceed the total number of pages minus one.

All figures and tables must contain legends or titles that precisely describe their content and the context or sample from which the information was obtained (i.e. what the results presented are and what the kind of sample or setting was). The legend or title sentence should be short but comprehensible without depending on reading the article.

All the figures and tables should be cited in the text.

São Paulo Medical Journal/Evidence for Health Care is for now published in black-and-white in its printed version. Photographs, photomicrographs, bar and line graphs and any image to be published must be prepared considering that there will be no color differentiation (any color information will be discarded). Shades of gray and printing patterns (dots, stripes and others) should be used instead, with good contrast.

Original articles

Clinical trial, cohort, case-control, prevalence, incidence, accuracy and cost-effectiveness studies, and systematic reviews with or without meta-analysis, are considered to original articles.

The São Paulo Medical Journal/Evidence for Health Care supports the clinical trial registration policies of the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) and recognizes the importance of these initiatives for registra­tion and international dissemination of information on randomized clin­ical trials, with open access. Thus, from 2008 onwards, manuscripts on clinical trials are accepted for publication only if they have received an identifi­cation number from one of the clinical trial registers that have been vali­dated in accordance with the criteria established by WHO and ICMJE. Authors of randomized clinical trials must thus register their studies before submitting them for publication in the São Paulo Medical Journal/Evi­dence for Health Care. The addresses for these registers are available from the ICMJE website (http://www.icmje.org/). The identification number should be declared at the end of the abstract.

Authors will be required to comply with the guidelines for writing each type of original article, as follows:

1. Observational articles: STROBE Statement;^5,6
2. Clinical trials: CONSORT Statement;²
3. Accuracy studies on diagnostic tests: STARD Statement;^7,8
4. Systematic reviews of the literature and meta-analyses: PRISMA⁴

The São Paulo Medical Journal takes the view that these guidelines not only aid in writing and organizing the content of articles in a standardized manner, thereby improving their quality and facilitating reading and assessment, but also these guidelines help to avoid situations in which important information on the methodology of studies remains outside of the manuscript.

As a partner institution of the Cochrane Collaboration and the Brazilian Cochrane Center, the Associação Paulista de Medicina considers that production of articles in accordance with these guidelines also aids in future production of systematic reviews of the literature and meta-analyses. Thus, articles submitted for publication that are not in accordance with these norms may be returned to their authors for readjustment before the peer review process begins.

Original articles must be structured so as to contain the following parts: Introduction, Objective, Methods, Results, Discussion and Conclu­sion. The text must not exceed 5,000 words (excluding tables, figures and references), from the introduction to the end of the conclusion, and must include a structured abstract with a maximum of 250 words.⁹ "Structured abstract" means that the abstract must contain the following items: Con­text and objective, Design and setting, Method, Results and Conclusion.

The structure of the document should follow the format laid out below:

1) Title and abstract: the study design and/or the way participants were allocated to interventions, for example "randomized" or "retrospective" study, should be mentioned in the title and in the abstract. The abstract should provide a summary of what was done and what was found.

2) Introduction: specify the reasons for carrying out the study, describing the present state of knowledge of the topic. Describe the scien­tific background and "the state of the art". Do not include here any results or conclusions from the study. Use the last paragraph to specify the prin­cipal question of the study, and the principal hypothesis tested, if there is one. Do not include discussions about the literature in the introduction; the introduction section should be short.

3) Objective: describe briefly what the main objective or question of the study was. Clearly describe the pre-specified hypotheses.

4) Methods

4.1) Type of study: describe the design of the study and specify, if appropriate, the type of randomization (the way in which draws were conducted), the blinding (how this was ensured), the diagnostic test standards (gold standard or range of normal values) and the time direction (retrospective or prospective). For example: "ran­domized clinical trial", "double-blind placebo-controlled clinical trial, "cross-sectional accu­racy study" ", "retrospective cohort study", "cross-sectional prevalence study" or "systematic review of clinical trials".

4.2) Sample, participants or patients: describe the eligibility criteria for participants (inclusion and exclusion criteria) and the sources and procedures for selection or recruitment. In case-control studies, describe the rationale for distributing the subjects as cases and controls, and the matching criteria. The numbers of patients at the beginning and end of the study (after exclusions) must be made clear. A flow diagram showing the initial recruitment, the exclusions and the final sample of patients included should be produced and inserted in the article.

4.3) Setting: indicate the place where the study was carried out, including the type of healthcare provide (i.e. whether primary or tertiary; and whether in a private or in a public hospital). Avoid stating the name of the institution where the study was developed (for blinding purposes in the peer review). Only the type of institution should be made clear, for example: "public university hospital" or "private clinic".

4.4) Procedures (intervention, diagnostic test or exposure): describe the principal characteristics of any intervention, including the method, the timing and the duration of its administration or of data col­lection. Describe the differences in interventions administered to each group (if the study is controlled). Detail the procedures in such a way that other researchers will be able to repeat them in other localities.

4.5) Main measurements, variables and outcome: state what the primary and secondary outcomes analyzed in the study are. Describe the method of measuring the primary result, in the way in which it was planned before data collection. For each variable of interest, detail the assessment methods. If the hypothesis of the study was formulated during or after data collection (and not before), this needs to be declared. Describe the methods used to enhance the quality of measurements (for example, multiple observers, training, etc.) and to avoid bias. Explain how quantitative variables were handled in the analyses.

4.6) Sample size and statistical analysis: describe the sample size cal­culation method, or the study period in the event that patients were consecutively admitted over a period. Readers need to understand why a given number of patients was used. The planned statistical analysis, the statistical tests used and their significance levels, along with any post hoc analyses, should be presented in this section. Describe the methods used to control for confounding factors and variables, and explain how missing data and cases lost from the follow-up were dealt with.

4.7) Randomization: describe the method used to implement the ran­dom allocation sequence (for example, sealed envelopes containing random sequences of numbers or software for generating random numbers). If appropriate, report that the study used "quasi-randomization".¹² In addition, describe who generated the random sequence, who assigned the participants to each group (in the case of controlled trials) and who recruited the participants.

5) Results: describe the main findings. If possible, these should be accompanied by their 95% confidence intervals and the exact level of sta­tistical significance (it is not enough to write "P < 0.05": the exact P value should be supplied). For comparative studies, the confidence interval must be stated for the differences between the groups.

5.1) Participant flow diagram: describe the flow of participants through each stage of the study (inclusions and exclusions) and the follow-up period and the number of participants completing the study (or lost from the fol­low-up). Use a flow diagram to demonstrate the numbers of patients, from the initial recruitment to the end of the study, and the reasons for exclusions. If there was any "intention-to-treat" analysis, describe it.

5.2) Deviations: if there was any deviation from the protocol, away from what was initially planned, describe it and the reasons for it.

5.3) Adverse events: describe any side effect, adverse event or complication.

6) Discussion: provide an interpretation of the results, taking into account the study hypotheses and conclusions. Emphasize the new and important factors encountered in the study, which will form part of the conclusion. Do not repeat data presented in the introduction or results in detail. Mention any limitations of the findings that should be noted and any possible implications for future research. Describe any potential bias. Report any relevant findings from other studies: it is important to review the recent literature to seek new evidence that may have been published, which needs to be discussed. State whether the findings can be generalized to populations (i.e. whether the findings have external validity). It is recommended that the last two paragraphs should contain implications for practice and for further research.

7) Conclusions: specify only the conclusions that can be sustained by the results, together with their clinical significance (avoiding excessive generalization). Draw conclusions based on the objectives and hypotheses of the study. The same emphasis should be placed on studies with positive and negative results.

Systematic reviews with or without meta-analyses should comply with the same publication norms established for original articles, and be produced in accordance with PRISMA⁴ and the Cochrane Collaboration's systematic review Handbook.¹³ The text should not exceed 5,000 words (excluding tables, figures and references).

Short communications, case reports or case series

Short communications and case reports must be limited to 3,000 words (from the introduction to the end of the conclusion). Short communications are reports on the results from ongoing studies or studies that have recently been concluded for which urgent publication is important. They should be structured thus: Introduction, Objective, Methods, Results, Dis­cussion and Conclusion, like in original articles. Individual case reports should contain: Introduction, Case Report, Discussion and Conclusion. Reports on case series constitute observational studies and these should be structured in accordance with the norms of the STROBE Statement.⁵

Both short communications and case reports must be submitted with abstracts and key words. The abstracts in short communications should be structured with Context and Objective, Design and Setting, Meth­ods, Results, Discussion and Conclusion, as for original articles. The abstracts in case reports and case series should contain Context and Case Report (with a description of the case and a pertinent discussion) and Conclusion.

The São Paulo Medical Journal/Evidence for Health Care is interested in publishing rare or instructive case reports, accompanied by a systematic search of the litera­ture, in which relevant studies found (based on their level of evidence) are presented and discussed.¹⁴ The results from the systematic search of the main databases - Medline (via PubMed), Embase, Lilacs and Cochrane Library - should be presented in a table with the search strategy for each database and the number of articles obtained.

Narrative review

Narrative reviews may be accepted by the São Paulo Medical Journal/Evidence for Health Care and should be structured with: Introduction, Objectives, Methods, Results, Discussion and Conclusions. The abstract must be structured with: Context and objective, Design and setting, Methods, Results and Conclusions, like in original articles. The manuscript must comply with the norms of the Vancouver style¹ and must include a systematic search in the main databases: Medline , Embase, Lilacs and Cochrane Library. The search strategy for each data­base and the number of articles obtained from each database should be presented in a table. The access route to the electronic databases used should be stated (for example, PubMed, OVID, Elsevier or Bireme). For the search strategies, MeSH terms must be use for Medline, LILACS and Cochrane Library. DeCS terms must be used for LILACS. EMTREE terms must be used for Embase. Also, for LILACS, search strategy must be performed, at the same time, with English (MeSH), Spanish (DeCS) and Portuguese (DeCS) terms. The search strategies must be presented exactly as they were used during the search, including parentheses, quotation marks and Boolean operators (AND, OR, AND NOT).

Letters to the editor

Letters to the editor may address articles published in the São Paulo Medical Journal/Evidence for Health Care publication or may deal with health issues of interest. Case reports must not be submitted as letters. In the category of letters to the editor, the text has a free format, but must not exceed 500 words and five references.

1. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals writ­ing and editing for biomedical publications. Available from: http://www.icmje.org. Accessed in 2012 (Aug 6).

2. The CONSORT statement. Available from: http://www.consort-statement.org/consort-statement/. Accessed in 2012 (Aug 6).

3. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised con­trolled trials: the QUOROM statement. Lancet. 1999;354(9193):1896- 900. Available from: http://www.thelancet.com/journals/lancet/article/PIIS0140673699041495/abstract. Accessed in 2012 (Aug 6).

4. PRISMA. Transparent Reporting of Systematic Reviews and Meta-Analyses. Available from: http://www.prisma-statement.org/index.htm. Accessed in 2012 (Aug 6).

5. STROBE Statement. Strengthening the reporting of observational studies in epidemiology. What is STROBE? Avaliable from: http://www.strobe-statement.org. Accessed in 2012 (Aug 6).

6. von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344-9.

7. STARD Statement. STAndards for the Reporting of Diagnostic accuracy studies. Available from: http://www.stard-statement.org/. Accessed in 2012 (Aug 6).

8. Rennie D. Improving reports of studies of diagnostic tests: the STARD initiative. JAMA. 2003;289(1):89-90.

9. Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990;113(1):69-76.

10. National Library of Medicine. Medical Subject Headings: annotated alphabetic list. Bethesda: NLM; 1998. Available from: http://www.ncbi.nlm. nih.gov:80/entrez/query.fcgi?db=mesh. Accessed in 2012 (Aug 6).

11. BVS Biblioteca Virtual em Saúde. Descritores em Ciências da Saúde. Available from: http://decs.bvs.br/. Accessed in 2012 (Aug 6).

12. Reeves BC, Deeks JJ, Higgins JPT, Wells GA. Including non-randomized studies. In: Cochrane Non-Randomised Studies Methods Group. The Cochrane Book Series. England: John Wiley & Sons; 2008. Available from: http://hiv.cochrane.org/sites/hiv.cochrane.org/files/uploads/Ch13_NRS.pdf. Accessed in 2012 (Aug 6).

13. The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions. Available from: http://www.cochrane.org/training/cochrane-handbook/. Accessed in 2012 (Aug 6).

14. Phillips B, Ball C, Sackett D, et al. Oxford Centre for Evidence- Based Medicine Levels of Evidence (May 2001). Available from: http://www.cebm.net/index.aspx?o=1047. Accessed in 2012 (Aug 6).